Woertz Katharina, Tissen Corinna, Kleinebudde Peter, Breitkreutz Joerg
Institute of Pharmaceutics and Biopharmaceutics, Heinrich-Heine-University Duesseldorf, 40225 Duesseldorf, Germany.
J Pharm Sci. 2011 Oct;100(10):4460-70. doi: 10.1002/jps.22629. Epub 2011 May 23.
Electronic tongues are sensor array systems that are increasingly being used in the field of pharmaceutics to provide taste assessment data of formulations. The applicability of an electronic tongue in the development of a taste masked generic ibuprofen suspension, starting from a commercial taste masked product, was evaluated in this study. The initial screening study on 3 proprietary and 11 generic products showed that sensors of the taste sensing system TS-5000Z could clearly detect differences between the products. The variation of sensor responses were mainly caused by sodium salts, sweeteners, and preservatives, whereas pH and viscosity did not affect sensor response. In addition, the presence of the particles (20-100 µm) did not damage the sensor membranes. Based on this screening, and the known qualitative composition of the proprietary formulations, the approximate quantitative composition of a proprietary formulation could be deduced and a taste masked generic formulation could be developed using the electronic tongue data. Differences in sensor responses between the proprietary and optimized generic formulation were smaller than 11 mV for each sensor. Based on these results a rational approach of implementing an electronic tongue to simplify the development of a taste masked generic formulation could be introduced.
电子舌是一种传感器阵列系统,在制药领域的应用越来越广泛,用于提供制剂的味道评估数据。本研究评估了一种电子舌从市售掩味产品出发,在掩味通用布洛芬混悬液开发中的适用性。对3种专利产品和11种通用产品的初步筛选研究表明,味觉传感系统TS-5000Z的传感器能够清晰地检测出产品之间的差异。传感器响应的变化主要由钠盐、甜味剂和防腐剂引起,而pH值和粘度不会影响传感器响应。此外,颗粒(20 - 100 µm)的存在不会损坏传感器膜。基于此筛选以及专利制剂已知的定性组成,可以推断出专利制剂的近似定量组成,并利用电子舌数据开发出掩味通用制剂。专利制剂与优化后的通用制剂之间,每个传感器的传感器响应差异小于11 mV。基于这些结果,可以引入一种合理的方法,即使用电子舌来简化掩味通用制剂的开发。