Pharma & Healthcare News Alsiano No. 19 • July 2014
Contents SlimMED - the natural weight loss solution ...............1 TM
SEPPIC obtains EXCiPACTTM certification.............................2 Vitafoods 2014 news from our suppliers.........3 Dermopharma with perfect texture........................4 Lynside® Pure SAMe: Supporting emotional well-being, liver and joint health.......................................5 Sorb-Cel ready-to-use effervescent.............................6 PalatinoseTM: positive effect on mental performance............................7 New area sales manager for Healthcare, Sweden..........8 The Alsiano Healthcare team ........................................8
SlimMED™ - the natural weight loss solution A reliable, proven and safe solution based on KiOnutrime-CsG®, the unique non animal chitosan, in capsules. SlimMEDTM binds up to 29% dietary fats By KitoZyme Slim MED™ is a class IIA medical device based on KiOnutrime-CsG® which has been developed for use in the treatment and prevention of overweight conditions and diseases related to excess weight and excess body fats. As such, SlimMED™ has a superior fat-binding capacity and contains 100% animal-free, naturally-sourced, safe and non-allergic chitosan, and its efficacy has been proven by more than 40 clinical studies and peer-reviewed articles. Technology The chitosan from KitoZyme is based on the KiOnutrime-CsG® technology which is certified in accordance with the provisions of Directive 93/42. KiOnutrime-CsG® is a unique, patented and CE-marked fat-binder with the following benefits:
Publisher: Alsiano A/S Circulation: 600 copies 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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• A fat-binding capacity that has been proven to be 33% more efficient than competitor products. • Self-affirmed GRAS status. • Positive opinion regarding maintenance of LDL-cholesterol issued by the EFSA. • Odourless and tasteless. • Appropriate for use in Kosher, Halal and vegetarian products/diets. • Safe and natural: 100% animal-free, GMO-free, allergen-free, gluten-free. • Efficacy proven by clinical studies and peer-reviewed articles. Mechanism of action SlimMED™ is composed of KiOnutrime-CsG®, a cationic biopolymer capable of binding negatively charged molecules such as fats, fatty acids and bile acids chiefly, avoiding their absorption and allowing their excretion. (continues on page 2 >>)
Pharma & Healthcare News Food News
• July 2014 No. 1No.• 19 February 2004
>> Upon ingestion of Slim MEDTM, the non-animal chitosan is protonated in the stomach. The positively charged amine functions (-NH3+) of the chitosan will bind a phenomenon of electrostatic interaction to the negatively charged acid (COO-) of fatty acids and bile acids. Consequently, a kind of gel is formed that is then excreted naturally. KitoZyme offers: • A commitment to safety and performance. • Distribution under the brand name or a private label. • A finished product on the market in a timeframe of just 4 months. • As manufacturer, KitoZyme takes full responsibility. 1
• Construction of the technical file. • Post market monitoring. • Systems are in place to ensure complete traceability. SlimMEDTM FORTE KitoZyme has recently launched a new formulation, SlimMED™ FORTE, which is composed of vitamin C added to the chitosan, KiObind® for a faster solubilisation of the chitosan in the stomach and an optimal effect by improving the fat-binding properties. KiObind® chitosan binds up to 33% fat, whereas KiOnutrime-CsG® binds up to 29%. Who is KitoZyme KitoZyme, founded in 2000, designs and manufactures cutting-edge functional health-oriented biopolymers
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KIOnutrime-CsG® is a cationic biopolymer capable of binding negatively charged molecules like fats, fatty acids and bile acids chiefly, avoiding their absorption and allowing their excretion.
Alsiano Alsiano KiOnutrime-CsG® is a purified D-glucosamine biopolymer produced from the cell walls of the mycelium of a non-genetically modified fungi (Aspergillus niger). KiOnutrime-CsG® is extracted without any synthetic manipulations and purified to meet nutraceutical requirements in terms of properties, performance and purity. exclusively from renewable, nonGMO, plant sources. The company develops medical devices and has a portfolio of 12 patents. KitoZyme is ISO-9001 and ISO-13485 certified. Production and headquarters are situated in Liège, Belgium. Article 396
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KitoZyme non-animal chitosan is protonated in the stomach.
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The positively charged amine functions (-NH3 +) of the chitosan will bind by a phenomenon of electrostatic interaction to the negatively charged acid (COO-) of fatty acids and bile acids.
Consquently, a kind of gel is formed that is then excreted.
