Express Pharma (Vol.15, No.2) November 16-30, 2019

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VOL. 15 NO. 2 PAGES 166

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www.expresspharmaonline.com This Issue is Brought to you by

16-30 NOVEMBER 2019, ` 40

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CONTENTS

Chairman of the Board Viveck Goenka

HYDERABAD PHARMA SUMMIT’19 IN IMAGES

Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty Editor Viveka Roychowdhury* BUREAUS Mumbai Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Prabhat Prakash, Tarannum Rana New Delhi Akanki Sharma Bengaluru Usha Sharma DESIGN Asst. Art Director Pravin Temble

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Chief Designer Prasad Tate Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar

THE VARIOUS FACETS OF DRUG CDSCO'S DIGITAL MOVE: THE WAY FORWARD? DISSOLUTION

Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet )

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Photo Editor Sandeep Patil Marketing Team Rajesh Bhatkal, Ambuj Kumar Debnarayan Dutta Ajanta Sengupta E Mujahid, Nirav Mistry Ashish Rampure

TAKEDA PHARMA PUBLISHES DENGUE VACCINE STUDY RESULTS

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PRODUCTION General Manager BR Tipnis

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Production Co-ordinator Dhananjay Nidre Scheduling & Coordination Arvind Mane CIRCULATION Circulation Team Mohan Varadkar

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Express Pharma® Regd. With RNI No.MAHENG/2005/21398. Postal Regd.No.MCS/164/2019-21. Printed and Published by Vaidehi Thakar on behalf of The Indian Express (P) Limited and Printed at The Indian Express Press, Plot No.EL-208, TTC Industrial Area, Mahape, Navi Mumbai-400710 and Published at Express Towers, Nariman Point, Mumbai 400021. Editor: Viveka Roychowdhury.* (Editorial & Administrative Offices: Express Towers, 1st floor, Nariman Point, Mumbai 400021) * Responsible for selection of news under the PRB Act. Copyright © 2017. The Indian Express (P) Ltd. All rights reserved throughout the world. Reproduction in any manner, electronic or otherwise, in whole or in part, without prior written permission is prohibited.

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November 16-30, 2019

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EDITOR’S NOTE

Lupin sells stakes in Kyowa but its not a Sayonara

L

upin’s recent move to sell stakes in its Japanese subsidiary Kyowa, while continuing its engagement with the company’s new owner (PE firm Unison Capital Partners), could signal a growing pragmatism among pharma promoters in India.

The promoters are positioning the stake sale as a partnership with the PE firm, like handing the baton to the next player in a relay race. As Vinita Gupta, CEO, Lupin commented, “We are very pleased to partner with Unison, a leading healthcare focussed private equity player.”

Japan’s pharma market has evolved a lot in the past 12 years since Lupin bought majority stakes in Kyowa in 2007. With an ageing population, the Japanese government warmed up to generics and companies like Lupin seized the opportunity to set up base. “Lupin grew the Kyowa business multi-fold in the last 12 years to emerge as the fifth largest generic company in Japan,” pointed out Nilesh Gupta, MD, Lupin.

But profit margins in the Japan pharma market were eroding, thanks to rising regulatory norms and pressure from the Japanese government.

However, the stake sale is definitely not Sayonara for Lupin. As Nilesh Gupta put it, “We believe that the partnership with Unison will enable Kyowa to leverage its strong platform and human capital to achieve its full potential. We remain committed to advancing our complex generics, biosimilars and specialty portfolio globally, including Japan.”

This deal looks like a win-win for all partners. Lupin gets to erase a large part of its debt while Unison gets control of the 5th largest generic company in the Japanese pharma market.

The transaction values Kyowa at an enterprise value of JPY 57,361 million (approximately Rs 37,024 million) and will generate post tax net cash inflow of approximately JPY 32,596 million (approximately Rs 21,039 million). This cash inflow will reduce Lupin’s net debt from Rs 43,618 million as on September 30, 2019 to Rs 11,290 million. Lupin’s net debt to equity ratio will improve to 0.08 as compared to 0.32 as on September 30, 2019.

Lupin has been hit by recurring regulatory red flags from the US FDA. Remediation work and facility re-inspections have kept valuations lower than expected in 2QFY20 to the delays of potential approvals.

The flip side to the deal is that Lupin will lose revenues from the divested business, which were JPY 14,241 million in H1, FY 2020 (JPY 28,335 million in FY 2019). Lupin’s global business will be impacted to the tune of around 13 per cent according to analysts.

Unison is a leader in healthcare investments, with an emphasis on investments in the pharma sector and there are hints of a longer-term engagement. As Tatsuya Hayashi, Founding Partner, Unison said, “We also look forward to supporting Kyowa’s partnership with Lupin and exploring opportunities for Unison to collaborate further in the healthcare sector with Lupin

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November 16-30, 2019

With headwinds in overseas markets, it is vital for pharma companies in India to grow their presence in the domestic market. But here too the going will be slow and tough

and its unparalleled global network in the healthcare industry.”

With Unison’s experience in the Japan market, the PE firm is ideally placed to steer Kyowa’s strategy in tune with Japanese regulations.

With such headwinds in overseas markets, it is vital for pharma companies in India to grow their presence in the domestic market. But here too, the going will be slow and tough.

Market research firm AIOCD AWACS’ data on medicine sales for October was not very encouraging for the sector. Patients can however take comfort that purchases of medicines across the country showed a decline, a sign perhaps that monsoon ailments are on the way out.

A certain amount of moderation was expected as the prolonged monsoon, which pushed up sales in the previous two months, finally receded. But the quantum of de-growth took most industry stakeholders by surprise.

October’s growth of 5.1 per cent against the previous year-same month’s growth of 12.5 per cent thus ends the slight upward trend of the last couple of months. Sales of medicines across categories in the country showed a de-growth from the previous two months. September had a growth of 11.9 per cent where as August clocked a growth of 9.5 per cent.

Volume growth in October was negative (-2.7 per cent), compared to 3.5 per cent in the previous month and 4.4 per cent as of October 2018. This volume growth is also quite lower than the rolling average of 12 month volume growth of 1.5 per cent.

This is disappointing news for some exportoriented companies, which had started to re-look strategies for the domestic market as exports to and revenues from key markets became challenging.

According to the Directorate General of Commercial Intelligence and Statistics (DGCIS), Government of India’s total pharma exports in FY-2018-19 were $ 19134 million, with the lion’s share of exports to the US ($ 6145.67 million).

While total pharma exports increased 10.72 per cent, exports to the US, India’s top pharma export destination, increased by almost 15 per cent in FY 2018-19. Other top pharma export markets show good growth potential, but the base is much lower. For instance, India’s pharma exports to UK, the second largest export market, is way behind the US at $ 630.17 million in FY 2018-19, with similar growth of 13.21 per cent over last year.

Industry stakeholders are taking solace from a forecast from the Pharmaceuticals Export Promotion Council of India (Pharmexcil) that the pharma exports from the country are likely to touch $22 billion in FY2019-20, which would be a growth of over 14.5 per cent. Let’s hope for a positive update on this front soon.

VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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India Pharma Inc needs to build a more efficient and innovation-centric ecosystem which is aligned with global trends and requirements

By Lakshmipriya Nair

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I

t is all about ‘smart ecosystems’ these days. Most conversations in every industry revolve around creating one and sustaining it to leapfrog progress.

But, how should the pharma industry go about doing it?

Well, the answer to this question lies in our understanding of the word ‘smart’. In this era of digitalisation, people often associate it with the deployment of ICT technologies that enable various elements in any given environment to integrate and interact to improve productivity and efficiency. Yet many, including us at Express Pharma, believe that a ‘smart ecosystem’ involves not just technology but also people, their strategies and collaborations.

As Tom Malone, American organisational theorist, management consultant, and Professor of Management at MIT Sloan School of Management highlights, “A lot of the most important innovations in the next couple of decades will not be innovations in technology itself but innovations in how people work together.”

Therefore, in our recently organised Hyderabad Pharma Summit, we chose the theme, ‘Co-creating a smart ecosystem for pharma’, with a focus on this larger definition. And, as Express Pharma continued with its quest to enable accelerated growth in India Pharma Inc by optimising the immense potential in various pharma hubs across the country, this thought-leadership platform in Hyderabad brought regulators, industry stalwarts and gamechangers together to deliberate on the creation of a ecosystem which would be aligned with and responsive to global trends and requirements.

In this article, we share some of our key learnings from the event: Constructive engagement between regulators and industry is vital — In a complex stakeholder environment like the pharma sector, only an effective relationship between regulators and industry can help to serve the interests of all

26 EXPRESS PHARMA November 16-30, 2019

and usher excellence. This message was clearly reiterated as Annam Visala, Deputy Drugs Controller India, Hyderabad Zonal Office CDSCO, the keynote speaker gave a detailed overview of the various endeavours by the regulatory body for the advancement of India’s pharma sector such as measures to make the country a

countability and the credibility of India Pharma Inc, their effective implementation would be largely dependent on open communication and constant dialogue between industry and the regulatory authorities.

Now, more than ever, mutual trust and understanding between regulatory authorities and industry are critical.

prove to provide significant benefits such as market growth, better product approval processes, and development of new and innovative therapies.

A growth mindset is key to succeed in the digital age — One of our eminent speakers, Chakravarthi AVPS, Global

Apart from chalking of a road map for the industry, we should look at harnessing the ecosystem we have in India right now. All of us have to bank of each other’s skills to move forward Annam Visala Deputy Drugs Controller India, Hyderabad Zonal Office CDSCO

By 2030, healthcare will become completely patient-driven with an emphasis on preventive healthcare. In this era, data and digital solutions will be key to this sector

pharmacogenetics, evolving regulations will be crucial factors while India Pharma Inc strategises to conquer new frontiers and establish its dominance in untapped markets.

And, our most important insight from his interesting session was that as the dynamics of the pharma industry change, organisations and their workforce will have to adopt a growth mindset culture to stay relevant and gain success. Profitability and competitiveness in global markets will be dependent on the ability to take the major shifts caused by technological advancements into account and build a culture that is agile, encourages transparency, promotes data-driven decision-making, as well as make room for experimentation and hyper-learning.

Only by designing more effective strategies and embracing a culture of constant learning will it be possible to differentiate in a crowded mar-

Chakravarthi AVPS Global Ambassador, World Packaging Organisation

India’s pharma industry has a unique chance to revive its API industry with proficiency in continuous flow synthesis or flow chemistry. It needs to build and strengthen its capabilities to maintain its current market share and grow Srinivas Lanka Mentor, Pharmaceuticals, Biotechnology, Ayurveda & Health Technologies, ElixGlobal and Consultant - Pharmexcil

hub for R&D. She also spoke at length on the need for these steps and how they can raise the reputation of India Pharma Inc globally.

But, our key learning from the session was that while these measures can definitely increase transparency, ac-

Therefore, regulators must comprehend business operations and risks in a better manner and the industry must appreciate regulatory and policy objectives better. Only then will the fragile and often contentious relationship between industry and regulators im-

Ambassador, World Packaging Organisation, highlighted that the pharma industry should get ready to be disrupted at a level unseen due to technological advancements. He also informed that patient empowerment, technological disruptions with AI, new therapeutic areas like

ketplace, optimise growth potential and emerge as a frontrunner in this era of digitalisation.

Skill building is an urgent need — Hyderabad Pharma Summit also addressed a topic that has a lot of bearing on India Pharma Inc’s progress – reducing its dependence on API imports.

Srinivas Lanka, Mentor, Pharmaceuticals, Biotechnology, Ayurveda & Health Technologies, ElixGlobal and Consultant - Pharmexcil took the stage to talk on this topic and informed that the imports have almost doubled in four years.

He also suggested remedial measures to tackle our dispro-

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CPHI & P-MEC INDIA 2019 SPECIAL

portionate dependency on API imports and underlined to the audience that India’s pharma industry has a unique chance to revive its API industry with proficiency in continuous flow synthesis or flow chemistry.

The cost disadvantage in large volume products due to large reactor capacity of China, could be overcome through continuous flow synthesis efficiency.

So, the most significant takeaway from this session was that we need to urgently invest in skilling to deal with the shortage of skilled manpower which is hindering the growth of the industry. He pointed out that creating a workforce that is skilled in specialised areas like fermentation, flow chemistry, asymmetric synthesis, catalysis, biocatalysts, formulations — drug delivery systems, fluorination chemistry, vapour phase technologies, and biologics will enable India to build and strengthen its capabilities as well as maintain our current market share and grow.

Thus, developing and implementing skill development and training programmes effectively will facilitate the pharma industry to enhance their research capabilities, encourage self-reliance and growth of exports as well as promote frequency of innovations.

As an OPPI report on ‘Workforce of the future’ recommends, “Leaders can leverage human ingenuity and technology to ready their organisations for growth and innovation, but they need to move fast. They must relentlessly anticipate and act on change. ” Create value beyond the product — Detailing how the pharma industry is battling various challenges, Barun Kumar Dey, Director & Head – Packaging Development, Dr Reddy’s Laboratories. He recommended every pharma company to draw out a programme or a strategy that will offer them end-to-end brand protection. He also touched on several traditional strategies such as

28 EXPRESS PHARMA November 16-30, 2019

Pharma logistics should evolve to enforce better quality control, safeguard therapeutic efficacy of products, enable faster delivery of services and improve regulatory compliance Shantanu Panda DGM-Global Packaging Strategy (OSD), Mylan Laboratories

As the industry evolves and matures, partnerships will become the way forward to grapple with heretofore unwitnessed challenges and move towards true progress

An agile supply chain is central to a smart ecosystem — It is been made abundantly clear that a smart ecosystem has to be flexible, transparent and responsive. And, none of this is really achievable without a highly-functioning and efficient supply chain. This fact was clearly accentuated by Shantanu Panda, DGM-Global Packaging Strategy (OSD), Mylan Laboratories. He highlighted the various opportunities and challenges in pharma logistics and elaborated on the ways and measures to optimise the growth potential in this sector.

His presentation reiterated

Ajit Rangnekar Director General, Research and Innovation Circle of Hyderabad Partner, SVP India

Every pharma company to draw out a programme or a strategy that will offer them end-to-end brand protection. Being customer-centric and creating value beyond the pill should be essential aspects of this strategy Barun Kumar Dey Director & Head – Packaging Development, Dr Reddy's Laboratories

Mutual trust and understanding between regulatory authorities and industry are critical.

Therefore, regulators must comprehend business operations and risks in a better manner and the industry must appreciate regulatory and policy objectives better quality improvement, automation, inventory management, efficient supply chain, authentication, alternates etc.

This session brought into focus how crucial it is to be customer-centric and create value beyond the pill to create a fool-

proof strategy for brand protection. It reiterated the importance of connecting with the stakeholders of the industry in newer ways, as customer experience will be the true differentiator in the pharma sector.

Thus, in the new patient

economy, a deeper understanding of disease and customers to, encouraging customer feedback, co-create customer services which will be one-of-a-kind to create superior customer experiences will help build brand loyalty.

the need for an agile supply chain to gain striking economic benefits to the top and bottom line of businesses.

And, be it integrated planning and execution, visibility, procurement, warehousing, inventory management, or logistics, the pharma supply chain needs newer efficiencies. It is vital to enhance customer experience and patientcentricity, by delivering the right product to the right person as swiftly as possible. It will also help enforce better quality control, safeguard therapeutic efficacy of products, enable faster delivery of services and improve regulatory compliance.

Thus, an agile supply chain ushers complete awareness and improved collaboration through the rapid exchange of information to bring in significant benefits at strategic and operational levels, and create a more perceptive ecosystem that fosters progress.

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Collaborations will be the way forward for continued success — This is a clear inference from the session on scaling R&D capabilities by Dr Ajit Rangnekar, Director General, Research and Innovation Circle of Hyderabad Partner, SVP India. He elaborated on how India Pharma Inc needs to ramp up its investment and efforts to hone and augment its skills in R&D and transform them into major determinants of success.

But, he pointed out how R&D expenditures are growing up while the outcomes are proportionate to the spend. He went on to point out that personalised medicine will take centre stage and highlighted the growing trend of technology players foraying into the pharma and healthcare sectors.

All these are clear indications that as the industry evolves and matures, partnerships will become the way forward to grapple with heretofore unwitnessed challenges and move towards true progress. This session drove home the message that it is important than ever before for pharma companies to share and exchange their knowledge

promptly to build future-ready business models for access, quality and financial viability.

Stakeholders must come together to shape the future direction in a way that allows broad-based health improve-

ment while building a sustainable business.”

Unlocking India Pharma Inc’s growth potential India needs to construct an ecosystem for pharma which

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CPHI & P-MEC INDIA 2019 SPECIAL

The various facets of drug dissolution Drug dissolution, a key attribute for determining the bioavailability of a drug, first became official in the United States Pharmacopeia in 1975 for just 12 dosage forms. But now, there are thousands of products which have the dissolution requirement. Further, efficacy is important for any dosage form, and dissolution provides the quality performance phenomena for these. Considered one of the crucial aspects during the drug development process, dissolution comes with a number of challenges, the biggest being simulating in-vivo conditions in toto in an in-vitro dissolution test.

Experts suggest we will never be able to simulate it 100 per cent. However, technologies like 3-D printing and automisation, among others, have helped the stalwarts in the industry to cope up to some extent with artificial intelligence (AI) also creating a space for itself. While a lot has been done so far, yet there is scope for more!

By Akanki Sharma

30 EXPRESS PHARMA November 16-30, 2019

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Understanding the science of drug dissolution is a must levels.

Interestingly, there has been a system and equipment developed in the Netherlands which mimics the human body. Tests can be done on

that equipment instead of doing it on human beings. It takes into account the effect of food ingestion in the body which can affect dissolution.

It would be interesting to

bring such a system in India for demonstration, possibly in a pharmacy college or, for instance, at the National Institute of Pharmaceutical Education and Research (NIPER),

Chandigarh. Financial assistance could, hopefully, be provided by the Government of India. Then, all industry can visit and take trials on this advanced system.

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rug dissolution is a key attribute for determining the bioavailability of a drug. Itâ&#x20AC;&#x2122;s the one which is least understood, and can affect the quality of the product. Taking the popular dosage form, hard capsules, for instance, when swallowed, it first disintegrates, which is always predictable within a few minutes. After that comes the process of dissolution which can be extremely variable depending on a number of factors.

The failures and problems of some Indian companies with the US FDA authorities are being caused partly due to dissolution failures and variability.

This has been serious enough to result in a recall of products from the market. This is not only expensive, but affects the reputation of the company as well. So, the science of dissolution needs to be studied and understood thoroughly. One solution is to consider the use of robotic equipment which are now available, wherein results are recorded online. This brings more accuracy and integrity, and is an effective way to give the inspectors the assurance they look for. Another important trend is the use of artificial intelligence (AI) which is already appearing in the pharma industry. In due course, robotics systems tend to become inevitable. Such work handled by human beings is subject to variability and skill

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Regulators will believe you onlywhen you provide data A

ny product that is administered to the patient must have proven to be safe.

Further, efficacy is important for any dosage form, and dissolution provides the quality performance phenomena for such dosage form. If it is a bad or has poor dissolution, the drug will not dissolve, which means it will not be absorbed, and the patient will have no effect. Dissolution first became official in the United States Pharmacopeia in 1975 for just 12 dosage forms (products), but now there are thousands of products which have the dissolution requirement.

Long back, it started as a quality control standard. In those times, it would require bioequivalence studies for approval of every generic product. In 1995, we published an article based upon the biopharmaceutics classification system (BCS) which said that if a product has a certain sol-

ubility, permeability characteristics, and dissolution characteristics compared with brand name drug product, then there is no need for bioequivalence studies in humans, and the applicant can be given biowaiver based upon the dissolution data. Hence, biostudies are not required. Just the dissolution studies can lead to the approval of a product, and if it is done appropriately, we can say that the product is going to be as good as the brand name drug which was approved with a number of clinical studies and biostudies.

Thatâ&#x20AC;&#x2122;s how dissolution has evolved. This was only for the solid oral dosage forms. But now, with the advances in science and development of biorelevant dissolution media, we are going beyond these earlier prediction of bioequivalence of simple tablet or capsule dosage forms, we can try to predict the bioavailability

one of the biggest challenges in drug dissolution is generating data to prove your point.You think you can achieve something but when you say that, you have to prove that with data integrity

Vinod Shah, Pharmaceutical Consultant and Ex-USFDA

of the controlled release preparations. A lot more complicated studies are required to be done for the approval of topical generic drug products like creams, ointments and gels. The work that we are doing now is going to simplify this to such an extent that the topical drug products, not to-

day, but five years from now, would be able to reduce those requirements and regulatory burdens. We started with dissolution in 1975. In 1995, the first publication came out and then we had the BCS guidance that came out in 2000. And five years after that, another publication came out which used the same BCS information from which you can even predict, when you take the drug, whether it is going to be metabolised in the body or not, and how it will be elimi-

nated from the body.

One of the biggest challenges in drug dissolution is generating data to prove your point. You think you can achieve something but when you say that, you have to prove that with data integrity.

You have to document that because regulators will believe you only when you provide the data. However, this is not easy because firstly, data generation takes time and then convincing someone with that data is another difficult task.

Simulating dynamic in-vivo environment in an in-vitro test is the biggest challenge in drug dissolution testing W

hen a drug substance is administered as a formulation to a patient, one critical requirement is that the drug has to appear in blood because unless it appears in blood, it cannot circulate to all parts of the body in order to exert its response. The formulation can contain the drug which is in solid state. Drug appearing in blood to elicit a response is in molecular state, where the molecularisation takes place in a solvent (biological fluid) outside blood.

The process of molecularisation of the free drug substance in a solvent is called solubalisation. The moment one takes this free drug and puts it into a composition, it is no longer in its free state because the formulation effects

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will come in, such as, processing effects, equipment effects and so on and so forth. So, molecularisation through the process of releasing and solubilising it into the medium from a formulation is dissolution. The end point in both cases is the same, but the starting points are different.

In one case, it is purely the drug alone in its free state and in the second case, it is processed.

Another aspect is that we donâ&#x20AC;&#x2122;t know how much of the drug that gets dissolved invivo gets into the blood, i.e., it is bioavailable. We only know what we see as drug in blood.

If I want to predict what would be my in-vivo bioavailability from a formulation, theoretically, I could take

Umesh V Banakar, Professor and President, Banakar Consulting Services

every formulation I make and conduct a biostudy or a clini-

cal trial in humans. However, it is ethically wrong, expensive and too much time-consuming. So, I need some measurement in-vitro to screen my formulations in order to get to the one that I would like to take forward. In addition, while doing this, I also want to have my in-vitro dissolution tests to give me an assurance that my chances of failing biostudy are decreased. Nobody can predict 100 per cent bioavailability from dissolution but one can enhance the chances of getting that prediction.

The challenge associated with the process of dissolution is trying to really simulate invivo conditions in toto in an invitro dissolution test. We will never be able to simulate it

100 per cent. The biggest challenge is how close we can get to in-vivo process as possible and the second one associated with it is, 'no matter whatever drug dissolution we do, it will be a stagnant test while the in-vivo environment is dynamic.' The solutions are then getting into the advanced understanding of the factors that dictate the in-vivo performance like, combined understanding of in-vitro dissolution with permeation as opposed to either one independently. This is because the first realisation is the chances of predicting bioavailability post in-vivo dissolution is highly possible only when invivo dissolution is slower than absorption. As a result, the quest continues !!

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Dissolution test is prescribed in all applicable pharmacopeial monographs gence (AI) in this area.

Pharma sector is the most dynamic sector and demands continual improvement. What is valid today may not necessarily be valid tomorrow. Who

knows that dissolution testing may become redundant tomorrow and we may have some absolutely novel way of determining the in-vitro performance of the product which may involve

rapid testing methods.

Training related to proper dissolution testing/bioequivalence/IVIVC is a weak area and SPDS (Society for Pharmaceutical Dissolution Science) is try-

ing to bridge the gap. SPDS, was founded in India and has now become global with the valuable support of pharma professionals all across the world.

Vijay Kshirsagar, President, Society for Pharmaceutical Dissolution Science

T

he most important part of drug dissolution is that invitro dissolution must mimic the body system. We must come to know what will happen in the body system after tracking this in-vitro exercise. Besides, dissolution is much regulated. All the products, irrespective of the dosage forms, are required to be mandatorily subjected to dissolution studies except certain products like liquid orals and liquid injectables. Dissolution data is an important part of product filing. Dissolution testing is now fairly harmonised-be it USP, IP, BP, JP or EP, though some differences do exist.

There are many challenges though, while performing dissolution test based on a particular formulation. The most critical one is the discriminatory nature of testing methodology which must differentiate between a good bioequivalent product and a bad non-bioequivalent product. You may need changes in the dissolution method prescribed in official pharmacopeial monograph.

Next challenge is to fix the specification based on in vitro and in vivo comparison. As far as the role of technology is concerned, dissolution testing is now highly automated with least manual intervention. Future may see application of artificial intelli-

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There is a huge space for research in the development of newer dissolution technologies D

issolution testing is a crucial parameter in drug development necessary to screen the optimal formulation.

It monitors two parameters — the rate of solution and the amount of drug going into solution in a defined time period under a pre-determined set of conditions. The dissolution test, therefore, predicts the rate at which a drug would be released from a formulation--be it solid dosage forms like tablets and capsules, semisolids like ointments and gels, and even other formulations like suppositories, implants, etc. Major challenges in the dissolution test include methodologies for complex dosage forms, simulation of sink condition and choice of biorelevant media. Complex dosage forms include suspensions, suppositories, semisolids, ophthalmic, injectables, nano formulations, etc. In case of such dosage forms where no compendial methods are defined, de-

signing a dissolution method that is relevant and can provide requisite and reliable information on dissolution of the drug from the formulation which could relate to the final use of the product, is the major challenge.

Some guidance may be available through research publications, nevertheless, their justification and finally convincing the regulators remains an onus. Sink conditions are generally attained through an understanding of the solubility of the drug in various dissolution media. It is important especially when no compendial methods and media are specified. Altering pH, use of cosolvents like alcohols, polyols and surfactants are widely practised to ensure sink. Biorelevant media is another important criterion in the development of a dissolution method. While this is relatively well-standardised for oral immediate release and controlled release formulations, there is immense scope for re-

Dr Padma V Devarajan, Professor-Pharmacy, Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, Mumbai

search in biorelevant media development for complex dosage forms.

For drug products where dissolution test is not official in the United States Pharmacopeia (USP), one may refer to the FDA Dissolution Methods Database

which is recommended by the Division of Biopharmaceutics, Office of Pharmaceutical Quality of the US FDA. The objective of this database is to provide information on various dissolution methods to assist the industry, specifically in the development of generic drug products. One such USFDA guidance is “Dissolution Testing and Acceptance Criteria for Immediate-Release Solid Oral Dosage Form Drug Products Containing High Solubility Drug Substances”. It is specifically developed to assist manufacturers in the development of new drug applications (NDAs), investigational new drug applications (INDs) or abbreviated new drug applications (ANDAs), specifically for oral immediate-release (IR) formulations containing highly soluble drugs. Attempts at harmonisation are evident in the ICH Q4B Annex 7 Dissolution test submitted by the Pharmacopoeial Discussion Group (PDG), which at-

tempts to enable recognition pharmacopoeial dissolution tests by regulators, especially in the ICH regions.

Technology has addressed the instrumentation with reference to specific dosage forms, specific devices and assemblies to be included in the standard USP II apparatus, the need to maintain sink conditions enabled through Apparatus IV, modifications in Apparatus IV to cater to complex formulations, special assemblies for transdermal formulations, suppositories etc. With rapid developments in drug delivery systems, there is a huge space for research in the development of newer dissolution technologies. As a beginning, AI could probably support decisions on the selection of apparatus based on the dosage form and sink condition, identify outliers during the test and abort, and enable the right time sampling based on drug dissolved etc.

Dissolution is pivotal to determine drug efficacy,safetyand quality M

ost of the drugs which are available in the market these days are Poorly Water Soluble Drugs (PWSDs) because they have been prepared using techniques like high throughput screening (HTS) and other new drug discovery techniques, which tend to favour the lipophilic molecules that have low water solubility, and which also exhibit the inherent problem of poor dissolution rate. In such cases, their gastrointestinal absorption gets influenced primarily by their dissolution performance. If dissolution is not taken care of, their bioavailability, and eventually, the therapeutic efficacy are going to be hampered.

So, dissolution is the major aspect for determining drug efficacy, safety and quality, as stated in the pharmacopeial monographs and otherwise. The quality specifications of the dissolu-

34 EXPRESS PHARMA November 16-30, 2019

tion rate are self-implied, although there is no such harmonisation as far as regulatory parameters are concerned. The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has not come up with any guidelines solely on dissolution, but every other regulatory guidance – be it FDA or Indian Drug Control, among others, has grossly been accentuating on the role of dissolution. Furthermore, there are multiple kinds of commercially available formulations with respect to dissolution – 85 to 90 per cent of which constitute the oral ones. And, amongst the oral ones, it can broadly be immediate release, extended release or modified release.

Currently, there are many challenges coming across with respect to dissolution. In predict-

Bhupinder Singh Bhoop, Chairman, University Institute of Pharmaceutical Sciences

ing the in-vivo bioequivalence using in-vitro dissolution — appropriate selection of the discriminative biorelevant dissolution medium as well as of the dissolu-

tion apparatus — Type 1, Type 2, Type 3, Type 4, etc for different kinds of tests — is a critical challenge before the formulation scientist. As far as AI is concerned, the current status of the introduction of AI in the dissolution equipment is not upto the mark.

