在最近提交的新药和缩写药物申请中观察到的常见缺陷
Lixia Cai1,2, Haitao Li3, Hang Guo3
1Office of Pharmaceutical Manufacturing Assessment, Office of Pharmaceutical Quality, CDER, Food and Drug Administration, Silver Spring, Maryland, 20993, USA. lixia.cai@fda.hhs.gov.
AAPS PharmSciTech
|January 23, 2026
概括
高剪切湿颗粒 (HSWG) 工艺控制对于药物产品质量至关重要. 对FDA数据 (2017-2022) 的分析揭示了HSWG终点,流体控制和扩展策略的常见缺陷.
科学领域:
- 制药制造业 制药制造业 制药制造业
- 过程化学 过程化学
- 药物产品质量 药物产品质量
背景情况:
- 高剪湿颗粒 (HSWG) 是一种标准的药品制造方法,用于口服固体剂型.
- 有效的工艺控制对于确保一致的颗粒和最终药物产品质量至关重要.
- 制造过程控制缺陷可能导致美国食品和药物管理局 (FDA) 等监管机构对药物申请的审查时间延长.
研究的目的:
- 在FDA评估的药物应用中分析高剪切湿颗粒处理 (HSWG) 控制的常见缺陷.
- 为了确定特定的关键过程参数,在HSWG中经常缺乏足够的控制.
- 为改善 HSWG 流程控制和确保药物产品质量提供建议.
主要方法:
- 分析2017年至2022年期间提交的FDA药物申请中的制造评估缺陷.
- 专注于使用高剪切湿颗粒 (HSWG) 用于口服固体剂型的应用.
- 在HSWG流程中识别和分类反复出现的控制缺陷.
主要成果:
- 缺乏对粒度终点的控制是一个经常出现的缺陷.
- 通常观察到的问题是对颗粒液水平和添加率的控制不足.
- 对于湿时间和工艺扩大规模的控制策略不足也被确定为重大缺陷.
结论:
- 在HSWG过程控制中常见的缺陷,特别是终点确定和流体管理,影响药物产品的质量.
- 解决已发现的控制缺陷,包括扩大规模的战略,对于强大的制药制造至关重要.
- 实施增强的过程控制可以提高监管审查的效率,并确保制造的药物产品的质量.
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