Injection of nicardinpine hydrochloride and process for the production thereof

Abstract

An injectable composition of nicardipine hydrochloride comprising an aqueous nicardipine hydrochloride solution containing 2-7 w/v % of polyhydric alcohol. This injectable composition can maintain its desired concentration and can be stably stored for a long period of time.

What is claimed is: 
     
       1. A stable, injectable composition of nicardipine hydrochloride .[.in ampoule form.]. comprising an aqueous nicardipine hydrochloride solution containing 0.04 to 0.6 W/V% nicardipine hydrochloride and 2 to 7 W/V% of a polyhydric alcohol and wherein the pH of said solution is from 2.5 to 5, and the percentage of nicardipine hydrochloride remaining in said solution after a 12 week storage period at 60° C. is between 69.24 percent and 74.39 percent. 
     
     
       2. The stable injectable composition as claimed in claim 1, wherein the polyhydric alcohol is selected from the group consisting of sorbitol, mannitol, xylitol, propylene glycol, glycerol, and inositol. .[.3. A process of producing a stable nicardipine hydrochloride injectable composition of claim 8, which process comprises dissolving nicardipine hydrochloride and a polyhydric alcohol in an amount of 2 to 7 W/V% of the whole amount of the injection in water and adjusting the pH of the solution to 2.5 to 5..]. .[.4. The process as claimed in claim 3, wherein the polyhydric alcohol is selected from the group consisting of sorbitol, 
     
     
        mannitol, xylitol, propylene glycol, glycerol and inositol..]. 5. The stable injectable composition of claim 1 wherein the aqueous nicardipine 
     
     
        solution contains 0.1 to 0.6 W/V% nicardipine hydrochloride. 6. A process of producing a stable nicardipine hydrochloride injectable composition of claim 5, which process comprises dissolving nicardipine hydrochloride and a polyhydric alcohol in an amount of 2 to 7 W/V% of the whole amount of the injectable composition in water and adjusting the pH of the solution 
     
     
        to 2.5 to 5. 7. The process as claimed in claim 6 wherein the polyhydric alcohol is selected from the group consisting of sorbitol, mannitol, xylitol, propylene glycol, glycerol, and inositol.