FDA’s quality-by-design (QbD) initiative is a systematic approach to designing and developing pharmaceutical formulations and manufacturing processes to ensure predefined product quality. Understanding the critical quality attributes of the ingredients in a formulation, including excipients, and the critical process parameters in the manufacturing process of the finished drug product is crucial for successfully implementing QbD. Pharmaceutical Technology will be holding a live webcast on Thursday May 23 from 10:00 AM to 11:00 AM EST to examine the regulatory and technical considerations in implementing QbD for coatings in modified-release formulations, including strategies to mitigate the risks associated with alcohol-induced dose-dumping and the application of alcohol-resistant coatings.
The panelists for the webcast include Peter Timmins, PhD, Executive Director, Drug Product Science and Technology, Research And Development, Bristol-Myers Squibb, who will provide insight and case examples of implementing QbD for modified-release formulations. Om Anand, Senior Reviewer and Dissolution Focal Point in the Division of Bioequivalence II, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration and also the Office of Generic Drugs liaison to the United States Pharmacopeia (USP) and USP Expert Panel member, will offer a regulatory perspective on in vitro performance testing of oral modified-release generic products, inclusive of consideration for alcohol-induced dose-dumping. And Rina Chokshi, Project Leader for Controlled Release Technology, FMC Biopolymer, will discuss how to design controlled-release formulations solutions that remain robust in the presence of alcohol and provide further insight about the critical material, formulation and performance attributes of alcohol-resistant coatings.