Ensuring Pharmaceutical Product Success through Excipient QbD Efforts

Abstract

It isessential to understand excipients’ critical material attributes. A QbDstrategy that includes historical data analysis and experimental work has beenused in functional excipients such as Hypromellose (HPMC) to develop thisunderstanding. The use of multivariate analysis helped to identify excipientvariability and the support it could provide to improve the final product robustness.