通过实验和建模,阐明结静态对冷化中的干燥动力学的影响
Andraž Košir1, Jan Zagar1, Nicole Ferru1
1Institute of Energy and Process Engineering, ETH Zurich, 8092 Zurich, Switzerland.
Journal of pharmaceutical sciences
|September 28, 2025
概括
干动力学取决于冰晶的形成. 早些时候的冰核化会导致更快的干燥,而晚些时候的核化会减缓过程,影响产品的稳定性.
科学领域:
- 制药工程 制药工程
- 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:
- 冷干燥 (冷化) 对于稳定制药和食品至关重要.
- 在冷过程中形成冰晶,形成一个有孔的结构,控制了化速率.
- 瓶子之间的冰核的变化使工艺控制和产品统一性变得复杂.
研究的目的:
- 为了研究结条件和冰核化变异对冷干燥动力学的影响.
- 为了将瓶级结参数与升华率相关联.
- 增强对孔状网络结构与干燥性能之间的关系的理解.
主要方法:
- 使用了一种新型的红外热图设置来实时监控产品温度.
- 结合热谱与重力测量分析,精确测量整个批次的升华率 (约. 60个小瓶).
- 进行了糖-曼尼托尔配方和纯水控制的实验.
主要成果:
- 证明了冷条件 (核化时间,温度,固化时间) 和沙克-曼尼托尔瓶中的干燥动力学之间的明显相关性.
- 观察到较早的核形成导致较慢的固化和更快的干燥.
- 在纯水中没有发现相关性,突出了多孔结构的关键作用.
结论:
- 冷条件通过改变瓶子的多孔网络,显著影响冷干燥动力学.
- 早期核化增强了干燥速度,而晚期核化则减缓了干燥速度.
- 开发了一种可靠的方法来量化结变异性对升华率的影响.
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