Oleaginous pharmaceutical and cosmetic foam

• US 20080063607A1
• Filed: 08/20/2007
• Published: 03/13/2008
• Est. Priority Date: 08/04/2003
• Status: Abandoned Application

• Current Assignee: Foamix Pharmaceuticals, Ltd. (VYNE Therapeutics, Inc.)
• Original Assignee: Foamix Ltd. (VYNE Therapeutics, Inc.)
• Inventors: Danziger, Jorge, Besonov, Alex, Schuz, David, Berman, Tal, Friedman, Doron, Tamarkin, Dov, Eini, Meir
• Application Number:
  US11/894,798
• Publication Number:
  US 20080063607A1
• Time in Patent Office: Days
• US Class Current: 424/43
• CPC Class Codes: A61K 2800/5422 nonionic
• CPC Class Codes: A61K 8/86 Polyethers
• CPC Class Codes: A61K 9/0031 Rectum, anus
• CPC Class Codes: A61K 9/0034 Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants
• CPC Class Codes: A61K 9/0046 Ear
• CPC Class Codes: A61K 9/122 Foams; Dry foams edible foams A61K9/0056
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 17/12 Keratolytics, e.g. wart or anti-corn preparations
• CPC Class Codes: A61P 23/02 Local anaesthetics
• CPC Class Codes: A61P 3/02 Nutrients, e.g. vitamins, minerals
• CPC Class Codes: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/12 Antivirals
• CPC Class Codes: A61P 35/00 Antineoplastic agents
• CPC Class Codes: A61Q 17/04 Topical preparations for affording protection against sunlight or other radiation; Topical sun tanning preparations
• CPC Class Codes: A61Q 19/007 Preparations for dry skin
• CPC Class Codes: A61Q 19/04 for chemically tanning the skin topical sun or radiation screening or tanning preparations A61Q17/04
• CPC Class Codes: A61Q 19/08 Anti-ageing preparations
• CPC Class Codes: A61Q 19/10 Washing or bathing preparations

Abstract

The invention relates to stable pharmaceutical or cosmetic foam compositions containing certain active agents, having unique therapeutic properties and methods of treatment using such compositions. The foamable composition includes at least one solvent comprising polyethylene glycol (PEG) or PEG derivative and mixtures thereof, or comprising propylene glycol, wherein the solvent is present at a concentration of about 70% to about 96.5% by weight of the total composition, at least a non-ionic surface-active agent at a concentration of about 0.1% to less than about 10% by weight of the total composition.

Claims

1. A foamable pharmaceutical or cosmetic composition, comprising:

a solvent comprising polyethylene glycol (PEG) or PEG derivative and mixtures thereof, wherein the PEG or PEG derivative is present at a concentration of about 70% to about 96.5% by weight of the total composition;

a surface-active agent at a concentration of about 0.1% to less than about 10% by weight of the total composition; and

a therapeutically effective amount of at least one active agent.

2. The composition of claim 1, further comprising:

at least one gelling agent at a concentration of about 0.1% to about 5% by weight of the total composition.

3. The composition of claim 2, wherein the at least one gelling agent is selected from the group consisting of natural polymeric materials, semi-synthetic polymeric materials, synthetic polymeric materials, inorganic gelling agents and mixtures thereof.

4. The composition of claim 2 wherein the gelling agent also has surface active agent properties.

5. The composition of claim 3, wherein the at least one gelling agent is a semi-synthetic polymeric material.

6. The composition of claim 5, wherein the semi-synthetic polymeric material is a cellulose ether.

7. The composition of claim 1, further comprising at least one liquefied or compressed gas propellant, at a concentration of about 3% to about 25% by weight of the total composition.

8. The composition of claim 1, wherein the composition is contained within a pressurized container.

9. The composition of claim 1, wherein the polyethylene glycol (PEG) or PEG derivative is liquid or is flowable at ambient temperature.

10. The composition of claim 1, wherein the polyethylene glycol (PEG) or PEG derivative has an average Molecular Weight ranging from about 190 kD to about 10,000 kD.

11. The composition of claim 1, wherein the polyethylene glycol (PEG) or PEG derivative is selected from the group consisting of PEG200, PEG300, PEG400, PEG600, PEG 4000, PEG 6000, PEG 10000 and mixtures thereof.

