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Background <p>Food intake can substantially alter the pharmacokinetics of orally administered drugs by changing gastrointestinal (GI) pH, motility, gastric emptying, bile secretion, luminal composition, drug solubility, and intestinal absorption. These interactions make the food effect an important determinant of systemic exposure, therapeutic response, and dosing recommendations, yet the mechanisms responsible for fed-fasted differences are often incompletely understood.</p> Areas covered <p>This structured mechanistic narrative review synthesizes the physiological, physicochemical, metabolic, transporter-mediated, and formulation-related determinants of food effects. Of 1,237 records identified, 241 articles underwent full-text assessment and 74 studies were included in the final mechanistic synthesis. The review evaluates how gastric pH and emptying, bile-mediated micellization, intestinal transporters, drug properties (including pKa, solubility, and logD), meal composition, and formulation design determine the direction and magnitude of food and beverage effects within the Biopharmaceutics Classification System framework.</p> Expert opinion <p>Mechanistic understanding of food-drug interactions supports rational formulation design, more reliable dosing instructions, and improved clinical decision-making. Controlled-release systems, amorphous solid dispersions, nanoparticles, and lipid-based formulations can reduce fed-fasted variability, although their performance must be confirmed under dynamic gastrointestinal conditions. Future research should integrate biorelevant dissolution, precipitation and lymphatic-uptake models, physiologically based pharmacokinetic simulations, and artificial intelligence to predict food effects earlier and more reliably during drug development.</p>

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From meal to medicine: exploring the roots and consequences of drug-food effects

  • 期刊论文

  • 发表日期：

    2026年8月5日

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  • Raimar Löbenberg,
  • James Kabalan,
  • Ben Macfarlane,
  • Selwan Djebbouri,
  • Sophia Daunoras,
  • Tariq Mougarbel,
  • Merva Qeshanna,
  • Patrick Pham,
  • Neal M. Davies,
  • Nadia Bou-Chacra,
  • Kylie Williams,
  • Gabriele De Rubis,
  • Kamal Dua

摘要

Background

Food intake can substantially alter the pharmacokinetics of orally administered drugs by changing gastrointestinal (GI) pH, motility, gastric emptying, bile secretion, luminal composition, drug solubility, and intestinal absorption. These interactions make the food effect an important determinant of systemic exposure, therapeutic response, and dosing recommendations, yet the mechanisms responsible for fed-fasted differences are often incompletely understood.

Areas covered

This structured mechanistic narrative review synthesizes the physiological, physicochemical, metabolic, transporter-mediated, and formulation-related determinants of food effects. Of 1,237 records identified, 241 articles underwent full-text assessment and 74 studies were included in the final mechanistic synthesis. The review evaluates how gastric pH and emptying, bile-mediated micellization, intestinal transporters, drug properties (including pKa, solubility, and logD), meal composition, and formulation design determine the direction and magnitude of food and beverage effects within the Biopharmaceutics Classification System framework.

Expert opinion

Mechanistic understanding of food-drug interactions supports rational formulation design, more reliable dosing instructions, and improved clinical decision-making. Controlled-release systems, amorphous solid dispersions, nanoparticles, and lipid-based formulations can reduce fed-fasted variability, although their performance must be confirmed under dynamic gastrointestinal conditions. Future research should integrate biorelevant dissolution, precipitation and lymphatic-uptake models, physiologically based pharmacokinetic simulations, and artificial intelligence to predict food effects earlier and more reliably during drug development.