Express Pharma (Vol.13, No.24) October 16-31, 2018 by Indian Express

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CONTENTS Vol.13 No.24 October 16-31, 2018

CONTINUALLY EVOLVING

Chairman of the Board Viveck Goenka

SOLID DOSAGE FORMS

Sr. Vice President-BPD Neil Viegas Asst. Vice President-BPD Harit Mohanty Editor Viveka Roychowdhury*

Solid dosage forms are a preferred option of drug administration. But, deployment of novel materials and new age manufacturing processes, supported by technology, to meet the evolving requirements of patients would be key to their relevance in future| P20

BUREAUS Mumbai Usha Sharma, Raelene Kambli, Lakshmipriya Nair, Sanjiv Das, Swati Rana, Tanuvi Joe New Delhi Prathiba Raju DESIGN Asst. Art Director Pravin Temble

MARKET

Chief Designer Prasad Tate

MANAGEMENT

Senior Designer Rekha Bisht Graphics Designer Gauri Deorukhkar

Senior Artist Rakesh Sharma Digital Team Viraj Mehta (Head of Internet ) Photo Editor Sandeep Patil Marketing Team Rajesh Bhatkal Ambuj Kumar Debnarayan Dutta Ajanta Sengupta E Mujahid Nirav Mistry PRODUCTION General Manager BR Tipnis

P12: INTERVIEW Dr Ramesh Hariharan CEO, Strand Life Sciences

14 16 19

SCIEX, BECKMAN COULTER AND EXPRESS PHARMA, ORGANISE SEMINAR IN BADDI IPC REVS UP FOR PLATINUM EDITION CPHI & P-MEC INDIA TO BE HELD IN DELHI NCR FROM DEC 12-14, 2018

Manager Bhadresh Valia Scheduling & Coordination Santosh Lokare CIRCULATION Circulation Team Mohan Varadkar

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US FDA EXPANDS APPROVAL OF ROCHE HEMOPHILIA DRUG

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October 16-31, 2018

EDITOR’S NOTE

The pharma play in Ayushman Bharat

ne man’s medicine is another man's poison. So while the falling rupee benefits sectors like pharmaceuticals with a large export component, it has an adverse impact on importers. Which is why it is not a surprise that a recent HDFC Securities analysis finds that the odds are in favour of this sector. A preview of 2QFY19 results of 18 pharma companies under their coverage, predicts that this will be the fifth straight quarter with a positive sequential top line growth for their coverage companies. With an approximate nine per cent fall in rupee and stabilising US base business, coverage EBITDA margin is likely to increase 130bps QoQ (20.2 per cent) in 2QFY19. Companies which have a strong CRAMS portfolio like Divi’s Laboratories, Suven Life Sciences and Jubilant Life Sciences are likely to report strong numbers in 2QFY19, benefiting from the falling rupee. But year on year, the universe growth would remain subdued at 6.7 per cent, with margins to decline on a high base of 2QFY18, which was affected by restocking due to the roll out of GST. Some good news is in store once the US regulatory issues get resolved (for example, Sun Pharma’s Halol plant). With continuing consolidation at the manufacturer level to continue in the US and withdrawal of nonprofitable products by key US generic companies, HDFC Securities believes Indian companies should start reporting substantial improvement in their operational performance from 3QFY19. In fact, it expects pharma stocks to outperform in 2HFY19. Except for DRL, which will witness price erosion in its US base business, the report anticipates improved performance by large generic companies in 2QFY19. How will government initiatives like the Ayushman Bharat scheme, which rolled out this September, impact pharma companies in India? While such schemes will definitely increase healthcare penetration in India, will pharma companies be likely to see this as a good opportunity? Experts point out that as the

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With saturation in export markets and rising regulatory constraints, will we see a refocus on the domestic market, prodded by schemes like Ayushman Bharat?

profitability of the domestic pharma industry kept reducing over the years, with EBITDA margin dropping from approximately 30 per cent to approximately 18 per cent, domestic pharma companies focused on exports. With saturation in export markets and rising regulatory constraints, will we see a renewed focus on the domestic market, prodded by schemes like Ayushman Bharat? While this is a volumes driven business, with government pushing for lower prices, there are bound to be profits at the bottom of the pyramid. It’s also common knowledge that some previous high profile initiatives of the government have not been as successful as hoped. One aspect is that the structure has failed to attract the bigger pharma companies. Take for instance the Jan Aushadi stores initiative. Certain pain points in the tendering process have discouraged both MNC as well as domestic pharma companies. The irony is that the same companies are part of the tendering process for major public health schemes like the CGHS, defence and state government schemes. The difference is that the Jan Aushadi tender is a not a rate contract, but a quantity contract, which means that a fresh tender is floated for fresh requirements. Major public health schemes run by other government institutions like the CGHS, etc., are rate contracted for a particular period and have good participation from major pharma companies. These are aspects which we hope will be rectified as Ayushman Bharat rolls out. At the recently held fourth edition of Healthcare Sabha, a panel comprising senior representatives of both MNC and domestic pharma companies, applauded the spirit behind Ayushman Bharat. They also shared their thoughts on what can be added to the scheme to make it more comprehensive. Do catch the full coverage in a subsequent edition! Booster shot or damp squib, it's wait and watch for the pharma sector for now. VIVEKA ROYCHOWDHURY Editor viveka.r@expressindia.com

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Strand aims to carve out a unique niche in the area of clinical research Dr Ramesh Hariharan, CEO, Strand Life Sciences, elaborates on his company’s future projects, growth strategies and more, in an interview with Usha Sharma Tell us about the Strand Life Science’s strategic partnership with Quadria Capital and how will this partnership enable preventive healthcare? Strand Life Sciences is an investee of Quadria Capital and we partnered with them in early 2018. The partnership was made with a view of redefining precision medicine by increase the accessibility and affordability of Strand’s key technology. Given their deep operating knowledge and experience of building healthcare businesses around the region, we felt that they were the right partner to help launch Strand into its next phase of growth. Strand’s technology includes cutting-edge genomic tests for both preventive and diagnostic applications. Preventive applications include testing individuals for inherited risk of cancer (10 per cent or so of all breast and ovarian cancers have an inherited cause), so they can take preventive and prophylactic measures. Strand has a leadership position in India on this test. Quadria’s investment has helped Strand with continued R&D to reduce the cost of this testing down to a fraction of western costs. Another emerging preventive application is that of the use of a liquid biopsy (a blood draw) for the early detection of cancer. As is well known, cure rates and survival in cancer are highest when detected early, and reduce sharply if the detection happens late. Quadria’s investment has also helped

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treatments in cancer. However, the efficacy of this process is not well understood and the rather large range of mutations and genes requires large clinical trials, which are hard to conduct. A vibrant clinical research environment can help separate the wheat from the chaff here. Of course, India presents an added challenge that molecularly targeted treatments are often very expensive given typical affordability patterns.

Strand continue it’s R&D programne. Strand’s first publication on this topic has just appeared in press and shows that ~35 per cent of a wide range of cancers can indeed be detected at a very early stage from just a blood draw. Strand is now in the midst of its next study on this theme, in collaboration with key academic groups in the US. Are more and more practitioners depending on genetics to decide their treatment protocols? If yes, please elaborate and if not, what’s hindering them? Yes. The use of genetics is increasing growing across oncology and obstetrics. For instance, the use of BRCA gene testing and testing of mutations in related genes has become standard worldwide for determining whether a breast

or ovarian cancer patient should be treated using a class of drugs called PARP inhibitors, which have been approved by the FDA for BRCA mutated cancers. It is standard to test every lung cancer patient for EGFR mutations and treat them with EGFR inhibitors (or which there are multiple generations, successively targeting more mutations). Of course, gene sequencing for rare disease diagnosis and the subsequent use of pre-natal testing to determine the health of the foetus has become very standard and indeed there isn’t another way to ensure the child born is disease free. There are other emerging applications, whose growth is currently challenged by various factors. For instance, a much broader range of mutations can be explored for targeted

We have been hearing about the role of Exosomes in cancer treatment, can you throw some light on it? Can you tell us about Strand Life sciences endeavours in this area? Exosomes are cellular organelles that carry RNA. Exosomes from dying cancer cells are released into the bloodstream (just as DNA from dying cancer cells is released). By drawing blood, extracting this DNA and RNA (from exosomes), and sequencing these to identify cancercausing mutations, one can in principle detect cancer early. I mentioned Strand’s first publication on this topic has just appeared in press and shows that ~35 per cent of a wide range of cancers can indeed be detected at a very early stage from just a blood draw. This publication uses DNA alone; we are now in late stages of R&D with our DNA/RNA combined product that uses exosomes to obtain RNA. The advantage of adding RNA to the mix is that some mutations, particularly those that involve splicing and

pasting of multiple genes, are best detectable from RNA. The company is involved in molecular research, undertaking sponsored research projects for pharma and biotech companies, give us a brief insight on it and what are the outcomes expected from these projects? Strand aims to carve out a very unique niche in the area of clinical research. This is a niche that combines deep expertise in laboratory analysis and in bioinformatics, with a large hospital network in India. The combination of all three elements is rare and much needed, given how clinical research is moving towards more detailed molecular measurements as well as careful analysis of the resulting data. The large pool of patients in India coupled with the high quality R&D platform at Strand provides a unique answer to the general problem of patient access which plagues the industry. Finally, patients in India get access to cutting-edge and otherwise unaffordable therapies in this process, providing the social impact that we seek in everything we do. A few examples of projects and outcomes. One of our projects seeks to establish that the presence of oral cancer can be detected from the saliva itself (thus rendering frequent biopsies unnecessary). Another project tries to determine whether patients in India respond well to cancer therapies that suppress immune system brakes and thus enable the immune system to attack cancer cells (the topic

of this year’s Nobel prize, by the way). A third project tries to establish if patients with Chronic Obstructive Pulmonary Disease have a certain immune signal that can be targeted by specific drugs. Tell us about the emerging trends seen in the biotech industry. What are the challenges and opportunities associated with it? There are three key trends with much promise for the future. The first is the use of drugs/vaccines and other bioengineering methods that spur the immune system to attack and kill cancer cells. Cancer is a dynamic adversary and the use of versatile and adaptive immune system as compared to a static drug is seen as more powerful approach. This approach has seen success in some cancers like melanomas, where a fraction of patients who do not respond otherwise show a sustained response. The main challenge here is to determine who will respond and who won’t. This needs much clinical research. The second is the use of a method called CRISPR/CAS to edit DNA in living systems to correct problematic mutations. In principle, stem cells from the bone marrow can be taken from a thalassemic patient (one in 25 in India is a carrier of a thalassemia mutation, so roughly one in 2500 births is at risk), the DNA edited to correct any problematic mutations, and then the stem cells injected back, thus providing a one-time lifelong cure. Contrast this with the monthly blood transfusion and associated complications due to iron build up leading to organ failure. The main challenge is to show that these methods are safe from other side effects and work reliably. The third I have already referred to earlier, is the early detection of cancer from easily accessible samples like blood, saliva, urine and stool. The main challenge here is to prove in larger clinical studies that this early detection does not lead to false alarms and that it

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indeed leads to improved survival. Artificial Intelligence (AI) is going to play an important role in healthcare, how keen is Strand Life Sciences on it? Strand has been using AI right from its inception, and much before AI in its modern form became popular. We use AI to extract information from the

medical vast literature, to distil down the large number of genetic variants each person has down to a meaningful few, to automate and aid complex manual processes like pathology to diagnose cancer. Tell us about the company's future plans? We have built a solid and differentiated platform for

diagnostics and clinical research built on the three pillars I mentioned earlier: bioinformatics, molecular measurement, and the clinical network. Our immediate plan on the commercial front is to focus on expanding our sales, marketing and operational reach. Technology wise, we are investing in a number of areas

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which include early detection of cancer from blood and saliva, the use of digital pathology to provide expert and sometimes automated diagnosis, molecular profiling of markers of immune response etc. We also continue to invest in further cost optimisations of our multi-gene diagnostic tests. u.sharma@expressindia.com

MARKET POST EVENT

Beckman Coulter and Express Pharma, organise seminar in Baddi The seminar on ‘Importance of impurities profiling and formulation stability studies in regulated pharma environment’ was attended by more than 80 delegates Prathiba Raju Baddi PURE WATER plays a crucial role in pharma and bio-pharma manufacturing process as presence of bacte-

ria and other organic compounds in water can cause failure in filtration, storage and other components and systems. Total Organic Carbon (TOC) analysers which conduct the standard test for

quality is one of the significant component which ensures the quality of water used in pharma and bio-pharma products. Highlighting the importance of TOC analysers, Beckman Coulter Life Sci-

ences recently hosted a seminar on ‘Importance of impurities profiling and formulation stability studies in regulated pharma environment’ in Baddi, Himachal Pradesh.

