Journal Article

Acceptability, Swallowability, Palatability, and Safety of Multiple Film-Coated Mini-Tablets in Children Aged ≥2–<7 Years: Results of an Open-Label Randomised Study

Klingmann, Viviane, Fishman, Vladislav, Bosse, Hans Martin, Münch, Juliane, Farhan, Madhi, Leng, Sining, Kloft, Carolin

2023

Overview

This single-centre, open-label, randomised, parallel-group study assessed the acceptability, swallowability, palatability, and safety of film-coated, 3 mm diameter mini-tablets in children aged ≥2–<7 years. In total, 300 participants were randomised (2:2:1:1) to receive a single oral administration of 16 (group A) or 32 (group B) mini-tablets with soft food or 16 (group C) or 32 (group D) mini-tablets with water. Children in each group were stratified by age group (2–<3 years; 3–<4 years; 4–<5 years; 5–<6 years; and 6–<7 years). Groups C and D were pooled for statistical analyses. The rates of acceptability (swallowed ≥80% of the mini-tablets with or without chewing), swallowability (swallowed all mini-tablets without chewing or any leftover), and palatability (positive/neutral responses) were ≥80.0%, ≥42.0%, and ≥82.0%, respectively, across the study groups. No marked differences were observed between groups or across age groups. No adverse events or issues of clinical relevance with deglutition were reported. Mini-tablets taken with soft food or water provide a suitable method for administering medicines to children aged ≥2–<7 years. This study was registered in the German Clinical Trial Register (No. DRKS00024617).

• Publisher: MDPI AG,MDPI
• Subject: acceptability / Age groups / Children & youth / Drug dosages / Food / formulation / Medicine / mini-tablet / paediatric / palatability / Pediatric pharmacology / Pediatrics / Safety and security measures / swallowability / Swallowing / Tablets (Medicine) / Testing