US2019231797A1PendingUtilityA1

Topical compositions and methods for treating psoriasis

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Assignee: BAUSCH HEALTH US LLCPriority: Jun 18, 2015Filed: Apr 8, 2019Published: Aug 1, 2019
Est. expiryJun 18, 2035(~8.9 yrs left)· nominal 20-yr term from priority
Inventors:Gordon J. DowRadhakrishnan PillaiVarsha Bhatt
A61P 43/00A61P 17/06A61K 47/14A61K 9/0014A61K 9/107A61K 9/12A61K 31/4436A61K 9/06A61K 47/26A61K 31/573A61K 45/06A61K 47/44A61K 31/192A61K 2300/00
67
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Claims

Abstract

Topical pharmaceutical compositions comprise a combination of a corticosteroid a retinoid; and methods for treating psoriasis with same.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A topical pharmaceutical composition for treating psoriasis the composition comprising:
 (a) a corticosteroid or a pharmaceutically acceptable salt or ester thereof, at a positive concentration of less than 0.05 percent by weight of the composition;   (b) a retinoid or a pharmaceutically acceptable salt or ester thereof at a positive concentration of less than 0.09 percent by weight of the composition; and   (c) a dermatologically acceptable carrier; wherein the corticosteroid is selected from the group consisting of halobetasol, clobetasol, betamethasone, diflorasone, and fluocinonide.   
     
     
         2 . The topical pharmaceutical composition of  claim 1 , wherein the corticosteroid or a pharmaceutically acceptable salt or ester thereof is selected from the group consisting of halobetasol propionate, clobetasol propionate, betamethasone dipropionate, diflorasone diacetate, and fluocinonide. 
     
     
         3 . The topical pharmaceutical composition of  claim 1 , wherein the retinoid is selected from the group consisting of tazarotene, bexarotene, and adapalene. 
     
     
         4 . The topical pharmaceutical composition of  claim 1 , wherein the corticosteroid is halobetasol propionate, and the retinoid is tazarotene. 
     
     
         5 . The topical pharmaceutical composition of  claim 1 , wherein (a) the corticosteroid is halobetasol or a pharmaceutically acceptable salt or ester thereof, and (b) the retinoid is tazarotene or a pharmaceutically acceptable tazarotenic acid salt, wherein (a) halobetasol or a pharmaceutically acceptable salt or ester thereof is present in the composition at a concentration in the range from about 0.005 to about 0.03 percent by weight of the composition, and (b) tazarotene or a pharmaceutically acceptable tazarotenic acid salt is present in the composition at a concentration in the range from about 0.005 to about 0.049 percent by weight of the composition. 
     
     
         6 . The topical pharmaceutical composition of  claim 1 , comprising:
 (a) halobetasol propionate at a concentration of 0.01 percent by weight of the composition; and   (b) tazarotene at a concentration of 0.045 percent by weight of the composition.   
     
     
         7 . The topical pharmaceutical composition of  claim 1 , wherein the composition is an oil-in-water emulsion. 
     
     
         8 . The topical pharmaceutical composition of  claim 7 , wherein the corticosteroid and the retinoid are dissolved in a liquid oil component of the emulsion. 
     
     
         9 . The topical pharmaceutical composition of  claim 7 , wherein the liquid oil component comprises a DCAE, MCAE, or combinations thereof. 
     
     
         10 . The topical pharmaceutical composition of  claim 8 , wherein the liquid oil component is selected from the group consisting of DCAE, MCAE, combinations thereof, and mixtures thereof. 
     
     
         11 . The topical pharmaceutical composition of  claim 7 , wherein an oil phase of the oil-in-water emulsion comprises a liquid oil component, which comprises diethyl sebacate and light mineral oil. 
     
     
         12 . The topical pharmaceutical composition of  claim 11 , wherein the corticosteroid and the retinoid are dissolved in the liquid oil component of the emulsion. 
     
     
         13 . The topical pharmaceutical composition of  claim 7 , wherein the emulsion is a lotion. 
     
     
         14 . The topical pharmaceutical composition of  claim 7 , wherein the emulsion is a cream. 
     
     
         15 . A method of treating psoriasis, the method comprising topically applying a pharmaceutical composition to an affected area of a body of a subject suffering from psoriasis; wherein the composition comprises:
 (a) a corticosteroid or a pharmaceutically acceptable salt or ester thereof, at a positive concentration of less than 0.05 percent by weight of the composition;   (b) a retinoid or a pharmaceutically acceptable salt or ester thereof at a positive concentration of less than 0.09 percent by weight of the composition; and   (c) a dermatologically acceptable carrier; wherein the corticosteroid is selected from the group consisting of halobetasol, clobetasol, betamethasone, diflorasone, and fluocinonide; and wherein said applying is carried out one or more times per day for a period of time sufficient to treat such psoriasis.   
     
     
         16 . The method of  claim 15 , wherein said applying is carried out once per day for eight weeks. 
     
     
         17 . The method of  claim 15 , wherein the corticosteroid or a pharmaceutically acceptable salt or ester thereof is selected from the group consisting of halobetasol propionate, clobetasol propionate, betamethasone dipropionate, diflorasone diacetate, and fluocinonide. 
     
     
         18 . The method of  claim 15 , wherein the retinoid is selected from the group consisting of tazarotene, bexarotene, and adapalene. 
     
     
         19 . The method of  claim 15 , wherein the corticosteroid is halobetasol propionate, and the retinoid is tazarotene. 
     
     
         20 . The method of  claim 15 , wherein (a) the corticosteroid is halobetasol or a pharmaceutically acceptable salt or ester thereof; and (b) the retinoid is tazarotene or a pharmaceutically acceptable tazarotenic acid salt; wherein (a) halobetasol or a pharmaceutically acceptable salt or ester thereof is present in the composition at a concentration in the range from about 0.005 to about 0.03 percent by weight of the composition; and (b) tazarotene or a pharmaceutically acceptable tazarotenic acid salt is present in the composition at a concentration in the range from about 0.005 to about 0.049 percent by weight of the composition. 
     
     
         21 . The method of  claim 15  comprising: (a) halobetasol propionate at a concentration of 0.01 percent by weight of the composition, and (b) tazarotene at a concentration of 0.045 percent by weight of the composition. 
     
     
         22 . The method of  claim 15 , wherein the composition is an oil-in-water emulsion. 
     
     
         23 . The method of  claim 22 , wherein the corticosteroid and the retinoid are dissolved in a liquid oil component of the emulsion. 
     
     
         24 . The method of  claim 22 , wherein the liquid oil component comprises a DCAE, MCAE, or combinations thereof. 
     
     
         25 . The method of  claim 23 , wherein the liquid oil component comprises a DCAE, MCAE, or combinations thereof. 
     
     
         26 . The method of  claim 22 , wherein an oil phase of the oil-in-water emulsion comprises a liquid oil component, which comprises diethyl sebacate and light mineral oil. 
     
     
         27 . The method of  claim 26 , wherein the corticosteroid and the retinoid are dissolved in the liquid oil component of the emulsion. 
     
     
         28 . The method of  claim 22 , wherein the emulsion is a lotion. 
     
     
         29 . The method of  claim 22 , wherein the emulsion is a cream. 
     
     
         30 . The method of  claim 21 , wherein said applying is carried out once per day for eight weeks.

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