综合连续湿颗粒和干燥:过程评估和与批量加工进行比较
Seth P Forster1, Erin Dippold1, Abbe Haser2
1Merck & Co., Inc., West Point, PA 19486, USA.
Pharmaceutics
|September 28, 2023
概括
药品的连续制造正在推进. 持续湿颗粒和干燥的新设备显示出有前途,生产高质量的颗粒与传统批量方法相比.
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:
- 制药行业正在从批量制造转向连续制造.
- 由于设备的局限性,湿颗粒对连续加工带来了独特的挑战.
- 对于连续颗粒干燥的选择有限.
研究的目的:
- 描述新型连续湿颗粒和干燥设备的工艺空间.
- 用这种新设备生产的颗粒与传统的批量方法进行比较.
- 评估连续湿颗粒和干燥的有效性和质量.
主要方法:
- 使用了试点和商业规模的设备,结合了双螺丝湿颗粒机和水平振动液床干燥器.
- 描述了连续设备的工艺空间.
- 通过连续和批量 (高剪切和流体床) 湿颗粒加工过程产生的颗粒性能进行比较.
主要成果:
- 这种新型设备有效地在各种配方中进行颗粒和干燥.
- 生产的颗粒的质量与批处理过程中的颗粒相比或更好.
- 该设备展示了一个可行的工艺空间,用于连续的湿颗粒和干燥.
结论:
- 开发的双螺杆颗粒器和振动流体床干燥系统对于连续湿颗粒和干燥是有效的.
- 这项技术为传统的批量湿颗粒制造提供了可行的替代方案,生产高质量的颗粒.
- 这些发现支持湿颗粒工艺向连续制造的过渡.
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