On the Design of Food Effect Studies in Adults for Extrapolating Oral Drug Absorption Data to Infants

an Exploratory Study Highlighting the Importance of Infant Food

Marina Statelova, Konstantinos Goumas, Nikoletta Fotaki, René Holm, Mira Symillides, Christos Reppas, Maria Vertzoni

Research output: Contribution to journalArticle

Abstract

In the present investigation, it was explored whether food effect on drug absorption in adults is similar with the food effect after administration of an infant meal with the drug product to adults. After confirming lack of pharmaceutical and pharmacokinetic interaction, a paracetamol suspension and an ibuprofen suspension were co-administered to eight healthy adults on a crossover basis in three different occasions, i.e. in the fasted state (as defined by regulatory agencies, fasted conditions), in the fed state (as defined by regulatory agencies, fed conditions) and under conditions simulating the fed state in infants (infant fed conditions). Unlike under fed conditions, under infant fed conditions early exposure was significantly lower than under fasted conditions for both paracetamol and ibuprofen. Also, for ibuprofen, Cmax values under infant fed conditions were significantly higher than under fed conditions. These data suggest that, even for drugs with non-problematic absorption administered in simple dosage forms, food effects in infants may not be adequately evaluated if the protocol suggested by regulatory agencies is applied. The usefulness of the methodology employed in the present investigation for simulating the fed state in infants deserves further evaluation. Until then, food effects in infants should be considered cautiously or be evaluated in infants.

Original languageEnglish
Article number6
JournalAAPS Journal
Volume22
Issue number1
DOIs
Publication statusPublished - 1 Jan 2020

Keywords

  • food effect
  • ibuprofen
  • infant formula
  • infants
  • paracetamol

ASJC Scopus subject areas

  • Pharmaceutical Science

Cite this

On the Design of Food Effect Studies in Adults for Extrapolating Oral Drug Absorption Data to Infants : an Exploratory Study Highlighting the Importance of Infant Food. / Statelova, Marina; Goumas, Konstantinos; Fotaki, Nikoletta; Holm, René; Symillides, Mira; Reppas, Christos; Vertzoni, Maria.

In: AAPS Journal, Vol. 22, No. 1, 6, 01.01.2020.

Research output: Contribution to journalArticle

Statelova, Marina ; Goumas, Konstantinos ; Fotaki, Nikoletta ; Holm, René ; Symillides, Mira ; Reppas, Christos ; Vertzoni, Maria. / On the Design of Food Effect Studies in Adults for Extrapolating Oral Drug Absorption Data to Infants : an Exploratory Study Highlighting the Importance of Infant Food. In: AAPS Journal. 2020 ; Vol. 22, No. 1.
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