Fenoldopam topical formulations for treating skin disorders

Abstract

Embodiments of stable topical compositions for administering fenoldopam (compound (I) or a pharmaceutically acceptable salt or solvate thereof are disclosed for immediate or continued slow release administration, over prolonged periods of time with safe minimal systemic exposure of fenoldopam (reducing the risk for lowering blood pressure). The compositions include those compositions that increase the stability and skin absorption of the drug, particularly anhydrous semi-solid compositions and creams. This is accomplished by incorporating fenoldopam in soluble or dispersed form into semi-solid compositions like ointments or anhydrous gels that are not irritative. Embodiments of methods for using the topical compositions in the treatment of dermatological disorders including psoriasis, alopecia atopic dermatitis and vitiligo are disclosed.

What is claimed is: 
     
         1 - 21 . (canceled) 
     
     
         22 . A method of treating skin disorders, the method comprising topically administering to the site of the skin disorder a therapeutically effective amount of fenoldopam or its pharmaceutical acceptable salts, wherein at least 80% of fenoldopam is in a solubilized form. 
     
     
         23 - 28 . (canceled) 
     
     
         29 . A method of inhibiting psoriasis-induced proinflammatory cytokine secretion, the method comprising topically applying a therapeutically effective amount of fenoldopam, thereby inhibiting the cytokine secretion, wherein the concentration of fenoldopam is less than 5% w/w. 
     
     
         30 . The method of  claim 22 , wherein the therapeutically effective amount of fenoldopam administered further comprises an acidifying agent and/or buffering system. 
     
     
         31 . The method of  claim 30 , wherein the buffering system is a molecular or polymeric acidic buffering agent. 
     
     
         32 . The method of  claim 31 , wherein the molecular or polymeric acidic buffering agent is citric acid and sodium citrate, acetic acid and sodium acetate, alginic acid and sodium alginate and polyacrylic acid, and/or polyacrylic acid sodium salt. 
     
     
         33 . The method of  claim 30 , wherein the acidifying agent is citric acid, maleic acid, malonic acid, lactic acid, glycolic acid, acrylic or methacrylic acid, maleic acid containing polymers or alginate, or sulfate, sulfonate, phosphate or phosphonate acids. 
     
     
         34 . The method of  claim 22 , wherein the skin disorders is psoriasis, atopic dermatitis, alopecia, vitiligo or combinations thereof. 
     
     
         35 . The method of  claim 22 , wherein the therapeutically effective amount of fenoldopam is less than 3% w/w. 
     
     
         36 . The method of  claim 35 , wherein the therapeutically effective amount of fenoldopam is about 0.1% to about 1% w/w. 
     
     
         37 . The method of  claim 35 , wherein the therapeutically effective amount of fenoldopam is about 1% w/w. 
     
     
         38 . The method of  claim 35 , wherein the therapeutically effective amount of fenoldopam is about 0.1% w/w. 
     
     
         39 . The method of  claim 29 , wherein the therapeutically effective amount of fenoldopam administered further comprises an acidifying agent and/or buffering system. 
     
     
         40 . The method of  claim 39 , wherein the buffering system is a molecular or polymeric acidic buffering agent. 
     
     
         41 . The method of  claim 40 , wherein the molecular or polymeric acidic buffering agent is citric acid and sodium citrate, acetic acid and sodium acetate, alginic acid and sodium alginate and polyacrylic acid, and polyacrylic acid sodium salt. 
     
     
         42 . The method of  claim 39 , wherein the acidifying agent is citric acid, maleic acid, malonic acid, lactic acid, glycolic acid, acrylic or methacrylic acid, maleic acid containing polymers or alginate, or sulfate, sulfonate, phosphate or phosphonate acids. 
     
     
         43 . The method of  claim 29 , wherein the therapeutically effective amount of fenoldopam is less than 3% w/w. 
     
     
         44 . The method of  claim 43 , wherein the therapeutically effective amount of fenoldopam is about 0.1% to about 1% w/w. 
     
     
         45 . The method of  claim 43 , wherein the therapeutically effective amount of fenoldopam is about 1% w/w. 
     
     
         46 . The method of  claim 43 , wherein the therapeutically effective amount of fenoldopam is about 0.1% w/w. 
     
     
         47 . The method of  claim 29 , wherein the psoriasis-induced proinflammatory cytokines are interleukin-17 (IL-17), interleukin-23 (IL-23), tumor necrosis factor (TNF-α) and/or interleukin-22 (IL-22).