Treatment of mucositis using N-acetylcysteine

Abstract

This present invention provides a therapeutic composition for use in the treatment of mucositis and a method for using such a therapeutic composition. The therapeutic composition includes a pharmaceutical substance effective for treating mucositis formulated with a biocompatible polymer, such as a biocompatible reverse-thermal gelation polymer.

1 . A method for treatment of mucositis at a mucosal site of a human patient, the method comprising: 
 introducing a therapeutic composition comprising N-acetylcysteine into the patient directed to contact at least a portion of the N-acetylcysteine with the mucosal site;    wherein the N-acetylcysteine is in an amount effective, as formulated in the therapeutic composition, for treatment of the mucositis at the mucosal site.    
   
   
       2 . The method of  claim 1 , wherein the therapeutic composition comprises from 0.01 weight percent to 50 weight percent of the N-acetylcysteine.  
   
   
       3 . The method of  claim 1 , wherein the therapeutic composition comprises from 0.1 to 25 weight percent of the N-acetylcysteine.  
   
   
       4 . The method of  claim 1 , wherein the therapeutic composition comprises a carrier liquid in which the N-acetylcysteine is dissolved when introduced into the patient during the introducing.  
   
   
       5 . The method of  claim 4 , wherein the carrier liquid comprises mostly or all water.  
   
   
       6 . The method of  claim 5 , wherein the therapeutic composition is at a refrigerated temperature in a range of from 1° C. to 10° C. when introduced into the patient during the introducing.  
   
   
       7 . The method of  claim 1 , wherein the therapeutic composition comprises a biocompatible polymer.  
   
   
       8 . The method of  claim 7 , wherein the biocompatible polymer is a polyoxyethylene-polyoxypropylene block copolymer.  
   
   
       9 . The method of  claim 8 , wherein the polyoxyethylene-polyoxypropylene block copolymer is poloxamer 407.  
   
   
       10 . The method of  claim 8 , wherein the therapeutic composition comprises from 1 weight percent to 70 weight percent of the polyoxyethylene-polyoxypropylene block copolymer.  
   
   
       11 . The method of  claim 8 , wherein the therapeutic composition comprises from 1 weight percent to 20 weight percent of the polyoxyethylene-polyoxypropylene block copolymer.  
   
   
       12 . The method of  claim 8 , wherein: 
 the therapeutic composition comprises from 1 weight percent to 70 weight percent of the polyoxyethylene-polyoxypropylene block copolymer; and    the therapeutic composition exhibits reverse-thermal viscosity behavior over some range of temperatures between 1° C. to 37° C.    
   
   
       13 . The method of  claim 12 , wherein the polyoxyethylene-polyoxypropylene block copolymer is poloxamer 407.  
   
   
       14 . The method of  claim 8 , wherein the therapeutic composition comprises a carrier liquid in which both the N-acetylcysteine and the polyoxyethylene-polyoxypropylene block copolymer are dissolved when introduced into the patient during the introducing.  
   
   
       15 . The method of  claim 14 , wherein the therapeutic composition is at a refrigerated temperature in a range of from 1° C. to 10° C. when introduced into the patient during the introducing.  
   
   
       16 . The method of  claim 15 , wherein the therapeutic composition exhibits reverse-thermal viscosity behavior over some range of temperatures between the refrigerated temperature and 37° C.  
   
   
       17 . The method of  claim 1 , wherein the therapeutic composition comprises about 10 weight percent of the N-acetylcysteine.  
   
   
       18 . The method of  claim 1 , wherein the introducing is through the oral cavity of the patient, and the therapeutic composition comprises a taste masking component.  
   
   
       19 . The method of  claim 18 , wherein the taste masking component imparts a lemon flavor to the therapeutic composition.  
   
   
       20 . The method of  claim 1 , wherein the therapeutic composition comprises a preservative.  
   
   
       21 . The method of  claim 1 , wherein the mucositis is oral mucositis.  
   
   
       22 . The method of  claim 1 , wherein the mucositis is esophagitis.  
   
   
       23 . The method of  claim 1 , wherein the mucositis is proctitis.  
   
   
       24 . The method of  claim 1 , wherein the mucositis is a side effect of the human patient undergoing cancer therapy.