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Details for Patent: 9,370,586

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Details for Patent: 9,370,586

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 (Freemont, CA), Stephens; Norma V. (Skokie, IL), Zamiri; Camellia (Fremont, CA)
Assignee: EKR Therapeutics, Inc. (Cary, NC)
Filing Date:Dec 23, 2010
Application Number:12/977,965
Claims:1. A method for making a pharmaceutical composition for intravenous administration comprising: preparing a pre-mixed aqueous solution with a pH from about 3.6 to about 4.4 comprising: a tonicity agent, a buffer, and from about 0.1 mg/mL to about 0.4 mg/mL nicardipine hydrochloride; and filling a pharmaceutically acceptable container with the aqueous solution such that the aqueous solution is in contact with non-polar polymers, the aqueous solution when stored in the container for at least three months at room temperature exhibiting (i) less than a 10% decrease in the concentration of nicardipine or pharmaceutically acceptable salt thereof 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, wherein the aqueous solution further comprises a cosolvent.

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

5. 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 4.4 comprising: from about 0.1 mg/mL to about 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 a buffer; such that the aqueous solution contained in the pharmaceutically acceptable container is in contact with non-polar polymers, the aqueous solution when stored in the container for at least three months at room temperature exhibiting (i) less than a 10% decrease in the concentration of the nicardipine hydrochloride and (ii) a total impurity formation of less than about 3%.

6. The method of claim 5, wherein the aqueous solution further comprises at least one pH adjuster selected from the group consisting of hydrochloric acid, sodium hydroxide and a mixture thereof.

7. The method of claim 5, wherein the aqueous solution further comprises from about 1 mg/ml to about 4 mg/ml sorbitol.

8. The method of claim 5, wherein the non-polar polymers comprise copolyester, polyethylene or polyolefin.

9. 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 4.4 comprising: from about 0.1 mg/mL to about 0.2 mg/mL nicardipine hydrochloride; a tonicity agent selected from (i) about 46 mg/mL to about 50 mg/mL dextrose or (ii) about 8.3 mg/mL to about 9 mg/mL sodium chloride; and a buffer; such that the aqueous solution contained in the pharmaceutically acceptable container is in contact with non-polar polymers, the aqueous solution when stored in the container for at least three months at room temperature exhibiting (i) less than a 10% decrease in the concentration of the nicardipine hydrochloride and (ii) a total impurity formation of less than about 3%.

10. The method of claim 1, wherein the non-polar polymers comprise copolyester, polyethylene or polyolefin.

11. The method of claim 9, wherein the non-polar polymers comprise copolyester, polyethylene or polyolefin.

12. The method of claim 1, wherein the non-polar polymers comprise polyethylene.

13. The method of claim 5, wherein the non-polar polymers comprise polyethylene.

14. The method of claim 9, wherein the non-polar polymers comprise polyethylene.

15. The method of claim 1, wherein the aqueous solution when stored in the container for at least one year at room temperature exhibits (i) less than a 10% decrease in the concentration of the nicardipine hydrochloride and (ii) a total impurity formation of less than about 3%.

16. The method of claim 5, wherein the aqueous solution when stored in the container for at least one year at room temperature exhibits (i) less than a 10% decrease in the concentration of the nicardipine hydrochloride and (ii) a total impurity formation of less than about 3%.

17. The method of claim 9, wherein the aqueous solution when stored in the container for at least one year at room temperature exhibits (i) less than a 10% decrease in the concentration of the nicardipine hydrochloride and (ii) a total impurity formation of less than about 3%.

18. The method of claim 1, wherein the aqueous solution further comprises from 0 mg/mL to about 4 mg/mL sorbitol.

19. The method of claim 5, wherein the aqueous solution further comprises from 0 mg/mL to about 4 mg/mL sorbitol.

20. The method of claim 9, wherein the aqueous solution further comprises from 0 mg/mL to about 4 mg/mL sorbitol.

21. The method of claim 1, wherein the pre-mixed aqueous solution comprises from about 0.1 mg/mL to about 0.2 mg/mL nicardipine hydrochloride.

22. The method of claim 5, wherein the pre-mixed aqueous solution comprises from about 0.1 mg/mL to about 0.2 mg/mL nicardipine hydrochloride.
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