New study highlights the need to set common high quality standards for the preparation and analysis of bilberry extracts

Milan, October 16th, 2007 – A study led by Indena researchers and recently published in the Journal of AOAC International [90 (4):911-9] has measured the quality of products containing bilberry extracts on the market. Its purpose was to reveal differences between the various brands in terms of identity, conformity, dosages and labelling. The results were disappointing.

Forty preparations containing bilberry extract, marketed under 24 different brands, were bought in the US, Italy, Japan and Malaysia and analyzed with a validated HPLC method to establish their content in anthocyanins (anthocyanosides). Anthocyanins, the poliphenols responsible for the beneficial proprieties of bilberry extract, are useful in the prevention and treatment of conditions associated with fragility of blood vessels and eye health.

The HPLC fingerprint of 25% of the products revealed a profile different from the authentic bilberry (Vaccinium myrtillus, L.) extract; 10% of the products examined did not even contain the active principle anthocyanin, and only 15% of the preparations examined were found to possess a sufficient quantity of anthocyanin proven to be effective in clinical trials.

According to Roberto Pace, Indena’s Analytical Research Director and author of the study “in order to unequivocally identify and quantify the profile of a botanical extract, Indena has always developed and validated analytical methods, which are recognised as reliable and reproducible. With this study we have highlighted how the use of validated analytical methods to determine identity can be successfully applied to single or multi-component formulations”.
It also emerged from the analysis that only 65% of products sold in the United States contained ingredients that matched what was declared on the label.

Commenting on these results, Christian Artaria, Director Marketing at Indena, confirmed that: “Indena has always strived to ensure that the production of botanical derivatives respects Good Agricultural Practices (GAPs) and Good Manufacturing Practices (GMPs). Indena has also been collaborating with different associations, such as the European pharmacopoeia and the USP, to establish common analytical standards and methods of analysis. With this latest study we have unequivocally proven the importance of using validated analytical methods to guarantee not only the quality of raw materials, but also the quality and authenticity of finished formulations. At Indena, we believe that the introduction and correct application of the new GMPs in the U.S, together with the use of officially validated analytical methods, will at last ensure high quality dietary products ".

For more than 30 years, Indena’s MirtoSelect® has been recognized as the gold standard for bilberry extracts. MirtoSelect® (36% anthocyanins) has been clinically tested and proven effective in the treatment of peripheral circulatory and ophthalmic disorders. Furthermore, anthocyanins are today among the most investigated compounds for their role in cancer prevention. Almost 50 peer-reviewed papers have been published on Indena's standardized bilberry extract since the early seventies. They demonstrate its quality, safety and efficacy.

Indena is the world's leading company dedicated to the identification, development and production of active principles derived from plants, for use in the pharmaceutical, health food and cosmetics industries. The key to Indena's success is its research, covering: the screening of medicinal plants for their pharmacological benefits; the identification of new active principles; and the development of extraction and purification systems at the cutting-edge of industrial application. Backed up by over 80 years of botanical experience, the phyto-chemical research is carried out in Indena's own Settala Research Center, near Milan. Indena also co-operates with the world's most prestigious universities and private research institutions in the biological assessment of safety and effectiveness up to clinical phase I. The company has more than 150 primary patents and has published around 700 scientific studies. Indena, with more than 700 employees, including 10% dedicated to full-time research, manages cultivation, manufacturing, and distribution operations in more than 40 countries throughout the world. The Company's experts communicate and interact constantly with the major international regulatory authorities such as WHO, EMEA, and ESCOP, and work with all the main pharmacopoeias.

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Further information on Mirtoselect

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