The Increased Relevance of Excipients in the Pharmaceutical Industry

Excipients have an important role in the development, manufacture, and delivery of safe and efficacious drug therapies but are often of little focus. This session will explore a variety of hot topics related to excipients that may have regulatory or formulation impact on drug products. The presenters will discuss nitrosamines, PFAS, TiO2, FD&C Red No. 3, QbD, novel and co-processed excipients, and other trends related to excipient manufacture, their application, and potential regulatory considerations.