%0 Clinical Trial
%T In vitro gastrointestinal model (TIM) with predictive power, even for infants and children?
%A Havenaar R
%A Anneveld B
%A Hanff LM
%A de Wildt SN
%A de Koning BA
%A Mooij MG
%A Lelieveld JP
%A Minekus M
%J Int J Pharm
%V 457
%N 1
%D Nov 2013 30
%M 23906665
%F 6.51
%R 10.1016/j.ijpharm.2013.07.053
%X 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.