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制剂,开发和优化含有塔潘塔多尔化的快速溶解片
Chandrashekar Thalluri1, Mallikarjun Vasam2, Rajkumar Jampala3
1Department of Pharmaceutics, Faculty of Pharmaceutical Science, Assam Downtown University, Gandhinagar, Panikhaiti, Guwahati-781026, Assam, India.
这项研究开发了优化的Tapentadol快速溶解片 (FDTs),使用超级分解剂,实现快速分解和增强药物释放,以改善患者的服药性. 最好的配方遵循Fickian扩散用于药物释放.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
背景情况:
- 塔潘塔多尔化物是适度至严重疼痛的关键止痛药.
- 快速溶解片 (FDTs) 通过快速缓解疼痛来改善患者的服药性.
- 优化FDT需要仔细选择超级分解剂和配方参数.
研究的目的:
- 为了制造和优化Tapentadol化快速溶解片 (FDTs).
- 为了评估超级分解剂 (croscarmellose和crospovidone) 对FDT特性的影响.
- 使用响应表面方法 (RSM) 确定最佳配方.
主要方法:
- 使用直接压缩制备九种塔潘达洛化FDTs (TH1-TH9).
- 通过RSM优化超级分解剂度 (croscarmellose,crospovidone) 通过RSM.
- 使用DD Solver评估分解时间,药物释放 (Q15,Q30) 和药物释放动力学.
主要成果:
- TH5配方表现出最快的分解和最高的药物释放率.
- 超级分解剂显著提高了塔达醇化水的可溶性和溶解率.
- 从优化的TH5配方中释放的药物遵循一阶动力学和Fickian扩散.
结论:
- 超级分解剂对于优化FDT分解时间和溶解概况至关重要.
- 优化的TH5配方提供快速分解和药物释放,提高患者的服药性.
- RSM是优化FDT配方的有效工具,其稳定性得到证实.
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