Topical compositions of urea

• US 20050042182A1
• Filed: 05/21/2004
• Published: 02/24/2005
• Est. Priority Date: 08/13/2003
• Status: Abandoned Application

• Current Assignee: Perrigo Israel Pharmaceuticals Limited (Perrigo Company PLC)
• Original Assignee: Perrigo Israel Pharmaceuticals Limited (Perrigo Company PLC)
• Inventors: Buriakovsky, Olga, Schneider, Benjamin, Zeevi, Amira, Arkin, Moshe, Avram, Nir, Cherkez, Stephen
• Application Number:
  US10/850,435
• Publication Number:
  US 20050042182A1
• Time in Patent Office: Days
• US Class Current: 424/47
• CPC Class Codes: A61K 2300/00 Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
• CPC Class Codes: A61K 31/17 having the group >N—C(O)—N< or >N—C(S)—N<, e.g. urea, thiourea, carmustine isoureas, isothioureas A61K31/155; sulfonylureas A61K31/64
• CPC Class Codes: A61K 31/19 Carboxylic acids, e.g. valproic acid salicylic acid A61K31/60
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 8/365 Hydroxycarboxylic acids; Ketocarboxylic acids
• CPC Class Codes: A61K 8/42 Amides
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/122 Foams; Dry foams edible foams A61K9/0056
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin
• CPC Class Codes: A61Q 19/007 Preparations for dry skin
• CPC Class Codes: A61Q 5/006 Antidandruff preparations

Abstract

Pharmaceutical, cosmetic and cosmeceutical foamable compositions for topical application, containing, as an active ingredient, urea and/or a derivative thereof, processes of manufacturing these compositions and uses of these compositions in the treatment of various dermatological conditions such as, for example, conditions associated with dry skin and/or scalp.

Claims

1. A foamable pharmaceutical, cosmetic or cosmeceutical composition for topical application, identified for use in the treatment of a medical, cosmetic and/or cosmeceutical condition associated with dry skin and/or scalp, comprising urea and/or a derivative thereof, at least one propellant and a pharmaceutically, cosmetically or cosmeceutically acceptable carrier.

2. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 1, packaged in a packaging material and identified in print, in or on said packaging material, for use in the treatment of said condition.

3. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 1, wherein said medical, cosmetic and/or cosmeceutical condition is selected from the group consisting of xerosis, ichthyosis, keratosis, keratoderma, pruritus, acne, dermatitis, neuro-dermatitis, dermatitis herpetiformis, actinic keratosis, hyper keratosis, inflamed keratosis, eczema, atopic eczema, melanoma, psoriasis, rosacea, urticaria, seborrheic dermatitis, skin cancer, warts, dandruff and xeroderma pigmentosum.

4. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 2, wherein said medical, cosmetic and/or cosmeceutical condition is selected from the group consisting of xerosis, ichthyosis, keratosis, keratoderma, pruritus, acne, dermatitis, neuro-dermatitis, dermatitis herpetiformis, actinic keratosis, hyper keratosis, inflamed keratosis, eczema, atopic eczema, melanoma, psoriasis, rosacea, urticaria, seborrheic dermatitis, skin cancer, warts, dandruffs and xeroderma pigmentosum.

5. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 1, wherein a concentration of said urea and/or said derivative thereof is greater than 5 weight percentages of the composition.

6. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 5, wherein said concentration of said urea and/or said derivative thereof is greater than 10 weight percentages of the composition.

7. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 5, wherein said concentration of said urea and/or said derivative thereof ranges between 5.1 weight percentages and about 48 weight percentages of the composition.

8. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 7, wherein said concentration of said urea and/or said derivative thereof ranges between about 20 weight percentages and about 48 weight percentages of the composition.

9. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 1, wherein a concentration of said at least one propellant ranges between about 0.5 weight percentage and about 60 weight percentages.

10. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 9, wherein said concentration of said at least one propellant ranges between about 10 weight percentages and about 20 weight percentages.

11. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 1, wherein said at least one propellant is selected from the group consisting of propane, iso-butane, n-butane, isopentane, n-pentane, and mixtures thereof.

12. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 1, being devoid of an enduring perfume composition.

13. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 1, further comprising at least one additional active ingredient.

14. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 13, wherein said at least one additional active ingredient is selected from the group consisting of an antibiotic agent, an antimicrobial agent, an anti-acne agent, an antibacterial agent, an antifungal agent, an antiviral agent, a steroidal anti-inflammatory agent, a non-steroidal anti-inflammatory agent, an anesthetic agent, an antipruriginous agent, an antiprotozoal agent, an anti-oxidant, a chemotherapeutic agent, an antidepressant, an anti histamine, a vitamin, a hormone and an antidandruff agent.

15. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 13, further identified for use in the treatment of a medical, cosmetic and/or cosmeceutical condition in which applying said at least one additional active ingredient is beneficial.

16. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 1, further comprising at least one ingredient selected from the group consisting of a humectant, a deodorant agent, an antiperspirant, a sun screening agent, a sunless tanning agent, a hair conditioning agent, a pH adjusting agent, a chelating agent, a preservative, an emulsifier, an occlusive agent, an emollient, a thickener, a solubilizing agent, a penetration enhancer, an anti-irritant, a colorant and a surfactant.

17. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 1, having a pH value that ranges between about 4.0 and about 7.0.

18. The foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 17, having a pH value that ranges between about 5.0 and about 6.0.

34. A method of treating a medical, cosmetic and/or a cosmeceutical condition, the method comprising topically applying, onto at least one biological surface of a subject in need thereof, a pharmaceutically, cosmetically or cosmeceutically effective amount of the foamable pharmaceutical, cosmetic or cosmeceutical composition of claim 1.

35. The method of claim 34, wherein said medical, cosmetic and/or cosmeceutical condition is a condition associated with dry skin and/or scalp.

36. The method of claim 35, wherein said condition is selected from the group consisting of xerosis, ichthyosis, keratosis, keratoderma, pruritus, acne, dermatitis, neuro-dermatitis, dermatitis herpetiformis, actinic keratosis, hyper keratosis, inflamed keratosis, eczema, atopic eczema, melanoma, psoriasis, rosacea, urticaria, seborrheic dermatitis, skin cancer, warts, dandruffs and xeroderma pigmentosum.

37. The method of claim 34, wherein said at least one biological surface is selected from the group consisting of a lateral aspect of a forearm, a lateral aspect of a leg, an elbow, a palm, a foot, a backhand, a back and a scalp.

38. The method of claim 34, wherein a concentration of said urea and/or said derivative thereof is greater than 5 weight percentages of said composition.

39. The method of claim 38, wherein said concentration of said urea and/or said derivative thereof is greater than 10 weight percentages of said composition.

40. The method of claim 38, wherein said concentration of said urea and/or said derivative thereof ranges between 5.1 weight percentages and about 48 weight percentages of said composition.

41. The method of claim 40, wherein said concentration of said urea and/or said derivative thereof ranges between about 20 weight percentages and about 48 weight percentages of said composition.

42. The method of claim 34, wherein a concentration of said at least one propellant ranges between about 0.5 weight percentage and about 60 weight percentages.

43. The method of claim 42, wherein said concentration of said at least one propellant ranges between about 10 weight percentages and about 20 weight percentages.

44. The method of claim 34, wherein said at least one propellant is selected from the group consisting of propane, iso-butane, n-butane, isopentane, n-pentane, and mixtures thereof.

45. The method of claim 34, wherein said composition is devoid of an enduring perfume composition.

46. The method of claim 34, wherein said composition further comprises at least one additional active ingredient.

47. The method of claim 46, wherein said at least one additional active ingredient is selected from the group consisting of an antibiotic agent, an antimicrobial agent, an anti-acne agent, an antibacterial agent, an antifungal agent, an antiviral agent, a steroidal anti-inflammatory agent, a non-steroidal anti-inflammatory agent, an anesthetic agent, an antipruriginous agent, an antiprotozoal agent, an anti-oxidant, a chemotherapeutic agent, an antidepressant, an anti histamine, a vitamin, a hormone and an antidandruff agent.

