通过设计优化贝达基林固体脂质纳米颗粒的质量方法,以提高产品性能
Mercy A Okezue1,2, Chidi Uche3, Adekoya Adebola4
1Industrial and Molecular Pharmaceutics Department, Purdue University, West Lafayette, Indiana, 47907, USA. Amaka_u@hotmail.com.
AAPS PharmSciTech
|July 2, 2024
概括
这项研究开发了口服贝达基林固体脂质纳米颗粒 (SLN),以改善结核病治疗的坚持. 口服SLN配方改善了药物输送和患者的服药效果,相比于亲肠道选择.
科学领域:
- 制药科学 制药科学
- 纳米技术纳米技术
- 药物运输 药物运输 药物运输
背景情况:
- 肠道Bedaquiline (BQ) 固体脂质纳米颗粒 (SLNs) 在结核病治疗中面临患者不遵守的挑战.
- 开发口服输送系统对于改善患者坚持治疗和治疗结果至关重要.
研究的目的:
- 开发和表征Bedaquiline (BQ) 固体脂质纳米颗粒 (SLN) 用于口服.
- 通过改进的药物输送系统,提高患者对结核病治疗的坚持.
主要方法:
- 使用全因数设计 (3x2x2x2) 来优化使用BQ,莱素,Tween 80和PEG的BQ-SLN配方.
- 粒子大小分布 (PSD),多分散度指数 (PdI) 和泽塔潜力 (ZP) 使用泽塔测量器和TEM进行了评估.
- 固态特性涉及X射线衍射和SEM;体外药物释放研究比较BQ-SLN与BQ自由基.
主要成果:
- 超声波显著影响PSD,PdI和ZP,BQ在超声波配方中表现出更大的影响 (p<0.0091).
- SEM图像证实BQ纳米晶体嵌入在脂质矩阵内,范围为100-400nm.
- 与BQ自由基相比,BQ-SLN配方在体外释放的药物更高,相似度因子 (f2) 为18.3.3.
结论:
- 口服贝达基林 (BQ) 固体脂质纳米颗粒 (SLNs) 为改善结核病治疗的坚持提供了一个有前途的策略.
- 开发的SLN配方增强了药物输送和生物可用性,可能导致更好的患者遵守.
- 这种口服输送系统代表了对结核管理的亲口服配方的重大进步.
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