However, it is permeating rapidly and progressively along with its expanding database. So, there is a tangible scope if somebody wishes to work, though it's not a day's job. It will require years of cumulative wealth of analysis and implementation. On the contrary, certainly, the use of other emerging techniques – robotics, automation, fuzzy logic and machine learning – have been duly implemented in dissolution apparatuses. And, recently, there have been some reports (although not yet implemented in commercial manufacturing) that 3-D printing can be used to customise the bas-

kets and pedals, so that biorelevance of the in-vitro data and the consequent prognosis of the corresponding in-vivo data thereof could be established as invitro/in-vivo correlation (IVIVC) in a much better manner. Biostudies, essentially carried out in healthy human volunteers, incur a lot of expenditure of manpower, money and time, and these could be rationally waived off or even replaced with suitable in-vitro surrogate, particularly dissolution – using varied combinations of media and apparatus. If scientists can work on piling up the pertinent database and subsequently come up with suitable prognostic strategies, by virtue of which, when one feeds in the requisite input data and the corresponding bioperformance is predicted quite rightly, there would be tangible scope of AI in the times to come.

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Drug dissolution a vital parameter to understand batch-to-batch consistency trained analysts to pinpoint and address observations like swelling, capping, sticking, etc can also help perform drug dis-

Dange Veerapaneni, CEO and MD, Sparsha Pharma

D

rug dissolution is a process in which segregation of molecules from the solid drug surface occurs and the same enters into surrounding solution. Rate of drug release, which in turn is determined by drug dissolution is important for effectiveness/efficacy of a dosage form. It is a vital parameter to understand batch-to-batch consistency/reproducibility and to make formulation and optimisation decisions, equivalence decisions, product compliance and release decisions. However, there are many challenges associated with this process. These comprise equipment-related challenges, which can be overcome by choosing appropriate equipment that suits particular formulation, usage of filters to avoid undissolved materials in the sample solution, suitable calibration.

Then, the problems related to process can be resolved via suitable dissolution medium, minimising error in sample introduction and deaeration of medium. Understanding the Active Pharma Ingredient (API) physicochemical properties is another challenge that one can solve by having knowledge of drug solubility, pH, crystallinity and preparation of clear standard solution. Further, recognising drug formulation properties can be made easy by maintaining content uniformity, anticipating or analysing reactions, and avoid drug and excipient interactions. Lastly, having well-

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solution better.

Over the years, automisation, fiber optic technology, and more sophisticated equipment have

helped in the drug dissolution activities. Besides, research conducted using AI such as artificial neural network, three- or four-

layered models to predict dissolution profile exhibited their upper hand over linear regression models.

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Dissolution testing plays a major role in the decision-making process T

he purpose of dissolution testing for a commercial pharmaceutical product is routine use for QC-QA purposes, to ensure consistency between production batches, and justify scale-up and post approval changes made to the manufacturing process. It is primarily carried to assess product stability, monitor formulation changes over time and study drug release pattern in the presence of various excipients used in the formulation, and finally establish in-vivo-in-vitro correlations. In cases where invivo-in-vitro correlations have been demonstrated, dissolution test can be used as a surrogate test to predict the in-vivo performance of the drug product.

From a regulatory perspective, dissolution testing plays a major role in the decision-making process, particularly in the development and approval of

SR Vaidya, Chairman, IDMA, SME Committee

SD Joag, Ex-General Secretary, IPA

generic dosage forms, where unnecessary human clinical studies can be avoided without compromising the quality of generic drug products.

The overall variability of a dissolution method might not be fully understood at the time

of regulatory approval, given that method reproducibility via an inter-laboratory trial is not required to be thoroughly assessed as part of the marketing application in accordance with ICH Q2. It is common that dissolution testing might be per-

formed routinely at only one laboratory during product development, usually the laboratory that also conducts method validation. But once the product is approved for commercialisation, there are multiple drivers for needing to conduct analytical method transfers for dissolution testing including outsourcing of commercial stability activities.

In recent times, the regulatory perspective of dissolution has shifted due to improved knowledge and understanding of dissolution science and mechanisms. FDAâ&#x20AC;&#x2122;s guidance for industry on the Biopharmaceutics Classification System (BCS Guidance) emphasises how the dissolution test can be used to grant biowaivers for highly soluble and highly permeable drugs formulated in rapidly dissolving IR solid oral dosage forms. Till now, not too

much importance was given to the aspect in terms of providing the right apparatus necessary to ascertain the appropriate dissolution profiles studies in most of the colleges of pharmacy in India. Even in most of the pharmaceutical companies too, the later evolved models of dissolution apparatus have not been procured by many companies in order to upgrade the dissolution profiles. However, now that CDSCO is harping on stability studies, bioequivalence studies and appropriate validated data on both for licensing, these have become essential to get the license renewed even for older already approved formulations, as the regulator feels that these are utmost essential parameters for establishing the quality of products and their predictable therapeutic efficacy for patients.

The exact dissolution technique is determined bythe dosage form characteristics and the intended route of administration T

he dissolution of a drug is important for its bioavailability and therapeutic effectiveness. To properly evaluate the dissolution of drug products, it is critical for procedures to be standardised, which helps to show consistent quality in production and may serve as a predictive measure of efficacy. A dissolution test uses an apparatus with specific test conditions in combination with acceptance criterion to evaluate the performance of the product. There are four standardised apparatus: basket, paddle, reciprocating cylinder, and flow-through cell.

The exact dissolution technique employed is determined by the dosage form characteristics and the intended route of administration. For solid dosage forms, the industry standard dissolution testing

36 EXPRESS PHARMA November 16-30, 2019

methodologies are the United States Pharmacopoeia (USP) Apparatus I (basket) and USP Apparatus 2 (paddle). Immediate, modified and extended releases are usually tested in standard dissolution baths with USP 2 paddles. For oral dosage forms that are prone to floating, USP 1 (baskets) would generally be required. Besides, other techniques are also available, like USP 3 (reciprocating cylinders), USP 4 (flowthrough-cell), USP 5 (paddleover-disc), USP 6 (cylinder) and USP 7 (reciprocating holders).

When developing a dissolution method, it is important to take a logical, systematic approach to the process, and ensure that both the scientific and regulatory principles are borne in mind. A robust dissolution method should be free of

Dr Prashant Bodhe, Pharmaceutical Consultant

significant interferences (e.g. matrix effects due to excipients), give low variability (precision) and produce a good profile shape. The method should also be challenged to discriminate between batches of material with different quality at-

tributes. However, the major challenges associated with drug dissolution that will always remain are: mimic in-vivo situation of drug safety, and efficacy into in-vitro technique and procedure, repetitively, consistently with accuracy; predictable in-vitro in-vivo correlation; predict impact and effect of various events happening during manufacturing, storage and handling during shelf life and at patients end; determine the effect on safety and efficacy; and design and development of robust predictably, safe and efficacious bioavailable product.

In the past few years, medical advances and breakthroughs have included new technologies including 3D printing, implanted and remote-controlled devices.

Graphene, an extremely flexi-

ble material 200 times stronger than steel, is now being produced at a lower cost and can be used to develop revolutionary medical devices used in biomedical applications like tissue engineering, an artificial pancreas, etc. Predictive medicine is a major focus of start ups. In the past, formulators tended to use statistical techniques to model their formulations, relying on response surfaces to provide a mechanism for optimisation.

However, the optimisation by such a method can be misleading, especially if the formulation is complex. AI is a technology that is going to revolutionarise the treatment â&#x20AC;&#x201C; safety and efficacy of medicines. Dissolution testing, as always, will remain a bridge to achieve this perpetual objective.

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Adiscriminating medium plays an important role in routine dissolution evaluation tests dissolution profile generated for a sample formulation matches with the dissolution profile of the standard formu-

lation, it can be predicted that both the sample and standard formulation will exhibit similar performance in vivo. Disso-

lution profiling is a laborious and time-consuming procedure. However, advancement of automation in entire disso-

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issolution process depends on two consecutive steps: liberation of the drug from the formulation matrix (disintegration), followed by its dissolution in the liquid medium. The overall rate of dissolution depends on the slower of these two steps. Dissolution testing over the last half-a-century has emerged as a highly valuable and powerful tool for assurance of drug product quality and drug product performance. It basically started as a tool to test the quality of a solid oral dosage form like a tablet. However, it has now expanded to all areas in the pharmaceutical industry, drug development as well as quality control. Its applications and usefulness have clearly expanded in regulatory arena of bioequivalence, to provide biowaiver and to reduce regulatory burden in drug approval process, and maintaining the product quality and performance.

A discriminating medium plays an important role in routine dissolution evaluation tests by aiding to differentiate between good and bad formulations. Dissolution profiles generated by use of discriminating media can be used to compare the performance of two formulations in vivo. If the

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akanki.sharma@expressindia.com

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CDSCO's digital move: The way forward?

The Central Drugs Standard Control Organisation (CDSCO) is planning to develop a common software platform for all the states in India for online filing and processing of applications for the grant of drug manufacturing licences. The objective is to build a transparent system as well as keep up with global benchmarks. However, the industry experts believe that the move will come with its own sets of challenges as they discuss its pros and cons and offer helpful suggestions

By USHA SHARMA

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Manufacturers should get adequatelytrained to prepare for the newprocess optional and later mandatory, once we arrive at smooth functioning of the system.

The sugam portal launched

S V Veerramani, Chairman & Managing Director, Fourrts Laboratories

ting receipts for online payments made. While the system is accepting payment, it requires reminders to issue re-

ceipts for the payments, which is important for our records. I am sure, this will be sorted out soon.

®

T

he proposal of creating a common software platform for drug licenses management for all the states in the country is a welcome step. it harmonise the licenses issued all over the country. But, it will require support and co-ordination from all state drug control departments as well as manufacturers.

Issue of drug licenses by state drug controllers in time is very important for the survival and growth of the pharmaceutical industry. If there are any delays or glitches in getting online, it can cause hardship to the manufacturers. Further, the staff in the state drug control department needs to be trained in the implementation of the systems and the systems also may require adequate upgradation and speed.

All along, the Indian Drug Manufacturers have been following a conventional path in getting their drug licenses and they have been going on smoothly. Now, the manufacturers also need to get adequately trained to make online application for drug licenses.

Many manufacturers are apprehensive that there may be delays in implementation of the new system. Hence, more time needs to be given to them to comply with the new requirements. Initially, it can be made

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by the Central Drugs Standard Control Organisation (CDSCO) is running smoothly now except for some glitches in get-

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Success of this portal will depend upon the back-end data A

robust single portal for the online approval in India, to obtain any kind of drug license approval is a great initiative by the CDSCO and Ministry of Health & Welfare. Primarily, implementation and success of this portal will depend upon the back-end data which has been used. We need to have all approved drugs, APIs, their combinations, excipients and dosage to be synchronised in such a way that for any available drug combination in the market if asked for a license should immediately be approved or rejected, based on the parameters and compliance of manufacturing. Apart from that, all the manufacturing units should have the complete online monitoring of manufacturing processes at their plant level, which can be checked by authorities any time, including their quality parameter which cannot be altered by human intervention. The objective of this is, when these processes will be in place, the system itself will approve/reject the three validation batches. That means, who so ever the manufacturer may be the ‘quality’ will be ensured before the standard approval by CDSCO.

Most importantly, to ensure that the manufacturers adhere to the system, a penalty standard should also be set-in. I believe, that the renewal of licenses should be done only if the drug manufactured by the unit for that approved period of license, adheres to 100 per cent compliance and if there is online rejection/recall of three batch any time in this period, that product should not get an approval for that manufacturing unit. This will help in keeping up the quality, ethical and healthy competition, reduce the load on the department and spurious drug manufacturing will automatically brought here to closure.

We should not adopt online system for the approval of “New Drug/Formulation” Now, but we need to continuously work on developing the model and take a call when the system for existing product/combinations becomes robust.

The reason behind it is that for a new drug/formulation approval, there is a lot of new data which is generated by the researcher/manufacture. Their data will not be with department in prior, hence requires lots of studies/analyses/discussion before approval. this data

Deepak Kumar Verma, General Manager, Zuventus Healthcare

can be uploaded so that after approval, it becomes a standard and a reference point for other manufacturers seeking approval. The role of drug inspectors and authorities then becomes very different, then they will be able to utilise their time in developing better processes and give their advice to the manufacturing plant to adhere to better compliance.

Secondly, training and development through the online portal should be the second very important aspect which needs to be considered. There should be a level wise examination to

work in a manufacturing/R&D/ any institution where ever the scope of CDSCO goes. Online examinations needs to be conducted to qualify, to work in these units. Every level worker in the manufacturing unit must appear for the examination to qualify to work in the manufacturing unit. It is not the basics Qualification which should be the only criteria. The questions should be objective. But their sequences should be such that people cannot memorise the questions and cannot communicate to the other examines. This is possible when each question is given the time only read and answer, not to think. This will also help the manufactures management in deciding about the career plan and justification of salary to their employees.

I am of the firm opinion that to meet up to the expectation of international standards and survive in future, which is going to be a quality based market, price is not going to be a big factor. Where ever here is price concern to poor, the government should provide free medicines. The govt should focus on quality and not on price. Yes, there should essential drugs which should be in DPCO. I be-

lieve, medicines/drugs/formulations should have ONE standard in the world as, the disease is only ONE, across the WORLD. Therefore, there should be one standard, one process, and one system for the manufacturing/analysis/approval of drugs in the world. Looking into the world’s current approach towards pharma manufacturing, each country is being challenged at all fronts.

Therefore to be in the completion and escalate the pharma business, it is the need of the hour that we up-scale our standards, meeting up to global standards and bring in policies to encourage API manufacturing before 2024.

I am confident that Indian Pharmaceutical Drug Authorities would be certainly working upon standardising the quality standards, matching the Global Standards. We are very hopeful that there will be a positive, digital transformation in the CDSCO online system, which will help improve the system, by adopting robust processes to strengthen the standardisation of the approvals to make India a quality driven country on the map of world of pharmaceutical manufacturing.

Arobust e-governance system is the foundation for an effective compliant regulatoryframework A

s the demand for Indian made pharmaceutical products increases globally, we have a very sure possibility of investment in green field manufacturing and supply facilities. Timely approval and completion will be the key as the market is highly competitive and several other growing economies are competing with India to grab a significant share of global pharma market. We cannot afford to lose any of the opportunities.

Moreover, new greenfield capacities mean more direct and

40 EXPRESS PHARMA November 16-30, 2019

indirect employment opportunities.

It is a herculean task for the CDSCO and other ancillary agencies to manually monitor the cGMP status, licencing and various aspects of regulatory compliance for pharma manufacturing and supply. The step taken by CDSCO to bring an e-initiative to streamline the manufacturing licencing centrally through a central data base is a welcome step and need of the hour. India is aggressively pushing for increasing our share in the

Himanshu Saxena, Founder Director, SISHA PHARMA

global pharma market and it is extremely important that we have a e-system of monitoring and governance.

Pharma manufacturing and supply are governed by drug product quality. This means that there needs to be a system of knowing who the approved sources of supply of the medicines are. Apart from knowing the source of supply, it is also to be noted that data should be made available to know the manufacturing capabilities and technology employed. This means an in-

creased emphasis on computerisation and automation of processes of data gathering and data reporting. For any esystem design, development and its launch must help in enforcing the regulations imposed upon the drug manufacturer for 100 per cent compliance to the law of the land.

A robust e-governance system is the foundation for an effective compliant regulatory framework. It is a known fact that a well thought and designed e-governance system helps as follows :

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a) Productivity Improvement b) Simplification in regulatory administration c) Encourages transparency d) Removes inconsistency in data & duplication of data e) Faster licence clearances and regulatory compliances f ) Upgrades from person led to system led g) Improves data accessibility and security h) Ready for harmonised data anytime Some of the important suggestions to plan for successful implementation could be as follows : a) Creation of a central team with Subject Matter Experts on E System design, development and implementation. Should have industry participation also. b) Upgrading the software and hardware infrastructure at our central and local FDA centres. c) Every manufacturer to have a system based unique login and password so that they can upload data on their own. d) All licences sequence can be based on bar code structure wherein each bar gives some information like, location, date of issue, API/Formulation etc. e) Common specifications for all the IT infrastructure need across all locations in India. f) Training of FDA officials in the system software’s for effective monitoring and compliance. g) Good internet connections and hardware configuration to reduce any chances of website crashes, data upload issues, etc. h) The software should be designed as per the latest data integrity guidelines so that the data cannot be compromised in any manner. i) There should be a planned movement time frame from manual to esystem. j) Manufactures should be provided easy training via

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YouTube, Self-Training etc. k) Central team to help in data sanitisation and remove any corrupt and conflicting data. l) Regular maintenance of the data and website is essen-

tial to improve efficiency.

We need to clearly understand that global pharma market is increasingly moving towards e-system based governance system and India cannot afford to lag. In fact,

as the number of manufacturers increases to satisfy the global demand, it is important that the regulatory agencies in the country go for automation and e-governance at faster pace. This

will help us to prepare our agencies for handing of volumes of data in a much faster time.

Speed and accuracy are the results of a successful implementation of E-system.

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Newsystem will enable central control in the true sense T

he intention of CDSCO is pragmatic and well thought out. This, if fructified, will enable to control central licensing in the true sense. In order to achieve this, initially Sugam portal was established in 2015. However, Sugam portal has run in to a rough weather.

The salient observations are listed below.

1. First and most important is that the Sugam portal of CDSCO is not user friendly. The attempts have been made to improve in this direction, but still there is a room for improvement.

2. There are various home pages of CDSCO for log in for different applications and registration.

3. Application status is not communicated properly. For example, even after the expiry of specific period it shows 0 days left continuously.

4. The documents to be submitted on the portal for specific

Neesha Rawool, Sr. Manager (Operations), Bliss GVS Pharma

application do not match with the list given in the D&C Rules 5. Multiple uploading of documents for specific requirement is not possible. Needs combining of documents to one document.

6. The earlier site FDA WHO MAHARASHTRA.GOV.IN and

now we need to enter whole data in Sugam portal. So, we need to go for registration in the following manner Site registration, Licence registration Product registration – uploading of these details is not going to be cost effective for the manufacturer.

For site registration: If user is having 4-5 sites, we need different Login E-mail address. If we don’t have, we need to create a new E-mail address.

If we use a repeat e-mail for another login it is showing the message user already registered.

For new product registration / Already registered products –in category – there is no provision for Dash and to select Excipients q.s.

7. We need to upload documents of 1-10 MB size, but for uploading 526 KB size also we are getting an error.

Overlooking all the above

points, one can see and visualise a colossal amount of work and duplication which will be involved in filing the application by the state software linked to Sugam portal.

It is pertinent here, to monitor that CDSCO will monitor every application so applied by state manufacturer in various parameters like rationale for FDC, BA/BE studies, stability studies and clinical studies if required before approving the license.

Our suggestions are as follows; 1. To make Sugam portal more user friendly through the inputs that are forwarded by the manufacturers.

2. Delegate the colossal work that each state has submitted in terms of application by decentralising the work by appointing the CDSCO officials in every state or employing dedicated supervisors at zonal level.

CONCLUSION The latest proposal for a common software platform for drug licenses management for all the states in the country needs hi-end tech expertise. The industry is hoping to have a glitch-free access to software which will enhance the industry's capabilities. The CDSCO needs to resolve all the existing technical glitches in the Sugam portal before streamlining the single window magic for all the states. u.sharma@expressindia.com

The formula for those who formulate the pharmA sector.

www.expresspharma.in

42 EXPRESS PHARMA November 16-30, 2019

Regulators should ensure effective dessimnation of information on the newsystem

Nipun Jain, CEO, Pharmchem

T

he main technical glitch which I am facing is that in Sugam, as a manufacturer, I cannot upload or access the same. Mainly it is designed for importers, blood banks etc.

Though our regulators have asked to upload all or product permissions on SUGAM - we are unable to do it.

Regulators need to update the software and also if possible, conduct seminars/ workshops or webinars to disseminate the information.

Regulators should disseminate information on the new setup.

Express Pharma has been the backbone of this sector since 20 years. It is what the experts look to when the entire industry looks to them.

That is because the magazine contains a potent mix of innovative ideas, cutting-edge analyses and expert insights. It’s no wonder then that the finest in the field trust the foremost in the field.

For any queries, call 022-67440000/22022627 or email at healthcare@expressindia.com.

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I N T E R V I E W

B&R acts as a trusted automation partner for leading machine builders Jhankar Dutta, Managing Director â&#x20AC;&#x201C; B&R Industrial Automation talks about how B&R is gearing up for CphI 2019 and the various progressions the company has made in terms of innovation and digital upgradations Can you explain briefly about the company's portfolio?

B&R Industrial Automation, a member of the ABB group, is an innovative automation company with headquarters in Austria and offices all around the world. As a global leader in industrial automation, B&R combines state-of-the-art technology with advanced engineering to provide customers in virtually every industry with complete solutions for machine and factory automation, motion control, HMI and integrated safety technology. With Industrial IoT communication standards like OPC UA, POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is constantly redefining the future of automation engineering. The innovative spirit that keeps B&R at the forefront of industrial

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automation is driven by a commitment to simplifying processes and exceeding customer expectations.

We are global automation provider with groundbreaking motion control, machine operation and control solutions for pharmaceutical packaging.

Our comprehensive portfolio fulfills all the requirements of a pharmaceutical packaging line – regardless of whether the product is in solid, liquid or powder form or whether it is packaged in blisters, paper, plastic, glass or metal. From blister packaging to fillers and cappers, from cartoning to case packers or palletizers, robotics, integrated machine vision and intelligent product transport – we provide the best automation solutions for pharmaceutical packaging machines and plants. We delivers products such as industrial PC, panels, transport systems, vision system, I/O systems, servo and stepper drives and motors, process control systems amongst others. All our hardware and software are fully compliant with FDA 21 CFR Part 11 regulations. In addition, we provide our customers an add-on package of technology libraries that support all FDA criteria for electronic records and signatures.

What are your plans for the Indian market in forthcoming fiscal? What kind of investment would be made in this market?

The market is taking a conservative approach from the investments but we expect the situation to be better soon and have high expectations and hopes from the market. India is a huge market and government is also supporting the manufacturing with various initiatives and programs, which also provide equal importance on MSMEs and SMEs. As B&R, we not only focus on providing innovative solutions and technologies but also collaborating with machine builders during selection, commissioning, after

44 EXPRESS PHARMA November 16-30, 2019

investment in industrial automation at home of B&R in Austria. ABB is to invest €100 million in Austria to build a state-of-the-art innovation and training campus at the home of B&R in Eggelsberg. B&R has also invested in its Gilgenberg site, aiming to establish Gilgenberg as a competence center for the development and production of electromechanical products.

B&R motors are already assembled there. In the future, Gilgenberg will also host development and production of the intelligent ACOPOStrak transport system.

sales support. With our “World Class Support” initiative, we provide a dedicated hotline, which ensures high quality support and quick response times. Our World Class Support hotline will further enhance our customers' experience, in turn enabling them to offer their customers faster service and reduced machine downtime.

B&R is committed to promoting talent among engineering community in the context of education in advanced topics of automation with a view to prepare students for the exciting innovations coming in future. The Education Network is a program to promote cooperation between technical training centers, colleges, universities and B&R. Our Education Network is a wellstructured program of collaboration to improve the employability of engineering graduates.

What kind of growth do you envisage in the next three years? What would be factors driving this growth?

Digitisation, Industrial IoT and Industry 4.0 have been discussed for some time and we are witnessing some implementations in this direction in India. We expect

companies to move in this direction in coming years with an aim to become globally competitive. These will act as some of the major drivers for growth in the Indian market.

Changing consumer needs and landscape are further driving changes.

Tell us about your international presence. Any plans to expand your footprints overseas?

B&R Industrial Automation, a member of the ABB group, is an innovative automation company with headquarters in Austria and offices all around the world. B&R India has expanded its Pune office space to 16000 sq. ft. This new and modern office is now fully operational with unique architecture and efficient office automation. Globally, ABB has made largest organic

What are the growth opportunities opening up in the pharma sector both, globally and India? How poised are you to leverage these opportunities?

Pharmaceutical industry is highly automated. Today, machine builders and plants are focusing on improving productivity, efficiency at the same time optimising operations and processes.

Machine builders are looking at reinventing machine design for eliminating the need for conveyors for product transport. Moreover, reducing time-to-market, improving RoI, improving product quality with lower rejections, reducing maintenance and improving machine uptime have increasingly gained importance. Plants too are looking at higher plant availability with reduced maintenances, higher product quality, reduced losses with higher efficiency and productivity. We provide complete solutions for various needs of pharmaceutical machines and plants. With APROL our process and factory automation solution, plants are able to acquire data analyse it and convert it to valuable information. APROL is equipped with condition monitoring (predictive maintenance) and energy monitoring solution and plants can have a single solution for these requirements. Inspection enables pharmaceutical

machines and plants reduce rejections and improve product quality. Inspection was conventionally treated as a standalone solution incurring higher costs and slow response times due to multiple controllers. B&R has combined the worlds of vision and automation together. With this unique offering, we reduce complexities in incorporating vision systems in the automation system at the same time reduce machine costs.

B&R trusts in open connectivity standards and with OPC UA, Ethernet POWERLINK and openSAFETY we enable machines and plants achieve a seamless horizontal and vertical connectivity. B&R acts as a trusted automation partner for many leading global and Indian machine builders.

What are you showcasing at PMec/CphI this year and what are your expectations from the event?

PMEC is the biggest gathering of pharmaceutical machine builders and users in India. We have been participating in PMEC for many years and have seen the show grow yearon-year. This year too, we will showcase our advanced automation solutions, which enable pharmaceutical machine builders to build next generation efficient and productive machines. Visitors will witness our machine and factory automation solutions in Hall 10 Stall 10.B29. They will also be able to see our latest integrated machine vision and intelligent product transport technology. In addition, visitors will be able to see the ABB YuMi and other solutions from ABB focusing on pharmaceutical and packaging industry. We expect to meet all our machine-building customers who are exhibiting at the show as well as meet other show visitors while highlighting our innovative solutions in the pharmaceutical and pharmaceutical packaging market.

CPHI & P-MEC INDIA 2019 SPECIAL

I N T E R V I E W

‘Novozymes seldom competes on price’ A global leader in industrial enzymes, production firm Novozymes is looking positively at bringing in innovation. It plans to invest in removal of water contaminants, gut and oral health, alternative specialty proteins, and is working on a new portfolio structure.

Krishna Mohan Puvvada, Head of India & HHC India and Africa, Novozymes South Asia discusses future strategies with Usha Sharma

Novozymes manufactures industrial enzymes. Tell us about the trends in the area and how are they shaping the global demands, particularly in pharma and biopharma segment?

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need for using better sustainable technologies, the drivers across vertical are different but the voice is only growing stronger including in the Pharma and Bio Pharma segments. Globally, there is an increasing awareness of the impact of consumption on the environment. Consumers are more open to making sustainable choices in their purchase. Companies have recognised this and have started working on products which are good not only for consumption but also post consumption for the environment. This trend is amplified in certain industries such as biotechnology.

How much business comes from the pharma and biopharma sectors? And what are your plans for scaling it up?

Right now, our biggest business comes from the household care and food & beverages segments in line with our global trends, technical & pharma, which is our smallest business segment. We continue to push our technologies across the customers, the timelines of incorporating our technologies in pharma is longer as it involves complying with the demands of the sector. The outlook is in the positive direction. We continuously work with our partner customers to bring innovation which will affect the end consumer and the environment positively.

Towards that, we work with their formulation to make them more energy efficient and better performance on consumer relevant needs.

Globally, regulations are becoming more stringent.

Do you feel that it is obstructing the growth?

As companies, we need to comply with the regulatory demands that are in front of us. The larger picture needs to be looked into. As the industry matures, it is but natural that regulations are

46 EXPRESS PHARMA November 16-30, 2019

conversions are very low.

How can they be scaled-up and what are the challenges and opportunities your way?

We do not work in the area of artificial enzymes so cannot comment.

How does Symbiotic enhance the application of pre and probiotics? What innovation are you

bringing in this space?

This is an interesting area, but it is too early to comment.

As the industry matures, it is but natural that regulations are setup to govern and protect the consumers interest. Novozymes views regulations as a positive way to streamline entry of players as well as ensuring that min quality standards are maintained for the benefit of the end consumer setup to govern and protect the consumers interest.

Novozymes views regulations as a positive way to streamline entry of players as well as ensuring that minimum quality standards are maintained in the industry for the benefit of the end consumer.

Tell us more about the

enzyme engineering research and how will it help the genetic engineering method.

Enzyme engineering is a key technology which entails genetic engineering to enhance enzyme performance, e.g. improving enzyme stability against high temperatures, variation in pH, or other stresses during

a process. The competencies needed to engineer proteins, involve molecular biology, understanding of enzyme structure: activity relationships, high throughput screening, data analytics, and application testing.

Presently, the â&#x20AC;&#x2DC;artificial enzymes catalyticâ&#x20AC;&#x2122;

Globally, who do you compete with and how do you maintain the competition in a healthy way?

We compete with global players like Dupont, DSM etc. We are in a business where there is tremendous opportunity to bring in innovation and expand the markets. This is typically that we like to do.

Novozymes seldom competes on price. We have grown the global enzyme market across industries and we believe there is far more value in bringing innovation to customers and making the pie larger than competing within a limited space. Our global growth has fundamentally rested on the growth of our customers.

Hence, the strong emphasis is on partnering with our customers.

The company recently announced that better business with biology will drive more value from the existing business as well,

CPHI & P-MEC INDIA 2019 SPECIAL

as it will free up the additional resources to invest in new strategic opportunities. Your strategy for this move?

We have identified the areas where we want to invest, they will be in the area of solving global challenges such as clean water, human health and food availability, as we speak teams have been formed to take the direction forward. We are working on a new portfolio structure with business portfolio units and clear portfolio roles, allowing the organisation to deliver to its full potential.

This includes more targeted

and differentiated value offerings and service levels depending on the different characteristics of the businesses. This will entail significant investments in new strategic opportunity areas â&#x20AC;&#x201C; combining enzymes and microbes â&#x20AC;&#x201C; with significant potential beyond the mid-term strategy period. We plan to invest in removal of water contaminants, gut and oral health, and alternative specialty proteins.

