涂层多颗粒物的平板:冲孔面配置的影响
Daniel Robin Thio1, Natalia Veronica1, Paul Wan Sia Heng1
1GEA-NUS Pharmaceutical Processing Research Laboratory, Department of Pharmacy, National University of Singapore, 18 Science Drive 4, Singapore 117543, Singapore.
International journal of pharmaceutics
|February 2, 2024
概括
穿孔面设计显著影响多单元颗粒系统 (MUPS) 平板质量. 深深的凸孔在压缩过程中最大限度地降低了颗粒涂层的损坏,但可能会导致较弱的颗粒,特别是在烯酸涂层下.
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:
- 多单元颗粒系统 (MUPS) 药片提供可控的药物释放.
- 打孔面设计是平板电脑制造中的一个关键参数.
研究的目的:
- 为了研究穿孔面设计对MUPS平板电脑性能的影响.
- 为了评估颗粒涂层的完整性和颗粒机械强度.
主要方法:
- 将装有药物的颗粒 (乙纤维素或烯酸涂层) 压缩成使用各种穿孔面设计的MUPS片 (标准,深,平面边,平面半径边).
- 在2kN和8kN的压缩力下评估了平板电脑的拉伸强度和弹性恢复.
- 通过药物释放概况和平均溶解时间评估颗粒外层损伤.
主要成果:
- 与平面平板相比,双凸平板显示出较低的抗拉强度和更高的弹性回收.
- 在较高的压缩力下,深深的孔将颗粒外层的损伤降低了13-26%.
- 当使用深凸孔时,烯酸涂层颗粒会导致较弱的平板.
结论:
- 穿孔面的几何形状深刻地影响了MUPS平板质量,影响了机械性能和颗粒完整性.
- 深深的凸穿孔提供了对颗粒外层损伤的保护,但需要仔细考虑配方.
- 优化穿孔面设计对于制造具有所需药物释放特性的强大的MUPS片至关重要.
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