连续制造中的粉末剂量:用于重力度剂量配置和设备选择的精简方法
Petra Schneider1, Martin Maus2, Shubhajit Paul3
1Pharmaceutical Development, Boehringer Ingelheim Pharma GmbH & Co. KG, Birkendorfer Straße 65, 88397 Biberach, Germany; Department of Pharmaceutical Technology, University of Bonn, Gerhard-Domagk-Straße 3, 53121 Bonn, Germany.
International journal of pharmaceutics
|November 10, 2024
概括
这项研究引入了一种新的方法,用于在制药生产中选择重力测量剂量设备. 它通过使用更少的材料属性,优化资源使用和提高剂量精度来简化选择.
科学领域:
- 制药工程 制药工程
- 过程化学 过程化学
- 材料科学 材料科学 材料科学
背景情况:
- 选择用于连续制药加工的重力测量剂量配置是复杂的.
- 现有的方法可能不是资源高效或适应新材料.
研究的目的:
- 开发一种简单,可靠的方法来选择重力测量剂量设备配置.
- 在药品连续制造中优化材料,时间和人员的使用.
主要方法:
- 从文学中确定了17个材料属性的减少集.
- 对13种材料测量了这些属性.
- 开发了一种使用12个材料属性的子集并结合精度指标 (相对平均bin内变化) 和模型参数 (fmax,fmin,β) 的预测模型.
主要成果:
- 该模型准确地预测了使用减少的一组材料属性的剂量配置.
- 建立了一种简化的设备选择方法,提高了资源效率.
- 与圆形底部跳跃器相比,平底跳跃器的剂量准确性更高.
结论:
- 这种新型模型简化了连续剂量制药设备的选择.
- 它通过数值排放特征引入了客观性,并提高了资源效率.
- 该方法通过结合精度和曲线适配参数,为连续剂量提供了新的可能性.
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