基于预配方策略的热挤压固体分散的制备及其增强的治疗效率
Seon-Kwang Lee1, Eun-Sol Ha1, Heejun Park2
1College of Pharmacy, Pusan National University, 63 Busandaehak-ro, Geumjeong-gu, Busan 46241, Republic of Korea.
Pharmaceutics
|December 23, 2023
概括
这项研究使用热挤出开发了bisacodyl的无形固体分散,增强了其治疗功效. 基甲基纤维素 (HPMC) 配方在子中表现出优越的物理稳定性和体内松作用.
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:
- 比萨科迪尔是一种水溶性较差的药物,限制了其治疗功效.
- 无形固体分散 (ASDs) 可以增强难溶性药物的可溶性和生物利用性.
研究的目的:
- 用热挤出方法制备和描述bisacodyl的无形固体分散物.
- 调查药物聚合物混合性和相互作用,以开发最佳配方.
- 评估开发的bisacodyl ASDs的体外和体内性能.
主要方法:
- 汉森溶解度参数计算和差异扫描热量计 (DSC) 用于混合性评估.
- 动态蒸汽吸附 (DVS),富里叶变换红外光谱 (FT-IR) 和拉曼光谱用于药物聚合物相互作用分析.
- 在便引起的子中进行非水槽溶解试验和体内研究,以评估治疗疗效.
主要成果:
- 证实了bisacodyl和聚合物之间的混合性,其中基甲基纤维素 (HPMC) 显示出优越的物理稳定性和抗沉效应.
- HPMC-bisacodyl ASDs在体外溶解中表现出显著改善的溶解概况.
- 与原始bisacodyl相比,含有HPMC-bisacodyl的肠涂片显示在体内增强了便疗效.
结论:
- 预制策略有效指导了对比萨科迪尔ASDs适合的聚合物的选择.
- 热挤出是一种可行的方法,可以生产稳定有效的bisacodyl ASDs.
- 开发的HPMC-bisacodyl ASDs为治疗便秘提供了更好的治疗潜力.
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