从批量转移到连续直接压缩制造的新诺氨酸化物持续释放片的框架
Guoming Zhou1, Hao Chang1, Guangpu Fang1
1College of Pharmaceutical Engineering of Traditional Chinese Medicine, Tianjin University of Traditional Chinese Medicine, Tianjin, 301617, PRC.
Drug development and industrial pharmacy
|February 10, 2026
概括
这项研究验证了将制药制造从批量转移到连续直接压缩的框架. 新的工艺确保了产品质量和与原始批发的等价性,提供了低风险的现代化途径.
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.
- 过程化学 过程化学
背景情况:
- 连续制造 (CM) 在不进行再配方的情况下转移传统制药产品时提出了挑战.
- 开发一个数据驱动的途径可以降低过渡到CM的风险.
- 与设计质量原则和ICH Q13指导方针保持一致,对于成功实施CM至关重要.
研究的目的:
- 建立和验证一个实用的框架,从批量转移Sinomenine化持续释放片到试点规模的连续直接压缩 (CDC).
- 通过CM.展示一个可复制的战略,通过CM.现代化传统药品.
- 为了实现更高的成本效益和过程可持续性.
主要方法:
- 使用了一条集成的试点规模的CDC线路 (1.9公斤/小时) 配有减肥料器,连续机和旋转平板压机.
- 通过实线NIR光谱技术实现了基于过程分析技术 (PAT) 的控制策略,并采用了部分最小方程 (PLS) 模型来实时量化API.
- 使用居住时间分布 (RTD) 分析描述了过程动态和材料可追溯性.
主要成果:
- 在300分钟的CDC稳定状态运行中表现出强大的稳定性和控制能力.
- 通过实时监控,通过实时监控确认了在±3%的宽容范围内一致的API内容统一性.
- 在所有关键质量属性 (包括溶解概况) 上,已证明CDC生产的片剂与参考批次的等价性.
结论:
- 成功验证了一种全面的框架,用于将持续释放药片的批量转移到连续转移.
- 支持PAT的控制策略确保了流程的稳定性和可靠的实时质量验证.
- 证明的产品质量相当性证实了现代化现有制药生产的低风险,符合指导方针的途径.
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