Use of a composition comprising formoterol and budesonide for the prevention or treatment of an acute condition of asthma

Abstract

The present invention relates to use of a composition for symptomatic relief, when needed, comprising, in admixture (a) a first active ingredient which is formoterol, a pharmaceutically acceptable salt or solvate thereof or a solvate of such a salt; and (b) a second active ingredient which is budesonide; for the manufacture of a medicament for use in the prevention or treatment of an acute condition of asthma and/or intermittent asthma and/or episodes in chronic asthma. The invention further relates to a method for prevention or treatment of an acute condition of asthma and/or intermittent asthma and/or episodes in chronic asthma by administering. by inhalation, a composition comprising the first and second active ingredients as defined previously.

1 . Use of a composition for symptomatic relief, when needed, comprising, in admixture 
 (a) a first active ingredient which is formoterol, a pharmaceutically acceptable salt or solvate thereof or a solvate of such a salt; and    (b) a second active ingredient which is budesonide; for the manufacture of a medicament for use in the prevention or treatment of an acute condition of asthma and/or intermittent asthma and/or episodes in chronic asthma.    
     
     
         2 . Use according to    claim 1   , wherein the molar ratio of (a) to (b) calculated as formoterol to budesonide is from 1:1 to 1:100, preferably from 1:1 to 1:70.  
     
     
         3 . Use according to    claim 1    or    2   , wherein the first active ingredient is formoterol fumarate dihydrate.  
     
     
         4 . Use according to any previous claim, wherein the first active ingredient is the R,R enantiomer of formoterol.  
     
     
         5 . Use according to any previous claim, wherein a unit dose of formoterol lies in the range of from 1 μg to 48 μg, preferably between 3 μg to 12 μg, calculated as formoterol fumarate dihydrate.  
     
     
         6 . Use according to any previous claim, wherein the daily dose of formoterol, including maintenance therapy, lies in the range of from 1 μg to 100 μg, preferably from 2 μg to 60 μg, calculated as formoterol fumarate dihydrate.  
     
     
         7 . Use according to any previous claim, wherein the second active ingredient is the 22 R epimer of budesonide.  
     
     
         8 . Use according to any previous claim, wherein a unit dose of budesonide lies in the range of from 20 μg to 1600 μg, preferably between 50 μg to 400 μg.  
     
     
         9 . Use according to any previous claim, wherein the daily dose of budesonide, including maintenance therapy, lies in the range of from 20 μg to 4800 μg, preferably from 30 μg to 3200 μg.  
     
     
         10 . Use according to any previous claim, wherein the particle size of the active ingredients (a) and (b) is less than 10 μm.  
     
     
         11 . Use according to any previous claim, wherein the composition additionally comprises one or more pharmaceutically acceptable additives, diluents or carriers.  
     
     
         12 . Use according to    claim 11   , wherein the pharmaceutically acceptable additive, diluent or carrier is lactose monohydrate.  
     
     
         13 . A method of prevention or treatment of an acute condition of asthma and/or intermittent asthma and/or episodes in chronic asthma, when needed, which comprises administering, by inhalation, to a patient an effective amount of a composition comprising, in admixture: 
 (a) a first active ingredient which is formoterol, a pharmaceutically acceptable salt or solvate thereof or a solvate of such a salt; and    (b) a second active ingredient which is budesonide.    
     
     
         14 . The method according to    claim 13   , wherein the molar ratio of (a) to (b) calculated as formoterol to budesonide is from 1:1 to 1:100, preferably from 1:1 to 1:70.  
     
     
         15 . The method according to    claim 13    or    14   , wherein the first active ingredient is formoterol fumarate dihydrate.  
     
     
         16 . The method according to any of    claims 13    to    15   , previous claim, wherein the first active ingredient is the R,R enantiomer of formoterol.  
     
     
         17 . The method according to any of    claims 13    to    16   , wherein a unit dose of formoterol lies in the range of from 1 μg to 48 μg, preferably between 3 μg to 12 μg, calculated as formoterol fumarate dihydrate.  
     
     
         18 . The method according to any of    claims 13    to    17   , wherein the daily dose of formoterol, including maintenance therapy, lies in the range of from 1 μg to 100 μg, preferably from 2 μg to 60 μg, calculated as formoterol fumarate dihydrate.  
     
     
         19 . The method according to any of    claims 13    to    18   , wherein the second active ingredient is the 22 R epimer of budesonide.  
     
     
         20 . The method according to any of    claims 13    to    19   , wherein a unit dose of budesonide lies in the range of from 20 μg to 1600 μg, preferably between 50 μg to 400 μg.  
     
     
         21 . The method according to any of    claims 13    to    20   , wherein the daily dose of budesonide, including maintenance therapy, lies in the range of from 20 μg to 4800 μg, preferably from 30 μg to 3200 μg.  
     
     
         22 . The method according to any of    claims 13    to    21   , wherein the particle size of the active ingredients (a) and (b) is less than 10 μm.  
     
     
         23 . The method according to any of    claims 13    to    22   , wherein the composition additionally comprises one or more pharmaceutically acceptable additives, diluents or carriers.  
     
     
         24 . The method according to    claim 23   , wherein the pharmaceutically acceptable additive, diluent or carrier is lactose monohydrate.