Levalbuterol salt

Abstract

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

1 . Levalbuterol L-tartrate. 
     
     
         2 . Levalbuterol L-tartrate as claimed in  claim 1 , which is in crystalline form. 
     
     
         3 . Levalbuterol L-tartrate as claimed in  claim 2 , containing from 0.3 to 0.7% ethanol. 
     
     
         4 . Levalbuterol L-tartrate as claimed in  claim 2 , which is in micronized form. 
     
     
         5 . Levalbuterol L-tartrate as claimed in  claim 4 , which is in the form of needle-like particles. 
     
     
         6 . A pharmaceutical composition, which comprises levalbuterol L-tartrate as claimed in  claim 1 , together with a pharmaceutically acceptable carrier. 
     
     
         7 . A pharmaceutical composition as claimed in  claim 6 , which is an aerosol formulation adapted for administration using a metered dose inhaler, the aerosol formulation comprising levalbuterol L-tartrate in crystalline form and a propellant. 
     
     
         8 . A pharmaceutical composition as claimed in  claim 7 , in which the propellant is 1,1,1,2-tetrafluoroethane. 
     
     
         9 . A pharmaceutical composition as claimed in  claim 7 , which further comprises a surfactant. 
     
     
         10 . A pharmaceutical composition as claimed in  claim 7 , which further comprises a co-solvent. 
     
     
         11 . A pharmaceutical composition as claimed in  claim 10 , in which the co-solvent is ethanol. 
     
     
         12 . An aerosol formulation adapted for administration using a metered dose inhaler, the aerosol formulation comprising levalbuterol L-tartrate crystals in the form of micronized, needle-like particles, and a propellant. 
     
     
         13 . An aerosol formulation as claimed in  claim 12 , in which the propellant is 1,1,1,2-tetrafluoroethane. 
     
     
         14 . An aerosol formulation as claimed in  claim 13 , which further comprises from 2 to 6% by weight of ethanol as a cosolvent. 
     
     
         15 . A metered dose inhaler comprising a canister containing an aerosol formulation as defined in  claim 7 , a metering valve and a valve stem. 
     
     
         16 . A metered dose inhaler comprising a canister containing an aerosol formulation as defined in  claim 12 , a metering valve and a valve stem. 
     
     
         17 . A pharmaceutical composition as claimed in  claim 6 , which is adapted for administration using a dry powder inhaler or insufflator.