Injection of nicardinpine hydrochloride and process for the production thereof
AssigneeYamanouchi Pharmaceutical Co., Ltd.
InventorsKatayasu Ogawa, Go Ohtani, Shoji Yokota, Masayoshi Aruga
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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.
Claims4
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.degree. C. is between 69.24 percent and 74.39 percent.
[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.
Dependencies are inferred from the claim text.