Methods and compositions for treating oral mucositis

Abstract

Methods and pharmaceutical compositions including Bisphosphocins for treating oral mucositis in a patient are disclosed.

What is claimed is: 
     
         1 . A method of treating oral mucositis in a patient in need thereof, the method comprising administering an effective amount of a Bisphosphocin, or a pharmaceutically acceptable salt thereof, to the patient, wherein the Bisphosphocin is selected from the group consisting of Nu-2, Nu-3, Nu-4, Nu-5, and Nu-8. 
     
     
         2 . The method of  claim 1 , wherein the administration is topical administration. 
     
     
         3 . The method of  claim 2 , wherein the topical administration is applied to the oral cavity of the patient. 
     
     
         4 . The method of  claim 1 , wherein the administration is carried out using the Bisphosphocin in a gel, ointment, oil, solution, suspension, emulsion or other viscous composition. 
     
     
         5 . The method of  claim 1 , wherein the administration is carried out using the Bisphosphocin in a mouthwash. 
     
     
         6 . The method of  claim 1 , wherein the patient is administered at least one additional active ingredient. 
     
     
         7 . The method of  claim 1 , wherein the Bisphosphocin is administered with a pharmaceutically acceptable carrier. 
     
     
         8 . The method of  claim 1 , wherein the administration is carried out as a multiple dose regimen. 
     
     
         9 . The method of  claim 8 , wherein the administration is carried out one or more times per day. 
     
     
         10 . The method of  claim 1 , wherein the patient is a human. 
     
     
         11 . A method of treating oral mucositis in a patient in need thereof, the method comprising topically administering to the oral cavity of the patient an effective amount of a pharmaceutical composition comprising a Bisphosphocin, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, wherein the Bisphosphocin is selected from the group consisting of Nu-2, Nu-3, Nu-4, Nu-5, and Nu-8. 
     
     
         12 . The method of  claim 11 , wherein the administration is carried out using the Bisphosphocin in a gel, ointment, oil, solution, suspension, emulsion or other viscous composition. 
     
     
         13 . The method of  claim 11 , wherein the administration is carried out using the Bisphosphocin in a mouthwash. 
     
     
         14 . The method of  claim 11 , wherein the Bisphosphocin is present in the pharmaceutical composition in an amount from about 1% to about 20% (weight/weight). 
     
     
         15 . The method of  claim 14 , wherein the Bisphosphocin is present in the pharmaceutical composition in an amount from about 5% to about 15% (weight/weight). 
     
     
         16 . The method of  claim 11 , wherein the Bisphosphocin is present in the pharmaceutical composition in an amount from about 30% to about 50% (weight/weight). 
     
     
         17 . The method of  claim 11 , wherein the administration is carried out as a multiple dose regimen. 
     
     
         18 . The method of  claim 11 , wherein the administration is carried out one or more times per day. 
     
     
         19 . The method of  claim 11 , wherein the patient is a human. 
     
     
         20 . A pharmaceutical composition for treating oral mucositis comprising a Bisphosphocin, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, wherein the Bisphosphocin is selected from the group consisting of Nu-2, Nu-3, Nu-4, Nu-5, and Nu-8. 
     
     
         21 . The pharmaceutical composition of  claim 20 , wherein the Bisphosphocin is present in the pharmaceutical composition in an amount from about 1% to about 20% (weight/weight). 
     
     
         22 . The pharmaceutical composition of  claim 21 , wherein the Bisphosphocin is present in the pharmaceutical composition in an amount from about 5% to about 15% (weight/weight). 
     
     
         23 . The pharmaceutical composition of  claim 20 , wherein the Bisphosphocin is present in the pharmaceutical composition in an amount from about 30% to about 50% (weight/weight). 
     
     
         24 . The pharmaceutical composition of  claim 20 , wherein the pharmaceutically acceptable carrier is a diluent. 
     
     
         25 . The pharmaceutical composition of  claim 24 , wherein the diluent is selected from water, glycerol, mannitol, and saline. 
     
     
         26 . The pharmaceutical composition of  claim 25 , wherein the saline is phosphate buffered saline. 
     
     
         27 . The pharmaceutical composition of  claim 24 , wherein the diluent is present in the pharmaceutical composition in an amount from about 1% to about 10% (weight/weight). 
     
     
         28 . The pharmaceutical composition of  claim 24 , wherein the diluent is present in the pharmaceutical composition in an amount from about 1% to about 15% (weight/weight). 
     
     
         29 . The pharmaceutical composition of  claim 24 , wherein the diluent is present in the pharmaceutical composition in an amount from about 1% to about 20% (weight/weight). 
     
     
         30 . A method of treating oral mucositis in a patient in need thereof, the method comprising topically administering to the oral cavity of the patient an effective amount of the pharmaceutical composition of  claim 20 . 
     
     
         31 . The method of  claim 30 , wherein the pharmaceutical composition has a pH of about pH 1.5 to about pH 4. 
     
     
         32 . The method of  claim 30 , wherein the pharmaceutical composition has a pH of about pH 3 to about pH 4.