Pre-mixed, ready-to-use pharmaceutical compositions
AssigneeEKR Therapeutics, Inc.
InventorsMichelle Renee Duncan, Supriya Gupta, David Hartley Haas, Norma V. Stephens, Camellia Zamiri
Life of this patent
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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.
Claims15
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%.
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%.
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%.
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.
Dependencies are inferred from the claim text.