Topical skin care composition

Abstract

A cream base for the topical application of skin care therapeutics and a process for making the cream base. In one embodiment, the therapeutic is tretinoin, hydroquinone and fluocinolone acetonide for the treatment of hyperpigmented skin conditions, such as melasma.

What is claimed is: 
     
         1 . A process of making a pharmaceutical composition for topical application, the composition being an emulsion comprising water and at least one active ingredient selected from the group consisting of fluocinolone acetonide, hydroquinone and tretinoin, the process comprising:
 (a) combining water and at least one hydrophilic compound while heating at a temperature in the range of 75° C. to 80° C. to form an aqueous phase;   (b) combining at least two hydrophobic compounds while heating at a temperature in the range of 75° C. to 80° C. to form a non-aqueous phase;   (c) combining the aqueous phase and non-aqueous phase to form a biphasic mixture;   (d) stirring and cooling the biphasic mixture to a temperature in the range of 68° C. to 72° C., then adding at least one active ingredient;   (e) while stirring and cooling, adding at least one emulsifier; and   (f) homogenizing the mixture to form the emulsion.   
     
     
         2 . The process of  claim 1 , wherein the aqueous phase consists essentially of water, magnesium aluminum silicate and butylated hydroxytoluene. 
     
     
         3 . The process of  claim 1 , wherein the non-aqueous phase comprises at least two hydrophobic compounds selected from the group consisting of cetyl alcohol, stearic acid, stearyl alcohol, methyl gluceth, methylparaben, propylparaben, and glycerin. 
     
     
         4 . The process of  claim 1 , wherein the non-aqueous phase consists essentially of cetyl alcohol, stearic acid, stearyl alcohol, methyl gluceth, methylparaben, propylparaben, and glycerin. 
     
     
         5 . The process of  claim 1 , wherein the emulsifier is glyceryl stearate, polyethylene glycol (PEG) stearate or a combination thereof. 
     
     
         6 . The process of  claim 1 , wherein the glyceryl stearate, polyethylene glycol stearate or combination thereof is Arlacel® 165. 
     
     
         7 . The process of  claim 1 , further comprising the step, following the addition of the emulsifier in step (e), of stirring and cooling the biphasic mixture to about 55° C., then adding hydroquinone. 
     
     
         8 . The process of  claim 1 , wherein the biphasic mixture is homogenized when the temperature of the mixture is about 50° C. 
     
     
         9 . The process of  claim 1 , further comprising the step of:
 (g) stirring and cooling the biphasic mixture to about 45° C., then adding sodium metabisulfite.   
     
     
         10 . A pharmaceutical composition for topical application, the composition being an emulsion comprising water and at least one active ingredient selected from the group consisting of fluocinolone acetonide, hydroquinone and tretinoin, the composition made by a process comprising the steps of:
 (a) combining water and at least one hydrophilic compound while heating at a temperature in the range of 75° C. to 80° C. to form an aqueous phase;   (b) combining at least two hydrophobic compounds while heating at a temperature in the range of 75° C. to 80° C. to form a non-aqueous phase;   (c) combining the aqueous phase and non-aqueous phase to form a biphasic mixture;   (d) stirring and cooling the biphasic mixture to a temperature in the range of 68° C. to 72° C., then adding at least one active ingredient;   (e) while stirring and cooling, adding at least one emulsifier; and   (f) homogenizing the mixture to form the emulsion.   
     
     
         11 . The pharmaceutical composition of  claim 10 , wherein the active ingredient is selected from the group consisting of 0.01% fluocinolone acetonide, 4% hydroquinone and 0.05% tretinoin 
     
     
         12 . The pharmaceutical composition of  claim 10 , wherein the active ingredient is selected from the group consisting of 4% hydroquinone and 0.05% tretinoin; 0.01% fluocinolone acetonide and 0.05% tretinoin; and 0.01% fluocinolone acetonide and 4% hydroquinone. 
     
     
         13 . The pharmaceutical composition of  claim 10 , wherein the active ingredient comprises 0.01% fluocinolone acetonide, 4% hydroquinone and 0.05% tretinoin. 
     
     
         14 . A pharmaceutical composition, consisting essentially of 0.01 weight % fluocinolone acetonide; 4 weight % hydroquinone; 0.05 weight % tretinoin; 0.04 weight % butylated hydroxytoluene; 4 weight % cetyl alcohol; 0.05 weight % citric acid; 4 weight % glycerin; 3 weight % magnesium aluminum silicate; 5 weight % methyl gluceth; 0.18 weight % methylparaben; 3.5 weight % glyceryl stearate, polyethylene glycol (PEG) stearate or a combination thereof, 0.02 weight % propylparaben, 0.2 weight % sodium metabisulfite, 3 weight % stearic acid and 4 weight % stearyl alcohol.