Formulation and Delivery
Catherine Sheehan, DRSc. MS. MS.
Senior Director, Excipients and Foods
U.S. Pharmacopeia (USP)
Rockville, Maryland
Kenny Xie, PhD MBA (he/him/his)
Principal Scientist
US Pharmacopeia, Maryland
The quality of excipients is important since they can make up to about 90% of the total mass/volume of drug products. Fatal consequences are linked to excipients at a higher risk of adulteration and contamination as well as product recalls and facility closures due to excipient quality/GMP violations.
Traditionally, excipient specifications were established with a focus on intended use in the drug product and less on excipient composition, however, the increasing demand for high quality excipients used in the development of advanced nanomedicines and novel delivery systems requires higher quality and purity, e.g., use of phospholipids in development of Covid-19 vaccine nanomedicine delivery systems. USP is collaborating with stakeholders to address the lack of standardized methods for complex polymeric type excipients (e.g. lipids/LG polymers), by expanding its offerings to be more flexible in its approaches introducing evolving, iterative approaches that address excipient compositional and variability issues. This presentation will highlight the recent updates to excipient monographs at risk for adulteration and contamination with DEG/EG and general chapters for excipient <1078> GMP and <1059> Excipient Performance, and introduction of excipient nomenclature guidelines and definitions. In addition, the presentation will provide an overview of evolving compendial approaches (e.g., standalone chapters) and expanded offerings through use of expanded non-compendial approaches (use of analytical reference materials (ARMs) and associated application (App) notes). Lastly, the presentation will provide an overview of the complexities surrounding the use of novel excipients in pharmaceutical formulations and safety assessments, USPs collaboration with stakeholder's, creation of a Novel Excipients Knowledge Hub, and the establishment of the Novel Excipients Expert Panel to revise General Chapter <1074> Excipient Biological Safety Evaluation Guidelines.