12. The composition of claim 1, wherein the polyethylene glycol (PEG) or PEG derivative is PEG400.

13. The composition of claim 1, wherein the surface-active agent is a non-ionic surface-active agent.

14. The composition of claim 1, wherein the surface-active agent is selected from the group consisting of sorbitan derivatives, alkoxylated alcohols, hydroxylated derivatives of polymeric silicones, alkylated derivatives of hydroxylated polymeric silicones, glyceryl esters, beeswax derivatives, lecithin and mixtures thereof.

15. The composition of claim 1, wherein the surface-active agent is selected from the group consisting of polysorbates, polyoxyethylene fatty acid esters, polyoxyethylene alkyl ethers, sucrose esters, partial esters of sorbitol and its anhydrides, fatty alcohols, fatty acids, mono and diglycerides, isoceteth-20, sodium methyl cocoyl taurate, sodium methyl oleoyl taurate, sodium lauryl sulfate, triethanolamine lauryl sulfate and betaines.

16. The composition of claim 14, wherein the surface-active agent is a glyceryl ester.

17. The composition of claim 14, wherein the surface-active agent is an alkoxylated alcohol.

18. The composition of claim 15, wherein the surface-active agent is a polyoxyethylene alkyl ether.

19. The composition of claim 15, wherein the surface-active agent is a polyoxyethylene fatty acid ester.

20. The composition of claim 1, further comprising a mixture of a non-ionic surface-active agent and an ionic surface-active agent.

21. The composition of claim 1, further comprising a foam adjuvant selected from the group consisting of fatty alcohols having greater than or equal to 15 carbons and fatty acids having greater than or equal to 16 carbons.

22. The composition of claim 1 further comprising at least one other solvent selected from the group consisting of polyols, glycerol (glycerin), propylene glycol, hexylene glycol, diethylene glycol, propylene glycol n-alkanols, terpenes, di-terpenes, tri-terpenes, terpen-ols, limonene, terpene-ol, 1-menthol, dioxolane, ethylene glycol, other glycols, sulfoxides, dimethylsulfoxide (DMSO), dimethylformanide, methyl dodecyl sulfoxide, dimethylacetamide;

monooleate of ethoxylated glycerides (with 8 to 10 ethylene oxide units);

azone (1-dodecylazacycloheptan-2-one), 2-(n-nonyl)-1,3-dioxolane;

isopropyl myristate/palmitate, ethyl acetate, butyl acetate, methyl proprionate, capric/caprylic triglycerides, octylmyristate, dodecyl-myristate;

myristyl alcohol, lauryl alcohol, lauric acid, lauryl lactate ketones;

acetamide;

triolein;

alkanoic acids, caprylic acid;

lactam compounds, azone;

alkanols, dialkylamino acetates, polyethylene glycol (PEG) or PEG derivative and mixtures thereof.

23. The composition of claim 1 further comprising at least one other solvent selected from the group consisting of propylene glycol, hexylene glycol, butanediols and isomers thereof, glycerol, benzyl alcohol, DMSO, ethyl oleate, ethyl caprylate, diisopropyl adipate, dimethylacetamide, N-methylpyrrolidone, N-hydroxyethylpyrrolidone, polyvinylpyrrolidone, isosorbide derivatives, dimethyl isosorbide, glycofurol and ethoxydiglycol (transcutol).

24. The composition of claim 22 wherein the at least one other solvent is glycerol (glycerin).

25. The composition of claim 22, wherein the at least one other solvent is propylene glycol.

26. The composition of claim 1, wherein the composition contains less than about 5% of a lower alcohol having up to 5 carbon atoms in its carbon chain skeleton.

27. The composition of claim 1, wherein the composition contains no water.

28. The composition of claim 1, wherein the composition contains substantially no water.

29. The composition of claim 1, wherein the composition contains less than about 10% of water by weight of the total composition.

30. The composition of claim 1, wherein the composition contains less than about 20% of water by weight of the total composition.

31. The composition of claim 1, wherein the composition contains less than about 30% of water by weight of the total composition.

32. The composition of claim 1, wherein the composition has a specific gravity of about 0.01 g/ml to about 0.3 g/mL upon release from the pressurized container.

