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Development and evaluation of taste masked dry syrup formulation of potassium chloride.
AAPS Open Pub Date : 2019-01-22 , DOI: 10.1186/s41120-019-0030-z
Madhur Kulkarni 1 , Brijesh Vishwakarma 2 , Samik Sen 2 , Sandhya Anupuram 1 , Abhijit A Date 3
Affiliation  

Potassium chloride (KCl) syrup is widely used for the oral treatment of the hypokalemia. However, it is associated with unacceptable taste. In the present study, we sought to develop a palatable and easy to reconstitute KCl dry syrup as a commercially viable alternative to currently available KCl syrup. We explored the potential of Eudragit E100 as a taste-masking polymer to coat and improve the palatability of the KCl. With the help of fluid bed processor, KCl was coated with the solution containing varying amounts of Eudragit E100 (4, 6, 10 and 15%). Coating with 10% polymer solution enabled optimal fluid bed processing, higher entrapment of the KCl (81%) and better in vitro release profile in 0.1 N HCl and pH 6.8 phosphate buffer. A dry syrup formulation containing Eudragit E100 coated KCl with good physical and chemical stability in dry and reconstituted state was developed. The palatability of the optimized formulation and commercially available KCl syrup was evaluated using the Electronic Taste Sensing Machine. The developed formulation showed~ 2-fold better taste-masking compared to the commercial KCl syrup. Thus, present investigation describes the development of an effective alternative to the current KCl syrup that can offer better palatability, stability and patient compliance.

中文翻译:

掩味氯化钾干糖浆配方的开发和评估。

氯化钾(KCl)糖浆被广泛用于低钾血症的口服治疗。然而,它与不可接受的味道有关。在本研究中,我们寻求开发一种可口且易于重构的KCl干糖浆,以作为目前可用的KCl糖浆的商业可行替代品。我们探索了Eudragit E100作为掩味聚合物涂覆和改善KCl适口性的潜力。借助于流化床处理器,用含有不同量的Eudragit E100(4%,6%,10%和15%)的溶液涂布KCl。用10%的聚合物溶液包被可实现最佳的流化床处理,更高的KCl截留率(81%)和在0.1 N HCl和pH 6.8磷酸盐缓冲液中更好的体外释放特性。开发了包含Eudragit E100包被的KCl的干糖浆制剂,该干糖浆在干燥和复溶状态下具有良好的物理和化学稳定性。使用电子味觉感应机评估了优化配方和市售KCl糖浆的适口性。所开发的配方显示出比市售KCl糖浆好2倍的掩味效果。因此,目前的研究描述了一种有效替代现有KCl糖浆的方法,该方法可以提供更好的适口性,稳定性和患者依从性。
更新日期:2019-01-22
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