Formulation Design that Contributes to the Development of Pediatric-friendly Drugs

Age-appropriate pediatric formulations are needed to achieve optimal medication adherence in children. In Europe and the United States, mini-tablets (MTs) have garnered interest as a new pediatric formulation that is easier to swallow than liquid formulations (LFs). In Japan, fine granules (FGs) are also common for children. Acceptability of a medicine is likely to have significant impact on pediatric adherence. We examined the acceptability of drug-free MTs and compared it with that of FGs and LFs in children aged 6 months to 8 years who were visiting a pediatric department in Showa University Hospital. The primary endpoint was the measure of acceptability by observation of healthcare professionals according to pre-defined evaluation criteria. We compared the percentage of children who could swallow MTs without chewing with that of children who could swallow FGs or LFs without leftover. MTs showed lower swallowability compared to FGs and LFs in children aged 2-6 years, likely because children tend to chew on MTs. In contrast, significantly more children aged 6-11 months could swallow the MTs than those who could swallow all the FGs and LFs. No significant differences were observed in children aged 12-23 months. Palatability and swallowability are important for acceptability. Parents of children aged 6-23 months rated palatability after taking the three formulations. We combined the swallowability and palatability results into a new acceptability analysis. MTs did not differ significantly from FGs and LFs in acceptability for infants, but this new endpoint is useful for evaluating oral pediatric formulations.