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Published on: August 9, 2022
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Analytical method development and comparability study for AmBisome® and generic Amphotericin B liposomal products
Yayuan Liu1, Zihan Mei1, Ling Mei1
1Department of Pharmaceutical Sciences, College of Pharmacy, University of Michigan, NCRC, 2800 Plymouth Road, Ann Arbor, MI 48109, United States.
Summary
Analytical methods were developed to characterize liposomal Amphotericin B (AmBisome®) and its generics. The study found that Indian generic products Phosome® and Amphonex® were similar to AmBisome®, unlike less stable controls.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Analytical Chemistry
Background:
- Liposomal Amphotericin B (AmBisome®) is a critical antifungal agent with a complex structure ensuring low toxicity and high stability.
- Replication of AmBisome®'s precise structure is challenging, with failed attempts leading to increased toxicity and faster drug release.
- The pharmaceutical industry shows significant interest in developing generic AmBisome® formulations.
Purpose of the Study:
- To establish and apply analytical methodologies for characterizing liposomal Amphotericin B (AmpB) products.
- To compare the quality attributes and performance of AmBisome® with Indian generic products (Phosome®, Amphonex®) and control formulations.
- To provide valuable tools for the development and quality control of generic liposomal AmpB drugs.
Main Methods:
- Quantification of liposomal AmpB components and characterization of thermal properties.
- Determination of particle size distribution, AmpB aggregation state, and drug release kinetics.
- In vitro assessment of hemolytic potential and antifungal activity.
Main Results:
- Phosome® and Amphonex® demonstrated comparable characteristics to AmBisome®.
- Fungizone® (micellar formulation) and "leaky" liposomes showed significant differences in thermal properties and AmpB aggregation.
- Control formulations exhibited faster drug release and higher toxicity compared to AmBisome® and its generics.
Conclusions:
- The developed analytical methodologies are effective for characterizing liposomal AmpB products.
- Indian generic liposomal AmpB products (Phosome®, Amphonex®) appear to closely mimic AmBisome®.
- These methods are crucial for ensuring the quality and safety of generic liposomal Amphotericin B formulations.
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