By: DSM Pharma Solutions Editors
Alpha-Tocopherol (vitamin E) can promote health, prevent, and treat various chronic oxidative stress-induced pathologies via its function as an antioxidant and its roles in anti-inflammatory processes. It has shown promise in the treatment regimen of several diseases, such as non-alcoholic fatty liver disease (NAFLD). DSM is pleased to announce the approval of a new Certificate of Suitability with European Pharmacopoeia (CEP) for alpha-Tocopheryl acetate concentrate, a vitamin E powder form. The CEP helps our partners to accelerate the product development process through optimal content uniformity in oral solid dose formulations.
With the support of the new CEP, the vitamin E active pharmaceutical ingredient (API) powder form is available for our partners worldwide in more than 40 countries, including the European Union, Turkey, Canada, and Malaysia, and so enables faster geographical expansion. Today, DSM is the first and only CEP holder for alpha-Tocopheryl acetate concentrate. This vitamin formulation speeds up the development process through easy processability and content uniformity of alpha-Tocopheryl acetate in oral dose formulations (direct compression tablets, chewable and effervescent, and hard-shell capsules), allowing timelier patient access. The new CEP will considerably facilitate the registration process, save time and resources, help accelerate market entry, and optimize life-cycle management in compliance with the latest regulatory requirements. For DSM partners, the CEP provides new opportunities to address growing market demand innovatively and in line with applicable regulatory and quality standards.
Manufactured under GMP-compliant conditions in Sisseln, Switzerland, the largest vitamin production site in the world, alpha-Tocopheryl acetate concentrate API can be reliably supplied long-term.
Alpha-Tocopheryl acetate is a powerful biological antioxidant and the most active form of vitamin E in humans. The main therapeutic applications are the result of its prominent antioxidant effect, reported in scientific publications related to ischemic heart disease, atherosclerosis, arterial hypertension, diabetes, cognitive performance, cancer, and more.1 Alpha-Tocopheryl acetate is currently recommended by some treatment guidelines for use in the treatment of patients with NAFLD, which is a growing public health concern worldwide, affecting a quarter of the global population.2,3
Moreover, NAFLD is closely associated with type 2 diabetes and obesity, and both of these conditions drive NAFLD progression toward the more advanced stages.4 According to the World Health Organization, in 2016, more than 1.9 billion adults worldwide were overweight or obese,5 and more than 422 million had type 2 diabetes in 2014.6 As the clinical burden of NAFLD grows, so will its economic burden.
The development of effective counterstrategies is a priority in view of the increasing prevalence of NAFLD, obesity, and diabetes. The therapeutic potential of alpha-tocopherol is supported by studies reporting improved clinical outcomes with alpha-tocopherol in patients with non-alcoholic steatohepatitis (NASH), the progressive form of fatty liver disease associated with inflammation and cellular injury, including in children.7-9
With more than 70 years of experience in producing and securing the supply of APIs, we develop life-changing therapies that safely and efficiently improve people’s lives. Our strong research team, portfolio of patents, global network of regulatory specialists, and key scientific, academic, and manufacturing partnerships provide the foundation for timely and effective product co-innovation.
DSM brings expertise and innovation to co-develop new over-the-counter products and prescription medicines in an ever-changing and competitive marketplace. Our commitment to quality, innovation, and reliable supply of API makes us your ideal end-to-end partner to address emerging therapeutic areas benefiting global patient health while helping our partners achieve long-term growth.
Partner with DSM for access to our broad portfolio of vitamin APIs and Lipid API intermediates supported by comprehensive regulatory packages, customized solutions, and expert services aimed at supporting your entire product life cycle – and to together grow in a fast-evolving alpha-Tocopherol market. Together we can address emerging therapeutic areas benefiting global patient health, while helping customers achieve long-term growth. Contact us for more information.
20 May 2021
4 min read
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1. Tucker, J. M. & Townsend, D. M. Alpha-tocopherol: roles in prevention and therapy of human disease. Biomed Pharmacother 59, 380-387 (2005).
2. Younossi, Z. et al. Global burden of NAFLD and NASH: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol 15, 11-20 (2018).
3. Huang, D. Q., El-Serag, H. B. & Loomba, R. Global epidemiology of NAFLD-related HCC: trends, predictions, risk factors and prevention. Nat Rev Gastroenterol Hepatol 18, 223-238 (2021).
4. Marjot, T., Moolla, A., Cobbold, J. F., Hodson, L. & Tomlinson, J. W. Nonalcoholic Fatty Liver Disease in Adults: Current Concepts in Etiology, Outcomes, and Management. Endocr Rev 41 (2020).
5. World Health Organization Factsheets. Obesity and overweight. 1 April 2020. Available from: http://www.who.int/mediacentre/factsheets/fs311/en/ (accessed April 2021).
6. World Health Organization Factsheets. Diabetes. 13 April 2021. Available from: http://www.who.int/mediacentre/factsheets/fs312/en/ (accessed April 2021).
7. Vilar-Gomez, E. et al. Vitamin E Improves Transplant-Free Survival and Hepatic Decompensation Among Patients With Nonalcoholic Steatohepatitis and Advanced Fibrosis. Hepatology 71, 495-509 (2020).
8. Sanyal, A. J. et al. Pioglitazone, vitamin E, or placebo for nonalcoholic steatohepatitis. N Engl J Med 362, 1675-1685 (2010).
9. Lavine, J. E. et al. Effect of vitamin E or metformin for treatment of nonalcoholic fatty liver disease in children and adolescents: the TONIC randomized controlled trial. JAMA 305, 1659-1668 (2011).