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
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
复制标题
通过味觉测试、新型崩解装置 OD-mate 和人工味觉传感器评价 10 种市售氨氯地平口腔崩解片的适口性
DOI：
10.1111/jphp.12101
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发表时间：
2013
影响因子：
3.3
通讯作者：
Hidekazu Ikezaki
中科院分区：
文献类型：
--
作者：
Takahiro Uchida;Miyako Yoshida;Mai Hazekawa;Tamami Haraguchi;Hiroyuki Furuno;Makoto Teraoka;Hidekazu Ikezaki
目的：通过人体味觉试验、崩解/溶出度试验以及味觉传感器苦味强度评价方法，评价和比较氨氯地平口腔崩解片（ODT）10种制剂（原厂制剂和9种仿制药）的适口性。方法首先通过味觉试验评价ODTs的适口性、溶出度和苦味强度。其次，使用 OD-mate（一种新开发的用于测量 ODT 崩解的仪器）测量 ODT 的崩解时间，最后，使用人工味觉传感器评估苦味强度。 主要发现通过因素分析，发现最影响氨氯地平 ODT 适口性的因素是崩解和味道。人类味觉测试中估计的 10 种氨氯地平 ODT 的崩解时间与使用 OD-mate 发现的崩解时间之间存在高度相关性。氨氯地平 ODT 在开始常规短暂溶出试验后 10、20 和 30 s 的苦味强度以及味觉传感器测定的苦味强度与味觉测试中测定的苦味强度高度相关。结论 OD-mate 和味觉传感器可用于预测氨氯地平 ODT 在口中的崩解和苦味强度。
ObjectivesThe 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.MethodsInitially, 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.Key findingsUsing 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.ConclusionsThe OD-mate and the taste sensor may be useful for predicting the disintegration and bitterness intensity of amlodipine ODTs in the mouth.