Reverse engineering of Onivyde® - Irinotecan liposome injection.

ABSTRACT: Onivyde® is an intravenous irinotecan liposomal injection approved by the FDA for the treatment of gemcitabine-refractory metastatic adenocarcinoma of the pancreas in combination with fluorouracil and leucovorin. In the Onivyde® formulation, irinotecan is encapsulated in the inner compartment of the liposome using sucrose octasulfate as a trapping agent, and stabilized by a pegylated lipid membrane, resulting in prolonged circulation in the body. Due to its complex formulation design, there is limited information available regarding the critical quality attributes (CQAs) of Onivyde® and suitable methods for evaluating these attributes. In this study, we have developed a series of analytical methods to comprehensively characterize Onivyde®. These methods encompass particle size analysis, mo

SUBMITTER: Gan J 

PROVIDER: S-EPMC11791869 | biostudies-literature | 2025 Jan

REPOSITORIES: biostudies-literature