Topical Compositions Comprising Telmesteine for Treating Dermatological Disorders

Abstract

This invention relates to topical compositions, such as creams and lotions, that comprise or consist essentially of Telmesteine, or a pharmaceutically acceptable salt thereof, as the active ingredient, and methods for their use in treating a variety of dermatological diseases and disorders, including atopic, dermatitis (eczema), allergic contact dermatitis, seborrheic dermatitis, radiation dermatitis, psoriasis, xerosis and atopy.

1 . A pharmaceutical composition comprising Telmesteine, or a pharmaceutically acceptable salt thereof, and a pharmaceutically acceptable carrier, which composition is suitable for topical administration.  
   
   
       2 . The composition of  claim 1 , wherein the composition consists essentially of Telmesteine and a pharmaceutically acceptable carrier.  
   
   
       3 . The composition of  claim 1 , wherein the composition is in the form of a cream, gel, lotion, suspension, spray or ointment.  
   
   
       4 . The composition of  claim 3 , wherein the composition is in the form of a cream, gel or lotion.  
   
   
       5 . The composition of  claim 1 ,  2 ,  3   4 ,  22  or 23, further comprising a surfactant, stabilizing agent/preservative, fragrance, or a co-solubilizer.  
   
   
       6 . The composition of  claim 1 ,  2 ,  3 ,  4 , or  22 , or  23 , further comprising an antibacterial agent, disinfectant agent, antifungal agent, analgesic, emollient, or a local anesthetic.  
   
   
       7 . A pharmaceutical composition comprising 0.01% Telmesteine, 0.1% sodium hyaluronate, 10.1% ethylhexyl palmitate, 6.0% pentylene glycol, 4.5% arachidyl alcohol, behenyl alcohol, arachidyl glycoside, 4.5% glyceryl stearate PEG-100 stearate, 4.5% butylene glycol, 2.5% capriloyl glycine, 1.2% tocopheryl acetate, 1.7% carbomer, 1.6% ethylhexyl glycerin, 0.5% piroctone olamine, 0.387% sodium hydroxide, 0.85% allantoin, 0.3% DMDM hydantoin, 0.08% EDTA disodium salt, 0.05% tetrahexyldecyl ascorbate, 0.02% propyl gallate, and 61.103% water.  
   
   
       8 . A pharmaceutical composition consisting essentially of 0.01% Telmesteine, 0.1% sodium hyaluronate, 10.1% ethylhexyl palmitate, 6.0% pentylene glycol, 4.5% arachidyl alcohol, behenyl alcohol, arachidyl glycoside, 4.5% glyceryl stearate PEG-100 stearate, 4.5% butylene glycol, 2.5% capriloyl glycine, 1.2% tocopheryl acetate, 1.7% carbomer, 1.6% ethylhexyl glycerin, 0.5% piroctone olamine, 0.387% sodium hydroxide, 0.85% allantoin, 0.3% DMDM hydantoin, 0.08% EDTA disodium salt, 0.05% tetrahexyldecyl ascorbate, 0.02% propyl gallate, and 61.103% water.  
   
   
       9 . A pharmaceutical composition comprising 0.01% Telmesteine, 11.0% ethylhexyl palmitate, 7.0% pentylene glycol, 4.0% arachidyl alcohol, behenyl alcohol, arachidyl glycoside, 4.0% glyceryl stearate, PEG-100 stearate, 4.0% butylene glycol, 2.5% capriloyl glycine, 2.0% tocopheryl acetate, 1.0% salicylic acid, 0.785% sodium hydroxide, 1.8% carbomer, 0.6% ethylhexyl glycerin, 0.35% allantoin, 0.3% DMDM hydantoin, 0.08% EDTA disodium salt, 0.05% tetrahexyldecyl ascorbate, 0.02% propyl gallate, and 59.805% water.  
   
