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Claims for Patent: 8,263,580

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Claims for Patent: 8,263,580

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), Ye; Rose (Rowville, AU), Larm; Maria Graziella (Rowville, AU), Loupenok; Leon (Rowville, AU)
Assignee: Stiefel Research Australia Pty Ltd (Rowville, AU)
Application Number:11/420,700
Patent 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 D or a vitamin D analogue thereof, wherein the analogue is selected from the group consisting of calcidiol, calcitriol, calcipotriene, paricalcitol, 22-oxacalcitriol, dihydrotachysterol, calciferol, 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; and a water soluble organic solvent, and 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 D or analogue thereof is calcipotriene.

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

4. The topical oil-in-water emulsion composition of claim 3, wherein said water soluble organic solvent is propylene glycol.

5. The topical oil-in-water emulsion composition of claim 1, wherein said stabilizer is vitamin E or a derivative thereof; wherein said vitamin D or analogue thereof is calcipotriene and is present in an amount of from approximately 0.001% by weight to approximately 1% by weight, based on the total weight of the composition; and wherein said emulsifier is present in an amount of from approximately 2.0% to approximately 5.0% by weight, based on the total weight of the composition.

6. The topical oil-in-water emulsion composition of claim 1, wherein said vitamin D or analogue thereof is present in an amount of from approximately 0.0001% by weight to approximately 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% by weight, 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 11, wherein said C.sub.14-C.sub.22 alcohol is a mixture of cetyl alcohol and stearyl alcohol.

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

14. 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.

15. 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.

16. The topical oil-in-water emulsion composition of claim 1, wherein said occlusive agent is present in an amount of about 1% to about 55% by weight based on the total weight of the composition.

17. The topical oil-in-water emulsion composition of claim 16, wherein the occlusive agent is present in an amount of approximately 1% to about 10% by weight, based on the total weight of the composition.

18. The topical oil-in-water emulsion composition of claim 13, wherein the emulsifier is present in an amount of from approximately 2.0% to approximately 5.0% by weight, based on the total weight of the composition.

19. The topical oil-in-water emulsion composition of claim 1, further comprising a buffering agent.

20. The topical oil-in-water emulsion composition of claim 19, wherein the pH of said composition is from about pH 4.0 to about pH 9.0.

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

22. The topical oil-in-water emulsion composition of claim 1, further comprising a humectant.

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

24. The topical oil-in-water emulsion composition of claim 23, wherein said aerosol propellant comprises a mixture of hydrocarbons.

25. A method for treating psoriasis in a mammal, said method comprising: administering a topical oil-in-water emulsion composition of any one of claims 1, 2, 3-5 and 6-24, to treat psoriasis.

26. The topical oil-in-water emulsion composition of claim 1, wherein the composition further comprises a corticosteroid.

27. A topical oil-in-water emulsion composition, said topical oil-in-water emulsion composition comprising: a water phase comprising water and a vitamin D or a vitamin D analogue thereof, wherein the analogue is selected from the group consisting of calcidiol, calcitriol, calcipotriene, paricalcitol, 22-oxacalcitriol, dihydrotachysterol, calciferol, 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; and a water soluble organic solvent, and wherein the stabilizer is Vitamin E or an analogue thereof, and wherein said emulsion is an aerosol emulsion, which is a foam when released from a pressurized container.

28. The topical oil-in-water emulsion composition of claim 27, wherein said vitamin D or analogue thereof is calcipotriene.

29. The topical oil-in-water emulsion composition of claim 27, 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 a mixture thereof.

30. The topical oil-in-water emulsion composition of claim 27, wherein the occlusive agent is present in an amount of approximately 1% to about 10% by weight, based on the total weight of the composition.

31. The topical oil-in-water emulsion composition of claim 27, 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.

32. The topical oil-in-water emulsion composition of claim 31, wherein said emulsifier is a mixture of a C.sub.14-C.sub.22 alcohol and a polyoxyethylene fatty alcohol ether.

33. The topical oil-in-water emulsion composition of claim 27, wherein said water soluble organic solvent is propylene glycol, ethylene glycol, butylene glycol or a polyol.

34. The topical oil-in-water emulsion composition of claim 33, wherein said water soluble organic solvent is propylene glycol.

35. The topical oil-in-water emulsion composition of claim 27, wherein said water soluble organic solvent is PEG 200, PEG 300, PEG 400, PEG800, ethylene glycol monoethyl ether, diethylene glycol monoethyl ether, ethyl acetate, propylene carbonate, or n-methylpyrrolidone.

36. The topical oil-in-water emulsion composition of claim 27, which further comprises a viscosity modifying agent.

37. The topical oil-in-water emulsion composition of claim 36, wherein the viscosity modifying agent is isopropyl myristate.

38. The topical oil-in-water emulsion composition of claim 27, further comprising a buffering agent, and wherein the pH of said composition is from about pH 4.0 to about pH 9.0.

39. The topical oil-in-water emulsion composition of claim 34, further comprising a buffering agent, and wherein the pH of said composition is from about pH 4.0 to about pH 9.0.

40. The topical oil-in-water emulsion composition of claim 27, which further comprises a humectant.

41. The topical oil-in-water emulsion composition of claim 1, wherein said emulsifier is a surfactant or blend of surfactants having an HLB value of about 9 to about 14.

