The Generic Strategy of PEGylated Liposomal Doxorubicin / 中国药学杂志

ABSTRACT

OBJECTIVE: To illustrate the generic strategy of doxorubicin liposome®. METHODS: Referencing literatures,the development and technical characteristics of Doxil® were reviewed. FDA guidance of the liposome was referred, and combined with experience in research and development, the generic strategy of Doxil® was summarized. RESULTS AND CONCLUSION: Generic strategy of liposomes need to analyze the final formulation, process formulation and preparation of Reference list drug (RLD). Using QbD principle to determine the appropriate formulation process conditions. Reasonable quality control and key attributes were determined according to product characteristics, appropriate evaluation methods and standards were established, and overall quality comparison was made between generic drug and RLD. Studies on bioequivalence of liposome drugs in vivo need to compare the pharmacokinetic behavior of free drugs and encapsulated drugs and even metabolite at the same time.