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制药配方双螺丝湿颗粒的机械建模:校准,灵敏度分析和基于模型的工作流程
Neeru Bala1, Jeremiah Corrigan2, Jonathan Meyer2
1Department of Chemical & Biological Engineering, University of Sheffield, UK.
International journal of pharmaceutics
|May 22, 2024
概括
这项研究开发了一个人口平衡模型 (PBM) 用于双螺杆湿颗粒,提高制药粉末的质量. 该模型准确地预测了颗粒大小分布,有助于开发新的活性药物成分 (API).
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:
- 在制药生产中,湿颗粒对于改善粉末特性和片剂形成至关重要.
- 现有的模型往往缺乏针对双螺丝颗粒化工艺的特异性.
- 了解粒子动力学是控制关键质量属性的关键.
研究的目的:
- 应用机械人口平衡模型 (PBM) 于双螺丝湿颗粒.
- 为了整合一个新的破裂核和其他颗粒化机制 (核化,分层,巩固).
- 用不同的制药配方校准和验证模型.
主要方法:
- 开发和应用基于机制的人口平衡模型 (PBM).
- 纳入一个特定的破碎核用于双螺丝颗粒.
- 校准和验证使用甲和乙氨基配方.
- 全球灵敏度分析以确定关键输入参数.
主要成果:
- 核化速率过程模型准确地表示了两种配方的粒子大小分布.
- 通过根据材料特性和螺丝配置调整核和断裂速率参数来提高模型的准确性.
- 灵敏度分析确定了影响粉末质量属性的关键输入.
结论:
- 开发的PBM有效地模拟了不同制药粉末的双螺丝湿颗粒.
- 材料特性和螺杆配置显著影响颗粒化参数.
- 提出了一个以模型为驱动的工作流程,以指导PBM在未来API配方中的应用.
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