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Preparation, Administration, and Assessment of In Vivo Tissue-Specific Cellular Uptake of Fluorescent Dye-Labeled Liposomes

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Reverse engineering of Onivyde® - Irinotecan liposome injection.

Jingyao Gan¹, Vivian Juang¹, Kaikai Wang¹

¹Department of Pharmaceutical Sciences and the Biointerfaces Institute, University of Michigan, Ann Arbor, MI 48109, USA.

International Journal of Pharmaceutics

|November 28, 2024

Summary

This study developed analytical methods to characterize Onivyde®, a liposomal irinotecan injection. These methods assess critical quality attributes for this complex pancreatic cancer treatment.

Keywords:

Analytical methods Characterization Drug release Liposome Onivyde®Quantification

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Area of Science:

Pharmaceutical Sciences
Drug Delivery Systems
Oncology Therapeutics

Background:

Onivyde® (irinotecan liposome) is FDA-approved for metastatic pancreatic cancer.
Its complex liposomal formulation aids prolonged circulation but lacks detailed quality attribute data.
Understanding critical quality attributes (CQAs) is crucial for ensuring therapeutic efficacy and safety.

Purpose of the Study:

To develop and present a comprehensive suite of analytical methods for characterizing Onivyde®.
To establish a foundation for evaluating the critical quality attributes (CQAs) of this complex drug product.
To support the quality control and further development of irinotecan liposome formulations.

Main Methods:

Particle size analysis using dynamic light scattering.
Morphology and structure assessment via electron microscopy.
Physicochemical property evaluation, drug/lipid content determination, and in vitro drug release studies.

Main Results:

A comprehensive analytical methodology was successfully developed and applied.
Characterization included particle size, morphology, drug encapsulation, and release kinetics.
The developed methods provide a robust framework for Onivyde® quality assessment.

Conclusions:

The established analytical methods enable thorough characterization of Onivyde®.
These methods are essential for ensuring the consistent quality and performance of the liposomal irinotecan injection.
This work provides critical insights into the CQAs of Onivyde®, aiding future research and manufacturing.