title: In vivo methods for drug absorption - comparative physiologies, model selection, correlations with in vitro methods (IVIVC), and applications for formulation/API/excipient characterization including food effects.
abstract: This review summarizes the current knowledge on anatomy and physiology of the human gastrointestinal tract in comparison with that of common laboratory animals (dog, pig, rat and mouse) with emphasis on in vivo methods for testing and prediction of oral dosage form performance. A wide range of factors and methods are considered in addition, such as imaging methods, perfusion models, models for predicting segmental/regional absorption, in vitro in vivo correlations as well as models to investigate the effects of excipients and the role of food on drug absorption. One goal of the authors was to clearly identify the gaps in today's knowledge in order to stimulate further work on refining the existing in vivo models and demonstrate their usefulness in drug formulation and product performance testing.
authors.affiliation: Department of Pharmacy, Uppsala University, Uppsala, Sweden.
authors.forename: Erik
authors.initials: E
authors.lastname: Sjögren
authors.affiliation: AstraZeneca R&D, Mölndal, Sweden.
authors.forename: Bertil
authors.initials: B
authors.lastname: Abrahamsson
authors.affiliation: Drug Delivery and Disposition, KU Leuven, Leuven, Belgium.
authors.forename: Patrick
authors.initials: P
authors.lastname: Augustijns
authors.affiliation: Vivo Drug Delivery GmbH, Wollerau, Switzerland.
authors.forename: Dieter
authors.initials: D
authors.lastname: Becker
authors.affiliation: Simulations Plus Inc., Lancaster, CA, USA.
authors.forename: Michael B
authors.initials: MB
authors.lastname: Bolger
authors.affiliation: Janssen Research and Development, Beerse, Belgium.
authors.forename: Marcus
authors.initials: M
authors.lastname: Brewster
authors.affiliation: Drug Delivery and Disposition, KU Leuven, Leuven, Belgium.
authors.forename: Joachim
authors.initials: J
authors.lastname: Brouwers
authors.affiliation: AstraZeneca R&D, Macclesfield, UK.
authors.forename: Talia
authors.initials: T
authors.lastname: Flanagan
authors.affiliation: Simcyp Ltd., Sheffield, UK.
authors.forename: Matthew
authors.initials: M
authors.lastname: Harwood
authors.affiliation: Institute of Pharmacy and Biochemistry, Johannes Gutenberg University Mainz, Mainz, Germany.
authors.forename: Christian
authors.initials: C
authors.lastname: Heinen
authors.affiliation: H. Lundbeck A/S, Valby, Denmark.
authors.forename: René
authors.initials: R
authors.lastname: Holm
authors.affiliation: Sanofi-Aventis Deutschland GmbH, Frankfurt, Germany.
authors.forename: Hans-Paul
authors.initials: HP
authors.lastname: Juretschke
authors.affiliation: Institute of Pharmacy and Biochemistry, Johannes Gutenberg University Mainz, Mainz, Germany; National Institute for Public Health and the Environment (RIVM), Bilthoven, The Netherlands.
authors.forename: Marlies
authors.initials: M
authors.lastname: Kubbinga
authors.affiliation: Medical Products Agency, Uppsala, Sweden.
authors.forename: Anders
authors.initials: A
authors.lastname: Lindahl
authors.affiliation: Simulations Plus Inc., Lancaster, CA, USA.
authors.forename: Viera
authors.initials: V
authors.lastname: Lukacova
authors.affiliation: Bayer Pharma AG, Wuppertal, Germany.
authors.forename: Uwe
authors.initials: U
authors.lastname: Münster
authors.affiliation: Simcyp Ltd., Sheffield, UK.
authors.forename: Sibylle
authors.initials: S
authors.lastname: Neuhoff
authors.affiliation: Institute of Pharmacy and Biochemistry, Johannes Gutenberg University Mainz, Mainz, Germany.
authors.forename: Mai Anh
authors.initials: MA
authors.lastname: Nguyen
authors.affiliation: Janssen Research and Development, Beerse, Belgium.
authors.forename: Achiel van
authors.initials: Av
authors.lastname: Peer
authors.affiliation: Faculty of Pharmacy, National and Kapodistrian University of Athens, Athens, Greece.
authors.forename: Christos
authors.initials: C
authors.lastname: Reppas
authors.affiliation: University of Manchester, Manchester, UK.
authors.forename: Amin Rostami
authors.initials: AR
authors.lastname: Hodjegan
authors.affiliation: AstraZeneca R&D, Mölndal, Sweden.
authors.forename: Christer
authors.initials: C
authors.lastname: Tannergren
authors.affiliation: Center of Drug Absorption and Transport, University of Greifswald, Greifswald, Germany.
authors.forename: Werner
authors.initials: W
authors.lastname: Weitschies
authors.affiliation: University of Strathclyde, Glasgow, UK.
authors.forename: Clive
authors.initials: C
authors.lastname: Wilson
authors.affiliation: Sanofi US, Bridgewater, NJ, USA.
authors.forename: Patricia
authors.initials: P
authors.lastname: Zane
authors.affiliation: Department of Pharmacy, Uppsala University, Uppsala, Sweden.
authors.forename: Hans
authors.initials: H
authors.lastname: Lennernäs
authors.affiliation: Institute of Pharmacy and Biochemistry, Johannes Gutenberg University Mainz, Mainz, Germany. Electronic address: langguth@uni-mainz.de.
authors.forename: Peter
authors.initials: P
authors.lastname: Langguth
mesh_terms: D000284:Administration, Oral; D000818:Animals; D001702:Biopharmaceutics / Q000379:methods*; D002626:Chemistry, Pharmaceutical; D005079:Excipients / Q000737:chemistry*; D018565:Food-Drug Interactions; D005769:Gastrointestinal Motility; D041981:Gastrointestinal Tract / Q000378:metabolism*; D006801:Humans; D007408:Intestinal Absorption; D023421:Models, Animal; D008954:Models, Biological; D004364:Pharmaceutical Preparations / Q000008:administration & dosage / Q000737:chemistry / Q000378:metabolism*; D010599:Pharmacokinetics; D015203:Reproducibility of Results; D013045:Species Specificity
chemical_list: D005079:Excipients; D004364:Pharmaceutical Preparations
keywords: Bioavailability; Biopharmaceutic characterization; Drug product development; In vivo model selection