Key Factor Study for Generic Long-Acting PLGA Microspheres Based on a Reverse Engineering of Vivitrol^®.

ABSTRACT: The FDA (U.S. Food and Drug Administration) has approved only a negligible number of poly(lactide-co-glycolide) (PLGA)-based microsphere formulations, indicating the difficulty in developing a PLGA microsphere. A thorough understanding of microsphere formulations is essential to meet the challenge of developing innovative or generic microspheres. In this study, the key factors, especially the key process factors of the marketed PLGA microspheres, were revealed for the first time via a reverse engineering study on Vivitrol^® and verified by the development of a generic naltrexone-loaded microsphere (GNM). Qualitative and quantitative similarity with Vivitrol^®, in terms of inactive ingredients, was accomplished by the determination of PLGA. Physicochemical characterizati

SUBMITTER: Hua Y 

PROVIDER: S-EPMC7975983 | biostudies-literature | 2021 Feb

REPOSITORIES: biostudies-literature