Rat Palatability Study for Taste Assessment of Caffeine Citrate Formulation Prepared via Hot-Melt Extrusion Technology
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- 作者：Roshan V. Tiwari ; Ashley N. Polk ; Hemlata Patil ; Xingyou Ye…
- 关键词：caffeine citrate ; hot ; melt extrusion ; pediatric ; rat model (single bottle test) ; taste masking
- 刊名：AAPS PharmSciTech
- 出版年：2017
- 出版时间：February 2017
- 年：2017
- 卷：18
- 期：2
- 页码：341-348
- 全文大小：1639KB
- 刊物主题：Pharmacology/Toxicology; Biotechnology; Biochemistry, general; Pharmacy;
- 出版者：Springer US
- ISSN：1530-9932
- 卷排序：18
文摘
Developing a pediatric oral formulation with an age-appropriate dosage form and taste masking of naturally bitter active pharmaceutical ingredients (APIs) are key challenges for formulation scientists. Several techniques are used for taste masking of bitter APIs to improve formulation palatability; however, not all the techniques are applicable to pediatric dosage forms because of the limitations on the kind and concentration of the excipients that can be used. Hot-melt extrusion (HME) technology is used successfully for taste masking of bitter APIs and overcomes some of the limitations of the existing taste-masking techniques. Likewise, analytical taste assessment is an important quality control parameter evaluated by several in vivo and in vitro methods, such as the human taste panel, electrophysiological methods, electronic sensor, and animal preference tests to aid in selecting a taste-masked formulation. However, the most appropriate in vivo method to assess the taste-masking efficacy of pediatric formulations remains unknown because it is not known to what extent the human taste panel/electronic tongue can predict the palatability in the pediatric patients. The purpose of this study was to develop taste-masked caffeine citrate extrudates via HME and to demonstrate the wide applicability of a single bottle-test rat model to record and compare the volume consumed of the taste-masked solutions to that of the pure API. Thus, this rat model can be considered as a low-cost alternative taste-assessment method to the most commonly used expensive human taste panel/electronic tongue method for pediatric formulations.