The company targets annual growth of more than five per cent from food and healthcare industry in the period 2020-2022. Tell us about the product pipeline and how do you plan to execute it?

Cannot comment on this at this stage.

Any investment plans for

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the current fiscal?

We have just commissioned a new production unit near Mumbai. As interesting opportunities emerge, we will look at enhancing our investments to meet the

business needs and challenges. We also work closely with emerging talents in many institutes across the country and remain open to exploring opportunities to jointly

initiate research in biotechnology with budding PHD students.

The company also finds inorganic route to grow.

Will we be seeing more

coming in from there?

We constantly keep evaluating interesting companies, we will continue to do so. u.sharma@expressindia.com

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Volumetric size numbers for capsules Dr Milind Biyani, Director, Aspire Advisors, gives an insight on how managing capsules by volume number will be more convenient during whole life cycle of the product management

C

apsule is a container to carry the material. Hard capsules are usually cylindrical in shape consisting of the body and cap whereas empty capsules are supplied in partially pressed form. These can be opened and the material can be filled and closed completely. Some capsule types after filling are tightly closed while some types can be opened by pulling out the cap even after filling the material.

Capsules can be sealed using band sealing to make them tamper proof and leak proof and are available as transparent or in different colours.

These can be pre-printed up to four colours, vertically or across the circumference with product name, company name, logo, etc.(1) Capsules are soluble or

bio-degradable when they are made from gelatin, HPMC (Hydroxy Propyl Methyl Cellulose), modified starch or pulullan. Capsules are available in large variety of sizes. Capsule sizes widely used in pharma, nutra and dietary supplements industry are given in Figure 1 and Table 1 (2) . Capsule sizes given in Table 2 are mainly used in veterinary practice (mice to elephant). Capsule sizes in 36 ml, 90 ml and 120 ml are also available (3) . It is possible to fill in the capsules with one or more of powders, granules, different pellets, mini/micro tablets, another capsule or even non-aqueous liquids.

Non-aqueous liquids could be solutions, suspensions, semisolids, self emulsifying systems or hot melts. Acidic

Figure 1- Capsule sizes used in pharma, nutra and dietary supplements

Table 1 - Capsule size, volume of body in ml, height of closed in mm, diameter of body in mm

50 EXPRESS PHARMA November 16-30, 2019

aqueous solutions can be filled in enteric capsules. Fill weight can be obtained after considering bulk density of the material to be filled and the volume that can be filled in a capsule.

Non-pharma uses are combination with medical devices as soluble aid to insertion, test kits, products for water treatment, soil treatment, for reagents, bath products, toys, optics etc.; for special effects in movies, television (capsules for gun, container for simulated blood/when broken in mouth - the effect of blood created, â&#x20AC;&#x2DC;birthing effectâ&#x20AC;&#x2122; etc).

Use of transparent capsules enable to see contents whenever desirable.

As seen from Table 1, 2 and the Figure 1, capsule sizes are described by some number.

The first criteria for selection of particular capsule size is the volume that can be filled in the capsule. Capsule number does not give any clue about capacity or the volume that can be filled in the capsule. Capsule size number inversely increases with capsule volume for Table 1 but does not hold good for Table 2.

Hence, this system of numbering is not convenient and is confusing.

Soft gelatin capsules are one piece and hermetically sealed. Filled volume when expressed in minims, it is closer with the capsule size numbers as shown in Table 3.

A minim is equivalent to the amount of water in a drop, which is also equal to one grain. We believe that origin of size of hard capsules ex-

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pressed as numbers were based on the standard rod dia (mesh size) used for making pin bards for dip moulding.

Hence, the present system has been derived from engineering background and not from pharma. Therefore, it will be useful to identify hard capsule size by its volume in ml. Capsule size number can be mentioned in the bracket to correlate with the existing use and specifications. This will help users to quickly identify desired size of the capsule. Accordingly, volumetric sizes will be as per Table 4 and Table 5 when compared to existing size nomenclature by numbers.

The weight of the product to be filled in gram can be converted in ml volume based on the bulk density of the

Table 2 - Other capsule sizes, volume of body, height or locked length, diameter outer

product to be filled and nearest capsule size in ml can be easily selected. For example, if the quantity to be filled is 500 mg and bulk density is

0.5, then volume will be 1 ml and capsule of 1 ml size (Number 00 as per existing system) can be selected. If the quantity to be filled is 50 mg

of the bulk density 0.5, volume will be 0.1 ml and the capsule of 0.1 ml volume can be selected (Number 5 as per existing system).

The volume in ml = Weight in gm / Bulk density.

Accordingly, the capsules of similar volume or slightly higher volume can be selected

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to accommodate the excipients.

Soft gelatin capsulesâ&#x20AC;&#x2122; size may also be indicated by volume that can be filled in minim on higher side of the range as shown in Table 3.

The volume to be filled in ml can be converted to minims by multiplying it by 16.231 to find out desired minims number of the soft gelatin capsule.

Thus in the proposed new system of calling capsule size by volume, the volume number increases with increase in size of the capsule. In the present system, capsule size increases inversely with the volume of the capsule which is confusing. The volumetric size number will enable formulator to quickly select the capsule size based on the volume of the product to be filled. For packaging personnel also, it will be easier and faster to select the pocket size for blister pack or bottle pack. It will be useful for pharma as well as veterinary industry. The practice will be equally useful for nonpharma users. Non-pharma uses include combination with medical devices, products for water treatment, soil treatment, reagents, bath products, toys, optics etc. Use of the transparent capsule enables to see contents when-

ever desirable. For capsule manufacturers also, managing capsules by volume num-

ber will be more convenient during whole life cycle of the product management.

Reference 1. Milind Biyani, Choosing Capsules: A Primer, Pharmaceutical

Technology, 41(10), 36-41, 2017.

2. www.acg-world.com 3. www.torpac.com

Table 3 -Soft gelatin capsule sizes and volume in minims (1 cc = 16.231 minims)

Table 4- Volumetric sizes in ml as compared to existing sizes by number and letters for hard capsules commonly used in pharma, nutra and dietary supplements

Tables 5- Volumetric sizes in ml as compared to existing sizes by number or letter for hard capsules commonly used in veterinary practice (mice to elephant)

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Sustainable manufacturing practices to combat growing AMR With antibiotic residues from effluents listed as the third highest cause of Antimicrobial Resistance (AMR), pharmaceutical companies will have to deploy clean manufacturing and waste management practices to remove such residues. This would serve to reduce antibiotic pollution and thus reduce AMR. The good news is that there are already products available to help pharma companies switch to cleaner manufacturing processes Viveka Roychowdhury

W

hile the role of misuse and overuse of antibiotics in increasing Antimicro-

bial Resistance (AMR) has received a lot of attention, there are many other factors contributing to AMR. AMR is recognised by the

World Health Organisation (WHO) as one of the top ten threats to public health worldwide. According to the AMR Review (2014), nearly 700,000

people die each year due to AMR, and by 2050, this number is projected to reach 10 million per year unless strong actions against the

drivers of AMR are taken.

After misuse and overuse of antibiotics, environmental factors like release of inadequately treated antibiotic

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manufacturing effluent into the environment have been identified as major contributors to the development of drug resistant ‘superbugs’.

Showing signs that the government is gearing up to take action on this front, the Department of Pharmaceuticals (DoP) has reportedly written to pharma industry associations in October to urge their members to monitor and check release of antibiotic residue in their effluents.

The DoP's letter has reportedly mentioned that the Central Pollution Control Board (CPCB) has set up an expert committee to draft standards for antibiotic residue in industrial effluents.

The draft is now close to finalisation and the DoP has asked pharma manufacturers to switch to more sustainable manufacturing processes.

Why antimicrobial residues are harder to treat According to a review paper, titled Antimicrobial Resistance in the Environment: The Indian Scenario, published in February 2019 in the Indian Journal of Medical Research, (Taneja & Sharma: Antibiotic Resistance in India) antimicrobial classes such as fluoroquinolones and sulphonamides produce stable residues while beta-lactam group of drugs degrade relatively faster from the environment. While the former constitute an ever-growing pool of AMR, the latter indicates recent contamination of wastewater.

Referencing various reports, the two authors, Neelam Taneja & Megha Sharma from the Department of Medical Microbiology, Postgraduate Institute of Medical Education & Research (PGIMER), Chandigarh, India point out that both the types of these drugs are widely present in the wastewaters of Indian pharma companies which pollute the neighbouring rivers, ponds and sea coasts.

For example, Lübbert et al

54 EXPRESS PHARMA November 16-30, 2019

Antibiotic manufacturing units need to properly treat their effluent in order to remove active pharmaceutical ingredients and antibiotic residue from it. The industry needs to take responsibility for this and realize that common treatment plants are often not equipped to remove these chemicals Tim Rutten, Business Director– Asia Pacific and Africa, Centrient Pharmaceuticals

28 found antibiotic residues from 28 environmental sampling sites in the sewers of industrial area in Hyderabad, India. Wastewater is generated by every pharma company of the world, but as per the risk assessment, the adequate treatment of this wastewater in developed countries decreases the overall associated risk while the lack of optimal wastewater treatment increases its overall risk in India. They also point how how the high cost associated with regular monitoring of antimicrobial levels in pharma waste water makes it a lowpriority objective for India.

With the antibiotic factories

There is a pre-conceived notion amongst some industry players that responsible manufacturing entails a significant cost burden.

However, the antibiotic load in effluent can be significantly reduced by changes in the manufacturing process, for instance, by using enzymatic treatment instead of a chemical one. Upgradation of the treatment technology does require some capital investment, but that is mostly a one-time cost Prof Anurag Rathore, Indian Institute of Technology, Delhi

in India and China being the largest contributors in global rise of AMR, the authors caution that a strict vigilance on the effluent produced is needed.

Not surprisingly, they rec-

ommend regulation of waste water discharges from pharma companies with regular monitoring of antimicrobial residues in them along with provision of legislative support to punish offenders.

According to a Scoping Report on Antimicrobial Resistance in India, published in 2017 (Sumanth Gandra, Jyoti Joshi, Anna Trett, Anjana

Sankhil Lamkang, and Ramanan Laxminarayan. 2017.

Scoping Report on Antimicrobial Resistance in India. Washington, DC: Center for Disease Dynamics, Economics & Policy), India has at least 40 antibiotic API manufacturers and at least 250 antibiotic formulation companies manufacturing at least one antibiotic for human use, as per data from

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CIMS INDIA, April–July 2017 edition.

Some of the antibiotic API manufacturer hot spots include, Ankleshwar and Karkhadi (in state of Gujarat), Aurangabad, Mumbai area, and Tarapur (Maharashtra), Baddi and Paonta Sahib (Himachal Pradesh), Derabassi (Punjab) and Hyderabad (Telangana). Similarly, some of the antibiotic formulation companies’ hot spots include Ahmedabad (Gujarat), Aurangabad, Bengaluru (Karnataka), Hyderabad, Verna (Goa), and Sikkim.

Cleaning up Some manufacturers of antibiotics have started sensitisation and awareness campaigns to urge pharma companies to switch to cleaner and more sustainable manufacturing practices.

Centrient Pharmaceuticals' partnership with Indian Institute of Technology – Delhi and their workshops on ‘Sustainability Through Excellence in Manufacturing’ (STEM) is one such initiative. The company is a manufacturer of beta-lactam antibiotics.

For example, this August, the pharma company and IIT Delhi conducted a joint workshop in Korea on the theme.

The session was attended by nearly 50 participants from manufacturing, R&D, Regulatory Affairs, Quality Control/Assurance and Purchasing departments of leading pharma companies in Korea, to introduce them to clean manufacturing and waste management practices to reduce antibiotic pollution.

By 2017, Korea had allocated funds worth 65 million euros to AMR related research, in-

cluding developing new-age antimicrobials and modernisation of livestock and poultry management systems to eliminate non-therapeutic use of antibiotics.

In India, this September, the company partnered with the Punjab Pollution Control Board (PPCB) to conduct a sensitisation workshop on the environmental aspects of AMR.

Giving more details, Tim Rutten, Business Director Asia Pacific & Africa, Centrient Pharmaceuticals explained, "As manufacturers of antibiotics, it is important that we look at the long-term sustainability of our products, not merely because of business interests, but more so because over the past decades, antibiotics have become the foundation of modern healthcare, not only curing bacterial infections, but enabling advanced medical procedures such organ transplants and cancer treatments, saving millions of lives every year."

He rues the fact that while in the last few years, awareness about AMR has increased, action to contain this public health threat until recently remained focused mostly on responsible use of antibiotics and the develop-

ment of new molecules. While Rutten agrees that these are indeed vital fields of action, he emphasises that the role of sustainable production practices also deserves due attention in the fight against AMR. "Several reports suggest that part of the AMR burden can be attributed to environmental factors including effluent containing anti-microbial activity from antibiotic manufacturing units reaching the environment," he pointed out.

Long term view required Urging industry to take a long term view from both a business and a public health perspective, Professor Anurag Rathore, Professor, Department of Chemical Engineering, IIT Delhi explained,“Antibiotic residue that reaches water bodies through effluent and wastewater spurs the de-

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Participants at a joint workshop conducted in Korea this August by Centrient Pharmaceuticals and Indian Institute of Technology, Delhi, on Sustainable Manufacturing of Pharmaceuticals

velopment of resistance in bacteria present in the environment, creating ‘hotspots’ where resistant microbes can flourish.”

“By reducing the environmental load of antibiotics, it is possible to slow down the pace of AMR development.

This will mean that existing antibiotics will remain effective for longer and so the industry will buy itself a few years’ time of continued sales for these products and for research and development of new antimicrobials,” reasoned Rathore.

Busting some myths, the IIT Delhi expert clarified, “There is a preconceived notion amongst some industry players that responsible manufacturing entails a significant cost burden. However, the antibiotic load in effluent can be significantly reduced by changes in the manufactur-

56 EXPRESS PHARMA November 16-30, 2019

ing process, for instance, by using enzymatic treatment instead of a chemical one.

Upgradation of the treatment technology does require some capital investment, but that is mostly a one-time cost.”

The good news is that there are already products available to help pharma companies switch to cleaner manufacturing processes.

Showing the way forward, Rathore pointed out that advancement is also being made in testing technology and lowcost tests that can measure the level of some antibiotics in effluent are already available.

These will help not only manufacturers but also environment regulators charged with keeping tabs on pharma pollution, he concludes.

Giving some direction to pharma companies Rutten said, “Antibiotic manufacturing units need to properly

treat their effluent in order to remove APIs and antibiotic residue from it. The industry needs to take responsibility for this and realise that common treatment plants are often not equipped to remove these chemicals.”

According to him, Centrient Pharmaceuticals therefore uses the cleanest production technologies, have dedicated wastewater treatments plants and monitor an-

timicrobial activity in their effluent.

He appreciates the efforts that India is taking commenting, “At present, there are no regulations governing monitoring and treatment of antibiotic content in effluent around the world. It is encouraging to see that India is working on drafting standards to ensure that effluent being released into the environment through industrial wastewater is below predicted no-effect (PNEC) levels for antibiotic residues.”

In conclusion, Rutten emphasised the ‘One Health’ approach with governments, civil society, and industry playing their part, saying, "The issue of AMR needs to be addressed by a multi-sectoral approach. We all need to take responsibility to fight this global health threat. Industry, governments and non-

governmental organisations should work together to ensure sustainability in all parts of the supply chain, from pharma manufacturing, sustainable procurement and responsible consumption.”

International cooperation Recognising that issues like AMR go beyond boundaries, India's government has ongoing cooperation with the Netherlands, the UK, Sweden, the US, Norway and Japan to promote and support research on various aspects of AMR and strengthen India’s surveillance capacities.

This October, the Department of Science and Technology, Government of India, along with CII organised the India-Netherlands Technology Summit in New Delhi marking 25 years of the summit. The central theme of the

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summit was ‘NEXUS’, with discussions focused on co-creating innovative solutions for global challenges pertaining to water, food and good health.

One of the key areas of joint efforts between the two countries has been tackling AMR through a ‘One Health’ approach, as AMR is a multifaceted challenge, with drivers going beyond mere overuse or misuse of antibiotics in humans and animals. That is why the ‘One Health’ approach also looks at environmental factors that contribute to the AMR burden, including inadequately treated effluent from pharma manufacturing units, run-off from poultry farms, slaughterhouses, and liquid waste from hospitals.

Compared to other countries in the European Union, resistance rates are particu-

larly low in the Netherlands, primarily because of early adoption of the ‘One Health’ approach, which aims to combat AMR holistically in the healthcare system, in animals, in food and in the environment through coordinated action.

The Indian National Action Plan on AMR (NAPAMR) goes one step beyond the Global Action PLan on AMR, adding a sixth priority – Leadership and Collaborations – which covers international, national as well as state-level collaborations.

The Netherlands’ National Institute of Public Health and the Environment (RIVM), which advises the Government of Netherlands on AMR related matters, has also been working closely with the Indian Ministry of Health and

Family Welfare. Speaking about the work, Lav Aggarwal, Joint Secretary, Ministry of Health and Family Welfare, Government of India said, “Our collaboration with the Netherlands has helped us learn from their experiences

and success on AMR surveillance, and containment of resistance in the environment.”

The Minister for Medical Care, Government of the Netherlands, Bruno Bruins, who was present at the Summit, gave the example, of the Memorandum of Understanding that was signed during the visit between the Bangalorebased CCAMP and the Dutch public-private partnership AMR-Global, which will kick start India/Dutch collaboration in this field."

The WHO is the technical partner for the India-Netherlands collaborative project on AMR, and Dr Henk Bekedam, the WHO Representative to India, stated that his organisation will support the analysis and dissemination of lessons learnt to help scale up interventions across India.

Work has already started, with an ongoing pilot study being conducted in Andhra Pradesh, a hotspot for antimicrobial pollution, and Dr Sujeet Singh, National Centre for Disease Control, Government of India indicated that the study would be expanded to other states.

The crux of the issue is that tackling the AMR problem requires coordinated action between various stakeholders. For instance, the DoP can only issue a directive to pharma associations but cannot enforce it as that is the purview of the environment ministry. However, a start has been made and one hopes that pharma companies will work towards long term sustainability. viveka.r@expressindia.com

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AST,Shilpa Medicare partner on GENiSYS C20 aseptic small batch filling and closing machine The GENiSYS C20 will add flexibility to manufacturing capabilities considering the multi format filling operations in accordance with strict cGMP requirements

A

utomated Systems of Tacoma (AST), a leading provider of flexible aseptic filling systems, and Shilpa Medicare, a Contract Development and Manufacturing Organization (CDMO) announced

58 EXPRESS PHARMA November 16-30, 2019

their partnership on a GENiSYS C20 multi-format filling and closing machine for syringes, cartridges and vials.

Shilpa Medicare has purchased a GENiSYS C20 system, capable of automated cGMP aseptic

small batch processing, and will collaborate with AST on its installation at its Dharwad site, Karnataka India location.

ASTâ&#x20AC;&#x2122;s GENiSYS C20 is the ultimate 'multi-format' filling and closing machine for small

batch aseptic applications. The design provides unrivaled flexibility in a compact layout, with an intuitive and simple user interface. The GENiSYS C can process nested, ready-to-use (RTU) and custom vials, sy-

ringes and cartridges. The system can be configured with advanced features, including: peristaltic and rotary piston pumps, integrated in-process weighing (IPC), viable, non-viable and particle monitoring

CPHI & P-MEC INDIA 2019 SPECIAL

Village Magthane, Off W.E.Highway, Borivali East, Mumbai – 400066 Maharashtra, India Phone: +91-9920857077 Email: abhayacharya@astinc.com (EM), electronic batch record (EBR) reporting, inert gas purging, and vacuum or vent-tube piston insertion of pre-filled syringes and cartridges. The integrated Electronic Batch Report (EBR) System records critical process information that can be used to create 21 CFR Part 11 compliant batch reports.

“The GENiSYS C20 will add flexibility to our manufacturing capabilities considering the multi format filling operations in accordance with strict cGMP requirements. The wellestablished brand module will enable Shilpa Medicare to continue delivering sterile clinical &amp; commercial supplies with very aggressive timelines,” said Vinay Konaje, Business Head of Biologics, Shilpa Medicare.

AST has established their 100 per cent-owned subsidiary Tacoma PharmaSolutions Private in Mumbai India on July 24, 2018, with the launch of Indian subsidiary, AST would be able to closely address the needs and enhance serviceability of Asia, the Middle East and African region customers with world-class quality products.

“AST’s line of semi-automatic to fully robotic machines are highly efficient and successful for automated cGMP aseptic small batch processing. AST is excited and grateful to be partnering with such an innovative partner on the install of this GENiSYS C at Shilpa Medicare, and we look forward to supporting with their future aseptic fill needs,” said Joe Hoff, President and CEO, AST. Contact Abhay Acharya General Manager – AMEA Tacoma PharmaSolutions Regd. Office: E-702, Pruthvi Enclave Co-op HSL

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Brittany Hoff Media Marketing Manager Automated Systems of Tacoma, 4110 South Washington Street, Tacoma, WA 98409, Phone: 253-475-0200 Email: marketing@astinc.com

Vinay Konaje Business Head of Biologics Shilpa Medicare #12-6-214/A1, Hyderabad Road, Raichur – 584 135, Karnataka, India.

Phone: 08532 - 238704

Innovation & Flexibility.

AST and Shilpa Medicare Limited are proud to announce their partnership to serve the global pharmaceutical market with a GENiSYS® C.

253-475-0200 marketing@ast-inc.com www.ast-inc.com

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Tacoma PharmaSolutions Private Limited Regd. Office: E-702, Pruthvi Enclave Co-op HSL Village Magthane, off W.E.Highway, Borivali East, Mumbai – 400066 Maharashtra, India Phone: +91-9920857077 | Email: abhayacharya@ast-inc.com

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Sheffield scientists identify new potential treatment pathway for cardiovascular disease Research has shown for the first time that a protein expressed in a subset of immune cells contributes towards the build-up of fatty deposits in arteries, which leads to cardiovascular disease

S

cientists from the University of Sheffield have identified a new potential treatment pathway for cardiovascular diseases.

Their research has shown for the first time that a protein expressed in a subset of immune cells contributes towards the build-up of fatty deposits in arteries, which leads to cardiovascular disease.

These fatty deposits are caused by macrophages, a subset of immune cells known to take up surplus cholesterol.

When this is present in excess, they mature into larger cholesterol-laden cells known as foam cells which accumulate and cause blockages inside arteries.

The study published in Science Advances, shows for the first time that levels of a protein called Tribbles-1 (TRIB1) inside macrophages controls the amount of cholesterol taken up by foam cells.

The research shows that higher levels of TRIB1 increased specific cholesterol uptake receptors, promoting arterial disease, whereas decreasing TRIB1 reduced disease.

The findings of this early translational study which involved the University of Leicester and scientists from Hungary and the US, suggest that inhibiting TRIB1 in macrophages could be a viable therapeutic target in treating cardiovascular disease.

Researchers have long been trying to identify the proteins regulated by TRIB1 to understand their effects, and whether they are of benefit or are detrimental to disease development.

Dr Jessica Johnston from

60 EXPRESS PHARMA November 16-30, 2019

The research shows that higher levels of TRIB1 increased specific cholesterol uptake receptors, promoting arterial disease, whereas decreasing TRIB1 reduced disease. The study, involving University of Leicester and scientists from Hungary and the US also found that inhibiting TRIB1 in macrophages could be a viable therapeutic target in treating cardiovascular disease

the Department of Infection, Immunity and Cardiovascular Disease (IICD) at the University of Sheffield was first author of the study and her PhD research focused on the project. She said, “The role of TRIB1 in macrophages has remained elusive for some time. Our research provides the missing link and highlights the importance of cell-specific expression in cardiovascular disease.”

“I am proud that our collaborative efforts have resulted in these findings.”

Professor Alison Goodall from the University of Leicester, said, “We were delighted to be able to support the study with data from our large cohorts of human subjects, to demonstrate the links between TRIB1 and cholesterol uptake in humans.”

Professor Endre Kiss-Toth also from the Department of IICD led the study. He said, “Studying the genetics of cardiovascular disease in large human populations has revealed that TRIB1 contributes to its development.

“However, this is the first time that its role in immune cells has been directly addressed, thus uncovering a new mechanism by which arterial disease develops.”

“The research into this mechanism has not yet translated into novel medical interventions. However, we now have pre-clinical proof that it would be beneficial to build on this research and see which patients with cardiovascular disease would benefit from the development of treatments to manage their lipid-laden foam cell formation.”

EP News Bureau

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FDArejects Lipocine’s testosterone drug US FDA cited a dosing irregularity and asked for more data on whether the drug could cause a rise in blood pressure

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he US Food and Drug Administration declined to approve Lipocine's oral drug to treat a condition that results in lower production of male sex hormone for the third time.

The company said a letter from the regulator indicated the application could not be approved in its present form as Lipocine’s trial did not meet three secondary goals that were designed to assess if higher lev-

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The FDA had first declined to approve Tlando in 2016 and then again in 2018 els of testosterone in patients could raise safety concerns.

The decision marks the third regulatory setback in over three years for Lipocine’s Tlando, which aims to restore normal testosterone levels in men with deficiency or absence of testosterone.

The US Census Bureau estimates that 21.7 million men in the US aged between 30 and 79 may have low testosterone levels, a condition that could lead to a loss of libido, decreased muscle mass, fatigue and depression.

The FDA had first declined to approve Tlando in 2016 and then again in 2018, citing a dosing irregularity and asked for more data on whether the drug could cause a rise in blood pressure.

Through Tlando, Lipocine hopes to offer patients a safer alternative to topical treatments that could result in accidental transference of testosterone.

If approved, it will compete with an oral rival from Clarus Therapeutics that was approved in March.

Reuters

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Takeda pharma publishes dengue vaccine study results The study, which covered trial of Takeda’s dengue vaccine, demonstrated its overall efficiency of 80.2 per cent against virologically confirmed dengue

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akeda Pharmaceutical Company announced that results from the primary endpoint analysis of the ongoing pivotal Phase 3 Tetravalent Immunization against Dengue Efficacy Study (TIDES) trial of its dengue vaccine candidate (TAK-003) were published in the New England Journal of Medicine. Takeda’s dengue vaccine candidate demonstrated protection against virologically-confirmed dengue (VCD), the trial primary endpoint, in children ages four to 16 years.

Vaccine efficacy (VE) was 80.2 per cent (95 per cent confidence interval [CI]: 73.3 per cent to 85.3 per cent; p<0.001) in the 12-month period after the second dose, which was administered three months after the first dose. Similar degrees of protection were seen in individuals who had and had not been previously infected with dengue based on planned exploratory analyses of secondary endpoints (VE: 82.2 per cent [95 per cent CI: 74.5 per cent to 87.6 per cent] vs. VE: 74.9 per cent [95 per cent CI: 57.0 per cent to 85.4 per cent], respectively).

Other exploratory analyses showed a 95.4 per cent reduction in dengue-associated hospitalisations (95 per cent CI: 88.4 per cent to 98.2 per cent). Efficacy against severe disease could not be assessed due to the limited number of cases. Onset of protection was seen after the first dose, with 81 per cent VE (95 per cent CI: 64.1 per cent to 90.0 per cent) between the first and second doses.

Takeda’s dengue vaccine candidate was generally well tolerated, and no important safety risks have been observed to date. The observed safety profile was consistent with results reported in previous studies of TAK-003.1,2,3,4 The TIDES trial will continue to

62 EXPRESS PHARMA November 16-30, 2019

assess safety and efficacy in study subjects for a total of four and a half years.

“The results of this first analysis are very encouraging, indicating that the vaccine could potentially provide important public health benefits against dengue fever and hospitalization,” said Humberto Reynales, a lead author of the New England Journal of Medicine paper. “It will be important to further analyse the trial results over time in order to assess the long-term efficacy and safety of the vaccine. If longer follow-up data confirm this initial observation, we are looking at a significant step forward in the global fight against dengue.”

“According to the World Health Organization, dengue represents one of the ten biggest global health threats, and it is critical that we have access to a safe and effective vaccine candidate that can reduce the devastating impact

dengue fever has in endemic regions,” said In-Kyu Yoon, Senior Advisor, International Vaccine Institute. “Historically, vaccine development against dengue has been challenging, especially for people who haven’t previously been exposed to dengue, and these results demonstrate protection from dengue fever, including among many participants without prior dengue.”

Dengue virus infections caused by all four serotypes were observed in the global TIDES trial. Exploratory analyses of secondary endpoints showed efficacy varied by serotype: VE was 73.7 per cent for serotype 1 (95 per cent CI: 51.7 per cent to 85.7 per cent), 97.7 per cent for serotype 2 (95 per cent CI: 92.7 per cent to 99.3 per cent), and 62.6 per cent for serotype 3 (95 per cent CI: 43.3 per cent to 75.4 per cent). There were too few dengue serotype 4 virus cases to fully assess efficacy at this

time (VE: 63.2 per cent [95 per cent CI: -64.6 per cent to 91.8 per cent]).

Further analyses of exploratory endpoints also showed that, for both serotypes 1 and 2, efficacy levels among seropositives and seronegatives were similar. For dengue serotype 3, VE in baseline seropositives was 71.3 per cent (95 per cent CI: 54.2 per cent to 82.0 per cent), and in seronegatives, results were inconclusive but suggested a lack of efficacy (VE: -38.7 per cent [95 per cent CI: –335.7 per cent to 55.8 per cent]). No dengue serotype 4 cases were observed in seronegative participants.

While in the process of publishing the primary endpoint data, Takeda received additional data from the ongoing TIDES trial, which adds six months of follow-up and provides formal assessment of the secondary efficacy endpoints.

