Wax foamable vehicle and pharmaceutical compositions thereof

• US 8,636,982 B2
• Filed: 08/07/2008
• Issued: 01/28/2014
• Est. Priority Date: 08/07/2007
• Status: Active Grant

• Current Assignee: VYNE Therapeutics, Inc.
• Original Assignee: Foamix Ltd. (VYNE Therapeutics, Inc.)
• Inventors: Tamarkin, Dov, Keynan, Rita, Schuz, David, Berman, Tal
• Primary Examiner(s): Singh, Anoop
• Assistant Examiner(s): FALKOWITZ, ANNA R
• Application Number:
  US12/187,840
• Publication Number:
  US 20090041680A1
• Time in Patent Office: 2,000 Days
• Field of Search: 424/45, 424/400
• US Class Current: 424/45
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/32 Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers , poly(meth)acrylates, or polyvinyl pyrrolidone
• CPC Class Codes: A61K 47/34 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers A61K47/10 takes precedence
• CPC Class Codes: A61K 47/36 Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 47/44 Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14
• CPC Class Codes: A61K 8/046 Aerosols; Foams
• CPC Class Codes: A61K 8/31 Hydrocarbons
• CPC Class Codes: A61K 8/342 Alcohols having more than seven atoms in an unbroken chain
• CPC Class Codes: A61K 8/361 Carboxylic acids having more than seven carbon atoms in an unbroken chain; Salts or anhydrides thereof
• CPC Class Codes: A61K 8/4993 Derivatives containing from 2 to 10 oxyalkylene groups
• 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 9/0043 Nose
• CPC Class Codes: A61K 9/0046 Ear
• CPC Class Codes: A61K 9/1075 Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers A61K9/0026 takes precedence
• CPC Class Codes: A61K 9/122 Foams; Dry foams edible foams A61K9/0056
• CPC Class Codes: A61K 9/124 : characterised by the propellant
• CPC Class Codes: A61P 43/00 : Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
• CPC Class Codes: A61Q 19/00 : Preparations for care of the skin
• CPC Class Codes: A61Q 19/02 : for chemically bleaching or whitening the skin
• CPC Class Codes: A61Q 19/08 : Anti-ageing preparations
• CPC Class Codes: A61Q 5/006 : Antidandruff preparations
• CPC Class Codes: A61Q 7/00 : Preparations for affecting hair growth

Abstract

Unique foamable vehicles or carriers comprising at least one wax, waxy substance, counterpart or derivative, a stabilizer, water, and a propellant are provided. In some embodiments, the wax is a liquid wax. In some embodiments, the wax includes a solid wax and a liquid wax. The compositions are substantially free of crystals. The components are selected to provide a composition that is substantially resistant to aging and to phase separation, and/or can substantially solubilize and or stabilize active ingredients. Pharmaceutical and cosmetic compositions with potentially enhanced skin delivery and their uses are also provided.

Claims

1. A foamable emulsion composition comprising:

A. a carrier comprising;

a. a liquid wax comprising at least one fatty acid or at least one fatty alcohol;

b. a stabilizer component comprising a non ionic surface-active agent;

c. water; and

d. more than 7% by weight of a solid wax of the carrier selected from the group consisting of a fatty acid, a fatty alcohol, a microcrystalline wax, a paraffin wax, a petroleum wax, a polyethylene wax, beeswax, candelilla wax, castor wax, Chinese wax, Fischer-Tropsch wax, rice bran wax, tallow, wool wax and mixtures thereof; and

B. a liquefied hydrocarbon gas propellant at a concentration of about 3% to about 35% by weight of the foamable emulsion composition;

wherein, when the liquid wax comprises at least one fatty acid, the fatty acid is present in the composition at a concentration of more than 35% or about 35% by weight of the carrier;

wherein, when the liquid wax comprises at least one fatty alcohol, the fatty alcohol is present in the composition at a concentration of more than 12% or about 12% by weight of the carrier;

wherein the liquid wax enables the solid wax to solubilize;

wherein the composition is substantially free from crystals and is sufficiently flowable;

wherein the carrier being otherwise free of polymeric agent; and

wherein, upon release from a pressurized container, a breakable foam is produced.

