Formulation Development

FORMULATION DEVELOPMENT – A Quick Approach for Evaluation of Drug-Excipient Compatibility: Case of Acetylsalicylic Acid

Masumi Dave, PhD, and Rollie Fuller monitor in this study ASA hydrolysis in different formulations using UPLC and TAM with the objective of comparing these methods for agreement, speed, and efficiency in predicting drug stability. In parallel, they assess the impact of the excipient choices on the stability of ASA.

NASAL SPRAY BIOEQUIVALENCE – Between-Batch Bioequivalence (BBE): An Alternative Statistical Method to Assess In Vitro Bioequivalence of Nasal Product

Jonathan Bodin, Stéphanie Liandrat, Gabriel Kocevar, and Céline Petitcolas explain how one way to prove equivalence, without long and expensive clinical trials, is to conduct in vitro bioequivalence evaluation between the Innovator (Reference product) and the proposed generic (Test product).