Both the primary endpoint analysis and formal assess-

ment of secondary endpoints will be presented at the American Society of Tropical Medicine and Hygiene (ASTMH) 68th Annual Meeting, November 20-24, 2019, in National Harbor, Md, and submitted to a peer-reviewed journal.

“We are excited to share this long-anticipated data from our TIDES trial, which is evaluating the performance of our dengue vaccine candidate in a diverse set of countries across Asia and Latin America, and in a study population that intentionally includes a large proportion of children who had never been exposed to dengue,” said Rajeev Venkayya, President of the Global Vaccine Business Unit at Takeda. “While more data is needed to fully understand the safety and efficacy profile of TAK-003, these findings strongly suggest that it could help address the massive global burden of dengue in all populations. We look forward to sharing more data in the coming weeks, and engaging health authorities and the scientific, public health and medical communities on these findings, priorities for future evidence generation, and ways we can work together to maximize the reach and impact of this vaccine upon licensure.”

The Phase 3 TIDES trial is ongoing, and longer-term data will be important in determining the efficacy and safety profile, particularly in baseline seronegative participants with dengue serotype 3 virus.

Takeda is engaging global health experts to provide insights into the burden of dengue in endemic regions and analyses of results from the trial. Takeda’s dengue vaccine candidate is not currently licensed anywhere in the world.

EP News Bureau

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AstraZeneca succeeds in treating lupus in late-stage study According to the Lupus Foundation of America, about five million people affected globally due to the disease

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straZeneca said its experimental treatment significantly reduced disease activity in patients with autoimmune disorder lupus, in a late-stage study.

The results pit the British drugmaker’s anifrolumab against rival GlaxoSmithKline's Benlysta - the only new drug approved for lupus in the last 60 years.

Benlysta recorded 473 million pounds of global sales in 2018, up 26 per cent from a

year earlier.

In the trial of 365 patients on standard therapy for moderate-to-severe systemic lupus erythematosus (SLE), 47.8 per cent of those who received anifrolumab experienced improvement in disease activity after 52 weeks of treatment, compared with 31.5 per cent of patients on placebo.

SLE is a debilitating and sometimes fatal chronic inflammatory autoimmune

disorder that can affect the joints, skin, heart, lungs, kidneys and brain, with about five million people affected globally, according to the Lupus Foundation of America.

More than half the patients on the intravenous treatment, administered every four weeks, were able to reduce their use of oral corticosteroids, compared with 30.2 per cent of patients on placebo, the company said.

Corticosteroids are used to

control problems caused by lupus, including inflammation, pain and tissue damage. “(The) results demonstrated that, by targeting the type I interferon receptor, anifrolumab reduces overall disease activity, reduces corticosteroid use and improves skin manifestations,” Eric Morand, principal investigator on the trial, said in a statement.

Reuters

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Insomnia symptoms tied to increased risk of heart attack and stroke Researchers followed 487,200 people in China for about a decade starting when they were 51 years old on average

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eople who have trouble falling asleep or staying asleep may be more likely to have a heart attack or stroke than individuals who don’t have any sleep difficulties, a recent study suggests.

Researchers followed 487,200 people in China for about a decade starting when they were 51 years old on average. None of them had a history of heart disease or stroke at the start of the study.

After almost a decade of follow-up, there were 130,032 cases of stroke, heart attack and other similar diseases.

Overall, people who had three insomnia symptoms trouble falling or staying asleep, waking too early in the morning, and trouble staying focussed during the day due to poor sleep - were 18 per cent more likely to have events like a heart attack or stroke than people without any of these sleep issues, the researchers reported in Neurology.

“These results suggest that if we can target people who are having trouble sleeping with behavioral therapies, it’s possible that we could reduce the number of cases of stroke, heart attack and other diseases later down the line,” Dr Liming Li, senior author of the study and a researcher, Peking University in Beijing, said in a statement.

About 11 per cent of the people had difficulty falling asleep or staying asleep; 10 per cent reported waking up too early; and 2 per cent had trouble staying focussed during the day due to poor sleep, the study found. The researchers didn’t determine if the people met the full definition of insomnia.

64 EXPRESS PHARMA November 16-30, 2019

The study wasn’t a controlled experiment designed to prove whether or how insomnia symptoms might cause events like a heart attack or stroke Compared with participants without specific insomnia symptoms, those who did have sleep problems were older, more likely to be female, not married, and from rural areas. People with insomnia symptoms also less education, lower income, and were more

likely to have a history of diabetes or mood disorders like anxiety or depression.

People who had trouble falling asleep or staying asleep were 9 per cent more likely to have events like a heart attack or stroke than people who did not have this trouble.

And, people who woke up too early in the morning were 7 per cent more likely to have these events than individuals without this issue.

When people had trouble staying focussed during the day due to poor sleep, they were 13 per cent more likely to experience events like a heart attack or stroke.

The increased risk of heart attack and stroke persisted even after researchers accounted for other factors that could independently affect the risk of stroke or heart disease like alcohol use, smoking, and level of physical activity.

“The link between insomnia symptoms and these dis-

eases was even stronger in younger adults and people who did not have high blood pressure at the start of the study, so future research should look especially at early detection and interventions aimed at these groups,” Li said.

The study wasn’t a controlled experiment designed to prove whether or how insomnia symptoms might cause events like a heart attack or stroke. Another limitation is that researchers relied on participants to report their own sleep symptoms and any heart attacks or strokes they had.

Reuters

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The United Engineering Company: Serving the pharma industry for the last five and half decades T

HE UNITED ENGINEERING COMPANY (UEC) with the brand name ‘UNITED’ is known for being the pioneer and commander in packaging machinery manufacturing in India. UEC, which was started in the year 1963 by GD Roy, has attained high reputation in providing machines and services of highest standards since the beginning. With the founder’s innovative ideas and unmatched leadership qualities, UEC crossed various boundaries in different fields of work.

Initiating the business with solutions for parenterals (ampoules and vials), UEC has diversified its business into the bottle packaging sector and has also mastered in providing machines for automatic tablet coating Initiating the business with solutions for parenterals (ampoules and vials), UEC has diversified its business into the bottle packaging sector and

has also mastered in providing machines for automatic tablet coating. UEC also provides customised solutions for its customers.

With a vision to provide the best pharmaceutical manufacturing technology, UEC has also ventured into different industries such as distilleries,

cosmetics, foods and beverage, paints, chemicals, home care, office and student stationery and others.

The company has also expanded its footprints abroad in a large way. Today, ‘UNITED’ machines are exported to more than 21 countries across the globe namely the US, Canada, Bolivia, Nigeria, Kenya, the UAE, Iran, Sri Lanka, Bangladesh, Malaysia, Indonesia, Vietnam, Korea, Russia, Ukraine and others.

UEC puts in a lot of effort for

TO ADVERTISE IN EXPRESS PHARMA, CONTACT:

HEAD OFFICE MUMBAI Rajesh Bhatkal The Indian Express (P) Ltd. Business Publication Division 1st Floor, Express Tower, Nariman Point, Mumbai- 400 021 Board line: 022- 67440000 Ext. 527 Mobile: +91 9821313017 Email id: rajesh.bhatkal@expressindia.com BRANCH OFFICES NEW DELHI Ambuj Kumar The Indian Express (P) Ltd.

Business Publication Division Express Building, B-1/B Sector 10 Noida 201 301 Dist.Gautam Budh nagar (U.P.) India.

Board line: 0120-6651500.

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HYDERABAD E.Mujahid The Indian Express (P) Ltd. Business Publication Division Malik Solitaire, No.401, 4th Floor, BPD, 8 - 2 - 293/82/A/701 - II, Road No. 36, Jubilee Hills, Hyderabad – 500 033 Mobile: +91 9849039936, Email Id: e.mujahid@expressindia.com

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IMPORTANT Whilst care is taken prior to acceptance of advertising copy, it is not possible to verify its contents. The Indian Express (P) Ltd. cannot be held responsible for such contents, nor for any loss or damages incurred as a result of transactions with companies, associations or individuals advertising in its newspapers or publications. We therefore recommend that readers make necessary inquiries before sending any monies or entering into any agreements with advertisers or otherwise acting on an advertisement in any manner whatsoever.

66 EXPRESS PHARMA November 16-30, 2019

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their R&D and strives to provide the best and optimized solution to its customers. By virtue of dedication and continuous hard work of their R&D team, ‘UNITED’ machines provide technically advanced solution for its customers. Presently, UEC is having its head office in Kolkata. It has three manufacturing units in West Bengal, covering an area of over 10000 sq ft. UEC is having its marketing and sales office in Mumbai to cater to the eastern part of the

never shirked the responsibility of the society and has always been an active participant in nu-

merous social events which help in uplifting the quality of living of the deprived. With almost every

pharma formulation manufacturer being an ‘UNITED’ machine user coupled with more

than 50 years experience, UEC commits in becoming better than the best in the near future.

For its customers, UNITED machines are cost effective but are guaranteed with the highest quality, optimum production and ensured unconditional service nation and overseas. The company has also set up well equipped service shop in Mumbai to service its clients. The United Engineering Company has been honoured by the prestigious ‘Innovator’s Award’ from the Indian Pharmaceutical Congress for their innovation and development and continuous value additions to the pharma packaging industry.

Today, at UEC, machines are equipped with the latest technology. For its customers, UNITED machines are cost effective but are guaranteed with the highest quality, optimum production and ensured unconditional service.

UEC is equally focussed on being a corporate citizen. It has

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HYDERABAD PHARMA SUMMITâ&#x20AC;&#x2122;19 IN IMAGES I

ndia Pharma Inc is also looking at capitalising these opportunities by making a transition from a mere generics manufacturer to a developer and supplier of innovative medicines. It is focusing on pioneering R&D and developing speciality/targeted therapies to ensure its continued progress.And, as a major life sciences hub,Hyderabad is well poised to lead Indiaâ&#x20AC;&#x2122;s growth story in the pharma sector.Therefore, Express Pharma, a leading industry publication from The Indian Express Group, organised the first edition of Hyderabad Pharma Summit on October 18, 2019 at Mansarovar the Fern, Hyderabad Hyderabad.

Hence, under the theme, 'Co-creating a smart ecosystem for pharma', the inaugural edition of Hyderabad Pharma Summit witnessed stakeholders in the pharma industry brainstorm on strategies to implement smart approaches in pharma with the help of technology and meet evolving business needs.

Check out a few glimpses of the event!

An auspicious start to Hyderabad Pharma Summit 2019 with a lamp lighting ceremony

AVPS Chakravarthi, Global Ambassador, World Packaging Organisation

68 EXPRESS PHARMA November 16-30, 2019

Chief Guest: Annam Visala, Deputy Drugs Controller (India), Hyderabad Zonal Office, CDSCO,

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Ramanuj Samal, Application Specialist, Beckman Coulter Life Sciences, India

Satya Prasad, Managing Director, Smart Lab Tech

Rajesh Premchandran, Director, Elgi Equipments

Atul Shastri, Associate President, Aurobindo Pharma

Barun Kumar Dey, Director & Head â&#x20AC;&#x201C; Packaging Development, Dr Reddy's Laboratories

Ajit Rangnekar, Director General, Research and Innovation Circle of Hyderabad Partner, SVP India

Vaibhav Datke, Sr Manager-Business Development, Ami Polymer

Sandeep Kulkarni, Co-Owner & Director, ImageProVision Technology

Srinivas Lanka, Mentor, Pharmaceuticals, Biotechnology, Ayurveda & Health Technologies, ElixGlobal and Consultant- Pharmexcil

Shantanu Panda, Deputy General Manager - Global Packaging Strategy, Mylan Laboratories

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First Global Bio-India 2019 to be hosted in Delhi Global Bio-India 2019 would deliberate on the opportunities and key challenges in the areas of bio-pharma, bio-agri, bio-industrial, bio-energy and bio-services sectors

T

he Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India, along with its Public Sector Undertaking (PSU), Biotechnology Industry Research Assistance Council (BIRAC) is organising Global Bio-India 2019 from 21-23 November, 2019 at Aerocity, New Delhi, in partnership with Confederation of Indian Industry (CII), Association of Biotech Led Enterprises (ABLE) and Invest India.

Recognised as one of the key drivers for contributing to India’s economy target of $5 trillion by 2024, the biotechnology sector is poised to grow exponentially over the next decade.

Policy initiatives of the Government of India (GoI), such as ‘Make in India’ programme, are aimed at developing India as a world-class biotechnology innovation and bio-manufacturing hub. India is among the top-12 destinations for biotechnology in the world valued at $51 billion during 2018-19.

Speaking at the curtainraiser of the event at the Ministry of Earth Sciences (MoES) in New Delhi, Union Minister for Science and Technology, Earth Sciences and Health and Family Welfare, Dr Harsh Vardhan, said,“India for the first time is hosting a mega event for the biotech community to attract investments, showcase our indigenous strengths and more importantly, fuel the hopes and aspirations of the indigenous talent pool.”

Global Bio-India 2019 would deliberate on the opportunities and key challenges in the areas of bio-pharma, bio-agri, bio-industrial, bio-energy and bioservices sectors. Some of the components of Global Bio-India 2019 would be events such as bio-partnering, policy dialogues, CEO roundtable, global regulators meet, investors roundtable, exhibition/pavilion

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including countries, ministries, departments, states, startups and others.

Also present at the occasion, Dr Renu Swarup, Secretary, DBT, stated, “Biotech is one of the identified champion sectors in the ‘Make in India 2.0.’ Our ambition for the event is to showcase the strength in the sector and let the world know that India is the destination to invest.”

A brochure of Global Bio-India 2019 was released at the event, along with the ‘Guidelines for Evaluation of Nanaopharmaceuticals in India.’

Speaking on the guidelines, Dr S Eswara Reddy, Joint

The event is expected to draw over 3,500 delegates connecting the Indian biotechnology ecosystem with the global ecosystem

Drugs Controller, said, “There is a huge potential to come up to develop the technology to reduce the toxicity and to improve the efficacy of the existing drugs that will lead to benefits in this area. In this connection, the DBT, in consultation with the Indian Council of Medical Research (ICMR) and Central Drugs Standard Control Organisation (CDSCO), has come up with the guidelines for the evaluation of the nanopharmaceuticals. As on date, we don’t have a clearly defined regulatory pathway for the approval of nanopharmaceuticals. With these guidelines, I am sure the industry, innovators as well as regula-

tors will help us for commercialisation of any information with respect to nanopharmaceuticals.”

Global Bio-India 2019 is expected to draw nearly more than 3,500 delegates from across the globe connecting the Indian biotechnology ecosystem with the international ecosystem. Further, the event is expected to strengthen the indigenous research and development capabilities, bio-entrepreneurship, investments at centre and state level and integration of innovative affordable products and technologies for the last-mile-delivery across India, including tier II and tier III cities and rural areas.

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Coming soon: 71st Indian Pharmaceutical Congress in Chennai The theme for this year is 'Pharma Vision 2030: Health care system- Role of Regulators'.The congress promises to provide immense food for thought and will act as a feast for the intellectual mind

C

oming December 20-22, 2019, the 71st Indian Pharmaceutical Congress-one of India's largest pharmaceutical congress will be held at Sri Ramachandra Institute of Higher Education and Research (DU), Chennai and organised by the Indian Pharmaceutical Congress Association.

Five national associations under one umbrella constitute the Indian Pharmaceutical Congress Association (IPCA). The constituent federation are sizeable and active in themselves.

The association comprises of Indian pharmaceutical association

(IPA), Indian Hospital Pharmacists Association (IHPA), Association of Pharmaceutical Teachers of India ( APTI), Indian Pharmacy Graduates Association (IPGA), and All India Drugs Control Officers Confederation (AIDCOC). The objective of the IPC is to dessiminated industry specific information to students, academia and constantly update the industry with latest advancements in pharma.

This year's IPC will be hosted by AIDCOC. The All India Drugs Control Officers’ Confederation was framed on December 28, 1995 at Visakhapatnam as a re-

sult of untiring efforts of many officers across the country and the initiative taken by the Andhra Pradesh Drugs Inspectors’ Association, the Kerala Drugs Control Enforcement Officers’ Association and Tamil Nadu Drugs Inspectors’

Association.

The theme for this year is 'Pharma Vision 2030: Health care system- Role of Regulators'.

The congress promises to provide immense food for thought and will act as a feast for the intellectual mind. The scientific programme has been designed to address challenges associated with offering quality medicines at affordable prices and fostering good manufacturing practices amongst pharma manufacturers. The conference will also cover advancements in new drug discoveries and delivery.

Besides this, the conference

programme will also offer sessions that will widen career opportunities and update students on scientific and academic advancements in pharma. On the sidelines of the conference AIDCOC will host a skill development programme on animal experimentation and regulatory toxicology.

There will be poster presentations as well.The last date for online submission of abstracts and summary for e-poster presentations is extended up to 7th November 2019 and Quiz registration extended up to 5th November 2019.

PHARMACONNECT 2020 to be held in Mumbai The event's purpose is to demonstrate the importance of optimised pharma supply chain and devise the innovative practices to overcome the current operational inconsistencies

O

n the way becoming one of Asia’s largest gatherings of pharma supply chain professionals, 2020's edition of PHARMACONNECT will be held on 16th January at The Lalit, Mumbai.

The event will feature highly interactive sessions, specialised tracks related to the pharma supply chain. PHARMACONNECT's last edition was attended by more than 300 delegates in Mumbai and earned the accolades of top industry leaders.

The purpose of the event is to demonstrate the importance of optimised pharma supply chain and devise the innovative practices to overcome the current operational inconsistencies. Driven by a broad range of pharma supply chain professionals and experts who firmly believe in the maxim of Walk the Talk, Conference also claims the support of leading logistics associations of India like, Air Cargo Agents Association of India, Association of

GOCONNECT has also positioned itself as the “Knowledge Chamber” with 5 conferences on logistics, heading different segments of Industry.

Important Information ◗ The selection procedure for Multimodal Transporters Association of India, National Association of Container Freight Stations of India, Federation of Indian Export Organizations, Federation of Freight Forwarders Association of India, Air Cargo Club of India, Custom House Association Delhi.

The event will coincide with the CARGOCONNECT excellence awards, which are based on the Performance Excellence Survey, which is attributed to the survey of more than 2,500 market participants in respective supply chain verticals to determine the top players. The awards, commenced by CAR-

GOCONNECT, are presented annually to players in the logistics domain achieving the highest points in the survey based on several performance factors, keeping in view the holistic and integrated approach taken by the Government in structuring the National Logistics Policy with new steps and initiatives taken to strengthen quality in the existing ecosystem.

CARGOCONNECT is a logistics industry magazine, serving the business for about two decades with over three lakh plus readership has been striving hard to bring desired reforms in logistics sector. CAR-

Awards nomination is sequential. ◗ The project will be first nominated through a Form (attached) ◗ The project will be evaluated according to the laid down criteria by the expert team. ◗ The project will also be evaluated by an independent set of jury members ◗ Winners will be announced at the Conference venue. ◗ The Winner in each category will be announced and CARGOCONNECT Trophy presented ◗ A booklet of the awardees in each category with the citation will be published in upcoming edition of magazine

The above mentioned Awards would be decided by the eminent Jury governing rules & procedural system for the evaluation of the entries. The Award selection process will go through a dual process of Jury.

The selected winners will be felicitated with Awards at the PHARMACONNECT 2020 Conference held on 16th January 2020.

Nomination forms can be downloaded from www.surecommedia.com , nominees can submit the form and send it to sales@surecommedia.com .

All entries will be acknowledged immediately on submission. In case the acknowledgement is not received within 24 Hrs, kindly contact, Contact: Ajeet Kumar E-mail: ajeet@ surecommedia.com Mobile: +91 9810962016

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Advantages of calcium phosphate based excipients in pharmaceutical formulations development Daniel Zakowiecki, Marek Lachmann, Vivienne Schaum and Tobias Hess of Budenheim, a Germany based company, discuss the advantages of calcium phosphate based excipients and the developments Budenheim has made in the area

Fig.1. Comparison of mechanical properties of tablets made of 99.5 per cent of various anhydrous dibasic calcium phosphates and 0.5 per cent of magnesium stearate compressed under tree different compression forces

I

n the series of articles published earlier in the Express Pharma magazine, the authors (Daniel Zakowiecki, Marek Lachmann, Vivienne Schaum and Tobias Hess â&#x20AC;&#x201C; BUDENHEIM, Germany) showed the advantages of using calcium phosphate based excipients in

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pharmaceutical technology, especially in the development of solid dosage oral formulations.

[1-6] In the present article we are going to summarise all information and highlight Budenheim new developments which provide further possibilities.

Calcium phosphates based

excipients have been present in the pharmaceutical technology for many years. They are widely used for plenty of reasons. First of all, calcium phosphates are inorganic substances of mineral origin, generally recognized as safe (GRAS) by the United States Food and Drug Adminis-

tration (FDA). They are GMOand animal-free substances which do not contain any organic residual solvents. They show good chemical and physical stability and are compatible with majority of known active pharmaceutical ingredients. The fact that calcium phosphates are a

natural source of such important elements as phosphorus and calcium makes them a very safe solution for patients.

Calcium phosphates as active pharmaceutical ingredients Owing to the safety and very

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high quality, some of Budenheim phosphates have recently gone beyond traditional application as excipients and are used as active pharmaceutical ingredients (API) as well – these API grades (calcium, sodium and magnesium phosphates) are registered and offered under the family brand name PharSQ Active.

Benefits for poorly flowable powders In addition to the benefits related to the safety of use, calcium phosphate based excipient offer many advantages from a technological perspective. Especially attractive are coarse, directly compressible grades. Due to their favorable particle size and shape they exhibit excellent flowability. In many cases they are able to govern the flow pattern of very poorly flowable powders which allows relatively easy preparation of tableting mixtures without a granulation.

Very high density of calcium phosphates allows either using of larger amounts of excipients without increasing the size of the dosage form or decreasing it when the same quantity of excipients is used.

Fig.2. Microscopic picture of PharSQ Spheres CM

Excellent compaction properties Dibasic calcium phosphates undergo mainly brittle fracture during compression. Thanks to that, they show very good compaction properties as well as low lubricant sensitivity. Increased amounts of lubricants or longer mixing time do not significantly affect the compaction properties of powder mixtures containing calcium phosphate based excipients.

Physical stability in aqueous media Calcium salts of orthophosphoric acid do not dissolve in water.

Moreover, in contact with aqueous media they do not swell or change their physical properties.

Therefore they can be successfully used in any technological operations involving water, e.g. wet granulation, as a completely inert densifier. In this case fine grades are the most frequently used. Another significant advantage is the immaculate white

colour that gives the tablets containing calcium phosphates more attractive appearance.

Improved characteristics Formulation scientists sometimes do not consider calcium phosphate based excipients as the first choice because of a common belief about their abrasive nature which might be problematic for a tablet press tooling.

This belief is rather obsolete since the progress in crystal chemistry and technology resulted in the development of new types of phosphates which are devoid of these adverse features.

However, it should be remembered that not all phosphates available on the market are the same - more information on this topic will be provided later in this article.

Various types of calcium phosphate based excipients There are many different grades

of calcium phosphate based excipient on the market. Budenheim also offers various forms of specialized calcium phosphates which can be flexibly used in different types of pharmaceutical processes: Dibasic calcium phosphate dihydrate (USP/NF), Calcium Hydrogen Phosphate Dihydrate (Ph.Eur.) – a coarse grade DICAFOS D 160 is the most widely used product for direct compression because of its very good both compaction and flow properties while a fine grade DICAFOS D 14 is very popular product used mainly in wet granulation processes. [1,7] Anhydrous dibasic calcium phosphate (USP/NF), Calcium Hydrogen Phosphate (Ph.Eur.) – directly compressible grade DICAFOS A 150 which has a very high binding capacity allowing to significantly increase the mechanical strength of tablets even at high drug concentration. The product is slightly acidic and the

possible effect on the microenvironment of the formulation should be considered. DICAFOS A 60 is another DC grade which has neutral pH and can be safely processed with pHsensitive drugs. Owing to elevated density the product helps to reduce the size dosage forms.

The level of water sorption is minimal making it ideal partner for water sensitive drugs. DICAFOS A 12 is another product with neutral pH and limited water uptake mostly employed in wet granulation processes.

Thanks to the very high intrinsic density, it allows to increase the density of obtained granules, as well as final drug products. [1,7] Tribasic Calcium Phosphate (USP/NF), Calcium Phosphate (Ph.Eur.) also known as hydroxyapatite [Ca5(OH)(PO4)3]. Budenheim offers fine grades for wet granulation (TRI-CAFOS 250 and TRI-CAFOS 350) as well as two unique, highly specialized products. First, TRI-

CAFOS 500, is a directly compressible material with elevated specific surface area. It is employed in tablet formulations to increase their porosity and consequently shorten disintegration time. Moreover, when used as co-diluent, it enhances the bonding capacity of powder mixtures and allows producing tablets with improved mechanical strength. [1,7] The second very interesting product is, TRICAFOS 200-7, thanks its special particle structure and properties it can be used as a flow regulating agent. In comparison to other popular glidants it offers a much higher bulk density which reduces dust formation and increases safety of handling. [2-5]

Comparison of various commercial calcium phosphate based excipients As mentioned earlier, it should be borne in mind that not all calcium phosphate based excipients available on the market are

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the same and can be mutually replaced in the formulation.

Even types intended for direct compression, although having a similar particle size, may differ significantly in terms of functional properties. Fig.1. shows the comparison of tabletting properties of four calcium phosphate based products for direct compression coming from different vendors. The placebo formulations consisted of 99.5 per cent w/w of anhydrous dibasic calcium phosphates and 0.5 per cent w/w of magnesium stearate.

Both substances were blended for 5 min at a rotational speed of 32 rpm using a Turbula mixer (Willy A. Bachofen AG, Muttenz, Switzerland). The powder mixtures were compressed into tablets using the Fette 102i rotary tablet press (Fette Compacting GmbH, Schwarzenbek, Germany) at 62.5 rpm using flat faced punches of 8 mm in diameter under three compaction forces: 10 kN, 20 kN and 30 kN (equivalent to 200 MPa, 400 MPa and 600 MPa respectively).

The comparison shown in Fig.1. reveals some significant differences between products available on the market not only in terms of particle structure and morphology, but what is more important, functional properties. Tablets made of two high quality products: DICAFOS A 150 and a product having similar morphology (described as Producer A) give similar results with regard to mechanical strength (hardness expressed as breaking force and friability. Material coming from both Producer B and Producer C are completely different in term of particle shape and structure. It has crucial impact on their performance. Tablets produced using these two materials demonstrate much lower hardness and are very friable.

This case study shows how crucial the proper choice of an excipient vendor is. One can imagine how costly could be the replacement of an excipient already used and established in the routine manufacturing with a lower quality material. Tablets produced could not meet the specification requirements which, in turn ended up with re-

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give new opportunities in new drug products development.

REFERENCES

Fig.3. SEM image of PharSQ Spheres CM

jection of the whole batch produced.

New possibilities with PharSQ Spheres CM starter pellets It would seem that we already know everything about calcium phosphate excipients. On the market there are many different products available. They have different properties and offer solutions for various formulation challenges. So what new could be still developed?

Well, it turns out that there are still many new possibilities.

Last year Budenheim launched a new product: calcium phosphate based starter pellets (PharSQ Spheres CM). These unique inert cores owe their properties to the combination of brittle material – dibasic calcium phosphate anhydrous – and the elastic one – microcrystalline cellulose. In comparison with other commercial inert pellets PharSQ Spheres CM offer

many interesting properties which can facilitate production of Multiple Unit Pellet System.(MUPS). [6,8] First of all, PharSQ Spheres CM exhibit much higher unit density compared to other existing starter pellets. This feature can be utilised in preparation of high-density systems which are able to increase the gastric residence time. Moreover, high density in combination with very spherical shape (Fig.2,3) assures excellent flow characteristic as well as good fluidization properties. Another important property is very low friability which is desired as it limits attrition and prevents from dust formation especially at the beginning of coating process.

PharSQ Spheres CM do not dissolve in water and are characterized by low hygroscopicity, which significantly facilitates the technological processes. The high content of anhydrous calcium hydrogen phosphate deter-

mines the physicochemical properties of the inert cores and significantly limits the contact of microcrystalline cellulose fibers with particles of drug substances, which in turn eliminates the possibility of unwanted drug absorption.

Summary: Budenheim is a Germany based company with an over 100- yearold tradition of producing phosphates. This experience allows delivering high quality excipients which help formulation scientists to meet their formulation challenges. Striving to make the pharmaceutical portfolio more attractive for industry partners, Budenheim has introduced the family brand PharSQ. Moreover, the company is strongly committed to develop new innovative products. One can soon expect the introduction of new products which will facilitate existing technological processes and

[1] Zakowiecki D, Lachmann M, Hess T. Beyond just a filler – application of calcium phosphates in direct compression formulations. Express Pharma 2017, 13 (3): 90-92 [2] Zakowiecki D, Lachmann M, Hess T. A new perspective on flow enhancement in solid oral dosage formulation – advantages of an unique glidant material TRI-CAFOS® 200-7 - Part 1. Express Pharma, Goa Pharma Summit Special, November 2018: 17 – 19 [3] Zakowiecki D, Lachmann M, Hess T. A new perspective on flow enhancement in solid oral dosage formulation – advantages of an unique glidant material TRI-CAFOS® 200-7 - Part 2. Express Pharma 2018, 14 (4): 142144 [4] Zakowiecki D, Lachmann M, Hess T. Tribasic calcium phosphate one compound, so many possibilities (Part 1). Express Pharma 2019, 14 (15): 54-57 [5] Zakowiecki D, Lachmann M, Hess T. Tribasic calcium phosphate one compound, so many possibilities (Part 2). Express Pharma 2019, 14 (19): 33-35 [6] Zakowiecki D, Lachmann M, Schaum V, Hess T. Novel starter pellets based on dibasic calcium phosphate anhydrous: properties and application. Express Pharma, November 1-15, 2019: 34-36 [7] Zakowiecki D, Lachmann M, Hess T. Eye on Excipients.