2. The foamable emulsion composition of claim 1, wherein the solid wax is selected from the group consisting of stearic acid, cetyl alcohol and stearyl alcohol.

6. The foamable emulsion composition of claim 1, wherein the solid wax is at a concentration of more than 10% or about 10% by weight of the carrier.

7. The foamable emulsion composition of claim 1, wherein the composition further comprises a solvent selected from the group consisting of an organic carrier, a hydrophilic solvent, a hydrophobic solvent, a potent solvent, a polar solvent, a silicone, an emollient, and mixtures thereof.

8. The foamable emulsion composition of claim 1, wherein the surface active agent is selected from the group consisting of a polysorbate, polyoxyethylene (20) sorbitan monostearate, polyoxyethylene (20) sorbitan monooleate, a polyoxyethylene fatty acid ester, polyoxyethylene (8) stearate (Myrj 45), polyoxyethylene (20) stearate (Myrj 49), polyoxyethylene (40) stearate (Myrj 52), polyoxyethylene (100) stearate (Myrj 59), a polyoxyethylene alkyl ether, polyoxyethylene cetyl ether, polyoxyethylene (23) cetyl ether (Brij 38), polyoxyethylene (2) cetyl ether (Brij 52) polyoxyethylene (10) cetyl ether (Brij 56), a sucrose ester, a partial ester of sorbitol, sorbitan monolaurate,. a monoglyceride, a diglyceride, isoceteth-20, steareth 2, glyceryl stearate, steareth-21, sorbitan stearate, laureth 4, sorbitan monooleate, ceteareth 20, steareth 20, ceteth 20, macrogol cetostearyl ether, PEG-30 dipolyhydroxystearate, sucrose distearate, cetomacrogol ether, cetearyl glucoside, polysorbate 20;

, methyl glucose sesquistearate, a sucrose stearic acid ester, and mixtures thereof.

11. The foamable emulsion composition of claim 1, wherein the liquid wax is a fatty acid or fatty alcohol having 12-22 carbon atoms in its carbon backbone.

15. The foamable emulsion composition of claim 1, wherein the liquid wax is an unsaturated and or branched chain fatty acid or fatty alcohol.

17. The foamable emulsion composition of claim 1, wherein the liquid wax is a saturated and or straight chain fatty acid or fatty alcohol.

21. The foamable emulsion composition of claim 1, wherein the liquid wax is selected from the group consisting of isostearic acid, oleyl alcohol, oleic acid, lauric acid, myristic acid, octyldodecanol, isostearyl alcohol and jojoba oil or mixtures thereof.

24. The foamable emulsion composition of claim 1, further comprising an active agent.

26. The foamable emulsion composition of claim 1, further containing a foam adjuvant.

27. The foamable emulsion composition of claim 7, wherein the organic carrier is at a concentration of about 2% to about 50% by weight of the carrier and is selected from the group consisting of mineral oil, triglycerides, medium chain triglyceride (MCT) oil, capric/caprylic triglyceride, alkyl esters of fatty acids isopropyl palmitate, isopropyl myristate, isopropyl isostearate, poly propylene glycol 15-stearly ether, 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, ricinoleate, isopropyl lanolate, pentaerythrityl tetrastearate, neopentylglycol dicaprylate/dicaprate, isononyl isononanoate, isotridecyl isononanoate, myristyl myristate, triisocetyl citrate, octyl dodecanol, maleated soybean oil, unsaturated or polyunsaturated oils, olive oil, corn oil, soybean oil, canola oil, cottonseed oil, coconut oil, sesame oil, sunflower oil, borage seed oil, syzigium aromaticum oil, hempseed oil, herring oil, cod-liver oil, salmon oil, flaxseed oil, wheat germ oil, evening primrose oils;

essential oils;

silicone oil, dimethicone, cyclomethicone, polyalkyl siloxane, polyaryl siloxane, polyalkylaryl siloxane, a polyether siloxane copolymer, a poly(dimethylsiloxane)-(diphenyl-siloxane); and

mixtures thereof.

