Nitroxide radioprotector formulations and methods of use

Abstract

Pharmaceutical compositions useful in preventing and treating negative side effects accompanying radiotherapy are disclosed. More particularly, new formulations that can be applied to the skin and mucous membranes of patients undergoing radiotherapy and methods of using these formulations are disclosed.

1 . A composition comprising
 a solvent suitable for topical administration to a mucous membrane; and   an effective amount of a nitroxide sufficient for treating or preventing mucositis or proctitis;   wherein the composition is a liquid composition suitable for topical administration to a mucous membrane;   whereby upon the application of radiation, the administered composition does not leave an amount of residue sufficient to enhance burning of the mucous membrane.   
     
     
         2 . The composition of  claim 1 , wherein the composition does not comprise significant amounts of alcohol. 
     
     
         3 . The composition of  claim 1 , wherein the solvent does not comprise alcohol. 
     
     
         4 . The composition of  claim 1 , wherein the mucous membrane is the oral mucosa. 
     
     
         5 . The composition of  claim 4 , wherein the effective amount of the nitroxide is sufficient for treating or preventing mucositis. 
     
     
         6 . The composition of  claim 5 , wherein the mucositis is oral mucositis. 
     
     
         7 . The composition of  claim 1 , wherein the liquid composition is a spray. 
     
     
         8 . The composition of  claim 1 , wherein the nitroxide is 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl. 
     
     
         9 . The composition of  claim 1 , wherein the nitroxide is 2,2,6,6-tetramethylpiperidine-1-oxyl. 
     
     
         10 . The composition of  claim 1 , wherein an effective amount of the nitroxide is about 70 mg/mL. 
     
     
         11 . A composition comprising
 a solvent suitable for topical administration to the oral mucosa of a human subject;   an effective amount of 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl sufficient for treating or preventing oral mucositis;   wherein the composition is a liquid composition suitable for topical administration to the mouth;   wherein the composition does not contain a significant amount of alcohol;   whereby upon the application of radiation, the administered composition does not leave an amount of residue sufficient to enhance burning of the mucous membrane.   
     
     
         12 . A method of treating or preventing mucositis or proctitis in a subject, comprising:
 administering the composition of  claim 1  to a mucous membrane of a human subject, wherein said administering prevents or treats mucositis or proctitis.   
     
     
         13 . The method of  claim 12 , wherein the nitroxide is 4-hydroxy-2,2,6,6-tetramethylpiperidine-1-oxyl. 
     
     
         14 . The method of  claim 12 , wherein the human subject is a cancer patient. 
     
     
         15 . The method of  claim 12 , further comprising administering chemotherapy to the patient.