Tablets &Capsules Magazine, 2019, 17 (4): 39-43 [8] Zakowiecki D, Lachmann M, Huhn A, Papaioannou M, Hess T, Centkowska K, Milolaszek B, Cal K. Characterization of physical properties of novel calciumphosphate-based starter pellets (PharSQ Spheres CM). Poster presented at the AAPS Annual Meeting and Exposition, 2019 November 3-6; San Antonio, TX, US Contact: E-mail: sanjay.purohit@budenheim.com Webpage: www.budenheim.com

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INSTACOATSFC evaluation on multienzyme actives Suresh Pareek, MD, Ideal Cures and Sanjay Negi, GM, Tech Services, Ideal Cures give an insight on how INSTACOAT SFC adds value by reducing cost and improve product quality attributes

T

raditional sugar coating process is a multistage coating process with too much skill dependency and is often very time-consuming.

INSTACOAT SFC is the first and most advanced ready-touse sugar coating formulation that can be sprayed and well suited for all type of coating

Table No.1

Active Core Tablets Physical Characteristics:

Sr. No.

Parameter

1

Core Tablet Dimensions

2 3 4

Hardness (Kg/cm2) Friability (%) DT (min.)

Table No. 2

Sugar Coating Process Details:

Coating steps

Coating material

Seal coat

Instamoistshield Step1 Instacoat SFC Step 2 Instacoat SFC(Smoothening) Instaglow

Sugar fast coating Polishing

Specifications 5.32 mm thick black mottled, caplet shape, biconvex uncoated tablet plain on both sides.

4-5 0.22 7-8

Table No. 3

Reconstitution level (%w/w) 7

Solvent system organic

Weight gain (%) 3

28

Aqueous

26

12

Aqueous

2

7

Aqueous

0.2

Coating Pan Details:

Suresh Pareek, MD, Ideal Cures

Pan Details Type Pan Size (Inches) Baffles (No.)

Conventional 48 3 Gun Details

Gun Type No of Guns Nozzle Diameter (mm)

Sanjay Negi, DGM Film Coatings, Ideal Cures

equipment (conventional, perforated and continuous). INSTACOAT SFC has given the pharmaceutical industry opportunity to shift from skill to science-based sugar coating process. INSTACOAT SFC adds value by reducing cost and improving product qual-

ity attributes.In this study, INSTACOAT SFC formulation performance is evaluated on multienzyme actives.

Experimental method 5.32 mm thick black Mottled, caplet shape, biconvex uncoated (plain on both sides)

4-Port ABC 2 1.5

multienzyme tablets(Fungal Diastase and Papain) were used as core for the sugar coating process. The core tablets were evaluated for hardness, friability and disintegration (Table No.1). A 48 inches conventional coating pan was used for the coating

process (Table no. 3). Seal coating( Instamoistshield), Sugar Coating(SFC) and polishing of the tablets were done (Table No.2 and 4). InstacoatT SFC coating suspension was prepared as per Ideal Cures product usage guidelines. Instaglow was used in

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the final polishing step.

Table No. 4

Coating Process Parameters

Results The coating process parameters for Instacoat SFC were well optimised in the 48’’ conventional coating pan. Multienzyme tablets were successfully coated using Instacoat SFC and the coated tablets achieved very smooth coating finish as compared to the manual conventional sugar coating. The coating process was completed without any process concerns and nil coating defects. The physical characteristics and disintegration time of the coated tablets were found well within the desired specifications. Instacoat SFC coated tablets showed excellent coating weight uniformity and glossy finish.

Conclusion The coating process results demonstrated that Instacoat SFC is well optimised for a spraying process in an autocoater. Instacoat SFC-based scientific coating process was very simple and user friendly when compared with the customers inhouse sugar coating process. The coating finish was more uniform and the process was more efficient as compared to the conventional ladling process which doesn’t

Parameters

Seal Coating

Weight Gain (%) Product Bed Temp (°C) Atomizing air pressure (bar) Pan speed (rpm) Table No. 5

3 33-36 2.0 3-5

Process Steps Sugar fast Sugar fast coating coating Step I Step II 26 2 34-39 38-40 3.0 3.0 6-8 6-8

Polishing 0.2 38-40 3.0 8-10

Coating Suspension Observations Process Steps

Sr. No.

Parameters Seal Coating

Sugar fast coating

Sugar fast coating

Polishing

1

Sprayability

The suspension was smooth free flowing without any agglomerates and was easily sprayable.

2

Gun Blockage

No gun blockage was seen throughout the process.

Table No. 6

Characteristics of Sugar coated tablets

Sr. No.

Parameters

1

Appearance

2 3

Dimensions (mm) Disintegration Time (min.)

Observations A black, caplet shape, biconvex sugar coated tablet plain on both sides.

17.66 x 9.61 x 6.3 mm ± 0.2 mm 20-33

Multienzyme tablets were successfully coated using Instacoat SFC and the coated tablets achieved very smooth coating finish as compared to the manual conventional sugar coating yield consistent results in terms of product quality and process.The reproducibility of Instacoat SFC coating process was good and have been proved successfully at commercial scale batches (Autocoater and Conventational

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Coating Pans). Instacoat SFC is the first and the most advanced sprayable sugar coating formulation designed to simplify the sugar coating process, improve process efficiency and overall product quality.

Figure No. 1: Instacoat™ SFC Coated Tablets

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I N T E R V I E W

‘We have very aggressive plans for the Indian market’ Sandeep Kulkarni, Co-Owner & Director, ImageProVision Technology, in an interaction with Express Pharma, talks about ImageProVision Technology’s growth prospects in the Indian and global markets Can you explain briefly about (company) portfolio?

ImageProVision Technology is a leading Indian company in physical testing space with an emphasis on Image Analytics.

ImageProVision’s products and services cater to pharmaceutical, life sciences, bio-technology, medical, chemical, defence segments.

In a very short period of time, ImageProVision has created a dominant position in microscopic image analysis and has developed some pathbreaking solutions for optical, polarised, hot stage, scanning electron microscopy. Some popular products like microscopic particle analyser, particle classifier, particulate matter counter, nano particle analyser, smart proof reading system, etc are being used by major Indian pharma companies. ImageProVision has also developed high technology products powered by machine learning and artificial intelligence.

With more than 140 installations at 60 customers locations, ImageProVision is working with leading pharma companies. These products are used in R&D for new drug development and in manufacturing QA/QC during drug production. All products comply to regulatory requirements such as 21 CFR compliance.

ImageProVision has a strong team of technology and domain experts. Innovation

maximum number of customers. We are increasing our sales team and also investing in marketing with sponsoring major events and reaching to the customers. We have also significantly increased our investment in R&D with a dedicated laboratory for sample inspection and demonstration. New products powered with machine learning and artificial intelligence is being developed at our R&D.

New state-of -the-art technology development would enable new frontiers for growth being the core theme of ImageProVision’s culture, ImageProVision has won prestigious awards like India Pharma Award, Startup Masterclass Award, NASSCOM Emerge-50 award etc.

What are your plans for the Indian market in

forthcoming fiscal? What kind of investment would be made in this market?

We have very aggressive plans for Indian market. We plan to double our revenue this financial year compared to last year. We are progressing well with our plans.

We are investing in sales and marketing to reach to

What kind of growth do you envisage in the next three years? What would be the factors driving this growth?

We have an aggressive growth plan for next three years, by growing at least five times of current size.

Major factors are: ◗ Strengthen and Grow Indian business at higher pace ◗ Establish US and European business ◗ Enter into new territories of the world.

We are strengthening our team to prepare for exponential growth. New state-of -the-art technology development would enable new frontiers for growth.

Tell us about your international presence. Any plans to expand your footprints overseas?

We have recently started working in the North American market. Initial

results are encouraging.

However, we need to put the sales and support network to address the requirements of customer in the US. Similarly, we have initiated our efforts in the European market. We see a very good potential in both the markets.

What are the growth opportunities opening up in the pharma sector both, globally and India? How poised are you to leverage these opportunities?

The pharma sector becoming more concerned about regulatory aspects gives us a lot of opportunities. Our products are conforming to all regulatory requirements.

Particle characterisation is a fundamental requirement of all R&D. Our new patented technology has helped many customers to successfully get regulatory approvals.

Our initial success encourages us to for exponential opportunities.

What are you showcasing at P-Mec India/CphI this year and what are your expectations from the event?

CPhI / P-Mec India is a major pharma event. We look forward to get more insights about the market, customer expectations and new trends in pharma industry.

EP News Bureau

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‘We want to increase our global footprints’ Dr Kiran Badgujar, Co- founder & Director, Mack Pharmatech and Manoj Choudhari, Cofounder & Director, Mack Pharmatech, in an interaction with Express Pharma talk about the on the company’s growth strategy, the challenges and the roadmap ahead

Can you explain briefly about (company) portfolio?

In 1999, Manoj Chaudhari, Cofounder & Director, Mack Pharmatech and I started a service-based business. Both of us share an engineering background. At the moment, Mack Pharmatech is one of the top brands in the pharma and laboratory equipment industry.

Mack Pharmatech is the first Indian company to have acquired the CE certification.

All our products are CE marked. We have worked our way up from the absolute ground level. We develop our own products with the latest technology.

Starting with just two employees, today we have a strength of more than 200. We have our own service stations across the India with 24x7 technical support for machine as well as software. At present, Mack Pharmatech has four operational plants.

All these plants are equipped with latest technologies and highly skilled human work force.

What are your plans for the Indian market in forthcoming fiscal? What kind of investment would be made in this market?

Customer satisfaction is always a priority for us. Mack Pharmatech plans to develop the service stations with the necessary technical aspects.

Quick and timely service is the basic need of this industry and customers always require support from the back end team. Hence, it is our top

80 EXPRESS PHARMA November 16-30, 2019

Dr Kiran Badgujar, Co- founder & Director, Mack Pharmatech

Manoj Choudhari, Co- founder & Director, Mack Pharmatech

priority to invest and develop the backend team. We are looking at increasing the strength of our marketing team as well, across the different regions of the country.

What are the growth opportunities opening up in the pharma sector both, globally and in India? How poised are you to leverage these opportunities?

Many new companies plan to develop their facilities in India. As mentioned before, Indian government has developed industry-friendly policies. States like Gujarat and southern states are particularly considered more industry friendly and you would see different industries setting up their plants over there. The pharma industry in India will definitely have a great future in the coming years.

CphI this year and what are your expectations from the event?

Mack Pharmatech plans to show its new product Autoclave with all latest technologies and we also plan to show our software with few unique features and technologies. We are confident that our products are going to raise the curiosity levels of pharma clients in Cphi.

In this event, we expect to get new business leads. We also hope to get an opportunity to expand our business in overseas countries. And last but not the least, we want to keep our tradition of having huge number of visitors this year too.

What are you showcasing at

EP News Bureau

What kind of growth do you envisage in the next three years? What would be factors driving this growth?

There is an ample growth for the pharma sector in the country. Many new brands are willing to set up their palnts in India due to favourable government policies and resources. We expect to reach the turnover of more than Rs 50 crores by 2023.

Tell us about your

international presence. Any plans to expand your footprints overseas?

Since 2005, Mack Pharmatech has supplied its products and also completed many projects in the countries like Sri lanka , the UAE, Philippines ,Nepal , Vietnam , Saudi, Nigeria and many more. To be more specific, we have our operations in more than 25 countries.

Currently, we are focussing more on the South Asian and the Middle Eastern Markets. Mack Pharmatech is working with channel partners in different countries. Our next big target is to have our footprints in the European as well as the US markets.

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InstaSphere TAâ&#x20AC;&#x201D; Creating the perfect pH modulation for the extended release of weakly basic drugs Ideal Cures has expanded their line of spheres by introducing seal coated tartaric acid spheres i.e.

InstaSpheres TA which are robust, round and consistent with narrow particle size distribution.

Suresh Pareek, MD, Ideal Cures, Saryu Pareek Gupta, VP- Marketing Communication and Sanjay Negi, GM, Tech Services, Ideal Cures, reveal more Physico chemical characteristics of InstaSpheres TA

T

he last few years have seen an increase in the number of newly developed drug molecules with greater lipophilicity, higher molecular weight, and poor pH dependant solubility.

About 40 per cent of drugs with market approval and nearly 90 per cent of molecules in the discovery pipeline for the next decade have solubility issues.

The majority of failures in new drug development have been attributed to poor water solubility of the drug. Most drug substances are either weak acids or weak bases, so they are ionizable depending on the pH of the gastro-intestinal (GI) tract. This pH dependent drug release may result in variable plasma levels and resultant bioavailability.

In order to enhance the solubility of weakly acidic and basic drug molecules, there have been attempts to maintain the pH profile within microenvironment of the dosage form. The success of this approach requires the presence of sufficient pH modifier having adequate solubility and pKa to maintain low pH around the drug. The pH modifier should not leach out quickly from the dosage form but should remain until the drug is completely released. Studies have suggested the use of tartaric acid spheres acid as pH modifier owing to its lower acidic strength and high aqueous solubility however, this has met with limited success. Tartaric acid has been often applied as a coat over neutral sugar spheres for pH modulation.

Keeping this scenario in mind, Ideal Cures has expanded their line of spheres by introducing seal coated tartaric acid spheres i.e. InstaSpheres TA which are robust,

Suresh Pareek, MD, Ideal Cures

Saryu Pareek Gupta

Sanjay Negi, GM, Tech Services, Ideal Cures

Figure 1: InstaSphere TA Features

The physical and chemical characteristics of InstaSpheres are shown in Table 1. Uniform size of spheres is very essential for uniform drug loading.

Microscopic examination (Optical Microscope Make: Olympus Model: CX 41) of InstaSpheres TA reveals good integrity of seal coat layer. The spheres have higher aspect ratio which suggests high degree of sphericity. InstaSpheres TA are smooth, spherical, consistent, robust and within narrow size distribution. Here, we want to exemplify application of InstaSphere TA (seal coated tartaric acid spheres) as a pH modifier for extended drug delivery of weakly basic drug. We selected a weakly basic model drug with markedly pH-dependent solubility and irregular and incomplete absorption from the gastro-intestinal tract for the study.

Experimental work

Table 2: Physical and chemical characteristics of InstaSpheres TA

Parameter pH (2% w/w Slurry) Bulk Density (g/cc) Friability (%) Assay of tartaric acid (%w/w) Sphericity (%) LOD (% w/w) Residue on ignition (% w/w) Heavy metals (ppm) Microbial enumeration test

Limit 1.5-2.5 0.85-1.15 NMT 1% NLT 75.0% NLT 75% NMT 1% NMT 5% NMT 10 Meet the requirement of current USPNF

round and consistent with narrow particle size distribution. InstaSpheres TA â&#x20AC;&#x201C; Seal coated tartaric acid matrix pellets from Ideal Cures is expected to be used as a functional starter core to modulate the pH around the drug. The seal coat would prevent direct contact between tartaric acid and drug to avoid acidic degradation of drug and control the release of tartaric acid in microenvironment which in turn modulates the pH around the drug.

The design of multilayer coated weakly basic drug pellets with InstaSphere TA as starter core is presented in Figure 1. The multilayer coating was conducted in fluid bed coater (GPCG1.1-PamGlatt) with Wurster column (bottom spray). The manufacturing process was conducted by loading the drug suspension on InstaSpheres TA followed by protective coating and extended release coating.

If tartaric acid depletes faster, the dissolution of weakly basic drug will show limited release at higher pH above 5.

Hence, to understand the release mechanism, the dissolution of tartaric acid from the pellets was also studied along with

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Table 3: Microscopic examination of InstaSpheres TA # 20/30 (0.6 to 0.85 mm)

1

InstaSphere TA

Mean ± SD Mean ± SD 700.06 ± 35.34 700.06 ± 35.34

Tartaric acid adsorbed on sugar spheres

120 Tartaric acid remaining (%)

Parameter Parameter Length 1 μm) Lengthdm dm(d(d μm)

Figure 2: Tartaric acid remaining inside core pellets in InstaSphere TA during dissolution

Length dm (d2 μm) 776.47 ± 31.59 Length dm (d2 μm) 776.47 ± 31.59 Aspect Ratio (d1/d2) 0.9 Aspect Ratio (d1/d2) 0.9 Sphericity (%) 85 Figure 1: Microscopic image of InstaSpheres TA # 20/30 (0.6 to 0.85 mm)

100 80 60 40 20 0 -20 0

2

4

6

8

10

Time (Hrs) dissolution of drug. The drug release from the pellets was characterised in 0.1 N HCl for first hour, followed by 0.1 M Phosphate Buffer, pH 5.5, for 7 hours.

Our results show controlled drug release by simultaneous release of tartaric acid. The pH dependency of the drug release was found to be reduced which confirms that the acidic microenvironment provided by InstaSphere TA can modulate the drug release. Tartaric acid from Figure 3: Pictorial presentation of multilayered extended release pellets

InstaSpheres TA (Seal coated Tartaric acid spheres) Drug Suspension layer Protective Coat with Instacoat Universal Extended release coating with Ecolpol S 100

Figure 4: An Example of In vitro drug release with simultaneous release of tartaric acid from ER pellets

Drug

Tartaric acid

120

% Release

100 80 60 40 20 0 0

1

2

3

4

5

Time (Hours)

82 EXPRESS PHARMA November 16-30, 2019

6

7

8

9

InstaSphere TA retained for the entire duration of drug release.

Our results suggest that InstaSphere TA containing tartaric acid works as a pH modifier to release the weakly basic drug and remains within the pellets for the entire duration of drug dissolution. The drug release was found significantly lesser in the absence of InstaSphere TA. It is confirming the formation of an acidic microenvironment by InstaSphere TA. Earlier methods of application of tartaric acid as pH modifier were based on coating of tartaric acid on sugar spheres. We observed that the release of tartaric acid is more controlled from InstaSphere TA compared to tartaric acid coated sugar spheres. InstaSpheres shows superior retention of tartaric acid which is essential for the desired release of drug.

Our observations from accelerated stability study suggests that the prepared pellets are stable up to six months when packed in HDPE bottles with desiccant (silica bag) and doesn’t show any sign of physical or chemical instability. The seal coat present in InstaSpheres TA can prevent direct contact of tartaric acid and drug during storage and stabilizes the drug in presence of acid. The result doesn’t show any significant change in the dissolution of drug during accelerated stability period upto six months.

Conclusion Our results suggested ability of InstaSpheres TA to lower the

micro-environmental pH for the desired extent and duration. The coated pellets can provide acidic microenvironment facilitating the extended drug release in higher pH of GI tract. InstaSpheres TA due to the seal coat, avoids direct contact of tartaric acid with drug and reduces the pH dependency of the drug release. The study shows stability of drug over entire duration of accelerated stability studies. The findings show the effectiveness of InstaSpheres TA as a pH modifier functional starter core for pH independent release of weakly basic drugs.

‘The development of seal coated tartaric acid has been in line with the company’s vision.

We already offer a range of neutral spheres and plan to expand the range further.Being an excipient company, we take pride in making products that enhance the value of our customer’s products and our seal coated tartaric acid Instaspheres do just that!’

While some properties don’t seem significant at small scale, they strongly affect products success at larger scale. As the pellet formulation becomes more and more complex, the quality aspects of starter cores and their processability can have a greater impact on cost and quality of final product than the base price of pellets does. Even though the starter pellets like Tartaric acid pellets may seem like a small detail compared to the entire formulation, its strength and quality has a huge impact on the performance and quality of the final dosage form.

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0

ULTFreezer -86 C provide safe and reliable performance to fulfill storage conditions Ultra Low Temperature Freezers — (All for the safety of your samples) REMI ULT Freezers models ULT -490 and ULT -650 with their environmentally friendly design incorporates the latest in cabinet, refrigeration, temperature control and monitoring features. They provide a safe and reliable performance to fulfill storage conditions in life science, biological, medial and other applications.

ULT Freezer -860C

ULT Freezer -860C

Features ◗ Energy-efficient design, non CFC foamed in place urethane insulation ◗ Multi-colour touch screen display with Passowrd ID recognition ◗ Front USB for data logging ◗ Graphic User interface for temperature settings and alarms ◗ Vacuum relief port for pressure equalisation ◗ Exterior door gasket providing energy efficient thermal barrier and reduce frost build up ◗ Port for LN2/CO2 back up system (optional) ◗ 485 communication interface ◗ Remote alarm contacts Contact www.remilabworld.com website: sales@remilabworld.com

Technical Data Model

ULT-490

Temperature Range (0C) Nominal Capacity (Litres)

ULT-650 -50 to -86

490

650

Inner door

4

Shelves

3

Controller type

Microprocessor, Touch Screen Display

Minimal temperature (0C)

-86

Screen Password

Yes

Alarms available for:

Power failure, Sensor failure, Low Battery, Backup battery, High/Low temperature, Door open, High condenser temperature, and Remote alarm,

Exterior dimensions (mm) W x D x H

900 x 929 x 1990

1091 x 929 x 1990

Interior dimensions (mm) W x D x H

589 x 637 x 1310

780 x 637 x 1310

Supply: 220-240 Volts, 50 Hz Single Phase

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India will remain the ‘core hub’ for the Asian market OPTEL is a leading global provider of traceability systems. Louis Roy, Founder President of OPTEL GROUP and a leader in supply chain transparency and human behavior changes, along with Shaunak J Dave, CEO (Asia), OPTEL GROUP divulges more details about the company and its growth plans, in an interview with Express Pharma What are your plans for the Indian market in forthcoming fiscal? What kind of investment would be made in this market?

Since 2011, when we initiated our business development activity in Asia, India has been a very significant market and we firmly believe that it is going to be a key driver of OPTEL GROUP’s growth in this region.

As per our long-term commitment, we invested noticeably to set up our manufacturing facility in 2015 and now more than 80+ young and dynamic engineers are shaping our vision into action.

We have been investing in India for an 'autonomous yet collaborative' global organisation where a local team will engineer solutions based on the market needs. Our investment will further strengthen our capability with the 'Intelligent supply chain' solution for Asia.

What kind of growth do you envisage in the next three years? What would be factors driving this growth?

The next three to five years will be disruptively challenging for us as we envisage a big growth globally with increasing application of our 'Intelligent Supply Chain' concept in diverse industries. The business will be driven with passion and mission. The mission is to build a better

Indian pharma industry with our breakthrough “Intelligent Supply Chain solution for a secure, visible and integrated supply chain platform that will increase efficiencies, reduce waste, increase transparency and enhance consumer/customer experiences .

What are you showcasing at CPhI this year and what are your expectations from the event?

Louis Roy, Founder President, OPTEL GROUP

Shaunak J Dave, CEO (Asia) OPTEL GROUP

world through traceability technologies. Our passion is to change the behaviour of the entire business and social ecosystem to encourage sustainability and responsible capitalism.

solution for diverse markets.

Tell us about your international presence. Any plans to expand your footprints overseas?

OPTEL is a global multicultural company with diverse nationalities working across the world . We have our manufacturing base in Canada, USA , Brazil , Ireland and India. We are looking at a few countries in Asia for future expansion, but India will remain the 'core hub' for the Asian market. A few years back, we acquired two companies to strengthen our end-to-end traceability

What are the growth opportunities opening up in the pharma sector both, globally and India? How poised are you to leverage these opportunities?

The Indian pharma industry has earned a reputation as a 'global generic hub' and around 20 per cent of world’s generic medicines are produced in India. Our export market is very huge and diverse, we export to over 200+ countries. Now, we have set ourselves an ambitious goal but to achieve that the pharma industry must focus on 'innovation' and 'efficiency'. As serialisation is a move towards building efficiency in the pharma supply chain, the OPTEL is committed to serving the

The concept of Intelligent Supply Chain, powered by traceability and disruptive technologies, will be showcased at our booth, along with Serialization and Aggregation Units. We would like to demonstrate to Asian pharma customers how to leverage this solution for business growth (improving top and bottom line), earn customer trust and contribute to a sustainable world .

NEWAGE SOLUTIONS FROM OPTEL Raw Material Traceability Solution OPTEL’s raw material traceability solutions offer unparalleled data collection and analysis, providing qualitative and quantitative data to track and authenticate raw materials. Our solutions can help you leverage such data as demographics, field characteristics, infrastructure, monitoring and more. The result is increased visibility at the source and direct communication with raw-material suppliers.

Product identification (serialization) Assigning a unique product identifier (UID) to every item and the ability to track the parent-child relationship during packaging and shipping operations are key components of the Intelligent Supply Chain®. Also known as serialization and aggregation, these processes can be driven by regulatory requirements or by a desire to ensure product safety and prevent counterfeiting.

Vision & Inspection Solutions Vision inspection solutions, also called machine vision systems, are automated inspection systems and solutions based on imaging technologies such as cameras or scanners. Automated vision solutions allow complete inspection of labels and packaging, using artificial vision systems that are part of what we now call artificial intelligence (AI). They are an essential part of quality control.

Track & Trace Solutions Traceability allows you to view data in a multidimensional context. It strengthens authentication, safeguards against counterfeiting and grey-market diversion, and wins litigations thanks to item-level traceability and chain-ofcustody reports. OPTEL’s digital traceability software and hardware solutions ensure real-time visibility into your supply chain’s state of health, helping you to prevent outbreaks, quickly identify sources of contamination, and manage recalls faster and more efficiently.

Behaviour insights for customer engagement With so much marketing chatter, you need to reach your customers with the right offer at the right time. Our customer engagement solutions help you rise above the noise and deliver unique, personalized offers via digital, mobile, social and instore channels. Use our secure, unique identifiers on physical products or in digital campaigns to supercharge your customer rewards programs.

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” Vision is the art of seeing what is invisible to others ” - Jonathan Swift

Traceability technologies for a better world

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In this disruptive era, what differentiates a successful company from others is its ability to see the

B IG

PIC TU R E

Serialisation in Pharma has open immense potential of end to end traceability that will create a disruption in the supply chain, impacting organisation top- (Business Growth) and bottom-line (Profitability) as well as beneficial to all the stakeholders.

Resource Extraction

B

I

Waste & Recycling

Y IT

EN

T R A C E A

L

D

T

O

D N E

Production

End-users

Distribution

While you select your serialisation partner, do not forget to

STOP and LOOK at the BIG PIC TURE of the INTELLIGENT

Please contact SME [sme-asia@optelgroup.com] at Optel Group to find out how traceability can help build integrated, transparent, visible, efficient, secure and customer-centric supply chains.

OPTEL Vision India Pvt Ltd N6, Phase IV, Verna Industrial Estate, Goa India 403722 Phone: +91 832 669 9600

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‘ Don’t miss the Big Picture’ Sanjay Sonar, Subject Matter Expert – Traceability, (OPTEL GROUP) emphasis that while choosing a serialisation system in a purchasing decision, drug manufacturers should look not just at a short- term cost benefits , or its initial purchase price, but , its total cost of ownership (TCO) aligned with long-term big gains as serialisation is first step towards integrated , transparent , visible and secure supply chain leads to tremendous impact on company’s bottom line ( profitability ) and top line ( growth)

I

n the global economy, where critical pharmaceutical products move across international borders, preventing counterfeiting, and ensuring patient safety has been an essential focus for the industry and regulatory body across the globe. Today, regulations include allocating a unique identification number to the smallest unit of sale (for example, a bottle) and tracking that product through its serial number all the way along the supply chain, such that the authenticity of the product is verifiable at any point. These regulations have been in place for quite some time in markets like Turkey and China. More recently, markets such as India, the US, and EMEA have come with similar laws to require serialization and track & trace to be implemented over the next several years.

Serialisation ensures the integrity of pharma products, and it goes a long way toward protecting patients from dangerous counterfeit drugs. It also protects the pharma companies from loss of revenues and potentially brand disrupting recalls. However, for drug manufacturers, mandatory serialisation does come with its own set of business challenges.

Compliance with new regulations requires them to make significant investments in serialization technologies, and adapt their packaging lines to adapt serialisation operations. The initial investment can be estimated anywhere from $100,000 to $1,000,000 per line depending on the complexity and level of automation required, such as auto bundlers, case packers, palletizers, etc. This requirement comes at a time when pharma manufacturers are facing increasing pricing and margin pressures.

TCO in Action Acquiring serialisation systems brings purchase costs, but ownership will also lead to many other

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‘hidden’ costs. When choosing among alternatives in a purchasing decision, drug manufacturers should look not just at a shortterm price, or its purchase price, but also at its long-term price, or its total cost of ownership (TCO).

The serialisation system with the lower TCO is the better value in the long run. There is an obvious need among the buyers in the industry to effectively evaluate the TCO to uncover both the obvious costs and the "hidden" costs of ownership of a serialisation system.

Let us try to understand the importance of TCO analysis while making the right purchasing decision with the help of the example shown in the bar chart below.

In this example, we will try to compare the TCO of two imaginary suppliers (Option A and Option B) based on five major parameters that affect the TCO of the serialisation system.

The role of these parameters are as follows: Initial capital investment (or cost of acquisition of serialisation system): This is a sum of the cost of engineering, project management, installation-startup, equipment qualification, and operator training. The cost incurred

due to production downtime required for the initial integration of the serialization system with the production line can be added in this category.

Rejection cost (hidden cost incurred due to rejection rate of the system): This cost can be estimated by multiplying 'the cost incurred due to rejection of each product (for example, a bottle)' with the 'total no. of the rejected unit at a given period'. Here the cost incurred due to rejection of each product can be a sum of the value of the lost drug, lost packing material, lost printing, lost serial number, etc. The cost of rework can be in addition to this cost.

Operator cost: This is the cost of skilled and unskilled labor required to operate the serialization system. It can be estimated by multiplying the “cost of each man-

hour” with the “total number of required man-hours at a given period”.

