Stable topical compositions of fenoldopam

Abstract

The present disclosure is directed to a topical composition, e.g., a physically and chemically stable topical composition of Fenoldopam comprising about 0.1% to about 5% by weight of Fenoldopam or a pharmaceutically acceptable salt thereof, at least one polyacrylamide-type gelling agent, at least one cellulose-type gelling agent, and at least one solvent, wherein the Fenoldopam is substantially solubilized in the composition, and wherein the composition is stable for at least twelve months at 25° C. and 60% relative humidity.

1 . A topical composition of Fenoldopam comprising about 0.1% to about 5% by weight of Fenoldopam or a pharmaceutically acceptable salt thereof, at least one polyacrylamide-type gelling agent, and at least one solvent, wherein the Fenoldopam is substantially solubilized in the composition, and wherein the composition is chemically stable for at least one month at 25° C. and 60% relative humidity. 
     
     
         2 . The topical composition of  claim 1 , wherein the Fenoldopam pharmaceutically acceptable salt is Fenoldopam mesylate. 
     
     
         3 . The topical composition according to  claim 1 , comprising about 1% to about 3% by weight of Fenoldopam or a pharmaceutically acceptable salt thereof. 
     
     
         4 . The topical composition according to  claim 1 , wherein the amount of the at least one polyacrylamide-type gelling agent in the composition is about 1% to about 5% by weight of the composition. 
     
     
         5 . (canceled) 
     
     
         6 . The topical composition according to  claim 1 , wherein the polyacrylamide-type gelling agent is selected from acrylamide/sodium acryloyldimethyl taurate copolymer/isohexadecane/polysorbate 80 mixture (Sepineo™ P600), potyacrylamide/C13-14 i soparaffin/laureth-7 mixture (Sepigel™ 305), hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer mixture (Sepinov™ EMT 10) and hydroxyethyl acrylate/sodium acryloyldimethyl taurate copolymer (Sepineo™ DERM). 
     
     
         7 . The topical composition according to  claim 6 , wherein the polyacrylamide-type gelling agent is acrylamide/sodium acryloyldimethyl taurate copolymer/isohexadecane/polysorbate 80 mixture (Sepineo™ P600). 
     
     
         8 . (canceled) 
     
     
         9 . (canceled) 
     
     
         10 . The topical composition according to  claim 1 , wherein the composition further comprises at least one co-solvent. 
     
     
         11 . The topical composition according to  claim 1 , wherein the solvent is selected from propylene glycol, dimethyl isosorbide, glycerin, ethanol, polyethylene glycol, hexylene glycol, diethylene glycol monoethyl ether and combinations thereof 
     
     
         12 - 14 . (canceled) 
     
     
         15 . The topical composition according to  claim 1 , wherein at least 80% by weight of the Fenoldopam or a pharmaceutically acceptable salt thereof is solubilized. 
     
     
         16 . (canceled) 
     
     
         17 . The topical composition according to  claim 1 , wherein the weight % of Fenoldopam in tire composition is reduced by less than about 10% after one month at 25° C. and 60% relative humidity. 
     
     
         18 . (canceled) 
     
     
         19 . (canceled) 
     
     
         20 . The topical composition according to  claim 1 , wherein the weight percentage of Fenoldopam in the composition is between 90%-110% of the label claim of Fenoldopam for at least one month. 
     
     
         21 . (canceled) 
     
     
         22 . The topical composition according to  claim 1 , wherein the composition comprises less than about 1% by weight impurity B after at least one month at 25° C. and 60% relative humidity. 
     
     
         23 - 26 . (canceled) 
     
     
         27 . The topical composition according to  claim 1 , wherein the dosage form is an ointment, cream, lotion, gel, spray, foam, cloth, patch, wipe or pad. 
     
     
         28 . The topical composition according to  claim 1 , wherein the composition is an anhydrous composition. 
     
     
         29 . The topical composition according to  claim 28 , wherein the anhydrous composition is an anhydrous gel. 
     
     
         30 . The topical composition according to  claim 1 , wherein the composition further comprises water. 
     
     
         31 . The topical composition according to  claim 30 , wherein the composition is an O/W emulsion. 
     
     
         32 . (canceled) 
     
     
         33 . (canceled) 
     
     
         34 . The topical composition according to  claim 1 , wherein the pH of the composition is from about 4 to about 5 after at least one month at 25° C. and 60% relative humidity. 
     
     
         35 . (canceled) 
     
     
         36 . The topical composition according to  claim 1 , wherein the composition further comprises at least one preservative, at least one penetration enhancer, at least one stabilizer, at least one viscosity-increasing agent, at least one thickener, at least one foaming agent, at least one chelating agent or at least one antioxidant. 
     
     
         37 - 39 . (canceled) 
     
     
         40 . A method of treating a D1 receptor-mediated skin disorder in a subject in need thereof, the method comprising topically administering the composition of  claim 1  to an affected skin area of the subject, wherein the D1 receptor-mediated skin disorder is selected from psoriasis or atopic dermatitis.