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Claims for Patent: 8,629,128

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Claims for Patent: 8,629,128

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 West Coast, LLC (Wilmington, New Castle, DE)
Application Number:13/623,568
Patent Claims: 1. A topical oil-in-water emulsion composition, said topical oil-in-water emulsion composition comprising: a water phase and an oil phase; calcipotriene, wherein the calcipotriene is solubilized in said water phase and a stabilizer is solubilized in said oil phase; an emulsifier; an occlusive agent; an organic co-solvent; an aerosol propellant; and wherein said emulsion is an aerosol emulsion, which is a foam when released from a pressurized container, and the stabilizer prevents oxidation of the calcipotriene.

2. The topical oil-in-water emulsion composition of claim 1, wherein said calcipotriene is first solubilized in said organic co-solvent, which is water soluble.

3. The topical oil-in-water emulsion composition of claim 2, wherein said organic co-solvent is selected from the group consisting of propylene glycol, ethylene glycol, butylene glycol, a polyol, and mixtures thereof.

4. 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.

5. The topical oil-in-water emulsion composition of claim 4, wherein said stabilizer is vitamin E or a derivative thereof.

6. The topical oil-in-water emulsion composition of claim 1, wherein said calcipotriene 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 3, wherein said organic co-solvent is propylene glycol.

13. The topical oil-in-water emulsion composition of claim 1, 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.

14. The topical oil-in-water emulsion composition of claim 9, 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 acid esters, polyoxyethylene fatty alcohol ethers, polyoxyethylene sorbitan fatty acid esters, sorbitan esters, alkyl glycosides, fatty acid ethanolamides, and a mixture thereof.

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 about 1% to about 10% by weight, based on the total weight of the composition.

18. 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 4 to about 9.

19. The topical oil-in-water emulsion composition of claim 9, wherein said emulsifier is a mixture of surfactants which are sorbitan monostearate and polysorbate 60.

20. The topical oil-in-water emulsion composition of claim 1, further comprising a viscosity modifying agent.

21. The topical oil-in-water emulsion composition of claim 20, wherein the viscosity modifying agent is isopropyl myristate.

22. 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.

23. The topical oil-in-water emulsion composition of claim 22, wherein said aerosol propellant comprises a mixture of hydrocarbons.

24. A method for treating a dermatological disorder in a human, said method comprising: administering a topical oil-in-water emulsion composition of claim 1, to treat said dermatological disorder.

25. The method of claim 24, wherein said dermatological disorder is psoriasis.

26. 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.

27. The topical oil-in-water emulsion composition of claim 1, wherein said organic co-solvent is PEG 200, PEG 300, PEG 400, PEG 800, ethylene glycol monoethyl ether, diethylene glycol monoethyl ether, ethyl acetate, propylene carbonate, or n-methylpyrrolidone.

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

29. A topical oil-in-water emulsion composition, said topical oil-in-water emulsion composition comprising: a water phase comprising water and calcipotriene, which is solubilized in said water phase; an oil phase comprising an occlusive agent and a stabilizer that is Vitamin E or a derivative thereof solubilized in said oil phase; an emulsifier; an organic co-solvent; an aerosol propellant; and wherein said emulsion is an aerosol emulsion, which is a foam when released from a pressurized container, and the stabilizer prevents oxidation of the calcipotriene.

30. The topical oil-in-water emulsion composition of claim 29, wherein said calcipotriene is first solubilized in said organic co-solvent, which is water soluble.

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

32. The topical oil-in-water emulsion composition of claim 31, wherein said organic co-solvent is propylene glycol.

33. The topical oil-in-water emulsion composition of claim 29, wherein said organic co-solvent is PEG 200, PEG 300, PEG 400, PEG 800, ethylene glycol monoethyl ether, diethylene glycol monoethyl ether, ethyl acetate, propylene carbonate, or n-methylpyrrolidone.

34. The topical oil-in-water emulsion composition of claim 29, wherein said calcipotriene 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.

35. The topical oil-in-water emulsion composition of claim 29, wherein said composition comprises water in an amount up to 90% w/w, based on the total weight of the composition.

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

37. The topical oil-in-water emulsion composition of claim 29, wherein said emulsifier is a surfactant or blend of surfactants having an HLB value of about 9 to about 14.

38. The topical oil-in-water emulsion composition of claim 29, 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.

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

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

41. The topical oil-in-water emulsion composition of claim 38, 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 acid esters, polyoxyethylene fatty alcohol ethers, polyoxyethylene sorbitan fatty acid esters, sorbitan esters, alkyl glycosides, fatty acid ethanolamides, and a mixture thereof.

