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在双螺丝湿颗粒中对结合剂的评估 - - 优化可平板化
Claudia Köster1, Peter Kleinebudde1
1Institute of Pharmaceutics and Biopharmaceutics, Faculty of Mathematics and Natural Sciences, Heinrich Heine University, Universitätsstr. 1, 40225 Düsseldorf, Germany.
International journal of pharmaceutics
|May 31, 2024
概括
基烯纤维素 (HPC) 粘合剂度和填充剂类型显著影响平板性和分解. 与DCP/MCC配方相比,具有更高HPC度的乳糖填充剂产生了更好的可分片性和更快的分解.
科学领域:
- 制药技术 制药技术 制药技术
- 材料科学 材料科学 材料科学
背景情况:
- 优化药片配方需要平衡可服用性和分解性.
- 基基纤维素 (HPC) 是制药制造中常见的粘合剂.
- 填充剂的选择影响了颗粒化,压缩和药物释放.
研究的目的:
- 调查HPC类型,度和填充剂对双螺杆湿颗粒和片剂的影响.
- 为了确定具有高可表达性和可接受分解性的配方.
- 为了确定成功生产平板电脑的最佳加工参数.
主要方法:
- 配方的双螺旋湿颗粒化,具有不同的HPC度 (2-5%) 和填充剂 (乳糖,DCP/MCC).
- 在不同压缩压力下测试可平板性.
- 根据药库标准评估分解时间.
主要成果:
- 乳糖填充剂含有5%的HPC结合剂,表现出比DCP/MCC更高的可分片性和更快的分解速度.
- 乳糖配方的可分片性随着粘合剂度和压缩压力而增加.
- DCP/MCC配方仅在压缩压力下显示出有限的可板性改善,并且在高粘合剂/压力下未能分解.
- 经过修改的DCP/MCC配方实现了更快的分解,但表可降低.
结论:
- 最佳的片剂配方使用乳糖填充剂与3.5%或5%的HPC粘合剂,实现高可片性和在500秒内分解.
- 仔细选择粘合剂度,填充剂类型和压缩压力对于成功打片至关重要.
- 配方调整可以克服诸如DCP/MCC系统中缺陷解体等挑战.
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