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

A method for making a pharmaceutical composition for intravenous administration comprising: providing an aqueous solution comprising a tonicity agent, a buffer, and at least one active ingredient selected from the group consisting of nicardipine and/or pharmaceutically acceptable salts thereof; adjusting the pH of the aqueous solution as necessary to achieve a pH within the range of from about 3.6 to 4.7; further diluting the aqueous solution to a final active ingredient concentration from about 0.1 to 0.4 mg/mL; and filling pharmaceutically acceptable containers with the aqueous solution such that the 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%.

A method for making a pharmaceutical composition for intravenous administration comprising: packaging in a pharmaceutically acceptable container a pre-mixed aqueous solution with a pH from about 3.6 to about 4.7 comprising:nfrom 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; anda buffer;such that the aqueous solution contained in the pharmaceutically acceptable container 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%.

A method for making a pharmaceutical composition for intravenous administration comprising: packaging in a pharmaceutically acceptable container a pre-mixed aqueous solution with a pH from about 3.6 to about 4.7 comprising:nfrom 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; anda buffer;such that the aqueous solution contained in the pharmaceutically acceptable container 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%.