33. The composition of claim 1, further comprising an antioxidant.

34. The composition of claim 33, wherein the antioxidant is selected from the group consisting of ascorbic acid (vitamin C) and its salts, ascorbyl esters of fatty acids, ascorbic acid derivatives, tocopherol (vitamin E), tocopherol sorbate, tocopherol acetate, other esters of tocopherol, butylated hydroxy benzoic acids and their salts, 6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid, gallic acid and its alkyl esters, especially propyl gallate, uric acid and its salts and alkyl esters, sorbic acid and its salts, lipoic acid, amines, sulfhydryl compounds, dihydroxy fumaric acid and its salts, lycine pidolate, arginine pilolate, nordihydroguaiaretic acid, bioflavonoids, curcumin, lysine, methionine, proline, superoxide dismutase, silymarin, tea extracts, grape skin/seed extracts, melanin, and rosemary extracts.

35. The composition of claim 1, further comprising an emollient.

36. The composition of claim 35, wherein the emollient is selected from the group consisting of hexyleneglycol, propylene glycol, isostearic acid derivatives, isopropyl palmitate, isopropyl isostearate, diisopropyl adipate, diisopropyl dimerate, maleated soybean oil, octyl palmitate, cetyl lactate, cetyl ricinoleate, tocopheryl acetate, acetylated lanolin alcohol, cetyl acetate, phenyl trimethicone, glyceryl oleate, tocopheryl linoleate, wheat germ glycerides, arachidyl propionate, myristyl lactate, decyl oleate, propylene glycol ricinoleate, isopropyl lanolate, pentaerythrityl tetrastearate, neopentylglycol dicaprylate/dicaprate, isononyl isononanoate, isotridecyl isononanoate, myristyl myristate, triisocetyl citrate, octyl dodecanol, sucrose esters of fatty acids, octyl hydroxystearate and mixtures thereof.

37. The composition of claim 1, further comprising a buffering agent.

38. The composition of claim 1, further comprising a chelating agent.

39. The composition of claim 1, wherein the at least one active agent is selected from the group consisting of an anti-infective, an antibiotic, an antibacterial agent, an antifungal agent, an antiviral agent, an anti-parasitic agent, an anti-inflammatory agent, an immunosuppressive agent, and immunomodulator, an immuno regulating agent, an anesthetic, an analgesic, an anti-allergic agent, a corticosteroid, a non-steroidal anti-inflammatory agent, a retinoid, a keratolytic agent, an anti-proliferative agent, an anticancer agent, a photodynamic therapy agent, an anti-wrinkle agent, a radical scavenger, a self-tanning agent, a skin whitening agent, a skin protective agent, an anti-cellulite agent, a massaging oil and an anti-wart agent, a refatting agent, a lubricating agent and mixtures thereof.

40. The composition of claim 1, wherein the at least one active agent is selected from the group consisting of an anti-inflammatory agent, an antinfective agent, a keratolytically active agent, a vasoactive agent and a retinoid.

41. The composition of claim 1, wherein the at least one active agent is selected from the group consisting of a corticosteroid, a non steroid anti-inflammatory agent, an anti-bacterial agent, a keratolytically active agent, a vasoactive agent and a retinoid.

42. The composition of claim 1, wherein the at least one active agent is vitamin.

43. The composition of claim 41, wherein the corticosteriod is selected from the group consisting of Clobetasol proprionate, Halobetasol proprionate, Betamethasone diproprionate, Betamethasone valerate, Fluocinolone acetonide, Halcinonide, Betamethasone valerate, Fluocinolone acetonide, Hydrocortisone valerate, Triamcinolone acetonide and Hydrocortisone.

44. The composition of claim 41, wherein the non steroid anti-inflammatory active agent is selected from the group consisting of:

oxicams, piroxicam, isoxicam, tenoxicam, and sudoxicam;

salicylates, salicylic acid, ethyl salicylate, methyl salycilate, aspirin, disalcid, benorylate, trilisate, safapryn, solprin, diflunisal, and fendosal;

acetic acid derivatives, diclofenac, fenclofenac, indomethacin, sulindac, tolmetin, isoxepac, furofenac, tiopinac, zidometacin, acematacin, fentiazac, zomepirac, clindanac, oxepinac, felbinac, and ketorolac;

fenamates, mefenamic, meclofenamic, flufenamic, niflumic, and tolfenamic acids;

propionic acid derivatives, ibuprofen, naproxen, benoxaprofen, flurbiprofen, ketoprofen, fenoprofen, fenbufen, indopropfen, pirprofen, carprofen, oxaprozin, pranoprofen, miroprofen, tioxaprofen, suprofen, alminoprofen, and tiaprofenic; and

pyrazoles, phenylbutazone, oxyphenbutazone, feprazone, azapropazone, and trimethazone.

