通过设计的质量方法优化微生物和pH触发的结肠向药片配方,使用卡尔博西甲基 (Carboxymethyl Tamarind Gum) 进行设计
Jaymin Patel1,2, Kaushika Patel1, Shreeraj Shah1
1L. J. Institute of Pharmacy, LJ University, Ahmedabad, India.
Assay and drug development technologies
|October 13, 2023
概括
使用设计质量方法开发的Carboxymethyl tamarind,有效地准结肠以提供布德索尼德. 优化的配方显示稳定性和在目标部位完全释放药物.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 自然聚合物的应用 自然聚合物的应用
背景情况:
- 针对结肠的药物输送旨在提高局部疾病的治疗疗效.
- 由于微生物的降解,天然的多糖具有潜在的结肠特异性药物释放的潜力.
- 布德索尼德是一种用于炎症性肠道疾病的皮质类固醇,受益于向输送.
研究的目的:
- 使用设计质量 (QbD) 方法开发和优化一种微生物和pH触发的针对结肠的布德索尼德片.
- 为了评估各种天然多糖的适合性在结肠向.
- 确定碳甲基塔玛林作为布塞尼德结肠向配方的优质聚合物.
主要方法:
- 对多糖体牙 (鱼,格兰兰,卡拉亚,牙古蒂,哈亚) 进行微生物降解和结肠向的回顾性选.
- 使用模仿老鼠乳液含量的益生菌培养基进行粘度分析.
- 使用Box-Behnken设计的配方优化,使用carboxymethyl tamarind,水含量和Eudragit S100涂层作为变量.
- 根据国际协调理事会的指导方针进行稳定性测试和用于体内评估的X光学研究.
主要成果:
- 碳氧甲基 (CM) 茄子在结肠向方面表现优越,与原生茄子相比.
- 在湿颗粒中使用的水也有助于减缓药物释放.
- 优化的配方 (F3) 符合预定义的释放标准:在2小时内释放<5%,在5小时内释放<10%,在8小时内释放>70%.
- 放射性基因检查证实,该药片在5小时内保持完整,并在7小时后完全传播.
结论:
- CM茄是一种有效的聚合物,用于开发微生物和pH触发的结肠向布德索尼德片.
- QbD方法成功优化了配方,实现了所需的结肠向特征.
- 优化的配方表现出良好的稳定性和体内性能,表明其治疗潜力.
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