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Acceptability of small-sized oblong tablets in comparison to syrup and mini-tablets in infants and toddlers: A

Juliane Münch1, Thomas Meissner1, Ertan Mayatepek1

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

European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Fur Pharmazeutische Verfahrenstechnik E.V
|June 21, 2021
PubMed

Insights

Oblong tablets demonstrate comparable acceptability to syrup in children aged 1-5 years. These tablets also show superior swallowability and better palatability, making them a safe alternative to liquid medications.

Area of Science:

  • Pediatric Pharmacology
  • Drug Formulation Science
  • Clinical Pharmacy

Background:

  • Pediatric medication administration faces challenges with patient acceptability and adherence.
  • Novel drug formulations are crucial for improving therapeutic outcomes in children.
  • Mini-tablets have shown promise, but higher-dose requirements necessitate alternative options like oblong tablets.

Purpose of the Study:

  • To assess the non-inferiority of oblong tablet acceptability compared to glucose syrup in children aged 1-5 years.
  • To evaluate the acceptability, swallowability, and palatability of oblong tablets, mini-tablets, and glucose syrup in pediatric patients.
  • To establish oblong tablets as a viable alternative for pediatric drug delivery.

Main Methods:

  • An open-label, randomized, two-way cross-over study involving 280 children aged 1-5 years.
  • Children were stratified into age groups and randomized to receive either an oblong tablet, glucose syrup, or mini-tablets.
  • Acceptability, swallowability, and palatability were assessed using pre-defined criteria and video documentation.

Main Results:

  • Non-inferiority in acceptability of oblong tablets versus syrup was demonstrated (84.4% vs. 80.1%).
  • Oblong tablets showed superior swallowability compared to syrup (74.5% vs. 53.2%).
  • Fewer children experienced unpleasant reactions with oblong tablets (<10%) compared to syrup (up to 40%).

Conclusions:

  • Oblong tablets are a safe and promising alternative to liquid formulations for pediatric medication.
  • The study supports the use of oblong tablets for improved drug administration in children.
  • Oblong tablets offer advantages in swallowability and palatability over traditional syrup formulations.
Abstract

Keywords:
AcceptabilityDrug administrationDrug dosage formsInfantsOblong tabletPalatabilityPediatric drug formulationsSwallowabilityToddlers

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