42. The topical oil-in-water emulsion composition of claim 1, wherein said emulsifier is a non-ionic surfactant selected from the group consisting of glycerol fatty acid esters, glycol fatty acid esters, polyhydric alcohol fatty acid esters, polyoxyethylene fatty alcohol ethers, polyoxyethylene sorbitan fatty acid esters, sorbitan esters, alkyl glycosides, fatty acid ethanolamides, and a mixture thereof.

43. The topical oil-in-water emulsion composition of claim 1, wherein said emulsifier is a mixture of surfactants which are sorbitan monostearate and polysorbate 60.

44. A topical oil-in-water emulsion composition, said topical oil-in-water emulsion composition comprising: a water phase comprising water, water soluble organic solvent and calcipotriene present in an amount of from approximately 0.005% to approximately 10.0% by weight, based on the total weight of the composition and which is first solubilized in said water soluble organic solvent and further solubilized into said water phase; an oil phase comprising an occlusive agent and a stabilizer solubilized in said oil phase; and an emulsifier present in an amount of from approximately 2.0% to approximately 5.0% by weight, based on the total weight of the composition; said occlusive agent present in an amount of approximately 1% to about 10% by weight, based on the total weight of the composition; and wherein said emulsion is an aerosol emulsion, which is a foam when released from a pressurized container.

45. The topical oil-in-water emulsion composition of claim 44, further comprising a buffering agent.

46. The topical oil-in-water emulsion composition of claim 44, wherein the pH of said composition is from about pH 4.0 to about pH 9.0.

47. The topical oil-in-water emulsion composition of claim 44, wherein the stabilizer is Vitamin E or an analogue thereof.

48. The topical oil-in-water emulsion composition of claim 44, further comprising a humectant.

49. The topical oil-in-water emulsion composition of claim 44, wherein said water soluble organic solvent is propylene glycol, ethylene glycol, butylene glycol or a polyol.

50. The topical oil-in-water emulsion composition of claim 49, wherein said water soluble organic solvent is propylene glycol.

51. The topical oil-in-water emulsion composition of claim 44, wherein said water soluble organic solvent is PEG 200, PEG 300, PEG 400, PEG800, ethylene glycol monoethyl ether, diethylene glycol monoethyl ether, ethyl acetate, propylene carbonate, or n-methylpyrrolidone.

52. The topical oil-in-water emulsion composition of claim 44, wherein said composition comprises water in an amount up to 90% w/w, based on the total weight of the composition.

53. The topical oil-in-water emulsion composition of claim 44, wherein said composition comprises water in an amount from about 70% to about 90% by weight, based on the total weight of the composition.

54. The topical oil-in-water emulsion composition of claim 44, 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.

55. The topical oil-in-water emulsion composition of claim 54, wherein said emulsifier is a mixture of a C.sub.14-C.sub.22 alcohol and a polyoxyethylene fatty alcohol ether.

56. The topical oil-in-water emulsion composition of claim 55, wherein said C.sub.14-C.sub.22 alcohol is selected from the group consisting of cetyl alcohol, stearyl alcohol, and a mixture thereof.

57. The topical oil-in-water emulsion composition of claim 56, wherein said C.sub.14-C.sub.22 alcohol is a mixture of cetyl alcohol and stearyl alcohol.

58. The topical oil-in-water emulsion composition of claim 44, 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.

59. The topical oil-in-water emulsion composition of claim 44, further comprising a viscosity reducer.

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

61. The topical oil-in-water emulsion composition of claim 60, wherein said aerosol propellant comprises a mixture of hydrocarbons.

62. The topical oil-in-water emulsion composition of claim 44, wherein the composition further comprises a corticosteroid.

63. The topical oil-in-water emulsion composition of claim 44, which further comprises a viscosity modifying agent.

64. The topical oil-in-water emulsion composition of claim 63, wherein the viscosity modifying agent is isopropyl myristate.

65. The topical oil-in-water emulsion composition of claim 44, wherein said emulsifier is a surfactant or blend of surfactants having an HLB value of about 9 to about 14.

66. The topical oil-in-water emulsion composition of claim 44, wherein said emulsifier is a non-ionic surfactant selected from the group consisting of glycerol fatty acid esters, glycol fatty acid esters, polyhydric alcohol fatty acid esters, polyoxyethylene fatty alcohol ethers, polyoxyethylene sorbitan fatty acid esters, sorbitan esters, alkyl glycosides, fatty acid ethanolamides, and a mixture thereof.

67. The topical oil-in-water emulsion composition of claim 44, wherein said emulsifier is a mixture of surlactants which are sorbitan monostearate and polysorbate 60.

68. A method for treating psoriasis in a mammal, said method comprising: administering a topical oil-in-water emulsion composition of claim 44 to treat psoriasis.

69. The topical oil-in-water emulsion composition of claim 1, wherein said stabilizer is selected from the group consisting of Vitamin E, Vitamin E derivatives, beta-carotene, coenzyme Q10, lutein, tocotrienols, soy isoflavones, s-adenosylmethionine, butylated hydroxytoluene, and a mixture thereof.

70. The topical oil-in-water emulsion composition of claim 44, wherein said stabilizer is selected from the group consisting of Vitamin E, Vitamin E derivatives, beta-carotene, coenzyme Q10, lutein, tocotrienols, soy isoflavones, s-adenosylmethionine, butylated hydroxytoluene, and a mixture thereof.
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