通过双螺旋融涂层和颗粒化,高剂量修饰释放配方的难溶药物
Shashwat Gupta1, Thamer Omar1, Qiushi Zhou1
1Chemical and Biochemical Engineering, Rutgers University, 98 Brett Road, Piscataway, NJ 08854, USA.
International journal of pharmaceutics
|December 16, 2024
概括
一种新的化涂层和颗粒化方法增强了Favipiravir的口服输送,这是一种难以溶解的抗病毒药物. 这种技术有效地产生高剂量,修饰释放片用于治疗各种疾病.
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
- 材料科学 材料科学 材料科学
背景情况:
- 法维皮拉维尔是一种有效的口服抗病毒药物,用于治疗COVID-19,但其水溶性不佳.
- 制造低溶性药物的高剂量配方具有重大挑战.
- 尽量减少辅助剂的使用对于有效的药物配方至关重要.
研究的目的:
- 开发一种简单,低成本的融涂层和颗粒化 (MCG) 方法,用于高剂量法维皮拉维尔片.
- 为了制造具有更好的溶解性和可片性的法维皮拉维尔颗粒.
- 为了达到所需的可控释放配置,用于高剂量配方的难溶性药物.
主要方法:
- 使用双螺旋融涂层和颗粒化 (MCG) 用Poloxamer P188作为粘合剂和表面活性剂.
- 创建了具有增强溶解性和可分片性的法维皮拉维尔颗粒.
- 用额外颗粒状成分 (HPMC,酸) 压缩的颗粒成可控释放片.
主要成果:
- 成功开发了高剂量 (82.5% w/w API) 法维皮拉维尔片 (600 mg 和 800 mg).
- MCG有效地涂层和颗粒化了难以溶解的药物.
- 配方表现出所需的可控释放配置文件.
结论:
- MCG是制造低溶性药物的高剂量修饰释放配方的有效方法.
- 该方法使用低点表面活性剂作为粘合剂和湿化剂.
- 这种技术适用于用于治疗传染病,癌症和自身免疫性疾病的药物.
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