Methods of preparing pre-mixed, ready-to-use pharmaceutical compositions

摘要

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.

主权项

1. A method for making a pharmaceutical composition for intravenous administration comprising:
preparing a pre-mixed aqueous solution with a pH from about 3.6 to about 4.4 comprising: a tonicity agent, a buffer, and from about 0.1 mg/mL to about 0.4 mg/mL nicardipine hydrochloride; and filling a pharmaceutically acceptable container with the aqueous solution such that the aqueous solution is in contact with non-polar polymers, 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%.