45. The composition of claim 41, wherein the anti-bacterial agent is selected from the group consisting of macrolide antibiotics, erythromycin;

sulfonamide (in its base form), sulfanilamide, sulfadiazine and sulfacetamide;

mupirocin;

tetracyclines, tetracycline and doxycycline;

specific oil-soluble species of synthetic and semi-synthesic penicillins and beta-lactams;

cloramphenicol;

specific oil-soluble species of imidazoles;

dicarboxylic acids, such as azelaic acid;

salicylates;

peptide antibiotics;

cyclic peptides, such as cyclosporine, tacrolimus, pimecrolimus and sirolimus (rapamycin); and

non-specific antibacterial agents such as strong oxidants and free radical liberating compounds, bleaching agents, iodine compounds and benzoyl peroxide.

46. The composition of claim 41, wherein the keratolytically active agent is selected from the group consisting of phenol and substituted phenolic compounds;

dihydroxy benzene and derivatives;

resorcinol (m-dihydroxybenzene) and derivatives;

hydroquinone (p-dihydroxybenzene);

cresols;

vitamin A and its derivatives, such as retinoic acid, isoretinoic acid, retinol and retinal;

alpha-hydroxy acids, such as lactic acid and glycolic acid and their respective salts and derivatives;

beta-hydroxy acids, such as Salicylic acid (o-hydroxybenzoic acid) and its salts and pharmaceutically acceptable derivatives; and

urea and its derivatives.

47. The composition of claim 41, wherein the vasoactive agent is selected from the group consisting of minoxidil, sildenafil and caffeine.

48. The composition of claim 41, wherein the retinoid agent is selected from the group consisting of retinol, retinal, all trans retinoic acid and derivatives, etretinate, actiretin, isotretinoin, adapalene and tazarotene and isomers and analogs thereof.

49. The composition of claim 41, wherein the at least one active agent is selected from the group consisting of Acyclovir, Azelaic acid, Benzoyl peroxide, Betamethasone 17 valerate micronized, Caffeine, Calcipotriol hydrate, Ciclopiroxolamine, Diclofenac sodium, Ketoconazole, Miconazole nitrate, Minoxidil, Mupirocin, Nifedipine regular, Permethrin BPC (cis:

trans 25;

75), Piroxicam, Salicylic acid and Terbinafine HCl.

50. The composition of claim 1, wherein the active agent is selected for the treatment of a disorder of the skin, mucosal membrane, ear channel, vagina, penile urethra, colon and rectum.

51. The composition of claim 1, wherein the active agent is administered via transdermal delivery.

52. The composition of claim 1, wherein the at least one active agent is of solid matter.

53. The composition of claim 1, wherein the at least one active agent is soluble in the composition.

54. The composition of claim 1, having the properties of breakable foam for treating, alleviating or preventing a dermatological or mucosal disorder.

55. The composition of claim 1 wherein a component of the foamable composition selected from a potent solvent, a co-solvent, a surface-active agent, a gelling agent, an emollient and a foam adjuvant may itself contribute to the pharmaceutical or cosmetic effect of the composition.

59. A method of treating, alleviating or preventing a dermatological, cosmetic or mucosal disorder, comprising administering topically to a subject having said disorder a therapeutically effective amount of a foamable composition according to any of claims 1, 56, 57 or 58.

60. The method of claim 59 wherein the disorder is selected from the group consisting of an inflammatory disorder, an infection, dermatoses, keratosis, hyperkeratinization and a vaso disorder.

121. The composition of claim 1, wherein the surface-active agent is Mirj 52.

56. A foamable pharmaceutical or cosmetic carrier composition for dermatological use, comprising:

a solvent comprising polyethylene glycol (PEG) or PEG derivative and mixtures thereof, wherein the PEG or PEG derivative is present at a concentration of about 70% to about 96.5% by weight of the total composition;

a surface-active agent at a concentration of about 0.1% to less than about 10% by weight of the total composition;

at least one gelling agent at a concentration of about 0.1% to about 5% by weight of the total composition; and

at least one liquefied or compressed gas propellant, at a concentration of about 3% to about 25% by weight of the total composition,

wherein the composition is stored in an aerosol container and upon release expands to form a breakable foam.

