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Last Updated: April 24, 2024

Claims for Patent: 4,880,823

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Summary for Patent: 4,880,823

Title:	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.
Inventor(s):	Ogawa; Katayasu (Saitama, JP), Ohtani; Go (Tokyo, JP), Yokota; Shoji (Tokyo, JP), Aruga; Masayoshi (Saitama, JP)
Assignee:	Yamanouchi Pharmaceutical Co., Ltd. (Tokyo, JP)
Application Number:	07/338,402
Patent Claims:	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.degree. 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.

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