28. The foamable emulsion composition of claim 7, wherein the polar solvent is selected from the group consisting of dimethyl isosorbide, glycerol, propylene glycol, hexylene glycol, diethylene glycol, propylene glycol n-alkanols, terpenes, di-terpenes, tri-terpenes, limonene, terpene-ol, 1-menthol, dioxolane, ethylene glycol, other glycols, oleyl alcohol, alpha-hydroxy acids, lactic acid, glycolic acid, sulfoxides, dimethylsulfoxide (DMSO), dimethylformanide, methyl dodecyl sulfoxide, dimethylacetamide, azone (1-dodecylazacycloheptan-2-one), 2-(n-nonyl)-1,3-dioxolane, alkanols, dialkylamino acetates, and admixtures thereof.

29. The foamable emulsion composition of claim 1, wherein at least one of the liquid wax or the solid wax is a branched and/or unsaturated fatty alcohol or a branched and/or unsaturated fatty acid.

31. The foamable emulsion composition of claim 1, further comprising an additional component selected from the group consisting of a modulating agent, a polar solvent, an anti perspirant, an anti-static agent, a buffering agent, a bulking agent, a chelating agent, a colorant, a conditioner, a deodorant, a diluent, a dye, an emollient, fragrance, a humectant, an occlusive agent, a penetration enhancer, a perfuming agent, a permeation enhancer, a pH-adjusting agent, a preservative, a skin penetration enhancer, a sunscreen, a sun blocking agent, a sunless tanning agent, a vitamin, and mixtures thereof.

32. The foamable emulsion composition of claim 24, wherein the active agent is selected from the group consisting of active herbal extracts, acaricides, age spot and keratose removing agents, allergen, analgesics, local anesthetics, antiacne agents, antiallergic agents, antiaging agents, antibacterials, antibiotics, antiburn agents, anticancer agents, antidandruff agents, antidepressants, antidermatitis agents, antiedemics, antihistamines, antihelminths, antihyperkeratolyte agents, antiinflammatory agents, antiirritants, antilipemics, antimicrobials, antimycotics, antiproliferative agents, antioxidants, anti-wrinkle agents, antipruritics, antipsoriatic agents, antirosacea agents antiseborrheic agents, antiseptic agents, antiswelling agents, antiviral agents, antiyeast agents, astringents, topical cardiovascular agents, chemotherapeutic agents, corticosteroids, dicarboxylic acids, disinfectants, fungicides, hair growth regulators, hormones, hydroxy acids, immunosuppressants, immunoregulating agents, immunomodulators, insecticides, insect repellents, keratolytic agents, lactams, metals, metal oxides, mitocides, neuropeptides, steroids, non-steroidal anti-inflammatory agents, oxidizing agents, pediculicides, photodynamic therapy agents, retinoids, sanatives, scabicides, self tanning agents, skin whitening agents, vasoconstrictors, vasodilators, vitamins, vitamin D derivatives, wound healing agents, wart removers;

agents having activity against superficial basal cell carcinomas, actinic keratoses, Bowen'"'"'s disease or other squamous cell carcinomas and molluscum contagiosum;

agents having activity against herpes simplex virus infections, other viral infections, or eczema, a vaccine adjuvant, and mixtures thereof.

33. The foamable emulsion composition of claim 32, wherein the active agent is selected from the group consisting of imiquimod, resiquimod, gardiquimod, laquinimod an interferon, an immunomodulator, cyclic peptide, cyclosporine, tacrolimus, tresperimus, pimecrolimus, sirolimus, verolimus, laflunimus, podophyllin (anti-mitotic), podofilox, 5-fluorouracil (5-FU), and trichloroacetic acid (TCA), fluorouracil, afovirsen, inosine pranobex, podophyllum, trichloroacetic acid, thiotep, diclofenac, 5-aminolevulinic acid and derivatives, and tretinoin, and mixtures thereof.

34. The foamable emulsion composition of claim 33, wherein the active agent is used in combination cryotherapy or with at least one compound selected from the group consisting of meglumine antimoniate, acyclovir, 5- aminolevulinic acid, fluorouracil, salicylic acid, a COX inhibitor and sulindac.

