This study aimed to validate the newly developed composite acceptability endpoint to investigate acceptability of oral pediatric drug formulations that integrates swallowability and palatability assessments.
In this open-label study acceptability of oral formulations was tested in three age groups (1–<6 months, 6–<12 years, and 12–<18 years) with a 2-way cross-over design in children aged 1–<6 months (syrup and mini-tablets), and with an incomplete block design of four sequences with three out of four formulations (syrup, mini-tablets, oblong tablet, and round tablet) each in children aged 6–<18 years. The primary endpoint was acceptability derived from the composite acceptability endpoint. Secondary endpoints were palatability and acceptability derived from swallowability.
A total of 320 children were stratified into three age groups (80 children aged 1–<6 months, 120 children aged 6–<12 years, and 120 children aged 12–<18 years). All participants completed the study. Age-specific differences were observed in acceptability derived from the composite acceptability endpoint. Mini-tablets had the highest acceptability in participants aged 1–<6 months and 6–<12 years while the oblong tablet was leading in adolescent participants (12–<18 years).
This study demonstrated that the composite acceptability endpoint method integrating both swallowability and palatability assessments is a sensitive method to assess acceptability of drug formulations in children of different age.