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03-02-2025 | Commentary

Solubility-Limited Absorption Identified by a Simplified PBPK Model for the Prediction of Positive Food Effect for BCS II/IV Drugs

Authors: Karine Rodriguez-Fernandez, José David Gómez-Mantilla, Suneet Shukla, Victor Mangas-Sanjuán, Sheila Annie Peters

Published in: Clinical Pharmacokinetics

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Excerpt

Multiple factors in the gut can influence absorption of orally administered drugs. These include gastric emptying, transit in the small intestine, dissolution, solubilization by bile salts, absorption, gut metabolism, and transporter-mediated efflux [1]. Dissolution is also influenced by solubility, drug formulation, and gastric pH, while absorption depends on drug permeability and splanchnic blood flow [2]. Food can influence each of these processes, leading to a positive or negative food effect (FE) through changes in plasma concentration of drugs, thereby impacting the onset and duration of the therapeutic effect [35]. The net impact of food on the absorption of drugs depends on the physiological mechanisms it influences and the solubility/permeability of drugs, according to the biopharmaceutical classification system (BCS) classes of compounds [6] (Fig. 1).
Literature
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go back to reference Peters SA. Chapter 12 applications of hypothesis generation and testing with PBPK models. In: Physiologically based pharmacokinetic (PBPK) modeling and simulations: principles, methods, and applications in the pharmaceutical industry. John Wiley and Sons, Inc. 2022. pp. 337–52. Peters SA. Chapter 12 applications of hypothesis generation and testing with PBPK models. In: Physiologically based pharmacokinetic (PBPK) modeling and simulations: principles, methods, and applications in the pharmaceutical industry. John Wiley and Sons, Inc. 2022. pp. 337–52.
23.
go back to reference Peters SA. Chapter 17 Absorption-related applications of PBPK modeling. In: Physiologically based pharmacokinetic (PBPK) modeling and simulations: principles, methods, and applications in the pharmaceutical industry. John Wiley & Sons, Inc. 2022. pp. 430–56. Peters SA. Chapter 17 Absorption-related applications of PBPK modeling. In: Physiologically based pharmacokinetic (PBPK) modeling and simulations: principles, methods, and applications in the pharmaceutical industry. John Wiley & Sons, Inc. 2022. pp. 430–56.
Metadata
Title
Solubility-Limited Absorption Identified by a Simplified PBPK Model for the Prediction of Positive Food Effect for BCS II/IV Drugs
Authors
Karine Rodriguez-Fernandez
José David Gómez-Mantilla
Suneet Shukla
Victor Mangas-Sanjuán
Sheila Annie Peters
Publication date
03-02-2025
Publisher
Springer International Publishing
Published in
Clinical Pharmacokinetics
Print ISSN: 0312-5963
Electronic ISSN: 1179-1926
DOI
https://doi.org/10.1007/s40262-025-01472-w