Biopharmaceutical considerations in paediatrics with a view to the evaluation of orally administered drug products – a PEARRL review.

Mariana Guimarães, Marina Statelova, René Holm, Christos Reppas, Moira Symilllides, Maria Vertzoni, Nikoletta Fotaki

Research output: Contribution to journalReview articlepeer-review

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Objectives: In this review, the current biopharmaceutical approaches for evaluation of oral formulation performance in paediatrics are discussed. Key findings: The paediatric gastrointestinal (GI) tract undergoes numerous morphological and physiological changes throughout its development and growth. Some physiological parameters are yet to be investigated, limiting the use of the existing in vitro biopharmaceutical tools to predict the in vivo performance of paediatric formulations. Meals and frequencies of their administration evolve during childhood and affect oral drug absorption. Furthermore, the establishment of a paediatric Biopharmaceutics Classification System (pBCS), based on the adult Biopharmaceutics Classification System (BCS), requires criteria adjustments. The usefulness of computational simulation and modeling for extrapolation of adult data to paediatrics has been confirmed as a tool for predicting drug formulation performance. Despite the great number of successful physiologically based pharmacokinetic models to simulate drug disposition, the simulation of drug absorption from the GI tract is a complicating issue in paediatric populations. Summary: The biopharmaceutics tools for investigation of oral drug absorption in paediatrics need further development, refinement and validation. A combination of in vitro and in silico methods could compensate for the uncertainties accompanying each method on its own.
Original languageEnglish
Pages (from-to)603-642
Number of pages40
JournalJournal of Pharmacy and Pharmacology
Issue number4
Early online date3 Jul 2018
Publication statusPublished - 30 Apr 2019


  • biopharmaceutics
  • food effect
  • oral absorption
  • paediatric
  • physiology

ASJC Scopus subject areas

  • Pharmacology
  • Pharmaceutical Science


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