Formulation and Delivery
Bruno Hancock, PhD (he/him/his)
Senior Advisor
Pfizer Inc.
Westerly, Rhode Island
Haichen Nie, PhD
Associate Director
Teva Pharmaceuticals
West Chester
The performance of pharmaceutical dosage forms relies heavily on the characteristics of the excipients that are incorporated into the drug product during the manufacturing process. Therefore, it is imperative that formulation scientists are able to accurately and completely specify the key chemical and physical properties of those excipients. Current approaches to describing excipients are outdated and inadequate for the needs of the 21st century and in this presentation the authors highlight the benefits of a more systematic and comprehensive approach to specifying and controlling excipient properties. It is hoped that this will prompt the users, suppliers, and manufacturers of excipients to take a careful look at current approaches and develop tangible proposals for attaining an enhanced future state.