SEPPIC obtains EXCiPACT™ certification SEPPIC became the fourth company worldwide to obtain the quality assurance mark for pharmaceutical excipients By Kathleen Allain, Marketing Manager, Solid forms, SEPPIC In December 2013, Seppic was granted the EXCiPACTTM certification as only the fourth supplier worldwide and the first French company. EXCiPACTTM is a certification created by Excipact, an affiliate of IPEC and launched in January 2012. This certification is provided by an independent third party according to the IPEC/ PGQ GMP guidelines. EXCiPACT can be an answer to the suppliers audit requirements of Directive 2011/62/ EU known as the “falsified medicine directive”.
EXCiPACTTM certification is voluntary for excipients suppliers and enables the auditee to obtain an audit report based on the IPEC/PGQ GMP guidelines. Seppic has undergone on audit in September with a very good feedback from auditors. Conclusions of the audit can be given on request. IPEC (International Pharmaceutical Excipients Council) is a professional association that serves the interests of producers, distributors and users of pharmaceutical excipients. Globally more than 200 companies are members. IPEC represents the views of its
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members vis-à-vis to appropriate regulatory bodies (European Commision, EMA, European Pharmacopoeia) and is recognised by Government agencies around the world as the voice of European producers and users of pharmaceutical excipients. Article 397
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Vitafoods 2014 - news from our suppliers More than 700 suppliers showcased their latest innovations and among them also a wide range of Alsiano’s suppliers From 6-7 May the Vitafoods Europe show returned to Geneva with more than 700 suppliers showing their latest innovations within ingredients, raw materials, products and technologies to approx 13,000 buyers, influencers, scientists and R&D professionals. Here is a brief summary of what our suppliers presented at Vitafoods 2014: Afriplex focuses on the development and production of novel plant extracts derived from African botanicals and destined for applications within the food and beverage, pharmaceutical and cosmetic industries. In the New Products Zone at Vitafoods, Afriplex presented their newly developed extract of Moringa leaf standardised on polyphenol content. Moringa oleifera leaf is the new supplement that is currently taking the world by storm. The extract consists of a range of nutrients, including unique anti-oxidants, vitamins, minerals, and anti-inflammatories. Grap’Sud showcased exGrape Total and exGrape Seed polyphenols with guaranteed content of OPCs and high ORAC values. Also oléoGrape Seed and oléoGrape Total that com-
bine the benefits of grape and olive polyphenols were displayed, together with Olivex olive extract with guaranteed content of hydroxytyrosol and tyrosol and with scientific studies available. At Jost’s stand, the focus was on high purity specialty chemicals for food, food supplements, nutrition and infant formulas - more specifically low heavy metals minerals, low aluminium Ca salts, custom particle sizes and microencapsulated minerals, and special low contaminant salts. Jost’s FDA registered site manufactures 250+ mineral salts under cGMP that routinely meet very low levels of Pb, As, Hg & Cd. Their minerals comply with the most restrictive regulations in the food, nutrition, clinical and infant nutrition markets. Quality, purity, ethics and sustainability are the main strategic drivers for Jost. Alsiano’s new supplier, KitoZyme, designs and manufactures innovative solutions aimed at improving people’s health. These products come in the form of medical devices that are based on unique and patented technologies, namely chitosan and chitinglucan produced from animal-free and non-GMO sources. KitoZyme showcased their latest formulation:
Slim MEDTM Forte which is a further development of Slim MEDTM – a natural weight loss solution. Read more about these two products on page 1. Lesaffre Human Care showcased Lynside® Pure SAMe for mood, joints and liver health in the New Products Zone and also Probisis BS for immune health. Lynside® Pure SAMe is a molecule naturally produced in the human body. This API plays a vital role in hundreds of metabolic reactions. Based on more than 20 years of studies, SAMe is now a reference for its therapeutic effects on depression, liver disease, detoxification and joint health. Read more about Lynside® Pure SAMe on page 5. Probisis BS, is a patented probiotic strain of Bacillus subtilis, clinically tested to significantly strengthen the immune defenses and reduce the average number of days of illness. It is a spore forming bacteria with a high survival through the gastrointestinal tract and a high stability (24 months: 40°C, 75% RH).
Moringa leaf extract from Afriplex were among the products in the New Products Zone at Vitafoods Europe 2014.
