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Claims for Patent: 7,612,102

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Claims for Patent: 7,612,102

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. (
Application Number:11/788,076
Patent Claims: 1. A pharmaceutical composition for parenteral administration comprising 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 in an amount to maintain pH from about 3.6 to about 4.7; 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%.

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

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

4. The composition of claim 1, wherein the container comprises copolyester, polyethylene or polyolefin.

5. A pharmaceutical composition for parenteral administration comprising 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 a buffer in an amount to maintain pH from about 3.6 to about 4.7; the aqueous solution contained in a pharmaceutically acceptable container comprising copolyester, polyethylene or polyolefin; 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%.

6. A pharmaceutical composition for parenteral administration comprising a pre-mixed aqueous solution 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; from 0 mg/mL to about 4 mg/mL sorbitol; and a buffer in an amount to maintain pH from about 3.6 to about 4.7; the aqueous solution contained in a pharmaceutically acceptable container comprising copolyester, polyethylene or polyolefin; 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%.

7. A pharmaceutical composition for parenteral administration comprising a pre-mixed aqueous solution 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; from 0 mg/mL to about 4 mg/mL sorbitol; and a buffer in an amount to maintain pH from about 3.6 to about 4.7; the aqueous solution contained in a pharmaceutically acceptable container comprising copolyester, polyethylene or polyolefin.

8. The pharmaceutical composition for parenteral administration of claim 7. wherein the aqueous solution when stored in the container for three months at room temperature exhibits less than a 10% decrease in the concentration of nicardipine hydrochloride.

9. The pharmaceutical composition for parenteral administration of claim 7, wherein the aqueous solution when stored in the container for three months at room temperature exhibits a total impurity formation of less than about 3%.

10. The pharmaceutical composition for parenteral administration of claim 7, wherein the aqueous solution when stored in the container for one year at room temperature exhibits less than a 10% decrease in the concentration of nicardipine hydrochloride.

11. The pharmaceutical composition for parenteral administration of claim 7, wherein the aqueous solution when stored in the container for one year at room temperature exhibits a total impurity formation of less than about 3%.

12. The pharmaceutical composition for parenteral administration of claim 1, wherein the buffer is citric acid.

13. The pharmaceutical composition for parenteral administration of claim 5, wherein the buffer is citric acid.

14. The pharmaceutical composition for parenteral administration of claim 6, wherein the buffer is citric acid.

15. The pharmaceutical composition for parenteral administration of claim 7, wherein the buffer is citric acid.
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