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Claims for Patent: 7,939,516

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Claims for Patent: 7,939,516

Title: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.
Inventor(s): Puglia; Nancy (Sanford, FL), Roth; Jerry (Sanford, FL), Ramirez; Rosario (Sanford, FL)
Assignee: Galderma S.A. (Cham, CH)
Application Number:11/747,806
Patent Claims: 1. A medicated composition for topical application comprising active ingredients consisting of fluocinolone acetonide, hydroquinone and tretinoin, the composition being an emulsion obtainable by a process comprising the steps of: (a) mixing water and at least one hydrophilic compound while heating at a temperature in the range of 75.degree. C. to 80.degree. C. to form an aqueous composition; (b) mixing at least two hydrophobic compounds while heating at a temperature in the range of about 75.degree. C. to about 80.degree. C. to form a non-aqueous composition; (c) combining the aqueous and non-aqueous compositions to form a mixture; (d) stirring and cooling the mixture and adding the active ingredients; (e) adding at least one emulsifier to the mixture after the step (c); and (f) homogenizing the mixture containing the at least one emulsifier and the active ingredients to form the emulsion.

2. The composition of claim 1, wherein the active ingredients are added in the sequence fluocinolone acetonide and tretinoin followed by hydroquinone in the course of the stirring and cooling.

3. The composition of claim 2, wherein the at least one emulsifier is added in the course of the stirring and cooling prior to the addition of the hydroquinone.

4. The composition of claim 1, wherein the active ingredient content of the homogenized emulsion is 0.01% fluocinolone acetonide, 4% hydroquinone and 0.05% tretinoin based on the total weight of the composition.

5. A medicated composition in the form of an emulsion, 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.

6. A medicated composition for topical application, comprising active ingredients consisting of fluocinolone acetonide, hydroquinone, and tretinoin, wherein the active ingredients are effective to treat or alleviate symptoms of hyperpigmented skin conditions, and wherein the composition is an emulsion made by a process comprising the steps of (a) mixing water and at least one hydrophilic compound to form an aqueous composition; (b) mixing at least two hydrophobic compounds to form a non-aqueous composition; (c) mixing the aqueous and non-aqueous compositions to form a mixture, the steps (a) through (c) being conducted in the absence of an emulsifier; (d) mixing fluocinolone acetonide, tretinoin and hydroquinone into the mixture of step (c); (e) mixing an emulsifier into the mixture immediately after step (c) or in the course of step (d); and (f) homogenizing the mixture of step (e) to form the emulsion.

7. The composition of claim 6, wherein the emulsion comprises active ingredients consisting of about 0.01 wt % fluocinolone acetonide, about 4 wt % hydroquinone, and about 0.05 wt % tretinoin, based on the total weight of the composition.

8. The composition of claim 6, wherein the emulsion comprises at least one inactive ingredient selected from butylated hydroxytoluene, cetyl alcohol, citric acid, glycerin, glyceryl stearate, magnesium aluminum silicate, methyl gluceth, methylparaben, polyethylene glycol (PEG-100) stearate, propylparaben, purified water, sodium metabisulfite, stearic acid, and stearyl alcohol.

9. The composition of claim 6, wherein the aqueous composition comprises, magnesium aluminum silicate and butylated hydroxytoluene.

10. The composition of claim 6, wherein the non-aqueous composition comprises at least two hydrophobic compounds selected from the group consisting of cetyl alcohol, stearic acid, stearyl alcohol, methyl gluceth, methylparaben, propylparaben and glycerin.

11. The composition of claim 10, wherein the non-aqueous composition comprises cetyl alcohol, stearic acid, stearyl alcohol, methyl gluceth, methylparaben, propylparaben and glycerin.

12. The composition of claim 6, wherein the at least one emulsifier is glyceryl stearate, polyethylene glycol (PEG-100) stearate, or a combination thereof.

13. The composition of claim 6, wherein the at least one emulsifier is a combination of glyceryl stearate and polyethylene glycol stearate.

14. The composition of claim 6, wherein the at least one emulsifier is added in the course of the step (d) and prior to adding the hydroquinone.

15. The composition of claim 14, further comprising sodium metabisulfite added after the at least one emulsifier and prior to the hydroquinone.

16. The composition of claim 6, wherein the aqueous and the non-aqueous compositions are each mixed at an elevated temperature within the range from about 75.degree. C. to about 80.degree. C.

17. The composition of claim 6, wherein the mixture of step (c) is cooled before adding the active ingredients in step (d).

18. The composition of claim 17, wherein the hydroquinone is added in step (d) following cooling of the mixture.

19. The composition of claim 17, wherein the homogenizing step (f) occurs at a temperature of about 50.degree. C.

20. A medicated composition for topical application, comprising active ingredients consisting of fluocinolone acetonide, hydroquinone, and tretinoin, wherein the active ingredients are effective to treat or alleviate symptoms of hyperpigmented skin conditions, wherein the composition is an emulsion made by a process comprising the steps of: (a) mixing water and at least one hydrophilic compound to form an aqueous composition; (b) mixing at least two hydrophobic compounds to form a non-aqueous composition; (c) mixing the aqueous and non-aqueous compositions to form a mixture, the steps (a) through (c) being conducted in the absence of an emulsifier; (d) mixing fluocinolone acetonide and tretinoin into the mixture of step (c); (e) mixing at least one emulsifier into the mixture of step (d); (f) mixing hydroquinone into the mixture of step (e); and (g) homogenizing the mixture of step (f) to form the emulsion.

21. A homogenous medicated composition in the form of an emulsion, comprising active ingredients consisting of fluocinolone acetonide, hydroquinone and tretinoin, wherein the active ingredients are effective to treat or alleviate symptoms of hyperpigmented skin conditions, the composition further comprising magnesium aluminum silicate, butylated hydroxytoluene, cetyl alcohol, stearic acid, stearyl alcohol, methylparaben, propylparaben, glycerol stearate, polyethylene glycol stearate, glycerol monostearate, or a combination thereof, methyl gluceth, glycerin, citric acid, and sodium metabisulfite.

22. The composition of claim 21, comprising active ingredients consisting of about 0.01 wt % fluocinolone acetonide, about 4 wt % hydroquinone, and about 0.05 wt % tretinoin; and further comprising about 3 wt % magnesium aluminum silicate; about 0.04 wt % butylated hydroxytoluene; about 4 wt % cetyl alcohol; about 3 wt % stearic acid; about 4 wt % stearyl alcohol; about 0.18 wt % methylparaben; about 0.02 wt % propylparaben; about 3.5 wt % glycerol stearate, polyethylene glycol stearate, glycerol monostearate, or a combination thereof; about 5 wt % methyl gluceth; about 4 wt % glycerin; about 0.05 wt % citric acid; and about 0.2 wt % sodium metabisulfite, based on the total weight of the composition.

23. The composition of claim 21 being in the form of an oil-in-water emulsion.

24. The composition of claim 23 being in the form of an oil-in-water cream emulsion.
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