Utility cost: This is the cost of all types of utility required to run the serialization system. It can be estimated by multiplying the “hourly cost of utility” with the “total no. of hours of operation at a given period”.

Service and maintenance cost: This is the cost incurred for planned and unplanned services, maintenance, and breakdown. It can be estimated by multiplying the “cost of each service manhour” with the “total no. of required man-hours at a given period”. Here the cost of production downtime due to service and maintenance activity can also be added in this category.

Lost opportunity cost: This is a hidden cost related to losing the opportunity due to the choice of the purchase option. This cost can evaluate by multiplying the “production loss (hours) due to breakdown, stoppages, rejection, and speed limitation” with the “cost of each hour of operation (operation + utility cost).”

Referring to this example of five-year TCO comparison from the bar chart, the following primary observations and conclu-

sion can be drawn: The initial capital investment of Option A is 30 per cent higher, and Service & maintenance cost is 50 per cent higher when compared to Option B. However, if we look at the cumulative five year TCO, Option A is more economical by over 20 per cent.

The significant factors that make the TCO of Option B more expensive are the rejection cost and loss of opportunity cost.

In Option B, over five years, the initial capital investment and rejection cost will contribute equally at 30 per cent to the overall TCO. Here, the rejection rates of Option B are considered 3 per cent against 0.5 per cent of Option A. With the help of some mathematics, it is also possible to find the payback period for the excess initial capital investment and service & maintenance cost if Option A is selected. This payback time will not be more than 1.6 years.

Conclusion At a time when drug manufacturers are facing increasing pricing and margin pressures, selecting the right supplier before you implement a serialization solution can save time and money as you begin the process. It must be acknowledged that TCO in the selection process goes beyond cost reduction. It helps develop a more comprehensive picture of exactly what you’re buying, what value that acquisition provides the company, and how much it costs in the long run. A right supplier will reduce your overall TCO by eliminating the hidden costs and improve the competitive advantage of its serialization system. Hence, TCO typically produces a win-win result for both the buyer and its supplier, as it can help strengthen buyer-supplier relationships by reducing the unnecessary strain of extreme cost-cutting measures.

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Kappa Bioscience and SAPharmachem to focus on Vitamin K2 in CPhI 2019 CPhI19 will mark the Asian release of Kappa’s new nine-year study on vitamin K2 product quality

K

appa Bioscience, maker of K2VITAL vitamin K2-7, will co-exhibit at CPhI in Delhi from November 26-28 alongside distributor SA Pharmachem, based in Mumbai. The two companies companies announced a first-ofits-kind drug import license for vitamin K2 in India at CPhI18 and will present recent market developments at this year’s show.

does not interfere with healthy cardiovascular function.

CPhI19 will mark the Asian release of Kappa’s new nine-year study on vitamin K2 product quality. Unprotected vitamin K2 is not stable in formulations with mineral salts such as calcium or magnesium. Kappa’s Market Study 2019 spans 409 global K2 products and demonstrates that 84 per cent of K2+minerals

ufacturers to launch successful K2 products. The new 2019 edition of the K2 Formulation LookBook will also be distributed at CPhI. The LookBook is a complete source of information on how to launch K2 products, including 150 formulations which are available for license-free use.

Kappa will also present several new sample concepts tailored to Indian consumers. DELTA’s

Kappa’s microencapsulated K2VITAL DELTA K2-7 product was granted registration and a drug import license. This enabled the expansion of vitamin K2 into the Indian pharma market and opened new channels to consumers. Osteoporosis is a significant problem within India’s large and growing elderly population, and calcium supplementation is a common prescription. Pharmaceutically approved vitamin K2 ensures that calcium supplementation optimally supports bone health, but

products failed label claim for K2 amount. These results mirror Kappa’s findings for Indian products published in 2018. Kappa’s protected, microencapsulated K2VITAL DELTA is the marketleading solution for K2 stability.

DELTA is the only microencapsulated K2 with Indian drug approval.

Kappa and SA Pharmachem will present recent market developments such as the newly developed Critical Quad model.

The model describes why the time is right for brands and man-

proven stability with calcium reduces overage, delivers better cost-per-use than unprotected K2, and ensures K2 label claim.

Vitamin K2 is essential to bone and cardiovascular health because it mediates calcium use in the body. K2 activates osteocalcin proteins which incorporate calcium into bone, and matrix Gla proteins (MGP) which bind excess calcium to prevent deposit in the arteries. Bone health products containing calcium and vitamin D3 are widely available in Indian markets, pro-

viding a strong platform for K2 consumer adoption.

K2VITAL is pure, crystalline >99.7 per cent all-trans MK-7 produced in Norway. K2VITAL DELTA provides commercial opportunities in eight different supplement categories and is applicable to all consumer types. K2 has synergistic bone and cardiovascular health effects with 4 of the 5 top-selling ingredients: calcium, magnesium, omega-3 and multivitamin blend.

Pradeep Anaokar of SA

Pharmachem aid, ‘The K2VITAL DELTA drug import and approval licenses created a new opportunity for doctors and practitioners in the Indian medical community to address osteoporosis and bone health.’ He continued, ‘Equally important have been the opportunities for brands and manufacturers to add a premium ingredient to portfolios and launch successful K2 products. This year at CPhI we will highlight commercial solutions that increase product returns.’

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Uhlmann India opens new office cum assembly shop in Pune Deepens commitment to India market, with plans for IoT, serialisation as well as expanding presence in non-pharma sectors Viveka Roychowdhury

T

his November 1 marked a major milestone in Uhlmann Indiaâ&#x20AC;&#x2122;s journey, as it welcomed key clients to its new office cum assembly shop premises in Chakan, Pune in Maharashtra state. This is the German company's fourth such facility in Asia after Shanghai, Jinzhou, and Singapore. Aimed at supplying high quality precision format parts and faster turnaround service support, the full-fledged functioning unit was inaugurated by Parminder Dureja, Additional Director, Serum Institute of India in the presence of Michael Mrachacz, CSO and Managing Director, Uhlmann Group, Klaus Braig, Director Sales, Uhlmann PacSysteme Germany and Sumeet Arora, Managing Director, Uhlmann India.

Established in 1948, the Germany headquartered Uhlmann Group of companies is today headed by Tobias Uhlmann, grandson of founder Josef Uhlmann. The group reportedly has a turnover of 426 million euros for the financial year 2018-19 with around 2,400 employees worldwide.

Uhlmann India was formally launched in 2016 and is headquartered in Pune with regional presence in Mumbai and Hyderabad. The legacy in India dates back much further, with some facilities using Uhlmann equipment dating back over 40 years, a testament to the durability of the equipment, superior design and quality of craftsmanship.

Parminder Dureja, Additional Director, Serum Institute of India inaugurates the new facility

India strategy Compared to its peers, the Uhlmann group had a late entry into the India market,

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(From L-R) Klaus Braig, Director Sales, Uhlmann Pac-Systeme Germany, Sumeet Arora, Managing Director, Uhlmann India and Michael Mrachacz, CSO and Managing Director, Uhlmann group at the Chakan facility

though their equipment, across sectors beyond pharma, has been considerable. The group's focus on the India market has increased over the past three years. During this period, Uhlmann group has doubled its installation base in India. (See previous story: https://www.expresspharma.in/pharma-ally/indian-operations-are-strategicallyvery-important-for-uhlmann/) Speaking about how Uhlmann India fits perfectly into the Uhlmann strategy, Michael Mrachacz, CSO and Managing Director Uhlmann Group said that the Chakan facility was part of the Uhlmann strategy of "local for local strategy of having local people, serving the local market for local requests."

When Uhlmann India started in 2016, the sales team focused on maturing the mar-

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ket, serving existing customers and equipment. In progression to the next stage, the Chakan facility will provide "local added value with local format parts" for the India market.

In addition, Uhlmann India is capable of taking up complete integrated line projects in India as a member company of Excellence United, an alliance covering the entire valueadded chain of pharma production. Excellence United is a strategic alliance of five familyowned, German-based companies, all market leaders in manufacturing equipment used for the production of pharma products.

Through this alliance, the five-member companies Bausch+StrĂśbel, Fette Compacting, Glatt, Harro HĂśfliger, and Uhlmann - have pooled their expertise to deliver topquality, technologically advanced solutions spanning the entire value chain for the production of medical goods and Pharmaceuticals Products.

The alliance also operates a large-scale network with more than 900 service professionals worldwide which offers customers in every market a comprehensive portfolio of services.

Much of the interest in India is due to the country's proven destination as a contract manufacturer of generics to most major markets of the world. As Arora pointed out, "Exports from India are increasing exponentially with a current contribution of 30 per cent by volume to the US generics market alone. We have observed a trend in customers who are looking for high-speed and sophisticated equipment to serve the international markets. But, their buying decisions hinge on the Total Cost of Ownership (TCO), which stay high due to higher cost of change parts imports over the machineâ&#x20AC;&#x2122;s long life cycle. Our current set up will facilitate to lower the tooling costs and thus, offer an attractive TCO." With a team of a dozen people, India operations are headed by Arora, with four in the technical team, an equal

comes to format parts, clients need better delivery times and price."

Mrachacz summed it up when he said, "These format parts would get the benefit of 70 years of experience backing German design and quality, locally manufactured and available at a local pricing strategy, without any compromise in quality to provide a seamless Uhlmann Experience."

The second additional value-add to this localisation strategy, according to Arora, is that service engineers from India are now being used outside the country as well, after being qualified and trained by Uhlmann in Germany.

Next steps Unveiling of the plaque by Umesh Shirsavkar, senior general manager, Serum Institute of India (left) and Karamvir Singh, Associate Director - Manufacturing, Emcure Pharmaceuticals with Arora of Uhlmann India

number in sales and the rest in after-sales and support functions.

Emphasising on the importance of after-sales support, Mrachacz explained how the company is focussed on offering life cycle support, starting with the customer and closing the loop. "Uhlmann is the market leader in high-class pharma packaging systems. We bring the same best-in-class quality equipment, service support and digital solutions, to the Indian shores. Our equipment is ideally suited to match the dynamic customer requirements across both geographies and demographics. Further, we have established a strong and dedicated Uhlmann Customer Service platform with 24/7 hotline that leads to faster resolutions, enabling our machines to run at a sustainable higher efficiency than any other supplier."

Addressing customer pain points Explaining the advantages of expanding their presence in India, Braig pointed out how they can give better value-added products and service based on local market intelligence. Illustrating with an example from the service side he said, "When customers in India buy equipment from European suppliers,

they typically had to wait for engineers to come from Europe to attend to their queries. This is challenging as it is both costly as well as time-consuming."

The Chakan facility has addressed this problem. "We now have engineers qualified and trained in Uhlmann, Germany working completely independently in India, supporting site installations, site acceptance tests as well as after-sales service. They are also the ones doing the first level support, in terms of 24 hours troubleshooting support. They are also the one who take the onus to solve any issues, say with the software, etc. Once local track and trace starts, we will also have a team provide 24 hours troubleshooting support for this," said Braig.

Giving a second example, Mrachacz explains that the India market differs from other markets in terms of the high requirement for locally manufactured format sets, with expectations on the price, and after-sales support. So the company designs the format sets in Germany, supplies the drawings to the local organisation. They already have an approved vendor network which will supply those parts. Testing and installation will be done by

the India team.

Mrachacz expects such examples of local added value to expand as the business grows.

For instance, when the company starts offering its IoT solutions, there will be dedicated IoT specialists based in India to serve these customers.

Rationale for localisation According to Arora, "One of the biggest reasons for localisation was faster turnaround time (TAT). India is basically a contract manufacturing market for generics. Contract manufacturers have to bring the generic product to market extremely fast. The customers in India could still pay a little more for format parts but TAT was the most essential part."

The scale of the challenge and opportunity is huge. As Arora explained, "A customer in India would require at least 4-5 format parts per year for each machine. Larger companies catering to different customers and market needs would need hundreds of format parts, as each product may have many SKUs depending on the strength and the country of sale. All this adds to the number of format parts. This is why many a time, format part price and delivery is the key deciding factor in our business. When it

Speaking about the India operations, Arora mentioned that the next step would be for the Chakan facility to be able to offer equipment ready for line trials, local Factory Acceptance Tests (FATs). This would mean that clients would not be required to send their man and material for conducting FATs which entails a huge cost. They could test on a line set up for them as per their specifications at the Chakan facility itself. As Mrachacz pointed out, having such a facility locally would make it easy for the customer to make a decision to buy the equipment.

Supplying IoT-enabled packaging in India would definitely be one of the next steps for Uhlmann but for now, Mrachacz believes that it is not going to be a revolution but an evolution and the Indian industry will take some time to define the role of IoT. He points out, "Products are made in batches in the pharma industry, and compounded with this are regulatory needs to be taken care of.

Every batch requires having samples to be taken into labs.

Currently, track and trace is a preferred solution for traceability. However, we are also developing IoT functions like predictive maintenance, comprehensive machine monitoring systems and have hired people with similar skill sets. It

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can be said that the pharma industry will not be a forerunner, but will have IoT’s presence eventually."

Within Uhlmann, a team of over 120 people already support clients with IoT solutions beyond the packaging process and therefore "Uhlmann is prepared and ready for the future, today."

Clearly, Uhlmann's localisation strategy is a bet to know more about customer pain points, getting familiar with processes. The company believes that this knowledge would a differentiator, so that they can offer better solutions, both on the hardware and software side.

Uhlmann also offers digital solutions to the pharma packaging industry. Expanding on this, Braig informed, "Our world is becoming more and more digital. That makes communication less dependent on time and place. We see many opportunities in this development. The location is also no longer an issue when it comes to training employees. Your personnel can build up pharmaceutical packaging knowhow – anytime and anywhere – using our digital training platform LEON. This platform complements “classroom” instructions provided and enabling participants to steadily improve their skills anytime, anywhere – without having to release machines from production."

Pharma manufacturers in India have faced many implementation challenges with serialisation. Commenting on this, Arora said, "We offer our own equipment for track and trace, combined with the necessary software and hardware device for effective serialisation of product and enhanced traceability. We also offer serialisation solutions which can be retrofitted on existing equipment. Since 2008, we have developed our own in-house expertise and skills in handling a wide variety of applications that are customised to every customer’s processes. We have installed nearly 500 systems on a global scale. Today, we handle global projects, provide track

94 EXPRESS PHARMA November 16-30, 2019

Dureja at the inauguration with Mrachacz and Arora of the Uhlmann Group

and trace serialisation solutions across the different industry verticals."

Beyond pharma With a tagline of 'Beyond Packaging', the Uhlmann Group is not confined to the pharma sector. Giving details, Mrachacz said, "Our mission Beyond Packaging stands for our new,

far-reaching goals. We access markets outside the pharma industry and go beyond mere packaging with our services and digital solutions. We always look outside the box and set impulses for our customers and the industry."

The Uhlmann Group comprises Uhlmann Pac-Systeme, a world leader in pharma pack-

aging in blisters, bottles, and cartons. Other group companies are Koch Pac-Systeme (custom made packaging solutions and services for medical products, contact lenses and consumer products based in the Black Forest area of Germany), Cremer Speciaalmachines (counting and packaging solutions and services for

pharma, consumer and agricultural goods based in the Netherlands) and Wonder Packing Machinery (economic packaging machines and services for pharma applications in China).

Commenting that while Uhlmann Pac-Systeme's focus was on the pharma sector so far, the presence of other group companies was also sizable.

Giving details, Arora said, "Uhlmann India also represents KOCH Pac-Systeme in India. KOCH is a member company of Uhlmann-Group and has a clear focus and expertise on conventional and sustainable packaging for non-pharma applications. Most of our daily used products like toothbrushes, razors, medical devices, batteries, electronic devices and other special non-standard blister packing applications are the solutions offered at KOCH. We also offer packaging for single-use eye lenses and medical-grade sutures packs." He indicated that the company had plans to increase its presence in the FMCG/non-pharma industries in the country as well. viveka.r@expressindia.com

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VENDOR NEWS

Elgi Equipments conferred with 2019 Deming Prize in Tokyo The company received the award in the Total Quality Management category

E

lgi Equipments has now become the first globally established industrial air compressor manufacturer to be awarded the Deming Prize for excellence in Total Quality Management in over 60 years.

Dr Jairam Varadaraj, MD, ELGi Equipments received the coveted medal from Hiroaki Nakanishi, Chairman, Deming Prize Committee at the award ceremony in Tokyo, Japan.

In his acceptance speech, Dr Jairam Varadaraj, MD, ELGi Equipments dedicated this award to all the employees at ELGi saying, “On paper, the path to success is pretty straightforward. But realising it requires a secret sauce. An envelope that rigorously enables, executes and continuously improves the organisation through a process orientation. TQM has been our secret sauce. We have a long way to go but TQM has helped us become a better company for all of our stakeholders. I would like to dedicate this award to our employees, who are the key stakeholders in our company.”

ELGi’s TQM journey began in 2008, and gained momentum starting 2014. ELGi’s TQM system - EBS (ELGi Business System), implemented as a means to achieve ELGi’s goal of becoming the world’s second largest air compressor manufacturer by 2027, consists of diverse improvement activities and human resource development initiatives. Some of the indigenous improvement activities included the development of Gemba prowess and staff improvement activities that suit-

ELGi’s TQM system - EBS (ELGi Business System) consists of diverse improvement activities and human resource development initiatives

ably use problem - solving activities by Cross Functional Teams (CFTs). In addition, ELGi built out a robust employee training system investing 400 hours of training per person for every shop floor employee, employing both inhouse and external classroom quality education and the establishment of an in-house vocational training school. ELGi’s TQM focus also extended to the standardisation of all sales activities (the GTM go-to-market process) for sales expansion as well as the creation and promotion of various mechanisms using ICT. Also present at the award function were, R Jayakanthan, Director, People, Systems and Strategy, Sundarrajan Pattabiraman, Vice President, ELGi Business System, Ramesh Ponnuswami, Executive Director, Sriram Srinivas, Director Operations, Anvar Jay Varadaraj, Global Brand Head and Dr K Venu Madhav, Director, Technology.

ELGi, is a pioneer in cutting edge compressed air technology, offering a complete range of compressed air solutions from oil-lubricated and oil-free rotary screw compressors, oillubricated and oil-free reciprocating compressors and centrifugal compressors to dryers, filters and downstream accessories. With state-of-the-art manufacturing units and a product portfolio of 400+ compressed air systems, ELGi redefines reliability, efficiency and cost-effectiveness across installations all over the world.

EP News Bureau

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Yokogawa acquires Nanopipette Technology It acquired the technology from BioStinger, US, for use in life sciences applications related to single-cell injection of target substances and extraction of intracellular materials

Y

okogawa Electric Corporation announced that it has acquired a nanopipette technology that was developed by BioStinger, a spin-off from the University of California, Santa Cruz. This technology is able to target specific locations inside individual cells, enabling the injection of target substances such as genes or drugs and the extraction of intracellular materials. The low invasiveness of this technology to cells enables a more detailed analysis of live single cells, organelles, and cytoplasmic components.

To observe how cells react to new drug candidate compounds, the compounds are often infiltrated into the cells.

However, it can be difficult to

confirm that the compounds have passed through the cellular membrane and reached inside the cells. Therefore, there is a need for a technology that can inject experimental substances into cells with high levels of precision. Furthermore, organs and tissues are composed of many different cells, and the occurrence of abnormalities in specific cells leads to the onset of diseases. Since the cells are not in a uniform state, individual cells must be analysed to identify the cause of a disease and the pathological state. Accordingly, the ability to determine the shape and position of a particular cell and to extract intracellular information from that cell is consid-

ered to be useful in clarifying the disease onset mechanism and in researching and developing new drugs. However, until now there has been no established technology that is capable of both obtaining positional information on specific cells in a cell population and extracting materials from those individual cells.

This technology incorporates a manipulator that uses a nanopipette with a tip whose aperture is one of the smallest available for use in the biological research field, and a micropump that uses electrochemical phenomena. This technology enables the injection of target substances, such as genes and drugs, into the target location of a specific cell and the extraction of individual intracellular materials. Furthermore, its low invasiveness enables a more detailed analysis of live single cells, organelles, and cytoplasmic components.

Yokogawa has been developing single-cell analysis solutions since 2014. A single cell manipulator under develop-

ment uses a micropipette (1 micrometer is equal to a millionth of a meter), which enables the automatic sampling of single cells that have been selected using a graphical user interface and is suitable for use in research that requires the sampling of a large number of cells.

Yokogawa will accelerate the development of sampling systems that make use of micropipettes and will contribute to research and development in the drug discovery and life science fields by commercialising manipulator products that use this acquired nanopipette technology.

EP News Bureau

GE Healthcare Life Sciences to supplyAkeso Biopharma with FlexFactory platform Platform expected to be operational by end of 2020, create up to 150 jobs upon opening

A

keso Pharmaceuticals, a biotech company specialising in the development and commercialisation of novel biologics, will open a new facility in Guangzhou, China, based on GE Healthcare Life Sciences’ FlexFactory platform.

It will be designed for efficient and cost-effective manufacture of recombinant biologics.

GE Healthcare Life Sciences will speed up Akeso’s access to antibody production in support of Akeso’s pipeline of biopharmaceuticals, including therapies for the treatment of cancer, autoimmune diseases, arthritis, and Crohn’s disease.

The FlexFactory will be located on Akeso’s manufacturing site in Guangzhou Knowledge City. It is configured with capacity for 4 x 2000L bioreactors to

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support the clinical and commercial production of therapeutic antibodies.

This becomes the 21st automation-integrated FlexFactory platform provided by GE Healthcare Life Sciences in China (5 of which are in Guangzhou), and the 64th FlexFactory supplied globally to manufacturers of biopharmaceuticals. India currently has one FlexFactory installed at Dr

Reddy’s Laboratories in Hyderabad.

In 2018, Lonza announced an agreement with GE Healthcare, under which GE Healthcare will develop a biologics centre featuring a KUBio biomanufacturing facility in Guangzhou, China.

The centre is expected to be operational in 2020. In 2019, BeiGene opened a KUBio biomanufacturing facility in Guangzhou, China.

Akeso Pharmaceuticals is a joint venture between Akeso Biopharma and the Guangzhou Development District. The FlexFactory will support the company’s aim to expand its operations to large-scale manufacturing of biopharmaceuticals, with an initial focus on bispecific antibodies. Akeso’s plant is expected to be operational by end of 2020 and create up to 150 jobs upon opening.

Dr Michelle Xia, Chairman and CEO, Akeso Biopharma, says, “We strive to provide affordable and high-quality therapeutics to patients. In 2016, we were the first user of FlexFactory for monoclonal antibodymanufacturing in South China.

Once again, we chose to collaborate with GE to deploy new product lines and boost the pro-

duction of next-generation immunotherapy drugs in China.”

Olivier Loeillot, General Manager, BioProcess, GE Healthcare Life Sciences, says, “Akeso is one of China’s most innovative manufacturers of nextgeneration therapies. Rapid access to proven biomanufacturing technologies, and cost-efficient capabilities supplied by trusted and seasoned industry partners, are key to realise the potential of the industry. We are supporting the growth of Guangzhou’s biotech with flexible and scalable technologies, like FlexFactory and KUBio, as we recognise the needs of biomanufacturers to succeed in this highly competitive environment.”

EP News Bureau

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Dynamic vapor sorption – An important gravimetric technique Dr Majid Naderi, Associate Director for Science Applications – Surface Measurement Systems talks about the dynamic vapor sorption as an important gravimetric technique for materials characterisation in pharmaceutical laboratory and it’s key benefits and versatility What is DVS or Dynamic Vapor Sorption?

Dynamic Vapour Sorption (DVS) is based on a highly sensitive gravimetric system, which measures the adsorption and desorption of extremely small amounts of probe molecule. DVS is used to rapidly assess the sorption isotherms and the kinetics of vapour loss and drying of various materials. The analysis of the experimental data may be performed using the Advanced Data Analysis add-in suite, facilitating rapid and reliable evaluation of the drying conditions.

The DVS system is equipped with a high or low mass microbalance. The high mass balance is capable of accommodating samples as heavy as 5g whereas the low mass balance can lift samples as heavy as 1g.

The DVS instrument measures changes in mass which is related to uptake or release of vapour at different concentrations and temperatures. The sample mass is monitored using an Ultrabalance with a resolution of ± 1.0ug (high mass balance) and ± 0.1ug (low mass balance) in a temperature controlled (±0.1°C) incubator. The concentration of the moisture is controlled by mixing saturated vapour and dry air us-

materials that can be measured by DVS?

ing mass flow controllers at a standard total gas flow of 200sccm.

Why is DVS widely used in Pharmaceutical researches and product development?

The water vapour or moisture sorption properties of pharmaceutical materials such as excipients, drug formulations and packaging films are recognised as critical factors in determining their storage, stability, processing and application performance. According to the US Pharmacopeia, moisture is not treated as an impurity, but water in a drug substance should be monitored and controlled as strictly as possible (USP general chapter 1241). Further, the moisture content affects crystallinity and influences storage modulus, permeability, density and melting point of pharmaceutical products. In particular to amorphous materials, moisture can significantly alter the glass transition temperature, and even initiate spontaneous transformation to the crystalline form.

Additionally, water facilitates hydrolysis and induces drug degradation. Finally, water content is routinely used in determining

the dry and solvent-free assay value of a drug substance. For the above reasons, a rapid, highly sensitive and automated method to study moisture sorption properties is desired.

Hence, the invention of the Dynamic Vapour Sorption (DVS) instrument by Surface Measurement Systems in the early 1990’s. Today, the DVS is widely used across numerous industries for investigating the vapour sorption properties of solids, fibres, gels, particulates, and composite materials.

What are the different

Figure 1. Schematic of the DVS sample chamber. The DVS varies the RH around a sample placed in the sample chamber and a sensitive microbalance monitors the mass changes. Figure 2b and c show plotted data of the mass against time (2b) and isotherm s(2c) of water vapour adsorption and desorption

Dynamic vapour sorption is a powerful physico-chemical characterisation tool for a range of materials including powders, fibres, films, particulates and semi-solids. DVS has become the standard method for investigating the vapour sorption properties for dissolution, stability, storage, permeability, formulation of drugs and excipients as well as food and packaging materials. Any material that can be placed inside the sample chamber of the DVS instrument and is within the balance range can be analysed.

DVS has a range of instruments that can either do water or organic vapor or both. What instruments are included in this family range?

The DVS instrument models primarily include the DVS Intrinsic, DVS Adventure, DVS Resolution, DVS Endeavour and DVS Vacuum series. The DVS Intrinsic is a water-only instrument with a small foot-print, high- sensitivity microbalance and full iso-activity measurement capability. The DVS Adventure, DVS Resolution and DVS Endeavour have a temperature range of 5 - 85°C. The ability to use organic vapour besides water allows these systems to be used for some unique applications.

Study of Vacuum adsorption processes are better performed

by DVS Vacuum system because of a number of advantages over ambient flow sorption instruments. Dynamic and Gravimetric vacuum sorption instrument offers a flexible research platform for studying adsorption

processes under dynamic or static experimental conditions.

In addition to what flow sorption instruments can offer such as activation energy, BET surface area, diffusion constants, micro/meso-pore size distributions, and glass transition, SMS DVS Vacuum instrument can also offer measurements on vapour pressure and heat of evaporation of solids, low pressure vapour/gas sorption and vacuum drying.

What are the benefits of running co adsorption experiments?

In co adsorption experiments, two vapours are generated simultaneously. The resulting multi component isotherms would allow to assess the sorption mechanism for a particular vapour in the absence or presence of background humidity.

This would have many applications including the escape of flavours through packaging membranes at different relative humidity conditions as well as measuring the physical properties of hydrated materials without changing their hydrated state.

How are samples in the DVS systems prepared for analysis?

One of the advantages of this technique is that there is no need for sample preparation. Any sample with the right dimension and within the balance range can be used. Depending on the nature of the material the samples may be hung from the hang down wire or placed in a sample pan. There are different pans available for various applica-

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tions. Quartz pans are suitable for general material characterisation. Stainless steel mesh pans are also available for use with the DVS Resolution and Endeavour systems. These pans would speed up diffusion through high volume samples such as leaves.

Before loading the sample, the likely change in mass due to vapour uptake should be considered. If the change in mass is likely to be less than 0.5 per cent, then a sample mass of 50 mg or even 100 mg will produce a more acceptable signal-to-noise ratio.

However, for changes greater than this a sample mass of 10-20 mg is normally more than adequate, and for very hydrophilic materials, less than 10 mg may in fact be more suitable in order to optimise the experimental time.

The rate of change of mass over time (DMDT mode) permits the DVS software to automatically determine when equilibrium has been reached and complete a relative humidity step. When the rate of change of mass falls below this threshold over a determined period of

perature and pressure. The SMS Ultrasonic Sensor measures the transit time of ultrasonic pulses through a sample of a gas/vapour mixture before the mixture interacts with the sample. By measuring the speed of sound through the medium the exact relative proportions of the composition can be determined.

The advantage of the Ultrasonic sensor over traditional measurements, such as DPAs, is that the Ultrasonic sensor is non-interacting (does not condense vapours) and can work on a wide range of solvents (high degree of solvent compatibility).

How can Raman spectroscopy be integrated with the new instruments?

Figure 2. DVS family of products

time, the humidity will proceed to the next programmed level.

Furthermore, samples such as compressed tablets will respond very slowly to partial pressure changes, which will necessitate the use of low dm/dt settings.

Before placing the sample, the pan should be removed by

Figure 3. Pulling forward the arm or cam will release the manifold and permit access to the sample pan area

98 EXPRESS PHARMA November 16-30, 2019

lowering the DVS sample chamber as shown in Figure 3.

The pan is then removed using tweezers and after loading the sample the pan is placed on the hang down wire.

The sample is then allowed to settle for a short time before starting the experiment. This ensures that the first few data points are not affected by the swinging of the sample pan, and also allows the sample to equilibrate to the temperature and humidity of its new environment.

