Pharma & Healthcare News February 2012

Pharma & Healthcare News Alsiano No. 15 • February 2012

Contents SEPICOATTM coating revolution................................1 Kolb: new supplier for personal care formuations .....2 A fresh approach to natural products . ...................3 SEPICLEAR , the clear solution....................4 TM

Vidya Herbs: the best from nature.............................5 Positive EFSA opinion on olive extract.............................6 Alsiano invests in Kryta Krydderier . ...................7 The Alsiano Healthcare team ........................................7

SEPICOATTM coating revolution SEPPIC has launched a new generation of immediate release, already coloured coating agents for pharmaceutical and nutraceutical applications

By Seppic SEPICOATTM is a patented, innovative coating solution in which all constituents are of natural origin. It is based on a new polymer for coating making it possible to maintain a low viscosity dispersion even at high dry content concentration.

This new powder-based, ready-touse solution can reduce the coating time by 25% at the production stage because of the high concentration of dry material, which can be as much as 25% in dispersion (against 15-20 % conventionally). In contrast to other coating solutions, SEPICOATTM has a neutral taste. Moreover, it does not affect the release of the API. SEPICOATTM does not involve any change in the manufacturer practices and process, but can increase productivity and reduce energy consumption.

Smooth & natural high gloss effect SEPICOATTM enables an extremely glossy and pleasant appearance to be achieved on the coated tablet, without the introduction of an additive.

Furthermore, SEPICOATTM provides a very smooth film compared to other film coating products - even at 25%.

Publisher: Alsiano A/S Circulation: 600 copies

Colour range SEPICOATTM comes in a range of 17 colours chosen to favour pigments of

Editor-in-chief: Anders Hager Coordinator, text, lay-out: Dorthe Andersson Pharma & Healthcare News is published twice a year and distributed to customers and other interested parties. Reproduction of articles appearing in Pharma & Healthcare News requires prior consent of the author. Alsiano is not responsible for the content of articles written by external authors.

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natural origin. Because of its colouring know-how, SEPPIC is able to develop other colours on request.

SEPICOATTM is aimed at the pharmaceutical market, at both branded and generic segments, and also at the food supplements market. This new innovative solution thus extends the SEPIFILMTM and SEPISPERSETM coating ranges. (continues on page 2 >>)

• Patented innovation • High dry content • Inherent glossy aspect • Neutral taste • Cost efficiency coating system • Faster coating system • From natural source, GMO free • Complies with pharmacopeia

Pharma & Healthcare News Food News

• February 2012

No.No. 1 15 • February 2004

Alsiano Alsiano

Kolb: new supplier for personal care formulations Alsiano has entered into cooperation with Kolb’s personal care products division that manufactures a broad line of emulsifiers, emollients and solubilisers We are pleased to announce that we have entered into cooperation with Kolb, Europe’s largest independent alkoxylator and well experienced in manufacturing non-ionic surfactants dedicated to personal care products.

Kolb offers an innovative range of emulsifiers, emollients and solubilisers for all purposes:

• Face and body care • Mild emulsifiers for baby care • Electrolyte-stable emulsifiers for antiperspirants • Co-emulsifiers for shaving foams and deodorants • Emulsifiers that withstand alkaline conditions in hair care products • Emulsifiers designed for use in natural care • Solubilisers for formulation of clear aqueous solutions Kolb’s broad range of emulsifiers, emollients and solubilisers are marketed under the trade names SYMPATENSTM, KOTILENTM and KOSTERANTM. Thanks to the cooperation with Kolb, Alsiano now offers a wide product palette for formulation of personal care products. We look forward to presenting the many opportunities that Kolb’s versatile and innovative range holds.

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SEPICOATTM brightness compared to other film coating products SEPICOATTM colour range

Technical support • Development of new coating formulations • Coating trials on customer tablets • Coating process optimisation • Assistance on regulatory questions, especially for use of pigments • Colour-matching • On-site technical support • SEPISCHOOL: theoretical and practical coating courses at SEPPIC’s laboratory Article 370

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About Kolb The Kolb Group is a successful Swiss manufacturer of non-ionic surfactants, paper process chemicals and chemical intermediates, employing 270 people. The company processes natural and synthetic raw materials into high-quality products at its production sites in Switzerland and the Netherlands. Product manufacturing is based on their own production methods in the field of alkoxylation, esterification and special processes.

