使用SITUA评估溶解纳米配方的温度依赖药物释放
Stephan T Stern1, Sarah L Skoczen2, Young Hwan Park3
1Nanotechnology Characterization Laboratory, Cancer Research Technology Program, Frederick National Laboratory for Cancer Research, Frederick, MD, USA. sternstephan@mail.nih.gov.
Methods in molecular biology (Clifton, N.J.)
|March 20, 2024
概括
一种改性稳定同位素超过试验 (SITUA) 评估纳米药物的温度依赖的药物释放. 该方法通过评估溶解度与温度的变化,有助于对肠道药物进行批量释放决策.
科学领域:
- 制药科学 制药科学
- 纳米技术纳米技术
- 药物运输 药物运输 药物运输
背景情况:
- 溶解纳米配方对于亲肠道药物输送至关重要.
- 评估药物释放对于监管批量释放至关重要.
- 取决于温度的溶解度会影响药物释放特征.
研究的目的:
- 为了评估从溶解纳米配方中取决于温度的药物释放.
- 建立一种用于评估监管批发释放药物释放的方法.
- 为了利用药物溶解度和温度之间的关系进行质量控制.
主要方法:
- 使用了一种修改的稳定同位素超过试验 (SITUA).
- 该测定使用血模拟介质 (4.5%的人类血清白蛋白).
- 测量了取决于温度的药物溶解度.
主要成果:
- 修改后的SITUA方法证明了对亲肠道纳米药物的特异性.
- 药物释放特征与温度依赖的溶解度相关.
- 该方法允许在可接受和失败的批次之间进行歧视.
结论:
- 修改后的SITUA是评估纳米配方中温度依赖的药物释放的合适方法.
- 这种测试支持对子肠纳米药物的监管批量释放.
- 温度-可溶性关系为纳米药物配方的质量控制提供了基础.
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