BRIEFING

 〈1156〉 LG Polymer Microparticle Drug Products—Characterization Methods. This new general chapter introduces essential product quality and characterization tests for lactide-glycolide (LG) polymer-based microparticle preparations, as well as specific requirements not covered in other chapters. The chapter focuses on marketed, extended-release microparticle drug products that consist of drug substances formulated with biocompatible, bioabsorbable polymer excipients, including poly(lactide-co-glycolide), polylactide, poly(lactic acid-co-glycolic acid), or poly(lactic acid) polymer excipients (collectively referred to as LG polymers). The chapter details LG polymer manufacturing and characterization, microencapsulation processes, mechanism of drug substance release, general drug product quality tests, and methods for characterizing extended-release LG polymer microparticle drug products.

 (GCDF: R. Kaja)

 Case ID—SUB-2552