Application of a novel PhysioCell apparatus for biopredictive dissolution tests of oral immediate release formulations – A case study workflow for in vitro-in vivo predictions

Michał Romański,Marcela Staniszewska,Jadwiga Paszkowska,Justyna Dobosz,Svitlana Romanova,Jarosław Pieczuro,Michał Kątny,Dagmara Roznerska, Janusz Szczepański,Michał Schraube,Monika Renn-Hojan,Ewa Puk,Oksana Hrem,Grzegorz Garbacz,Dorota Danielak

International Journal of Pharmaceutics（2023）

引用 3|浏览4

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摘要

•First application of PhysioCell in the model-informed generic product’s development.•Simulated gastric pressure waves differently impacted the tested formulations.•Tablet disintegration found as a drug dissolution rate-limiting factor.•Stress-related disintegration enhancement involved in the mechanistic modeling.•In vitro-in vivo predictions agreed with the reported drug concentrations in plasma.

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关键词

Administration,Oral,Pharmacokinetics,In vitro techniques,Models,Biological,Chemistry,Pharmaceutical/methods,Drug liberation

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