Recent Trends in Product Development and Regulatory Issues on Impurities in Active Pharmaceutical Ingredient (API) and Drug Products. Part 1: Predicting Degradation Related Impurities and Impurity Considerations for Pharmaceutical Dosage Forms
Journal Title: AAPS PharmSciTech - Year 2014, Vol 15, Issue 1
Abstract
The conference sessions summarized in this white paper (Part 1 of 2) covered a variety of important aspects involved in the study of drug degradation, both as the drug substance and in the drug product. Important advances in technology to predict drug degradation were investigated and reviewed. Focus was drawn to specific analytical and mass balance considerations involved in conducting successful and informative forced degradation studies of drug substances. Investigation of degradation in pharmaceutical dosage forms was shown to include a consideration of both the strategic design of solid-state compatibility studies and the need to understand reactive impurities present in pharmaceutical excipients. Stress testing of liposomal and small-molecule parenteral products requires in-depth understanding of these complex systems and need to be approached with concerns of both chemical and physical stability. Finally, a timely discussion of recommendations for stress testing of combination drug products was presented. Overall, the sessions served to highlight the importance of having the ability to rapidly predict and assess the potential for impurity formation in drug products, which can lead to performance, regulatory, efficacy, and safety concerns.
Authors and Affiliations
Karen M. Alsante, Kim Huynh-Ba, Steven W. Baertschi, Robert A. Reed, Margaret S. Landis, Mark H. Kleinman, Christopher Foti, Venkatramana M. Rao, Paul Meers, Andreas Abend, Daniel W. Reynolds, Biren K. Joshi
Keywords
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- EP ID EP682364
- DOI 10.1208/s12249-013-0047-x
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