If you’re not in Baltimore this week, you’re missing out on a lot of great educational information regarding the use of excipients in the pharma industry. ExcipientFest in partnership with IPEC is hosting its annual conference and exhibition. The entertainment for participants, including a reception on the USS Constellation naval ship in the Inner Harbor, has also been quite an experience.
Chief among the seminar topics discussed thus far are coprocessed excipients, taste-masking techniques, continuous processing, excipient functionality and variability, spectroscopic libraries (quite an innovative initiative), and atypical actives. On the latter, Pfizer’s Janeen Skutnik-Wilkinson, current vice-chair of the IPEC Federation, discussed the growing concerns in using excipients as the active ingredient in pharmaceutical, including many OTC, products. Most of these products, such as rubbing alcohol, have been on the market for decades so while the risk may be low, the current era of communication and transparency throughout the industry is begging some questions. For example, APIs must adhere to ICH Q7 (the harmonized guideline for API GMPs). But there is a gap between this guideline and the GMPs for excipients (put out by IPEC/PQG) in that atypical actives are not specifically addressed. This becomes a problem when an excipient manufacturer is not aware that its excipient is being used by a pharma company as an active and then perhaps gets audited or inspected by FDA. It also becomes a problem should an atypical active cause patient harm. These issues are being examined by IPEC, PDA, FDA, USP and other stakeholders. Look for potential IPEC guidance and even FDA information in the near future.
Coprocessed excipients are also a hot topic at this year’s meeting–for the most part, because industry is still seemingly afraid to use them for fear of regulatory uncertainty, expressed speaker Dave Schoneker of Colorcon and past chair of IPEC. The fact is that these combination products are largely un-novel. The compounds have been used and approved in the past–it’s the physical composition and functionality of the final product that are new and require a bit more work. But there are ways to get past this challenge and to continue to innovate. IPEC’s Novel Excipient Evaluation Procedure, for instance, which PharmTech has covered in the past, and which FDA supports offers such a mechanism.
Excipient functionality and variability are also on the minds of conference participants here in Baltimore. As PAT and QbD approaches become more commonplace across industry, process understanding and product understanding are crucial, and understanding each component of the product and how it acts, interacts, and performs, are critical to product quality and patient safety. In the past, industry has largely focused on understanding its APIs but the excipients and inactive materials are just as important. USP’s 1059 informational general chapter addresses this issue in part with its functional categories and recommended tests, and the chapter is going to be revised and expanded again in the coming months, according to speaker Catherine Sheehan, USP’s director of excipients.
More to come!