35. The foamable emulsion composition of claim 32, wherein the steroid is selected from the group consisting of hydrocortisone, hydroxyltriamcinolone, alpha-methyl dexamethasone, dexamethasone-phosphate, beclomethsone dipropionate, clobetasol valemate, desonide, desoxymethasone, desoxycorticosterone acetate, dexamethasone, dichlorisone, diflorasone diacetate, diflucortolone valerate, fluadrenolone, fluclorolone acetonide, fludrocortisone, flumethasone pivalate, fluosinolone acetonide, fluocinonide, flucortine butylester, fluocortolone, fluprednidene (fluprednylidene) acetate, flurandrenolone, halcinonide, hydrocortisone acetate, hydrocortisone butyrate, methylprednisolone, triamcinolone acetonide, cortisone, cortodoxone, flucetonide, fludrocortisone, difluorosone diacetate, fluradrenolone acetonide, medrysone, amcinafel, amcinafide, betamethasone and its esters, chloroprednisone, chlorprednisone acetate, clocortelone, clescinolone, dichlorisone, difluprednate, flucloronide, flunisolide, fluoromethalone, fluperolone, fluprednisolone, hydrocortisone valerate, hydrocortisone cyclopentylpropionate, hydrocortmate, mepreddisone, paramethasone, prednisolone, prednisone, beclomethasone dipropionate, triamcinolone, and mixtures thereof.

36. A method of treating or ameliorating a skin, mucosal or body cavity disorder of a mammalian subject, comprising administering the foamable therapeutic emulsion composition of claim 24 to the skin, a mucosal surface, or a body cavity of said mammalian subject.

38. The method of claim 36, wherein the disorder is selected from the group consisting of dermatological pain, dermatological inflammation, acne, acne vulgaris, inflammatory acne, non-inflammatory acne, nodular papulopustular acne, dermatitis, bacterial skin infections, fungal skin infections, viral skin infections, parasitic skin infections, skin neoplasia, skin neoplasms, pruritis, cellulitis, cutaneous abscesses, folliculitis, furuncles, hidradenitis suppurativa,carbuncles, rashes, erythrasma, impetigo, warts, molluscum contagiosumtrauma or injury to the skin, post-operative or post-surgical skin conditions, scabies, pediculosis, eczemas, psoriasis, pityriasis rosea, lichen planus, pityriasis rubra pilaris, granuloma annulare,sunburn, photosensitivity, pemphigus, bullous pemphigoid,keratosis pilaris,callouses, corns, ichthyosis, skin ulcers, ischemic necrosis, hyperhidrosis, moles, Kaposi'"'"'s sarcoma, melanoma, basal cell carcinoma, squamous cell carcinoma, contact dermatitis, atopic dermatitis, rosacea, purpura, candidiasis, baldness, alopecia, Dercum disease, hair loss, Hailey-Hailey disease, chemical or thermal skin burns, scleroderma, aging skin, wrinkles, sun spots, scarring, and vitiligo;

and wherein the active agent is suitable for treating said disorder;

or wherein the disorder is selected from the group consisting of chlamydia infection, gonorrhea infection, herpes, human papillomavirus, genital warts, bacterial vaginosis, chancroid,granuloma Inguinale, lymphogranuloma venereum, mucopurulent cervicitis, nongonococcal urethritis, vulvar disorders, vulvodynia, vulvar pain, yeast infection, vulvar dystrophy, vulvar intraepithelial neoplasia, pelvic inflammation, endometritis, salpingitis, oophoritis, genital cancer, cancer of the cervix, cancer of the vulva, cancer of the vagina, vaginal dryness, dyspareunia, anal and rectal disease, anal abscess/fistula, anal cancer, anal fissure, anal warts, Crohn'"'"'s disease, hemorrhoids, anal itch, polyps of the colon and rectum, superficial basal cell carcinomas, actinic keratoses, and Bowen'"'"'s disease, and wherein the body cavity is selected from the group consisting of the nose, the mouth, an ear canal, the vagina, and the rectum.

