Senel S, Capan Y, Hincal A A
Hacettepe University, Faculty of Pharmacy, Pharmaceutical Technology Department, Ankara, Turkey.
Pharmazie. 1991 Nov;46(11):792-5.
In this study, influence of several formulation factors on the release kinetics of potassium chloride from directly compressed matrices are investigated. Formulations containing hydrophilic (methylcellulose, carbomer), plastic (polyvinyl chloride), and wax (glycerol palmitostearate) matrix materials at concentrations of 10, 15 and 20%, incorporated with potassium chloride as active ingredient and insoluble excipients were prepared and studied in vitro using the USP XXI/NF XVI rotating paddle method. Hardness had no markedly effect on the release characteristics of formulations except for wax matrix material formulation. Results of goodness of fit analysis applied to release data had shown that the release mechanism was described by the Higuchi diffusion controlled model. Positive deviations from Higuchi equation might be due to the erosion of gel layer. Analysis of in vitro release mechanisms indicated that the most suitable results were obtained by methylcellulose and glycerol palmitostearate.
在本研究中，研究了几种制剂因素对直接压片基质中氯化钾释放动力学的影响。制备了含有浓度为10%、15%和20%的亲水性（甲基纤维素、卡波姆）、塑性（聚氯乙烯）和蜡质（甘油棕榈硬脂酸酯）基质材料的制剂，其中加入氯化钾作为活性成分和不溶性辅料，并采用美国药典 XXI/国家处方集 XVI 旋转桨法进行体外研究。除蜡质基质材料制剂外，硬度对制剂的释放特性没有明显影响。应用于释放数据的拟合优度分析结果表明，释放机制符合 Higuchi 扩散控制模型。与 Higuchi 方程的正偏差可能是由于凝胶层的侵蚀。体外释放机制分析表明，甲基纤维素和甘油棕榈硬脂酸酯获得了最合适的结果。
