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西尔德纳菲尔-HPBCD含有复合剂与制药辅助剂的兼容性研究

Răzvan Adrian Bertici^1,2, Amalia Ridichie^3,4, Nicoleta Sorina Bertici^2,5

¹Doctoral School, "Victor Babeş" University of Medicine and Pharmacy Timișoara, Eftimie Murgu Square No. 2, 300041 Timișoara, Romania.

|September 27, 2025

概括

研究人员开发了一种西尔代纳菲尔酸盐和2-基基-β-环氧德克斯含复合物. 这种复合物与制药辅料具有良好的兼容性,为新的药物输送系统铺平了道路.

科学领域:

制药科学制药科学
药物输送系统药物输送系统
物理化学物理化学

背景情况:

西尔德纳菲尔酸盐的治疗用途已经从胸痛演变为勃起功能障碍和肺动脉高血压.
作为生物制药分类系统II类药物,西尔德纳菲尔酸盐由于第一通代谢,具有较低的生物利用性.
优化西尔代纳菲尔酸盐的生物制药特征对于开发先进药物配方至关重要.

研究的目的:

为了创建和描述1: 1包含的复杂的西尔代纳菲尔酸盐与2-基基-β-环氧.
为了评估这个含有六种不同的辅助物质的复合物的药物兼容性.
为了研究西尔代纳菲尔酸盐和选定的辅助剂之间的潜在化学相互作用.

主要方法:

通过分子建模,乔布的方法和贝内西-希尔德布兰德的方法来确定复杂的固体测量.
纳入复合物和二进制混合物的表征使用减弱总反射率里埃变换红外光谱 (ATR-FTIR) 进行.
热分析,包括热重力测量 (TG/DTG) 和差分扫描热量测量 (DSC),用于评估热稳定性和相互作用.

主要成果:

ATR-FTIR证实,在环境温度下,西尔德纳菲尔酸复合物和所有六种辅助剂之间没有化学相互作用.
在非异热加热条件下,热分析 (TG/DTG和DSC) 揭示了包含复合物和三种辅助物之间的化学相互作用.
1: 1 摩尔比率纳入复合体形成成功验证.

结论:

一种新型的西尔代纳菲尔酸盐和2-基基-β-环氧素含有复合物被成功制备和表征.
纳入复合体表明与测试的辅助剂具有显著的药物兼容性,这对于预制剂研究至关重要.
这些发现支持开发具有改进生物制药性质的先进的西尔德纳菲尔酸输送系统.

关键词:

兼容性研究兼容性研究循环德克斯特林 (Cyclodextrin) 是一种循环德克斯特林.包容复杂的包容复杂的包容西尔德纳菲尔酸

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