Yoshida Miyako, Hazekawa Mai, Haraguchi Tamami, Uchida Takahiro
Department of Clinical Pharmaceutics, School of Pharmaceutical Science, Mukogawa Women's University , Hyogo , Japan.
Drug Dev Ind Pharm. 2015;41(8):1387-92. doi: 10.3109/03639045.2014.954583. Epub 2014 Sep 8.
The purpose of this study was to evaluate the palatabilities of the original and nine generic versions of famotidine orally disintegrating tablets (FODTs) by means of disintegration times and bitterness intensities determined using in combination disintegration device and taste sensor comparison of human gustatory sensation tests. The disintegration times were determined using a new disintegration testing equipment for ODTs, the OD-mate and bitterness intensities were determined using the SA501C taste-sensing system. The disintegration time and bitterness of each FODT was evaluated in gustatory sensation tests. There was a good correlation between the disintegration times of 10 FODTs estimated in human gustatory testing and those found using the OD-mate. The bitterness intensities of FODTs at 10, 20 and 30 s after starting the disintegration using the OD-mate and the values determined by the taste sensor were highly correlated with the bitterness intensities determined in gustatory sensation testing. A combination of the OD-mate and the SA501C was capable of predicting the palatabilities, disintegration properties and bitterness intensity of FODTs.
本研究的目的是通过使用崩解装置和味觉传感器相结合的方法,测定原研法莫替丁口腔崩解片(FODTs)及其9种仿制药的崩解时间和苦味强度,以评估其适口性,并进行人体味觉测试比较。使用新型ODT崩解测试设备OD-mate测定崩解时间,使用SA501C味觉传感系统测定苦味强度。在味觉测试中评估每种FODT的崩解时间和苦味。人体味觉测试中估计的10种FODT的崩解时间与使用OD-mate测得的崩解时间之间存在良好的相关性。使用OD-mate开始崩解后10、20和30秒时FODTs的苦味强度以及味觉传感器测定的值与味觉测试中测定的苦味强度高度相关。OD-mate和SA501C的组合能够预测FODTs的适口性、崩解特性和苦味强度。