Matt Harle, Senior Manager, Field Marketing, Particle and Automation Products, Beckman Coulter Life Sciences

Neeraj Khurana, Head Marketing, Beckman Coulter

Tulasi Krishna, Sales Leader- Particle Business, Beckman Coulter

Delegates at the event

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Organised by Express Pharma, the seminar witnessed participation of over 80 delegates, which included plant heads, quality control officers, quality assurance managers, project heads, sci-

MARKET

entific officers and engineering heads from various pharma companies. The seminar began with a welcome address by Express Pharma correspondent. A presentation by Matt Harle, Senior Manager, Field Marketing, Particle and Automation products at Beckman Coulter Life Sciences followed.

The delegates also got an opportunity to see the online TOC Analysers equipment and also deliberated and discussed unique features of it

Mark said, “In pharma industry, high purity water is a key ingredient that is used throughout the production processes, purity of the water helps to eliminate the impact that bacteria and other organic compounds may have on the quality of product. Unlike others Anatel TOC analysers not just helps with water purity but helps to improve compliance, get better data integrity and reduce operating costs.” Explaining about Anatel TOC Analysers, Mark informed that it is a fully complaint and a unique solution that has UV detector combined with auto-switching main and standby UV lamps, which means even if one fails there is another one and there is no need to stop the production, as the instrument continues to run, and is still compliant. “Anatel is the first

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company to produce the online TOC analysers, which was initially used in semiconductor industry, but when the pharma industry realised that online TOC analysers exists they were interested in using it. With increasing interest by the pharma manufacturers we further developed the A643 analysers as per the needs of

the pharma industry in late 1990s. In my view the Anatel TOC analysers are dynamic analysers with significant benefits. We are very optimistic that many Indian pharma companies will use this advanced TOC analysers,” Mark added. He also added that the Anatel TOC analysers is a

genuine walk away method, where the technicians have to just load the standards, hit the start keys and walk away. Tulasi Krishna, Sales Leader- Particle Business, Beckman Coulter, pointed out the unique points of the Anatel TOC analysis in pharma waters. The event concluded with a vote of thanks by

Neeraj Khurana, Head Marketing, Beckman Coulter. The delegates also got an opportunity to see online TOC Analysers equipment and discuss on the unique features with their peers at the networking dinner that followed the event. prathiba.raju@expressindia.com

MARKET

IPC revs up for platinum edition Women empowerment added as a new theme this year WITH 70 TH Indian Pharmaceutical Congress (IPC) round the corner, the mood at the fifth meeting of the Local Organising Committee (LOC) was focussed and diligent, with commendable attendance for a Sunday evening. As various committee members presented updates on their designated tasks, the PHD Chamber of Commerce hall resembled a strategy room, with the heads of the dais strategising with their people on how this year’s edition would exceed the previous year’s. This competition with each year’s succeeding LOC, has kept the event relevant for delegates both from academia and industry, as well as speakers and sponsors. In his welcome address Chairman LOC BR Sikri informed the members that he and AK Nasa, organising secretary, LOC have been meeting members of various national level associations. So far, IDMA, FOPE, HDMA, BDMA, CIPI, and Pharmexcil have assured full support for registration from their members as well as suggestions for good speakers and topics. Nasa informed the audience that the website was

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working well, with many registrations coming in. He also informed that the scientific programme was almost ready. Briefing on the scientific programme, Dr Arun Garg, Chairperson, Scientific Committee, said this year there were four tracks. While the first one focusses on the pharma industry, the second

on regulations, third on academia, and fourth on pharmacy practice. Giving more details of the sub topics, Dr Ramkishan, Convenor, Scientific Committee, said that it includes sessions focussing on gene therapy, OTC issues, rare diseases, e pharmacy, medical device rules, etc. One impor-

tant session would be on how to prepare pharmacy students for the future, aptly titled ‘Pharmacists yesterday, today and tomorrow’. Trends in drug development, with a special focus on formulation, biosimilars, trends in cosmetic technology, opportunities and challenges regarding stem cells trends products, re-

BR Sikri speaking at the latest LOC meeting of the 70th IPC held on September 30 in Delhi

generative medicine, trends on drug discovery as well as success stories from the industry would find prominent place in the 70 th IPC conference agenda. In terms of applications for poster presentations, he updated the audience that they have received 450 abstracts. Nasa reminded the audience

MARKET about the deadline for submission of poster and scientific presentations they should spread the news through their networks. A user friendly app will be launched 15 days after the scientific programme is finalised. This will inform delegates about the scientific programme of the day, hall locations, companies available for job fair, hall attendance,

The committee also plans to circulate a feedback form for women delegates to gauge the areas where they can help and mentor, even beyond the 70th IPC highlights of IPC, etc. Each committee presented their status report and progress, with senior members responding with suggestions based on experience of the past editions. Given the fact that this year’s venue is Amity University, there was additional emphasis on short listing adequate accommodation for student delegates as well as safe transportation facilities. One innovative process adopted in the run up to this year’s IPC is the creation of a bulk registration facility for student members. Vijay Bhalla, Chairperson, Registration Committee said that he has created a bulk registration excel sheet for registrations of student delegates from universities. In addition, the LOC members decided at the meeting that for every 25 students registering from a

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single institution, one faculty would be offered complimentary registration. Dr Raman Dang, Chairperson, Volunteers Task Committee informed that more PG students have registered this year. Another big first at this year’s IPC is the presence of a full track focussing on the issues faced by women who are part of the pharma sector. The Women Empowerment

Committee, chaired by Dr Prajita, coined the Five Es as their goals. They hope to encourage, engage, empower, enact and establish women to survive and thrive in a male dominated sector like the pharma sector. The committee also plans to circulate a feedback form for women delegates to gauge the areas where they can help and mentor, even beyond the

70 th IPC. All experts in their own fields, the members of this committee will no doubt use their own personal experiences to inspire the younger generation on how to cope with gender issues as well as other considerations to make a mark in this competitive sector. Their aim will be to present as many examples of successful women leaders in the sector to be inspirational

and aspirational. Closing the LOC meeting, Nasa informed the audience that the next meeting would be on November 10. He expressed full confidence that all committee members and volunteers would work toward making this year’s IPC a landmark event like previous editions held in Delhi in 2001, 2008, and 2013. EP New Bureau

MARKET EVENT BRIEFS 17

Kenya Pharma Expo 2018

9th edition of PHARMAC India

India Tech Conclave 2018

Global Pack 2018

CPhI & P-MEC India

KENYA PHARMA EXPO 2018 Date: October 17 -19, 2018 Venue: KICC, Nairobi, Kenya Summary: The international pharma exhibition on technologies and trade will focus on East & South African Pharmaceutical Industries. The expo will be organised by GPE Expo where pharma machinery and allied-industries OEMs across the world will exhibit their Technologies/ Services. Contact details: Paresh Jhurmarwala CEO KENYA PHARMA EXPO 2018 E-mail: contact@ kenyapharmaexpo.com Website: www.Kenya PharmaExpo.com Phone: +91 (0) 79 26406680

9TH EDITION OF PHARMAC INDIA Date: October 25-27, 2018 Venue: The Arena by Transstadia, Ahmedabad, Gujarat Summary: Pharmac India is 9th international pharma machinery, equipment, bulk drugs, API, pharma lab, pharma pack and material exhibition in India. It has successfully brought together manufacturers and buyers on a common platform and contributed substantially towards the growth of the industry. Pharmac India 2018 is jointly organised by Orbit Exhibitions and Indian Drug Manufacturers’ Association (IDMA-GSB). Contact Varsha Surve Orbit Exhibitions Email: info@ pharmacindia.com Phone: +91 9322037955 Dr RS Joshi Indian Drug Manufacturers' Association (IDMA-GSB) Email: idmagsb@gmail.com

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INDIA TECH CONCLAVE 2018 Date: October 25, 2018 Venue: The Westin Mumbai Garden City International Business Park, Oberoi Garden City, Yashodham, Goregaon East, Mumbai, Maharashtra Summary: The objective of India Tech Conclave is to highlight how AI and Automation will be the norm and break away from being a novel tool in core business processes especially for pharmaceutical and FMCG manufacturing companies in the near future. When AI becomes the industry standard domestically and internationally, the need to carefully compile and curate data will be the driving force to successfully implement Automation enabled by AI. Variables selected by companies today are what will set the tone for AI efficacy in the long run, and the aim to

achieve industry 4.0 will be the need of the hour for Indian pharmaceutical and FMCG companies. Contact details Sana Khan M: 9930160343 sana@tsbmedia.world

GLOBAL PACK 2018 Date: November 23-25, 2018 Venue: Labh Ganga Exhibition Centre, Indore, MP Summary: GLOBAL PACK 2018 is an International Trade Exhibition & Tech Summit for the packaging material, machinery and ancillary industry. Organised by Integrral Business Exhibitions & Media in association with SIES School of Packaging, it is being designed to serve as a platform for the packaging and printing industry, both in terms of business and technical content. Contact Email: info@ibem-india.com

CPHI & P-MEC INDIA Date: December 12-14, 2018 Venue: India Expo Mart, Greater Noida, Delhi NCR Summary: UBM India is all set to bring in the third edition of India Pharma Week (IPW), a week-long celebration packed with avant-garde events alongside its flagship expo CPhI & P-MEC India. This will enable all the key stakeholders and professionals of the pharma industry the convenience to congregate, network and celebrate the industry under one giant umbrella for an entire week. Apart from India Pharma Week, the 2018 edition will also feature dynamic engagements such as the Pharma Leader’s Golf Pre-Connect Congress, plant visits, Women in Pharma – Power Breakfast, India Pharma Awards, Networking Evening, and a closed-door CEO Roundtable, amongst others. Contact UBM India TIMES SQUARE

Unit No. 1 and 2, B Wing, 5th Floor, Andheri Kurla Road, Marol, Andheri (East) Mumbai - 400 059 Tel.: +91 22 61727272 Fax. +91 22 61727273

ACREX INDIA 2019 Date: February 28 to March 2, 2019 Venue: BEC Mumbai Summary: The event will focus on building automation (BMS) and indoor air quality (IAQ). The mega event will witness participation from more than 25 countries including Belgium, China, Czech Republic, Egypt, France, Germany, Italy, Japan, Korea, Malaysia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, the Netherlands, UAE, the UK, Ukraine and the US. Contact details NürnbergMesse India, German House, 2, Nyaya Marg, Chanakyapuri, New Delhi – 110 021 T : +91 (0)11 47168888

MARKET PRE EVENT

CPhI & P-MEC India to be held in Delhi NCR from Dec 12-14,2018 UBM INDIA is all set to bring in the third edition of India Pharma Week (IPW), a week-long celebration packed with avant-garde events from December 12-14, 2018 alongside its flagship expo CPhI & P-MEC India. CPhI & PMEC India will be held in India Expo Mart, Greater Noida, Delhi NCR. Unlike the previous editions organised in Mumbai across a number of venues, this year all the engagements of the IPW, which is also South Asia’s largest pharma event will be held at the world-class venue the India Expo Mart - Greater Noida, with all its attendant facilities. This will enable all the key stakeholders and professionals of the pharma industry the convenience to congregate, network and celebrate the industry under one giant umbrella for an entire week. As the pharma industry is increasingly looking towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the perfect event for companies to pick up on the latest trends and innovations the market has to offer. Apart from India Pharma Week, the 2018 edition will also feature dynamic engagements such as the Pharma Leader’s Golf Pre-Connect Congress, plant visits, Women in Pharma – Power Breakfast, India Pharma Awards, Networking Evening, and a closed-door CEO Roundtable, amongst others. The ultimate goal of all these intertwined events is to help nurture a complete pharma ecosystem in India and better enable networking with the country’s corridors of power. P-MEC India will represent the platform where international and domestic pharma experts meet to to do business, network and shape the future of the Indian and South East Asian pharmaceutical industry.

