酸味料の小児に対する嗜好型官能試験

Abstract

Palatability plays a significant role in treatment compliance, notably in children. Poor compliance increases the risk of therapeutic failure. The European Medicines Agency considers it desirable that the acceptability of oral medicines for pediatric patients is evaluated by target age group based on the Guideline on the pharmaceutical development of medicines for paediatric use. However, the palatability test of the pediatric population is concerned about the lack of versatility, robustness and repeatability. In this study, we evaluated the palatability of sour syrups as a corrigent in children aged 3 to 6 years old. The repeatability and acceptability were tested in 50 children using 6 test drugs (25％ or 50％ simple syrup solutions, dilute hydrochloric acid solution with 25％ or 50％ simple syrup and citric acid solutions with 25％ or 50％ simple syrup solutions). The repeatability was evaluated by the correlation of the palatability score in two tests on different days. The palatability assessment was based on a 5-point scale, according to a method in a previous study by Popper R et al. As a result of the repeatability test, the palatability scores of all 6 syrups revealed a correlation (correlation coefficient (r) > 0.75). In the 4 sour syrups, a greater preference was shown for dilute hydrochloric acid solutions with simple syrups than for the citric acid solution with simple syrups. These results suggest that the syrup containing citric acid might cause avoidance. Sour syrup including citric acid and syrup have the effect of suppressing bitterness, so an acceptability test of the mixture of the drug and sour syrup is required.