Method and Composition for Treatment of a Mucosal Tissue Disorder

Abstract

Methods of treating a subject suffering from a disorder in a mucosal tissue, such as interstitial cystitis; cancer in a mucous membrane such as bladder or vaginal cancer; Crohn's disease; inflammatory bowel disease or colitis, by administering a medicament containing a sulfated chitinous polymer administered topically are described. Pharmaceutical compositions containing the sulfate chitinous polymer are also disclosed.

1 . A method for treating a disorder in a mucosal tissue comprising topically administering a medicament containing an effective amount of a sulfated chitinous polymer including subunits of the formula: 
     
       
         
         
             
             
         
       
     
     wherein
 X is independently selected from hydrogen, SO 3   − B, —(CH 2 ) b COG, or —(CH 2 ) b COOZ for each occurrence; 
 Y is independently selected from SO 3   − B, —C(═O)—R—CO 2 Z, —C(C═O)—R—COG, hydrogen, carboxyalkyl, acetyl, or a pharmaceutically acceptable salt thereof for each occurrence, provided that at least 1% of Y groups and/or 1% of X groups on said polymer are SO 3   − B; 
 R is independently selected from the group consisting of alkyl, alkenyl, and aryl; 
 b is 1-5; 
 B is hydrogen or a cation; 
 G is an additional therapeutic agent or a pharmaceutically acceptable salt thereof; and 
 Z is hydrogen, a cation, an additional therapeutic agent, or a pharmaceutically acceptable salt thereof. 
 
   
   
       2 . A pharmaceutical composition, acceptable for administration via catheter or enema, comprising an effective amount of a sulfated chitinous polymer and a pharmaceutically acceptable carrier, said sulfated chitinous polymer including subunits of the formula: 
     
       
         
         
             
             
         
       
     
     wherein
 X is independently selected from hydrogen, SO 3   − B, —(CH 2 ) b COG, or —(CH 2 ) b COOZ for each occurrence, provided that at least 10% of X groups on said polymer are —(CH 2 ) b COOZ or —(CH 2 ) b COG; 
 Y is independently selected from SO 3   − B, —C(═O)—R—CO 2 Z, —C(C═O)—R—COG, hydrogen, carboxyalkyl, acetyl, or a pharmaceutically acceptable salt thereof for each occurrence, provided that at least 1% of Y groups and/or 1% of X groups on said polymer are SO 3   − B; 
 R is independently selected from the group consisting of alkyl, alkenyl, and aryl; 
 b is 1-5; 
 B is hydrogen or a cation; 
 G is an additional therapeutic agent or a pharmaceutically acceptable salt thereof; and 
 Z is hydrogen, a cation, an additional therapeutic agent, or a pharmaceutically acceptable salt thereof.