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Details for Patent: 8,298,515

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Details for Patent: 8,298,515

Title:Vitamin formulation
Abstract: A pharmaceutical aerosol foam composition, comprising: an effective amount of a pharmaceutically active ingredient, wherein said pharmaceutically active ingredient is a vitamin or analogue thereof; an occlusive agent; an aqueous solvent; an organic cosolvent; wherein the pharmaceutically active ingredient is insoluble in both water and the occlusive agent; and the occlusive agent being present in an amount sufficient to form an occlusive layer on the skin, in use. In a second embodiment, an oil-in water emulsion having a vitamin, an occlusive agent; an aqueous solvent; and an organic cosolvent, wherein the occlusive agent is present in an amount sufficient to form an occlusive layer on the skin.
Inventor(s): Buchta; Richard (Rowville, AU), Houlden; Robert James (Rowville, AU), Larm; Maria Graziella (Rowville, AU), Loupenok; Leon (Rowville, AU), Ye; Rose (Rowville, AU)
Assignee: Stiefel Research Australia Pty Ltd. (Rowville, Victoria, AU)
Filing Date:Sep 28, 2010
Application Number:12/892,572
Claims:1. A topical oil-in-water emulsion composition, said topical oil-in-water emulsion composition comprising: a water phase comprising water and a vitamin A or a vitamin A analogue thereof, wherein the analogue is selected from the group consisting of acitretin, retinol, retinaldehyde, retinoic acid, dehydroretinol, fenretinide, tazarotene, hydroxyretroretinol, didehydroretinoic acid, carotenes, tretinoin, and combinations thereof and which is solubilized in said water phase; an oil phase comprising an occlusive agent and a stabilizer solubilized in said oil phase; an emulsifier; a water soluble organic solvent; and an aerosol propellant present in an amount of about 2.5% to about 20% by weight, wherein said emulsion is an aerosol emulsion, which is a foam when released from a pressurized container.

2. The topical oil-in-water emulsion composition of claim 1, wherein said vitamin A or vitamin A analogue thereof is tretinoin.

3. The topical oil-in-water emulsion composition of claim 1, wherein said vitamin A or vitamin A analogue thereof is acitretin.

4. The topical oil-in-water emulsion composition of claim 1, wherein said vitamin A or analogue thereof is first solubilized in said water soluble organic solvent.

5. The topical oil-in-water emulsion composition of claim 4, wherein said water soluble organic solvent is selected from the group consisting of propylene glycol, ethylene glycol, butylene glycol, and mixtures thereof.

6. The topical oil-in-water emulsion composition of claim 1, wherein said vitamin A or vitamin A analogue thereof is present in an amount of from about 0.0001% by weight to about 10% by weight, based on the total weight of the composition.

7. The topical oil-in-water emulsion composition of claim 1, wherein said composition comprises water in an amount up to 90% w/w, based on the total weight of the composition.

8. The topical oil-in-water emulsion composition of claim 7, wherein said composition comprises water in an amount from about 70% to about 90% w/w, based on the total weight of the composition.

9. The topical oil-in-water emulsion composition of claim 1, wherein said emulsifier is selected from one or more of the group consisting of a non-ionic, cationic or anionic surfactant, a fatty alcohol, a fatty acid, and fatty acid salts thereof.

10. The topical oil-in-water emulsion composition of claim 9, wherein said emulsifier is a mixture of a C.sub.14-C.sub.22 alcohol and a polyoxyethylene fatty alcohol ether.

11. The topical oil-in-water emulsion composition of claim 10, wherein said C.sub.14-C.sub.22 alcohol is selected from the group consisting of cetyl alcohol, stearyl alcohol, and a mixture thereof.

12. The topical oil-in-water emulsion composition of claim 1, wherein said emulsifier is present in an amount of from about 1 to 15% by weight, based on the total weight of the composition.

13. The topical oil-in-water emulsion composition of claim 10, wherein the amount of said C.sub.14-C.sub.22 alcohol present is from about 0.5% to about 5% w/w, based on the total weight of the composition.

14. The topical oil-in-water emulsion composition of claim 1, wherein said occlusive agent is selected from the group consisting of a mineral oil, grease, petrolatum, a fatty acid, an animal fat, a vegetable fat, a water insoluble polymer, and mixtures thereof.

15. The topical oil-in-water emulsion composition of claim 1, wherein the occlusive agent is present in an amount of about 1% to about 10% by weight, based on the total weight of the composition.

16. The topical oil-in-water emulsion composition of claim 12, wherein said emulsifier is present in an amount of from about 2.0% to about 5.0% by weight, based on the total weight of the composition.

17. The topical oil-in-water emulsion composition of claim 1, further comprising a buffering agent, and wherein the pH of said composition is from about pH 4.0 to about pH 9.0.

18. The topical oil-in-water emulsion composition of claim 1, further comprising a viscosity reducer.

19. The topical oil-in-water emulsion composition of claim 1, wherein said aerosol propellant is selected from the group consisting of a hydrocarbon, a chlorofluorocarbon, dimethyl ether, hydrofluorocarbons, and a mixture thereof.

20. The topical oil-in-water emulsion composition of claim 19, wherein said aerosol propellant comprises a mixture of hydrocarbons.

21. A method for treating acne in a mammal, said method comprising: administering a topical oil-in-water emulsion composition of claim 1, to treat said acne.

22. The topical oil-in-water emulsion composition of claim 4, wherein said water soluble organic solvent is selected from the group consisting of PEG 200, PEG 300, PEG 400, PEG 800, ethylene glycol monoethyl ether, diethylene glycol monoethyl ether, ethyl acetate, propylene carbonate, n-methylpyrrolidone, and mixtures thereof.

