Jain S, Srinath Ms, Narendra C, Reddy Sn, Sindhu A
Department of Pharmaceutics, Government College of Pharmacy, No. 2, P. Kalinga Rao Road, Bangalore-560 027, India.
J Young Pharm. 2010 Oct;2(4):342-9. doi: 10.4103/0975-1483.71619.
The objective of this study was to evaluate the effect of formulation variables on the release properties, floating lag time, and hardness, when developing floating tablets of Ranitidine hydrochloride, by the statistical optimization technique. The formulations were prepared based on 3(2) factorial design, with polymer ratio (HPMC 100 KM: Xanthan gum) and the amount of aerosil, as two independent formulation variables. The four dependent (response) variables considered were: percentage of drug release at the first hour, T(50%) (time taken to release 50% of the drug), floating lag time, and hardness of the tablet. The release profile data was subjected to a curve fitting analysis, to describe the release mechanism of the drug from the floating tablet. An increase in drug release was observed with an increase in the polymer ratio, and as the amount of aerosil increased, the hardness of the tablet also increased, without causing any change in the floating lag time. The desirability function was used to optimize the response variables, each having a different target, and the observed responses were in accordance with the experimental values. The results demonstrate the feasibility of the model in the development of floating tablets containing Ranitidine hydrochloride.
本研究的目的是通过统计优化技术，在研发盐酸雷尼替丁胃漂浮片时，评估处方变量对其释放特性、漂浮滞后时间和硬度的影响。基于3(2)析因设计制备处方，将聚合物比例（羟丙甲纤维素100 KM：黄原胶）和气硅用量作为两个独立的处方变量。所考虑的四个因变量（响应变量）为：第1小时的药物释放百分比、T(50%)（释放50%药物所需的时间）、漂浮滞后时间和片剂硬度。对释放曲线数据进行曲线拟合分析，以描述药物从胃漂浮片中的释放机制。随着聚合物比例的增加，药物释放增加，并且随着气硅用量的增加，片剂硬度也增加，而漂浮滞后时间未发生任何变化。使用合意函数对各有不同目标的响应变量进行优化，观察到的响应与实验值一致。结果证明了该模型在研发含盐酸雷尼替丁胃漂浮片中的可行性。
