均喷雾干燥的loxapine微粒可能用于鼻腔分娩:探索歧视性体外释放评估方法
Mengyuan Li1, Ziwei Nie1, Shen Yan1
1Engineering Research Centre of Advanced Powder Technology, School of Chemical and Environmental Engineering, College of Chemistry, Chemical Engineering and Materials Science, Soochow University, Suzhou, Jiangsu Province, 215123, People's Republic of China.
The AAPS journal
|March 13, 2025
概括
研究人员开发了测试鼻粉 (NP) 释放的新方法. 他们使用洛克萨平酸盐 (LOX) 和凝 (GEL) 制造了微粒,发现Transwell®系统最适合评估NP性能.
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:
- 开发有效的鼻粉 (NP) 试验室评估方法对于药物输送至关重要.
- 准确的释放研究需要具有可调节性质的标准化微粒.
研究的目的:
- 建立可靠的体外方法来评估鼻粉的释放行为.
- 为了研究洛克萨糖酸盐 (LOX) 和凝 (GEL) 微粒的制造和表征.
主要方法:
- 使用微流体喷射干燥机 (MFJSD) 与乙醇/水溶剂同时喷雾干燥LOX和GEL.
- 系统地调查LOX/GEL比率和溶剂组成对粒子特征 (大小,形态,晶度) 的影响.
- 使用各种介质,装置和膜进行体外释放分析,重点是改进的Transwell®系统和模拟的鼻电解质溶液 (SNES).
主要成果:
- 成功合成了具有可调整大小和形态的标准化微粒.
- 确定了修改后的Transwell®系统与SNES作为区分NP性能的最佳设置.
- 证明了粒子特征 (大小,形态,结晶性) 对体外释放谱的影响.
结论:
- 已经建立了一种可靠的方法来对NP释放概况进行体外评估.
- 该研究为制造高质量的NP产品提供了实用方法.
- 了解微粒子属性和释放行为之间的关系是产品开发的关键.
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