48. The method of claim 46, wherein said medical, cosmetic and/or cosmeceutical condition is a condition in which applying said at least additional active ingredient is beneficial.

49. The method of claim 34, wherein said composition further comprises at least one ingredient selected from the group consisting of a humectant, a deodorant agent, an antiperspirant, a sun screening agent, a sunless tanning agent, a hair conditioning agent, a pH adjusting agent, a chelating agent, a preservative, an emulsifier, an occlusive agent, an emollient, a thickener, a solubilizing agent, a penetration enhancer, an anti-irritant, a colorant and a surfactant.

50. The method of claim 34, wherein said composition has a pH value that ranges between about 4.0 and about 7.0.

51. The method of claim 50, wherein said composition has a pH value that ranges between about 5.0 and about 6.0.

19. A process of preparing a foamable pharmaceutical, cosmetic or cosmeceutical composition for topical application, identified for use in the treatment of a medical, cosmetic and/or cosmeceutical condition associated with dry skin and/or scalp, the process comprising admixing urea and/or a derivative thereof, at least one propellant and a pharmaceutically, cosmetically or cosmeceutically acceptable carrier.

20. The process of claim 19, wherein said medical, cosmetic and/or cosmeceutical condition is selected from the group consisting of xerosis, ichthyosis, keratosis, keratoderma, pruritus, acne, dermatitis, neuro-dermatitis, dermatitis herpetiformis, actinic keratosis, hyper keratosis, inflamed keratosis, eczema, atopic eczema, melanoma, psoriasis, rosacea, urticaria, seborrheic dermatitis, skin cancer, warts, dandruffs and xeroderma pigmentosum.

21. The process of claim 19, wherein a concentration of said urea and/or said derivative thereof is greater than 5 weight percentages of said composition.

22. The process of claim 21, wherein said concentration of said urea and/or said derivative thereof is greater than 10 weight percentages of said composition.

23. The process of claim 21, wherein said concentration of said urea and/or said derivative thereof ranges between 5.1 weight percentages and about 48 weight percentages of said composition.

24. The process of claim 23, wherein said concentration of said urea and/or said derivative thereof ranges between about 20 weight percentages and about 48 weight percentages of said composition.

25. The process of claim 19, wherein a concentration of said at least one propellant ranges between about 0.5 weight percentage and about 60 weight percentages.

26. The process of claim 25, wherein said concentration of said at least one propellant ranges between about 10 weight percentages and about 20 weight percentages.

27. The process of claim 19, wherein said at least one propellant is selected from the group consisting of propane, iso-butane, n-butane, isopentane, n-pentane, and mixtures thereof.

28. The process of claim 19, further comprising admixing, with said urea and/or said derivative thereof, said at least one propellant and said carrier, at least one additional active ingredient.

29. The process of claim 28, wherein said at least one additional active ingredient is selected from the group consisting of an antibiotic agent, an antimicrobial agent, an anti-acne agent, an antibacterial agent, an antifungal agent, an antiviral agent, a steroidal anti-inflammatory agent, a non-steroidal anti-inflammatory agent, an anesthetic agent, an antipruriginous agent, an antiprotozoal agent, an anti-oxidant, a chemotherapeutic agent, an antidepressant, an anti histamine, a vitamin, a hormone and an antidandruff agent.

30. The process of claim 19, further comprising admixing, with said urea and/or said derivative thereof, said at least one propellant and said carrier, at least one ingredient selected from the group consisting of a humectant, a deodorant agent, an antiperspirant, a sun screening agent, a sunless tanning agent, a hair conditioning agent, a pH adjusting agent, a chelating agent, a preservative, an emulsifier, an occlusive agent, an emollient, a thickener, a solubilizing agent, a penetration enhancer, an anti-irritant, a colorant and a surfactant.

31. The process of claim 19, wherein said composition has a pH value that ranges between about 4.0 and about 7.0.

32. The process of claim 31, wherein said composition has a pH value that ranges between about 5.0 and about 6.0.

33. The process of claim 19, wherein said composition is devoid of an enduring perfume composition.