Dexmedetomidine premix formulation

Abstract

The presently disclosed subject matter relates to pharmaceutical compositions comprising dexmedetomidine or a pharmaceutically acceptable salt thereof wherein the composition is formulated as a liquid for parenteral administration to a subject, and wherein the composition is disposed within a sealed container as a premixture. The pharmaceutical compositions can be used, for example, in perioperative care of a patient or for sedation.

What is claimed is: 
     
         1 . A method of manufacturing a ready to use liquid pharmaceutical composition for parenteral administration to a subject, the method comprising:
 forming a liquid mixture comprising dexmedetomidine or a pharmaceutically acceptable salt thereof at a concentration of about 0.005 to about 50 μg/mL and sodium chloride at a concentration of between about 0.01 and about 2.0 weight percent.   
     
     
         2 . The method of  claim 1 , wherein the composition is disposed within a sealed glass container. 
     
     
         3 . The method of  claim 2 , wherein the composition when stored in the sealed glass container for at least five months exhibits no more than about 2% decrease in the concentration of dexmedetomidine. 
     
     
         4 . The method of  claim 1 , wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is present at a concentration of about 0.05 to about 15 μg/mL. 
     
     
         5 . The method of  claim 1 , wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is present at a concentration of about 0.5 to about 10 μg/mL. 
     
     
         6 . The method of  claim 1 , wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is present at a concentration of about 1 to about 7 μg/mL. 
     
     
         7 . The method of  claim 1 , wherein the dexmedetomidine or pharmaceutically acceptable salt thereof is present at a concentration of about 4 μg/mL. 
     
     
         8 . The method of  claim 1 , wherein the sodium chloride is present at a concentration of about 0.9 weight percent. 
     
     
         9 . The method of  claim 1 , wherein the composition is formulated as a total volume selected from the group consisting of 20 mL, 50 mL and 100 mL. 
     
     
         10 . The method of  claim 1 , wherein the dexmedetomidine is formulated as a hydrochloride salt. 
     
     
         11 . The method of  claim 1 , wherein the composition has a pH of about 2 to about 10. 
     
     
         12 . The method of  claim 11 , wherein the composition has a pH of about 4 to about 8. 
     
     
         13 . The method of  claim 11 , wherein the composition has a pH of about 4.5 to about 8. 
     
     
         14 . The method of  claim 1 , wherein the method comprises sparging the liquid mixture with nitrogen. 
     
     
         15 . The method of  claim 1 , wherein the method comprises terminally sterilizing the composition.