Bioequivalence Study of Pegylated Doxorubicin Hydrochloride Liposome (PEGADRIA) and DOXIL® in Ovarian Cancer Patients: Physicochemical Characterization and Pre-clinical Studies

Abstract

Doxorubicin is an anthracycline antibiotic isolated from Streptomyces peucetius var. caesius and is one of the most widely used chemotherapeutic agents. It is known for its ability to bind DNA and inhibit nucleic acid synthesis [1]. Doxorubicin has been utilized against variety of tumors, leukemias, sarcomas, and breast cancer. However, the therapeutic use of doxorubicin is limited due to its dose-dependent cardiotoxicity leading to congestive heart failure and death in addition to common toxicities such as bone marrow suppression and alopecia as observed with other chemotherapeutic agents [2]. To circumvent the toxicities associated with free doxorubicin, various pegylated and non-pegylated liposomal formulation of doxorubicin such as Doxil®, and Myocet® were developed [3,4]. Doxil® is a formulation that encapsulates doxorubicin in an aqueous compartment of liposome.