Hydrobromide salt of n-(4-chloro-2-hydroxy-3-((3s)-3-piperidinylsulfonyl)phenyl-n'-(3-fluoro-2-methylphenyl)urea

Abstract

A compound which is the hydrobromide salt of N-{4-chloro-2-hydroxy-3-[(3S)-3-piperidinylsulfonyl]phenyl}-N′-(3-fluoro-2-methylphenyl)urea, compositions, combinations and medicaments containing said compounds and processes for their preparation. The invention also relates to the use of said compounds, combinations, compositions and medicaments.

1 . A pharmaceutical composition in an oral dosage form comprising a hemihydrate of the hydrobromide salt of N-{4-chloro-2-hydroxy-3-[(3S)-3-piperidinylsulfonyl]phenyl}-N′-(3-fluoro-2-methylphenyl)urea and one or more pharmaceutically acceptable carriers, diluents or excipients,
 wherein the oral dosage form is selected from the group consisting of capsule, tablet, powder, granule, solution, suspension in aqueous or non-aqueous liquids, edible forms, whips, oil-in-water liquid emulsion and water-in-oil liquid emulsion. 
 
     
     
         2 . The pharmaceutical composition according to  claim 1 , wherein the oral dosage form is a tablet or capsule. 
     
     
         3 . The pharmaceutical composition according to  claim 1 , wherein the pharmaceutically acceptable carrier is selected from the group consisting of ethanol, glycerol, water. 
     
     
         4 . The pharmaceutical composition according to  claim 1 , wherein the pharmaceutically acceptable carrier is selected from starch or mannitol. 
     
     
         5 . The pharmaceutical composition according to  claim 1 , wherein a pharmaceutically acceptable excipient is a lubricant selected from the group consisting of sodium oleate, sodium stearate, magnesium stearate, sodium benzoate, sodium acetate, sodium chloride. 
     
     
         6 . The pharmaceutical composition according to  claim 1 , wherein a pharmaceutically acceptable excipient is a disintegrator selected from the group consisting of starch, methyl cellulose, agar, bentonite, and xanthan gum. 
     
     
         7 . The pharmaceutical composition according to  claim 1 , wherein a pharmaceutically acceptable excipient is a binder selected from the group consisting of carboxymethyl cellulose, an aliginate, gelatin, polyvinyl pyrrolidone, paraffin, a quaternary salt, bentonite, kaolin and dicalcium phosphate. 
     
     
         8 . A method of treating chronic obstructive pulmonary disease comprising administering to a human in need thereof a pharmaceutical composition according to  claim 1 .