Development and optimization of an in vitro release assay for evaluation of liposomal irinotecan formulation.

ABSTRACT: Onivyde®, a pegylated irinotecan liposomal formulation, is approved by the USFDA for treating metastatic pancreatic adenocarcinoma. Despite the substantial interest in developing its generic versions, the unique structural and manufacturing complexities of liposomal formulations pose challenges. In this study, we address this gap by developing a robust in vitro release test (IVRT) using dialysis membrane techniques. The release of Onivyde® is influenced by several key factors, including the composition of the release medium, temperature, initial formulation concentration, the materials and molecular weight cut-offs of dialysis bags, and the pH of the release medium. Our optimized IVRT for Onivyde® incorporates a release medium containing 5 mM ammonium bicarbonate in a HEPES solution with a

SUBMITTER: Juang V 

PROVIDER: S-EPMC11611377 | biostudies-literature | 2024 Dec

REPOSITORIES: biostudies-literature