合理的基于函数的方法,以整合平板的减少顺序模型与上游单位运营:滑剂和滑翔剂案例研究
Sunidhi Bachawala1, Dominik Tomasz Nasilowski1, Marcial Gonzalez1,2
1School of Mechanical Engineering, Purdue University, West Lafayette, IN 47907, USA.
Pharmaceuticals (Basel, Switzerland)
|October 29, 2025
概括
一种新的建模方法量化了滑翔剂和滑剂如何影响平板电脑制造. 这有助于在连续制造过程中预测和控制平板电脑质量.
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.
- 材料科学 材料科学 材料科学
背景情况:
- 滑行剂和滑剂是必不可少的药物辅助剂,可以改善粉末流动,但可能会对药片质量属性产生负面影响.
- 了解这些影响对于制药行业向连续制造转变至关重要.
研究的目的:
- 开发基于理性的功能建模框架,以量化滑翔剂和滑剂对平板加工过程的影响.
- 识别和建模影响平板电脑质量的关键材料属性和过程参数.
主要方法:
- 开发了一种基于理性的功能建模方法,以捕捉滑剂和滑动剂对平板电脑的作用.
- 构建了减少顺序模型来评估诸如辅助剂度和粉末缩阶段混合时间等变量.
- 使用的配方含有乙氨基,微晶纤维素,酸或合体二氧化,通过工艺调整变化片密度.
主要成果:
- 成功量化了滑剂和滑滑剂混合在粉末压缩每个阶段的影响.
- 提供了关于上游条件如何影响平板电脑和关键质量属性的机制性见解.
- 证明了该模型能够预测辅助剂度和混合时间的影响.
结论:
- 基于理性的功能框架提供了一个系统的方法来预测滑剂和滑动剂对平板电脑性能的影响.
- 增强对产品和过程的理解,这对于优化连续制造至关重要.
- 促进更好地控制药品药片生产中的关键质量属性.
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