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

Int J Pharm. 2013 Nov 30;457(1):327-32. doi: 10.1016/j.ijpharm.2013.07.053. Epub 2013 Jul 29.


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.

Keywords: Bioaccessibility; Drug handling; In vitro gastrointestinal model; Pediatric drug.

Publication types

  • Clinical Trial
  • Validation Study

MeSH terms

  • Acetaminophen / pharmacokinetics
  • Biological Availability
  • Child
  • Diclofenac / pharmacokinetics
  • Esomeprazole / pharmacokinetics
  • Gastrointestinal Tract / physiology*
  • Humans
  • Infant
  • Infant, Newborn
  • Models, Biological*


  • Diclofenac
  • Acetaminophen
  • Esomeprazole