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A bio-predictive release assay for liposomal prednisolone phosphate

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Title: A bio-predictive release assay for liposomal prednisolone phosphate
Authors: Nagpal, S
Png, J
Kahouadji, L
Wacker, MG
Item Type: Journal Article
Abstract: Predictive performance assays are crucial for the development and approval of nanomedicines and their bioequivalent successors. At present, there are no established compendial methods that provide a reliable standard for comparing and selecting these formulation prototypes, and our understanding of the in vivo release remains still incomplete. Consequently, extensive animal studies, with enhanced analytical resolution for both, released and encapsulated drug, are necessary to assess bioequivalence. This significantly raises the cost and duration of nanomedicine development. This work presents the development of a discriminatory and biopredictive release test method for liposomal prednisolone phosphate. Using model-informed deconvolution, we identified an in vivo target release. The experimental design employed a discrete L-optimal configuration to refine the analytical method and determine the impact of in vitro parameters on the dosage form. A three-point specification evaluated the key phases of in vivo release: early (T-5%), intermediate (T-20%), and late release behavior (T-40%), compared to the in vivo release profile of the reference product, NanoCort®. Various levels of shear responses and the influence of clinically relevant release media compositions were tested. This enabled an assessment of the effect of shear on the release, an essential aspect of their in vivo deformation and release behavior. The type and concentration of proteins in the medium influence liposome release. Fetal bovine serum strongly impacted the discriminatory performance at intermediate shear conditions. The method provided deep insights into the release response of liposomes and offers an interesting workflow for in vitro bioequivalence evaluation.
Issue Date: Oct-2024
Date of Acceptance: 29-Jul-2024
URI: http://hdl.handle.net/10044/1/113871
DOI: 10.1016/j.jconrel.2024.07.069
ISSN: 0168-3659
Publisher: Elsevier
Start Page: 61
End Page: 75
Journal / Book Title: Journal of Controlled Release
Volume: 374
Copyright Statement: Copyright © 2024 Elsevier. This is the author’s accepted manuscript made available under a CC-BY licence in accordance with Imperial’s Research Publications Open Access policy (www.imperial.ac.uk/oa-policy)
Publication Status: Published
Online Publication Date: 2024-08-09
Appears in Collections:Chemical Engineering



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