Claims for Patent: 8,455,524

Summary for Patent: 8,455,524

Title:	Methods of treatment with 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:	12/971,084
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,455,524
Patent Claims:	1. A method for treating acute elevations of blood pressure in a human subject in need thereof, said method comprising parenterally administering 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; wherein the aqueous solution requires no dilution before administration and has a pH from about 3.6 to about 4.7, the aqueous solution stored in a container 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. A method for inducing hypotension in a human subject in need thereof, said method comprising parenterally administering 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; wherein the aqueous solution requires no dilution before administration and has a pH from about 3.6 to about 4.7, the aqueous solution stored in a container 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%. 3. A method for treating acute elevations of blood pressure in a human subject in need thereof, said method comprising parenterally administering to a subject in need thereof, 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 a buffer; the aqueous solution contained in a pharmaceutically acceptable container 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 a total impurity formation of less than about 3%. 4. The method of claim 3, further comprising at least one pH adjuster selected from the group consisting of hydrochloric acid, sodium hydroxide and a mixture thereof. 5. The method of claim 3, further comprising from about 1 mg/ml to about 4 mg/ml sorbitol. 6. The method of claim 3, wherein the non-polar polymers comprise copolyester, polyethylene or polyolefin. 7. The method of claim 3, wherein the pre-mixed aqueous solution comprises: from about 0.1 to about 0.2 mg/mL nicardipine hydrochloride; and 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. 8. A method for inducing hypotension in a human subject in need thereof said method comprising parenterally administering to a subject in need thereof, 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 a buffer; the aqueous solution contained in a pharmaceutically acceptable container such that the 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%. 9. The method of claim 8, further comprising at least one pH adjuster selected from the group consisting of hydrochloric acid, sodium hydroxide and a mixture thereof. 10. The method of claim 8, further comprising from about 1 mg/ml to about 4 mg/ml sorbitol. 11. The method of claim 8, wherein the non-polar polymers comprise copolyester, polyethylene or polyolefin. 12. The method of claim 8, wherein the pre-mixed aqueous solution comprises: from about 0.1 to about 0.2 mg/mL nicardipine hydrochloride; and 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. 13. The method of claim 1, wherein the wherein the non-polar polymers comprise copolyester, polyethylene or polyolefin. 14. The method of claim 2, wherein the wherein the non-polar polymers comprise copolyester, polyethylene or polyolefin. 15. The method of claim 1, wherein the non-polar polymers comprise polyethylene. 16. The method of claim 2, wherein the non-polar polymers comprise polyethylene. 17. The method of claim 3, wherein the non-polar polymers comprise polyethylene. 18. The method of claim 8, wherein the non-polar polymers comprise polyethylene. 19. 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 nicardipine or pharmaceutically acceptable salt thereof and (ii) a total impurity formation of less than about 3%. 20. The method of claim 2, 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 nicardipine or pharmaceutically acceptable salt thereof and (ii) a total impurity formation of less than about 3%. 21. The method of claim 3, 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 nicardipine or pharmaceutically acceptable salt thereof and (ii) a total impurity formation of less than about 3%. 22. The method of claim 8, 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 nicardipine or pharmaceutically acceptable salt thereof and (ii) a total impurity formation of less than about 3%. 23. The method of claim 1, further comprising from 0 mg/mL to about 4 mg/mL sorbitol. 24. The method of claim 2, further comprising from 0 mg/mL to about 4 mg/mL sorbitol. 25. The method of claim 3, further comprising from 0 mg/mL to about 4 mg/mL sorbitol. 26. The method of claim 8, further comprising from 0 mg/mL to about 4 mg/mL sorbitol. 27. The method of claim 1, wherein the pre-mixed aqueous solution comprises from about 0.1 to about 0.2 mg/mL nicardipine hydrochloride. 28. The method of claim 2, wherein the pre-mixed aqueous solution comprises from about 0.1 to about 0.2 mg/mL nicardipine hydrochloride.