在微波辅助的体内光谱度表征,使用质量通过设计的方法,使用teneligliptin加载的固体分散吸附剂
Pintu Prajapati1, Princy Ardeshana1, Yashwini Kansara1
1Department of Quality Assurance and Department of Pharmaceutics, Maliba Pharmacy College, Maliba Campus, Bardoli-Mahuva Road, Tarsadi, Mahuva, Surat, 394 350, Gujarat, India.
Analytical biochemistry
|February 1, 2025
概括
一种新的微波辅助方法准确地量化了固体分散吸附剂 (TNG-SDA) 中的丁利普丁. 这种绿色分析技术提高了teneligliptin的生物可用性和溶解性,以改善药理动力学研究.
科学领域:
- 分析化学 分析化学
- 制药科学 制药科学
- 绿色化学 绿色化学
背景情况:
- 丁利普丁是一种BCSII类药物,具有较差的溶解性和生物可用性.
- 固体分散吸附剂 (SDA) 配方增强了药物的溶解性.
- 准确的in-vivo表征对于药物开发至关重要.
研究的目的:
- 开发一种微波辅助的光谱法测法方法,用于测量丁利格利的量化.
- 使用设计质量 (QbD) 原则优化方法.
- 评估TNG-SDA的药理动力学和药理动力学益处.
主要方法:
- 用NBD-Cl.Cl进行微波辅助的利格利普丁衍生物化.
- 通过设计质量 (QbD) 方法来优化方法 (包括FMEA和响应表面建模).
- 谱流量测量分析,质谱学,体外溶解,药理动力学和药理动力学研究.
主要成果:
- 确立了特内利格利普丁光的线性 (50-250 ng/mL,R2=0.9978).
- 开发的方法是准确的,精确的,坚固的,特定的和敏感的.
- 与商业配方相比,TNG-SDA显著改善了利格利普丁的溶解性和生物可用性.
结论:
- 微波辅助光谱测量方法提供了一种灵敏,绿色和具有成本效益的替代方案,用于分析teneligliptin.
- 这种方法适用于药理动力学研究中的纳米克级检测.
- 开发的TNG-SDA配方增强了teneligliptin的治疗潜力.
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