Claims for Patent: 7,659,291

Summary for Patent: 7,659,291

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. (Bedminster, NJ)
Application Number:	12/407,557
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 7,659,291
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 composition 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 composition requires no dilution before administration and has a pH from about 3.6 to about 4.7, the composition when stored in 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 composition 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 composition requires no dilution before administration and has a pH from about 3.6 to about 4.7, the composition when stored in a 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 from about 0.01 to about 0.1 mg/mL citric acid; the aqueous solution contained in a pharmaceutically acceptable container such that the solution 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%; wherein the administering does not comprise diluting the aqueous solution prior to administration. 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 container comprises 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; 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. 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 from about 0.01 to about 0.1 mg/mL citric acid; the aqueous solution contained in a pharmaceutically acceptable container such that the solution 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%; wherein the administering does not comprise diluting the aqueous solution prior to administration. 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 container comprises 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; 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.