优化自我乳化药物输送系统,以口服输送一种疏水离子离子配对的酶复合物
Martin Deák1, Nur Aslan2, Eslam Ramadan1,3
1Institute of Pharmaceutical Technology and Regulatory Affairs, University of Szeged, Eötvös u. 6., H-6720 Szeged, Hungary.
Pharmaceutics
|February 27, 2026
概括
这项研究开发了自乳化药物输送系统 (SEDDS) 用于口服lyszyme的输送. 优化的SEDDS配方实现了小滴体大小,并在6小时内释放了80%的酶,显示了口服生物制药输送的前景.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 生物技术是生物技术.
背景情况:
- 由于胃肠道的降解和吸收不良,口服生物制药的输送具有挑战性.
- 自乳化药物递送系统 (SEDDS) 通过保护宏分子和增强肠道吸收提供了一个潜在的解决方案.
- 莱索 (LYZ) 被选为口服研究的模型/蛋白质.
研究的目的:
- 为了研究SEDDSs对口服lyszyme输送的疗效.
- 通过使用SEDDSs来模拟和蛋白质的口服.
- 了解影响生物制药SEDDS性能的配方参数.
主要方法:
- 酶/二硫酸盐 (SDS) 疏水离子对 (HIP) 已准备好,以提高溶解性和稳定性.
- 使用各种表面活性剂 (Tween® 20/80) 和共表面活性剂 (Span® 20/80) 通过2^2全因数设计和混合物设计来制定液体SEDDS.
- 使用动态光散射 (DLS) 分析了关键质量属性 (CQAs),包括滴滴大小,PDI和zeta潜力.
- 响应表面方法 (RSM) 和三元轮图定义了过程设计空间.
- 实验室释放研究使用样本和分离方法进行.
主要成果:
- 优化的SEDDS配方实现了滴滴大小<200nm,PDI<0.4和zeta电位<-10mV.
- 成功地实现了10 mg/g的疏水离子对 (HIP) 负荷.
- 试验室释放特征遵循明显的第一阶动力学,大约80%的溶酶在6小时内释放.
结论:
- 这项研究提供了关于SEDDSs用于口服生物制药的配方的见解.
- 了解配方组件的相互作用对于优化SEDDS性能至关重要.
- 开发的SEDDS方法显示了可以口服和蛋白质的潜力,如lyszyme.
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