当它太多时:通过拉曼映射来确定制药预制剂样本表面的布坦过量
Hery Mitsutake1, Gustavo H Rodrigues da Silva2, Eneida de Paula2
1Department of Biochemistry and Tissue Biology, Institute of Biology, University of Campinas - Unicamp, Campinas 13083-862, SP, Brazil; Niels Bohr Institute, University of Copenhagen, Universitetsparken 5, 2100 Copenhagen, Denmark.
Journal of pharmaceutical and biomedical analysis
|August 26, 2023
概括
为局部麻醉剂Butamben开发稳定的纳米结构脂质载体 (NLC) 配方需要仔细选择辅助剂. 这项研究确定了用于增强药物递送系统 (DDS) 的最佳辅助剂和配方策略.
科学领域:
- 制药科学 制药科学
- 药物输送系统 药物输送系统
- 材料科学 材料科学 材料科学
背景情况:
- 布坦是一种局部局部麻醉剂,由于其对水性辅助剂的亲和力,它在基于脂质的药物递送系统 (DDS) 中提出了配方挑战.
- 开发稳定的纳米结构脂质载体 (NLC) 需要仔细选择中极性的辅助剂,以确保活性药物成分 (API) 溶解度和药物加载.
研究的目的:
- 选和确定最佳的助剂,以获得稳定的Butamben NLC配方.
- 评估NLCs中的API溶解和分布均性.
- 建立配方参数以最大限度地提高药物上传和稳定性.
主要方法:
- 针对Butamben溶解的各种辅助剂的全面选.
- 微观评估使用拉曼映射来评估分布式同质性指数 (DHI).
- 实验设计 (DoE) 用于模拟辅助剂相互作用和优化配方参数.
主要成果:
- 辅助剂的选择显著影响API溶解度和NLC稳定性.
- 拉曼映射和DHI分析揭示了最佳的辅助剂组合,以使API分布均.
- DoE模型 (R2 > 0.8824) 阐明了辅助剂相互作用,API度超过30% (w/w),表明可混合系统中的同质性.
- 度与平均图像得分提供了一种替代方法来确定API和限值.
结论:
- 中等极性助剂对于稳定的Butamben NLC配方至关重要.
- 溶解查,拉曼映射,DHI分析和DoE的组合对于优化NLC配方是有效的.
- 该研究为开发可靠的基于脂质的药物递送系统提供了一个框架,用于挑战API.
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