Claims for Patent: 8,653,053

Summary for Patent: 8,653,053

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. (CH)
Application Number:	13/533,516
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) preparing an aqueous composition comprising water and at least one hydrophilic compound while heating at a temperature in the range of about 75.degree. C. to about 80.degree. C.; b) preparing a non-aqueous composition comprising at least two hydrophobic compounds while heating at a temperature in the range of about 75.degree. C. to about 80.degree. C.; c) combining the aqueous phase and non-aqueous compositions to form a mixture; d) adding at least one emulsifier to the mixture comprising the aqueous and non-aqueous compositions; e) adding tretinoin to the mixture comprising the aqueous and non-aqueous compositions; f) adding fluocinolone acetonide to the mixture comprising the aqueous and non-aqueous compositions; g) adding hydroquinone to the mixture comprising the aqueous and non-aqueous compositions, wherein the hydroquinone is added after adding the at least one emulsifier; and h) homogenizing the mixture to form the emulsion; wherein the aqueous composition comprises butylated hydroxytoluene and 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. 2. The medicated composition of claim 1, wherein the non-aqueous composition comprises cetyl alcohol, stearic acid, stearyl alcohol, methyl gluceth, methylparaben, propylparaben, and glycerin. 3. The medicated composition of claim 1, wherein step (c) further comprises cooling the mixture to a temperature in the range of about 68.degree. C. to about 72.degree. C. 4. The medicated composition of claim 1, wherein the at least one emulsifier is a combination of glycerol stearate and polyethylene glycol stearate. 5. The medicated composition of claim 1, further comprising cooling the mixture after adding at least one emulsifier. 6. The medicated composition of claim 5, further comprising adding citric acid to the mixture after cooling. 7. The medicated composition of claim 6, further comprising cooling the mixture after adding citric acid. 8. The medicated composition of claim 1, wherein step (e) is conducted during step (d). 9. The medicated composition of claim 8, further comprising cooling the mixture after adding at least one emulsifier and tretinoin. 10. The medicated composition of claim 9, further comprising adding citric acid to the mixture after cooling. 11. The medicated composition of claim 10, further comprising cooling the mixture after adding citric acid. 12. The medicated composition of claim 1, wherein steps (e) and (f) are conducted during step (d). 13. The medicated composition of claim 12, further comprising cooling the mixture after adding at least one emulsifier, tretinoin and fluocinolone acetonide. 14. The medicated composition of claim 13, further comprising adding citric acid to the mixture after cooling. 15. The medicated composition of claim 14, further comprising cooling the mixture after adding citric acid. 16. The medicated composition of claim 1, further comprising cooling the mixture before adding the hydroquinone. 17. A homogenous medicated composition in the form of a cream, 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 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. 18. The composition of claim 17, 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 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. 19. The composition of claim 17 in the form of an oil-in-water emulsion. 20. The composition of claim 19 in the form of an oil-in-water cream emulsion.