CHINESE JOURNAL OF MEDICINAL GUIDE >

2026 , Vol. 28 >Issue 1: 22 - 22-27

DOI: https://doi.org/10.1009-0959.2026.020010

Discussion on the Pharmaceutical Development of Generic Multivesicular Liposome

  • Xiaofei SI ,
  • Yan LIU ,
  • Junlin ZHANG ,
  • Xinzhu NA ,
  • Dianzhuo JIANG
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  • Center for Drug Evaluation， National Medical Products Administration， Beijing 100076， China

Received date: 2025-07-14

  Revised date: 2025-10-29

  Accepted date: 2026-02-06

  Online published: 2026-02-11

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Abstract

Newly-developed multivesicular liposome （MVL） have been used gradually for treatment of postsurgical pain in recent years. Different from other types of liposomes， MVL contain mutilple non-concentric aqueous chambers， which can encapsulate much more drugs and provide a sustained release profile. As complex injections， MVL usually feature high technical barriers and obvious clinical advantages. Overcoming the technical challenges of generic MVL development requires joint efforts from industry， academia， and regulatory authorities. Pharmaceutical research runs through the entire lifecycle of MVL， and the critical quality attributes （CQAs） related to characteristics should be identified and evaluated sufficiently. Based on literature investigation， this study discusses the pharmaceutical research of generic MVL. In principle ，the composition should qualitatively （Q1） and quantitatively （Q2） same as the RLD，and the sources of lipid excipients （natural or synthetic） shall be strictly controlled. If the double-emulsion method is adopted in the production process， critical process parameters（CPPs）can be defined based on the equipment conditions. In quality research and stability studies， focus shall be placed on the CQAs particular to liposome drug products. For some post-approval changes， a supplementary application shall be submitted to ensure the comprehensiveness of change comparison. In some cases， the impact of changes that can affect the performance of the drug cannot be determined solely through pharmaceutical research.The pharmaceutical considerations were put forward in terms of formulation， manufacturing process and quality control， in order to foster generic product development.


Key words： Multivesicular liposome； ; Generic drugs； ; Formulation and manufacturing process development； ; Quality control； ; Pharmaceutical research

Cite this article

Xiaofei SI , Yan LIU , Junlin ZHANG , Xinzhu NA , Dianzhuo JIANG .

Discussion on the Pharmaceutical Development of Generic Multivesicular Liposome

[J]. CHINESE JOURNAL OF MEDICINAL GUIDE, 2026 , 28(1) : 22 -22-27 . DOI: 10.1009-0959.2026.020010

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