In vitro - in vivo relations for the parenteral liposomal formulation of Amphotericin B: A clinically relevant approach with PBPK modeling
نویسندگان
چکیده
In vitro release testing is a useful tool for the quality control of controlled parenteral formulations, but in test conditions that reflect or are able to predict vivo performance advantageous. Therefore, it important investigate factors could affect drug from formulations and relate them performance. this study effect media composition including albumin presence, type buffer hydrodynamics on were evaluated liposomal Amphotericin B formulation (Ambisome®). A physiologically based pharmacokinetic (PBPK) model was developed using plasma concentration profiles healthy subjects, order impact each variable tests prediction It found presence most factor Ambisome®; both setups, coupled with PBPK model, had comparable predictive ability simulating profiles. The extrapolated hypothetical hypoalbuminaemic population its activity against fungal cells simulated. Selected these AmB exposure, driven approach development benefit such formulations.
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ژورنال
عنوان ژورنال: European Journal of Pharmaceutics and Biopharmaceutics
سال: 2021
ISSN: ['0939-6411', '1873-3441']
DOI: https://doi.org/10.1016/j.ejpb.2020.03.001