What is Speed of Sound DVS? The award winning SMS Ultrasonic Sensor is a patented novel method of measuring the composition of gases and vapours accurately as opposed to the traditional measurements, such as chilled mirror devices (DPAs) which predict the concentration of the organic vapours.

The speed of sound through a medium is a fundamental property of the medium and is dependent on composition, tem-

The DVS instrument has the ability to couple in-situ video microscopy and spectroscopy (Raman and/or Near-IR) with the gravimetric sorption measurements. There are provisions for fibre optic probes to be inserted into the sample chamber of the DVS instrument allowing in situ measurement of the Raman spectra whilst the sample is exposed to different moisture / vapour conditions. This would allow for the investigation of vapour induced morphological and structural changes in the material.

Figure 4. Open DVS chamber showing the loaded sample pan on the hang down wire

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Transition from manual to automated dissolution sampling: Impact of rinsing Darshana Kamble, EFFORT Fellow, Electrolab, Dr Namita Varde, Application Scientist, Electrolab and Aditya Marfatia, Director, Electrolab discuss the nuances of automated sampling, critical parameters to be considered and expand on the usage of different rinsing cycles depending on the application

D

issolution testing plays a critical role throughout the product development cycle right from early formulation development up to quality control. During formulation development, the dissolution profile of all formulations are evaluated and f1, f2 values are compared. However, in quality control, mostly single or two-point dissolutions are conducted to accelerate batch release. During earlier times, manual sampling was the most commonly practiced form of sampling. It is typically performed with the help of syringes or pipettes, where samples are withdrawn directly from the test vessel.

Manual sampling is very technique dependent that can result in analyst-to-analyst variability, reproducibility concerns, etc. The pharmacopoeial sampling zone can be either missed or be variable for each time-point resulting in erroneous results.

Automation in dissolution testing is well established. All steps such as test preparation, sample introduction, sampling and cleaning can be automated.

Automated sampling facilitates in maintaining the pharmacopoeial sampling zone for every time-point. Automated sampling is a useful alternative to manual sampling, especially if the test includes multiple time-points. In addition, sample filtration can be performed using in line filters, which minimises human intervention.

Overall, automated sampling increases accuracy by reducing variability that occurs during manual sampling and enhances compliance to time points,

Darshana Kamble, EFFORT Fellow, Electrolab

Dr Namita Varde, Application Scientist, Electrolab

Aditya Marfatia, Director, Electrolab

sampling zone and sample volume.

Automation in sampling can be achieved by tube attachments from the test vessel or by robotic devices. Most commonly, samples are collected with the use of a syringe pump, which can then be analysed online via UV/HPLC or offline post-test. The USP guidelines state that manual and automated procedures should be compared to evaluate the interchangeability of the procedures. In addition, it is a requirement that the difference in mean values for dissolution results between the manual and automated tests be <10 per cent for time-points with <85

1. Rinse by Purge 4. Replenishment volume

Sr No.

Steps

Collected from

Dispensed to

1

Dead volume

Dissolution vessel

Waste

2

Rinse volume

Dissolution vessel

Waste

3

Sampling

Dissolution vessel

Collection vials

4

Replenishment

Replenishment vessel

Dissolution vessel

3. Sampling volume 2. Rinse volume X2 1. Dead Volume

Loop back vials Replenishment

2. Rinse by LoopBack 5.

4.

3.

2.

Replenishment volume Loopback volume Sampling volume Rinse volume X2

Sr No.

Steps

Collected from

Dispensed to

1

Dead volume

Dissolution vessel

Loopback vial

2

Rinse volume

Dissolution vessel

Loopback vial

3

Sampling

Dissolution vessel

Collection vials

4

Loopback

Loopback vial

Dissolution vessel

5

Replenishment

Replenishment vessel

Dissolution vessel

1. Dead Volume

Loop back vials Replenishment

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per cent dissolved and be <5 per cent for time-points with >85 per cent dissolved.

There are several considerations which have to be taken into account while performing automated sampling. Sampling volume has to be stated considering the dead volumes of the tubings. The in line filter type, size and pore size has to be optimised to prevent any pressure buildup during sampling. Rinsing cycles need to be optimised such that no carryover effects are observed in the following time-points. Designing an optimum rinsing cycle is important to match the automatic sampling dissolution profile with the manual sampling dissolution profile as required by USP. There are several advanced rinsing cycles, which can help achieve overlapping profiles when using automatic sampling.

Rinse by Purge

3. Rinse by IntenseRinse 6.

5.

4.

3.

2.

1.

Sr No.

Steps

Collected from

Dispensed to

1

Dead volume

Dissolution vessel

Loopback vial

2

Intense rinse

Dissolution vessel

Dissolution vessel

3

Rinse volume

Dissolution vessel

Loopback vial

4

Sampling

Dissolution vessel

Collection vials

5

Loopback

6

Replenishment

Replenishment vessel

Dissolution vessel

Sr No.

Steps

Collected from

Dispensed to

1

Dead volume

Dissolution vessel

Loopback vial

2

Intense rinse

Dissolution vessel

Dissolution vessel

3

Rinse volume

Dissolution vessel

Loopback vial

4

Sampling

Dissolution vessel

Collection vials

5

Loopback

Loopback vial

Dissolution vessel

6

Replenishment

Replenishment vessel

Dissolution vessel

7

Air purge

Sample collector

Dissolution vessel

Replenishment volume Loopback volume Sampling volume Rinse volume X2 Intense rinse X3 Dead Volume

Loop back vials Replenishment

Loopback vial

4. Rinse by AirPurge

7.

6.

5.

4.

3.

2.

1.

Air purgeX2 Replenishment volume Loopback volume Sampling volume Rinse volume X2 Intense rinse X3 Dead Volume

Loop back vials

In this cycle, both dead volume and rinse volume is dispensed to waste, which results in loss of drug as well. This cycle is recommended for high label claim drug products.

Replenishment

gating the differences in the release rate of BCS class I drug Lidocaine hydrochloride from water based topical marketed gel LOX 2 per cent. The release study was performed using an Immersion cell (Enhancer cell) apparatus. An immersion cell of 2 cm2 orifice was used. The average amount of gel filled in each cell was 1.6 g (~32 mg API).

A nitrocellulose membrane of 0.45 Îź and 25 mm diameter was used. 200 mL of acetate buffer, pH 4.5 was used at the medium.

The test was performed at 32°C for six hours. It was observed that the profile obtained with LoopBack, IntenseRinse and AirPurge (rinse volume of 5 mL) cycle did not demonstrate statistically significant difference when compared with the manual test profile.

Rinse by LoopBack In this cycle, both dead volume and rinse volume is dispensed to the loop back vial, which avoids drug loss. This cycle is recommended for low label claim drug products.

Rinse by IntenseRinse In this cycle, to better mimic the real-time concentration in the dissolution vessel, i.e. for better tube saturation, a small volume is continuously drawpurged from the dissolution vessel before sampling. This cycle is recommended for low label claim drug products and for API or excipients that are known to adsorb on the tubings.

Rinse by AirPurge In this cycle, to better mimic manual dissolution sampling, the tubings are emptied out in the last step of sampling. This cycle is recommended for drug products requiring small medium volumes.

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Dissolution vessel

References

Manual to Automatic sampling transition for a BCS

Class I containing drug product The impact of rinse volume (3

and 5 mL) and LoopBack, IntenseRinse and AirPurge cycles was evaluated by investi-

1. Chapter <711>Dissolution of USP 41 2. Chapter <1092>The Dissolution Procedure: Development and Validation

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LANXESS India adds to employability through its vocational skill centre LANXESS B-ABLE Skill Centre helps train 129 candidates with vocational training and job assistance in Thane in 2019

L

ANXESS India established a skill development centre in Thane as part of its corporate social responsibility programme to provide training to aspiring candidates looking for suitable employability. The LANXESS B-ABLE SKILL CENTRE was set up in association with BASIX Academy for Building Lifelong Employability Limited (B-Able) who is the implementation partner for the project for a period of three years covering Thane, Jhagadia and Nagda.

At a brief event in Thane, LANXESS Board of Management members Dr Rainier van Roessel and Dr Anno Borkowsky along with Neelanjan Banerjee, Vice Chairman and MD, LANXESS India, presented a cheque of Rs 5 million to D Sattaiah, CEO and MD of B-Able for project implementation in the second year.

In its first year, LANXESS India successfully trained 129 candidates in its centre in Thane wherein the candidates were given training under the categories of sewing machine operators and call centre executives. The courses started in January 2019 and after completion, candidates were assisted with placements. A total of 96 candidates which is 78 per cent of the total enrolments, have been placed in companies or have started their own business after the project concluded. LANXESS has supported B-Able on this project with the cost of mobilisation, training, human resource, rent for the facility etc.

The project is focussed on providing skill development training for the youth who are unskilled, semi-skilled, school

drop outs and come from the underprivileged sections living in and around LANXESS India’s operations. LANXESS India has funded the project to provide sustainable livelihood to such underprivileged youth.

This programme has been designed for three years starting from Thane in the first year, Jhagadia in the second and Nagda in the third year with nearly 125 candidates being trained each year.

For the current financial year, an on-ground survey in and around Jhagadia in Gujarat found that the most popular employability choices for

The project is focussed on providing skill development training for the youth who are unskilled, semi-skilled and school drop outs

the local youth with lower academic qualification was that of a retail trainee associate. Taking a lead from the survey conducted by B-ABLE, LANXESS has financially supported the project in Jhagadia this year.

The first batch of candidates has already commenced with batch strength of 25 participants.

Commenting on the project, Banerjee said, “Lack of higher education due to any reason should not be a hindrance in employability opportunities for the underprivileged youth of our nation. Through this project we have attempted to pro-

vide skills to such youth that will help them sustain a decent livelihood. We see this project as a small gesture in contributing positively to the country’s skill development goals.”

D Sattaiah, CEO and MD of B-ABLE said, “It is a gratifying experience to see these young boys and girls becoming selfconfident and securing gainful employment with our training.

We are fortunate to have partnered with LANXESS for this extremely productive and positive skill development programme. I am sure we will do exceedingly well going ahead, also.”

EP News Bureau

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Y TRON LIQUIDS PROCESSING HIGH VELOCITY (HV) EMULSIFIER.

Pre Emulsion Homogeneous emulsion • • •

Y TRON HV emulsifiers used for macro (1-10 μm) and sub micron emulsions.

Used in wet milling, homogenization, mixing insoluble liquids oil/water suspensions.

Modify texture or smoothening, fine particle dispersion.

Industry

: Pharma & API , Food , Dairy , Beverages , Cosmetics , Paints , Chemicals

Application : Pharma suspensions like dispersed solid in liquid, liquid is often syrup, sorbitol or water.

• Corticosteroid creams and lotions, water in oil emulsion with dispersed TiO2, ZnO suspension to achieve size in range of 1-10 μm.

• Opthalmic suspension to achieve D99 < 0.2 μm.

• Crystalline API wet milling for injectables achieving PSD of 10-20 μm.

Features:

136

• Y TRON disperser/emulsifiers use a specially designed set of stator rotors moving at high speeds to create high shearing effect in single pass delivering consistent repeatable results.

• Reduces air entrapment to very large extent.

• Reduces process time by 50-80% thereby increasing batch capacity simultaneously.

• High shear rotor, stator by close tolerances.

• Addition of minor ingredients to large volumes.

• Unmatched cGMP design fully drainable and assembled with quick clamps for easy removal.

• Unique mechanical seal eliminating trap areas around rotor for CIP/SIP results.

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Products For Isolator

AETRON

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Neoprene

Gloves For Isolator

APPLICATOR (Model - SPRAYLIN) TLC/HPTLC SAMPLE S PRODUCT CODE- AE-05 HIGH REESOLUTION 0.1μl E Easy selection of delivery speed as per polarity.

Superimpose facility.

35 fixed method.

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PC controlled.

21 CFR PART11 Compliance software.

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June Range of Products for free download look for JUNE4GMP

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UV Trans Illuminator

Colony Counter

Development Chambers.

HPTLC-TLC PLATE HEATER

Contact: AETRON H-303, 3rd Floor, Sharad Industrial Estate, Lake Road, Bhandup (West) Mumbai - 400078.

Cell No : +91 99206 68812, Email: aetroninfo@gmail.com

Complete range of

CLEANROOM MONITORING & LABORATORY EQUIPMENTS from One Source

Airborne Particle Counters (Offline / Online) Liquid Particle Counters Microbial Air Sampler DOP / PAO Aerosol Photometer

Non-Toxic Smoke Generator Compressed Air Teting & Gas Measurement Equipments Cleanroom Decontamination System

TOC Analyzer

B-23,1st Floor, Narayan Plaza, Next to Boomerang Building, Chandivali Farm Road, Chandivali, Andheri East, Mumbai-400 072.

Ph: -022 – 49701393 Email: info@measuretest.com / jyoti@measuretest.com Website: www.measuretest.com

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MarkVi Trac Systems: Trusted name in the packaging and printing industry M

ark Vi Trac Systems was founded by a team of people having a vast experience in the packaging and printing industry and is supported by a group of technically qualified engineers with a vast experience in the machinery maintenance.

The motivation is to give the best every day which comes from the company’s core purpose. The company will challenge conventional thinking and innovatively use all it resources to drive positive change in the lives of its clients, to enable them to prosper.

Feeder conveyor with printer camera and rejection ◗ Friction Feeder with guided descending of unfolded cartons ◗ Flat bed conveyor with guides ◗ Printing up to 25.4 mm with 2 stitched printers ◗ Vision system for Inspection of 2D code and text ◗ Pneumatic Rejection system with bin ◗ Collection conveyor for collating the good cartons in an orderly pile ◗ PLC & HMI based automation

of the godown has been checked and authenticated for prime performance by a member of the team of service engineers before dispatch.

All accessories and consumables have been sourced from leading manufacturers and/ or authorised agents of the manufacturers. All mounting brackets and stands are built on the lines of the design provided by us and verified by our engineers before dispatch.

Contact Mark Vi Trac Systems, Znit No. 111 & 112, Diamond Indl Estate No. 2, Ketkipada, Near Dahisar Toll Naka, Dahisar (East), Mumbai 400 068 Cell: +91 9820509630 022 28977078

Carton conveyor with printer camera and rejection ◗ Flat bed conveyor with guides ◗ Printing up to 25.4 mm with 2 stitched printers ◗ Vision system for Inspection of 2D code and text ◗ Pneumatic Rejection system with bin ◗ PLC & HMI based automation

Quality assurance Every printer that comes out

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Carton conveyor with printer

Feed Conveyor with printer

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Meeting global standards and barcode compliance for pharma serialisation Global Standards and Compliance on ISO/IEC Barcode Verification for Pharma as per serialisation

M

ajor pharma companies have been working on the needs for marking their products and labelling them with appropriately selected barcode symbols over different packaging levels.

This is to be ofcourse done with high data integrity and traceability. Any incorrect data or non-readable barcode symbols would lead to problems for the product movement along the supply chain. The challenge here is to provide the right and readable information to all stake holders handling and ofcourse finally consuming the product.

Often there has been a common misconception to use a reader or a scanner for checking that the barcode is alright and that the information encoded is accurate. Often followed by many manufacturers to report the barcode data, this rather inadequate and rudimentary ‘check’ in many instances is also done by the packaging suppliers included.

It is needless to say that a scanner would be required at the point of sale or warehouse to merely read the barcode symbol. This is limited to data capture alone, and needed as a source of input of the barcode information into the ERP, WMS, Retail POS and so on. Hence called a barcode reader !

Reading of the barcode, as evident provides no authentication or check, on the accuracy of the symbol itself in all its aspects. Errors can also occur in reading the right barcode information as per the reflectivity of the optics which can vary by the scanner types and even as per the algorithms used in reading.

This really begs the question, how would one know if the barcode is encoded, designed and printed properly apart from being fit for use?

Increased importance of barcodes, moving along the supply-chain The increased level of dependency on barcode symbols for automatic identification has transformed it from a tool of mere identification to that of product traceability. Therefore data accuracy, and readability have assumed far greater importance along the products movement on the supply chain. Aspects such as the defined ISO/IEC standards relevant to Linear and the 2D matrix codes assume criticality in ensuring readable codes on packaging.

The ISO/IEC verification process also defines angle of illumination, the aperture of reading that lends the most critical aspect of repeatability on quality inspection of the matrix codes.

Through a true ISO verification process all defined parameters are analysed and reported comprehensively. Importantly the clarity of the barcode grading process and quality of the symbol as assessed by the verifier is really what the manufacturer and any packaging printing company should ever work to comply with. Meeting the standards ensures that the product packaging would be far better placed to be read without hassles along its journey, be it shipper, secondary or primary packaging levels.

What goes unsaid is also the fact that the quality, production and engineering teams would be well benefitted in understanding the results from the barcode verifier. This really is a vital diagnostic tool to correct any mistakes in any aspect of the final printed symbol.

With the verifier delivering comprehensive and repeatable analysis, the information provides an invaluable insight into

tance felt by countries like Russia as per their pharmacy guidelines implemented recently. The aim remains traceability and the tools need to work right each time.

the usage of the GS / FNC1, the right symbologies, the dimensioning, data encodation and ofcourse the region-specific compliance reporting too. This report becomes therefore the valid and globally compliant record of barcode quality for the manufacturer and the printing Companies involved in generating barcode symbols.

The regulations defined by the recent US HDA and European standards for the pharma manufacturers also include the CMO or contract manufacturing organisations. The key to sustain these challenges faced by the pharma manufacturers in the global supply chain, is todeliver the right level of data traceability with compliance reporting. These guidelines applicable as per Country-specific applications is growing multifold as we speak, and impor-

Measure, analyse and improve barcode compliance for better scannability The GS1 Datamatrix symbology has been almost the universal choice of symbology within the Pharma Industry ( apart from GS1-128 linear codes ) to define the traceability within the supply chain. It has well defined structures, and starting from the smallest size around 8 mm to a maximum size of data capacity which can encode alpha and numeric characters up to 3116 characters in the largest 144 modules square symbol, the ECC 200 Datamatrix is now integral to the process. The reliability of the reading methods used in online scanners can be often misleading and questionable.

Inline validation systems are intrinsically not ISO compliant, although many of them can produce some basic reports based on select ISO parameters for barcode quality. The report is

not what makes a reader into a verifier : the testing instrument itself is what makes the verifier.

To be an ISO compliant verifier, the device must demonstrate that it measures and grades to the defined international standard within published tolerances, under specific, controlled lighting conditions, analysing the barcode at a fixed, known distance and angle. Meeting Global Standards and Barcode Compliance for Pharma Serialisation Compliant barcode verifiers eliminate the influence of ambient light; ten-scan averaging of 1D barcodes is recommended.

All of the ISO parameters must be tested and graded; so-called ‘partial ISO grading’ is simply not compliant.

Further, the data validation too is imperative apart from quality assessment. So this makes reporting on GS1 compliance, and regional compliance including DAVA guidelines, CIP, Russian, European guidelines, Turkish healthcare or Brazil guidelines, important.

The successful scan of a barcode is not meaningful if “successful” means that data— some kind of data—was captured. Only an ISO compliant verifier can authoritatively decode and grade a barcode and predict future scanning success with virtually any type of scanner. To meet the healthcare guidelines it is important for the pharma manufacturers to check quality of the product packaging barcode symbols.

The importance of a standalone ‘judge’ performing the task of verification irrespective of the printing process, is indeed a very vital cog in the wheel of data traceability, along the journey of the product, ever so critical to all stake holders of the health industry.

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MACK UNIVERSAL believes to create business relationship by sourcing through least cost suppliers M

ACK UNIVERSAL, started in 2012 and it deals with Muffle Furnaces.

MACK UNIVERSAL believes that it can create a business relationship by sourcing through the least cost suppliers and are the reliable suppliers of quality equipment to pharmaceuticals, chemical plants, universities and petrochem industries, research institutes and other industries.

The company is happy to announce the industry’s first discount offer on Muffle Furnace and it hopes that it will create huge interest among the buyers.

GMP MODEL ◗ Inner body: Ceramic bricks and outer body: SS 304, 7 litres

capacity ◗ Microprocessor-based PID controller system with 2 RAMP 2 SOAK facility ◗ Printing facility through software only ◗ Heating Up to 1150 deg C maximum (Range 500 – 1200 deg C) ◗ Inner dimensions: 180W x 160H x 260D & Outer dimensions: 476W x 628H x 655D in mm ◗ Modular inner body; replacement and fully renewing the furnace ◗ One-year AMC included with Calibration – one hour@ one set point and validation – Two hours for two set points i.e. 500 & 1150 deg C only ◗ Qualification Documentation

by Mack Universal (DQ, IQ, OQ & PQ)

◗ Inner dimensions: 150W x 150H x 225D & Outer dimensions: 446W x 618H x 620D in mm ◗ Modular inner body; replacement and fully renewing the furnace ◗ Qualification Documentation

by Mack Universal (DQ, IQ, OQ & PQ) ◗ 12 months warranty against delivery date

15 months warranty against delivery economical model

Starter series model

◗ Non-GMP Model (Inner body: ceramic bricks & outer body: MS Powder Coated), five litres capacity ◗ Microprocessor-based PID controller system with 2 RAMP 2 SOAK facility ◗ Heating Up to 1150 deg C maximum (Range 500 – 1200 deg C)

◗ Non-GMP Model (Inner body: ceramic bricks & outer body: MS Powder Coated), three litres capacity ◗ Microprocessor-based PID controller system ◗ Heating Up to 1050 deg C maximum (Range 500 – 1100 deg C) ◗ Inner dimensions: 130W x

105H x 230D & Outer dimensions: 384W x 470H x 475D in mm ◗ Qualification Documentation

by Mack Universal (DQ, IQ, OQ & PQ) ◗ 12 months warranty against delivery date Contact Factory address Plot no 10, Gate No. 144/1, Near Yogeshwari Petrochem Co, Malegaon Village, Tal Sinnar, Nashik – 422 113, Maharashtra Email: sales@mckuniversal.com / manoj@mackuniversal.com Mobile: +91 9320668848, 91 2551 230877

Multipoint magnetic strirrer – Hexamag Technical Data

e

ltek Multipoint magnetic strirrer christened as ‘HexaMag’ is a state-of-the-art magnetic stirrer which is excellent for stirring of light liquids. All the six stirring points can be independently controlled . The parameters of speed, timer, heating level and direction can be set as per user requirement. HexaMag is extremely beneficial especially in laboratory and pharma industries which involve continuous stirring of bulk solutions.

Contact Anish Ramchandran The Vasai Taluka Indl Co-op Estate Plot no.35, Sector II, Gauraipada, Vasai(E), Palghar - 401208. info@eltekindia.com, Sales +91 9145693925 sales@eltekindia.com

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Multi Point Magnetic Stirrer with High Volumes are also offerd

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PRODUCTS

Dock Houses — ‘Creating a working environment where there was none’ A

re you planning to extend your facility? And are you looking for a cost-efficient way of realising this extension? A dock house is an alternative that offers you, besides to fiscal advantages, many advantages.

In the current climate, we have found that our load house solutions are proving popular as they can be added to the main building once occupancy has been taken. This can save the main building contractor installing at great expense loading bays that may not be used or are unsuitable for a potential tenant.

All Gandhi Automations products can be installed in or around a dock house. A dock house is positioned in front of your warehouse floor. This makes the warehouse floor itself free from obstacles. Dock houses can also be supplied in an angle, connected to each other, with extra insulating cladding and in our stepped dock layout.

The dock house is a bolt-on loading dock that maximises energy efficiency and preserves interior floor space. Unlike conventional pit-style loading dock levellers that require carving out valuable floor space inside a facility, the modular dock house is bolted to a building’s exterior to save thousands of sq ft inside.

Popular at loading bays, these units seal out contaminants, protect against theft, and provide thermal insulation ideal for temperature-controlled warehouses and distribution centres.

Dock houses are often used to expand existing buildings or where internal space is limited.

Dock houses are also used to extend space within leased properties that have building restrictions. This is an ideal solution if warehouse space is limited and loading/unloading turnaround time must be quick and efficient.

Dock pods/houses improve thermal insulation by creating a separation between the building and dock equipment which is important for controlled environments. The loading dock can also reduce accidents thereby having a direct benefit to the site health and safety, again adding to their ever-increasing popularity.

Dock houses are quick and easy to erect, without disruption to inside warehouse/factory operations, they can be repositioned on site if required and are also a highly cost-effective retrofit option for an existing building.

Their lightweight but exceptionally strong structure provides an insulated, hygienic, weatherproof area – with resulting energy saving potential – making them ideal for ambient and temperature-controlled buildings such as cold stores.

They are indispensable in areas, where it is necessary to enable the storage space as much as possible and where high demands are made for temperature regime, as well as in area, where the truck parking perpendicularly to the building is impossible. One of the transshipment tambour qualities is the possibility of their modernisation without changing of the building design.

The dock house, also called a load house, provides facilities with robust, yet removable load-

◗ No warehouse space required ◗ Relocatable ◗ Quick installation ◗ Improves safety ◗ Made to measure

Types

ing docks by integrating the following: ◗ Dock shelter ◗ Wall-mounted dock leveller ◗ Trailer restraint ◗ Environmentally - sealed interior door A dock house is a construction combining a dock leveller and a dock shelter. It offers a good solution for situations where pit recesses cannot be built, for example in existing concrete bays. Cutting out floors is often an expensive and awkward job. When a dock house can be placed against the existing facade, it can be simply moved after a few years if required. In refrigeration and freezer applications, locating a dock house may involve specific considerations. In order to maintain the extra insulated construction, it is often better to place the entire loading and unloading unit outside the facade.

The dock house can be built with a substructure in steel or

concrete framework. The top structure, consisting of hot-dip galvanised profiles, can be clad with uninsulated sheeting or insulated panels. The size of the dock house will depend on the shelter and dock leveller model selected.

Once the dock seal, dock leveller and a sectional insulated overhead door are fitted they can fulfil most loading bay demands. These can be used for new-build, extensions and loading bay upgrades and offer complete protection for your team, the building can be completed with no interference from the loading bay installation work.

Salient features ◗ Improve thermal insulation by creating a separation between the building and dock ◗ Ideal for existing warehouses, planning for expansion, or reducing the footprint for construction ◗ Meets EN1398 standard

Dock house The dock leveler along with the, in front of the leveller closing, sectional overhead door, preferably in combination with the stepped frame ensures optimal insulation and is particularly well suited for cold stores.

Stepped frame dock house With stepped frames, the doors of the trailer can be opened after docking to prevent theft. This also makes it possible to dock trailers or containers at night.

Furthermore, for cold storage with refrigerator vehicles or fresh food processing environments where food contamination is a concern, it is important that vehicle doors are only opened after the vehicle is actually docked.

Contact details Gandhi Automations Chawda Commercial Centre Link Road, Malad (W) Mumbai – 400064, Off : +91 22 66720200 / 66720300(200 Lines) Fax : +91 22 66720201 Email : sales@geapl.co.in Website : www.geapl.co.in

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Cole-Parmer launches Stuart customisable hotplate stirrers W

ith the use of an online configurator, customers can customise their own colourful, sleek and technology rich Stuart Hotplate Stirrer.

Cole-Parmer launched their newest Stuart customisable hotplate stirrers. Individuals can select from a variety of parameters including model type, interface, surface and colour.

Each unit can be designed to unique specifications, built for its specific application, and is personal to the owner.

The range comprises three versions: hotplate, stirrer or

hotplate stirrer, and three interfaces to choose from analog, digital and premium, with the latter boasting enhanced versa-

tility. The former two are available in white, black, and blue, while the premium is supplied in an additional five colours:

pink, avocado, tangerine, red and ultraviolet.

All three versions offer minimal storage and footprint, accommodation for a retort stand to receive an external temperature probe, while an independent hot light LED clearly shows when instrument temperature is over 50°C, making it safe even when the unit is unplugged. These latest additions mean researchers have even greater control over their experiments and processes, while making their lab safer.

Each unit is robust and has

a host of user-friendly features that will keep individuals safe including chemically toughened glass interface, glass ceramic or ceramic-coated aluminum hotplate, and an independent hotwarning light. They also have temperature sensor compatibility, programming with built-in timer (premium version only) and 50 to 2000 rpm.

Contact www.ColeParmer.in Tel: 022-6139-4444 / email: response@coleparmer.in

Cole-Parmer introduces additions in Oakton family of water testing and analysis products C

ole-Parmer, a manufacturer and supplier of laboratory and industrial products, instrumentation and supplies introduced new additions in the Oakton family of water testing and analysis products.

The new additions in the Oakton family are compactly designed and economical meters for benchtop pH and conductivity measurement. These small meters provide precise measurement of pH and conductivity, offering high-quality at a low price, without compromise. The meters have IP54rated housing which is dustand spill-proof, whilst connectors are protected by silicone seal caps. Both meters have the capacity to automatically recognise NIST and USA calibration solutions and can store and recall up to 50 groups of data. Whatâ&#x20AC;&#x2122;s more, these meters have a warranty of up to three years.

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The PH 550 benchtop pH meter features a microprocessor chip which provides automatic temperature compensation, data storage, parameter setup, and Max/Min reading display. The meter offers a pH range from 0 to 14 and a threepoint automatic calibration.

The advanced digital processing technology improves meter response time and measuring accuracy. A stable reading display icon appears when the measuring value is stable. The 3-in-1 combination pH electrode measures pH and temperature simultaneously. The

compact meter includes a detachable electrode holder and three bottles of pH buffer solution.

The CON 550 benchtop conductivity meter features a microprocessor chip which provides automatic calibration, automatic temperature

compensation, data storage, parameter setup, and Max/Min reading display. The meter reads 0 to 200 mS/cm across four ranges and the four-point conductivity calibration. The advanced digital processing technology improves meter response time and measuring accuracy. A stable reading display icon appears when the measuring value is stable. A conductivity electrode with temperature sensor measures conductivity and temperature simultaneously and allows for automatic temperature compensation.

