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Claims for Patent: 5,164,405

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Claims for Patent: 5,164,405

Title: Nicardipine pharmaceutical composition for parenteral administration
Abstract:There is disclosed a stable pharmaceutical composition containing nicardipine hydrochloride, a non-chloride isotonicity agent, a buffering agent and a pharmaceutically acceptable aqueous vehicle for parenteral administration.
Inventor(s): McFarlane; Calum B. (Linlithgow, GB6), Selkirk; Alistair B. (Edinburgh, GB6), Dey; Michael J. (East Calder, GB6)
Assignee: Syntex (U.S.A.) Inc. (Palo Alto, CA)
Application Number:07/600,277
Patent Claims: 1. In a process for producing a stable pharmaceutical composition containing nicardipine hydrochloride suitable for parenteral administration and useful in the treatment of disease conditions which may be alleviated by the administration of calcium channel blocking agents, which process comprises admixing a therapeutically effective amount of nicardipine hydrochloride and a pharmaceutically acceptable aqueous vehicle comprising at least a major proportion of water, the improvement comprising:

(a) dissolving in an aqueous vehicle consisting essentially of water a physiologically and pharmaceutically acceptable buffer in an amount effective to maintain the pH of the pharmaceutical composition at about 3.0 to about 4.5, thereby forming a buffered solution; and

(b) adding to said buffered solution

at least 1 mg/ml of said therapeutically effective amount of nicardipine hydrochloride, and

a physiologically and pharmaceutically acceptable non-chloride compound selected from saccharides, including sorbitol, mannitol, dextrose and glucose, and non-saccharides, including polyethylene glycol and glycerol, in an amount effective to render the pharmaceutical composition isotonic.

2. The process of claim 1 further comprising the step of terminally sterilizing said pharmaceutical composition by autoclaving.

3. A pharmaceutical composition suitable for parenteral administration to mammals and useful in the treatment of disease conditions which may be alleviated by the administration of calcium channel blocking agents, which composition comprises:

(a) a physiologically and pharmaceutically acceptable non-chloride compound selected from saccharides, including sorbitol, mannitol, dextrose and glucose, and non-saccharides, including polyethylene glycol and glycerol, in an ammount effective to render the pharmaceutical composition isotonic;

(b) a physiologically and pharmaceutically acceptable buffer, selected from citrate, acetate, phosphate, and lactate buffers, in an amount effective to maintain the pH of the composition at about 3.0 to about 4.5;

(c) a pharmaceutically acceptable aqueous vehicle consisting essentially of water; and

(d) at least about 1 mg/ml nicardipine hydrochloride in solution herein.

4. A composition according to claim 3 wherein the therapeutically effective amount of nicardipine hydrochloride is from about 0.5 mg/ml to about 10 mg/ml of aqueous vehicle and the aqueous vehicle is water (water for injection) alone.

5. A composition according to claim 3 wherein the buffer is selected from citrate and acetate buffers.

6. A composition according to claim 3 wherein:

(a) the therapeutically effective amount of nicardipine hydrochloride is from about 1 mg/ml to about 2.5 mg/ml of aqueous vehicle;

(b) the non-chloride compound is a saccharide selected from sorbitol and mannitol used in an amount of about 48.0 to about 50.0 mg per ml of aqueous vehicle.

(c) the buffer is citrate used in an amount of about 0.002-0.003M; and

(d) the aqueous vehicle is water alone.

7. A composition according to claim 6 wherein the non-chloride compound is sorbitol.

8. A pharmaceutical composition suitable for parenteral administration useful in the treatment of cardiovascular and cerebrovascular conditions comprising:

(a) about 1.0 mg/ml of composition of nicardipine hydrochloride;

(b) about 48-50 mg/ml of sorbitol;

(c) an amount of citric acid monohydrate and sodium hydroxide sufficient to render the composition about 0.002-0.003M in citric acid monohydrate and having a pH of about 3.5-4.5; and

(d) sufficient water to make up 1 ml volume.

9. A pharmaceutical composition suitable for parenteral administration useful in the treatment of cardiovascular and cerebrovascular conditions comprising:

(a) about 2.5 mg/ml of composition of nicardipine HCl;

(b) about 48-50 mg/ml of composition of sorbitol;

(c) an amount of citric acid monohydrate sufficient to render the composition about 0.002-0.003M in citric acid monohydrate and having a pH of about 3.5-4.5; and

(d) sufficient water to make up 1 ml volume.
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