一种经过修改的机械方法,用于预测不同滚筒压缩速度的带固体分数
Jingzhe Li1, Yin-Chao Tseng1, Shubhajit Paul1
1Boehringer Ingelheim Pharmaceuticals Inc., Department of Material and Analytical Sciences, Ridgefield, CT 06877, USA.
International journal of pharmaceutics
|June 20, 2024
概括
这项研究通过调整约翰逊模型以滚动速度和配方属性来增强制药滚筒紧缩建模. 这提高了对带固体分量的预测,这对于制造控制至关重要.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 材料科学 材料科学 材料科学
- 化学工程是化学工程的重要组成部分.
背景情况:
- 滚筒压缩对于制药生产至关重要,但准确的建模仍然具有挑战性.
- 约翰逊模型是预测压缩行为的基本工具.
- 预测带固体分数是过程控制和药物产品质量的关键.
研究的目的:
- 通过结合滚动速度和配方效应来完善约翰逊的滚动压缩模型.
- 为了提高药品制造中带固体分量的预测准确度.
- 建立一个机械方法来优化滚筒紧缩参数.
主要方法:
- 将停留时间参数集成到经典的约翰逊模型中.
- 分析了不同滚动速度 (1-15 RPM) 对带固体部分的影响.
- 与粉末机械性质相关的模型校正因子 (收益应力,弹性模量).
主要成果:
- 开发了一个浮动校正因子,取决于滚动速度和配方成分.
- 证明了校正因子和粉末变形能力 (收益应力,弹性模量) 之间存在很强的相关性.
- 用多组分药物配方验证了修改后的模型,显示最小的预测差异 (±0.4-1.3%).
结论:
- 经过修改的约翰逊模型使用机械性能准确地预测了带状固体分数.
- 这种方法提高了药品滚筒紧缩的控制和准确性.
- 提供了优化后期制药制造工艺的宝贵见解.
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