Gohel M C, Amin A F, Chhabaria M T, Panchal M K, Lalwani A N
Department of Pharmaceutical Technology, L. M. College of Pharmacy, Navrangpura, Ahmedabad, India.
Pharm Dev Technol. 2000;5(3):375-81. doi: 10.1081/pdt-100100553.
The feasibility of using succinic acid-treated ispaghula husk in matrix-based tablets of diltiazem-HCl was investigated. The sample prepared using 4:1 weight ratio of ispaghula husk to succinic acid showed improved swelling and gelling. A 3(2) factorial design was employed to investigate the effect of amount of succinic acid-treated ispaghula husk and dicalcium phosphate (DCP) on the percentage of the drug dissolved in 60, 300, and 480 min from the compressed tablets. The results of multiple linear regression analysis revealed that the significance of the amount of succinic acid-treated ispaghula husk was greater in magnitude than that of the amount of DCP in controlling the drug release. Acceptable batches were identified from a contour plot with constraints on the percentage drug released at the three sampling times. A mathematical model was also evolved to describe the entire dissolution profile. The results of F-test revealed that the Higuchi model fits well to the in vitro dissolution data. The tablets showed considerable radial and axial swelling in distilled water. Succinic acid-treated ispaghula husk can be used as an economical hydrophilic matrixing agent.
研究了将琥珀酸处理的卵叶车前子壳用于盐酸地尔硫卓骨架片的可行性。使用卵叶车前子壳与琥珀酸4:1重量比制备的样品显示出改善的溶胀和胶凝性能。采用3(2)析因设计研究琥珀酸处理的卵叶车前子壳和磷酸二钙(DCP)的用量对压制片中药物在60、300和480分钟时溶解百分比的影响。多元线性回归分析结果表明,在控制药物释放方面,琥珀酸处理的卵叶车前子壳用量的显著性在数值上大于DCP用量的显著性。根据在三个取样时间的药物释放百分比受到限制的等高线图确定了可接受的批次。还建立了一个数学模型来描述整个溶出曲线。F检验结果表明,Higuchi模型与体外溶出数据拟合良好。该片剂在蒸馏水中显示出相当大的径向和轴向溶胀。琥珀酸处理的卵叶车前子壳可用作经济的亲水性骨架剂。