Kolb is a mid-sized company with a worldwide reach, maintaining a significant presence in the global value chain of the chemical industry. Amongst their strengths is the flexibility with which they tackle the market. Their services include optimal application of products, product development in strong cooperation with partners and customers, and rapid identification of needs and provision of solutions - even in unforeseen situations.

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A fresh approach to natural products Alsiano has entered into cooperation with Synergy Production Laboratories™, the internationally recognised and trendsetting manufacturer of organic, wholefood nutraceutical and functional food ingredients

By Synergy Production Laboratories Synergy Production Laboratories (SPL) USA, is a grower, processor, formulator and supplier of certified organic and ethically wild-crafted, concentrated bioactive ingredients.

Thirty years of research and the creation of its innovative, proprietary technologies and groundbreaking raw materials have made SPL a trendsetter and have yielded an array of organic, fresh freeze-dried and CO2 low-temperature dried whole-food ingredients.

SPL’s Synergized® brand provides a sophisticated range of whole-food ingredients packed with highly valuable phytonutrients, rich in healthenhancing colourful pigments and concentrated in a wide spectrum of naturally occurring bioactive compounds.

The Synergized® brand protocol The Synergized® raw materials brand protocol was developed by the founder of SPL, Mitchell May. “Synergized®” equates to demanding standards in all aspects of production from heirloom seed selection and organic cultivation, proprietary freeze-drying and CO2 cold-temperature drying to state-of-the-art, natural processing, rigorous QA and QC testing, and Ultra Fresh Packaging technologies.

All Synergized® processes optimise and retain the bioactive potencies of fresh-processed plant materials.

SPL's extremely versatile Synergized® ingredients are ideal for powdered drink mixes, smoothie mixes, tablets, capsules, food bars, and cosmetics.

Article 371

Product range – certified organic The Synergized® ingredients are extremely versatile, allowing numerous consumer applications.

The range includes: • Pure grass juice powders (barley, wheat, oat, alfalfa, kamut) - CO2 low-temperature dried • Sprouts grown from heirloom seeds, fresh freeze-dried - more than 20 varieties, including broccoli • Natural vitamin C products - organic acerola and wildcrafted camu camu standardised to 20% • Vegetable powders/juice powders (spinach, kale, parsley and many others) - fresh freeze-dried or specialty-dried • Fruit and berry powders/juice powders - fresh freeze-dried or cold-temperature dried • Enzymatically active mushroom mycelium powders • Pure spirulina and pharmaceutically grown pure chlorella • Green superfood blend

©2012 Synergy Production Laboratories

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SEPICLEARTM, the clear solution Seppic launches a new patented solubilising agent designed for efficient dissolution of poorly soluble actives, peptides and proteins

By Seppic SEPICLEARTM 01 PPI is a new powerful and patented solubiliser developed on the basis of SEPPIC’s research in lipoaminoacid technology. It is designed to dissolve very poorly soluble actives, peptides or proteins in water for oral, topical and parental applications. Being a pure lipoaminoacid, SEPICLEARTM 01 PPI has excellent solubilising properties and disperses very easily in water at pH 7.

SEPICLEARTM 01 PPI can be used at a very low percentage: from 0.2% to 5% in the final solution depending on the API. The SEPICLEARTM 01 PPI solution can be heated up to 60°C if necessary to increase the solubility of some APIs. Clearly convincing solubility To demonstrate SEPICLEARTM’s efficiency, Seppic has tested the product with different actives such as DHEA, Vitamin D3 and very poorly soluble peptides (example 1-3). The solubility profile of SEPICLEARTM compared to that of usual solubilisers is shown in the top right corner.

QA Seppic follows the GMP part II standards for its production of PPI grade products. Every aspect of the manufacturing process from the raw materials to the release of the finished products is controlled.

Furthermore, Seppic ensures low peroxide value, low free fatty acid value, microbiologic and endotoxins test for each batch and uses a process completely free of solvents.

Seppic offers all necessary regulatory documents for registration of your formulation.

