Preparation and Characterization of Liposomal Doxorubicin for Human Use

A liposome-associated doxorubicin formulation that has been utilized in two phase I clinical trials at two separate medical centers is described. This work deals with formulation optimization, process development, quality control assays on raw materials, characterization assays for these liposomes, and their short-term stability. One of the main goals of this work is to provide a model for the production of liposomal formulations of sufficient quantity and quality to be used in clinical trials.