Details for Patent: 7,544,674

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)
Filing Date:	Oct 25, 2002
Application Number:	10/280,483
Claims:	1. A method of making a topical medicated composition comprising water, hydrophilic compounds and hydrophobic compounds, and active ingredients consisting of fluocinolone acetonide, hydroquinone and tretinoin, the method comprising: (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 composition and the non-aqueous composition to form a mixture, said steps (a) through (c) being conducted in the absence of an emulsifier; (d) mixing the fluocinolone acetonide and the tretinoin into the mixture of step (c); (e) adding at least one emulsifier after step (c) into the mixture of step (c), or during step (d); and thereafter (f) homogenizing the mixture; wherein the hydroquinone is added in step (d) after adding the at least one emulsifier. 2. The method of claim 1, wherein said aqueous composition comprises, magnesium aluminum silicate and butylated hydroxytoluene. 3. The method of claim 1, wherein said 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. 4. The method of claim 3, wherein said non-aqueous composition comprises cetyl alcohol, stearic acid, stearyl alcohol, methyl gluceth, methylparaben, propylparaben and glycerin. 5. The method of claim 1, wherein said at least one emulsifier is glyceryl stearate, polyethylene glycol (PEG) stearate or a combination thereof. 6. The method of claim 5, wherein said at least one emulsifier is a combination of glyceryl stearate and polyethylene glycol stearate. 7. The method of claim 1, further comprising adding sodium metabisulfite to said mixture of step (e) after adding said at least one emulsifier. 8. The method of claim 1, wherein said water and said at least one hydrophilic compound are mixed at an elevated temperature. 9. The method of claim 8, wherein said elevated temperature is from about 75.degree. C. to about 80.degree. C. 10. The method of claim 1, wherein said at least two hydrophobic compounds are mixed at an elevated temperature. 11. The method of claim 10, wherein said elevated temperature is from about 75.degree. C. to about 80.degree. C. 12. The method of claim 1, wherein said water and said at least one hydrophilic compound are mixed at a temperature of from about 75.degree. C. to about 80.degree. C., and said at least two hydrophobic compounds are mixed at a temperature of from about 75.degree. C. to about 80.degree. C. 13. The method of claim 12, wherein said mixture of step (c) is cooled before adding said fluocinolone acetonide and said tretinoin in step (d). 14. The method of claim 13, wherein said cooled temperature is from about 68.degree. C. to about 72.degree. C. 15. The method of claim 12, wherein said mixture of step (d) is cooled while the at least one emulsifier is mixed into the mixture of step (d). 16. The method of claim 12, wherein the hydroquinone is added in step (d) after the mixture of tretinoin and fluocinolone acetonide is cooled. 17. The method of claim 16, wherein said mixture is cooled to about 55.degree. C. before adding said hydroquinone. 18. The method of claim 12, wherein said homogenizing step (f) occurs at a temperature of about 50.degree. C. 19. The method of claim 18, wherein sodium metabisulfite is added to the homogenized mixture after the hydroquinone is added and after the homogenized mixture is cooled to about 45.degree. C. 20. A method of making a topical medicated composition comprising water, hydrophilic compounds and hydrophobic compounds, and active ingredients consisting of fluocinolone acetonide, hydroquinone and tretinoin, the method comprising: (a) mixing water and at least one hydrophilic compound to form an aqueous composition comprising magnesium aluminum silicate and butylated hydroxytoluene; (b) mixing at least two hydrophobic compounds to form a non-aqueous composition, wherein the hydrophobic compounds are selected from the group consisting of cetyl alcohol, stearic acid, stearyl alcohol, methyl gluceth, methylparaben, propylparaben, and glycerin; (c) mixing the aqueous composition and the non-aqueous composition to form a mixture, said steps (a) through (c) being conducted in the absence of an emulsifier; (d) mixing the fluocinolone acetonide and the tretinoin into the mixture of step (c); (e) adding at least one emulsifier after step (c) into the mixture of step (c), or during step (d); and thereafter (f) homogenizing the mixture; wherein the hydroquinone is added in step (d) after adding the at least one emulsifier. 21. The method of claim 20, wherein at least one emulsifier is glyceryl stearate, polyethylene glycol (PEG) stearate or a combination thereof.