使用阴离子交换树脂作为单一辅助剂制备的diltiazem HCl-修改释放配方
Khouloud A Alkhamis1, Suhair S Al-Nimry1
1Department of Pharmaceutical Technology, Faculty of Pharmacy, Jordan University of Science and Technology, Irbid, Jordan.
Pharmaceutical development and technology
|February 28, 2025
概括
这项研究表明,Dowex® 50WX8 (Na+形式) 树脂可以作为diltiazem配方的单一辅助剂,确保化学稳定性和持续的药物释放,无需额外的涂层.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
背景情况:
- 修改释放的迪尔提亚制剂以前需要多种辅助剂,其中包括带离子交换树脂.
- 开发一种更简单的配方,只使用药物树脂复合物是可取的.
研究的目的:
- 仅使用药物树脂复合物制备diltiazem的修改释放剂型.
- 为了评估从树脂中释放的diltiazem的化学稳定性和释放特性.
主要方法:
- 吸附实验使用了一个旋转瓶装置,其中含有Dowex® 50WX8树脂和diltiazem溶液.
- 使用逆相高性能液态染色学 (HPLC) 分析药物度.
- 在酸盐缓冲器中使用USP装置2进行溶解研究.
主要成果:
- 在树脂的H+形式中,diltiazem表现出不稳定性,但在Na+形式中稳定.
- 吸附等温法遵循一个类似兰格穆尔方程,参数受树脂交联和颗粒大小的影响.
- 在初始释放率和药物吸收程度之间观察到正线性关系.
结论:
- 杜韦克斯50WX8 (Na+形式) 有效地作为diltiazem配方的单一辅助剂.
- 这种方法既能提供化学稳定性,又能持续释放药物.
- 在使用这种优化的药物树脂复合物时,不需要额外的聚合物涂层.
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