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Claims for Patent: 9,364,564

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Claims for Patent: 9,364,564

Title: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. (Cary, NC)
Application Number:12/645,169
Patent Claims: 1. A pharmaceutical composition for parenteral administration comprising a pre-mixed aqueous solution comprising: from about 0.1 to 0.4 mg/mL nicardipine or a pharmaceutically acceptable salt thereof; a tonicity agent; and a buffer; the aqueous solution contained in a pharmaceutically acceptable container such that the solution is in contact with non-polar polymers, wherein the composition requires no dilution before administration and has a pH from about 3.6 to about 4.4, 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 formulation of less than about 3%.

2. The pharmaceutical composition for parenteral administration of claim 1, 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 or pharmaceutically acceptable salt thereof and (ii) a total impurity formation of less than about 3%.

3. The composition of claim 1, wherein the tonicity agent is one or more inorganic salts.

4. The composition of claim 1, wherein the tonicity agent is selected from the anhydrous or hydrous forms of sodium chloride, dextrose, sucrose, xylitol, fructose, glycerol, sorbitol, mannitol, potassium chloride, mannose, calcium chloride, or magnesium chloride.

5. The composition of claim 1, wherein the buffer is selected from pharmaceutically acceptable salts and acids of acetate, glutamate, citrate, tartrate, benzoate, lactate, histidine or other amino acids, gluconate, phosphate, malate, succinate, formate, propionate, or carbonate.

6. The composition of claim 1, further comprising at least one pH adjuster selected form the group consisting of hydrochloric acid, sodium hydroxide and a mixture thereof.

7. The composition of claim 1, further comprising from about 1 mg/mL to about 4 mg/mL sorbitol.

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

9. The composition of claim 1, comprising from about 0.1 to about 0.2 mg/mL of the nicardipine or pharmaceutically acceptable salt thereof.

10. The composition of claim 1, wherein the tonicity agent is selected from sodium chloride or dextrose.

11. The method of claim 1, further comprising from 0 mg/mL to about 4 mg/mL sorbitol.

12. A pharmaceutical composition for parenteral administration comprising a pre-mixed aqueous solution comprising: from about 0.1 to 0.4 mg/mL nicardipine or a pharmaceutically acceptable salt thereof; a tonicity agent selected from sodium chloride or dextrose; a buffer; and from 0 mg/mL to about 4 mg/mL sorbitol; the aqueous solution contained in a pharmaceutically acceptable container comprising copolyester, polyethylene or polyolefin, wherein the composition requires no dilution before administration and has a pH from about 3.6 to about 4.4, 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 formulation of less than about 3%.

13. The pharmaceutical composition for parenteral administration of claim 12, 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 or pharmaceutically acceptable salt thereof and (ii) a total impurity formation of less than about 3%.

14. The composition of claim 12, comprising from about 0.1 to about 0.2 mg/mL of the nicardipine or pharmaceutically acceptable salt thereof.

15. The composition of claim 1, wherein the tonicity agent is dextrose in a quantity of from about 46 to about 50 mg/mL.

16. The composition of claim 12, wherein the tonicity agent is dextrose in a quantity of from about 46 to about 50 mg/mL.

17. The composition of claim 1, wherein the tonicity agent is sodium chloride in a quantity of from about 8.3 to about 9 mg/mL.

18. The composition of claim 12, wherein the tonicity agent is sodium chloride in a quantity of from about 8.3 to about 9 mg/mL.

19. The composition of claim 1, wherein the non-polar polymers comprise polyethylene.

20. The composition of claim 12, wherein the solution is in contact with polyethylene.
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