Key reasons to attend P-MEC India ◗ Meet the biggest representation of pharma ingredients manufacturers in one single location ◗ Source high quality products at the most competitive price

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◗ Network and do business with over 50,000 experts from 120+ countries ◗ Grow your client range and establish new business relation-

ships Exhibitor’s profile include analytical equipment, automation and robotics, batching systems/equipment, cleanroome-

quipment, filling equipment, filtration/separation/purification, health and safety products,instruments, laboratory products and equipment, machin-

ery, packaging equipment and supplies etc. Express Pharma is the media partner for the event. EP News Bureau

cover )

20 EXPRESS PHARMA October 16-31, 2018

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THE MAIN FOCUS

(L-R) Brij Motwani, Vice President & Cluster Head USI Operations, Cadila Healthcare; Dr Hemant Koshia, Commissioner, FDCA Gujarat, Shirish Belapure, MD, Zydus Hospira Oncology; Naresh Gaur, Vice President Operations, Amneal Pharmaceuticals; Dr Shirish Dhande, Ex-CEO, ACG Pharma Technologies; and Manish Chauhan, Associate Vice President, Intas Pharma

olid dosage forms such as tablets, capsules, pills, powders etc. are among the most commonly used pharmaceuticals to treat various ailments. Since ages, they have been a reliable and preferred route to administer medications and generate the preferred pharmacological response. Yet, with changing consumer demands, advent and progress of newer dosage forms and ever evolving regulations, it has become imperative to re-examine the current products and processes in solid dosage forms. To keep pace with the advancements of the pharma industry and meet the requirements of the present and the future, they will also have to continuously evolve and transform. Therefore, it is essential to keep refining this dependable and convenient way to adminis-

ter drugs through innovation. And, this would involve deployment of novel materials and new age manufacturing processes. Hence, the professionals involved in formulation R&D and manufacturing of solid dosage forms have to constantly update their skills and stay informed on the evolving trends, and advancements in this arena. Therefore, Express Pharma and ACG recently organised a panel discussion on ‘Continually evolving solid dosage forms,’ second in a series of Knowledge Exchanges on this subject. The first one, titled 'Reinventing Pharma Tabletting, was held earlier this year. Check out the learnings from that discussion at http://www.expressbpd.com/ pharma/cover-story/reinventingpharma-tabletting/400284/. This time around, an eminent panel reviewed the progress in solid dosage forms

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and ascertained that technological advancements are steering newer approaches in the development of these medications. Dr Shirish Belapure, Managing Director, Zydus Hospira Oncology, the moderator for the discussion very effectively established the relevance and importance of solid dosage forms for the pharma industry today. He informed that solid dosage forms are very important because of their dose accuracy, high stability, cost efficiency and patient compliance. In the course of the discussion, while several crucial aspects were discussed, the panelists also established that as solid dosage forms continue to evolve, technology will be a major enabler of future progress in this field, creating significant impact in some crucial areas. Let’s examine a few of them.

Ensuring quality Panelists concurred that automation and digitalisation will drive a high degree of competence and value in the process of development of solid dosage forms. Therefore, new-age equipment and manufacturing technologies are incorporating features to enable segregation between process steps, control contamination, limit and control the impact of environmental factors on the product etc. to usher improved quality and thereby better outcomes for the patients. Similarly, integrated process control systems and manufacturing execution system (MES) solutions are enabling increased productivity and efficiency in the development and production of solid dosage forms. Throwing more light on this aspect, Brij Motwani, Vice President & Cluster Head USI Operations, Cadila Healthcare,

informed that every company is going for measures such as lean manufacturing, operational excellence, reduce wastages, increase batch sizes, etc to improve operational efficiencies and product quality. He further informed that alternate technologies such as hot melt extrusion, weight granulation, 3D printing will have a great role to play in future and enhance efficiency and quality. Dr Shirish Dhande, Ex-CEO, ACG Pharma Technologies informed that standardisation would also be key to ensuring quality in solid dosage forms and this would come with adoption of technology. Manish Chauhan, Associate Vice President, Intas Pharma also recommended going for modification of current technologies to gain faster approvals and sail through regulatory audits. He also pointed out the benefits of these technologies to

EXPRESS PHARMA

October 16-31, 2018

cover ) offer more differentiation in products and safeguard quality.

Cost optimisation Dr Dhande pointed out that as price pressures mount, the pharma industry is looking for more and more cost-effective solutions without compromising on quality. He opined that this is where technology will have a crucial role to play. Motwani also highlighted that every industry is looking at ways to contain costs and the pharma sector is no exception. He opined that automation is likely to be answer to a lot of these cost challenges and ensure that we produce maximum at minimum cost. Adoption of new age technologies in the development and manufacture of solid dosage forms has also led to significant cost savings through the means of simplified processes, better space utilisation, improved energy savings, optimal use of resources, and increased batch sizes. Experts highlighted that return on investment is also seen in reduced production time and elimination of product failures. This, in turn, provides a lot of benefits to the pharma company and the patients.

Improving efficacy The growing demand, newer therapies and treatment protocols have made it imperative to bring in differentiation and ameliorate the performance of solid dosage forms as well to improve their ease of use and efficacy. As a result, tech-led innovations and alternative formulation techniques are being applied and adopted to gain better product benefits and meet the changing requirements. This has also led to more patient medication compliance, alongwith better cost-effectiveness and enhanced overall disease management. Motwani predicts that one machine is going to do a lot of jobs in future such as drying, granulation, blending, compression, coating etc. In the next 2030 years, one might see that

22 EXPRESS PHARMA October 16-31, 2018

Ajit Kanetkar, Head Process Technology and Training, ACG

Sanjay Motipwer, GM (Pharma technology, formulation & development), Zydus Healthcare

It deliberately regulates the bioavailability of active ingredients in both generic and non-generic medications in a way that reduces the opportunity for overdose and/or abuse. PODRAS delivery technology is designed to prevent overdose when more pills than prescribed are swallowed intact.

processes will be a major challenge that would have to be tackled. He emphasised on the need for the adoption of qualityby-design (QbD) and effective utilisation of new-age technology to achieve it effectively. Dr Dhande recommended that the industry needs to have a more risk-based approach to eradicate errors. He empahsised that it is important to understand the quality parameters well and maintain them with the help of technology rather than trying to rectify errors which have several adverse after effects in terms of costs and compliance.

Osmotic Release Oral System (OROS)

Regulatory compliance

It is an advanced controlled release oral drug delivery system in the form of a rigid tablet with a semi-permeable outer membrane and one or more small laser drilled holes in it. As the tablet passes through the body, water is absorbed through the semipermeable membrane via osmosis, and the resulting osmotic pressure is used to push the active drug through the opening(s) in the tablet.

A range of new age processing technologies, including continuous manufacturing are being utilised in the current times to produce high-quality, solid dose, pharma products. Sensors, automated transfer system, cameras, automation in compression and coating machines etc. are a few examples. The use of these technolo-

SOME UPCOMING TRENDS & TECHNOLOGIES 3-D printed drugs Tablet is made by 3-D printing layers of the powdered drug. The advantage of this process is that the drugâ&#x20AC;&#x2122;s unique structure allows it to dissolve considerably faster than the average pill.

Digital pill A new â&#x20AC;&#x2DC;digital pillâ&#x20AC;&#x2122; can tell doctors whether a patient has taken his or her medicine. The pill, which was approved by US Food and Drug Administration on Nov. 13, sends a signal to a wearable sensor when a patient has taken the medication, and that information is then sent to a doctor's office.

PODRAS (Paradoxical Overdose Resistance Activating System)

Source: Sanjay Motipwer, GM (Pharma technology, formulation & development), Zydus Healthcare

millions and millions of tablets are being manufactured in one small room .

Naresh Gaur, Vice President Operations, Amneal Pharmaceuticals believes that technol-

ogy will be a gamechanger but also cautions that scalability of these technologies and

( gies have also brought in better understanding of the QbD concept, leading to optimisation of raw material, formulation, and processing variables. This, in turn is aiding regulatory compliance. Gaur explained this point with a very pertinent example. He pointed out that paracetamol is an age-old product but we continue to see quality and efficacy issues even in that. These things can be avoided through QbD, enabled by technology. He also accentuated that as new regulations such as GDUFA come into place, it will be essential for pharma companies to restrategise and be future ready. Interestingly, regulators themselves are also using technology to ensure that the companies adhere to their requirements. Dr Hemant Koshia, Commissioner, FDCA Gujarat explained how technology is not only enabling regulatory compliance but also helping in regulatory enforcement. He cited the example of how the Gujarat government has a database maintained through a software for product licenses given out to pharma companies since May 1, 1960, when Gujarat came into existence as a state. He informs that they have the details of over 375850 product licenses given out and the list is growing with each passing day. Of these licenses, 65 per cent of them are for solid dosage forms. Dr Koshia also spoke on how technology ranging from simple, chemistry-based kits to high-end technologies such as LED infrared, X-ray analyser, photometers, mobile drug testing labs etc., are being utilised help enforce adherence to regulations.

What does future behold? The discussion very clearly brought out that the pharma industry is undergoing a change which is unprecedented and the market for novel products will continue to grow. However, as Ajit Kanetkar, Head Process Technology and

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training, ACG highlighted in an informative presentation, solid dosage forms have been around for centuries and they are evolving at a very fast pace, falsifying predictions that they would cease to exist. But, solid dosage forms will also have to tackle the

challenges that hamper its future prospects such as poorly soluble drugs, huge tablet size limitation, outdated manufacturing techniques, obsolete equipment, lack of trained resources etc. Thankfully, with the advent of new coating technologies,

THE MAIN FOCUS

avant-garde manufacturing technologies, novel designing methods, and innovative formulation techniques and delivery methods, solid dosage forms can disassociate itself from the disadvantages. Thus, it is clear that pharma companies need to adopt

alternate processes. They would also have to invest in innovation which will enhance the quality, efficacy and reproducibility of solid dosage forms and be better equipped to meet the requirements of patients. lakshmipriya.nair@expressindia.com

MANAGEMENT REPORTS

Promising pipeline drugs and a shift in perception could be key to tackling Alzheimer’s disease The AD pipeline features 657 drugs across all stages of development, and out of these, only 3.2 per cent of drugs are in late-stage development

ith the aim to raise global awareness and understanding of the issues faced by people affected by dementia it’s timely to reflect that no new drug for Alzheimer’s disease (AD) has been approved in the past 16 years. This is despite more than 400 clinical trials and billions of dollars being spent in an attempt to tackle the disease and address unmet needs, says GlobalData a leading data and analytics company. According to GlobalData’s latest report, ‘Alzheimer’s Disease: Competitive Landscape to 2026’, the pipeline has been characterised by big failures, as

AD drug development is considered to have one of the highest failure rates of all indications. The AD pipeline features 657 drugs across all stages of development, and out of these, only 3.2 per cent of drugs are in late-stage development; which is dominated by small molecules and monoclonal antibodies. The report reveals that amyloid precursor protein (Aß peptide and protein) and microtubule associated protein tau (MAPT) are the major targets being pursued by companies developing drugs against AD. Alessio Brunello, Pharma Analyst, GlobalData, commented, ‘‘The need for new dis-

ease modifying drugs (DMDs) is urgent as the current competitive landscape in AD offers medications that are aimed at treating only the symptoms of the disease. A few key drugmakers have already stopped their research into AD, and given the significant amount of R&D failures, pharma companies may be disincentivized from producing new drugs.” “The amyloid hypothesis has been the central theory for the pathogenesis of AD, but all Aßtargeting drugs treating AD have ended in failure. In fact, recent studies indicated that one of the main factors concerning the development and progres-

sion of the disease could be tau and not beta amyloid.” Currently, treatments for AD consist only of symptomatic treatments, of which there are only five approved medications: three cholinesterase inhibitors (ChEIs) (donepezil, rivastigmine, and galantamine), one N-methyl-D-aspartate receptor (NMDA-R) antagonist (memantine), and one combination therapy (memantine/donepezil). These leave a lot to be desired in terms of efficacy, routes of administration, and dosing frequencies. The potential launch of promising monoclonal antibodies from

Biogen (aducanumab) and Roche (gantenerumab and crenezumab) will boost the size of the Alzheimer’s market given their potential to halt or prevent disease progression. Most of the tau-targeting approaches that are currently in clinical trials are immunotherapies such as Axon neuroscience’s AADvac-1 and Eli Lilly’s LY3303560. Tau is more likely to be a better target than Aß as the clinical stages of cognitive decline much better correlate with the number, density and distribution of tangles than does the Aß burden. EP News Bureau

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24 EXPRESS PHARMA October 16-31, 2018

Novo Nordisk’s NN9924 has potential to become new market leader in GLP-1RAspace NOVO NORDISK’S NN9924 is on track to become the firstto-market oral GLP-1RA within the next decade, says GlobalData, a leading data and analytics company. The growth in the GLP-1RA space will be heavily driven by agents that confer glycemic benefit, weight loss, and cardiovascular (CV) benefit, and increased patient compliance. In anticipation of GLP-1RA market trends, Novo Nordisk developed a follow-up onceweekly GLP-1RA of its own, Ozempic (semaglutide), which is a variant of Victoza that was shown to significantly reduce CV risk in T2D patients in the SUSTAIN-6 trial. In addition, Novo Nordisk is developing NN9924, an oral version of semaglutide. Recent results from the PIONEER 1 study, a Phase IIIa clinical trial investigating Novo Nordisk’s NN9924, indicates that the agent is already proving to confer both glycemic and nonglycemic benefits, while also boasting a convenient mode of administration. Jesus Cuaron, Managing Pharma Analyst, GlobalData, comments, “What sets NN9924 apart from its competitors is its route of administration. The oral GLP-1RA has an obvious advantage in terms of administration, as the marketed GLP-1 RAs are administered via injection, and thus are prone to heightened compliance issues.” “At the 54th EASD annual meeting in Berlin, the only issue raised pertaining to NN9924 was that the agent needs to be taken before breakfast, which may affect the timing of other medications that are taken. NN9924 is expected to achieve blockbuster status if approved, despite stiff competition from existing GLP-1RAs.”

