Tablets & Capsules

TC0120

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12 January 2020 Tablets & Capsules The US Pharmacopeia (USP) is seeking volunteers to serve on the organization's E xcipients E xper t Committees (ECs) for the 2020 - 2025 cycle. The ECs help develop and revise excipient general chap- ters, test methods, monog raphs, and reference standards. Commit- tee members will delve into every aspect of excipient production and useā€”development, characterization, formulation, manufacturing, supply chain, storage and distribution, qual- ity control, and regulation. Working toward purity USP strives to protect public health by helping to ensure that only quality medications reach the mar- ketplace. An important part of that work is establishing rigorous stan- dards through validated procedures that identify excipients' purity and quality [1]. From binders and sweet- eners to fillers and flavorings, USP's role is to help ensure consistency among excipients in every medicine. USP's Excipient ECs help address a host of issues, some concerning important standards that don't yet exist. Approximately 1,200 excipients are currently included in approved drugs around the world, but only around 520 of these appear in the National Formulary. Of the remain- ing compounds, USP has identified about 150 important excipients that require standards. The Excipient ECs will help with that work. In addition to developing new standards, the committees will also help evaluate how traditional excipi- ents fit into the newer drug product market. Of particular interest will be how substances that were origi- nally developed for solid oral dosage forms will be used in new therapies and routes of administration, such as implants and injectables. USP is looking at upgrading monographs to a deep understanding of their excip- ient composition, including potential impurities, the number of compo- nents, and their characterization. T he E xcipients ECs have an opportunity to address and solve some of the most challenging issues facing the pharmaceutical and health- care fields today. According to Chris Moreton, partner and vice president of pharmaceutical sciences at FinnBrit Consulting, Waltham, MA, and a vol- unteer on one of USP's Excipient ECs for nearly two decades, "By creat- ing standards for excipients, volun- teers play a key role in ensuring the purity of the whole drug product. At every step, we're protecting the public's health by helping to prevent poor-quality medicines from entering the marketplace." Beyond addressing specific issues around excipients, joining a USP E xper t C ommit tee of fer s many other benefits as well. "Volunteering with USP is an incredibly rewarding experience, a one-of-a-kind oppor- tunity to meet and work with other experts in your field, and a way to really make an impact on public health," says Moreton. For more information about USP's Expert Committees and the benefits of volunteering, please visit www. usp.org/trustneedschampions. References 1. www.usp.org/excipients 2 . w w w.u sp.or g / ve r if ic at ion- s e r v i c e s /e x c i p i e n t - i n g r e d i e n t - verification USP is a private, independent, non- profit organization founded in 1820 that develops scientific standards to help ensure the quality and safety of medi- cines, dietary supplements, and foods (301 881 0666, www.usp.org). keep them current with new uses and asking questions about other quality attributes. It's important to under- stand the excipients' microbiological and other physical properties and how these properties could impact drug products. Drug product manufacturers must ensure the quality of all ingredients in their products and are responsi- ble for qualifying excipient suppliers and manufacturers. However, phar- maceutical companies don't always deal directly with the excipient manufacturers and often work with dozens of distributors and brokers to acquire the ingredients for their products. This increases the risk of breakdowns along the supply chain and uncertainty about ensuring the integrity of some materials. It's incumbent on drug product manufact u r er s to per for m t asks such as identit y testing prior to releasing a product. USP is work- ing toward facilitating these pro- cesses to ease the burden on man- ufacturers and help ensure that the materials they are using will satisfy FDA requirements [2]. Addressing complex challenges As the phar maceutical market expands into biologics and biosim- ilars, the challenges for drug prod- uct developers and manufacturers are becoming increasingly complex, triggering the need for a more thor- ough, deeper understanding of these therapies' excipients. The gener- ics industry falls under a different set of regulations, requiring differ- ent understanding, knowledge, and expertise for clinical and manufac- turing submissions. Because excipi- ents comprise multiple components, the technologies to understand their complexities and composition are not t ypically part of compendial methods. Complex therapies require USP seeks volunteers for Excipients Expert Committees

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