Department of Clinical Pharmaceutics, Faculty of Pharmaceutical Sciences, Mukogawa Women's University, Nishinomiya City, Japan.
J Pharm Pharmacol. 2013 Sep;65(9):1312-20. doi: 10.1111/jphp.12101. Epub 2013 Jul 10.
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.
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.
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.
The OD-mate and the taste sensor may be useful for predicting the disintegration and bitterness intensity of amlodipine ODTs in the mouth.
本研究旨在通过人体味觉测试、崩解/溶解测试以及使用味觉传感器评估苦味强度，评估和比较 10 种（原制造商配方和 9 种仿制药）氨氯地平口崩片（ODT）的口感。
首先，在味觉测试中评估 ODT 的口感、溶解和苦味强度。其次，使用新开发的 OD-mate 测量 ODT 的崩解时间，该仪器用于测量 ODT 的崩解。最后，使用人工味觉传感器评估苦味强度。
通过因子分析，发现影响氨氯地平 ODT 口感的主要因素是崩解和口感。在人体味觉测试中估计的 10 种氨氯地平 ODT 的崩解时间与 OD-mate 中发现的崩解时间高度相关。开始常规快速溶解试验后 10、20 和 30 秒的氨氯地平 ODT 的苦味强度以及味觉传感器确定的值与味觉测试中确定的苦味强度高度相关。
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。
