Physiological Dynamics in the Upper Gastrointestinal Tract and the Development of Gastrointestinal Absorption Models for the Immediate-Release Oral Dosage Forms in Healthy Adult Human.

gastrointestinal dynamics intra-individual variability machine learning oral absorption model within-subject variability

Journal

Pharmaceutical research
ISSN: 1573-904X
Titre abrégé: Pharm Res
Pays: United States
ID NLM: 8406521

Informations de publication

Date de publication:
03 Oct 2023
Historique:
received: 31 05 2023
accepted: 26 08 2023
medline: 3 10 2023
pubmed: 3 10 2023
entrez: 2 10 2023
Statut: aheadofprint

Résumé

This review is a revisit of various oral drug absorption models developed in the past decades, focusing on how to incorporate the physiological dynamics in the upper gastrointestinal (GI) tract. For immediate-release oral drugs, GI absorption is a critical input of drug exposure and subsequent human body response, yet difficult to model largely due to the complex GI environment. One of the biggest hurdles lies at capturing the high within-subject variability (WSV) of bioavailability measures, which can be mechanistically explained by the GI physiological dynamics. A thorough summary of how GI dynamics is handled in the absorption models would promote the development of mechanism-based oral drug absorption models, aid in the design of clinical studies regarding dosing regimens and bioequivalence studies based on WSV, and advance the decision-making on formulation selection.

Identifiants

DOI: 10.1007/s11095-023-03597-8 PMID: 37783928
pubmed: 37783928
doi: 10.1007/s11095-023-03597-8
pii: 10.1007/s11095-023-03597-8
doi:

Types de publication

Journal Article Review

Langues

eng

Sous-ensembles de citation

IM

Informations de copyright

© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.

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Auteurs

Kai Wang (K)

Department of Pharmaceutical Sciences, University of Michigan, Ann Arbor, MI, 48109, USA. kaiwangy@umich.edu.
ORCID: 0000-0002-4475-4459

Gordon L Amidon (GL)

Department of Pharmaceutical Sciences, University of Michigan, Ann Arbor, MI, 48109, USA.

David E Smith (DE)

Department of Pharmaceutical Sciences, University of Michigan, Ann Arbor, MI, 48109, USA.

Classifications MeSH