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Details for Patent: 7,659,290

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Details for Patent: 7,659,290

Title:Methods of preparing pre-mixed, ready-to-use pharmaceutical compositions
Abstract: Provided herein are ready-to-use premixed pharmaceutical compositions of nicardipine or a pharmaceutically acceptable salt and methods for use in treating cardiovascular and cerebrovascular conditions.
Inventor(s): Duncan; Michelle Renee (Glenview, IL), Gupta; Supriya (Sunnyvale, CA), Haas; David Hartley (Fremont, CA), Stephens; Norma V. (Skokie, IL), Zamiri; Camellia (Fremont, CA)
Assignee: EKR Therapeutics, Inc. (Bedminster, NJ)
Filing Date:Mar 19, 2009
Application Number:12/407,551
Claims:1. A method for making a pharmaceutical composition for intravenous administration comprising: providing a solution comprising a tonicity agent, a buffer, and at least one active ingredient selected from the group consisting of nicardipine and/or pharmaceutically acceptable salts thereof; adjusting the pH of the composition as necessary to achieve a pH within the range of from about 3.6 to 4.7; further diluting the composition to a final active ingredient concentration from about 0.1 to 0.4 mg/mL; and filling pharmaceutically acceptable containers with the pre-mixed composition; the aqueous solution when stored in the container for at least one year at room temperature exhibiting (i) less than a 10% decrease in the concentration of nicardipine hydrochloride and (ii) a total impurity formation of less than about 3%.

2. The method according to claim 1, in which the tonicity agent is selected from the group consisting of dextrose and sodium chloride.

3. The method according to claim 1, further comprising adding at least one cosolvent to the buffered solution.

4. The method according to claim 3, in which the cosolvent is sorbitol.

5. The method according to claim 2, wherein providing the solution comprises the steps of providing an initial solution comprising water and at least one buffer at a pH less than about 5.0, and thereafter adding at least one active ingredient to the initial solution.

6. The method according to claim 5, wherein the initial solution has a pH less than about 3.6.

7. A method for making a pharmaceutical composition for intravenous administration comprising: packaging in a pharmaceutically acceptable container a pre-mixed aqueous solution with a pH from about 3.6 to about 4.7 comprising: from about 0.1 to 0.4 mg/mL nicardipine hydrochloride; a tonicity agent selected from (i) about 4.5% to about 5% dextrose or (ii) about 0.8% to about 0.9% sodium chloride; and from about 0.01 to about 0.1 mg/mL citric acid; such that the aqueous solution contained in the pharmaceutically acceptable container does not come into contact with polar polymers; the aqueous solution when stored in the container for at least one year at room temperature exhibiting (i) less than a 10% decrease in the concentration of nicardipine hydrochloride and (ii) a total impurity formation of less than about 3%.

8. The method of claim 7, further comprising at least one pH adjuster selected from the group consisting of hydrochloric acid, sodium hydroxide and a mixture thereof.

9. The method of claim 7, further comprising from about 1 mg/ml to about 4 mg/ml sorbitol.

10. The method of claim 7, wherein the container comprises copolyester, polyethylene or polyolefin.

11. A method for making a pharmaceutical composition for intravenous administration comprising: packaging in a pharmaceutically acceptable container a pre-mixed aqueous solution with a pH from about 3.6 to about 4.7 comprising: from about 0.1 to about 0.2 mg/mL nicardipine hydrochloride; a tonicity agent selected from (i) about 46 to about 50 mg/mL dextrose or (ii) about 8.3 to about 9 mg/mL sodium chloride; and from about 0.0192 to about 0.0384 mg/mL citric acid; such that the aqueous solution contained in the pharmaceutically acceptable container does not come into contact with polar polymers; the aqueous solution when stored in the container for at least one year at room temperature exhibiting (i) less than a 10% decrease in the concentration of nicardipine hydrochloride and (ii) a total impurity formation of less than about 3%.
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