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MANAGEMENT

Journey of the pill In the fourth of a series of six articles, Organisation of Pharmaceutical Producers of India (OPPI) launches the Know Your Pill initiative, which throws light on customised technologydriven supply chain management that can help deliver medicines in an organised manner, thereby advancing access to safe medicines, keeping patient safety in mind

26 EXPRESS PHARMA October 16-31, 2018

ost of us have experienced that one painful night of unbearable colic. Or worse still, seen our loved ones suffering from a high fever, especially in the middle of the night. The neighbourhood 24-hour pharmacy transforms to our beacon of hope and that one medicine is the much-sought relief. Do you that know your angel in distress, the pill has come from hundreds of miles away, or in these days of globalised manufacturing across continents. Manufacturers of medicines are increasingly accountable and responsible for the manufacture of medicines that are subject to extremes of temperature, humidity, physical pressure, etc. to ensure that they do not decompose or degenerate under such conditions. To ensure quality of medicines, the World Health Organisation (WHO) issued a set of Model Guidelines in 2011, which sets out in great detail, the manner in which medicines should be transported and stored during their journey. It has also formulated what are known as Good Distribution Practices (GDP), consisting of standard protocols to be followed while organising the transportation of medicines and biological substances. This document is to be used alongside the Good Manufacturing Practices (GMP), which is supposed to guarantee the requisite quality in pharmaceutical manufacture. The fascinating journey of the medicine from the factory to the market place considers the temperature and other factors

that need to be maintained and monitored. Some injectables, vaccines and sera, or other biological materials may require storage at minus 200 Celsius, while most must be transported between 20 and 80 Celsius. Exposure to moisture can cause tablets to crumble or change colour, liquids can be contaminated by fungus, etc, all of which can reduce the efficacy of the medicine. In the case of injections, extreme precautions are needed to prevent the slightest impurity from creeping in, because a defective injection can result in chills and rigours that patients may experience when an intra-

venous infusion is administered. Storage is another key element of the journey. The GDP documents and the WHO model guidelines describe in considerable detail the methodology of selection of warehousing and storage sites â&#x20AC;&#x201D; primarily to protect medicines from natural calamities such as earthquakes, landslides, volcanic eruptions or even floods. Technology plays a crucial role in supply chain management and in ensuring a safe journey of the pill from the factory to the patient. Innovation for safe transport and storage of medication especially like that of LifeinaBox, the worldâ&#x20AC;&#x2122;s smallest fridge, for the safe transport and storage of medication is meant to protect fragile medications, the types required by those who have conditions like diabetes, multiple sclerosis, arthritis, and Crohnâ&#x20AC;&#x2122;s Disease. Such innovations through digital health intervention go a long way in providing a practical solution that appeals to patients across different demographics and with varying medical needs. For all journeys, planning and coordination are essentials. The journey of the medicine is no different. A customised technology-driven supply chain management can help deliver medicines in an organised manner, thereby advancing access to safe medicines, keeping patient safety in mind.

Issued in public interest by OPPI Watch this space for the fifth in the KYP series - The Pill House

RESEARCH UPDATES

Affimed puts on hold cancer drug trial after patient death Affimed is testing the drug, AFM11, for treatment of acute lymphoblastic leukemia and non-Hodgkin lymphoma in two separate early-stage trials

rug developer Affimed recently put on hold the testing of its experimental cancer drug following the death of a patient and two life-threatening events. Affimed is testing the drug, AFM11, for treatment of acute lymphoblastic leukemia and non-Hodgkin lymphoma in two separate early-stage trials.

The patient death occurred in the acute lymphoblastic leukemia drug trial, while the life-threatening events took place in the non-Hodgkin lymphoma study. 33 patients have been treated in the two early stage studies, the company said. Affimed also said it was working with global health authorities,

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the safety monitoring committees and the studiesâ&#x20AC;&#x2122; clinical investigators to review the events and will update on AFM11 after completing the evaluation. The clinical hold would not affect the companyâ&#x20AC;&#x2122;s other ongoing experimental cancer drug studies, Affimed said. Reuters

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October 16-31, 2018

RESEARCH

US FDAexpands approval of Roche hemophilia drug Roche is counting on new medicines like Hemlibra to replace falling revenue from its trio of blockbuster cancer medicines, Rituxan, Avastin and Herceptin ROCHE, RECENTLY received an US regulators approval for expanded use of its drug Hemlibra to include almost all patients with hemophilia A, as the Swiss drugmaker increases its focus on diseases beyond cancer to help replace revenue from older products that have lost patent protection. The Food and Drug Administration cleared Hemlibra to treat adults, children and newborns with the genetic disorder in which blood does not clot properly, putting them at risk of dangerous bleeding. Hemlibra can now be used for patients who have not become resistant to standard treatment, known as factor replacement therapy. It is the only preventive treatment for hemophilia A patients with and without factor VIII inhibitors that can be self-administered subcutaneously once weekly, every two weeks or every four weeks. Older treatments, sold by companies like Shire, require more frequent intravenous infusions. Hemlibra won initial US approval last year only for hemophilia A patients with factor VIII resistance, or inhibitors. That accounted for only about 5 per cent to 7 per cent of the estimated 16,000 US hemophilia A patients. Factor VIII is a protein involved in clotting. For a hemophilia A patient of average weight of about 140 pounds (63.4 kg), the annual list price for Hemlibra will be about $ 492,000 per year, following the initial first-year dose that costs an additional $ 38,000, a spokeswoman for Roche’s US Genentech unit said on Thursday. Dosing is based on a patient’s weight. Roche is counting on new medicines like Hemlibra to replace falling revenue from its trio of blockbuster cancer medi-

28 EXPRESS PHARMA October 16-31, 2018

Roche is counting on new medicines like Hemlibra to replace falling revenue from its trio of blockbuster cancer medicines, Rituxan, Avastin and Herceptin

cines, Rituxan, Avastin and Herceptin, which account for about $ 21 billion in annual sales but will face increasing competition from less expensive biosimilar alternatives. “I’m hopeful (the expanded approval) will greatly increase the number of people receiving prophylactic treatment, because one of the major reasons that some people don’t do prophylaxis is it’s just too burdensome, too challenging to do,” Dr Gallia Levy, head of Roche’s Hemlibra programme said prior to the FDA approval. “Those people that are not doing prophylaxis, they’re bleeding a fair amount. The average is about 30 bleeds a year,” Levy said. Reuters

GSK candidate vaccine helps prevent active pulmonary tuberculosis in HIV negative adults Publication of primary results in the New England Journal of Medicine shows positive impact of innovative vaccine technology in clinical trial conducted in tuberculosis endemic regions RECENTLY, GSK and Aeras reported that GSK’s M72/AS01E candidate vaccine significantly reduced the incidence of pulmonary tuberculosis disease in HIV-negative adults with latent tuberculosis infection in an ongoing phase IIb clinical trial testing. These primary results published in the New England Journal of Medicine after two years of trial demonstrate an overall vaccine efficacy of 54 per cent, with varied response rates observed in different demographic sub-groups. The candidate vaccine had an acceptable safety and reactogenicity profile. Tuberculosis is the leading cause of death through infectious disease worldwide and represents a significant public health threat with 1.6 million attributed deaths in 2017. Dr Emmanuel Hanon, Senior Vice-President and Head of R&D, Global Vaccines GSK, said, “These initial findings represent a significant innovation in the development of a new and muchneeded vaccine and advance the scientific understanding of tuberculosis. This scientific breakthrough – one of the very few in tuberculosis vaccine development for almost 100 years – has been made possible by our strategic partnership with Aeras, in which GSK is providing the innovation expertise and technology platforms, such as the proprietary AS01 adjuvant.” The study assesses the safety and efficacy of M72/AS01E protecting adults with latent tuberculosis infection against developing pulmonary tuberculosis disease. The ongoing trial is con-

ducted in tuberculosis endemic regions (Kenya, South Africa and Zambia) and involves 3,573 HIV-negative adults. For this analysis, participants who received two doses of either M72/AS01E or placebo 30 days apart have been followed up for at least two years to detect evidence of pulmonary tuberculosis disease. Jacqui Shea, Chief Executive Officer, Aeras, which contributed to the partnership their decades long experience in tuberculosis vaccine clinical development, clinical operations capabilities and strong links with African clinical sites and patient communities, said, “This ground-breaking study shows – for the first time – that a subunit vaccine can significantly reduce the incidence of pulmonary tuberculosis in healthy, HIV-negative adults with latent tuberculosis infection, and that more effective vaccines against tuberculosis are achievable.” He further added, “Given the overwhelming public health need, the importance of these promising results, which need to be confirmed through additional clinical research, cannot be overstated. An effective vaccine, able to reduce transmission, would be by far the most impactful new intervention to end the global tuberculosis epidemic”. The study is still ongoing and a final analysis including all efficacy, safety, reactogenicity and immunogenicity data will be performed in 2019 after all participants have completed three years of follow up. EP News Bureau

RESEARCH

AstraZeneca announces positive results from Phase III DECLARE-TIMI 58 Forxiga achieved a positive result in the Phase III DECLARE-TIMI 58 trial, a large cardiovascular outcomes trial in 17,000 patients with type-2 diabetes ASTRAZENECA recently announced positive results from the Phase III DECLARE-TIMI 58 cardiovascular (CV) outcomes trial (CVOT) for Forxiga (dapagliflozin), the broadest SGLT2 inhibitor CVOT conducted to date. The trial evaluated the CV outcomes of Forxiga vs. placebo over a period of up to five years, across 33 countries and in more than 17,000 adults with type-2 diabetes (T2D) who have multiple CV risk factors or established CV disease. In the DECLARE (Da-

pagliflozin Effect on Cardiovascular Events)-TIMI 58 trial, Forxiga met its primary safety endpoint of non-inferiority for major adverse cardiovascular events (MACE). Forxiga achieved a statistically-significant reduction in the composite endpoint of hospitalisation for heart failure (hHF) or CV death, one of the two primary efficacy endpoints. Additionally, fewer MACE events were observed with Forxiga for the other primary efficacy endpoint, however, this did not reach statis-

tical significance. Data from DECLARETIMI 58 confirmed the wellestablished safety profile of Forxiga. Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development said, “Forxiga has achieved a statistically-significant and clinically-important reduction in hospitalisation for heart failure or CV death in a broad range of patients with type-2 diabetes and cardiovascular risk. The results from this

landmark trial are especially important since heart failure is an early and frequent complication of diabetes and associated with hospitalisations that result in a considerable societal and economic burden.” Dr Stephen Wiviott of Brigham and Women’s Hospital and Harvard Medical School, a senior investigator with the Thrombolysis in Myocardial Infarction (TIMI) study group and co-principal investigator of the trial, commented, “The DECLARE-

TIMI 58 results offer compelling evidence that dapagliflozin helps to address an important medical need among a diverse group of patients with type-2 diabetes by reducing the composite of hospitalisation for heart failure or CV death, with a safety profile supportive of broad use.” Detailed trial results will be presented on November 10 at the American Heart Association Scientific Sessions 2018 in Chicago, USA. EP News Bureau

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PHARMA ALLY I N T E R V I E W

