Nitric oxide-releasing device

Abstract

A device for generating nitric oxide is disclosed. The device is configured for applying to either a body cavity or a surface of a subject in need thereof. Also disclosed is a method for the treatment of diseases or conditions with the device.

1 . A method of treating a disease or condition in a subject, comprising:
 (a) placing a device in a body cavity or a surface of the subject in need thereof,
 wherein the device comprises: 
 a nitrite source; 
 a reservoir for loading the nitrite source and configured for being applied to the body cavity or the surface of the subject; 
   (b) contacting the nitrite source with a proton source to generates a therapeutically effective amount of nitric oxide (NO).   
     
     
         2 . The method of  claim 1 , wherein the nitrite source and the proton source are separately stored in the device prior to the device being applied to the body cavity. 
     
     
         3 . The method of  claim 1 , wherein the proton source is physically separate from the device. 
     
     
         4 . The method of  claim 1 , wherein the nitrite source comprises an alkali metal nitrite, an alkaline earth metal nitrite, a transition metal nitrite, an ammonium nitrite or any combination thereof 
     
     
         5 . The method of  claim 1 , wherein the nitrite source comprises nitrite loaded nanoparticles. 
     
     
         6 . The method of  claim 1 , wherein the proton source is water. 
     
     
         7 . The method of  claim 1 , wherein one or both of the nitrite source and the proton source are independently admixed with a gelling agent and/or a viscosity adjuster prior to the contact with the proton source. 
     
     
         8 . The method of  claim 7 , wherein the gelling agent comprising a material selected from the group consisting of honey, xanthan gum, guar gum, carrageenan gum, locust bean gum, sodium alginate, agar-agar, gelatin, modified starches, cellulose, crosslinked polyacrylic acids, and alkyl-substituted celluloses, wherein the gelling agent optionally further comprises a dilutor for adjusting the viscosity of the gelling agent. 
     
     
         9 . The method of  claim 7 , wherein the gelling agent comprises honey. 
     
     
         10 . The method of  claim 7 , wherein the nitrite source and/or the proton source are separately stored in the device from the gelling agent and/or the viscosity adjuster prior to being admixed with the gelling agent and/or the viscosity, and the method comprising admixing the nitrite source and/or the proton source independently with the gelling agent and/or the viscosity adjuster. 
     
     
         11 . The method of  claim 7 , wherein one or both of the nitrite source and the proton source are independently admixed with PEG prior to the contact between the nitrite source and the proton source. 
     
     
         12 . The method of  claim 7 , wherein the gelling agent and/or the viscosity adjuster and their respective amounts are selected to provide an extended release of the therapeutically effective amount of the NO over a period of at least 24 hours. 
     
     
         13 . The method of  claim 1 , wherein the reservoir is further loaded with a thiol source. 
     
     
         14 . The method of  claim 13 , wherein the source of thiol group is thiol-containing molecules. 
     
     
         15 . The method of  claim 13 , wherein the thiol source is thiol-containing nanoparticles, which either have the having thiol groups covalently thereto or have thiol-containing molecules loaded in the nanoparticles. 
     
     
         16 . The method of  claim 1 , further comprising a source of S-nitrosothiol (SNO) group. 
     
     
         17 . The method of  claim 1 , wherein the nitrite source comprises an immediate release portion and an extended release portion. 
     
     
         18 . The method of  claim 1 , wherein the disease or condition is viral or bacterial infection, inflammation, neuropathic pain, sinusitis, cystic fibrosis, bronchiectasis, surgical or trauma induced wounds, vaginal deterioration, and sexual dysfunction. 
     
     
         19 . The method of  claim 1 , wherein the body cavity is nose, nasal sinuses, ears, rectum, vagina, mucosa surface in the mouth, or an open wound. 
     
     
         20 . The method of  claim 1 , wherein the device is inserted into the nostril of the subject to treat chronic sinusitis, neuropathic pain, cystic fibrosis or bronchiectasis. 
     
     
         21 . The method of  claim 1 , wherein the device is inserted into the nostril of the subject to the ear of the subject to treat inner or outer ear infection. 
     
     
         22 . The method of  claim 1 , wherein the device is applied to the subject prophylactically. 
     
     
         23 . The method of  claim 1 , wherein the reservoir is a sponge or a patch.