THE IMPACT OF FOOD INTAKE ON THE LUMINAL ENVIRONMENT AND PERFORMANCE OF ORAL DRUG PRODUCTS WITH A VIEW TO IN VITRO AND IN SILICO SIMULATIONS: A PEARRL REVIEW
δείτε την πρωτότυπη σελίδα τεκμηρίου στον ιστότοπο του αποθετηρίου του φορέα για περισσότερες πληροφορίες και για να δείτε όλα τα ψηφιακά αρχεία του τεκμηρίου*
THE IMPACT OF FOOD INTAKE ON THE LUMINAL ENVIRONMENT AND PERFORMANCE OF ORAL DRUG PRODUCTS WITH A VIEW TO IN VITRO AND IN SILICO SIMULATIONS: A PEARRL REVIEW
Christina Pentafragka
Mira Symillides
Mark McAllister
Jennifer Dressman
Maria Vertzoni
Christos Reppas
Objective:
Using the type of meal and dosing conditions suggested by regulatory agencies as a basis, this review has two specific objectives. First, to summarize our understanding on the impact of food intake on luminal environment and drug product performance. Second, to summarize the usefulness and limitations of available in vitro and in silico methodologies for the evaluation of drug products performance after food intake.
Key findings:
Characterization of the luminal environment and studies evaluating product performance in the lumen, under conditions suggested by regulatory agencies for simulating the fed state, are limited. Various in vitro methodologies have been proposed for evaluating drug product performance in the fed state but systematic validation is lacking. Physiologically based pharmacokinetic (PBPK) modelling approaches require the use of in vitro biorelevant data and, to date, have been used primarily for investigating the mechanisms via which an already observed food effect is mediated.
Conclusion:
Better understanding of the impact of changes induced by the meal administration conditions suggested by regulatory agencies on the luminal fate of the drug product is needed. Relevant information will be useful for optimizing the in vitro test methods, and increasing the usefulness of PBPK modelling methodologies.
(EN)
*Η εύρυθμη και αδιάλειπτη λειτουργία των διαδικτυακών διευθύνσεων των συλλογών (ψηφιακό αρχείο, καρτέλα τεκμηρίου στο αποθετήριο) είναι αποκλειστική ευθύνη των αντίστοιχων Φορέων περιεχομένου.
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