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Evaluating the Acceptability, Swallowability, and Palatability of Film-Coated Mini-Tablet Formulation in Young

Juliane Münch1, Isabelle Sessler1, Hans Martin Bosse1

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

Pharmaceutics
|June 28, 2023
PubMed

Insights

Film-coated mini-tablets are well-accepted and safe for children aged 1 month to 6 years. Both 2.0 mm and 2.5 mm sizes demonstrated high swallowability and palatability, proving suitable pediatric formulations.

Area of Science:

  • Pediatric Pharmacology
  • Pharmaceutical Technology
  • Drug Delivery Systems

Background:

  • Mini-tablets offer advantages over liquid formulations for pediatric drug delivery, addressing challenges in stability, taste masking, and accurate dosing.
  • Assessing the acceptability and safety of novel dosage forms in diverse pediatric age groups is crucial for effective treatment adherence.

Purpose of the Study:

  • To evaluate the acceptability and safety of drug-free, film-coated mini-tablets in children aged 1 month to 6 years.
  • To compare children's preference and swallowing ability between 2.0 mm and 2.5 mm diameter mini-tablets.
  • To assess palatability and overall acceptability using composite endpoints.

Main Methods:

  • An open-label, single-dose, cross-over study design was employed.
  • Participants were stratified into five age groups: 1-<6 months, 6-<12 months, 1-<2 years, 2-<4 years, and 4-6 years.
  • Acceptability was primarily measured by swallowability, with secondary measures including palatability and a composite score; safety was monitored throughout.

Main Results:

  • High acceptability rates based on swallowability (≥87%) were observed across all tablet sizes, quantities, and age groups.
  • Palatability was rated as "pleasant/neutral" by 96.6% of children.
  • Composite acceptability rates were high, reaching at least 77% for 2.0 mm and 86% for 2.5 mm mini-tablets; no adverse events were reported, though recruitment in the youngest group was paused due to choking incidents.

Conclusions:

  • Both 2.0 mm and 2.5 mm film-coated mini-tablets demonstrate excellent swallowability and palatability in pediatric populations.
  • These mini-tablet formulations are deemed suitable and safe for administration to young children, offering a viable alternative to liquid medications.
  • Further vigilance regarding choking incidents in infants under 6 months is warranted during formulation development and administration.

Keywords:
acceptabilitymini-tabletspalatabilitypediatric formulationsswallowability

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