Pre-mixed, ready-to-use pharmaceutical compositions

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 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;

wherein the composition requires no dilution before administration and has a pH from about 3.6 to about 4.7, 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 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.

4. 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.

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

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

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

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

9. 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 (i) about 46 to about 50 mg/mL dextrose or (ii) about 8.3 to about 9 mg/mL sodium chloride; and

a buffer;

from 0 mg/mL to about 4 mg/mL sorbitol;

the aqueous solution contained in a pharmaceutically acceptable container such that the solution is in contact with copolyester, polyethylene or polyolefin;

wherein the composition requires no dilution before administration and has a pH from about 3.6 to about 4.7, 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%.

10. The pharmaceutical composition for parenteral administration of claim 9 , 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%.

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

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

13. The composition of claim 9 , wherein the solution is in contact with polyethylene.