冰核温度,工艺效率和冷产品质量之间的反向关系的根本原因分析
Maxwell Korang-Yeboah1, Ann-Marie Ako-Adounvo1, Leanna Hengst1
1Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, Food and Drug Administration, MD, USA.
Journal of pharmaceutical sciences
|August 30, 2023
概括
控制的冰核化 (CIN) 在冷化中意外影响产品属性和干燥效率. 较低的核化温度 (CIN-5°C) 提高了水活动的一致性,但增加了抵抗力,表明微观结构变化影响了过程结果.
科学领域:
- 制药科学 制药科学
- 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:
- 解热化是稳定药品的关键过程.
- 控制式冰核化 (CIN) 旨在提高冷化效率和产品质量.
- 冰核化温度 (TIN) 和产品属性之间的关系需要进一步研究.
研究的目的:
- 调查TIN,工艺效率和CIN冷凍化中的产品属性之间的意想不到的关系.
- 为了比较随着和没有受控的冰核化 (NOCIN) 的冷化.
- 分析不同TIN值对产品微观结构和性能的影响.
主要方法:
- 利用了先进的在线和离线过程分析技术 (PAT) 工具.
- 在冷凍化過程中監控的工藝參數和產品屬性.
- 采用热流分析,微型CT成像和人工智能图像分析.
主要成果:
- 在CIN过程中发现TIN和初级干燥效率之间存在间接关系.
- 与CIN-7°C和CIN-10°C相比,CIN-5°C的产品对质量流动的抵抗性更高.
- 微观结构变化,包括蛋糕壁变形和空气空隙分布,与工艺效率和TIN有关.
结论:
- 观察到的TIN与工艺效率之间的关系很可能是由于冷后的微观结构变化.
- 考虑到初级和二级干燥的坚固的工艺设计对于实现CIN的好处至关重要.
- 集成的PAT工具可以加速采用先进的冷化技术,如CIN.
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