40. The method of claim 36 wherein the active agent is selected from the group consisting of imiquimod, resiquimod, gardiquimod, an interferon, an immunomodulator, podophyllin (anti-mitotic), podofilox, 5-fluorouracil (5-FU), and trichloroacetic acid (TCA), fluorouracil, afovirsen, inosine pranobex, podophyllum, trichloroacetic acid, thiotep, diclofenac, 5-aminolevulinic acid and derivatives, tretinoin, a cyclic peptide, cyclosporine, tacrolimus, tresperimus, pimecrolimus, sirolimus, verolimus, laflunimus and laquinimod.

41. The foamable emulsion composition of claim 1, wherein the liquid wax comprises more than 10% or about 10% by weight of the carrier of jojoba oil.

42. The foamable emulsion composition of claim 41, wherein the solid wax is present at a concentration of more than 10% or about 10% by weight of the carrier.

43. The foamable emulsion composition of claim 41, wherein the concentration of the liquid wax, including the jojoba oil, in the composition is more than 20% or about 20% by weight of the carrier.

44. The foamable emulsion composition of claim 1, wherein the composition is in a non foam state.

46. The foamable emulsion composition of claim 41, wherein the composition is in a non foam state.

47. The foamable emulsion composition of claim 1, wherein at least one of the liquid wax is selected from the group consisting of isostearic acid, myristoleic acid, palmitoleic acid, oleic acid, linoleic acid, alpha linolenic acid, arachidonic acid, eicosapentaenoic acid, erucic acid, docosahexaenoic acid, isostearyl alcohol and oleyl alcohol.

3. A foamable emulsion composition comprising:

A. a carrier comprising;

a. more than 10% or about 10% by weight of the carrier of a solid wax selected from the group consisting of a fatty acid, a fatty alcohol, a microcrystalline wax, a paraffin wax, a petroleum wax, a polyethylene wax, beeswax, candelilla wax, castor wax, Chinese wax, Fischer-Tropsch wax, rice bran wax, tallow, wool wax and mixtures thereof;

b. a liquid wax wherein the liquid wax comprises at least one fatty acid or at least one fatty alcohol;

c. a stabilizer comprising a non ionic surface-active agent, a polymeric agent or a mixture thereof;

d. water; and

B. a liquefied hydrocarbon gas propellant at a concentration of about 3% to about 35% by weight of the foamable emulsion composition;

wherein the liquid wax enables the solid wax to solubilize;

wherein the composition is substantially free from crystals and is sufficiently flowable;

wherein, when the stabilizer component comprises a polymeric agent, the polymeric agent is present in the composition at a concentration of about 0.01% to about 5% by weight of the carrier and is selected from the group consisting of a bioadhesive agent, a gelling agent, a film forming agent and a phase change agent; and

wherein, upon release from a pressurized container, a breakable foam is produced.

4. The foamable emulsion composition of claim 3, wherein when the composition comprises at least one liquid fatty acid, the liquid fatty acid is present in the composition at a concentration of more than 35% or about 35% by weight of the carrier and wherein, when the composition comprises at least one liquid fatty alcohol, the liquid fatty alcohol is present in the composition at a concentration more than 12% or about 12% by weight of the carrier.

5. The foamable emulsion composition of claim 4, wherein the liquid wax, solid wax, stabilizer and water are selected to provide a composition that can substantially stabilize or solubilize an active ingredient.

9. The foamable emulsion composition of claim 3, wherein the surface active agent also functions as a solvent.

10. The foamable emulsion composition of claim 3, wherein the polymeric agent is selected from the group consisting of cross-linked polyacrylate polymer, acrylates/C10-30 alkyl acrylate crosspolymers, carboxy methyl cellulose, locust bean gum, sodium alginate, sodium caseinate, egg albumin, gelatin agar, carrageenin gum, xanthan gum, quince seed extract, tragacanth gum, guar gum, cationic guars, hydroxypropyl guar gum, starch, an amine-bearing polymer, chitosan, alginic acid, hyaluronic acid, a chemically modified starch, a carboxyvinyl polymer, polyvinylpyrrolidone, polyvinyl alcohol, a polyacrylic acid polymer, a polymethacrylic acid polymer, polyvinyl acetate, a polyvinyl chloride polymer, a polyvinylidene chloride polymer, methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, methylhydroxyethylcellulose, methylhydroxypropylcellulose, hydroxyethylcarboxymethylcellulose, carboxymethylhydroxyethylcellulose, a cationic cellulose, aluminum starch octenylsuccinate (ASOS), sodium starch octenylsuccinate, and mixtures thereof.

