对于吸入配方的干粉操作的新兴过程建模能力
1Drug Product Technologies, Process Development, Amgen, One Amgen Center Drive, Thousand Oaks, California 91320, United States.
制造干粉吸入器 (DPI) 涉及削,混合和填充等关键步骤. 过程建模,特别是离散元件方法 (DEM) 模拟,是优化DPI开发和性能的关键.
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
- 计算机建模 计算建模
背景情况:
- 干粉吸入器 (DPI) 产品通常以微小化药物颗粒与较大的载体颗粒混合的形式配制.
- DPI制造涉及关键单元操作:颗粒大小减小,混合,以及将粉末填充到各种剂量控制系统中.
研究的目的:
- 审查DPI制造单位运营中的关键过程参数 (CPP).
- 突出实证和机械模型的应用,特别是离散元件方法 (DEM) 模拟,在DPI过程开发中.
主要方法:
- 对喷气削,高剪切混合和囊填充的关键过程参数的审查.
- 对DPI流程开发的建模和模拟的最新进展进行分析.
主要成果:
- 确定影响DPI制造的关键过程参数.
- 展示建模和模拟,特别是DEM在理解和优化DPI过程中的日益增长的作用.
结论:
- DPI过程设计和开发越来越多地由建模和模拟驱动.
- 计算能力的进步将为现实世界DPI操作提供更准确和更复杂的模拟,改善过程性能评估.
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