Discussion on the pharmaceutical research of generic drugs of sacubitril valsartan sodium tablets
10.13699/j.cnki.1001-6821.2025.02.028
- VernacularTitle:沙库巴曲缬沙坦钠片仿制药药学研究探讨
- Author:
Yun-chuan HAN
1
;
Xiao-hong XU
1
;
Fei LI
1
Author Information
1. 国家药品监督管理局药品审评中心,北京 100076
- Publication Type:Journal Article
- Keywords:
sacubitril valsartan sodium;
pharmaceutical co-crystals;
generic drug;
drug research
- From:
The Chinese Journal of Clinical Pharmacology
2025;41(2):290-295
- CountryChina
- Language:Chinese
-
Abstract:
Sacubitril valsartan sodium tablets are a novel supramolecular co-crystal drug that combines the dual effects of angiotensin receptor blockade and neprilysin inhibitor.It has shown broad application prospects in heart failure,hypertension,maintaining water sodium balance in the body,and protecting target organs,etc.It is a major breakthrough in cardiovascular treatment drugs in recent years.It is clinically used in China for chronic heart failure in adult patients with reduced ejection fraction and primary hypertension.In recent years,pharmaceutical co-crystals has become a hot topic in the research of crystalline drugs,and sacubitril valsartan sodium tablets,as a marketed co-crystal drug,have attracted industry attention.This article summarizes the characteristics of sacubitril valsartan sodium co-crystal drug,the application and approval cases through relevant literature investigation,and discussses pharmaceutical research of the formulation,in order to provide some references for the research and development of generic drugs.
