Pre-mixed, ready-to-use pharmaceutical compositions
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.
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; and
a tonicity agent;
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 is buffered to a pH from about 3.6 to about 4.4, 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. 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 , further comprising from about 1 mg/mL to about 4 mg/mL sorbitol.
4. The composition of claim 1 , wherein the non-polar polymers comprise copolyester, polyethylene or polyolefin.
5. The composition of claim 1 , comprising from about 0.1 to 0.2 mg/mL nicardipine or a pharmaceutically acceptable salt thereof.
6. The composition of claim 1 , further comprising from about 0 mg/mL to about 4 mg/mL sorbitol.
7. The composition of claim 1 , wherein the tonicity agent comprises dextrose.
8. The composition of claim 7 , comprising about 4.5% to about 5% w/v dextrose based on the composition.
9. The composition of claim 1 , wherein the tonicity agent comprises sodium chloride.
10. The composition of claim 9 , comprising about 0.8% to about 0.9% w/v sodium chloride based on the composition.