自乳化药物输送系统:概念到应用,监管问题,最近的专利,当前的挑战和未来的方向
Rajib Lochan Maharana1, Suryakanta Swain2, Santosh Kumar Mahapatra3
1Pharmacy, Biju Patnaik University of Technology (BPUT), Chhend Colony, Rourkela, 769004, Odisha, India.
Current pharmaceutical biotechnology
|June 24, 2024
概括
自乳化药物输送系统 (SEDDS) 提高了难以溶解药物的溶解性和生物可用性. 本综述涵盖了SEDDS的进展,配方,表征以及改善药物输送的未来机会.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
背景情况:
- 很大一部分新药具有较差的水溶性,这给口服药物带来了挑战.
- 溶解性差导致剂量比例性,高可变性和有限的生物可用性等问题,特别是在肺部.
研究的目的:
- 总结自乳化药物输送系统 (SEDDS) 的进展,组件,变异,生产技术,特征,局限性和机遇.
- 提供关于生物制药在SEDDS方面的进展的当前情况,包括设计质量 (QbD) 和监管方面.
主要方法:
- 审查关于SEDDS的现有文献.
- 对配方成分的分析,包括表面活性剂,辅表面活性剂和辅溶剂.
- 探索SEDDS的生产和表征技术.
主要成果:
- 含有脂性药物的SEDDS配方可以在最小的动下形成微乳液和乳液.
- 对于脂性药物,各种SEDDS配方和技术的有效性已被证明.
- 该研究强调了QbD方法的应用,以优化SEDDS中的药物配方.
结论:
- SEDDS提供了一种有希望的方法来克服药物溶解性差并提高生物可用性.
- 未来的方向包括优化SEDDS组成,评估,多种剂型和固态转换技术.
- 解决监管障碍对于SEDDS技术的发展至关重要.
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