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Eur J Pharm Biopharm. 2019 Mar;136:70-83. doi: 10.1016/j.ejpb.2018.12.010. Epub 2018 Dec 20.

In vitro models for the prediction of in vivo performance of oral dosage forms: Recent progress from partnership through the IMI OrBiTo collaboration.

Author information

1
GlaxoSmithKline Research and Development, Park Road, Ware SG12 0DP United Kingdom.
2
Drug Delivery and Disposition, KU Leuven, Herestraat 49, Gasthuisberg, O&N2, Box 921, 3000 Leuven, Belgium.
3
Department of Pharmacy, National and Kapodistrian University of Athens, Panepistimiopolis, 157 84 Athens, Greece.
4
Institute of Pharmaceutical Technology, Goethe University, Frankfurt/Main, Germany.
5
Boehringer-Ingelheim Pharma Gmbh & Co KG, Pharmaceutical Development, Germany.
6
Pharmaceutical Technology & Development, AstraZeneca, Macclesfield, United Kingdom.
7
Drug Product Design, Pfizer PGRD, Sandwich, Kent CT13 9NJ, United Kingdom.
8
Certara UK Ltd, Simcyp Division, Sheffield, United Kingdom.
9
Biopharmaceutics and Specialty Dosage Forms, Pharmaceutical Sciences, Merck & Co. Inc., WP75B-210, 770 Sumneytown Pike, West Point, PA 19486-0004, USA.
10
Department of Pharmaceutical Technology and Biopharmaceutics, Johannes Gutenberg University Mainz, Staudinger Weg 5, Mainz D-55099, Germany.
11
TNO and Triskelion B.V., P.O. Box 844, 3700 AV Zeist, the Netherlands.
12
Pharmaceutical Design and Drug Delivery, University of Copenhagen, Denmark.
13
Biopharmaceutics and Pharmaceutical Technology, University of Greifswald, Felix-Hausdorff-Str. 3, D-17489 Greifswald, Germany.
14
Drug Delivery and Disposition, KU Leuven, Herestraat 49, Gasthuisberg, O&N2, Box 921, 3000 Leuven, Belgium. Electronic address: patrick.augustijns@kuleuven.be.

Abstract

The availability of in vitro tools that are constructed on the basis of a detailed knowledge of key aspects of gastrointestinal (GI) physiology and their impact on formulation performance and subsequent drug release behaviour is fundamental to the success and efficiency of oral drug product development. Over the last six years, the development and optimization of improved, biorelevant in vitro tools has been a cornerstone of the IMI OrBiTo (Oral Biopharmaceutics Tools) project. By bringing together key industry and academic partners, and by linking tool development and optimization to human studies to understand behaviour at the formulation/GI tract interface, the collaboration has enabled innovation, optimization and implementation of the requisite biorelevant in vitro tools. In this paper, we present an overview of the in vitro tools investigated during the collaboration and offer a perspective on their future use in enhancing the development of new oral drug products.

PMID:
30579851
DOI:
10.1016/j.ejpb.2018.12.010
[Indexed for MEDLINE]
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