Περίληψη:
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. © 2018 Elsevier B.V.
Συγγραφείς:
Butler, J.
Hens, B.
Vertzoni, M.
Brouwers, J.
Berben, P.
Dressman, J.
Andreas, C.J.
Schaefer, K.J.
Mann, J.
McAllister, M.
Jamei, M.
Kostewicz, E.
Kesisoglou, F.
Langguth, P.
Minekus, M.
Müllertz, A.
Schilderink, R.
Koziolek, M.
Jedamzik, P.
Weitschies, W.
Reppas, C.
Augustijns, P.
Λέξεις-κλειδιά:
drug; drug, Article; delayed release formulation; drug absorption; drug development; drug dosage form; drug formulation; drug release; drug solubility; gastrointestinal absorption; human; in vitro study; in vivo study; precipitation; biological model; chemistry; drug dosage form; drug effect; forecasting; gastrointestinal tract; intersectoral collaboration; metabolism; oral drug administration; pharmaceutics; physiology, Administration, Oral; Biopharmaceutics; Dosage Forms; Forecasting; Gastrointestinal Absorption; Gastrointestinal Tract; Humans; Intersectoral Collaboration; Models, Biological; Pharmaceutical Preparations
