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通过对氧酸盐盐的系统选,直接压缩的平板电脑配方的trimetazidine

Yuebin Ge¹, Zhangyaoyu Yuan¹, Mingzhen Zhang¹

¹School of Pharmaceutical Science, South-central Minzu University and Ethnopharmacology Level 3 Laboratory, National Administration of Traditional Chinese Medicine, Wuhan 430074 Hubei Province, China.

International journal of pharmaceutics

|January 24, 2025

概括

研究人员开发了新的trimetazidine (TMZ) 氧酸盐,以改善药物特性. 1:2的二盐提供了卓越的流量和稳定性,使得这种抗心痛药物的直接压缩片制造成为可能.

科学领域:

制药科学制药科学
材料科学材料科学材料科学

背景情况:

盐的形成对于增强活性药物成分 (API) 特性,如溶解性和稳定性至关重要.
目前的三甲 (TMZ) 片使用湿颗粒,这比直接压缩成本效益低.
商用二化盐 (TMZ-2HCl) 面临的挑战是流动性差和高湿度.

研究的目的:

选和制备三甲酸 (TMZ) 的新型氧酸盐 (Oxa) 盐.
与TMZ-2HCl相比,评估新的TMZ-Oxa盐的固态特性.
开发一种使用最有前途的TMZ-Oxa盐的直接压缩药片配方.

主要方法:

三种TMZ的制备和表征:氧盐 (2:1半盐, 1:1单盐, 1:2二盐).
评估固体特性,包括流动性,可表化性和高度性.
开发和评估一种直接压缩的药片配方.

主要成果:

与TMZ-2HCl.Cl相比,所有三种制备的TMZ-Oxa盐都显示出较好的固态特性.
在新盐中观察到增强的流量,可分片性和湿度稳定性.
TMZ-Oxa 1:2二盐表现出最好的整体性能,优于其他形式.

结论:

新的TMZ-Oxa盐比商用TMZ-2HCl盐有显著的改进.
该TMZ-Oxa 1:2二盐是一种非常有前途的替代晶体形式为trimetazidine.
通过使用TMZ-Oxa 1:2二盐成功开发了一种可行的直接压缩片剂配方.

关键词:

直接压缩直接压缩.流动性流动性流动性盐的形成盐的形成稳定的稳定性稳定的稳定性可以作为片剂的可用性.药片药片药片药片三甲丁是三甲丁的一种药物.

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