Excipients are essential to the formulation of drug products, but their importance in supporting innovative drug development is often underestimated. According to the International Pharmaceutical Excipients Council (IPEC), drugs that have yet to be developed may need more excipients than are currently available to us, and many new treatments are unlikely to succeed without novel excipients. In short – innovation in drug development requires innovation in excipient manufacturing.
However, the lack of an independent regulatory pathway for novel excipients has historically created barriers to their use and discouraged innovation in the excipients space. In this episode Nigel Langley, Chair of IPEC – Americas and Global Technology Director at BASF Corporation, joins us to discuss developments in the novel excipients arena, as well as the pilot review program launched by the FDA last year.