12. The foamable emulsion composition of claim 3, wherein at least one of the liquid wax or the solid wax is a fatty acid or fatty alcohol having 12-22 carbon atoms in its carbon backbone.

14. The foamable emulsion composition of claim 3,. wherein at least one of the liquid wax or the solid wax is a fatty acid or fatty alcohol having 12-22 carbon atoms in its carbon backbone.

16. The foamable emulsion composition of claim 3 wherein at least one of the liquid wax or the solid wax is an unsaturated and or branched chain fatty acid or fatty alcohol.

18. The foamable emulsion composition of claim 3, wherein at least one of the liquid wax or the solid wax is a saturated and or straight chain fatty acid or fatty alcohol.

19. The foamable emulsion composition of claim 3, wherein the carrier comprises a fatty acid and a fatty alcohol, wherein the ratio of the fatty alcohol to the fatty acid is between about 10:

9 to about 8;

1.

20. The foamable emulsion composition of claim 3, wherein the ratio of liquid wax to solid wax is between about 10:

1 to about 1;

10.

22. The foamable emulsion composition of claim 3, wherein the liquid wax is selected from the group consisting of isostearic acid, oleyl alcohol, oleic acid, lauric acid, myristic acid, octyldodecanol, isostearyl alcohol and jojoba oil and the solid wax is selected from the group consisting of stearic acid, cetyl alcohol and stearyl alcohol.

23. The foamable emulsion composition of claim 3, wherein at least one of the liquid wax or the solid wax is selected from the group consisting of an animal wax, spermaceti, lanolin (wool wax), an insect wax, beeswax, Chinese wax, a vegetable wax, candelilla wax, castor wax, jojoba oil, coconut oil, palm oil, tallow, rice bran wax, a petroleum wax, a paraffin wax, microcrystalline wax, a synthetic wax, a polyethylene wax, Fischer-Tropsch wax, and mixtures thereof.

25. The foamable emulsion composition of claim 3, further comprising an active agent.

30. The foamable emulsion composition of claim 3, wherein at least one of the liquid wax or the solid wax is a branched and/or unsaturated fatty alcohol or a branched and/or unsaturated fatty acid.

37. A method of treating or ameliorating a skin, mucosal or body cavity disorder of a mammalian subject, comprising administering the foamable therapeutic emulsion composition of claim 25 to skin, a mucosal surface, or a body cavity of said mammalian subject.

39. The method of claim 37, wherein the disorder is selected from the group consisting of dermatological pain, dermatological inflammation, acne, acne vulgaris, inflammatory acne, non-inflammatory acne, nodular papulopustular acne, dermatitis, bacterial skin infections, fungal skin infections, viral skin infections, parasitic skin infections, skin neoplasia, skin neoplasms, pruritis, cellulitis, cutaneous abscesses, folliculitis, furuncles, hidradenitis suppurativa, carbuncles, rashes, erythrasma, impetigo, warts, molluscum contagiosum, trauma or injury to the skin, post-operative or post-surgical skin conditions, scabies, pediculosis, eczemas, psoriasis, pityriasis rosea, lichen planus, pityriasis rubra pilaris, granuloma annulare, sunburn, photosensitivity, pemphigus, bullous pemphigoid, keratosis pilaris, callouses, corns, ichthyosis, skin ulcers, ischemic necrosis, hyperhidrosis, moles, Kaposi'"'"'s sarcoma, melanoma, basal cell carcinoma, squamous cell carcinoma, contact dermatitis, atopic dermatitis, rosacea, purpura, moniliasis, candidiasis, baldness, alopecia, Dercum disease, hair loss, Hailey-Hailey disease, chemical or thermal skin burns, scleroderma, aging skin, wrinkles, sun spots, scarring, and vitiligo;

and wherein the active agent is suitable for treating said disorder;

