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在双螺杆料器中,用于双组分混合粉末的料因子概况预测模型
Yuki Kobayashi1, Sanghong Kim2, Takuya Nagato3
1Department of Systems Science, Kyoto University, Yoshida-honmachi, Sakyo-ku, Kyoto 6068501, Kyoto, Japan.
International journal of pharmaceutics: X
|April 11, 2024
概括
这项研究开发了模型来预测制药制造中的粉末流速. 发现材料属性对于准确的料因子概况预测是不必要的,简化了过程控制.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 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:
- 在连续制药制造中,精确控制粉末流速至关重要.
- 料系数,表示每次螺丝旋转的粉末量,是关键参数.
- 以前的模型主要集中在单元粉末上,限制了混合物的应用.
研究的目的:
- 开发用于两组制药粉末混合物的料因子概况 (FFP) 的预测模型.
- 评估各种输入变量的影响,包括材料属性,对预测准确度.
- 为制药粉末养过程确定最佳的建模策略.
主要方法:
- 四个数据集的实验生成,具有不同的活性药物成分 (API) 质量分数和粉末重量.
- 开发和比较多种料因素预测模型.
- 分析输入变量的意义,包括API质量分数,工艺参数和材料特性.
主要成果:
- 开发了模型来预测双成分粉末混合物的FFP.
- 将材料属性作为输入变量并没有显著提高预测准确度.
- 高性能预测模型可以在没有繁的材料性质测量的情况下实现.
结论:
- 可以有效地开发制药粉混合物的FPF的预测模型.
- 材料特性对于在FFP预测模型中实现高精度并非必不可少.
- 由于降低了测量工作量,不包括材料属性的简化模型是可取的.
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