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.
