It’s no secret that excipients are not manufactured specifically for pharmaceutical use. In fact, pharma appears pretty low on many excipient makers’ lists of clients. But their importance in drug formulation and in ensuring final product quality has been gaining recognition over the past few years, unfortunately due to some specific events of contamination and adulteration. Because of growing concern in how excipients function and perform, the US Pharmacopeia has developed a new general information chapter on this topic, chapter <1059>.
The pharmacopeia is going to talk about the chapter and what it means for industry at its upcoming Science & Standards Symposium in September, in Boston. The workshop will focus on excipient performance, including test methods in the <1059> chapter, and how to best select performance tests. FDA perspectives on excipient variability will also be addressed.
In addition, PharmTech hosted an educational webinar on this topic in April that is available on demand. Speakers include the USP’s Excipient Director Catherine Sheehan, Colocon’s Ian Robertson, Finn Brit Consultant Chris Moreton, and The University of Michigan’s Greg Amidon. USP Expert Lawrence Block is also on the panel.
What are your company’s concerns about excipient performance? What testing challenges do you face?