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Int J Pharm. 2017 Mar 15;519(1-2):79-97. doi: 10.1016/j.ijpharm.2016.11.063. Epub 2016 Nov 30.

Exploring gastrointestinal variables affecting drug and formulation behavior: Methodologies, challenges and opportunities.

Author information

1
Drug Delivery & Disposition, KU Leuven, Leuven, Belgium; College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.
2
Nottingham Digestive Diseases Centre and NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals NHS Trust and the University of Nottingham, United Kingdom; Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.
3
Nottingham Digestive Diseases Centre and NIHR Biomedical Research Unit in Gastrointestinal and Liver Diseases at Nottingham University Hospitals NHS Trust and the University of Nottingham, United Kingdom.
4
Translational Research Center for Gastrointestinal Disorders (TARGID), KU Leuven, Leuven, Belgium.
5
Office of Generic Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, MD, USA.
6
College of Pharmacy, University of Michigan, Ann Arbor, MI, USA.
7
Drug Delivery, Disposition and Dynamics, Monash Institute of Pharmaceutical Sciences, Monash University, Parkville, Australia; Center of Drug Absorption and Transport, Department of Pharmaceutical Technology and Biopharmacy, University of Greifswald, Greifswald, Germany.
8
Center of Drug Absorption and Transport, Department of Pharmaceutical Technology and Biopharmacy, University of Greifswald, Greifswald, Germany.
9
Strathclyde Institute of Pharmacy and Biomedical Sciences, University of Strathclyde, Glasgow, United Kingdom.
10
Academic Medical Center Amsterdam, Department of Nuclear Medicine, Amsterdam, The Netherlands.
11
Drug Delivery & Disposition, KU Leuven, Leuven, Belgium.
12
Drug Delivery & Disposition, KU Leuven, Leuven, Belgium. Electronic address: patrick.augustijns@kuleuven.be.

Abstract

Various gastrointestinal (GI) factors affect drug and formulation behavior after oral administration, including GI transfer, motility, pH and GI fluid volume and composition. An in-depth understanding of these physiological and anatomical variables is critical for a continued progress in oral drug development. In this review, different methodologies (invasive versus non-invasive) to explore the impact of physiological variables on formulation behavior in the human GI tract are presented, revealing their strengths and limitations. The techniques mentioned allow for an improved understanding of the role of following GI variables: gastric emptying (magnetic resonance imaging (MRI), scintigraphy, acetaminophen absorption technique, ultrasonography, breath test, intraluminal sampling and telemetry), motility (MRI, small intestinal/colonic manometry and telemetry), GI volume changes (MRI and ultrasonography), temperature (telemetry) and intraluminal pH (intraluminal sampling and telemetry).

KEYWORDS:

Intestinal absorption; Intraluminal profiling; MRI; Manometry; Scintigraphy; Telemetry

PMID:
27915009
DOI:
10.1016/j.ijpharm.2016.11.063
[Indexed for MEDLINE]

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