or wherein the disorder is selected from the group consisting of chlamydia infection, gonorrhea infection, herpes, human papillomavirus, genital warts, bacterial vaginosis, chancroid, granuloma Inguinale, lymphogranuloma venereum, mucopurulent cervicitis, nongonococcal urethritis, vulvar disorders, vulvodynia, vulvar pain, yeast infection, vulvar dystrophy, vulvar intraepithelial neoplasia, pelvic inflammation, endometritis, salpingitis, oophoritis, genital cancer, cancer of the cervix, cancer of the vulva, cancer of the vagina, vaginal dryness, dyspareunia, anal and rectal disease, anal abscess/fistula, anal cancer, anal fissure, anal warts, Crohn'"'"'s disease, hemorrhoids, anal itch, polyps of the colon and rectum, superficial basal cell carcinomas, actinic keratoses and Bowen'"'"'s disease and, wherein the body cavity is selected from the group consisting of the nose, the mouth, an ear canal, the vagina, and the rectum.

45. The foamable emulsion composition of claim 3, wherein the composition is in a non foam state.

48. The foamable emulsion composition of claim 3, wherein at least one of the liquid wax is selected from the group consisting of isostearic acid, myristoleic acid, palmitoleic acid, oleic acid, linoleic acid, alpha linolenic acid, arachidonic acid, eicosapentaenoic acid, erucic acid, docosahexaenoic acid, isostearyl alcohol and oleyl alcohol.

13. The foamable emulsion composition of claim h wherein the liquid wax is a fatty acid or fatty alcohol having 16-22 carbon atoms in its carbon backbone.

49. A foamable emulsion composition comprising:

A. a carrier comprising;

a. about 20% to about 60% by weight of the carrier of isostearic acid;

b. a solid wax selected from the group consisting of a fatty acid and a fatty alcohol and mixtures thereof;

c. a non ionic surface-active agent;

d. imiquimod; and

e. water; and

B. a liquefied hydrocarbon gas propellant at a concentration of about 3% to about 35% by weight of the foamable emulsion composition;

wherein the carrier being otherwise free of polymeric agent; and

wherein, upon release from a pressurized container, a breakable foam is produced.

50. The foamable emulsion composition of claim 49, wherein the composition is capable of stabilizing or solubilizing imiquimod.

51. The foamable emulsion composition of claim 49, wherein the surface-active agent is selected from the group consisting of steareth 21, PEG-40 stearate, sorbitan stearate, glyceryl monostearate and polysorbate 80.

52. The foamable emulsion composition of claim 49, wherein the solid wax comprises stearyl alcohol.

53. A foamable emulsion composition comprising:

A. a carrier comprising

a. a liquid wax comprising at least one fatty acid or at least one fatty alcohol;

b. a stabilizer component comprising a non ionic surface-active agent;

c. water; and

d. more than 7% by weight of the carrier of a solid wax selected from the group consisting of a fatty acid, a fatty alcohol, a microcrystalline wax, a paraffin wax, a petroleum wax, a polyethylene wax, beeswax, candelilla wax, castor wax, Chinese wax, Fischer-Tropsch wax, rice bran wax, tallow, wool wax and mixtures thereof; and

B. a liquefied hydrocarbon gas propellant at a concentration of about 3% to about 35% by weight of the foamable emulsion composition;

wherein, the liquid wax comprises at least one fatty alcohol at a concentration of more than 12% or about 12% by weight of the carrier;

wherein presence of the liquid wax enables the solid wax to solubilize;

wherein the composition is substantially free from crystals and is sufficiently flowable;

wherein the carrier being otherwise free of polymeric agent; and

wherein, upon release from a pressurized container, a breakable foam is produced.

