一个混合系统用于设计空间估计在一个旋转平板电脑压力机
Mohammad Shahab1, Sunidhi Bachawala2, Marcial Gonzalez2
1Davidson School of Chemical Engineering, Purdue University, West Lafayette, 47907, IN, USA.
International journal of pharmaceutics
|May 16, 2025
概括
确定药品平板电脑印刷设计空间 (DS) 是设计质量 (QbD) 的关键. 使用半机械和数据驱动模型的混合方法有效地定义了滑动剂和滑剂混合物的DS,确保了平板电脑质量.
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.
- 过程分析技术 过程分析技术
背景情况:
- 通过设计质量 (QbD) 要求对制药制造进行强大的设计空间 (DS) 识别.
- 平板压力机 (TP) 是关键单元操作,其中材料属性和工艺条件影响最终产品质量.
- 现有的模型可能不足以进行全面的DS估计,需要先进的方法.
研究的目的:
- 开发和验证一种混合系统,用于在平板电脑压缩中识别DS.
- 评估不同类型混合物的不同建模方法 (滑动剂与滑剂) 的有效性.
- 确保在已识别的DS中满足平板电脑质量限制.
主要方法:
- 实施混合建模系统,将半机械和数据驱动 (响应表面) 模型结合起来.
- 用半机械模型对基于滑动剂的混合物进行DS的表征.
- 对基于滑剂的混合物应用数据驱动的响应表面模型.
- 实验验证混合系统所识别的DS.
主要成果:
- 混合系统有效地识别平板电脑印刷机的DS,以适应不同的材料属性.
- 半机械模型适用于滑动混合物,而数据驱动模型则非常适合滑混合物.
- 混合方法考虑了模型不确定性和材料过程相互作用,定义了以质量为导向的DS轮.
- 实验研究证实,与纯机械方法相比,混合系统的效率更高.
结论:
- 混合系统为平板电脑压缩中DS识别提供了一种高效准确的方法.
- 定制模拟策略以混合类型 (滑行剂/滑剂) 为最佳的DS定义至关重要.
- 这种方法可以降低实验成本,同时确保产品质量和工艺稳定性.
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