Development of a Taste-Masked Generic Ibuprofen Suspension: Top-Down Approach Guided by Electronic Tongue Measurements

作者：Woertz Katharina^*; Tissen Corinna; Kleinebudde Peter; Breitkreutz Joerg

来源：Journal of Pharmaceutical Sciences, 2011, 100(10): 4460-4470.

DOI：10.1002/jps.22629

• pediatric
• formulation
• analysis
• excipients
• in vitro models
• multivariate analysis

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 mu m) 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.

• 出版日期2011-10