Services Seppic can provide assistance in the solubilisation of non-soluble API, customised formulation that meets your requirements on process, specifications and formulation dosage as well as technical assistance on site.

Development status Production: The manufacturing process has been optimised in order to be compatible with an implementation of GMP rules. 3 batches have been produced at the pilot scale. Relevant physico chemical analyses to check the integrity of the chemical structure were carried out, but the specifications are not yet estalished. Therefore, samples of these 3 batches are available for lab trials, but cannot be used for any clinical trials. The 3 industrial batches under GMP conditions will be produced in 2012 and will be used to establish these specifications.

Toxicological data: A bibliographic document reviewing the toxicity of lipoaminoacid is available on request.

In addition, toxicity studies such as ADME, acute toxicity, are available.

Repeated dose toxicity through intra muscular route, Ames and micronucelus test data are pending.

Stability data: Stability studies are currently ongoing on the pilot batches.

These are preliminary studies which will be completed with ICH stability data on industrial batches.

Article 372

Solubility of SEPICLEARTM compared to other solubilisers

Peptide in PBS

Peptide in 10% DMSO

Peptide in 0.6% Peptide in 3% SEPICLEARTM 01 PP1 SEPICLEARTM 01 PP1

Example 1 - 5% of SEPICLEARTM can solubilise 3 times more Vitamin D3 than polysorbate 80 SEPICLEARTM Polysorbate

% of solubiliser

Example 2 - 5% of SEPICLEAR can solubilise 4 times more DHEA than polysorbate 80 SEPICLEARTM Polysorbate 80

% of solubiliser

Example 3 - In this experiment, Seppic tried to solubilise 1 mg of a peptide in 1 ml water.

With 0.6% of SEPICLEAR, 100% of the peptide is solubilised while with 0.6% of DMSO, only 50% of the peptide is solubilised.

SEPICLEARTM DMSO

% of solubiliser

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Alsiano

Vidya Herbs: the best from nature Vidya Herbs has launched a new range of extracts produced by the gentle and environmental-friendly supercritical fluid extraction ensuring an extra high content of phytonutrients Vidya Herbs has recently opened a brand new supercritical fluid extraction facility to suit the demands for high quality herbal extracts, essential oils and oleoresins.

With the use of supercritical extraction technology, it is possible to produce a higher grade of herbal extracts with flavour intensity and with a full spectrum of phytonutrients. All extracts are 100% natural, authentic and without solvent residues. These extracts offer new possibilities where quality and added value are important.

Vidya Herbs Inc has a wide selection of herbal extracts for every industry.

In fact, Vidya Herbs offers 61 different extracts.

Quality control A team of highly experienced individuals constantly monitors the quality control procedures to eliminate any deviations that can hamper the final output. In the product analysis, a high degree of accuracy, standardisation and quality evaluation of the extracts are carried out before dispatch.

Quality is monitored by atomic absorption spectrophotometry as well as HPLC/TLC/UV. Supercritical extraction Supercritical extraction is a new revolutionary manufacturing process that involves the use of highly pressurised CO2 (carbon dioxide). In this process, CO2 is pressurised at specific temperatures, and it transforms into a dense liquid gas known as supercritical CO2.

It is about 1.5 times as heavy as air and stable, inert, and nontoxic. At this level it becomes an inert solvent that can extract the active ingredients of various plant species without the usual high temperatures or harsh chemicals solvents found in other processes. The result of using the supercritical extraction process is a far more active, concentrated product.

Supercritical extraction has three primary advantages over conventional solvent extraction processes: • Extremely clean, absolutely solvent free extracts • More of the plants functional components are yielded

Hibiscus

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Cocoa

• The oxidation rate of the components is greatly reduced or eliminated compared to traditional methods Supercritical CO2 is biologically compatible and has been given a generally regarded as safe (GRAS) designation by the FDA. Article 374

Vidya Herbs extract range for the Nordic countries: • • • • • • • • • • • • • • • • • •

Acai Amla Apple Bilberry Chili Cocoa Green coffee bean Grean tea Gymnema Sylvestre Hibiscus Lemon grass Pomegranate Rosehips Rosemary Saffron Triphala Valerian White kidney bean

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Positive EFSA opinion on olive extract OLIVEX olive extract from Grap’Sud with guaranteed content of polyphenols is a bioactive ingredient of choice for nutraceuticals In 2011, the European Food Safety Authority (EFSA) published a positive scientific opinion on olive polyphenols stating that consumption of hydroxytyrosol and related polyphenols has a cause-and-effect relationship effect on the protection of blood lipids from oxidative damage. This concerns polyphenols from the olive fruit, olive water, olive oil, fruit extract or leaf extract since they are standardised by their content of Hydroxytyrosol and derivatives.