(continues on page 4 >>)
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Dermopharma with perfect texture SEPINEOTM P 600 is an effective and versatile polymer at the forefront of dermopharmaceutical innovation By Cathrine Bulcourt, Marketing Manager, Liquid & Semi-solid forms, SEPPIC SEPINEOTM P 600 is a 3-in-1 polymer: thickener, emulsifier and stabilising agent. It is a ready-to-use product designed for gel or cream formulations and is extremely easy to implement. This pre-neutralised liquid polymer acts in a wide pH range (3-11) and has accordingly excellent compatibility with numerous commonly used APIs and common pharmaceutical ingredients such as alcohol, propylene glycol, glycerine, etc. © BENEO
Depending on the treated disease and the active ingredients used, it adapts to all pharmaceutical galenics: gel, gel cream, O/W emulsion, but also W/O emulsion, GELTRAPTM, a new patented SEPPIC concept, or “gel in oil” with the advantage of a W/O process comfortable to the touch and based on an industrial process which consumes less energy.
>> Pulviver showcased their Egg Albumin Protein Sport for sports nutrition, which according to Pulviver probably has the best biological protein quality. The product has a protein content
Seppic showcased the new sustained release excipient SR 500 designed specifically for nutrition.
Its stabilising capacities, its compatibilities and properties as a texture agent make this polymer an indisputable ally to improve the effectiveness of topical treatments by enabling - the combination of different APIs - improved patient compliance With SEPINEOTM P 600, dermatology textures compare favourably to cosmetic textures. Application areas SEPINEO™ P 600 is easy to use as it does not require neutralisation or rehydration when new gels, creams, simple or multiple emulsions are developed for: • Formulas for topical application with drug status • Formulas with high solvent contents, anhydrous formulas, formulas with rich oil phase • Products composed of heat- or water-sensitive ingredients Article 398
of min. 84% and contains interesting essential amino acids, minerals and vitamins. In addition, it is free of fat and cholesterol and lactose-free. Pulviver, part of the Lodewijckx group, is a pioneer within the application of instant powder and has also developed a unique procedure for the drying and agglomeration of powdered egg albumin, which very few companies offer. Seppic presented SEPIFILMTM Naturally Coloured, their new ready-touse coating specifically designed for nutritional tablets and confectionery, ideally suited to meet the demand for naturalness within nutrition. Seppic also showcased the new sustained release excipient SR 500 designed
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specifically for nutrition. This excipient is a ready-to-use synergistic combination of natural co-processed gums for sustained release tablet formulations. Vidya Herbs, producer of high quality herbal extracts, essential oils and spice oleoresins showcased a line of certified organic extracts with particular focus on the green coffee bean extract for weight management. Vidya Herbs has state-of-the-art extraction facilities equipped with high end production & QC equipment including LCMS to meet international standards. The products include certified organic and conventional extracts. Article 399
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Lynside® Pure SAMe: supporting emotional well-being, liver and joint health Latest addition to its range, Lesaffre Human Care now provides SAMe, also known as S-Adenosyl-L-Methionine, a bioactive and API which has several health benefits and may improve the global health and quality of life By Lesaffre Human Care SAMe is a naturally occurring metabolite and is involved in many reactions throughout the body. It was discovered by an Italian researcher in 1952. Since then, many clinical trials and meta-analyses were carried out to discover the benefits and mechanisms of action of SAMe in the human body. SAMe helps maintain the S-AdenosylL-Methionine level in the metabolism and is already used worldwide. It has been routinely prescribed in Europe for nearly 30 years, and has gained popularity in the US since released as a dietary supplement in the late 90’s. LYNSIDE® Pure SAMe is a natural ingredient extracted from yeast, Saccharomyces cerevisiae, and produced in Italy by Omniabios, a Lesaffre company. LYNSIDE® Pure SAMe • improves mood and emotional well-being • reduces joint pain and inflammation
• prevents GSH (Glutathione) depletion, thus protecting liver against free radicals and toxins LYNSIDE® Pure SAMe is available as an pharmaceutical ingredient (API) and can be used in drugs or dietary supplements. The dietary supplement form is used in the USA, Australia and certain European countries such as Germany, France, Italy, Croatia, etc. The drug form is used in Mexico, Russia, Chile and certain European countries such as Finland, Belgium, UK, etc. Good mood & emotional well-being LYNSIDE® Pure SAMe is a natural solution to improving mood and emotional well-being. Many treatments for depressive disorders exist and are often associated with side effects, noncompliance and non-adherence of patients1. SAMe may have a role in the synthesis of neurotransmitters or mood hormones such as dopamine, serotonin and norepinephrine and may increase the rapidity of the information transmission.
