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Acceptability of an orodispersible film compared to syrup in neonates and infants: A randomized controlled trial

Viviane Klingmann1, Christoph Emanuel Pohly1, Thomas Meissner1

  • 1Department of General Pediatrics, Neonatology and Pediatric Cardiology, University Children's Hospital, Medical Faculty, Heinrich-Heine-University, Moorenstrasse 5, 40225 Düsseldorf, Germany.

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|April 30, 2020
PubMed

Insights

Pediatric orodispersible films (ODFs) are a safe and effective alternative to liquid medications for infants. Studies show ODFs are superior in acceptability, swallowability, and palatability compared to glucose syrup in children under one year.

Area of Science:

  • Pediatric pharmacotherapy
  • Drug delivery systems
  • Oral dosage forms

Background:

  • Pediatric pharmacotherapy requires age-appropriate drug administration.
  • Orodispersible films (ODFs) offer a promising solution for pediatric oral dosage forms.
  • Limited data exists on ODF acceptability, swallowability, and palatability in young children.

Purpose of the Study:

  • To assess the non-inferiority of drug-free ODFs compared to glucose syrup in infants under one year.
  • To evaluate the swallowability and palatability of ODFs versus glucose syrup in pediatric patients.

Main Methods:

  • Open-label, randomized, two-way cross-over study design.
  • 150 children aged 2 days to 12 months were divided into three age groups.
  • Comparison of ODFs with age-adapted amounts of glucose syrup, with assessments via video documentation and predefined criteria.

Main Results:

  • ODFs demonstrated non-inferior, and in fact superior, acceptability compared to glucose syrup (p < 0.0001).
  • ODFs showed significantly better swallowability than glucose syrup (p < 0.0001).
  • Palatability assessments favored the ODF formulation.

Conclusions:

  • ODFs are a promising and safe alternative to liquid formulations for pediatric use.
  • The study supports the use of ODFs even in the youngest pediatric age groups.
  • Orodispersible films meet key targets for pediatric drug administration, including acceptability and ease of use.
Abstract

Keywords:
AcceptabilityDrug administrationDrug dosage formsNeonates and infantsOrodispersible filmPediatric drug formulationsSwallowability

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