B&R is the right partner for implementing Industrial IoT solutions in both greenfield and brownfield facilities Mukund Patil, Head Sales & Applications - PFA, B&R Industrial Automation, in an interaction with Express Pharma, talks about B&Râ&#x20AC;&#x2122;s offering to the pharma industry The pharma industry is in a state of transition. What according to you are the current requirements in pharma industry? Gone are the days when manufacturing processes focussed on manufacturing the same product year after year. Nowadays, with advancements in drug development coupled with targeted therapies, it is necessary for manufacturers to manufacture drugs in smaller volumes for smaller populations. Industry is transitioning from mass production to batch size one. With flexible and agile facilities, manufacturers are capable of reacting to changing demands quickly. Advance automation solutions together with digitalisation, are helping the industry to eliminate challenges related to quality, productivity, wastage enabling them to become competent in market. Automation helps process optimisation, quality improvement along with reducing time to market with consistent and accurate results in drug discovery, manufacturing, inspection and quality control processes. Knowing the importance of compliances in this industry, we have made sure all our hardware and software are fully compliant with FDA 21 CFR Part 11 regulations. We provide our customers with ready-to-use technology libraries that support all FDA criteria for electronic records and signatures. In your opinion, which technological advances are benefiting the pharma industry? Today, digitalisation is about connected machines, people,

30 EXPRESS PHARMA October 16-31, 2018

and factories. Connected machines in factory are capable of reporting various essential parameters for an efficient functioning of the factory such as machine condition. Such information proves vital in predicting machine breakdown or failure providing huge savings in terms of averted unplanned down time. Realtime systematic data acquisition directly from the field is essential in modern manufacturing to measure productivity, OEE and RoI. Remote access and maintenance makes data logging as well as diagnosing and maintaining machinery easier than ever. The solution utilises the latest IT and security standards and allows for significant savings with low investment costs. However, in order to reap the benefits of data acquisition, remote access and smart predictive maintenance, organisations should wisely choose automation vendors and solutions. What are the major challenges faced by the industry? We are talking about smart

manufacturing and leveraging benefits offered by advanced automation concepts and technologies. However, we cannot neglect the fact that, India had many brownfield factories and decade old sites, which are still operational. This acts as a major hurdle in adopting new technologies and making manufacturing smart. The cost of upgrading legacy equipment to becoming digitised is unknown. Along with increasing compliance requirements, interconnecting machines with multi-vendor solutions and controllers, data security, lack of awareness of investment Vs. RoI are some of the concerns the industry is facing in their quest to digitisation.

Pharmaceuticals and compliances go hand in hand. How do you help factories comply with necessary standards? The pharma industry is highly regulated and that is why regulation and compliance has a major consideration in automation. The 21 CFR Part 11 regulations allow pharma companies to use electronic records and signatures in lieu of paper records and handwritten signatures for documentation. A common perception is that execution of 21 CFR Part 11 compliant machines or factories is costly as well as requires a lot of work. However, this has definitely standardised the process for electronic records. The early adoption can lead to more efficiencies and productivity within organisations. Eventually, this regulation can also reduce products time to market and increase traceability, which essentially benefits manufacturers, distributors and consumers. B&Râ&#x20AC;&#x2122;s automated solutions directly addresses all regulations prescribed by 21 CFR Part 11. B&R satisfies FDA requirements by its range of

Applications subject to the FDA's Title 21 CFR Part 11 requirements can be developed faster and with less investment risk using mapp Audit

hardware and software that are fully compliant with FDA 21 CFR Part 11 regulations. With our mapp Technology, we provide customers ready-touse technology libraries that support all FDA criteria for electronic records and signatures. Data security, data integrity, traceability and electronic signatures are a few basic requirements of 21 CFR Part 11. B&R thoroughly addresses these requirements of security by restrictive access to data through mapp Technology. It allows different levels of access control. Applications subject to FDA's 21 CFR Part 11 requirements can be developed faster and with less investment risk using mapp audit. All user actions are logged with a timestamp and username. The data can be exported as an encrypted PDF. It has the ability to retrace actions performed on a machine that can also be of great service to its manufacturer in event of warranty claims. Pharma companies demand ability to log operations performed by users seamlessly without the risk of being tampered with. B&Râ&#x20AC;&#x2122;s mapp Audit component serves as a quick and easy way to implement and customise necessary audit trail functionality. System manufacturers and end users benefit from maximum security without having to implement organisational measures to prevent tampering on the control system. In addition, solutions from B&R in the form of Edge controller, helps brownfield pharma factories comply with the 21 CFR Part 11. Industries are demanding

connected facilities. How B&R satisfies these requirements? There are four fundamental aspects to digitisation; the hardware used for data acquisition, the data itself, the software used to analyse data, and finally connectivity — in other words, the network that ties together all assets with IT. B&Rs Edge Architectures enables factories to become digitised providing real time control, security, internet connectivity, data aggregation, data historian, business intelligence, machine learning and long-term storage. Edge controller enables factory operators to leverage benefits of latest technologies even for legacy systems and brownfield installations. It is possible to easily connect existing equipment to higher-level IT systems, collect and evaluate previously inaccessible data to improve operational effectiveness and make

brownfield machines and factories more competitive. With three types of edge architecture; edge connect, edge embedded and edge controller, B&R offers a solution for every customer requirement. Edge computing enables factories to gather data and acts as a final physical hardware in the factory premise before the data is moved into the IT space from the OT space. Edge architecture coupled with open source communication standards such as OPC UA, Ethernet POWERLINK and openSAFETY – enable factories to add value to their already available production processes by increasing profitability and reducing losses and wastage. How would you summarise the strengths of B&R’s systems? To remain competitive in era of Industrial IoT, digital

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With three types of edge architecture, B&R offers a scalable solution for all factory needs

transformation is the need of the hour. B&R offers complete hardware and software solutions, comprehensive service and expertise in automation and digitalisation of pharma machinery and factories. Our ‘World Class Support’ with a dedicated number +91 83 80 800 008, ensures high quality support and accelerated response times. With next generation technologies and open source communication standards such as OPC UA, POWERLINK and openSAFETY as well as the powerful Automation Studio software development environment, B&R is the right partner for implementing Industrial IoT solutions in both greenfield and brownfield facilities. With solutions for machine to factory automation, B&R serves as a perfect partner to pharma industry for sustainability, flexibility, higher productivity and profitability. EP News Bureau

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October 16-31, 2018

PHARMA ALLY PRE EVENT

India Tech Conclave to be held in Mumbai The event will look at various components that are essential to the making of a good manufacturing process enabled by AI and automation technologies

ndia Tech Conclave will be held in Mumbai on October 25, 2018. The objective of the event will be to highlight how AI and automation will be the norm and break away from being a novel tool in core business processes especially for pharmaceutical and FMCG manufacturing companies in the near future. When AI becomes the industry standard domestically and internationally, the need to carefully compile and curate data will

be the driving force to successfully implement automation-enabled by AI. Variables selected by companies today are what will set the tone for AI efficacy in the long run, and the aim to achieve industry 4.0 will be the need of the hour for Indian pharmaceutical and FMCG companies. This will be possible only when AI and automation are implemented efficiently in various business processes. India Tech Conclave will look at various components

that are essential to the making of a good manufacturing process enabled by AI and automation technologies. It will attempt to encompass a spectrum of topics and themes to adequately address important variables that may or may not affect manufacturing companies in India especially when competing in an ever changing technologically driven global market. The conclave will have top industry leaders share their experiences on the challenges

and issues that they face while conforming to current industry standard practices and what steps they are taking to break the mould to gain competitive edge domestically and in an international platform. The issues and challenges may vary from data integrity, regulatory issues to human cum technology synchronisation. In order to address, if not resolve, these challenges, the conclave will have Industry and technology experts

who will share their insights, technical expertise and knowledge on the best solutions to embrace while solution and technology providers will showcase their latest innovations that are designed specific to these issues. The focus areas at the conclave will be: a) 4.0 Industry; b) Smart Manufacturing; c) Regulatory/Compliance Issues; d) Data Integrity; e) Technology in R&D. EP News Bureau

VENDOR NEWS

4 SCDM India Annual Conference to be held in Hyderabad th

The theme for this year’s conference has been identified as 'Data Management to Data Science – DM 4.0 – Digitalization | Analytics | Statistics.'

ociety for Clinical Data Management (SCDM) will be hosting its 4th SCDM India Annual Conference in India at Hyderabad on December 7 and 8, 2018. The conference will be co-chaired by Praveen Dass, Country Head, VP of Data Management, Quanticate, Shankar Arun, VP & Board Member (Director), Covance Clinical Research Unit, and Appalla VenkataPrabhakar, Group Head, Clinical Database Delivery. The theme for this year’s conference has been identified as 'Data Management to Data

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October 16-31, 2018

Science – DM 4.0 – Digitalization | Analytics | Statistics.' The theme is centered on the current conversation in the industry related to Big Data – Understanding how big data generated through digital technologies could be converted into actionable insights or intelligence to make informed decisions. This conference brings forth a diverse offering of thought provoking sessions like case studies of effective and efficient monitoring of data quality using RBM, data management in the world of

virtual trials, descriptive, predictive, prescriptive analytics and visualisations for better decision-making — Case studies, CDISC standards in the age of artificial intelligence and machine learning, data science - changing healthcare landscape, data lake - For accelerating data analytics and informed business decision. The conference will have presentations which will be delivered by industry experts on topics like practical applications of block chain, artificial intelligence, machine learning, deep learning in clin-

ical research landscape; how will evolving technologies change clinical data management and clinical trials in near future - are we ready; understanding GDPR and its impact on clinical trials and data subject. Also in line with the rapid explosion happening on technology front and the way clinical research landscape is evolving, Dermot Kenny, Global Head of Data Operations, Novartis will present the keynote talk on ‘Disruptive Technology - Key to Pharmaceutical Innovation.’ An-

other key thought leadership presentation on ‘Virtual Trials & Remote Trials - What is the future of truly patient centric trials’ will be led by Greg Dearhammer, SrVice President, Data Science, Safety & Regulatory Research, IQVIA. In the end, industry experts will present on QA and data integrity topics. This is a great opportunity for the CDM community to engage in peer-to-peer communication, learn and advance the CDM practice in India. EP News Bureau

PHARMA ALLY

BASF to increase capacity for Hexanediol at its Ludwigshafen site Global capacity to increase to more than 70,000 metric tonne per year BASF INTENDS to increase the production capacity of 1,6-Hexanediol (HDO) at its Ludwigshafen Verbund site by more than 50 per cent. After the start-up in 2021, BASF’s global annual nameplate capacity of HDO will be more than 70,000 metric tonne per year at its production facilities in Ludwigshafen, Germany and Freeport, Texas, US. “By increasing our HDO production capacity, we will

continue to support the fastgrowing customer demand for high-quality HDO formulations globally. The expansion is in line with the general trend for high performance and environmentally friendly technologies in the automotive, furniture and packaging industry,” said Dr Andrea Frenzel, President, BASF Intermediates Division. “As one of the leading global producers of HDO with decades of experience, we have highly

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efficient manufacturing processes and are supplying HDO to our customers across all regions.” Michael Britt, Senior Vice President, BASF Intermediates Europe, adds: “With the investment we provide our customers more flexibility and reliability of supply than we did before. The volumes from the additional capacity in Ludwigshafen will mainly serve the strong European customer base as well as the

fast growing Asian market.” HDO adds value in many applications by giving hydrolysis resistance, flexibility, adhesion and weatherability to the end-products. Due to its superior performance compared to other materials, BASF’s customers use the intermediate to formulate high quality industrial, automotive, wood or leather coatings, polyurethane plastics, adhesives and cosmetics. HDO also serves as a raw ma-

terial for environmentallyfriendly applications including low volatile organic compound formulations for coatings and adhesives. In addition there is the production of reactive thinners in the formulation of epoxy systems which are used for the efficient production of rotor blades for modern wind turbines and many other applications. EP News Bureau

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October 16-31, 2018

PHARMA ALLY

Arihant Innochem organises key pharma leaders forum across three cities The Key Leaders Forum is a knowledge sharing platform created by Arihant Innochem in 2015 ARIHANT INNOCHEM, the leading distributor of Speciality Pharmaceutical excipients and personal and homecare ingredients, organised seminars in three cities under their flagship platform – The Key Pharma Leaders Forum. The Key Leaders Forum is a knowledge sharing platform created by Arihant Innochem in 2015. The first series hosted lectures for the pharma leaders by eminent speakers including Dr Ajaz Hussain, exUSFDA, Dr Muddha, Microlabs and Rajiv Joshi for Ernst

