title: The prediction of the palatability of orally disintegrating tablets by an electronic gustatory system.
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.
authors.affiliation: Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan; Pharmaceutical Research and Technology Division, Central laboratories, Towa Pharmaceutical Co., Ltd., 26-7 Ichiban-cho, Kadoma, Osaka 571-0033, Japan.
authors.forename: Hideshi
authors.initials: H
authors.lastname: Nakamura
authors.affiliation: Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan.
authors.forename: Shinya
authors.initials: S
authors.lastname: Uchida
authors.affiliation: Pharmaceutical Research and Technology Division, Central laboratories, Towa Pharmaceutical Co., Ltd., 26-7 Ichiban-cho, Kadoma, Osaka 571-0033, Japan.
authors.forename: Takeshi
authors.initials: T
authors.lastname: Sugiura
authors.affiliation: Department of Pharmacy Practice and Science, School of Pharmaceutical Sciences, University of Shizuoka, 52-1 Yada, Suruga-ku, Shizuoka 422-8526, Japan. Electronic address: namiki@u-shizuoka-ken.ac.jp.
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Namiki
mesh_terms: D000284:Administration, Oral; D000328:Adult; D017311:Amlodipine / Q000008:administration & dosage*; D055615:Electrical Equipment and Supplies; D015738:Famotidine / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008297:Male; D013607:Tablets; D013649:Taste; D055697:Taste Perception; D055815:Young Adult
chemical_list: D013607:Tablets; D017311:Amlodipine; D015738:Famotidine
keywords: Amlodipine; Electronic gustatory system; Famotidine; Orally disintegrating tablet; Taste-masking; Visual analogue scale