Formulation

Abstract

The present invention relates to a new formulation of the oligonucleotide of SEQ ID NO: 1.

1 . A pharmaceutical composition comprising SEQ ID NO:1 with a cation, optionally selected from the following list Na + , K + , Mg ++ , Ca ++ , Ba ++ , Mn ++ , Ni ++ , Li ++ , Zn ++ , and Cr +++ , preferably Na + , more preferably 40-200 mM Na + , optionally including 2-20 mM Mg 2+ . 
     
     
         2 . A composition as claimed in  claim 1 , wherein the Na +  is 100-190 mM, more preferably 140-160 mM. 
     
     
         3 . A composition as claimed in any one of  claims 1  to  2 , which also comprises one or more of hydroxymethyl cellulose, methyl paraben sodium, propylparaben sodium, monobasic sodium phosphate monohydrate, sodium hydroxide, hydrochloric acid and/or water. 
     
     
         4 . A composition as claimed in any one of  claims 1  to  3  wherein the composition is in the form of a liquid syrup, gel, film, cream, powder, tablet and/or enema. 
     
     
         5 . A composition as claimed in any one of  claims 1  to  4 , wherein the components are in the following ranges 
       
         
           
                 
                 
                 
                 
               
                     
                     
                 
                     
                   SEQ ID NO: 1 
                   4 
                   mg 
                 
                 
                 
                 
               
                     
                   hydroxymethyl cellulose 
                   7-8 mg, optionally 7.5 mg 
                 
                 
                 
                 
                 
               
                     
                   methylparaben sodium 16.6 mM 
                   2.8-3.0 
                   mg 
                 
                     
                   propylparaben sodium 1.4 mM 
                   0.28-3 
                   mg 
                 
                     
                   monobasic sodium phosphate 
                   4.4-4.6 
                   mg 
                 
                     
                   monohydrate37.5 mM 
                 
                     
                     
                 
             
                
               
               
                
               
            
             
                
               
            
             
                
                
                
                
                
               
            
           
         
       
     
     
         6 . A composition as claimed in any one of  claims 1  to  5  for use in medicine. 
     
     
         7 . A composition, as claimed in  claim 6 , wherein the use is for the prevention or treatment of inflammatory bowel disease, rectal stump, radiation-induced proctitis, pouchitis, asthma, inflammation of the eye, dry eye, rhinitis, sinusitis or graft versus host disease. 
     
     
         8 . Use of SEQ ID NO:1 in the manufacture of a medicament as claimed in any one of  claims 1  to  6  for the prevention or treatment of inflammatory bowel disease, rectal stump, radiation-induced proctitis, pouchitis, asthma, inflammation of the eye, dry eye, graft versus host disease, rhinitis or sinusitis. 
     
     
         9 . A method of treating inflammatory bowel disease, rectal stump, radiation-induced proctitis, pouchitis, asthma, inflammation of the eye, dry eye, rhinitis or sinusitis, or grant-versus host disease, the method comprising administration of a composition as claimed in any one of  claims 1  to  5  to a patient in need thereof. 
     
     
         10 . A method of making a composition as claimed in any one of  claims 1  to  5 , the method comprising combining SEQ ID NO:1 with a cation, optionally selected from the following list Na + , K + , Mg ++ , Ca ++ , Ba ++ , Mn ++ , Ni ++ , Li ++ , Zn ++ , and Cr ++ , preferably Na + , more preferably 40-200 mM Na + , optionally including 2-20 mM Mg 2+ . 
     
     
         11 . A composition, as claimed in any one of  claims 1  to  6 , wherein the composition is in the form of an enema and wherein the composition is formulated in a dosage form to provide a concentration of SEQ ID NO:1 at 2 mg/ml per day. 
     
     
         12 . A composition, as claimed in any one of  claims 1  to  6 , wherein the composition is in the form of an enema and wherein the composition is formulated in a dosage form to provide a concentration of SEQ ID NO:1 at 1-4 mg/ml per day