在制药热挤出中预测停留时间和融温度
Judith Winck1, Tobias Gottschalk1,2, Markus Thommes1
1Laboratory of Solids Process Engineering, Department of Biochemical and Chemical Engineering, TU Dortmund University, Emil-Figge-Str. 68, 44227 Dortmund, Germany.
Pharmaceutics
|May 27, 2023
概括
这项研究开发了一种新方法,用于预测制药热挤出中的停留时间和化温度. 这些发现有助于优化连续加工,以提高产品质量,特别是对于热敏药物.
科学领域:
- 制药技术 制药技术 制药技术
- 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:
- 热挤出 (HME) 是药品中一个关键的连续制造技术.
- 控制停留时间和温度对于产品质量至关重要,特别是对于热敏材料.
研究的目的:
- 提出一种新的策略,用于预测制药HME中的停留时间分布和化温度.
- 以实验数据为基础,利用实验数据对HME过程进行优化预测.
主要方法:
- 使用自发挤压模式,没有外部加热/冷却.
- 在不同的特定料负载下加工了三种聚合物 (Plasdone S-630,Soluplus,Eudragit EPO).
- 模拟居住时间分布,采用两方法 (管道和水箱).
主要成果:
- 吞吐量显著影响了停留时间;螺丝速度的影响很小.
- 融化温度主要受到螺丝速度的影响,吞吐量的影响较小.
- 模型参数被编译成设计空间,用于预测建模.
结论:
- 开发的战略使HME过程参数的准确预测成为可能.
- 通过编译的模型参数,可以实现对制药HME过程的优化预测.
- 这种方法支持在连续制药制造中加强质量控制.
相关概念视频
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