Tokuyama Emi, Matsunaga Chiharu, Yoshida Koichi, Mifsud Jean-Christophe, Irie Tetsumi, Yoshida Miyako, Uchida Takahiro
School of Pharmaceutical Science, Mukogawa Women's University, Nishinomiya, Japan.
Chem Pharm Bull (Tokyo). 2009 Apr;57(4):382-7. doi: 10.1248/cpb.57.382.
The purpose of the present study was to compare the palatability of the original and eight generic versions of famotidine orally disintegrating tablets by means of human gustatory sensation tests, a comparison of the release profiles, and using an automated taste sensor, the alpha-Astree Electronic Tongue. In the gustatory sensation test, the original product (Gaster D, 10 mg) showed the lowest bitterness intensity. Among the eight generic products tested, the variance in the sweetness intensity was not great, but there were large variances in the intensity of bitterness, some of the generic products being significantly more bitter than that of the original product. On the other hand, some generic products show similar bitterness level as the original product. In a study of release profiles, the original product had the lowest release rates of both famotidine and aspartame; in comparison, some of the generic products had high release rates of famotidine and aspartame, even in the initial stages. Whereas some generic products had low release rates of famotidine and aspartame. Finally, sample solutions were analysed using the taste sensor. There was a good correlation between the taste predicted by principal component analysis and the Euclidean distance obtained by the taste sensor, and bitterness intensities obtained in the human gustatory tests.
本研究的目的是通过人体味觉测试、释放曲线比较以及使用自动味觉传感器（alpha-Astree电子舌）来比较法莫替丁口腔崩解片原研产品和八个仿制药版本的适口性。在味觉测试中，原研产品（Gaster D，10毫克）的苦味强度最低。在所测试的八个仿制药产品中，甜味强度的差异不大，但苦味强度存在较大差异，一些仿制药产品的苦味明显高于原研产品。另一方面，一些仿制药产品的苦味水平与原研产品相似。在释放曲线研究中，原研产品的法莫替丁和阿斯巴甜释放率最低；相比之下，一些仿制药产品即使在初始阶段，法莫替丁和阿斯巴甜的释放率也很高。而一些仿制药产品的法莫替丁和阿斯巴甜释放率较低。最后，使用味觉传感器对样品溶液进行分析。主成分分析预测的味道与味觉传感器获得的欧几里得距离以及人体味觉测试中获得的苦味强度之间存在良好的相关性。
