CA2536482A1 - Penetrating pharmaceutical foam - Google Patents

Penetrating pharmaceutical foam Download PDF

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Publication number
CA2536482A1
CA2536482A1 CA002536482A CA2536482A CA2536482A1 CA 2536482 A1 CA2536482 A1 CA 2536482A1 CA 002536482 A CA002536482 A CA 002536482A CA 2536482 A CA2536482 A CA 2536482A CA 2536482 A1 CA2536482 A1 CA 2536482A1
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Prior art keywords
active agent
foamable emulsion
weight
foamable
composition
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Granted
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CA002536482A
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French (fr)
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CA2536482C (en
Inventor
Dov Tamarkin
Doron Friedman
Meir Eini
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Vyne Pharmaceuticals Ltd
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Individual
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/12—Aerosols; Foams
    • A61K9/122—Foams; Dry foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/113—Multiple emulsions, e.g. oil-in-water-in-oil
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01N—PRESERVATION OF BODIES OF HUMANS OR ANIMALS OR PLANTS OR PARTS THEREOF; BIOCIDES, e.g. AS DISINFECTANTS, AS PESTICIDES OR AS HERBICIDES; PEST REPELLANTS OR ATTRACTANTS; PLANT GROWTH REGULATORS
    • A01N25/00—Biocides, pest repellants or attractants, or plant growth regulators, characterised by their forms, or by their non-active ingredients or by their methods of application, e.g. seed treatment or sequential application; Substances for reducing the noxious effect of the active ingredients to organisms other than pests
    • A01N25/16—Foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/04—Dispersions; Emulsions
    • A61K8/046—Aerosols; Foams
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/02—Cosmetics or similar toiletry preparations characterised by special physical form
    • A61K8/04—Dispersions; Emulsions
    • A61K8/06—Emulsions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/34—Alcohols
    • A61K8/342—Alcohols having more than seven atoms in an unbroken chain
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/37—Esters of carboxylic acids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/30—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds
    • A61K8/33—Cosmetics or similar toiletry preparations characterised by the composition containing organic compounds containing oxygen
    • A61K8/39—Derivatives containing from 2 to 10 oxyalkylene groups
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K8/00—Cosmetics or similar toiletry preparations
    • A61K8/18—Cosmetics or similar toiletry preparations characterised by the composition
    • A61K8/72—Cosmetics or similar toiletry preparations characterised by the composition containing organic macromolecular compounds
    • A61K8/73—Polysaccharides
    • A61K8/731—Cellulose; Quaternized cellulose derivatives
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0014—Skin, i.e. galenical aspects of topical compositions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61Q—SPECIFIC USE OF COSMETICS OR SIMILAR TOILETRY PREPARATIONS
    • A61Q19/00—Preparations for care of the skin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2800/00—Properties of cosmetic compositions or active ingredients thereof or formulation aids used therein and process related aspects
    • A61K2800/80—Process related aspects concerning the preparation of the cosmetic composition or the storage or application thereof
    • A61K2800/91—Injection
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers

Abstract

The invention relates to an alcohol-free cosmetic or pharmaceutical foam carrier comprising water, a hydrophobic solvent, a surface-active agent and a gelling agent. The foam carrier further comprises active agents and excipients with therapeutic properties having enhanced skin penetration.

Claims (80)

