使用DEM展示了两种混合器类型之间的可扩展性
Peter Boehling1, Johan Remmelgas1, Mohammadsadegh Salehi1
1Research Center Pharmaceutical Engineering GmbH, Graz, Austria.
International journal of pharmaceutics
|September 29, 2024
概括
离散元件方法 (DEM) 模拟优化了制药粉末的混合和滑剂分散. 这种方法准确地预测了平板电脑的抗拉强度,提高了制造效率和产品的一致性.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 粉末技术技术 粉末技术
- 计算流体动力学的流体动力学.
背景情况:
- 粉末混合对于制药品质量至关重要,它会影响平板电脑的性能,如抗拉强度.
- 优化混合过程对于一致的药物制造至关重要.
- 了解混合过程中的粒子行为是过程控制的关键.
研究的目的:
- 使用离散元件方法 (DEM) 模拟来研究粉末混合和滑剂分散.
- 开发基于混合参数的平板电脑拉伸强度的预测模型.
- 探索不同混合器设计之间的混合过程的可扩展性.
主要方法:
- 利用离散元件方法 (DEM) 模拟,在5升迷你批量和2升Turbula混合机中进行混合分析.
- 使用小规模粉末特征测试校准的DEM参数.
- 开发了一个平板电脑拉伸强度的预测模型,其中包含滑能量.
主要成果:
- DEM模拟准确地反映了颗粒的行为,并允许混合器尺寸之间进行缩放.
- 预测模型成功地将混合参数 (速度,持续时间,填充水平) 与平板电脑的抗拉强度相关联.
- 确定了最佳的工艺条件,以改善滑剂分散和混合均性.
结论:
- DEM是理解和优化制药粉末混合的强大工具.
- 开发的模型提供了一种方法来预测平板电脑的抗拉强度,帮助工艺设计.
- 这些发现支持开发半连续制造工艺,以提高效率和一致性.
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