Food effects in paediatric medicines development for products Co-administered with food

International Journal of Pharmaceutics
Hannah BatchelorDavid Storey

Abstract

A small amount of food is commonly used to aid administration of medicines to children to improve palatability and/or swallowability. However the impact of this co-administered food on the absorption and subsequent pharmacokinetic profile of the drug is unknown. Existing information on food effects is limited to standard protocols used to evaluate the impact of a high fat meal in an adult population using the adult medication. In the absence of a substantial body of data, there are no specific guidelines available during development of paediatric products relating to low volumes of potentially low calorie food. This paper brings together expertise to consider how the impact of co-administered food can be risk assessed during the development of a paediatric medicine. Two case studies were used to facilitate discussions and seek out commonalities in risk assessing paediatric products; these case studies used model drugs that differed in their solubility, a poorly soluble drug that demonstrated a positive food effect in adults and a highly soluble drug where a negative food effect was observed. For poorly soluble drugs risk assessments are centred upon understanding the impact of food on the in vivo solubility of the drug which re...Continue Reading

Citations

Jul 5, 2018·The Journal of Pharmacy and Pharmacology·Mariana GuimarãesNikoletta Fotaki
Jun 5, 2019·International Journal of Molecular Sciences·Fiona O'BrienCatherine Tuleu
Feb 29, 2020·European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences·Cordula StillhartAnette Müllertz
Apr 21, 2021·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·David Cheng Thiam TanArzu Selen

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