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In vitro gastrointestinal model (TIM) with predictive power, even for infants and children?

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Author: Havenaar, R. · Anneveld, B. · Hanff, L.M. · Wildt, S.N. de · Koning, B.A.E. de · Mooij, M.G. · Lelieveld, J.P.A. · Minekus, M.
Type:article
Date:2013
Source:International Journal of Pharmaceutics, 1, 457, 327-332
Identifier: 484270
doi: doi:10.1016/j.ijpharm.2013.07.053
Keywords: Biology · Bioaccessibility · Drug handling · In vitro gastrointestinal model · Pediatric drug · Biomedical Innovation · Healthy Living · Life · PHS - Pharmacokinetics & Human Studies (tot 2013 daarna KFP) · EELS - Earth, Environmental and Life Sciences

Abstract

There is a need for information on the bioavailability in pediatric patients of drugs from manipulated dosage forms when applied in combination with food and/or co-medication under realistic daily practice circumstances. We describe the development, validation and application of a dynamic, computer-controlled in vitro system mimicking the conditions in the upper gastrointestinal tract of neonates, infants and toddlers: TIMpediatric. Paracetamol and diclofenac in age-related food matrices and with esomeprazole co-medication were tested. The experiments showed relevant results on the impact of drug manipulation and co-medication on the availability for absorption of active compounds. Without ethical constraints, alternative approaches for oral dosing and new pediatric formulations can be studied in TIMpediatric with a high predictive value. © 2013 Elsevier B.V.