Development and evaluation of taste masked dry syrup formulation of potassium chloride.

AAPS Open Pub Date : 2019-01-01 Epub Date: 2019-01-22 DOI:10.1186/s41120-019-0030-z
Madhur Kulkarni, Brijesh Vishwakarma, Samik Sen, Sandhya Anupuram, Abhijit A Date
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引用次数: 3

Abstract

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.

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氯化钾掩味干糖浆配方的研制与评价。
氯化钾(KCl)糖浆广泛用于口服治疗低钾血症。然而,它与令人难以接受的味道联系在一起。在目前的研究中,我们试图开发一种可口且易于重组的KCl干糖浆,作为目前可用的KCl糖浆的商业上可行的替代品。我们探索了E100作为一种掩味聚合物的潜力,以包覆和改善KCl的适口性。在流化床处理机的帮助下,用不同含量的E100(4、6、10和15%)溶液涂覆KCl。包覆10%聚合物溶液的流化床处理效果最佳,KCl的包裹率更高(81%),在0.1 N HCl和pH 6.8磷酸盐缓冲液中体外释放效果更好。研制了一种干粉糖浆配方,该配方在干燥状态和重构状态下具有良好的物理和化学稳定性。用电子味感仪对优化配方和市售KCl糖浆的适口性进行了评价。该配方的掩味效果比市售KCl糖浆好2倍。因此,目前的研究描述了一种有效的替代目前的KCl糖浆,可以提供更好的适口性,稳定性和患者依从性的发展。
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