57. A composition, comprising:

a polyethylene glycol (PEG) or PEG derivative and mixtures thereof, wherein the PEG or PEG derivative is present at a concentration of about 70% to about 96.5% by weight of the total composition;

a surface-active agent at a concentration of about 0.1% to less than about 10% by weight of the total composition; and

a therapeutically effective amount of at least one agent selected from the group consisting of an antinfective agent, a keratolytically active agent, a vasoactive agent and a retinoid.

58. A composition, comprising:

a polyethylene glycol (PEG) or PEG derivative and mixtures thereof, wherein the PEG or PEG derivative is present at a concentration of about 70% to about 96.5% by weight of the total composition;

a surface-active agent at a concentration of about 0.1% to less than about 10% by weight of the total composition; and

a therapeutically effective amount of at least one anti-inflammatory or antiallergic agent, wherein said agent reduces the occurrence of pro-inflammatory cytokines and/or inhibits the effect of pro-inflammatory cytokines.

61. A foamable pharmaceutical or cosmetic composition, comprising:

a solvent comprising propylene glycol, wherein the propylene glycol is present at a concentration of about 70% to about 96.5% by weight of the total composition;

a surface-active agent at a concentration of about 0.1% to less than about 10% by weight of the total composition; and

a therapeutically effective amount of at least one active agent.

62. The composition of claim 61, further comprising:

at least one gelling agent at a concentration of about 0.1% to about 5% by weight of the total composition.

63. The composition of claim 62, wherein the at least one gelling agent is selected from the group consisting of natural polymeric materials, semi-synthetic polymeric materials, synthetic polymeric materials, inorganic gelling agents and mixtures thereof.

64. The composition of claim 62 wherein the gelling agent also has surface active agent properties.

65. The composition of claim 63, wherein the at least one gelling agent is a semi-synthetic polymeric material.

66. The composition of claim 65, wherein the semi-synthetic polymeric material is a cellulose ether.

67. The composition of claim 61, further comprising at least one liquefied or compressed gas propellant, at a concentration of about 3% to about 25% by weight of the total composition.

68. The composition of claim 61, wherein the composition is contained within a pressurized container.

69. The composition of claim 61, wherein the surface-active agent is a non-ionic surface-active agent.

70. The composition of claim 61, wherein the surface-active agent is selected from the group consisting of sorbitan derivatives, alkoxylated alcohols, hydroxylated derivatives of polymeric silicones, alkylated derivatives of hydroxylated polymeric silicones, glyceryl esters, beeswax derivatives, lecithin and mixtures thereof.

71. The composition of claim 61, wherein the surface-active agent is selected from the group consisting of polysorbates, polyoxyethylene fatty acid esters, polyoxyethylene alkyl ethers, sucrose esters, partial esters of sorbitol and its anhydrides, fatty alcohols, fatty acids, mono and diglycerides, isoceteth-20, sodium methyl cocoyl taurate, sodium methyl oleoyl taurate, sodium lauryl sulfate, triethanolamine lauryl sulfate and betaines.

72. The composition of claim 70, wherein the surface-active agent is a glyceryl ester.

73. The composition of claim 70, wherein the surface-active agent is an alkoxylated alcohol.

74. The composition of claim 71, wherein the surface-active agent is a polyoxyethylene alkyl ether.

75. The composition of claim 71, wherein the surface-active agent is a polyoxyethylene fatty acid ester.

76. The composition of claim 61, further comprising a mixture of a non-ionic surface-active agent and an ionic surface-active agent.

77. The composition of claim 61, further comprising a foam adjuvant selected from the group consisting of fatty alcohols having greater than or equal to 15 carbons and fatty acids having greater than or equal to 16 carbons.

