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使用融方法设计基于粉的纤维酸制剂.

Jeong Sun Sohn1, Ye Eun Choi2, Jin-Seok Choi3

  • 1Division of Interdisciplinary Studies, Chosun University, Ph.D, Associate Professor, Gwangju 61452, Republic of Korea.

International journal of biological macromolecules
|June 7, 2024
PubMed
概括

这项研究开发了一种丰纤维酸 (FNF) 固体分散 (SD) 以提高药物的溶解性和稳定性. 与商业产品相比,最佳的FNF-SD配方显著提高了FNF溶解率.

关键词:
解散的百分比 解散的百分比纤维酸盐的使用方法超脂血症是因为高脂血症利皮迪尔 (Lipidil®) 是一种药物.化方法 化方法稳定的稳定性 稳定的稳定性

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科学领域:

  • 制药科学 制药科学
  • 药物输送系统 药物输送系统
  • 物理药房 物理药房

背景情况:

  • 纤维酸 (FNF) 是一种水溶性较差的药物,用于治疗高脂血症.
  • 商业FNF配方,如Lipidil®,由于溶解性差,剂量高 (160毫克).
  • 开发增强的FNF配方对于提高治疗疗效至关重要.

研究的目的:

  • 开发一种全纤维化固体分散剂 (SD),以提高溶解度和稳定性.
  • 使用融方法优化FNF-SD配方.
  • 评估开发的FNF-SD的溶解,物理化学性质和稳定性.

主要方法:

  • 利用 FNF-SD 制备的融方法,利用 FNF 的低点.
  • 在不同时间点在各种介质 (pH1.2,蒸水,pH6.8缓冲剂与SLS) 中评估FNF溶解.
  • 评估了最佳FNF-SD配方的物理化学特性 (点,结晶性) 和长期稳定性 (六个月).

主要成果:

  • 与Lipidil®和纯 FNF相比,最佳的 FNF-SD (SD2) 配方在5分钟内显著增加了 FNF 溶解率.
  • 在60分钟内,SD2在所有测试的介质中实现了近100%的FNF溶解.
  • SD2配方在FNF的点和结晶度上出现了轻微的变化,稳定性保持了六个月,特别是添加粉#1500时.

结论:

  • 开发的FNF-SD配方有效地增强了FNF溶解,这是由于药物辅助剂的结合较弱而导致的.
  • FNF-SD配方表现出良好的稳定性,这对于制药应用至关重要.
  • 改善的溶解度和稳定性表明未来体内研究的结果很有希望.