   
       10 . A pharmaceutical composition consisting essentially of 0.01% Telmesteine, 11.0% ethylhexyl palmitate, 7.0% pentylene glycol, 4.0% arachidyl alcohol, behenyl alcohol, arachidyl glycoside, 4.0% glyceryl stearate, PEG-100 stearate, 4.0% butylene glycol, 2.5% capriloyl glycine, 2.0% tocbpheryl acetate, 1.0% salicylic acid, 0.785% sodium hydroxide, 1.8% carbomer, 0.6% ethylhexyl glycerin, 0.35% allantoin, 0.3% DMDM hydantoin, 0.08% EDTA disodium salt, 0.05% tetrahexyldecyl ascorbate, 0.02% propyl gallate, and 59.805% water.  
   
   
       11 . A pharmaceutical composition comprising 2.0% Telmesteine, 10.0% ethylhexyl palmitate, 6.1% pentylene glycol, 5.0% arachidyl alcohol, behenyl alcohol, arachidyl glycoside, 4.0% glyceryl stearate, PEG-100 stearate, 4.0% butylene glycol, 2.5% capriloyl glycine, 1.0% tocopheryl acetate, 0.762% sodium hydroxide, 0.7% carbomer, 0.6% ethylhexyl glycerin, 0.5% piroctone olamine, 0.35% allantoin, 0.3% DMDM hydantoin, 0.1% sodium hyaluronate, 0.08% EDTA disodium salt, 0.05% tetrahexyldecyl ascorbate, 0.02% propyl gallate, and 61.938% water.  
   
   
       12 . A pharmaceutical composition consisting essentially of 2.0% Telmesteine, 10.0% ethylhexyl palmitate, 6.1% pentylene glycol, 5.0% arachidyl alcohol, behenyl alcohol, arachidyl glycoside, 4.0% glyceryl stearate, PEG-100 stearate, 4.0% butylene glycol, 2.5% capriloyl glycine, 1.0% tocopheryl acetate, 0.762% sodium hydroxide, 0.7% carbomer, 0.6% ethylhexyl glycerin, 0.5% piroctone olamine, 0.35% allantoin, 0.3% DMDM hydantoin, 0.1% sodium hyaluronate, 0.08% EDTA disodium salt, 0.05% tetrahexyldecyl ascorbate, 0.02% propyl gallate, and 61.938% water.  
   
   
       13 . A method treating or preventing a dermatological disease or disorder comprising topically administering to the site of the dermatological disease or disorder a composition according to any one of claims  1 - 12  or  claims 21  to  24  in an amount effective to treat or prevent such disease or disorder.  
   
   
       14 . The method according to  claim 13 , wherein the disease or disorder is selected from the group consisting of atopic dermatitis (eczema), allergic contact dermatitis, seborrheic dermatitis, radiation dermatitis, psoriasis, xerosis and atopy.  
   
   
       15 . The method according to  claim 13 , further comprising topically administering a second composition comprising an additional active agent effective to treat or prevent a dermatological disease or disorder.  
   
   
       16 . (canceled)  
   
   
       17 . (canceled)  
   
   
       18 . A pharmaceutical composition according to any of  claims 1  to  4  or  claims 22  to  24 , wherein the composition does not comprise proanthrocyanadin or glycyrrhetinic acid.  
   
   
       19 . A composition according to  claim 1 , in the form of a shampoo.  
   
   
       20 . (canceled)  
   
   
       21 . A composition according to  claim 18 , in the form of a shampoo.  
   
   
       22 . The composition of  claim 2 , wherein the composition is in the form of a cream, gel, lotion, suspension, spray or ointment.  
   
   
       23 . The composition of  claim 22 , wherein the composition is in the form of a cream, gel or lotion.  
   
   
       24 . The composition of  claim 5 , further comprising an antibacterial agent, disinfectant agent, antifungal agent, analgesic, emollient, or a local anesthetic.  
   
   
       25 . A method of treating a dermatological disease or disorder comprising topically administering to the site of the dermatological disease or disorder shampoo comprising a composition according to  claim 1  in an amount effective to treat or prevent such disease or disorder.  
   
   
       26 . A method of treating a dermatological disease or disorder comprising topically administering to the site of the dermatological disease or disorder shampoo comprising a composition according to  claim 18  in an amount effective to treat or prevent such disease or disorder.