Epinephrine spray formulations

Abstract

The present invention is directed to epinephrine spray formulations. The present invention is further directed to methods of treating anaphylaxis by administering epinephrine spray formulations to subjects in need of such treatments.

What we claim is: 
     
         1 . An epinephrine spray solution comprising from about 0.1% w/w to about 15% w/w epinephrine or a salt thereof and from 0.9% to 80% w/w water, wherein w/w denotes weight by weight of the solution and wherein the solution has a pH from about 2 to about 7. 
     
     
         2 . The solution of  claim 1 , further comprising from about 1% w/w to about 99% w/w of a solvent selected from the group consisting of ethanol, glycerin, propylene glycol, polyethylene glycol 400 and a combination thereof. 
     
     
         3 . The solution of  claim 1 , further comprising from about 0.1% w/w to about 60% w/w of at least one acid. 
     
     
         4 . The solution of  claim 1 , wherein the solution does not contain sorbitol. 
     
     
         5 . The solution of  claim 2 , wherein the solvent comprises from about 2% w/w to about 60% w/w ethanol. 
     
     
         6 . The solution of  claim 1 , wherein the at least one acid is diluted hydrochloric acid. 
     
     
         7 . The solution of  claim 1 , wherein the epinephrine salts are selected from the group consisting of citrate, hydrochloride, halide, sulfate, bitartrate, tartrate, phosphate, acetate, malate, maleate, succinate, ascorbate, carbonate, mesylate and lactate. 
     
     
         8 . The solution of  claim 1 , further comprising a stabilizer or chelating agent selected from the group consisting of butylated hydroxyanisole (BHA), butylated hydroxytoluene (BHT), ascorbic acid, methionine, sodium ascorbate, sodium thiosulfate, sodium bisulfite, sodium metabisulfite, ascorbyl palmitate, thioglycerol, alpha tocopherol (vitamin E), cysteine hydrochloride, benzalkonium chloride (BKC), citric acid, edetate disodium dihydrate (EDTA), sodium citrate, propyl gallate, 8-hydroxyquinoline, boric acid, histidine and combinations thereof. 
     
     
         9 . The solution of  claim 8 , wherein the stabilizer or chelating agent comprises EDTA at a concentration from about 0.005% w/w to about 0.5% w/w. 
     
     
         10 . The solution of  claim 8 , wherein the stabilizer comprises sodium bisulfite or sodium metabisulfite or a combination thereof at a concentration from about 0.005% w/w to about 5% w/w. 
     
     
         11 . The solution of  claim 8 , wherein the stabilizer or chelating agent comprises BKC at a concentration from about 0.005% to about 0.5% w/w. 
     
     
         12 . A method of treating anaphylaxis comprising administering the solution of  claim 1  to a subject in need thereof. 
     
     
         13 . The method of  claim 12 , wherein the subject is suffering from nasal congestion. 
     
     
         14 . The method of  claim 12 , wherein administration occurs via an intranasal route. 
     
     
         15 . The method of  claim 12 , wherein administration occurs via a multi-dose device that delivers more than one dose of the solution of  claim 1  to the subject. 
     
     
         16 . The method of  claim 15 , wherein the multi-dose device is a bi-dose device that delivers two doses of the solution of  claim 1  to the subject.