通过结合压缩模拟器和振荡机来模拟滚筒压缩 - - 一种节约材料的方法
Layla Hassan1, René Jensen1, Andrew Megarry1
1Novo Nordisk A/S, Novo Nordisk Park 2, 2760 Maaloev, Denmark.
International journal of pharmaceutics
|July 31, 2023
概括
压缩模拟器和振荡机有效模仿滚筒压缩,减少了工艺开发的材料需求. 这种方法确保了类似的颗粒特性和平板质量,节省了时间和资源.
科学领域:
- 制药科学 制药科学
- 化学工程是化学工程的重要组成部分.
- 材料科学 材料科学 材料科学
背景情况:
- 滚筒压缩对于制药粉末加工至关重要.
- 开发新工艺往往需要大量的材料.
- 需要节省材料的技术来优化开发时间表和成本.
研究的目的:
- 评估压缩模拟器和振荡机作为滚筒压缩的替代方案.
- 评估这些方法对材料节约工艺开发的可行性.
- 为了比较通过不同的压缩方法产生的颗粒性质和平板电脑特性.
主要方法:
- 使用压缩模拟器和振荡机来模仿滚筒压缩机的性能.
- 采用微晶纤维素和二酸二水合物作为模型材料.
- 测量了相对密度 (pycnometry),颗粒大小分布 (激光衍射) 和平板拉伸强度 (硬度测试仪).
主要成果:
- 压缩模拟器在各种压力范围内 (1-12 kN/cm) 实现了与滚筒压缩机相似的相对密度.
- 振荡机生产的颗粒尺寸分布与具有类似间隙和布设置的滚筒压缩机相似.
- 平板的抗拉强度和相对密度是一致的,不论是颗粒化方法或材料特性.
结论:
- 压缩模拟器和振荡磨机的组合有效地复制了滚筒压缩.
- 这种综合方法为制药工艺开发提供了一个可行的材料节约策略.
- 在早期开发阶段可以节省大量的材料和时间.
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