As the second part of this series, this article focuses on the harmonization activities related to excipients under the work plan of the Pharmacopeial Discussion Group (PDG) that are also part of the USP Up-to-Date Initiative. As described in the first article, among the 19 FDA priority excipient monographs requested by FDA to be updated, fifteen (15) of them are in the PDG work plan among which eight (8) of these will be discussed in this article.1 Three expert panels were formed under the 2010-2015 Excipient Expert Committee to address FDA’s request to update five excipient monographs for Glycerin, Talc, and Povidones (Povidone, Crospovidone and Copovidone). The significant progress made through the efforts of these expert panels is discussed in this review and the impact on their harmonization within PDG. In addition, three cellulose-based excipient monographs, Microcrystalline Cellulose (MCC), Carboxymethylcellulose Sodium (CMC Na), and Croscarmellose Sodium (CROS Na), have been identified by FDA as high priority for updating. USP’s comprehensive approaches for identification and assay update in these cellulose-based excipient monographs are also discussed in this Review.
Kevin Moore, Ph.D. ,
Catherine Sheehan, MS, MS
Senior Director, Science –Excipients