(343) In vitro release testing system development for buprenorphine in situ forming implant
Introduction: PLGA-based in situ forming implants are complex parenteral offering sustained drug delivery for weeks to months [1]. However, there is lack of regulatory guidance on in vitro release testing (IVRT) system that is important for evaluating formulation differences. Most studies focus on drug suspensions products however Sublocade® is given as buprenorphine (BUP)−PLGA polymer solution involving subsequent precipitation of BUP which warrant studies to better understand this behavior [2].This study provide insights on depot formation and BUP distribution within PLGA matrix using dissolution studies.
Learning Objectives:
Develop in vitro release testing system for the in situ forming implants
Evaluate similarity of RLD and test in situ forming implant with established dissolution method.
Rudra Pangeni – Research Assistant Professor, Pharmaceutics, Virginia Commonwealth University; Qiangnan Zhang – Staff fellow, US Food and Drug Organization; Yan Wang – Director, US Food and Drug Organization; Bin Qin – Staff Fellow, US Food and Drug Organization; Matthew Halquist – Associate Professor, Pharmaceutics, Virginia Commonwealth University; Qingguo Xu – Associate Professor, Pharmaceutics, Virginia Commonwealth University
