Levalbuterol salt

Abstract

Levalbuterol L-tartrate affords crystals possessing properties desirable for use in a metered dose inhaler.

1 - 29 . (canceled) 
     
     
         30 . Levalbuterol L-tartrate, which is a hemitartrate. 
     
     
         31 . A pharmaceutical composition comprising the levalbuterol L-tartrate of  claim 30 . 
     
     
         32 . The pharmaceutical composition of  claim 31 , which further comprises a propellant. 
     
     
         33 . The pharmaceutical composition of  claim 32 , wherein the propellant is 1,1,1,2-tetrafluoroethane. 
     
     
         34 . The pharmaceutical composition of  claim 31 , which further comprises a surfactant. 
     
     
         35 . The pharmaceutical composition of  claim 34 , wherein the surfactant is oleic acid. 
     
     
         36 . The pharmaceutical composition of  claim 31 , which further comprises a co-solvent. 
     
     
         37 . The pharmaceutical composition of  claim 36 , wherein the co-solvent is ethanol. 
     
     
         38 . The pharmaceutical composition of  claim 37 , wherein the ethanol is dehydrated ethanol. 
     
     
         39 . The pharmaceutical composition of  claim 31 , which is adapted for administration by inhalation using a metered dose inhaler. 
     
     
         40 . The pharmaceutical composition of  claim 39 , which is adapted for administration of from about 45 μg to about 90 μg levalbuterol free base per actuation. 
     
     
         41 . A pharmaceutical composition comprising levalbuterol L-tartrate, 1,1,1,2-tetrafluoroethane, oleic acid, and ethanol. 
     
     
         42 . The pharmaceutical composition of  claim 41 , wherein the ethanol is dehydrated ethanol. 
     
     
         43 . The pharmaceutical composition of  claim 42 , which is adapted for administration by inhalation using a metered dose inhaler. 
     
     
         44 . The pharmaceutical composition of  claim 43 , wherein one gram of the composition contains about 1.04 mg of levalbuterol L-tartrate, about 0.951 g of 1,1,1,2-tetrafluoroethane, about 0.0521 mg of oleic acid, and about 0.0476 g of dehydrated ethanol. 
     
     
         45 . The pharmaceutical composition of  claim 43 , wherein one gram of the composition contains about 2.08 mg of levalbuterol L-tartrate, about 0.95 g of 1,1,1,2-tetrafluoroethane, about 0.104 mg of oleic acid, and about 0.0475 g of dehydrated ethanol.