ArticleInternational journal of pharmaceutics2024
Development and optimization of an in vitro release assay for evaluation of liposomal irinotecan formulation.
Article in International journal of pharmaceutics, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
4 citing papers in PubMed.
- Mechanistic PBPK/PD modeling of free and nano-liposomal irinotecan reveals formulation-specific determinants of disposition and efficacy.International journal of pharmaceutics · 2026Article
- In vitro release method development for Onivyde® using Agilent NanoDis® system.International journal of pharmaceutics · 2025Article
- Reverse engineering of Onivyde® - Irinotecan liposome injection.International journal of pharmaceutics · 2025Article
- Nanoarchitecting intelligently encapsulated designs for improved cancer therapy.Frontiers in bioengineering and biotechnology · 2025Review
Corrections and comments
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Authors and funding
5 authors.
Funding
Abstract
Onivyde®, a pegylated irinotecan liposomal formulation, is approved by the USFDA for treating metastatic pancreatic adenocarcinoma. Despite the substantial interest in developing its generic versions, the unique structural and manufacturing complexities of liposomal formulations pose challenges. In this study, we address this gap by developing a robust in vitro release test (IVRT) using dialysis membrane techniques. The release of Onivyde® is influenced by several key factors, including the composition of the release medium, temperature, initial formulation concentration, the materials and molecular weight cut-offs of dialysis bags, and the pH of the release medium. Our optimized IVRT for Onivyde® incorporates a release medium containing 5 mM ammonium bicarbonate in a HEPES solution with a pH of 7.4. Additionally, the method includes an initial formulation concentration of 4.6 µg/mL and 50 kDa dialysis bags, while maintaining a temperature of 37 °C with continuous agitation at 80 rpm. This optimized IVR assay effectively differentiates between varying qualities of irinotecan liposomal formulations. Our findings contribute to optimizing IVRT for liposomal irinotecan formulations, enabling better quality control procedures. This assay serves as a reliable tool for evaluating generic irinotecan liposomal formulations, aiding in their development and ensuring in vitro comparability.
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Registered trials
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