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配方通过热挤出技术开发固体自纳米乳化药物输送系统,通过热挤出技术:利用中央复合材料设计进行优化

Prateek Uttreja¹, Ahmed Adel Ali Youssef^1,2, Indrajeet Karnik¹

¹Department of Pharmaceutics and Drug Delivery, School of Pharmacy, The University of Mississippi, University, MS 38677, USA.

|March 28, 2024

概括

这项研究开发了一种新的固体自纳米乳化药物递送系统 (S-SNEDDS) 用于使用热挤出,用于氨酸烟酸 (QTF). S-SNEDDS配方增强了QTF的口服生物可用性,并提供延长释放,改善治疗结果.

科学领域:

制药技术制药技术制药技术
药物输送系统药物输送系统
纳米技术纳米技术

背景情况:

氨酸烟酸 (QTF) 由于溶解性差和系统前代谢,具有有限的口服生物利用性.
现有的配方可能无法完全解决QTF对精神分裂症,双相情感障碍和严重抑郁症的治疗挑战.

研究的目的:

开发和制造一个固体自纳米乳化药物输送系统 (S-SNEDDS) 的氨酸烟酸 (QTF).
通过单步热挤出 (HME) 工艺,克服QTF水溶性差和系统前代谢的局限性.

主要方法:

使用了Capmul® MCM,Gelucire® 48/16和烯基醇,分别作为油,表面活性剂和辅助表面活性剂.
使用Soluplus®和KlucelTM EF作为固体载体,比例为1:1.
应用响应表面方法 (中央复合设计) 用于通过连续HME技术进行配方优化.

主要成果:

优化的S-SNEDDS配方实现了92.27 ± 3.4nm的球体大小和3.4 ± 3.38分钟的乳化时间.
差分扫描热量计 (DSC) 和粉末X射线衍射 (PXRD) 证实了QTF在配方中的无形状态.
福利埃变换红外光谱 (FTIR) 显示没有药物辅助剂不兼容性.
该配方在24小时内表现出延长释放特征,并在40°C/75%RH下表现出三个月的稳定性.

结论:

开发的S-SNEDDS配方是一种有效的口服输送平台,用于提氨酸烟酸.
这种新的方法有可能改善QTF治疗的治疗疗效和患者治疗结果.

关键词:

中心复合设计设计的中心复合设计.热挤出方式奎蒂亚平烟酸的使用自行纳米乳化药物输送系统

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