平板印刷机停留时间分布对连续直接压缩过程中通过小批量混合对材料可追溯性的影响 - 第一部分:验证和应用
Peter Boehling1, Johan Remmelgas1, Johannes Poms1
1Research Center Pharmaceutical Engineering, Graz, Austria.
International journal of pharmaceutics
|February 8, 2026
概括
通过微批量混合 (CDC通过MBB) 制造的连续直接压缩需要了解材料流. 这项研究量化了平板电脑打印机的居住时间分布 (RTD),揭示了混合和实现优化材料转移策略.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 工艺工程是过程工程.
- 材料科学 材料科学 材料科学
背景情况:
- 连续直接压缩通过小批量混合 (CDC通过MBB) 是一种新兴的制药制造技术.
- 通过MBB线路在CDC中进行材料跟踪对于工艺控制至关重要,特别是在平板电脑印刷机内.
- 在初始混合阶段之后,评估平板电脑压力机中的停留时间分布 (RTD) 是必不可少的.
研究的目的:
- 通过MBB过程在CDC内部开发一种方法框架,用于通过MBB过程在平板电脑印刷机中描述RTD.
- 在压缩过程中量化微批量 (MB) 之间的混合.
- 根据RTD见解,评估不同材料转移策略的有效性.
主要方法:
- 实验性特征的RTD使用葡萄酸追踪器的步骤变化和传输拉曼光谱.
- 使用离散元件方法 (DEM) 模拟的in-silico建模,与实验数据进行了验证.
- 基于模拟的保守与智能材料转移策略的测试.
主要成果:
- 实验结果表明,相邻的小批次 (MB) 之间存在显著的混合.
- 基于RTD的模拟量化了这种混合,显示平板是多个MB的混合物.
- 发现智能材料转移策略可以显著减少不符合材料的干扰后.
结论:
- 描述平板电脑印刷机RTD是通过MBB了解CDC过程动态的关键.
- 研究和开发的洞察力有助于制定有效的采样和材料转移策略.
- 提出的框架和发现适用于各种平板电脑压力机配置.
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