ArticleInternational journal of pharmaceutics2025
In vitro release method development for Onivyde® using Agilent NanoDis® system.
Article in International journal of pharmaceutics, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper 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
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
5 authors.
Funding
Abstract
Onivyde® (irinotecan liposomal injection) is a pivotal treatment for metastatic pancreatic cancer, designed for enhanced stability and improved tumor accumulation via the enhanced permeability and retention (EPR) effect. As generic versions emerge with patent expiration approaching, a reliable in vitro release test (IVRT) is critical to ensure product quality and bioequivalence. This study develops an optimized IVRT for Onivyde® using the Agilent NanoDis® system, which integrates tangential flow filtration and standard dissolution equipment. Key parameters, including filter material, molecular weight cut-offs (MWCOs), medium composition and pH, and paddle speed, were systematically evaluated to refine the method. The final method effectively identified variations in formulations subjected to stress conditions, assessed batch consistency, and differentiate different mixtures of liposomal irinotecan and free drug. This optimized IVRT can support quality control, regulatory approval, and bioequivalence assessment of generic Onivyde® formulations, ensuring consistent therapeutic performance.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.