Effect of SAMe in depressive disorders1
Joint health & mobility LYNSIDE® Pure SAMe reduces joints pain and inflammation and may contribute to maintaining mobility. SAMe exerts anti-inflammatory and analgesic effects, stimulates in vitro the proteoglycan synthesis and does not have any side effects on cartilage3. Liver health & toxins detoxification4 LYNSIDE® Pure SAMe prevents GSH depletion and protects the liver against (continues on page 6 >>)
Effect of SAMe on Gluthatione level in alcoholic and non-alcoholic liver diseases4 4.5
100
4.0
total GSH (µmol/g liver)
% of patients showing a _ 25% decrease in HAM-D* >
It appears that the SAMe is as effective as an antidepressant treatment, and significantly better than placebo, with minimal side effects1,2.
80 60 40 20
3.5 3.0 2.5 2.0 1.5 1.0 0.5
0 SAMe Placebo
0.0
SAMe Antidepressant treatment
Normal
0 months 6 months ALD = Alcoholic Liver Disease
*HAM-D: Hamilton Depression Rating Scale
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ALD + Placebo
ALD + SAMe
NALD = Non Alcoholic Liver Disease
NALD + SAMe *p <- 0.05 Vs 0 months
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Sorb-Cel ready-to-use effervescent Simple and efficient production of tablets, granules, powders and sachets with the co-processed effervescent compound from Blanver By Xavier Sarrias, Sales Manager, Blanver Sorb-Cel is a ready-to-use co-processed product for use in solid pharmaceutical formulations such as tablets and granules where the effervescent property is needed. Sorb-Cel has excellent solubility properties avoiding the presence of superficial coating and resulting in a limpid final formulation free of insoluble residues.
• Stability and short disintegration time • Final solution totally clear, without insoluble material.
bicarbonate, PVP, Mannitol and PEG), making it easy to register and to substitute for ongoing formulations without major changes in labels.
Since Sorb-Cel is lactose and sugarfree, it can be used by diabetics, people on a diet and lactose intolerants in pharmaceutical or food products.
Owing to the stable formula, SorbCel is also a formulation compatible with the most used active ingredients in pharmaceutical market (vitamin C, calcium, acetaminophen, etc...).
Sorb-Cel contains components typical for effervescent (citric acid, sodium
Article 400
The direct incorporation of the active ingredients into Sorb-Cel is very simple and gives the following advantages when compared with normal effervescent manufacturing processes: • reduced process time • less equipment involved • better operational conditions All that is required to produce effervescent tablets, granules, powders or sachets is mixing Sorb-Cel with the API for approx. 20 minutes, and then immediately producing the tablets or packaging in sachets. In addition, Sorb-Cel co-processed compound has the following qualities: • Good compression characteristics • Homogeneous mixtures
>> free radicals and toxins. In some liver diseases the lack of the powerful antioxidant gluthatione (GSH) leads to toxins and free radicals accumulation. SAMe is essential for treating liver diseases because it normalises the GSH level. Lynside® Pure SAMe is available in two salts: SAMe PTS (SAMe Disulfate P-toluensulfonate) and SAMe SD4 (1,4 Butanedisulfonate). In both products the ration of the active in-
gredient S-S isomer is >70% for 3 years. A unique production process enables a long shelf life. Applications • Dietary supplements: oral form • Drug: oral form or injectable sterile form Recommended dosage as a dietary supplement in EU: ≤ 250 mg/day Article 401
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References G.M. Bressa. S-Adenosyl-L-Methionine [SAMe] as antidepressant: meta-analysis of clinical studies. Acta Neurol Scand. 1994; Supplement 154: 7-14
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Kate Bell et al. S-Adenosylmethionine treatment of Depression: a Controlled Clinical Trial. Am J Psychiatry. 1988; 145[9]: 1100-1114
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Carlo Di Padova. S-Adenosylmethionine in the Treatment of Osteoarthritis: Review of Clinical Studies. The American Jounal of Medicine. 1987; 83(suppl 5A): 60-65
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Vendemiale et al. Effects of oral S-Adenosyl-LMethionine on Hepatic Glutathione in Patients with Liver disease. Scand j Gastroenterol. 1989; 24: 407-415
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PalatinoseTM: positive effect on mental performance Initial research indicates BENEO’s low glycaemic carbohydrate, PalatinoseTM, enhances mood and memory By BENEO Initial research into the effects of BENEO’s functional carbohydrate, PalatinoseTM (isomaltulose), on health, mood and cognition has shown that its use can enhance a person’s mood and memory. Due to the slow but complete hydrolysis and absorption of PalatinoseTM, that provides energy to the body in a sustained way, there was interest in investigating if this sustained energy delivery would manifest in improvements in mood and cognition. The subsequent research carried out by Hayley Young and David Benton from the Department of Psychology, Swansea University, Walesi and funded by BENEO, shows significant mood and memory improvement amongst middle aged and older adults who have a better glucose homeostasisii. The results of the study, registered in ClinicalTrials.goviii, contribute to an increased understanding of brain function in relation to carbohydrate metabolism. Anke Sentko, Vice President Regulatory Affairs and Nutrition Communication at BENEO, comments:
PalatinoseTM is the only fully digestible, low glycaemic carbohydrate that provides prolonged energy release in the form of glucose while being completely toothfriendly. Its low glycaemic and toothfriendly benefits have been approved by EFSA. Derived from sugar beet, Palatinose™ is a disaccharide, providing the full carbohydrate energy (4 kcal/g); the white, crystalline powder is low hygroscopic and has a milder sweetness than sugar.
