在冷化产品中消除雾:制药加工的影响
Navpreet Kaur1, Apurva More2, Jacob McKeeby3
1Biologics Drug Product Development, Sanofi, Framingham, MA 01701, USA.
Journal of pharmaceutical sciences
|March 31, 2024
概括
在冷干燥药物中控制玻璃瓶雾化至关重要. 优化冷化循环,比如添加一个回暖步骤和预冷,显著减少了化品缺陷和潜在的完整性问题.
科学领域:
- 制药科学 制药科学
- 材料科学 材料科学 材料科学
背景情况:
- 玻璃瓶雾化是冷干燥药品的一个常见缺陷.
- 这种化品问题可能会影响容器封闭的完整性,并增加排斥率.
研究的目的:
- 评估加工条件对玻璃瓶雾化的影响.
- 确定缓解冷化药物产品雾的方法.
主要方法:
- 研究了瓶子的预处理,冷化周期的修改和填充条件.
- 使用雾评分量化雾严重程度.
- 使用基于染料的方法研究了溶液上升 (Marangoni流).
- 分析的头部空间相对湿度 (RH).
主要成果:
- 在冷化循环中的化步骤可测量地改善了雾.
- 在5°C的冷前异热保持减少了雾;增加的冷时间没有影响.
- 瓶子预处理影响了Type 1瓶子的雾化,但不是TopLyo®瓶子.
- 头部空间RH表示条件有利于水化膜的形成.
结论:
- 热化周期的修改,特别是化和冷前保持,有效地减少了玻璃瓶雾化.
- 瓶子类型会影响预处理条件对于雾控制的关键性.
- 了解头部空间条件是管理Marangoni流和雾的关键.
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