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

Abstract

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–&lt;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–&lt;3 years; 3–&lt;4 years; 4–&lt;5 years; 5–&lt;6 years; and 6–&lt;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–&lt;7 years. This study was registered in the German Clinical Trial Register (No. DRKS00024617).

Questionnaire Study to Investigate the Preferences of Children, Parents, and Healthcare Professionals for Different Formulations of Oral Medicinal Products

“…This preference was consistent among all stakeholders, despite some differences in formulation preferences of different stakeholders for the four age groups of pediatric patients. This very important result is in line with several other investigations and studies [ 8 , 9 , 10 , 11 , 12 , 14 , 15 , 16 , 17 , 18 , 23 ] and contrasts with the current practice of administering medicines to children aged 0–<6 y as a liquid formulation. As syrups or other liquid formulations might contain excipients with potential toxicological risks [ 35 ], a switch to alternative dosage forms could not only increase the acceptability but also improve the risk profile.…”

“…A number of studies have been performed investigating the acceptability of various formulations by more or less objective, validated-methodology-based investigations of swallowability and/or palatability in small children [ 7 , 8 , 9 , 10 , 11 , 12 , 13 , 14 , 15 , 16 , 17 , 18 ]. Interestingly, the current practice of liquid or syrup administration in children is considered to be unreliable, with significant under- or over-dosing [ 19 ].…”