& Young. The idea was to share valuable insights on Quality by Design (QBD) concepts and the importance of quality and data integrity. The initiative was well received and applauded by the industry leaders, which encouraged Arihant to bring part two of this series titled Advanced Performance Materials. In series 2 futuristic offerings from Arihant’s excipient basket were showcased. The first seminar was flagged-off in Hyderabad on September 18 followed by

The first seminar was flaggedoff in Hyderabad on September 18 followed by Ahmedabad on September 20, 2018 and in Mumbai on September 21, 2018 Ahmedabad on September 20, 2018 and in Mumbai on September 21, 2018. An introduction to Arihant Innochem was presented by the Arihant team along with a brief

history of its transition to a knowledge-driven excipient promoter. They also highlighted how their vision is to bring in more functional speciality excipients to their portfolio and

their foray into excipients for neutraceuticals, dermaceuticals and for niche therapeutic segments like parenterals and inhalation therapy. The presenters at the seminar were technical experts representing Shinestsu, Asahi, Freund, Nisso HPC and Omya. Each of these principals introduced their product basket with a special focus on advanced performance materials which are the future of pharmaceutical product development. EP News Bureau

Waters sponsors new research centre to address global food and water safety challenges Facility will serve as amodel for scientific collaboration between industry, government and academia WATERS CORPORATION opened the doors of the new International Food and Water Research Centre (IFWRC) in Singapore to address the growing challenges of food and water security and safety. Led by a Scientific Advisory Panel, the IFWRC will support scientists throughout the world working in areas such as food authenticity, food fraud discovery, water contamination research, food quality enhancement and new ingredient/formulation studies. The Scientific Advisory Panel will identify meaningful, innovative projects by working with academic and industrial leaders globally. As world populations grow, it has become increasingly important to ensure food and water supplies are safe, healthy and plentiful. How-

34 EXPRESS PHARMA October 16-31, 2018

Led by a Scientific Advisory Panel, the IFWRC will support scientists throughout the world working in areas such as food authenticity, food fraud discovery, water contamination research, food quality enhancement and new ingredient/ formulation studies ever, all over the globe, new challenges are arising — environmental contamination, food adulteration, access issues and more are putting people’s futures at risk. To find solutions, it’s critical to gather the leading food and water scientists together in collaborative environments. “In past decades, Singapore has become a major hub

for food and water research that has far-reaching impacts around the globe. The country has long had well-established academic laboratories where scientists have done significant work,” said Mike Harrington, Senior Vice President of Global Market, Waters. “Based on that, along with Waters’ storied history in Singapore, we are thrilled to open

the IFWRC, a model for scientific collaboration between industry, government and academia that will ultimately drive significant advances in food and water quality.” “As an innovation-led economy, Singapore values strong partnerships that accelerate the development of new, differentiating capabilities for our industries. The unique

collaboration model of the International Food and Water Research Centre will build upon Singapore’s strong academic base, while bringing together regional and global researchers within the food and water domains, to co-create and implement innovative solutions with a global impact,” said Thien Kwee Eng, Assistant Managing Director, Singapore Economic Development Board. Researchers will gain access to IFWRC’s state-of-theart facilities outfitted with the latest advanced analytical instrumentation from Waters. In addition, the laboratory will be staffed with scientists and researchers who will work closely with project owners throughout implementation. EP News Bureau

PHARMA ALLY PRODUCTS

Aptar Pharma launches QuickStart at CPhI Worldwide 2018 in Madrid,Spain APTAR PHARMA, a leading provider of innovative drug delivery systems, in combination with Schott Glass and EMA Pharmaceuticals, has launched Aptar Pharma QuickStart for injectable drug development at CPhI Worldwide 2018, in Madrid, Spain. Aptar Pharma QuickStart is a sterile, Ready-To-Use (RTU) drug development support kit designed specifically for research and development labs. A package complete with

glass vials, elastomeric stoppers and caps, QuickStart provides everything needed for the small volume filling of high value formulations. Also included in the kit are all the quality and technical documentation required to verify the sterilization and compatibility (CCI) of components. Co-developed alongside Schott and EMA Pharmaceuticals, Aptar Pharma QuickStart is available to cater to different sizes and configura-

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tions of vials, stoppers and caps. Aptar Pharmaâ&#x20AC;&#x2122;s proven expertise in device development and formulation helps ensure that QuickStart's compo-

nents satisfy all regulatory requirements, allowing users to access commercial scale quality at a development stage cost. CPhI Worldwide, which took place at IFEMA, Feria de Madrid, welcomed more than 45,000 pharma professionals, which provides a prime opportunity to demonstrate the value of Aptar Pharma QuickStart to prospective partners. QuickStart is all about convenience and speed by en-

abling R&D labs to maintain a positive development experience from project outset, including the ability to control the component configuration in terms of coating, volume and size, and that the integrity of the container closure for delivery mechanisms can be maintained.â&#x20AC;? Contact details Aptar Pharma Adam Shain +1 845 639 3700 adam.shain@aptar.com

EXPRESS PHARMA

October 16-31, 2018

PHARMA ALLY

Gandhi Automations spearheading operational solutions for loading bay and entrance automation for the rising E-commerce industry E-COMMERCE IS evolving to be the most feasible shop from home to the world; the smart way to do shopping for catching up with this fastpaced life. The time is far gone when it used to take 7-10 days for the ordered item to arrive. It has now come down to the next day to less than four hours in some special cases. The delay time in response of four hours has come down to less than four minutes. Without a doubt, E-commerce has emerged as one of the biggest logistical cynosures of the century, from wholesalers to retailers every business model is adapting to operate and manage expectations of different kinds of customers more than ever. E-commerce has changed the way we all shop, and Gandhi Automations Entrance Automation is adding intrinsic value to its seamless operations, warehousing and loading/unloading needs and solutions. Gandhi Automations entrance automation and loading bay solutions are nurturing warehousing and logistical industries from over a decade now. Last financial year, Gandhi Automations aided the biggest shark in the E-commerce industry to help reduce their loading/ unloading time, adapting to their in-house operations and meeting their new expectations; as consumers are no longer willing to wait for one to two weeks for a delivery. Because of these fast delivery options, the warehouse and logistics industry are under high pressure to deliver the best in a short span. Gandhi Automations HighSpeed Doors are versatile and solid ensuring long-lasting

36 EXPRESS PHARMA October 16-31, 2018

Dock Shelters

Prime Freezer

reliability for fast-moving industries and goods like Ecommerce. The modular structure of the curtains, assembled and joined by anodised aluminum extrusions, provides for a wide range of polyester sections available in a variety of colors. Wide, fullwidth window panels ensure a safer traffic and allow more light in. Their fast and easy replacement, in case of accidental tearing, saves money and time. The alternating metal tubular structure there

Prime Reset

inserted ensures high windresistance. Prime High-Speed Doors are the ideal solution for internal and external entrances and effectively operate in any situation, even when strong winds are blowing and in rooms with high volume traffic. Sturdy and dependable, Prime is the intelligent door for medium and large entrances. Due to the increasing demand in the Cold storage and FMCG warehousing facilities,

Gandhi Automations launched Prime Freezer Doors which are specially curated to be sturdy, dependable and are the ideal solution where temperature control is critical and safety concerns are at a premium. The doors are manufactured with European collaboration and technology with innovative and creative engineering. The high operating speed combined with an excellent seal optimises the internal traffic flow and provide energy savings. Heavy-duty

motor: 400V three phase, opening speed up to 2.5 m/s with inverter system. Suitable for both positive and negative temperature, operating temperature range +5 to -350 C. Prime Freezer Door has special double curtain construction with insulation. The increased demand on the industry means that both upgrades to and construction of distribution premises are at a record high, and loading bay requirements are having to be reconsidered. E-commerce industry delivers goods faster, more efficiently, and at a lower cost. Thus, this industry ought to possess entrance automation and loading bay equipmentâ&#x20AC;&#x2122;s from a company like Gandhi Automations which not only intends to provide unbeaten quality and but also an unparalleled output. The retractable PVC front panel Dock Shelters are commonly used. With its simplicity and efficiency, it grants for a constant payback of the investment. These are available for dock level installation or for ground level installation for the protection of doors without the dock. The front panels are made of high resistance black PVC reinforced with a double weaving of polyester that works like a spring in order to seal the vehicles of different shapes. The flaps are flexible and have very high wear and tear resistance. Designed to retract under the shock of any possible wrong maneuvers of the docking vehicles and extend when the vehicle drives away. Contact details Gandhi Automations visit www.geapl.co.in or please drop an enquiry at sales@geapl.co.in

PHARMA ALLY VALUE ADD

PHARM-A-SPHERES: Aversatile tool for multiparticulate oral drug delivery systems Divya Prabhudesai and Dr Heeshma Shah, Technical Services Department, Signet Chemical Corporation, Mumbai, give an insight on Pharm-A-Spheres (Sugar Spheres) which are specifically designed for use in immediate and modified/sustained release pharmaceutical formulations PHARM-A-SPHERES (Sugar spheres) are spherical, multiparticle, neutral solid units or non-pareil seeds manufactured by Hanns G Werner GmbH + Co. based at Germany. These are specifically designed for use in immediate and modified/sustained release pharmaceutical formulations as neutral cores/ carriers/ substrates for loading of active pharmaceutical ingredients (APIs). Pharm-A-Spheres are available in whole spectrum of diameters ranging from 90 and 2000 μm. They are free-flowing in nature and intended mostly for oral administration.1 Hanns G Werner GmbH + Co. KG, founded in 1952 is a 60year-old company specialised in the manufacture of dragees. Besides Pharm-A-Spheres for pharma applications, they also manufacture dragees for food and nutraceutical industry. They are manufacturing approximately 6,000 tonnes of dragees per year which includes Pharm-A-Spheres (sugar spheres), globuli sacchari, xylitol globuli and lactose globuli. They have a dedicated facility for Pharm-A-Spheres located at Tornesch, complying to the requirements of IPECGMP guidelines for bulk pharmaceutical excipients.

Need for multiple unit dosage systems / pellets In the past, tablets and capsules were the most preferred dosage forms of drug administration. As drug-delivery has become more sophisticated and advanced, the role of pellets in the design and development of multiparticulate drug delivery systems is increasing. These systems are oral dosage

Figure 1: Structure of sustained release pellet with sugar sphere core , active substance layer and film coating

forms consisting of small discrete particles having identical release profile and form a therapeutic dose.2 Formulation of drugs in multiple-unit dosage forms, such as coated pellets filled in capsules (Figure 1) or compressed into tablets, offers flexibility in terms of target release properties. The safety and efficacy of these formulations is higher than that of other dosage forms.3 Additionally, pellets are less susceptible to dose dumping thus lowering the risk of side effects.4 As compared to conventional dosage forms, pellets offer greater flexibility in the design and development of API into oral dosage forms like tablets, capsules and suspensions. The total drug dose gets divided into multiple units of desired dose strengths without formulation or process changes.5 Hence, failure of few units in the system would not significantly impact the dose, unlike single-unit system.2 Pellets are less dependent on gastric emptying than single unit systems.6 They maximise the drug absorption, minimise local irritation of gastro-intes-

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tinal mucosa by certain irritant drugs, reduce peak plasma fluctuations and minimise potential side effects with improved drug bioavailability. They offer more suitable fabrication of formulations with acid sensitive drugs like Erythromycin.5 A variety of drugs can be formulated into multiple-unit dosage forms e.g. Proton Pump Inhibitor (PPIs), anti-hypertensive, anti-depressant, anti-diabetic, anti-muscarinic, etc.

free state, it does not interfere with actives susceptible to hydrolysis.1

Key characteristics 1. High degree of sphericity and smooth surface: PharmA-Spheres present a high degree of sphericity (almost equals to 1) with smooth, nonporous surface which contributes to a precise layering and reproducible release of the API from final pellet.7 Figure 2

