改善现场形成仓库的体内释放预测,使用一种新型的流通式体外溶解装置
Charlotte Peloso1, Etienne Yvorra1, Romain Delamare1
1MedinCell S.A., 3 rue des Frères Lumi ère, 34830 Jacou, France.
International journal of pharmaceutics
|June 22, 2025
概括
为长效注射药物输送系统开发了一种新的流通溶解装置. 该系统提供了更具生物相关性和可翻译性的体外释放数据,有助于早期的研究和开发.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
背景情况:
- 经典的体外溶解系统对于长期作用的注射剂,如in situ形成仓库 (ISFD),是不够的.
- ISFD需要扩展释放测试,并且具有复杂的释放机制,不适合传统方法.
- 有意义和可翻译的体外数据对于可注射配方的早期研发至关重要.
研究的目的:
- 为ISFD开发一种替代的,生物相关的溶解装置.
- 为了促进ISFD从实验室研究向动物研究的过渡.
- 在各种条件下研究相位逆转ISFD技术的释放特性.
主要方法:
- 设计了一种新的流通溶解系统,配备了温度控制的反应室和阿加罗斯水凝.
- 该装置允许连续存储约束和缓冲流.
- 评估了BEPO® ISFD技术的释放概况,包括不同API的温度 (25-45°C) 和流量 (1-10毫升/小时).
主要成果:
- 开发的装置使得能够量身定制体外释放特征.
- 温度显著影响释放率,较高的温度增加了药物释放.
- 较高的温度通常会产生更易于翻译的体外-体内释放特征.
- 与温度相比,流速对释放动力学的影响较小.
结论:
- 这种新的体外溶解设置可以作为一种有价值的替代品,用于体内评估ISFD.
- 优化的条件,不一定是最生物相关的条件,提供了最可翻译的释放特征.
- 这种装置可以提高ISFD性能在早期开发阶段的可预测性.
相关概念视频
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