23. The topical oil-in-water emulsion composition of claim 4, wherein said water soluble organic solvent is selected from the group consisting of ethanol, n-propanol, isopropanol, n-butanol, t-butanol, and mixtures thereof.

24. The topical oil-in-water emulsion composition of claim 1, wherein the aerosol propellant is present in an amount of about 2.5% to about 7.5% by weight.

25. The topical oil-in-water composition of claim 1, wherein said vitamin A or vitamin A analogue thereof is tazarotene.

26. A topical oil-in-water emulsion composition, said topical oil-in-water emulsion composition comprising: a water phase comprising water in an amount up to 90% w/w, based on the total weight of the composition, and a vitamin A or a vitamin A analogue thereof present in an amount of from about 0.0001% by weight to about 10% by weight, based on the total weight of the composition, wherein the analogue is selected from the group consisting of acitretin, retinol, retinaldehyde, retinoic acid, dehydroretinol, fenretinide, tazarotene, hydroxyretroretinol, didehydroretinoic acid, carotenes, tretinoin, and combinations thereof and which is solubilized in said water phase; an oil phase comprising an occlusive agent present in an amount of about 1% to about 10% by weight, based on the total weight of the composition, and a stabilizer solubilized in said oil phase; an emulsifier present in an amount of from about 1 to about 15% by weight; a water soluble organic solvent present in an amount of from about 0.25% to about 50% by weight; and an aerosol propellant present in an amount of about 2.5% to about 20% by weight, wherein said emulsion is an aerosol emulsion, which is a foam when released from a pressurized container.

27. The topical oil-in-water emulsion composition of claim 26, wherein said vitamin A or vitamin A analogue thereof is tazarotene.

28. The topical oil-in-water emulsion composition of claim 26, wherein said vitamin A or vitamin A analogue thereof is tretinoin.

29. The topical oil-in-water emulsion composition of claim 26, wherein said vitamin A or vitamin A analogue thereof is acitretin.

30. The topical oil-in-water emulsion composition of claim 26, wherein said vitamin A or analogue thereof is first solubilized in said water soluble organic solvent.

31. The topical oil-in-water emulsion composition of claim 30, wherein said composition comprises said water soluble organic solvent in an amount of from about 0.5% to about 2% by weight.

32. The topical oil-in-water emulsion composition of claim 30, wherein said water soluble organic solvent is selected from the group consisting of propylene glycol, ethylene glycol, butylene glycol, and mixtures thereof.

33. The topical oil-in-water emulsion composition of claim 30, wherein said water soluble organic solvent is selected from the group consisting of PEG 200, PEG 300, PEG 400, PEG 800, ethylene glycol monoethyl ether, diethylene glycol monoethyl ether, ethyl acetate, propylene carbonate, n-methylpyrrolidone, and mixtures thereof.

34. The topical oil-in-water emulsion composition of claim 33, wherein said water soluble organic solvent is selected from the group consisting of ethanol, n-propanol, isopropanol, n-butanol, t-butanol, and mixtures thereof.

35. The topical oil-in-water emulsion composition of claim 26, wherein said composition comprises water in an amount from about 70% to about 90% w/w, based on the total weight of the composition.

36. The topical oil-in-water emulsion composition of claim 26, wherein said emulsifier is selected from one or more of the group consisting of a non-ionic, cationic or anionic surfactant, a fatty alcohol, a fatty acid, and fatty acid salts thereof.

37. The topical oil-in-water emulsion composition of claim 26, wherein said emulsifier is present in an amount of from about 2% to about 5% by weight, based on the total weight of the composition.

38. The topical oil-in-water emulsion composition of claim 37, wherein said emulsifier is a mixture of a C.sub.14-C.sub.22 alcohol and a polyoxyethylene fatty alcohol ether.

39. The topical oil-in-water emulsion composition of claim 38, wherein said C.sub.14-C.sub.22 alcohol is selected from the group consisting of cetyl alcohol, stearyl alcohol, and a mixture thereof.

40. The topical oil-in-water emulsion composition of claim 39, wherein the amount of said C.sub.14-C.sub.22 alcohol present is from about 0.5% to about 5% w/w, based on the total weight of the composition.

41. The topical oil-in-water emulsion composition of claim 26, wherein said occlusive agent is selected from the group consisting of a mineral oil, grease, petrolatum, a fatty acid, an animal fat, a vegetable fat, a water insoluble polymer, and mixtures thereof.

42. The topical oil-in-water emulsion composition of claim 26, further comprising a buffering agent, and wherein the pH of said composition is from about pH 4.0 to about pH 9.0.

43. The topical oil-in-water emulsion composition of claim 26, further comprising a viscosity reducer.

44. The topical oil-in-water emulsion composition of claim 26, wherein said aerosol propellant is selected from the group consisting of a hydrocarbon, a chlorofluorocarbon, dimethyl ether, hydrofluorocarbons, and a mixture thereof.

45. The topical oil-in-water emulsion composition of claim 44, wherein said aerosol propellant comprises a mixture of hydrocarbons.

46. The topical oil-in-water emulsion composition of claim 26, wherein the aerosol propellant is present in an amount of about 2.5% to about 7.5% by weight.

47. The topical oil-in-water emulsion composition of claim 26, wherein the aerosol propellant is present in the oil phase.

48. A method for treating acne in a mammal, said method comprising: administering a topical oil-in-water emulsion composition of claim 26, to treat said acne.
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