Composition and manufacturing Sugar spheres are the most common carrier pellets used in pharmaceutical industry. These are geometrically defined agglomerates composed of sucrose (80.0 – 91.5 per cent) and corn starch (8.5 – 20.0 per cent) using different processing conditions. Besides sucrose and starch, sugar spheres also contain some amount of water which is permanently bound to starch molecules and is required for the binding properties of sugar spheres. As this water is not in

illustrates SEM photograph of Pharm-A-Spheres. Sphericity is defined as the relationship of a particle’s perimeter to its area. It is determined using image analysis system and calculated as:8 where, Ap = area of area particle Vp = volume of a particle 2. High mechanical strength

and low friability: Robustness against mechanical stress is important during processing of sugar spheres. Pharm-ASpheres are sturdy in nature. Even when coated in fluidisedbed equipment and in contact with water or solvents, PharmA-Spheres do not disintegrate and show attrition. Friability is calculated as per with Ph. Eur. chapter 2.9.41 (method B: oscillating apparatus). Pharmacopeia methods do not specify acceptable friability limits for sugar spheres, however, friability values of less than 1.7 per cent have been reported as acceptable to withstand stresses associated with fluid bed coating, handling and other processes.8 Pharm-A-Spheres exhibit very low friability values of less than 1.2 per cent.7 3. Outstanding microbiological quality: The raw materials used in manufacturing of Pharm-A-Spheres (sucrose, starch and water) are of high quality and purity. The water activity (aw value) of final spheres is always lower than 0.65 which prevents any microbial growth.1, 7 4. Chemically indifferent raw materials and no incompatibities: Both the raw materials i.e. sucrose and starch used in the manufacturing process of Pharm-A-Spheres are of natural origin, digestible and biodegradable in nature. Water is the only solvent used in manufacturing process. No other organic solvents are used in the production of the spheres or their raw materials. The raw materials are unlikely to present any incompatibilities with the active ingredients.1, 7

EXPRESS PHARMA

October 16-31, 2018

PHARMA ALLY TABLE 1: DIFFERENT GRADES OF PHARM-A-SPHERES® ALONG WITH THEIR PARTICLE SIZE RANGE Grades (# ASTM)

Particle size range (μm)

170 – 100

90 – 150

100 – 80

150 – 180

80 – 70

180 – 212

70 – 60

212 – 250

60 – 50

250 – 300

50 – 45

300 – 355

60 – 45

250 – 355

60 – 40

250 – 425

50 – 40

300 – 425

45 – 40

355 – 425

45 – 35

400 – 450

40 – 35

425 – 500

35 – 30

500 – 600

35 – 25

500 – 710

30 – 25

600 – 710

30 – 20

600 – 850

25 – 20

710 – 850

20 – 18

850 – 1000

20 – 16

850 – 1180

18 – 16

1000 – 1180

16 – 14

1180 – 1400

16 – 12

1400 – 1700

14 – 12

1400 – 1700

12 – 10

1700 – 2000

Figure 2: SEM photograph of Pharm-A-Spheres

Nonpareil seed Drug layer Modified release/ taste masking coating

Figure 3: MUPS containing polymer coated pellets

5. Narrow, tailor-made, reproducible particle size distribution: Pharm-ASpheres are available in broad spectrum of particle size range from 90-2000 μm. The particle size is often a critical quality parameter in the customer’s coating process. Werner’s sophisticated combination of technological capabilities and analytical skills allows them to fulfill every specification of below mentioned particle sizes ranging from 90 to 500 micrometers (microspheres) and from 0.5 to 2.0 millimeters (standard spheres). The various particle sizes of Pharm-ASpheres offered to the pharmaceutical industry are listed in

38 EXPRESS PHARMA October 16-31, 2018

Table 1.1, 9 The width of particle size distribution curve is crucial for estimating the risk of segregation and non-uniform behaviour during coating. Pharm-ASpheres exhibit lot-to-lot uniformity and reproducibility in particle size distribution. 6. Bulk and tapped density: Density is influenced by the particle size distribution and shape of the pellets. Understanding bulk density is important as it can affect the final fill weight of the pellet-based formulation in capsule shells during capsule filling process.8 Pharm-A-Spheres display a lot-to-lot consistency in

bulk/tapped density. The bulk density of different grades ranges from 0.70 to 0.96 g/ml. 7. Excellent flowability: Sugar spheres are normally purchased in bulk; therefore, the rheological properties are important for handling and further processing. Flowability is determined using method described in Ph. Eur. Due to spherical shape and smooth surface, Pharm-A-Spheres exhibit high flowability. Thus, there is no need to define angle of repose after being poured in bulk.1 8. Worldwide acceptance and easy registration for regula-

tory drug application: PharmA-Spheres conform to the pharmacopoeial monographs for sugar spheres in the USP/NF and Ph. Eur. It also complies to JPE monograph for ‘Sucrose Starch Spheres.’ There is a Type IV DMF (17994) submitted to the USFDA.7 9. Non-involvement of active

ingredients in the forming process: The use of Pharm-ASpheres as core for subsequent layering with API and sustained release excipients is a smart alternative to the manufacturing of API pellets. This minimizes loss of precious APIs, saves thermal and chemical deterioration of the active ingredient and allows starting with a defined surface area for

PHARMA ALLY reproducible coating.7 10. Stability: Pharm-A-Spheres have a retest date of 24 months from the date of manufacturing. Several stability tests according to ICH have been carried out by the manufacturer and stability of five years is established under controlled storage condition of not more than 40 °C.

ities and experience allows manufacturing of special particle size range to cater customer specific requests for various controlled release, extended release and immediate release formulations. For additional information about Pharm-A-Spheres kindly refer to http://www.pharm-a-spheres.com/

References Applications Sugar spheres are extensively used for controlled and immediate release pharma formulations including enteric coating and taste masking applications. The active drug is loaded on the neutral core pellets followed by a release modifying polymer. Customised release profiles (pulsed, sustained or delayed) can be achieved by careful selection of polymers.10 Drug release from drug-layered inert spheres coated with functional membrane typically follows diffusion or controlled erosion mechanism.8 Complex drug mixtures or different drug moieties chemically compatible or incompatible simultaneously can be developed as a single dosage form with Pharm-A-Spheres to target different release profiles at the same site or different sites in the gastrointestinal tract. 5,10,12,13 Few of the marketed formulations containing sugar spheres as neutral cores are ENTOCORT EC (Budesonide Capsules) of AstraZeneca, SPORANOX (Itraconazole Capsules) of Janssen Pharmaceuticals, NEXIUM (Esomeprazole Magnesium Capsules) of AstraZeneca, PREVACID (Lansoprazole) of Takeda Pharmaceuticals USA Inc., PRILOSEC (Omeprazole Magnesium Delayed Release Capsules) of AstraZeneca, Metoprolol Succinate (Metoprolol Succinate Extended release Capsules) of Sun Pharmaceutical Industries, Duloxetine delayed-release capsules of Cadila Healthcare, etc.

Conclusion Sugar spheres are the first choice of neutral cores for pharma application because of multiple advantages. Sucrose and corn starch widely available in the necessary pharma quality and are commonly used as food ingredients. These natural substances are safe, digestible, non-toxic and biodegradable and thus meet the customer’s expectation for clean label products. Sugar spheres are multicompendial and included in the FDA Inactive Ingredients Database (oral capsules and tablets).7 Pharm-A-Spheres manufactured by Hanns G Werner are available in multiple and narrow particle sizes with advantages in terms of high sphericity, robustness, low friability and lot-to-lot uniformity. Werner’s technical capabil-

1. Werner D. Sugar spheres – A versatile excipient for oral pellet medications with modified release kinetics. Pharmaceutical Technology Europe 2006; 18(4); 35-41. 2. Patel N, et al. Multiple unit pellet system (MUPS technology) for development of modified release fast disintegrating tablets – A review. Journal of Pharmaceutical and Scientific Innovation 2017; 6(3); 50-56. 3. Jawahar N & Patel N. Multi unit particulates systems (MUPS) – A novel pellets for oral dosage forms. Journal of Pharmaceutical Sciences and Research 2012; 4 (9); 1915-1923. 4. Dalvi H, et al. Review on palletization: Techniques, Characterization and Applications. World Journal of Pharmaceutical Research 2018; 7 (7); 606-625. 5. Sirisha K, et al. Review of pellets and palletization process – A multiparticulate drug delivery system. International Journal of Pharmaceutical Sciences and Research 2013; 4 (6); 2145-2158. 6. Kandukuri J, et al. Pelletization techniques for oral drug delivery. International Journal of Pharmaceutical Sciences and Drug Research 2009; 1 (2); 63-70. 7. Technical Brochure of Pharm-ASpheres® – 10 reasons why you should decide to choose pharm-a-spheresTM sugar spheres. Germany: Hanns G. Werner GmbH + Co. KG. 8. Sidwell R, et al. (2017). Characterization of inert cores for multiparticulate dosage forms. In Rajabi A. (Ed.), Multiparticulate Drug Delivery (pp. 5-35). New York, USA: Springer Nature 9. Technical Brochure of Pharm-ASpheres® – Werner the right choice. Germany: Hanns G. Werner GmbH + Co. KG. 10. Yadav N & Verma A. Pharmaceutical pellets – A versatile carrier for oral controlled delivery of drugs. Indian Journal of Pharmaceutical Education and Research 2016; 50 (3); S146-S160. 11. Reddy S, et al. MUPS (Multiple unit pellet system) tablets – A brief review. Journal of Pharmaceutical and Biomedical Sciences 2011; 12 (12); 1-5. 12. Shah S, et al. A review on extended release drug delivery system and multiparticulate system. World Journal of Pharmaceutical Research 2015; 4 (8); 724-747. 13. Upadhyay S, et al. Recent advances in pellets and pelletization techniques for oral sustained release drug delivery. World Journal of Pharmaceutical Research 2015; 4 (3); 629-656.

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Not all cleanroom garments are created equal! June Enterprises gives an outlook on the benefits of specialised garments which will help to reduce the impact of contamination from people in cleanroom and to minimise the risk of contamination events IT IS an essential requirement that any cleanroom environment in which people are working will require a means of ensuring that the air is not compromised by contamination generated by those people. It is a well established fact that people are the number one source of viable and non-viable contamination in a cleanroom, with the average wearer dispersing millions of particles (i.e. skin, hair, perspiration) from their bodies every minute. A contamination event in a cleanroom can lead to expensive shut downs, increased production costs, product recalls and, in the worst case scenario, loss of life. On an average a pharmaceutical manufacturer spends approximately € 2 million a year to remediate contamination occurrences1. To reduce the impact of contamination from people in cleanroom and to minimise the risk of contamination events, specialised garments have to be worn along with other items such as gloves, goggles and facemasks. The purpose of all cleanroom apparel is to protect the manufactured product from contamination caused by wearer. It should also be comfortable to wear over long periods of time. There are two cleanroom garment options which are designed specifically to reduce contamination – both the particle generation from the wearer through the fabric. Without these garments, the cleanroom will be out of specification almost immediately. This would significantly increase the risk of contamination and undoubtedly compromise the products being manufactured within it.

Reusable or disposable garments? The first option is a reusable garment system consisting of a garment made

from synthetic woven fabric called monofilament polyester, and an associated specialised laundry service. This service is normally supplied as an all inclusive arrangement where the customer will have a full rental garment with the supplier providing the garments and associated services. The garments are constructed in a special way to ensure that the garment itself does not generate contamination and the laundry uses a special decontamination cycle with purified water to remove surface contamination from the garments. The garments then have to be dried in special dryers fitted with HEPA filters to prevent the reintroduction of contamination during the drying cycle. Laundered garments are then packed and hermetically sealed in bags before delivering back to the customer. Where sterile garments are required, sterilisation will take place prior to delivery to the customer. The second option is disposable garments. They are constructed from specialist PE-coated non-woven fabrics which do not generate contamination and also minimise the passage of contamination through the fabric by the use of encapsulated seams and an adhesive flap covering the zip. Disposable garments are designed to be single –use, in both sterile and non-sterile applications ,removing the requirement for them to be reprocessed. Their consistent performance in preventing contamination is a big advantage, but the time it takes to aseptically don them can lead to shortcuts in contamination. A new design concept using a totally aseptic technique to eliminate the cross–contamination risk is the innovative drop down design. This easy ‘over the head’ donning method al-

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PHARMA ALLY changing times, reduced risk of cross contamination (as the operator at no point touches the outside of the garment during donning) and reduced waste and costs resulting from deviation when donning goes wrong.

So, which option to choose? Consideration needs to be given to which of these two alternatives garment systems would be the most suitable and there are many and varied reasons why one would choose one over the other, Both systems will provide protection, every production has to take into account the pros and cons for one or the other option. If for example, a company has an irregular usage or has periods where the cleanroom is not occupied, then the disposable option could be more cost effective because the customer will only pay for what they actually use. With a reusable garment rental service, there is generally a fixed weekly cost which applies whether the garments are used or not. If the wearer size demographic changes, this would have an impact on the reusable rental contract. With disposables garments, it is simply a case of adjusting the quantities of each size required. Cleanroom garments are not created equal. While both options are acceptable alternatives to achieving the same goal (protecting your cleanroom from contamination from people) the choice you make will depend on which option best fits your cleanroom requirements.