The compact meter includes a detachable electrode holder and three bottles of conductivity calibration solution.

Contact ColeParmer.in or Tel: 022-6139-4444 / email: response@coleparmer.in

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Ikegami’s TIE-9000 series performs inspection with high accuracy I

kegami is a Japanese manufacturer to develop and to produce inspection systems at pharmaceutical industries based on the latest optical devices and image processing technologies with the accumulated knowledge and experience.

Ikegami tablet visual inspection system, TIE-9000 series performance, the high speed of inspection rate with 360 degrees high inspection accuracy. It achieves maximum 600,000 tablets per hour for minimum 50um inspection resolution for the surface, back and side.

Not only surface inspection, but also 3D inspection is available with the unique op-

tical composite 3D imaging to inspect embossing, split lines, chipping and cracking with higher accuracy.

The TIE-9000 series can contribute greatly to improving product quality, consistency and safety, as well as helping to improve overall production efficiency. Hundreds of inspection systems have been delivered to users for the recognised performance and some users keep using the systems more than 10 years without troubles due to the high stability and reliability.

Addition to the tablet visual inspection system, Ikegami has provided the power visual inspection sys-

tem, Non-destructive tablet X-ray inspection system and inkjet tablet printing system.

These professionally manufactured system can be the powerful tools to contribute to achieve higher quality management at the user productions.

Contact ACE Technologies 223, Blue Rose Industrial Premises CHSL,Western Express Highway, Opp Magathane Bus Depot, Borivali ( E ),Mumbai Phone: +91-22- 42089200 E-Mail: ace@acetechnologiesgroup.com Website: www.acetechnologiesgroup.com

BEYOND HMI, the new Human-Machine Interface

by Bonfiglioli Engineering B

onfiglioli Engineering is committed to its stake holders, right from persons that operate the machines to end users whose packaging is double-checked, thanks to the machines.

BEYOND HMI, the new human-machine interface by Bonfiglioli Engineering is dedicated to transforming and simplifying packaging integrity inspection tasks for all operators that work with the machines. Packaging inspection has never been so user-friendly!

Featuring ◗ Smartphone-like intuitive and user-friendly touch-screen display ◗ Personalised screen for each operator. ◗ Apps and widgets with drag and drop option. ◗ Fixed bar on bottom menu of control panel. ◗ Active Directory: An option

for interfacing with customer’s security access network. ◗ Linux-based operating system. ◗ Vertical and horizontal portrait display for adaptability and ease of use.

Powerful performance ◗ Linux-based operating system: robust and stable. ◗ Greater savings: Requires minimal power to operate. ◗ MySQL: For easy recovery. ◗ Double hard disk: One dedi-

cated to operating system and one for data collection. ◗ Interactive documentation ◗ Auto-description pop-up: for advanced warning along with a list of actions for troubleshooting right from the start. ◗ Flexible date storage: Daily report generation with guaranteed 1-year data storage and extendable up to five years.

User-friendly device ◗ It’s as easy as using your very

own smartphone! ◗ Timesaving: personalised for each operator and faster to use ◗ Flexibility: with easy upgrading and downloading of apps ◗ Intuitive icons: similar and familiar like the smart phone icons.

Contact ACE Technologies

223,Blue Rose Industrial Premises CHSL, Western Express Highway, Opp Magathane Bus Depot, Borivali (E) Mumbai Phone: +91-22- 42089200 E-Mail: ace@acetechnologiesgroup.com Website: www.acetechnologiesgroup.com

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ATE’s contributions to India’s sustainable development T

he average global temperature is on the rise, and according to a report published by a climate watch magazine, Climate.gov, the 10 warmest years on record have all occurred since 1998; nine of the 10 have occurred since 2005. The report further states that by 2020, the global surface temperature will be more than 0.5°C warmer than the 1986-2005 average.

Countries like India with tropical climates would be hit hard by the increasing temperature. This would lead to an increasing demand for cooling systems. However, conventional cooling systems, mainly the air conditioners, are energy guzzlers and also use the refrigerants that are harmful to the environment.

How do we resolve this conundrum?

ATE had the foresight to envisage the urgent need for an alternate eco-friendly technology that would provide cooling and comfort. So, it invested in a nascent technology, about 12 years ago, that has today revolutionised the concept of cooling. The technology, known as IDEC or Indirect Direct Evaporative Cooling, has the well-proven and unique DAMA (dry air most air) as its core, and is based on the principles of evaporative cooling. The DAMA is patented in India, Australia, and the US. This technology provides comfort cooling using just about 50 per cent energy of conventional air conditioners, and replaces the ozone depleting refrigerants used for cooling with nature’s own coolant, i.e., water. In addition, it provides 100 per cent fresh air, thus creating a healthy and more productive environment.

ATE is a leader in textile engineering with 80 years of experience and its foray into a totally unrelated territory had surprised many, but ATE’s passion and commitment to environment transcends

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business and profit to societal well-being.

ATE’s cooling business is handled by its business unit HMX which has already supplied more than 60 million CFM in India and other markets, cooling an area of more than 12 million sq ft, encompassing both the industrial and commercial segments and for varying applications.

Out of the 60 million CFM, close to 15 per cent of the CFM is supplied to commercial segment. With upto 50 per cent power saving compared to air conditioning, this technology offers huge potential to save energy while providing a cool and healthy ambience for the people inside the conditioned space.

It is with the same passion and commitment that ATE also invested in the wastewater business in the year 2008.

India, which is home to nearly 18 per cent of the world’s population has only about 4 per cent of the world’s water resources. The NITI Aayog’s Composite Water Management Index June 2018 presents a grim water situation in India. As per the report, currently, 600 million In-

dians face high to extreme water stress and about two hundred thousand people die every year due to diseases that are linked to inadequate access to safe water. The report goes on to say that the crisis is only going to get worse, and by 2030 the country’s water demand is projected to be twice the available supply, implying severe water scarcity for hundreds of millions of people and an eventual ~6 per cent loss in the country’s GDP. Contributing significantly to India’s water scarcity is the increasing generation of wastewater and its unsafe disposal. Two main sources of wastewater are sewage and industrial waste. It is estimated that around 62,000 million litres of sewage is generated in India every day (source: MakanIQ, July 2017), while 13,468 million litres per day of wastewater is generated by industries in India (FICCI April 2013). A report published by Down to Earth in April 2016 shows that 78 per cent of the sewage generated in India is untreated; similar statistics for industrial wastewater are not readily available.

So, why not look at the wastewater as the most secure source of fresh water?

With this idea, ATE invested in the business of treatment and recycling of wastewater and was recently joined by HUBER SE, Germany, the world leader in the field, to form ATE HUBER Envirotech.

AHE offers a comprehensive range of solutions for wastewater treatment, recycling, zero liquid discharge and sludge management covering both industrial and municipal sectors. AHE has introduced several novel technologies for industrial wastewater treatment. AAA technology is a highly successful innovation that treats textile wastewater. AVR based anaerobic bio-methanation plants have been proven to degrade fat successfully in the dairy industry. AHR handles difficult to treat effluents from pharma and petrochem, whereas SUFRO, an ultrahigh flow submerged UF membranes followed by a reverse osmosis membrane system, provide simple and hassle free recycling of wastewater.

AHE in collaboration with HUBER SE, Germany, also offers innovative and highly efficient equipment for municipal wastewater treatment right from headworks to comprehensive sludge management including faecal sludge treatment.

Thus, the endeavour at

AHE is to make wastewater the most reliable source of fresh water for industry and mankind.

Another area that ATE invested in that underscores its commitment to the environment is for the development of solar heating solutions.

This business is handled by its business unit HMX. With years of R&D and long term in-field testing, ATE has developed an innovative Concentrated Solar Thermal (CST) system that can provide steam (up to 160ºC and 6 bar pressure) and process heat for various industrial and commercial applications.

ATE is also active in the space of industrial IoT, through its business unit, EcoAxis, which helps businesses improve their bottom lines by unlocking intelligence of things using IoT-based advanced analytics. Key environmental benefits of EcoAxis’ IoT solutions are material and energy resource optimisation.

ATE’s concern and contributions to the environment also encompasses its own operations, under the theme Aiding The Environment.

Two of its newly built facilities are certified green buildings, ATE has installed rooftop solar panels in some of its facilities, and also drives green practices like waste segregation, conservation of power, water, and paper with total employee involvement.

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Romaco to showcase its selection of tableting and packaging solutions at P-MEC India R

omaco will take advantage of this year’s P-MEC in Delhi to show a selection of its tableting and packaging solutions. The pharmaceutical machinery manufacturer specialises in engineering technologies for solid pharmaceuticals.

Romaco Noack NBL 400 blister line Romaco’s new Noack NBL 400 blister line was specifically designed to meet the needs of the Asian pharma markets.

With an output of 400 blisters and up to 300 cartons per minute, this durable line is ideal for medium batch sizes. An integrated solution consists of a blister machine with rotary sealing and a continuous motion cartoner, it is very easy to use. Machine operators require no specialist technical know-

how to work on the blister packaging line and carry out product and format changes.

That is why the robust Noack NBL 400 is also recommended as an entry level model for contract packers and pharma manufacturers seeking to expand their business with solid products. What’s more, nearly all format parts of the Noack 921 blister machine, which is firmly established in the market, are also compatible with Romaco’s new Noack NBL 400 blister line. Here, too, the new blister technology convinces with outstanding versatility and excellent value for money.

Regarding product feeding, the Noack NBL 400 allows very flexible configurations.

Tablets and capsules with different specifications can be placed in the blister cavities either individually or using a brush-box feeder. The products can also be fed manually, which is mainly an advantage with sample packs or with very small or clinical batches. The NBL 400 from Romaco Noack is capable of processing any standard thermoformable laminate and can also be employed in the manufacture of aluminium-aluminium blisters.

Romaco trusts in BlisterMagic, its software solution, to design the cavity geometries and develop individual packaging layouts. This innovative tool provides a very quick and easy route to customise blister packaging. Users of the Noack

NBL 400 blister packaging line also profit from Romaco’s expert support when it comes to packaging designs.

Romaco Kilian KTP 720X: Powerful double-sided rotary press Cool, fast and clean – these three design features of the Romaco Kilian KTP 720X double-sided rotary press are attracting considerable attention among pharma manufacturers worldwide. ‘Cool’ is a set of measures which enable the temperature in the process area to be maintained at a constant level below 30 °C. Special compression rollers, bolts and

Kilian additionally impresses with innovative features on the operator side. The HMI panels of this tablet press incorporate zoom and swipe navigation inspired by modern smartphones.

Romaco Macofar MicroMaxX 18 microdosing machine

bearings are used, for example, to restrict mechanical friction to a minimum. At the same time, the efficient cooling of the V-ring seals and drives prevents unwanted heat. The powerful rotary press is consequently ideal for processing temperature sensitive medications such as Metformin or Ibuprofen. ‘Fast’ denotes the ability to speed up product changes: in order to shorten the retooling and cleaning times, the number of productcontacted format parts has been systematically reduced and access to the various components is now easier than ever.

‘Clean’ refers to the optimised hygienic design, which improves product quality and makes the process more reliable. The strict separation between the compaction and service areas prevents tablet dust from entering the machine compartment during the production process. The patented punch bellows moreover protect the tablets from

The Romaco Macofar MicroMaxX 18 microdosing machine processes pharmaceutical powders with different flow properties. The system is equipped with a dual dosing disc which also allows multiple dosing into the same vial. Furthermore, even very small product quantities right down to 20 mg can be dosed precisely. Thanks to an innovative in-line weighing system, one hundred percent weight control is now possible for the first time. The machine achieves a maximum filling speed of 12,000 vials per hour. Up to 18,000 vials an hour are possible in the version with statistical weight control. The Romaco Macofar MicroMaxX 18 can be supplied in different containment designs. Automated processes ensure reliable operation and meet the high cGMP requirements for dosing sterile

contamination with lubricants.

With a maximum output of 1,020,000 tablets per hour, the Kilian KTP 720X is classed as a high speed model. The Romaco

powders and liquids.

On show at P-MEC India in Delhi NCR from November 26 to 28, 2019 (India Expo Centre, Greater Noida, Stand 10.B03).

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B&R to present integrated automation solutions for pharma machinery and plants at P-MEC 2019

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&R will present its integrated automation solutions for pharmaceutical machinery and plants at P-MEC 2019 in Hall 10, Stall 10 B29 at India Expo Centre; Greater Noida. B&R’s scalable automation solutions fulfill all the requirements of the pharmaceutical industry. FDA 21 CFR Part 11 regulations are essential in the pharma industry and place great importance on digital documentation. All hardware and software from B&R is fully compliant with FDA 21 CFR Part 11 regulations.

Many pharma products are small, lightweight and delicate, which makes them complex to handle, position and move

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through production lines. Production processes like highspeed bottling and syringe filling, blister packaging and labelling require intelligent product transport systems that work quickly, precisely and safely.

B&R has introduced a new generation of industrial transport technology that delivers key advantages for efficient production while simultaneously improving product quality. B&R’s trackbased transport systems ACOPOStrak and SuperTrak feature independent shuttles moved by permanent magnets along a long-stator linear motor track.

Product movements are configured individually, including vari-

able speed and acceleration as well as batch grouping and ungrouping. The dramatic increase in processing speed makes the lines more productive.

Integrated machine vision B&R will also showcase the first ever machine vision solution – including cameras, lighting and intelligent image processing algorithms – to be fully integrated into the automation landscape. From simple machine vision sensors to highend smart cameras, B&R serves a broad spectrum of applications. Ready-made software components are available for creating applications with

minimal new programming.

Increased efficiency with APROL B&R’s APROL process control system makes it possible to monitor all lines and plants constantly, helping to reduce maintenance costs and downtime.

Moreover, it also optimises asset availability and utilisation. The APROL EnMon solution is used to collect relevant energy data and generate comprehensive reports for evaluation and interpretation – allowing users to considerably reduce energy costs. APROL ConMon provides vibration monitoring and analysis based on key condition pa-

rameters calculated from acquired process data. It detects cases when service work might be needed and can therefore prevent unplanned system downtime. Together, APROL PDA, EnMon and ConMon help users achieve financial savings while strengthening their competitive edge.

Contact Ninad Deshpande Tel: +91 / 20 4147 – 8999 marketing.in@brautomation.com B&R Industrial Automation 8, Tara Heights, Mumbai - Pune Road, Wakdewadi, 411003 Pune

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Dividella embraces sustainability with flexible design and 100 per cent monomaterial capabilities T

oploading and secondary packaging specialist Dividella says the current sense of ‘environmental emergency’ is vindicating its traditional focus on sustainability objectives via adaptable modular platforms and non-plastic monomaterials.

Sustainability and reduced total costs of packaging and ownership (TCP/TCO) have been core objectives for Dividella since it was founded more than 40 years ago.

It has achieved this by building greater flexibility and adaptability into its NeoTOP toploading packaging platforms with increasingly modular designs and interconnectivity that allows one line to handle multiple products and formats.

In recent years, it has further increased its emphasis on resource-saving monomaterials cardboard-based packaging formats that are inherently more economical and sustainable in materials use, avoiding plastics, as well as reducing weight and volume across the logistics chain.

The overall impact is to make pharma parental packaging more sustainable as well as reducing TCO and TCP.

Reduce, re-use and recycle The Dividella modular packaging concept recognises the 'reduce, re-use and recycle' mantra of sustainability across the whole process from machine design to final package format and function.

“Our production platforms are among the most adaptable and flexible in the whole in-

to around 10 cents. For an annual quantity of 2.5 million packs, total costs are reduced from $600,000 to around $250,000 for the monomaterials solution, producing recurring savings of $350,000 per annum in materials cost alone.

Logistics and energy efficiencies

Dividella’s highly modular cartooning systems provide adaptable and flexible feed and handling options to enable fast time to market

dustry,” commented Marta Berger, Head of Marketing Communications, Dividella.

“Our NeoTOP platforms are capable of handling far more than one product and can easily be configured to handle many, many, formats on the same line with an array of feeding modules that can be placed side by side,” Berger explained.

“Recently, we have delivered and installed systems with more than 10 product feeders with retro-fitting an increasingly important part of our business. This has included, for example, adapting NeoTOP platforms originally intended for vial and syringe packaging to handle injector pens as well,” she added.

“Meanwhile, recent events have proved we are correct to

embrace monomaterials packaging as not just favourable to manufacturer’s bottom line but also kinder to the environment,” Berger declared.

Material savings The use of chiefly board, fiber and paper-based monomaterials helps manufacturers meet the increasingly urgent imperative to become 'plastics free' as part of their sustainability goals with significant impact for the pharma industry, in which the packaging and logistics chain accounts for the greatest consumption of plastics.

Adopting monomaterials packaging can also deliver very significant cost savings, with direct impact on very many TCO/TCP factors, in-

cluding reduced material costs, greater efficiency and adaptability in packaging processes, reduced volume and weight in logistics and reduction, reuse and recyclability of materials.

The combined impact can drastically reduce the TCP of, for example, a typical parenteral package ‘classic’ plastics-based blister pack of three syringes and pack insert in side-loading folding box.

Adopting a 100 per cent monomaterial folding box with glued corrugated flute, produced on toploading machine, can deliver savings of around 25 per cent in box cost, around 70 per cent in tray and total elimination of foil costs, more than halving overall cost of package from around 24 cents

The monomaterials solution delivers further savings across the value chain, principally through weight and volume savings in logistics, with a NeoTOP produced monomaterials package taking up around half the volume required for a blister pack. This almost doubles payload for a nine cubic meter refrigerated container from just over 12,000 packs to almost 21,000, reducing per pack shipping cost from almost 41 cents to under 25c.

Monomaterial packaging savings further extend into energy use during packaging, reducing demand for the high heating demanded for film forming and sealing in blister packs. Using the same parenteral syringe pack example, energy costs per shift total some $5,000 for a TopLoader processing monomaterial packs, compared with $12,000 for a blister pack process.

Contact ACE Technologies 223,Blue Rose Industrial Premises CHSL,Western Express Highway,Opp Magathane Bus Depot,Borivali (E ), Mumbai Phone: +91-22- 42089200 E-Mail: ace@acetechnologiesgroup.com Website: www.acetechnologiesgroup.com

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Benefits of Ami Polymer’s metal detectable silicone elastomer Pritam Adhikary, Executive-R&D, Ami Polymer, talks about metal detector silicone rubber that can help prevent contamination

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ilicone elastomer based on polydialkyl siloxane is important and is used in critical application like medical and food industry, pharmaceuticals, biotechnology, microbiological research as well as in prosthetic application owing to its biocompatibility. Silicone elastomers are used as hose, tube, diaphragm, gasket of different machineries. So concerns within the food and beverage industry of having eroded silicone elastomeric byproducts originating from processing equipment entering the process lines is widespread and which are not detectable. This results in commercial problems of downtime and large quantities of waste being produced from such contamination.

Metal detectable silicone composite were established to counter the problem. If any contaminated particle is fragile to the online stream product it would be detectable by the metal detector. A metal detectable silicone elastomer com-

posite can be detected by integrated metal detectors fitted along the processing lines. In the event of eroding particles from a silicone seal entering the process line, such particles can be identified. The production process can then be quickly stopped, contaminated products segregated and the process modified to overcome the problem. The commercial benefit for the manufacturer is that the risk of production downtime and probability of waste being produced will be greatly reduced due to the properties of metal detector silicone composite enabling early detection of contamination.

Metal detector are principally based on electromagnetism phenomenon. Different metal detectors work in various different ways, but here's the science behind one of the simpler kinds.

So to make a material metal

detectable there should be a metal or a composite by contain metal. Metal detectable silicone elastomer are prepared by incorporating metal powder into

it at the stage of mixing. The metal particles response to metal detectors.

Contact research@amipolymer.com

Sifter sieves help segregate particle size distribution of powders and granules

A

sieve or sifter is a device for separating wanted elements from unwanted material or for characterising the particle size distribution of a sample typically using a woven screen such as a mesh.

Sifting is mainly used in two areas, check screening of raw material to remove extraneous material and sizing to sort, segregate or control the particle size distribution of powders and granules. Sifting is mainly

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achieved by used of vibratory, rotary and centrifugal screeners.

Characteristics ◗ Sieves have to be specially designed to resist the high tensile stress generated. Since particle size distributions plays a vital part in drug dissolutions, maintaining the accuracy of the sieves apertures in an essential part of sieves manufacturing. ◗ Proper thickness of wire, ac-

curate nominal apertures sizes, high tensile strength and tautness of the sieves are essential part of sieve for high sifting performance. ◗ Material of construction stainless steel – 316 and 316L. ◗ Aperture sizes – 4075 to 70 microns or mesh sizes 4# to 200# with ASTM standard being certified 90X microscope. ◗ Sieves are available in various sizes from 4” to 30” diameter. The most common size

used 20” (550mm) and 30” (750mm) diameter. ◗ The silicone is food grade material, transparent in appearance. ◗ Nontoxic and molded on the stainless steel ring.

Applications ◗ Pharmaceutical industries ◗ Food industries ◗ Used in vibro-shifter machine ◗ Chemical industries

Contact Ami Polymer 319, Mahesh Industrial Estate, Opp Silver Park, Mira-Bhayander Road, Mira Road (E), Thane - 401104, Maharashtra Tel: +91 22 28555 107 / 631 / 914 Cell: +91 86910 13935 Email: mktg@amipolymer.com Web: www.amipolymer.com

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Dividella’s approach to small-batch production L

ot Size One is a concept from Pharma 4.0 theory – that in that age of connected data, an individual customer order need no longer be satisfied from stock in the supply chain but might actually trigger a production machine to produce that specific item.

Dividella’s Lot Size One and Up approach, also rooted in 21st century production and packaging concepts, adopts a robotic work-cell system to boost the flexibility and sustainability of small-batch production.

In doing so, it can relieve stress points for pharmaceutical manufacturers and suppliers at every stage of the production and supply chain.

product and data transparency with future machines that know how many products were delivered, when the batch was produced, and can state how many were packed and what percentage may have been rejected and why,” said Huber.

Integrated approach

The need for small lot production Striking the right balance on batch size is difficult for any pharma company. Manufacturing thousands or even millions of identical pack iterations ensures ready supply but without catering to individual client needs and incurs huge hidden costs in inventory. Small batch manufacturing gives greater flexibility and responsiveness to customer needs and country-specific requirements but robs the pharma company of economies of scale.

In the 21st century, however, the advent of leveraged data, combined with modern lean production and just in time manufacturing/supply concepts are allowing pharma companies to square the circle: moving towards smaller batch sizes while simultaneously maintaining ready supply.

The trend to small lot production is driven not just by capability but by need: rising demand for personalised medicines, desire to get product to market quickly after successful clinical trial and the reality that most drugs and medical devices are no longer sold in bulk.

Small lot challenges Dividella and its Korber Medipak Systems group stablemates are well aware that this strategic shift raises a whole new set of production and packaging challenges, described by Dividella Product Manager Manuel Huber.

“Pharma companies cannot just produce one big batch, then split it into smaller batches in the warehouse and ship it to different countries. They have to produce several small batches with packaging material that has different artwork and individual data printed inline. Depending on the end user and its country’s regulations, the product label, leaflet and product container colour varies – even if the drug and dosage stay the same.”

These challenges are increased by ever-tighter regulations against counterfeiting, tampering and demanding full traceability across the supply chain along with the greater reliance on temperature controlled products and overall demands for enhanced sustainability and decreased use of plastics.

Customer-centric machines Dividella’s small-footprint Lot Size One and Up concept eases these stress points by adopting a robotic work-cell-based modular system designed for toploading and side-loading cartoning capable of producing optimised pack sizes using 100 per cent monomaterials.

Each work cell can be equipped, depending on the production configuration needed, with supply units that are exchangeable in a plugand-produce manner. Dividella caters to pharma manufacturers that are looking to produce small batches – down to individual units – more efficiently with its upcoming system, which has been designed for the semi and fully automatic packaging of vials, syringes, auto-injectors and other parenteral products.

The Lot Size One and Up solution is embedded into an intelligent software structure, meaning that the packaging line can be built around anything, from individual work cells to a fully automated pro-

duction line, and actively track the path of each product and carton through the line. In addition, Dividella has invested in an augmented reality solution that can help guide technicians and operators through troubleshooting small batch issues.

Exploiting the power of data The software can easily be linked up to a line management or manufacturing execution system and provide advantages with several pharma 4.0 features, such as predictive analytics.

Additionally, existing data from an upstream process like filling or inspection can be merged with new data from the line and transferred to the next downstream process, such as case packing or logistics. Serialisation and aggregation are supported as well.

Furthermore, the modular nature of the Lot Size One and Up solution enables easy modification, like the existing NeoTOP and NeoTRAY families of top and side-load cartoning machines.

“We aim to deliver full

Dividella’s innovations are part of a modular and integrated approach to intelligent small batch production implemented across the Medipak Systems Group .

Thus Dividella’s clients also enjoy beneficial services such as advanced PAS-X MES software from Werum IT Solutions that helps to run the Lot Size One and Up packaging line efficiently or the bespoke erecting service from Rondo that can deliver any batch of pre-erected cartons that are filled and closed inside the work cells.

Dividella has the breadth of product portfolio to provide optimal machine solutions for emerging requirements, leading to a more sustainable and environmentally friendly production environment, as well as more efficient operations.

“We feel that we have to offer the pharmaceutical industry equipment that is more sustainable, without compromising on flexibility,” Huber concluded.

ACE technologies is an official representative of DIVIDELLA in India.

Contact ACE Technologies 223,Blue Rose Industrial Premises CHSL, Western Express Highway, Opp Magathane Bus Depot, Borivali ( E ),Mumbai Phone: +91-22- 42089200 E-Mail: ace@acetechnologiesgroup.com Website : www.acetechnologiesgroup.com

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Advantages of Testo’s Saveris- Data MonitoringSystem P

harma is probably the most important and human welfare-oriented sector of the industry. Upcoming biopharma companies, new medicines/ drugs and latest technologies are creating an infrastructural renaissance where the companies are more inclined to utilise the best services available in order to deliver much better products. A lot of it depends on the regulation and inspection of the facilities as well.

A sector like pharma which is, governed by strict norms and regulations must operate with full efficiency. Automated processes and increasing digitisation of the existing systems can surely provide the desired results. Testo provides the best in class solution for comprehensive quality management in pharma industry called as the testo Saveris. This system constitutes of wireless or ethernet probes that are connected to one base station which documents and monitors all measurement data of its own uninterrupted making the process full proof. It even provides number of alarm options for nonfavourable situations to reduce human efforts and mistakes.

Some advantages of testo Saveris- Data Monitoring System include: ◗ Mixed system that provides option of both wireless and wired probes connected to the base station ◗ Data from multiple locations can be monitored centrally at one location via VPN network i.e. multiple probes communicate to the centrally located base station. ◗ CFR compliant systems for pharma industry. ◗ Most importantly, data compliance for audits and inspections. ◗ Option for 3 levels of access set

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up where we can restrict the authority to access the recorded data to 3 individuals. ◗ Facility to provide only viewing access if need be. ◗ The data is stored in the probes, so even if software connectivity is lost the data is safe and can be downloaded once the software is logged in.

Another important aspect is that this segment is data driven which can include the emphasis on measurement values as well. Testo offerings are majorly related to the data security along with comprehensive analysis and evaluation of all the recorded measurement data. Testo data loggers are ideal for continuous monitoring of temperature and relative humidity of pharma products whether during production, storage or during the transit of goods and ensure quality. Real time data monitoring is the need of the hour as it enables the supplier to prove the quality and credibility of the goods anytime anywhere. Transportation trucks, warehouses, cold rooms etc. can now be remotely monitored via Testo data loggers and data monitoring systems. They come with professional software where the data recorded cannot be modified.

Testo India provides sales support and consultation to adopt the right and most suitable measurement solutions.

Testo also has a NABL accredited service and calibration LAB that takes care of service and calibration locally from Pune. This facility maintains international standards.

Contact Website www.testo.com or write back to us on info@testo.in

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Visit us at - 26th - 28th November, 2019

To Visit us Scan this QR Code

Stand #: D21 | Hall #: 12 India Expo Centre, Knowledge Park - II, Greater Noida, Delhi

For Marking, Vision and Track & Trace Systems Feeder Conveyor with Printer Camera & Rejection

Carton Conveyor with Printer, Camera & Rejection

u

Friction Feeder with guided descending of unfolded cartons

u

u

Flat Bed conveyor with guides

u

u

Printing up to 25.4 mm with 2 stitched printers

u

Vision system for Inspection of 2D code and text

u

Pneumatic Rejection system with bin

u

Collection conveyor for collating the good cartons in an orderly pile

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PLC & HMI based automation

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Flat Belt conveyor with guides Printing up to 25.4 mm with 2 stitched printers Vision system for Inspection of 2D code and text

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Pneumatic Rejection system with bin PLC & HMI based automation

Markoprint X1JET

Integra Quadro Controller

Quadro Head

X1Jet Standard

It is a controller with HMI capable to control upto 4 heads of 0.5”

It is a ua r a o print upto 2” OR can be separated to print 2 nos of 1” OR 4 nos of 0.5” width.

Markoprint X1JET Standard uses true type fonts for printing

X1Jet Stitch

Unique Click n Print design eliminates the cartridge locking clip

Scan this QR code to view product applications Exp. Pharma November 16-30, 2019 - Pg 164

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REGD.WITH RNI NO. MAHENG/2005/21398, POSTAL REGD. NO. MCS/164/2019 – 21, PUBLISHED ON 5TH / 20TH EVERY FORTNIGHT, POSTED ON 5TH, 6TH, 7TH & 20TH, 21ST, 22ND OF EVERY FORTNIGHT POSTED AT MUMBAI PATRIKA CHANNEL SORTING OFFICE, MUMBAI – 400001

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