78. The composition of claim 61, further comprising at least one other solvent selected from the group consisting of polyols, glycerol (glycerin), hexylene glycol, diethylene glycol, propylene glycol n-alkanols, terpenes, di-terpenes, tri-terpenes, terpen-ols, limonene, terpene-ol, 1-menthol, dioxolane, ethylene glycol, other glycols, sulfoxides, dimethylsulfoxide (DMSO), dimethylformanide, methyl dodecyl sulfoxide, dimethylacetamide, monooleate of ethoxylated glycerides (with 8 to 10 ethylene oxide units), azone (1-dodecylazacycloheptan-2-one), 2-(n-nonyl)-1,3-dioxolane;

isopropyl myristate/palmitate, ethyl acetate, butyl acetate, methyl proprionate, capric/caprylic triglycerides, octylmyristate, dodecyl-myristate, myristyl alcohol, lauryl alcohol, lauric acid, lauryl lactate ketones, acetamide, triolein, alkanoic acids, caprylic acid, lactam compounds, alkanols, dialkylamino acetates, polyethylene glycol (PEG) or PEG derivative and mixtures thereof.

79. The composition of claim 61 further comprising at least one other solvent selected from the group consisting of polyethylene glycol, hexylene glycol, butanediols and isomers thereof, glycerol, benzyl alcohol, DMSO, ethyl oleate, ethyl caprylate, diisopropyl adipate, dimethylacetamide, N-methylpyrrolidone, N-hydroxyethylpyrrolidone, polyvinylpyrrolidone, isosorbide derivatives, dimethyl isosorbide, glycofurol and ethoxydiglycol (transcutol).

80. The composition of claim 78 wherein the at least one other solvent is glycerol (glycerin).

81. The composition of claim 78, wherein the at least one other solvent is polyethylene glycol (PEG) or PEG derivative and mixtures thereof.

82. The composition of claim 81, wherein the polyethylene glycol (PEG) or PEG derivative and mixtures thereof is liquid or is flowable at ambient temperature.

83. The composition of claim 81, wherein the polyethylene glycol (PEG) or PEG derivative and mixtures thereof have an average Molecular Weight ranging from about 190 kD to about 10,000 kD.

84. The composition of claim 81, wherein the polyethylene glycol (PEG) or PEG derivative is selected from the group consisting of PEG200, PEG300, PEG400, PEG600, PEG 4000, PEG 6000 and PEG 10000 and mixtures thereof.

85. The composition of claim 81, wherein the polyethylene glycol (PEG) or PEG derivative is PEG400.

86. The composition of claim 61, comprising less than about 5% of a lower alcohol having up to 5 carbon atoms in its carbon chain skeleton.

87. The composition of claim 61, wherein the composition contains no water.

88. The composition of claim 61, wherein the composition contains substantially no water.

89. The composition of claim 61, wherein the composition contains less than about 10% of water by weight of the total composition.

90. The composition of claim 61, wherein the composition contains less than about 20% of water by weight of the total composition.

91. The composition of claim 61, wherein the composition contains less than about 30% of water by weight of the total composition.

92. The composition of claim 61, wherein the composition has a specific gravity of about 0.01 g/mL to about 0.3 g/mL upon release from the pressurized container.

93. The composition of claim 61, further comprising an antioxidant.

94. The composition of claim 93, wherein the antioxidant is selected from the group consisting of ascorbic acid (vitamin C) and its salts, ascorbyl esters of fatty acids, ascorbic acid derivatives, tocopherol (vitamin E), tocopherol sorbate, tocopherol acetate, other esters of tocopherol, butylated hydroxy benzoic acids and their salts, 6-hydroxy-2,5,7,8-tetramethylchroman-2-carboxylic acid, gallic acid and its alkyl esters, especially propyl gallate, uric acid and its salts and alkyl esters, sorbic acid and its salts, lipoic acid, amines, sulfhydryl compounds, dihydroxy fumaric acid and its salts, lycine pidolate, arginine pilolate, nordihydroguaiaretic acid, bioflavonoids, curcumin, lysine, methionine, proline, superoxide dismutase, silymarin, tea extracts, grape skin/seed extracts, melanin, and rosemary extracts.

