Pharmaceutical composition for transdermal or transmucous administration

Abstract

The present invention relates to a novel pharmaceutical composition for transdermal or transmucous administration of at least one active substance, and comprising especially a fatty acid as a percutaneous absorption promoter, at least one alcoholic vehicle and also a stabilizer capable of stabilizing the fatty acid in the said pharmaceutical composition.

1 .- 21 . (canceled) 
   
   
       22 . A pharmaceutical composition for transdermal or transmucous administration of at least one active substance, comprising
 an active substance,   a fatty acid percutaneous absorption promoter,   an alcoholic vehicle comprising an alcohol, and   a fatty acid ester capable of stabilizing the fatty acid in said pharmaceutical composition.   
   
   
       23 . A pharmaceutical composition according to  claim 22 , wherein the fatty acid is selected from the group consisting of capric acid, lauric acid, myristic acid, palmitic acid, stearic acid, oleic acid, palmitoleic acid, linoleic acid and linolenic acid. 
   
   
       24 . A pharmaceutical composition according to  claim 22 , having a fatty acid content between 0.1% and 20%, these percentages being expressed on a weight basis relative to 100 g of pharmaceutical composition. 
   
   
       25 . A pharmaceutical composition according to  claim 22 , having a fatty acid content of between 0.2% and 10%, these percentages being expressed on a weight basis relative to 100 g of pharmaceutical composition. 
   
   
       26 . A pharmaceutical composition according to  claim 22 , having a fatty acid content of between 0.5% and 5%, these percentages being expressed on a weight basis relative to 100 g of pharmaceutical composition. 
   
   
       27 . A pharmaceutical composition according to  claim 22 , wherein the fatty acid ester is selected from the group consisting of ethyl oleate, isopropyl oleate, isopropyl myristate, isopropyl palmitate, ethyl octanoate, ethyl dodecanoate, ethyl linoleate and ethyl linolenate. 
   
   
       28 . A pharmaceutical composition according to  claim 22 , having a fatty acid ester content of between 0.1% and 10%, these percentages being expressed on a weight basis relative to 100 g of pharmaceutical composition. 
   
   
       29 . A pharmaceutical composition according to  claim 22 , having a fatty acid ester content of between 0.2% and 5%, these percentages being expressed on a weight basis relative to 100 g of pharmaceutical composition. 
   
   
       30 . A pharmaceutical composition according to  claim 22 , having a fatty acid ester content of between 0.5% and 2.5%, these percentages being expressed on a weight basis relative to 100 g of pharmaceutical composition. 
   
   
       31 . A pharmaceutical composition according to  claim 22 , wherein the alcoholic vehicle comprises ethanol. 
   
   
       32 . A pharmaceutical composition according to  claim 22 , wherein the alcoholic vehicle comprises isopropanal. 
   
   
       33 . A pharmaceutical composition according to  claim 22 , having an alcoholic vehicle content of between 10% and 90%, these percentages being expressed on a weight basis relative to 100 g of pharmaceutical composition. 
   
   
       34 . A pharmaceutical composition according to  claim 22 , having an alcoholic vehicle content of between 20% and 80%, these percentages being expressed on a weight basis relative to 100 g of pharmaceutical composition. 
   
   
       35 . A pharmaceutical composition according to  claim 22 , having an alcoholic vehicle content of between 40% and 70%, these percentages being expressed on a weight basis relative to 100 g of pharmaceutical composition. 
   
   
       36 . A pharmaceutical composition according to  claim 22 , further comprising a co-solvent selected from the group consisting of glycerol, propylene glycol, polyethylene glycol, and mixtures thereof. 
   
   
       37 . A pharmaceutical composition according to  claim 36 , having a co-solvent content of between 0.5% and 20%, these percentages being expressed on a weight basis relative to 100 g of pharmaceutical composition. 
   
   
       38 . A pharmaceutical composition according to  claim 36 , having a co-solvent content of between 1% and 10%, these percentages being expressed on a weight basis relative to 100 g of pharmaceutical composition. 
   
   
       39 . A pharmaceutical composition according to  claim 22 , wherein said composition is in the form of a gel, a solution, a cream, a lotion, a milk, an ointment, an aerosol or a patch. 
   
   
       40 . A pharmaceutical composition according to  claim 22 , wherein said composition is in the form of a gel or a solution. 
   
   
       41 . A pharmaceutical composition according to  claim 22 , being in the form of a gel, and further comprising between 0.2% and 30% of a gelling agent, these percentages being expressed on a weight basis relative to 100 g of formulation. 
   
   
       42 . A pharmaceutical composition according to  claim 22 , being in the form of a gel, and further comprising between 0.5% and 10% of a gelling agent, these percentages being expressed on a weight basis relative to 100 g of pharmaceutical composition. 
   
   
       43 . A pharmaceutical composition according to  claim 22 , being in the form of a gel, and-further comprising between 0.3% and 5% of a gelling agent, these percentages being expressed on a weight basis relative to 100 g of pharmaceutical composition. 
   
   
       44 . A pharmaceutical composition according to  claim 41 , wherein the gelling agent is selected from the group consisting of carbomers, non-preneutralized acrylic polymers, cellulose derivatives, poloxamers, poloxamines, chitosan, dextran pectins, natural gums, and mixtures thereof. 
   
   
       45 . A pharmaceutical composition according to  claim 41 , wherein the gelling agent is selected from the group consisting of carbomers, cellulose derivatives, and mixtures thereof. 
   
   
       46 . A pharmaceutical composition according to  claim 41 , wherein the gelling agent is selected from the group consisting of Carbopol® 980, hydroxypropylcellulose and mixtures thereof. 
   
   
       47 . A pharmaceutical composition according to  claim 41 , further comprising a neutralizer. 
   
   
       48 . A pharmaceutical composition according to  claim 47 , wherein the neutralizer is selected from the group consisting of triethanolamine, sodium hydroxide, ammonium hydroxide, potassium hydroxide, arginine, aminomethylpropanol and tromethamine, and mixtures thereof. 
   
   
       49 . A pharmaceutical composition according to  claim 47 , wherein the neutralizer is selected from the group consisting of triethanolamine, tromethamine, and mixtures thereof. 
   
   
       50 . A pharmaceutical composition according to  claim 47 , wherein the neutralizer/gelling agent ratio is between 10/1 and 0.1/1. 
   
   
       51 . A pharmaceutical composition according to  claim 47 , wherein the neutralizer/gelling agent ratio is between 7/1 and 0.5/1. 
   
   
       52 . A pharmaceutical composition according to  claim 47 , wherein the neutralizer/gelling agent ratio is between 4/1 and 1/1. 
   
   
       53 . A pharmaceutical composition according to  claim 22 , wherein the active substance is selected from the group consisting of oestrogens, progestins, androgens, anti-oestrogens and anti-androgens, and mixtures thereof. 
   
   
       54 . A pharmaceutical composition according to  claim 53 , having an active substance content of between 0.01% and 5%, these percentages being expressed on a weight basis relative to 100 g of pharmaceutical composition. 
   
   
       55 . A pharmaceutical composition according to  claim 22 , having a pH of between 4 and 10. 
   
   
       56 . A pharmaceutical composition according to  claim 22 , having a pH of between 5 and 9. 
   
   
       57 . A pharmaceutical composition according to  claim 22 , having a pH of between 6 and 8.