ments: “The current work underlines the importance of research into the metabolic effects of carbohydrates with different physiological properties and it particularly shows the potential of the slowly, yet fully absorbed carbohydrate PalatinoseTM for health and mental performance.” In the study, 155 middle aged and older adult volunteers were randomly divided into 3 groups. Participants in each group consumed a breakfast that included yoghurt and a drink with 40 grams of glucose, sucrose and PalatinoseTM respectively, representing decreasing glycaemic loads and an identical amount of calories. Mood and memory function tests were then carried out on all the participants. When analysing the subgroups according to their glucose tolerance (poor GT versus better GT) the statistically significant differences in validated mood and memory tests, which were not observed when interpreting the overall data, became obvious. The Palatinose™ group of participants with a better glucose homeostasis, performed significantly better on mood and memory. As well as showing better episodic memory compared to glucose and sucrose, they also made fewer mistakes than those who had ingested glucose. This occurred long after the meal, when blood glucose levels were declining. It was discovered that the group with better glucose homeostasis were in a better mood (measured by subjective scoring of related adjectives on a percentage scale) and were able to remember more words from a list, for instance, at 105 and 195 minutes after eating a breakfast with PalatinoseTM, compared to a breakfast with sucrose or glucose.
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The BENEO-Institute is an organisation which brings together BENEO’s expertise from Nutrition Science, Nutrition Communication and Regulatory Affairs teams. It acts as an advisory body for customers and partners reaching from ingredient approval, physiological effects and nutritional composition to communication and labelling. The key nutritional topics that form the basis of the BENEOInstitute’s work include weight management, digestive health, bone health, dental health, physical and mental performance, and the effects of a low glycaemic diet in the context of healthy eating and disease prevention, as well as dental health. The BENEO-Institute facilitates access to the latest scientific research and knowledge throughout all nutritional and regulatory topics related to BENEO ingredients. Article 402
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The Alsiano Healthcare team 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
Process Technology
Quality
Hedvig Åkesson
Niels Kjær Nielsen
Susse Liff Hansen
M.Sc. Agriculture Area sales manager
Area sales manager
Quality manager
E-mail: haa@alsiano.com Tel. dir.: +45 8230 0009 Mobile: +46 708 155 012
E-mail: nkn@alsiano.com Tel. dir.: +45 8230 0072 Mobile: +45 2270 1017
E-mail: slh@alsiano.com Tel. dir.: +45 8230 0017
Sales support
Sales support
Logistics
Malene Rask Harder
Signe Mørck
Lene Baldasano del Valle
Sales assistant
Sales assistant
Logistics manager
E-mail: mrh@alsiano.com Tel. dir.: +45 8230 0007
E-mail: sm@alsiano.com Tel. dir.: +45 8230 0042
E-mail: lb@alsiano.com Tel. dir.: +45 8230 0015
New area sales manager for Healthcare, Sweden We are pleased to announce that as of 1 June 2014 Hedvig Åkesson has joined Alsiano Healthcare. Hedvig has a background within quality management and product development in the Swedish food and pharmaceutical industry. She is educated at the Swedish University of Agricultural Science with a master’s degree in Agriculture with food science as area of specialisation. Furthermore, Hedvig has deepened her knowledge of e.g. food technology and microbiology at Rheinische FriedrichWilhelm-Universität Bonn, Germany.
We are confident that Hedvig will strengthen the Healthcare team and prove a great asset to Alsiano and our partners.
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