54. A foamable emulsion composition comprising:

A. a carrier comprising;

a. a liquid wax comprising at least one fatty acid or at least one fatty alcohol;

b. a stabilizer component comprising a non ionic surface-active agent;

c. water; and

d. more than 7% by weight of the carrier of a solid wax selected from the group consisting of a fatty acid, a fatty alcohol, a microcrystalline wax, a paraffin wax, a petroleum wax, a polyethylene wax, beeswax, candelilla wax, castor wax, Chinese wax, Fischer-Tropsch wax, rice bran wax, tallow, wool wax and mixtures thereof; and

B. a liquefied hydrocarbon gas propellant at a concentration of about 3% to about 35% by weight of the foamable emulsion composition;

wherein, the liquid wax comprises at least one fatty acid at a concentration of more than 35% or about 35% by weight of the carrier;

wherein presence of the liquid wax enables the solid wax to solubilize;

wherein the composition is substantially free from crystals and is sufficiently flowable;

wherein the carrier being otherwise free of polymeric agent; and

wherein upon release from a pressurized container, a breakable foam is produced.

55. A foamable emulsion composition comprising:

A. a carrier comprising;

a. a liquid wax comprising at least one fatty acid or at least one fatty alcohol;

b. a stabilizer component comprising a non ionic surface-active agent;

c. water; and

d. more than 8% or about 8% by weight of the carrier of a solid wax selected from the group consisting of a fatty acid, a fatty alcohol, a microcrystalline wax, a paraffin wax, a petroleum wax, a polyethylene wax, beeswax, candelilla wax, castor wax, Chinese wax, Fischer-Tropsch wax, rice bran wax, tallow, wool wax and mixtures thereof; and

B. a liquefied hydrocarbon gas propellant at a concentration of about 3% to about 35% by weight of the foamable emulsion composition;

wherein when the liquid wax comprises at least one fatty acid, the fatty acid is present in the composition at a concentration of more than 35% or about 35% by weight of the carrier;

wherein when the liquid wax comprises at least one fatty alcohol, the fatty alcohol is present in the composition at a concentration of more than 12% or about 12% by weight of the carrier;

wherein the presence of liquid wax enables the solid wax to solubilize;

wherein the composition is substantially free from crystals and is sufficiently flowable;

wherein the carrier being otherwise free of polymeric agent; and

wherein upon release from a pressurized container, a breakable foam is produced.

56. A foamable emulsion composition comprising:

A. a carrier comprising;

a. a liquid wax comprising at least one fatty acid or at least one fatty alcohol;

b. a stabilizer component comprising a non ionic surface-active agent;

c. water; and

d. more than 8% or about 8% by weight of the carrier of a solid wax selected from the group consisting of a fatty acid, a fatty alcohol, a microcrystalline wax, a paraffin wax, a petroleum wax, a polyethylene wax, beeswax, candelilla wax, castor wax, Chinese wax, Fischer-Tropsch wax, rice bran wax, tallow, wool wax and mixtures thereof; and

B. a liquefied hydrocarbon gas propellant at a concentration of about 3% to about 35% by weight of the foamable emulsion composition;

wherein when the liquid wax comprises at least one fatty alcohol, the fatty alcohol is present in the composition at a concentration of more than 12% or about 12% by weight of the carrier;

wherein presence of the liquid wax enables the solid wax to solubilize;

wherein the composition is substantially free from crystals and is sufficiently flowable;

wherein the carrier being otherwise free of polymeric agent; and

wherein upon release from a pressurized container, a breakable foam is produced.

57. A foamable emulsion composition comprising:

A. a carrier comprising;

a. a liquid wax comprising at least one fatty acid or at least one fatty alcohol;

b. a stabilizer component comprising a non ionic surface-active agent;

c. water; and

d. more than 8% or about 8% by weight of the carrier of a solid wax selected from the group consisting of a fatty acid, a fatty alcohol, a microcrystalline wax, a paraffin wax, a petroleum wax, a polyethylene wax, beeswax, candelilla wax, castor wax, Chinese wax, Fischer-Tropsch wax, rice bran wax, tallow, wool wax and mixtures thereof; and

B. a liquefied hydrocarbon gas propellant at a concentration of about 3% to about 35% by weight of the foamable emulsion composition;

wherein when the liquid wax comprises at least one fatty acid, the fatty acid is present in the composition at a concentration of more than 35% or about 35% by weight of the carrier;

wherein presence of the liquid wax enables the solid wax to solubilize;

wherein the composition is substantially free from crystals and is sufficiently flowable;

wherein the carrier being otherwise free of polymeric agent; and

wherein upon release from a pressurized container, a breakable foam is produced.