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

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-...

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Bibliographic Details
Published in:International journal of pharmaceutics 2013-11, Vol.457 (1), p.327-332
Main Authors: Havenaar, Robert, Anneveld, Bart, Hanff, Lidwien M., de Wildt, Saskia N., de Koning, Barbara A.E., Mooij, Miriam G., Lelieveld, Jan P.A., Minekus, Mans
Format: Article
Language:English
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Summary: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.
ISSN:0378-5173
1873-3476
DOI:10.1016/j.ijpharm.2013.07.053