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系统开发和优化微流体配方协议的脂质体亚胺酸的系统开发和优化.

Abdullah A Masud1, Nabilah Ibnat1, Areli Medina Hernandez1

  • 1Department of Pharmaceutical Sciences, College of Pharmacy, University of Kentucky Lexington KY 40536 USA Vincent.venditto@uky.edu.

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概括

微流体纳米沉提供了一种可扩展的方法,用于生产脂体亚胺素 (L-AZM),用于治疗心脏损伤. 与传统方法相比,这种优化的L-AZM配方显示出更好的质量属性,为临床使用铺平了道路.

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科学领域:

  • 制药科学 制药科学
  • 纳米技术纳米技术
  • 心血管研究研究心血管研究

背景情况:

  • 脂质体亚胺素 (L-AZM) 在心肌梗塞后治疗心脏损伤方面表现有前途.
  • 对于L-AZM生产的传统薄膜水化 (TFH) 面临着可扩展性和可重复性问题,阻碍了临床转化.

研究的目的:

  • 用微流体纳米沉来优化脂质体亚胺素 (L-AZM) 配方,以改善制造和临床适用性.
  • 与TFH相比,通过微流体生产的L-AZM的关键质量属性 (CQAs) 的评估.

主要方法:

  • 系统优化微流体纳米沉参数 (流速比,总流速).
  • 使用DSPC:DSPG:Chol:AZM摩尔比率进行配方调整.
  • 评估脂质体大小,多分散性指数 (PDI),封装效率和泄漏.
  • 微流体和TFH方法之间的体外巨细胞极化活性的比较.

主要成果:

  • 最佳的微流体参数确定为 4:1 流量比和 10 mL/分钟总流量.
  • 与TFH相比,一个优化的配方 (DSPC:DSPG:Chol:AZM 1:1:1:0.5) 显示了较小的尺寸和PDI.
  • 两种配方方法之间在体外巨细胞极化活性上没有显著差异.

结论:

  • 微流体纳米沉为生产具有增强质量属性的L-AZM提供了一种可复制和可扩展的方法.
  • 优化的L-AZM配方适合进一步的临床前开发和潜在的临床转换用于心肌梗塞治疗.
  • 这项研究为先进的脂质体药物递送系统建立了制造途径.