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  • Title: The prediction of the palatability of orally disintegrating tablets by an electronic gustatory system.
    Author: Nakamura H, Uchida S, Sugiura T, Namiki N.
    Journal: Int J Pharm; 2015 Sep 30; 493(1-2):305-12. PubMed ID: 26216412.
    Abstract:
    In this study, the human gustatory palatability sensation of taste-masked famotidine and amlodipine orally disintegrating tablets (ODTs) was quantitatively predicted by an electronic gustatory system (α-Astree e-Tongue). Furthermore, its use in formulation design was evaluated. The famotidine- and amlodipine-containing ODTs, which were bitter- and highly bitter-tasting, respectively, were prepared using a physical (granules spray-coated with ethyl cellulose) or organoleptic (the addition of a sweetener and a flavor) masking method and combinations thereof. The taste-masking effects of different masking methods on the ODTs were investigated in a human gustatory sensation test. In the test, volunteers scored the overall palatability using a 100mm visual analog scale (VAS). The electronic gustatory system was evaluated using the Euclidean distance (the distance between each drug-containing ODT and its corresponding placebo) and partial least squares (PLS) regression analysis of the sensor response values. A good linear relationship was observed between each ODT's Euclidean distance analysis, PLS regression analysis, and clinical VAS scores. Cross-validation verification of each analysis confirmed the model's predictive power. This study suggests that the α-Astree can quantitatively evaluate physical and organoleptic taste masking and that the palatability of unknown formulations can be predicted by Euclidean distance and PLS regression data analysis.
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