长效注射微球的微结构形成和特征:通往完全控制药物释放模式的门户
Mengdi Wang1, Shan Wang1, Changhao Zhang2
1State Key Laboratory of Toxicology and Medical Countermeasures, Beijing Institute of Pharmacology and Toxicology, Beijing, 100850, People's Republic of China.
International journal of nanomedicine
|February 26, 2024
概括
了解微球微观结构是开发可控制的长效注射剂的关键. 本综述详细介绍了影响微观结构的因素和药物输送系统的先进表征技术.
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:
- 长效注射微球提供持续的药物输送,但在控制释放动力学方面面临挑战.
- 只有12种这样的产品得到了FDA的批准,这凸显了改善配方和表征的必要性.
研究的目的:
- 审查影响微球微观结构形成的关键因素.
- 为了突出微球微观结构表征技术的最新进展.
- 为开发可控制的长效注射微球和通用替代品提供见解.
主要方法:
- 文献综述侧重于影响微球微观结构的配方成分和制备过程.
- 对微观结构特征化技术的最新进展进行分析.
主要成果:
- 微球微观结构,包括药物,PLGA和孔隙分布,对于药物释放至关重要.
- 美国食品和药物管理局 (FDA) 建议进行比较微观结构表征 (Q3) 进行生物等价性评估.
- 影响微观结构的关键变量来自配方和制备.
结论:
- 对微球微观结构的更深入的理解对于推进长效注射药物输送至关重要.
- 这种知识对于开发通用微球产品尤其有价值.
- 专注于微观结构有助于实现可预测和可控制的药物释放模式.
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