异质配方的终点确定,使用高剪切湿颗粒加工过程的直线扭矩测量
Ashley Dan1, Haresh Vaswani1, Alice Šimonová2,3
1Department of Chemical and Biochemical Engineering, Rutgers, The State University of New Jersey, Piscataway, NJ, USA 08854.
International journal of pharmaceutics: X
|June 30, 2023
概括
这项研究揭示了粉末特性和粘合剂类型如何影响颗粒式扭矩配置文件. 使用扭矩导数的改进方法准确地识别了不同配方类型的颗粒化终点.
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:
- 颗粒化是制药制造中的关键步骤,影响药物产品的性能.
- 扭矩监控提供了一个潜在的在线方法,用于在颗粒过程中的工艺控制.
- 了解配方特性和扭矩配置之间的关系对于过程优化至关重要.
研究的目的:
- 为了研究粉末性质 (颗粒大小,溶解性,可变形性,可湿性) 对粒度扭矩配置文件的影响.
- 评估识别颗粒结尾点的可行性,使用各种配方的扭矩配置.
- 为了将动态颗粒性质 (中等颗粒大小,孔隙性) 与扭矩测量相关联.
主要方法:
- 研究了不同粉末特性异质颗粒配方的扭矩形状.
- 与扭矩测量相关联的动态中间颗粒大小 (d50) 和孔隙性.
- 分析了基于粘合剂类型,API和螺旋速度的两种不同类型的扭矩配置.
主要成果:
- 扭矩配置文件被分为两种类型,主要受粘合剂特性 (粘度,溶解性) 的影响.
- 材料特性,如可变形性和可溶性,显著影响了颗粒的生长和扭矩形状.
- 通过将颗粒物特性与扭矩形状标记 (平原或拐点) 相关联,成功确定了颗粒结尾点.
结论:
- 配方参数极大地影响粒度扭矩形状和由此产生的颗粒性质.
- 为终点识别提出了一种改进的,与配方无关的方法,使用扭矩值的第一个导数.
- 这项研究为实时颗粒处理过程的监控和控制提供了一个强大的方法.
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