Compositions and methods for treating diseases or disorders using extended release nitric oxide releasing solutions

Abstract

The present invention relates to a liquid nitric oxide releasing solution (NORS) comprised of at least one nitric oxide releasing compound and at least one acidifying agent, wherein the NORS provides an extended release of a therapeutically effective amount of nitric oxide gas (gNO). The present invention also relates to a liquid NORS comprised of at least one nitrite compound having a concentration of no greater than about 0.5% w/v and at least one acidifying agent, wherein the NORS releases a therapeutically effective amount of gNO. The present invention also relates to a method for the treatment of a wound in a human, the method comprising administering to the human a liquid NORS comprised of at least one nitric oxide releasing compound and at least one acidifying agent, wherein the NORS provides an extended release of a therapeutically effective amount of gNO. The present invention also relates to a method for the treatment, prevention, or reduction of incidence of a disease or disorder in a human in need thereof, the method comprising administering to the human a liquid NORS comprised of at least one nitrite compound at a concentration of no greater than about 0.5% w/v and at least one acidifying agent, wherein the NORS releases a therapeutically effective amount of gNO.

1 . A liquid nitric oxide releasing solution (NORS) comprising at least one nitric oxide releasing compound and at least one acidifying agent, wherein the NORS provides an extended release of a therapeutically effective amount of nitric oxide gas (gNO). 
     
     
         2 . The solution of  claim 1 , wherein the at least one nitric oxide releasing compound is selected from the group consisting of a nitrite, a salt thereof, and any combinations thereof. 
     
     
         3 . The solution of  claim 2 , wherein the nitrite is sodium nitrite. 
     
     
         4 . The solution of  claim 1 , wherein the amount of the at least one nitric oxide releasing compound is not greater than about 0.5% w/v. 
     
     
         5 . The solution of  claim 1 , wherein the at least one acidifying agent is an acid. 
     
     
         6 . The solution of  claim 5 , wherein the acid is citric acid. 
     
     
         7 . The solution of  claim 1 , wherein the amount of the at least one acidifying agent is no greater than about 0.5% w/v. 
     
     
         8 . The solution of  claim 1 , wherein the therapeutically effective concentration of NO is about 160 ppm. 
     
     
         9 . The solution of  claim 1 , wherein the NORS is a saline-based solution. 
     
     
         10 . The solution of  claim 1 , wherein the gNO is released over a period of at least 30 minutes. 
     
     
         11 . The solution of  claim 1 , wherein the gNO is released over a period of at least 4 hours. 
     
     
         12 . The solution of  claim 1 , wherein the gNO is preferentially released over a period of at least 8 hours. 
     
     
         13 . The solution of  claim 1 , wherein the gNO is released over a period of at least 12 hours. 
     
     
         14 . The solution of  claim 1 , wherein the gNO is released over a period of at least 24 hours. 
     
     
         15 . A method of treating a skin site of a subject comprising topically administering to the subject's skin site a nitric oxide releasing solution (NORS) comprising at least one nitric oxide releasing compound and at least one acidifying agent, wherein the NORS provides an extended release of a therapeutically effective amount of nitric oxide gas (gNO). 
     
     
         16 . The method of  claim 15 , wherein the skin site contains an open wound, a cut, a scrape, a burn, an abscess, a lesion, a surgical wound, a trauma wound, tinea pedis, or a disease-associated wound. 
     
     
         17 . The method of  claim 15 , further comprising covering the skin site with a gas impermeable cover. 
     
     
         18 . The method of  claim 15 , further comprising covering the skin site with a gas semi-impermeable cover. 
     
     
         19 . The method of  claim 15 , wherein the cover comprises at least one bleed hole to control or limit pressure between the cover and the skin site. 
     
     
         20 . The method of  claim 15 , wherein the amount of the at least one nitric oxide releasing compound is not greater than about 0.5% w/v. 
     
     
         21 . The method of  claim 15 , wherein the amount of the at least one acidifying agent is no greater than about 0.5% w/v. 
     
     
         22 . The method of  claim 15 , wherein administration comprises soaking the skin site. 
     
     
         23 . The method of  claim 15 , wherein the gNO is released over a period of at least about 30 minutes to about 24 hours.