Purpose

The concept of in vitro-in vivo correlations (IVIVCs) for long-acting injectable (LAI) microsphere formulations has gained more significance in the past decade. However, this problem is challenging due to the multiphase release characteristics of compositionally equivalent formulations, the lack of a mechanistic deconvolution method, and the lack of compendial in vitro release testing methods. This study aims to (1) determine whether an IVIVC can be established for long-acting injectable microsphere formulations with different release profiles; (2) assess the role of mechanistic deconvolutions in determining the in vivo release profiles; and (3) explore the potential for using a triphasic Weibull function on improving results of the deconvolution process.

2017 AAPS Annual Meeting and Exposition, November 12-15, 2017, San Diego, CA

By Azar Shahraz, Jim Mullin, Jessica Spires, Viera Lukacova, Michael B Bolger, Walt S Woltosz