Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2025 Sep 15:682:125903.
doi: 10.1016/j.ijpharm.2025.125903. Epub 2025 Jun 25.

In vitro release method development for Onivyde® using Agilent NanoDis® system

Ji Li  1 , Vivian Juang  1 , Ziyi Lu  1 , Yan Wang  2 , Anna Schwendeman  3
Affiliations

In vitro release method development for Onivyde® using Agilent NanoDis® system

Ji Li et al. Int J Pharm. .

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.

Keywords: In vitro release; Irinotecan; Liposomes; NanoDis system; Onivyde®.

PubMed Disclaimer

Conflict of interest statement

Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

Similar articles

See all similar articles

References

    1. Zhang H, Onivyde for the therapy of multiple solid tumors. Onco Targets Ther, 2016. 9: p. 3001–7. - PMC - PubMed
    1. Milano G, Innocenti F, and Minami H, Liposomal irinotecan (Onivyde): Exemplifying the benefits of nanotherapeutic drugs. Cancer Sci, 2022. 113(7): p. 2224–2231. - PMC - PubMed
    1. Wang-Gillam A, et al. , Nanoliposomal irinotecan with fluorouracil and folinic acid in metastatic pancreatic cancer after previous gemcitabine-based therapy (NAPOLI-1): a global, randomised, open-label, phase 3 trial. Lancet, 2016. 387(10018): p. 545–557. - PubMed
    1. de Man FM, et al. , Individualization of Irinotecan Treatment: A Review of Pharmacokinetics, Pharmacodynamics, and Pharmacogenetics. Clin Pharmacokinet, 2018. 57(10): p. 1229–1254. - PMC - PubMed
    1. Cui J, et al. , Irinotecan hydrochloride liposome HR070803 in combination with 5-fluorouracil and leucovorin in locally advanced or metastatic pancreatic ductal adenocarcinoma following prior gemcitabine-based therapy (PAN-HEROIC-1): a phase 3 trial. Signal Transduct Target Ther, 2024. 9(1): p. 248. - PMC - PubMed

LinkOut - more resources