95. The composition of claim 61, further comprising an emollient.

96. The composition of claim 95, wherein the emollient is selected from the group consisting of hexyleneglycol, propylene glycol, isostearic acid derivatives, isopropyl palmitate, isopropyl isostearate, diisopropyl adipate, diisopropyl dimerate, maleated soybean oil, octyl palmitate, cetyl lactate, cetyl ricinoleate, tocopheryl acetate, acetylated lanolin alcohol, cetyl acetate, phenyl trimethicone, glyceryl oleate, tocopheryl linoleate, wheat germ glycerides, arachidyl propionate, myristyl lactate, decyl oleate, propylene glycol ricinoleate, isopropyl lanolate, pentaerythrityl tetrastearate, neopentylglycol dicaprylate/dicaprate, isononyl isononanoate, isotridecyl isononanoate, myristyl myristate, triisocetyl citrate, octyl dodecanol, sucrose esters of fatty acids, octyl hydroxystearate and mixtures thereof.

97. The composition of claim 61, further comprising a buffering agent.

98. The composition of claim 61, further comprising a chelating agent.

99. The composition of claim 61, wherein the at least one active agent is selected from the group consisting of an anti-infective, an antibiotic, an antibacterial agent, an antifungal agent, an antiviral agent, an anti-parasitic agent, an anti-inflammatory agent, an immunosuppressive agent, and immunomodulator, an immuno regulating agent, an anesthetic, an analgesic, an anti-allergic agent, a corticosteroid, a non-steroidal anti-inflammatory agent, a retinoid, a keratolytic agent, an anti-proliferative agent, an anticancer agent, a photodynamic therapy agent, an anti-wrinkle agent, a radical scavenger, a self-tanning agent, a skin whitening agent, a skin protective agent, an anti-cellulite agent, a massaging oil and an anti-wart agent, a refatting agent, a lubricating agent and mixtures thereof.

100. The composition of claim 61, wherein the at least one active agent is selected from the group consisting of an anti-inflammatory agent, an antinfective agent, a keratolytically active agent, a vasoactive agent and a retinoid.

101. The composition of claim 61, wherein the at least one active agent is selected from the group consisting of a, corticosteroid, an a non steroid anti-inflammatory agent, an anti-bacterial agent, a keratolytically active agent, a vasoactive agent and a retinoid.

102. The composition of claim 61, wherein the at least one active agent is vitamin.

103. The composition of claim 101, wherein the corticosteriod is selected from the group consisting of Clobetasol proprionate, Halobetasol proprionate, Betamethasone diproprionate, Betamethasone valerate, Fluocinolone acetonide, Halcinonide, Betamethasone valerate, Fluocinolone acetonide, Hydrocortisone valerate, Triamcinolone acetonide, and Hydrocortisone.

104. The composition of claim 101, wherein the non steroid anti-inflammatory active agent is selected from the group consisting of:

oxicams, piroxicam, isoxicam, tenoxicam, and sudoxicam;

salicylates, salicylic acid, ethyl salicylate, methyl salycilate, aspirin, disalcid, benorylate, trilisate, safapryn, solprin, diflunisal, and fendosal;

acetic acid derivatives, diclofenac, fenclofenac, indomethacin, sulindac, tolmetin, isoxepac, furofenac, tiopinac, zidometacin, acematacin, fentiazac, zomepirac, clindanac, oxepinac, felbinac, and ketorolac;

fenamates, mefenamic, meclofenamic, flufenamic, niflumic, and tolfenamic acids;

propionic acid derivatives, ibuprofen, naproxen, benoxaprofen, flurbiprofen, ketoprofen, fenoprofen, fenbufen, indopropfen, pirprofen, carprofen, oxaprozin, pranoprofen, miroprofen, tioxaprofen, suprofen, alminoprofen, and tiaprofenic; and

pyrazoles, phenylbutazone, oxyphenbutazone, feprazone, azapropazone, and trimethazone.

105. The composition of claim 101, wherein the anti-bacterial agent is selected from the group consisting of macrolide antibiotics, erythromycin;

sulfonamide (in its base form), sulfanilamide, sulfadiazine and sulfacetamide;

mupirocin;

tetracyclines, tetracycline and doxycycline;

specific oil-soluble species of synthetic and semi-synthesic penicillins and beta-lactams;

cloramphenicol;

specific oil-soluble species of imidazoles;

dicarboxylic acids, such as azelaic acid;

salicylates;

peptide antibiotics;

cyclic peptides, such as cyclosporine, tacrolimus, pimecrolimus and sirolimus (rapamycin); and

non-specific antibacterial agents such as strong oxidants and free radical liberating compounds, bleaching agents, iodine compounds and benzoyl peroxide.

