Evaluation of palatability of 10 commercial amlodipine orally disintegrating tablets by gustatory sensation testing, OD-mate as a new disintegration apparatus and the artificial taste sensor.
OBJECTIVE
The purpose of this study was to evaluate and compare the palatability of 10 formulations (the original manufacturer's formulation and nine generics) of amlodipine orally disintegrating tablets (ODTs) by means of human gustatory sensation testing, disintegration/dissolution testing and the evaluation of bitterness intensity using a taste sensor.


METHODS
Initially, the palatability, dissolution and bitterness intensity of the ODTs were evaluated in gustatory sensation tests. Second, the disintegration times of the ODTs were measured using the OD-mate, a newly developed apparatus for measuring the disintegration of ODTs, and lastly, the bitterness intensities were evaluated using an artificial taste sensor.


RESULTS
Using factor analysis, the factors most affecting the palatability of amlodipine ODTs were found to be disintegration and taste. There was high correlation between the disintegration times of the 10 amlodipine ODTs estimated in human gustatory testing and those found using the OD-mate. The bitterness intensities of amlodipine ODTs 10, 20 and 30 s after starting the conventional brief dissolution test and the values determined by the taste sensor were highly correlated with the bitterness intensities determined in gustatory sensation testing.


CONCLUSIONS
The OD-mate and the taste sensor may be useful for predicting the disintegration and bitterness intensity of amlodipine ODTs in the mouth.
Department of Clinical Pharmaceutics, Faculty of Pharmaceutical Sciences, Mukogawa Women's University, Nishinomiya City, Japan. takahiro@mukogawa-u.ac.jp
Takahiro
T
Uchida
Miyako
M
Yoshida
Mai
M
Hazekawa
Tamami
T
Haraguchi
Hiroyuki
H
Furuno
Makoto
M
Teraoka
Hidekazu
H
Ikezaki
D000284:Administration, Oral; D000293:Adolescent; D000328:Adult; D017311:Amlodipine / Q000008:administration & dosage*; D002626:Chemistry, Pharmaceutical / Q000295:instrumentation / Q000379:methods; D016568:Drugs, Generic / Q000592:standards*; D005260:Female; D006801:Humans; D009055:Mouth; D017060:Patient Satisfaction; D013607:Tablets / Q000737:chemistry / Q000592:standards*; D013649:Taste; D055815:Young Adult
D016568:Drugs, Generic; D013607:Tablets; D017311:Amlodipine
amlodipine; bitterness; disintegration method for orally disintegrating tablet; gustatory sensation test; taste sensor