42. The topical oil-in-water emulsion composition of claim 38, wherein said emulsifier is a mixture of surfactants which are sorbitan monostearate and polysorbate 60.

43. The topical oil-in-water emulsion composition of claim 29, 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.

44. The topical oil-in-water emulsion composition of claim 29, 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.

45. The topical oil-in-water emulsion composition of claim 29, 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.

46. The topical oil-in-water emulsion composition of claim 45, 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.

47. The topical oil-in-water emulsion composition of claim 29, further comprising a buffering agent, and wherein the pH of said composition is from about 4 to about 9.

48. The topical oil-in-water emulsion composition of claim 29, further comprising a viscosity modifying agent.

49. The topical oil-in-water emulsion composition of claim 48, wherein the viscosity modifying agent is isopropyl myristate.

50. The topical oil-in-water emulsion composition of claim 29, wherein said aerosol propellant is selected from the group consisting of a hydrocarbon, a chlorofluorocarbon, dimethyl ether, hydrofluorocarbons, and a mixture thereof.

51. A method for treating psoriasis in a human, said method comprising: administering a topical oil-in-water emulsion composition of claim 29, to treat said psoriasis.

52. A topical oil-in-water emulsion composition, said topical oil-in-water emulsion composition comprising: a water phase comprising water, a water soluble organic co-solvent, and calcipotriene present in an amount of from about 0.0001% by weight to about 10% by weight, based on the total weight of the composition, and which is first solubilized in said water soluble organic co-solvent and is further solubilized into 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 that is Vitamin E or a derivative thereof solubilized in said oil phase; an emulsifier present in an amount of from about 2% to about 5% by weight, based on the total weight of the composition; an aerosol propellant; and wherein said emulsion is an aerosol emulsion, which is a foam when released from a pressurized container, and the stabilizer prevents oxidation of the calcipotriene.

53. The topical oil-in-water emulsion composition of claim 52, wherein said water soluble organic co-solvent is selected from the group consisting of propylene glycol, ethylene glycol, butylene glycol, a polyol, and mixtures thereof.

54. The topical oil-in-water emulsion composition of claim 53, wherein said water soluble organic co-solvent is propylene glycol.

55. The topical oil-in-water emulsion composition of claim 52, wherein said water soluble organic co-solvent is PEG 200, PEG 300, PEG 400, PEG 800, ethylene glycol monoethyl ether, diethylene glycol monoethyl ether, ethyl acetate, propylene carbonate, or n-methylpyrrolidone.

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

57. The topical oil-in-water emulsion composition of claim 56, wherein said composition comprises water in an amount from about 70% to about 90% w/w, based on the total weight of the composition.

58. The topical oil-in-water emulsion composition of claim 52, wherein said emulsifier is a surfactant or blend of surfactants having an HLB value of about 9 to about 14.

59. The topical oil-in-water emulsion composition of claim 52, 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.

60. The topical oil-in-water emulsion composition of claim 59, wherein said emulsifier is a mixture of a C.sub.14-C.sub.22 alcohol and a polyoxyethylene fatty alcohol ether.

61. The topical oil-in-water emulsion composition of claim 60, wherein said C.sub.14-C.sub.22 alcohol is selected from the group consisting of cetyl alcohol, stearyl alcohol, and a mixture thereof.

62. The topical oil-in-water emulsion composition of claim 59, 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 acid esters, polyoxyethylene fatty alcohol ethers, polyoxyethylene sorbitan fatty acid esters, sorbitan esters, alkyl glycosides, fatty acid ethanolamides, and a mixture thereof.

63. The topical oil-in-water emulsion composition of claim 59, wherein said emulsifier is a mixture of surfactants which are sorbitan monostearate and polysorbate 60.

64. The topical oil-in-water emulsion composition of claim 52, 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.

65. The topical oil-in-water emulsion composition of claim 52, further comprising a buffering agent, and wherein the pH of said composition is from about 4 to about 9.

66. The topical oil-in-water emulsion composition of claim 52, further comprising a viscosity modifying agent.

67. The topical oil-in-water emulsion composition of claim 66, wherein said viscosity modifying agent is isopropyl myristate.

68. The topical oil-in-water emulsion composition of claim 52, wherein said aerosol propellant is selected from the group consisting of a hydrocarbon, a chlorofluorocarbon, dimethyl ether, hydrofluorocarbons, and a mixture thereof.

69. The topical oil-in-water emulsion composition of claim 52, wherein the composition further comprises a corticosteroid.

70. A method for treating psoriasis in a human, said method comprising: administering a topical oil-in-water emulsion composition of claim 52, to treat said psoriasis.
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