106. The composition of claim 101, wherein the keratolytically active agent is selected from the group consisting of—

phenol and substituted phenolic compounds;

dihydroxy benzene and derivatives;

resorcinol (m-dihydroxybenzene) and derivatives;

hydroquinone (p-dihydroxybenzene);

cresols;

vitamin A and its derivatives, such as retinoic acid, isoretinoic acid, retinol and retinal;

alpha-hydroxy acids, such as lactic acid and glycolic acid and their respective salts and derivatives;

beta-hydroxy acids, such as Salicylic acid (o-hydroxybenzoic acid) and its salts and pharmaceutically acceptable derivatives; and

urea and its derivatives.

107. The composition of claim 101, wherein the vasoactive agent is selected from the group consisting of minoxidil, sildenafil and caffeine.

108. The composition of claim 101, wherein the at retinoid agent is selected from the group consisting of retinol, retinal, all trans retinoic acid and derivatives;

etretinate, actiretin, isotretinoin, adapalene and tazarotene and isomers and analogs thereof.

109. The composition of claim 101, wherein the at least one active agent is selected from the group consisting of:

Acyclovir, Azelaic acid, Benzoyl peroxide, Betamethasone 17 valerate micronized, Caffeine, Calcipotriol hydrate, Ciclopiroxolamine, Diclofenac sodium, Ketoconazole, Miconazole nitrate, Minoxidil, Mupirocin, Nifedipine regular, Permethrin BPC (cis;

trans 25;

75), Piroxicam, Salicylic acid and Terbinafine HCl.

110. The composition of claim 61, wherein the active agent is selected for the treatment of a disorder of the skin, mucosal membrane, ear channel, vagina, penile urethra, colon and rectum.

111. The composition of claim 61, wherein the active agent is administered via transdermal delivery.

112. The composition of claim 61, wherein the at least one active agent is of solid matter.

113. The composition of claim 61, wherein the at least one active agent is soluble in the composition.

114. The composition of claim 61, having the properties of breakable foam for treating, alleviating or preventing a dermatological or mucosal disorder.

115. The composition of claim 61 wherein a component of the foamable composition selected from a potent solvent, a co-solvent, a surface-active agent, a gelling agent, an emollient and a foam adjuvant may itself contribute to the pharmaceutical or cosmetic effect of the composition.

116. A foamable pharmaceutical or cosmetic carrier composition for dermatological use, comprising:

a solvent comprising propylene glycol, wherein the propylene glycol is present at a concentration of about 70% to about 96.5% by weight of the total composition;

a surface-active agent at a concentration of about 0.1% to less than about 10% by weight of the total composition;

at least one gelling agent at a concentration of about 0.1% to about 5% by weight of the total composition; and

at least one liquefied or compressed gas propellant, at a concentration of about 3% to about 25% by weight of the total composition,

wherein the composition is stored in an aerosol container and upon release expands to form a breakable foam.

119. A method of treating, alleviating or preventing a dermatological, cosmetic or mucosal disorder, comprising administering topically to a subject having said disorder a therapeutically effective amount of a potent solvent foam composition according to any of claims 61, 116, 117, or 118.

120. The method of claim 119 wherein the disorder is selected from the group consisting of an inflammatory disorder, an infection, dermatoses, keratosis, hyperkeratinization and a vaso disorder.

117. A composition, comprising:

a solvent comprising propylene glycol, wherein the propylene glycol is present at a concentration of about 70% to about 96.5% by weight of the total composition;

a surface-active agent at a concentration of about 0.1% to less than about 10% by weight of the total composition; and

a therapeutically effective amount of at least one active agent selected from the group consisting of an antinfective agent, a keratolytically active agent, a vasoactive agent and a retinoid.

118. A composition, comprising:

a solvent comprising propylene glycol, wherein the propylene glycol is present at a concentration of about 70% to about 96.5% by weight of the total composition;

a surface-active agent at a concentration of about 0.1% to less than about 10% by weight of the total composition; and

a therapeutically effective amount of at least one anti-inflammatory or antiallergic agent, wherein said agent reduces the occurrence of pro-inflammatory cytokines and/or inhibits the effect of pro-inflammatory cytokines.