This positive opinion from EFSA on polyphenols in olive confirms the results of many years of research on olive science and specifically on olive polyphenols and heart health.

OLIVEX, olive extract from Grap’Sud, has a guaranteed content of polyphenols making it a bioactive ingredient of choice for nutraceuticals. The key benefits of OLIVEX are: • A high level of Hydroxytyrosol and Tyrosol • Liquid form available (10% Hydroxytyrosol) • Well defined for its polyphenolic profile by HPLC • A high ORAC value (over 4000 µmole TE/g for the powder form) • A great bioavailability • Produced in France from selected olives, complete traceability Experts propose the following formulation of the claim: “consumption of olive oil polyphenols contributes to

the protection of blood lipids from oxidative damage”. The condition for the use of this claim is to consume at least 5 mg of Hydroxytyrosol and Tyrosol per day, which corresponds to around 100 mg/day of OLIVEX ref PHO6.

Grap’Sud product range Grap’Sud specialises in the manufacturing and sales of grape by-products for various industries: nutraceuticals, food and winemaking. For nutraceu-

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ticals, the following wide range of products offered under the brand names exGrape, OLIVEX and OLEOGRAPE is: • grape seed extract • anthocyanins • grape polyphenols with a guaranteed content in resveratrol • olive polyphenols • olive/grape polyphenols.

Article 375

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Alsiano

The Alsiano Healthcare team It is always nice to be able to put a face on the person you talk to over the telephone or e-mail. So here we are ...

Pharmaceuticals - cosmetics health & nutrition

Key accounts

Pharmaceuticals - cosmetics health & nutrition

Anders Hager

Lene Aarøe Nissen

Annette Strarup

M.Sc. Chem.

Sales Director

B. Chem. Eng. Area sales manager

B.Sc. (Hons.) Chem. Eng. Area sales manager

E-mail: ahg@alsiano.com Tel. dir.: +45 8230 0026 Mobile: +45 2618 8545

E-mail: lan@alsiano.com Tel. dir.: +45 8230 0025 Mobile: +45 2270 1002

E-mail: ask@alsiano.com Tel. dir.: +45 8230 0049 Mobile: +45 2270 1015

Pharmaceuticals - cosmetics health & nutrition

Sales support

Sales support

Henrik A. Petersen

Malene Rask Harder

Signe Mørck

M.Sc. Pharm.

Senior area sales manager

Sales assistant

Sales assistant

E-mail: hap@alsiano.com Tel. dir.: +45 8230 0009 Mobile: +45 2067 1231

E-mail: mrh@alsiano.com Tel. dir.: +45 8230 0007

E-mail: sm@alsiano.com Tel. dir.: +45 8230 0042

Logistics

Quality Lene Baldasano del Valle

Susse Liff Hansen

Logistics manager

Quality manager

E-mail: lb@alsiano.com Tel. dir.: +45 8230 0015

E-mail: slh@alsiano.com Tel. dir.: +45 8230 0017

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Alsiano invests in Kryta Krydderier Alsiano A/S has entered as investor in Kryta Krydderier A/S. With this investment, both companies expect to benefit from each other’s knowledge and experience with spices, taste and other ingredients, and we see this interesting opportunity as a very positive development for Alsiano and for our customers.

Kryta is a privately-owned company which has manufactured and supplied spices and spice blends to the Danish food industry since 1955.

In connection with this cooperation, Alsiano’s managing director Jens Hummeluhr steps in as managing director for Kryta A/S. The previous managing director Mogens Kristensen

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stops by the end of March 2012 and will stay on as development manager until then.

We look forward to making use of both companies’ strengths and experiences and are confident that our customers will benefit from this new cooperation.