Suares Divya, Hiray Arti
Shobhaben Pratapbhai Patel School of Pharmacy and Technology Management, SVKM's NMIMS, Vile Parle (W), Mumbai-400 056, India.
Indian J Pharm Sci. 2015 Sep-Oct;77(5):550-5. doi: 10.4103/0250-474x.169027.
The objective of this research work was to mask the intense bitter taste of fexofenadine hydrochloride using weak cation exchange resins and to formulate orodispersible tablet of taste masked drug-resin complex. Five resins indion 204, indion 234, indion 414, kyron T-114 and kyron T-314 were used. Depending on maximum drug loading capacity of resins indion 234 and kyron T-314 were finalized for further study. Drug-resin complex was optimized by considering parameters such as drug to resin ratio, soaking time of resins, stirring time, temperature and pH on maximum drug loading. The drug-resin complex was characterized by Fourier transform infrared spectroscopy. The drug-resin complex was also subjected to various evaluation studies such as taste mask evaluation by panel method, drug content and in vitro drug release at salivary and gastric pH. The orodispersible tablets of taste masked drug-resin complex for indion 234 and kyron T-314 were prepared by direct compression method. Formulated orodispersible tablets were subjected to various evaluation parameters such as diameter and thickness measurement, hardness test, weight variation test, in vitro United States Pharmacopoeia disintegration test, wetting time, test for content uniformity, assay, friability test and in vitro dissolution studies. The results indicate that orodispersible tablets of fexofenadine hydrochloride containing indion 234 and kyron T-314 are palatable and provide quick disintegration and fast drug release without addition of superdisintegrants.
本研究工作的目的是使用弱阳离子交换树脂掩盖盐酸非索非那定的强烈苦味，并制备掩味药物-树脂复合物的口腔崩解片。使用了五种树脂，即Indion 204、Indion 234、Indion 414、Kyron T-114和Kyron T-314。根据树脂的最大载药量，最终确定Indion 234和Kyron T-314用于进一步研究。通过考虑药物与树脂比例、树脂浸泡时间、搅拌时间、温度和pH值等参数对最大载药量的影响，对药物-树脂复合物进行了优化。通过傅里叶变换红外光谱对药物-树脂复合物进行了表征。该药物-树脂复合物还进行了各种评价研究，如采用小组法进行掩味评价、药物含量测定以及在唾液和胃液pH值下的体外药物释放研究。采用直接压片法制备了Indion 234和Kyron T-314掩味药物-树脂复合物的口腔崩解片。对制备的口腔崩解片进行了各种评价参数的测定，如直径和厚度测量、硬度测试、重量差异测试、美国药典体外崩解测试、润湿时间、含量均匀度测试、含量测定、脆碎度测试和体外溶出度研究。结果表明，含有Indion 234和Kyron T-314的盐酸非索非那定口腔崩解片口感良好，无需添加超级崩解剂即可快速崩解和快速释放药物。
