Pre-Mixed, Ready-To-Use Pharmaceutical Compositions

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.

1 . A pharmaceutical composition for parenteral administration comprising: nicardipine or a pharmaceutically acceptable salt thereof; a tonicity agent; and
 a buffer; wherein the composition requires no dilution before administration and has a pH from about 3.6 to about 4.7.   
     
     
         2 . The pharmaceutical composition of  claim 1 , wherein the pharmaceutically acceptable salt is nicardipine hydrochloride. 
     
     
         3 . The pharmaceutical composition of  claim 2 , wherein quantity of nicardipine hydrochloride is in the range from about 0.1 to about 0.2 mg/ml. 
     
     
         4 . The pharmaceutical composition of  claim 1 , wherein the tonicity agent is selected from the group consisting of dextrose and sodium chloride. 
     
     
         5 . The pharmaceutical composition of  claim 4 , wherein the tonicity agent is dextrose. 
     
     
         6 . The pharmaceutical composition of  claim 4 , wherein the tonicity agent is sodium chloride. 
     
     
         7 . The pharmaceutical composition according to  claim 1 , wherein the buffer is citric acid or a pharmaceutically acceptable salt thereof. 
     
     
         8 . The pharmaceutical composition of  claim 1 , further comprising a cosolvent. 
     
     
         9 . The pharmaceutical composition of  claim 8 , in which the cosolvent is sorbitol. 
     
     
         10 . The pharmaceutical composition of  claim 1 , in which the pharmaceutically acceptable salt is nicardipine hydrochloride in a quantity in the range from about 0.1 to about 0.2 mg/ml, the tonicity agent is dextrose in a quantity in the range from about 46 mg/ml to about 50 mg/ml, and the buffer is citric acid in a quantity in the range of from about 0.0192 mg/ml to about 0.0384 mg/ml. 
     
     
         11 . The pharmaceutical composition of  claim 10 , further comprising sorbitol in a quantity in the range of from about 1.92 mg/ml to about 3.84 mg/ml. 
     
     
         12 . The pharmaceutical composition of  claim 1 , in which the pharmaceutically acceptable salt is nicardipine hydrochloride in a quantity in the range from about 0.1 to about 0.2 mg/ml, the tonicity agent is sodium chloride in a quantity in the range of from about 8.3 mg/ml to about 9 mg/ml, and the buffer is citric acid in a quantity in the range of from about 0.0192 mg/ml to about 0.0384 mg/ml. 
     
     
         13 . The pharmaceutical composition of  claim 12 , further comprising sorbitol in a quantity in the range of from about 1.92 mg/ml to about 3.84 mg/ml. 
     
     
         14 . The pharmaceutical composition of  claim 1 , further comprising a pH adjuster selected from the group consisting of an acid and a base. 
     
     
         15 . The pharmaceutical composition of  claim 1 , wherein the osmolality is in the range from about 250 to 350 mOsm/kg. 
     
     
         16 . The pharmaceutical composition of  claim 1 , further comprising a pharmaceutically acceptable container selected from the group consisting of intravenous bags and bottles. 
     
     
         17 . A pharmaceutical composition for parenteral administration comprising: nicardipine or a pharmaceutically acceptable salt thereof;
 a tonicity agent; and   a buffer; wherein the composition requires no dilution before administration, has a pH from about 3.6 to about 4.7, and has less than a 10% decrease in the concentration of nicardipine or a pharmaceutically acceptable salt thereof for at least one year at room temperature.   
     
     
         18 . The pharmaceutical composition of  claim 17 , wherein the pharmaceutically acceptable salt is nicardipine hydrochloride in a quantity in the range from about 0.1 to about 0.2 mg/ml. 
     
     
         19 . The pharmaceutical composition of  claim 17 , wherein the tonicity agent is dextrose. 
     
     
         20 . The pharmaceutical composition of  claim 17 , wherein the tonicity agent is sodium chloride. 
     
     
         21 .- 39 . (canceled)