References

lows the garment to simply use gravity to drop down over the operator’s body. Then whilst holding onto strategically placed quick releases tabs on the outside of the garment, the operator zips the garment up in one fluid movement. This unique drop-down design and innovative quick release tab system means that the wearer does not touch the outside surface of the garment at any point don-

42 EXPRESS PHARMA October 16-31, 2018

ning and the donning can be done in half the time.

A new kid on the block! With 80 per cent of process deviations in the pharma manufacturing environments down to human error2 and 10 per cent of clothing contaminated during donning every week3, the need for a new garment design which is easy and quick to don was long overdue. Many donning er-

rors also occur because of the way disposable garments are packed with the operator having to learn how to unfold the garment without touching the outside surface, which is not an easy task. Once unfolded, the problem of garment’s outside surface touching the floor or touching the operator’s body becomes the next big contamination risk. Disposable garments have been packed in a number

to try and overcome this and eliminate these donning problem, but they still don’t totally solve the contamination risk. The drop–down design enables the garment to be aseptically folded to ensure the operator takes it from the packaging by only touching the inside of the garment making the whole donning process much simpler and easier. This results in greater productivity due to reduced

1. PDA USA Midwest meeting 2012, study of environmental monitoring data from 1235 parenteral drug manufacturing sites 2. Reducing human error on the manufacturing floor, Ginette m Collazo, PhD. June 2010 3. http.//www.cleanroomtechnology.com/technical/article_pa ge/Donnin_by_design/55600 July 2010 (Red marks show crosscontamination occurring from donning a standard cleanroom garment, compared to no cross-contamination on a BioClean Drop-down garment)

PHARMA ALLY VALUE ADD

Tankless melters in packaging Suprotik Das, Managing Director, Nordson India, gives an insight into the most expensive problems faced in the use of hot melt adhesives, their root causes and solutions OF THE many challenges that packaging managers face, perhaps the most ironic is the poor performance of high quality hot melt adhesives. Products that fail to bond on the packaging line, or pop open on the supermarket shelf in spite of a highend adhesive having been used, are just a part of that story. Frequent line stoppages, excessive consumption of expensive adhesive and unnecessarily high human resource costs add to the inefficiencies that we seem to take for granted. An understanding of the root cause of these problems allows us to prescribe appropriate solutions and truly benefit from these modern adhesives. These are solutions that are available today, thanks to the rapid strides that state-of-the-art adhesive application equipment have made in recent years. If you have run a packaging line that uses hot melt adhesive (HMA), you have faced situations where the product fails to bond at the end of the line, or fails to remain bonded till the consumer opens it. Whether it’s a cartoning line, a case erector, a top-and-bottom case sealer, or another adhesive application in packaging, this problem is common. Equally common are two responses: (a) increase the pump pressure, (b) raise the temperature setting. Sadly, these are at best temporary solutions. Often, they are the wrong solutions. They simply do not address the likely root causes of the failure. So, what might the causes be? We will discuss here two possibilities that are most commonly encountered: Inadequate or missing adhesive beads is the first. A common problem in packaging lines, this is more often than not, caused by blocked nozzles, which in turn are triggered by

should be eliminated. The solution lies in first understanding that nozzles get blocked by particles that are not a part of the nozzle. They could have entered the hot melt system from the outside – typically dirt or dust from the environment. Or they could have been generated inside the system, as when the HMA gets charred and produces solid particles. Either way, you have a hot melt system that is dirty and contaminated. It is not uncommon to find melters that look like the one in Exhibit 1 below. So, you have external con-

Frequent line stoppages, excessive consumption of expensive adhesive and unnecessarily high human resource costs add to the inefficiencies that we seem to take for granted the contamination in the system. This is the root cause. Low temperature adhesive is a second problem, and can occur in spite of the temperature having been correctly set. HMA that is at too low a temperature has inadequate tack and this results in its inability

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to bond the substrates. The problem of blocked nozzles is so widespread, it is almost an epidemic. People have accepted this problem as inevitable, and have devised many work-arounds. The fact is, blocked nozzles are not inevitable. This problem can and

this? For the purposes of this article, let’s discount the problem of the temperature having been set too low. This is a trivial problem, with a simple solution. The less frequently understood problem is a phenomenon called thermal shock. Briefly, this problem occurs when a HMA tank has been allowed to become almost empty, before being refilled with solid adhesive. The result is a sudden drop in the temperature of the adhesive in the tank and hence a drop in the temperature of the adhesive as applied on the substrate. So we are dealing here with

Exhibit 1 - Contaminated Melt Unit

tamination and internal contamination that can cause a nozzle to block. Once these are recognised as the root causes of nozzle blockage, it is possible to devise counter measures. Next, one needs to address the issue of the adhesive temperature being too low. What causes

two common root causes: (a) contamination of the melt system and (b) the tank being refilled too late. Both problems are addressed by the current generation of tankless melt systems such as Nordson’s industry leading ProBlue Liberty™ system. This

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PHARMA ALLY is a self-contained product that integrates melt-on-demand tankless technology with an automatic fill system. Unlike conventional melters, the Liberty does not have a tank at all. It has a small, high-efficiency melt grid that receives solid HMA, on demand, from an automatic fill system. It then heats the HMA rapidly and produces molten HMA at the required application temperature. A pump then supplies the molten HMA through heated hoses and applicators to the point of application. Because the adhesive is melted on-demand, it is held at the elevated application temperature for a very short period. Consequently, the possibility of adhesive charring (a prime cause of blocked nozzles) is virtually eliminated. In addition, the automatic fill system does away with the manual intervention of periodically opening the tank lid for refilling. In conventional systems, this manual refilling operation is often extremely messy, and causes external contamination to find its way into the tank. Tankless melters, on the other hand, come with storage containers that can hold enough adhesive for several days’ consumption. In the case of the Liberty, for instance, the storage containers can hold up to 240 litres of solid adhesive. The system can therefore be left alone for

several days, with no manual intervention for tank filling. There is no adhesive spillage, and no possibility of contaminant entering the system from outside. Interestingly, the benefits of using the liberty go beyond this. Additional benefits are: ◗ Lower labour cost ◗ Reduced adhesive spillage loss. ◗ Fewer broken lids due to over-filling. ◗ Cleaner operation of the system and hence the need for less frequent maintenance. ◗ A safer operation due to minimized possibility of contact with hot surfaces. Tankless melt systems such as the Nordson ProBlue Liberty™ are setting new standards in optimising packaging operations, minimising loss and reducing cost. By eliminating the root causes of some of the most common problems, these systems allow the user to run an efficient, trouble-free packaging operation that consistently produces high quality packaged products for the modern consumer.

Exhibit 2: Nordson ProBlue Liberty™ system

Contact details Nordson India Tel: +91 80 4021 3600 or nordsonindia@nordson.com or visit nordsonadhesive.com

CONTRIBUTOR’S CHECKLIST ❒ Express Pharma accepts editorial material for

❒ We welcome information on new products and

regular columns and from pre-approved contributors / columnists. ❒ Express Pharma has a strict non-tolerance policy of plagiarism and will blacklist all authors found to have used/refered to previously published material in any form, without giving due credit in the industryaccepted format. All authors have to declare that the article/column is an original piece of work and if not, they will bear the onus of taking permission for re-publishing in Express Pharma. ❒ Express Pharma's prime audience is senior management and pharma professionals in the industry. Editorial material addressing this audience would be given preference. ❒ The articles should cover technology and policy trends and business related discussions. ❒ Articles for columns should talk about concepts or trends without being too company or product specific. ❒ Article length for regular columns: Between 1200 1500 words. These should be accompanied by diagrams, illustrations, tables and photographs, wherever relevant.

services introduced by your organisation for our various sections: Pharma Ally (News, Products, Value Add), Pharma Packaging and Pharma Technology Review sections. Related photographs and brochures must accompany the information. ❒ Besides the regular columns, each issue will have a special focus on a specific topic of relevance to the Indian market. ❒ In e-mail communications, avoid large document attachments (above 1MB) as far as possible. ❒ Articles may be edited for brevity, style, and relevance. ❒ Do specify name, designation, company name, department and e-mail address for feedback, in the article. ❒ We encourage authors to send their photograph. Preferably in colour, postcard size and with a good contrast.

44 EXPRESS PHARMA October 16-31, 2018

Email your contribution to: The Editor, Express Pharma, Business Publications Division,

The Indian Express (P) Ltd, 1st Floor, Express Towers, Nariman Point, Mumbai - 400 021. Tel: 91-22-2202 2627 / 2285 1964/ 6744 0000 Fax: 91-22-2288 5831 viveka.r@expressindia.com

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PVC RIGID FILM FOR BLISTER FORMING

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EMERGING AS THE MOST PREFERRED PRIMARY PACKAGING SOLUTIONS PROVIDER FOR THE PHARMA INDUSTRY. CALENDER

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S. P. PRODUCTS

PHARMA EQUIPMENTS AT IT'S BEST

S.S. MULTIPURPOSE TROLLEY

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S.S. CABINET FOR BLISTER S.S. LOCKER S.S. VISITOR CHANGE PART / STRIP CH PART / FOR KEEPING APPRON CABINET POLYBAG STREET GARMENT

• All products are custom made & available in 304, 316 & 316L Quality with optional Matt & Mirror finish. • We undertake the side work of Cladding of Machinery & others.

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OFFICE: F-823, VEENA SANTOOR BLDG., NEAR PAWANDHAM, BEHIND 'D' MART, MAHAVIR NAGAR EXTN. ROAD, BORIVALI (W), MUMBAI-400092. TELEFAX: 28197068 / 3082 MOBILE: 98200 54453. Email: info@pharmaequipments.com URL: www.pharmaequipments.com WORKS: W6, OM SAI COMMERCIAL COMPLEX, GODDEO ROAD, NEAR EKVIRA GAS GODOWN, BHAYENDER (EAST), THANE - 401 105 TEL: 2819 3082

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• Flexible wall barrier technology ideal for containment processes/dust free operations. • Available in MOC PU, PE and PVC anti-static for better compatibility with various solvents, SS scaffolding and Base tray for glovebag positioning & fitting. • Bespoke design and can be integrated with new and existing equipment/ process. • Ergonomic studies for better process understanding. • More visibility due to the transperent/ optical clarity of the glovebag. • System can be static / under negative pressure or positive pressure with AHU. • WIP (wash in place) arrangement for cleaning of the system. • Wide range of equipment can be integrated by using containment technology. • Applications: In API Industry - Weigh balance, reactor charging, Centrfiuge, Nustche filter, Multi Mill, Sifter & Pack off can be integrated with flexible containment system. In Formualtion R & D - High shear mixer, FBD, Blender, compression machine, auto coater, Blister pack can be integrated with Flexible containment system. • Possible OEL validation can be perfomed in Flexible isolator .

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EXPRESS PHARMA Most Favourable Sanitary Gaskets and Seals For Hygienic Application

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Sanitary Gaskets for Tri-clamp fittings : Helps seal clamp connections in sanitary pipelines. Application: Pharmaceutical, Biotech Food and Beverage, Dairy . Smart Gaskets : Allows to obtain the critical thermal mapping information needed during the validation process. Available with 1,2,3,4 ports.

Smart Gaskets Clamps : Required with Smart Gasket as they have slots in them that allow different ports. Available as per the number of ports on the Gaskets.

Material Meets the Requirements for :

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Get more mileage from your adhesive Nordson® OptiBond™ solutions – with the new EcoBead™ pattern generator – let you s-t-r-e-t-c-h your adhesive with intermittent bead dispensing. The EcoBeadTM pattern generator is a simple, drop-in, inline device that lets you replace long, continuous adhesive beads with shorter, intermittent beads to optimize adhesive use. There is no need for complex PLC reprogramming or to add a stand-alone pattern controller. Quick, plug-and-play cables connect the EcoBeadTM pattern generator to a Nordson MiniBlue® II applicator with Saturn® SP solenoid valve – and your packaging machine’s PLC control. Adhesive savings is easy with 40 pre-programmed pattern proﬁles. A USB programming device is also available to create custom patterns to meet virtually any packaging application.

Let Nordson help you get ahead of current and future adhesive availability challenges.

Visit http://www.nordson.com/optibond or call +91 80 4021 3600 to learn more.

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OSMOMETER 3250

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October 16-31, 2018

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Latex / Nitrile Gloves 12”, 16” & 24” Can Your Sterile Surgical Gloves Be Taken In To A Cleanroom ?

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