Development of In Vitro Release Testing Methods for Long-Acting Oily Depot Formulations

Bo Wan – Senior Scientist, Sanofi; Krutika Harish Jain – Senior Scientist, Gilead; Quanying Bao – Principal Scientist, Alexion Pharmaceuticals; Tzuchi Rob Ju – Director, AbbVie

Introduction: Oily depot formulations for long-acting injectables (LAIs) are gaining interest due to manufacturing efficiency and the growing number of lipophilic drugs. However, standardized in vitro release testing (IVRT) methods for oily LAIs remain poorly established, with no official compendial method available. This is mainly due to partition and diffusion controlled release and high sensitivity to interfacial area and hydrodynamic conditions. The current research aims to develop a biorelevant platform IVRT method for oily LAIs using compendial dissolution apparatus with different adapter designs.