US2016067266A1PendingUtilityA1

Stabilized composition for treating psoriasis

34
Assignee: NEXMED HOLDINGS INCPriority: Oct 3, 2008Filed: Nov 13, 2015Published: Mar 10, 2016
Est. expiryOct 3, 2028(~2.2 yrs left)· nominal 20-yr term from priority
A61P 43/00A61P 37/00A61P 17/06A61K 47/06A61K 31/58A61K 31/59A61K 9/06A61K 47/18A61K 31/573A61K 9/0014A61K 31/355A61K 31/221
34
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Claims

Abstract

A storage stable ointment of the present invention comprises a vitamin D compound, a corticosteroid, and an N,N-di(C 1 -C 8 ) alkylamino substituted, (C 4 -C 18 ) alkyl (C 2 -C 18 ) carboxylic ester a (C 1 -C 4 )-alkyl (C 8 -C 22 ) carboxylic ester in a petrolatum ointment base, and optionally containing mineral oil and/or tocopherol. Preferably, the vitamin D compound is calcipotriene, the corticosteroid is selected from the group consisting of clobetasol propionate and betamethasone dipropionate, and the N,N-di(C 1 -C 8 ) alkylamino substituted, (C 4 -C 18 ) alkyl (C 2 -C 18 ) carboxylic ester comprises dodecyl 2-(N,N-dimethylamino)-propionate (DDAIP).

Claims

exact text as granted — not AI-modified
1 - 23 . (canceled) 
     
     
         24 . A composition comprising:
 (a) a vitamin D compound;   (b) a corticosteroid; and   (c) an N,N-di(C 1 -C 8 ) alkylamino substituted, (C 1 -C 18 ) alkyl (C 2 -C 18 )carboxylic ester; and optionally containing mineral oil, tocopherol, or a combination of mineral oil and tocopherol.   
     
     
         25 . The composition of  claim 24  wherein the vitamin D compound comprises calcipotriene. 
     
     
         26 . The composition of  claim 24  wherein the corticosteroid is selected from the group consisting of a pharmaceutically acceptable clobetasol salt and a pharmaceutically acceptable betamethasone salt. 
     
     
         27 . The composition of  claim 24  wherein the N,N-di(C 1 -C 8 ) alkylamino substituted, (C 4 -C 18 ) alkyl (C 2 -C 18 )carboxylic ester comprises dodecyl 2-(N,N-dimethylamino)-propionate (DDAIP). 
     
     
         28 . The composition of  claim 24  wherein the vitamin D compound is present in the composition at a concentration in the range of about 0.001 to 0.01 percent by weight. 
     
     
         29 . The composition of  claim 24  wherein the corticosteroid is present in the composition at a concentration in the range of about 0.01 to 0.1 percent by weight. 
     
     
         30 . The composition of  claim 24  wherein the composition includes tocopherol at a concentration in the range of about 0.001 to 0.01 percent by weight. 
     
     
         31 . The composition of  claim 24  wherein the N,N-di(C 1 -C 8 ) alkylamino substituted, (C 4 -C 18 ) alkyl (C 2 -C 18 ) carboxylic ester is present in the composition at a concentration in the range of about 0.1 to about 5 percent by weight. 
     
     
         32 . A composition comprising:
 (a) about 0.001 to about 0.01 percent by weight of calcipotriene;   (b) about 0.01 to about 0.1 percent by weight of a corticosteroid selected from the group consisting of clobetasol propionate and betamethasone dipropionate;   (c) about 0.001 to about 0.01 percent by weight of tocopherol; and   (d) about 0.1 to about 5 percent by weight of dodecyl 2-(N,N-dimethylamino)-propionate (DDAIP);   in a petrolatum carrier, and containing up to about 10 percent by weight mineral oil.   
     
     
         33 . The ointment of  claim 32  wherein the composition comprises about 1 percent-about 2.5 percent by weight DDAIP. 
     
     
         34 . A method of treating psoriasis in a person in need thereof comprising topically applying a composition comprising:
 (a) a vitamin D compound;   (b) a corticosteroid; and   (c) an N,N-di(C 1 -C 8 ) alkylamino substituted, (C 4 -C 18 ) alkyl (C 2 -C 18 )carboxylic ester; and optionally containing mineral oil, tocopherol, or a combination of mineral oil and tocopherol.   
     
     
         35 . The method of  claim 34  wherein the vitamin D compound comprises calcipotriene. 
     
     
         36 . The method of  claim 34  wherein the corticosteroid is selected from the group consisting of a pharmaceutically acceptable clobetasol salt and a pharmaceutically acceptable betamethasone salt. 
     
     
         37 . The method of  claim 34  wherein the N,N-di(C 1 -C 8 ) alkylamino substituted, (C 4 -C 18 ) alkyl (C 2 -C 18 )carboxylic ester comprises dodecyl 2-(N,Ndimethylamino)-propionate (DDAIP). 
     
     
         38 . The method of  claim 34  wherein the vitamin D compound is present in the composition at a concentration in the range of about 0.001 to 0.01 percent by weight. 
     
     
         39 . The method of  claim 34  wherein the corticosteroid is present in the composition at a concentration in the range of about 0.01 to 0.1 percent by weight. 
     
     
         40 . The method of  claim 34  wherein the composition includes tocopherol at a concentration in the range of about 0.001 to 0.01 percent by weight. 
     
     
         41 . The method of  claim 34  wherein the N,N-di(C 1 -C 8 ) alkylamino substituted, (C 4 -C 18 ) alkyl (C 2 -C 18 ) carboxylic ester is present in the composition at a concentration in the range of about 0.1 to about 5 percent by weight. 
     
     
         42 . A method of treating psoriasis in a person in need thereof comprising topically applying a composition comprising:
 (a) about 0.001 to about 0.01 percent by weight of calcipotriene;   (b) about 0.01 to about 0.1 percent by weight of a corticosteroid selected from the group consisting of clobetasol propionate and betamethasone dipropionate;   (c) about 0.001 to about 0.01 percent by weight of tocopherol; and   (d) about 0.1 to about 5 percent by weight of dodecyl 2-(N,N-dimethylamino)-propionate (DDAIP);   in a petrolatum carrier, and containing up to about 10 percent by weight mineral oil.   
     
     
         43 . The method of  claim 42  wherein the composition comprises about 1 percent-about 2.5 percent by weight DDAIP.

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