1. An oil in water foamable emulsion that is stable in its pre-dispensed state comprising:
(i) about 5-50% by weight of composition of a liquid, non-volatile hydrophobic solvent;
(ii) about 0.1 to 5% by weight of a composition of a surface-active agent;
(iii) about 0.1 to 5% by weight of a gelling agent;
(iv) an active component selected from the group consisting of one or more of urea, a hydroxy acid, and a eutectic mixture of active agents; and (v) a liquefied gas propellant at a concentration of about 3% to about 18% by weight of the total composition;
wherein the emulsion is alcohol-free.
2. The foamable emulsion of claim 1, wherein said active component consists of a combination of active agents, which creates, upon admixing, a eutectic mixture.
3. The foamable emulsion of claim 1, wherein said active component consists of about 1 % to about 50% urea.
4. The foamable emulsion of claim 3, wherein said active component consists of about 10% to about 20% urea.
5. The foamable emulsion of claim 3, wherein said active component consists of about 20% to about 50% urea.
6. The foamable emulsion of claim 1, wherein said active component consists of about 1% to about 30% hydroxy acid.
7. The foamable emulsion of claim 6, wherein said active component consists of about 1% to about 10% hydroxy acid.
8. The foamable emulsion of claim 6, wherein said active component consists of about 10% to about 30% hydroxy acid.
9. The foamable emulsion of claim 1, wherein said active component consists of a combination of about 1% to about 50% urea and about 1% to about 30% hydroxy acid.
10. An oil in water foamable emulsion that is stable in its pre-dispensed state comprising:
(i) about 5-50% by weight of composition of a liquid, non-volatile hydrophobic solvent;
(ii) about 0.1 to 5% by weight of a composition of a surface-active agent;
(iii) about 0.1 to 5% by weight of a gelling agent;
(iv) a therapeutic enhancer selected from the group consisting of propylene glycol, butylene glycols, glycerol, pentaerythritol, sorbitol, mannitol, oligosaccharides, dimethyl isosorbide, monooleate of ethoxylated glycerides having about 8 to 10 ethylene oxide units, polyethylene glycol 200-600, transcutol, glycofurol and cyclodextrins;
(v) a therapeutically effective concentration of at least one active agent;
and (vi) a liquefied gas propellant at a concentration of about 3% to about 18% by weight of the total composition;
wherein the emulsion is alcohol-free.
11. The foamable emulsion of claim 10, wherein said active component consists of about 1% to about 10% of a therapeutic enhancer.
12. The foamable emulsion of claim 10, wherein said active component consists of about 10% to about 30% therapeutic enhancer.
13. The foamable emulsion of claim 3 and 6, further comprising a therapeutically effective concentration of at least one active agent.
14. The foamable emulsion of claim 1 and 10, wherein said hydrophobic solvent comprises about 5-10% by weight of the composition.
15. The foamable emulsion of claim 1 and 10, wherein said hydrophobic solvent comprises about 10-20% by weight of the composition.
16. The foamable emulsion of claim 1 and 10, wherein said hydrophobic solvent comprises about 20-50% by weight of the composition.
17. The foamable emulsion of claim 1 and 10, wherein said hydrophobic solvent comprises a mixture of mineral oil and an emollient in a ratio between 2:8 and 8:2 on a weight basis.
18. The foamable emulsion of claim 1 and 10, wherein said surface-active agent is selected from the group consisting of a non ionic surface active agent, a cationic surface active agent, an amphoteric surface active agent and a zwitterionic surface active agent.
19. The foamable emulsion of claim 1 and 10, wherein said surface-active agent is a mixture of a non ionic surface active agent and an ionic surface active agent in a 1:1 to 20:1 ratio.
20. The foamable emulsion of claim 1 and 10, wherein said surface-active agent is a non ionic surface-active agent.
21. The foamable emulsion of claim 1 and 10, wherein the surface-active agent has HLB value of more than 9.
22. The foamable emulsion of claim 1 and 10, wherein the hydrophobic solvent is selected from the group consisting of vegetable oil, marine oil, mineral oil, emollient, silicone oil, plant-derived therapeutic oil and mixture thereof at any proportion.
23. The foamable emulsion of claim 1 and 10, wherein the ratio between the surface active agent and the hydrophobic solvent is between about 1:8 and about 1:16.
24. The foamable emulsion of claim 1 and 10, wherein the ratio between the surface active agent and the hydrophobic solvent is between about 1:16 and about 1:32.
25. The foamable emulsion of claim 1, 2, 3, 6 and 10, wherein said composition is directed to the treatment of a disorder of the skin, mucosal membrane, vagina and rectum.
26. Use of the foamable emulsion of claim 2, 3, 6 and 10 for the treatment of pain.
27. Use of the foamable emulsion of claim 2, 3, 6 and 10 for the treatment of a disorder, selected from the group of dermatitis, atopic dermatitis, seborrheic dermatitis, nummular dermatitis, chronic dermatitis of the hands and feet, generalized exfoliative dermatitis, stasis dermatitis; lichen simplex chronicus;
diaper rash; bacterial Infections including cellulitis, acute lymphangitis, lymphadenitis, erysipelas, cutaneous abscesses, necrotizing subcutaneous infections, staphylococcal scalded skin syndrome, folliculitis, furuncles, hidradenitis suppurativa, carbuncles, paronychial infections, erythrasma;
fungal infections including dermatophyte infections, yeast infections; parasitic infections, scabies, pediculosis, creeping eruption; viral infections, disorders of hair follicles and sebaceous glands, acne, rosacea, perioral dermatitis, hypertrichosis, hirsutism, male pattern baldness, alopecia areata, alopecia universalis and alopecia totalis; pseudofolliculitis barbae, keratinous cyst, scaling papular diseases, psoriasis, pityriasis rosea, lichen planus, pityriasis rubra pilaris, benign tumors, moles, dysplastic nevi, skin tags, lipomas, angiomas, pyogenic granuloma, seborrheic keratoses, dermatofibroma, keratoacanthoma, keloid;
malignant tumors, basal cell carcinoma, squamous cell carcinoma, malignant melanoma, paget's disease of the nipples, kaposi's sarcoma; reactions to sunlight, sunburn, photosensitivity; Bullous Diseases including pemphigus, bullous pemphigoid, dermatitis herpetiformis, linear Immunoglobulin A disease, vitiligo, albinism, postinflammatory hypopigmentation, hyperpigmentation, melasma, chloasma, drug-induced hyperpigmentation, postinflammatory hyperpigmentation, ichthyosis, keratosis pilaris, calluses, corns, actinic keratosis;
pressure Sores, disorders of sweating, erythema multiforme, erythema nodosum, granuloma annulare, non-dermatological disorders, which respond to topical /
transdermal delivery of an active agent, localized pain, joint pain, muscle pain, back pain, rheumatic pain, arthritis, ostheoarthritis, acute soft tissue injuries and sports injuries, conditions, which respond to hormone therapy, hormone replacement therapy, transdermal nicotine administration, pelvic pain, premenstrual syndrome (PMS), mittelschmerz, dysmenorrhea, endometriosis, ectopic pregnancy, ovarian cysts and masses, acute pelvic inflammatory disease, pelvic congestion syndrome, vulvodynia, vulvovaginal infections, bacterial vaginosis, candidal vaginitis, trichomonas vaginalis, herpes simplex, genital ulcers and warts, pelvic inflammatory disease (PID), cervicitis, acute and chronic salpingitis, endometriosis, gynecological neoplasms, endometrial Cancer, ovarian cancer, cervical cancer, vulvar cancer, vaginal cancer, fallopian tube cancer, gestational trophoblastic disease, benign tumors; sexually transmitted diseases;
sexual dysfunction disorders that respond to pharmacological therapy, sexual arousal disorder, female orgasmic disorder, dyspareunia and vaginismus, anal abscess/fistula, anal cancer, anal warts, crohn's disease, haemorrhoids, perianal thrush, anal fissures, fecal incontinence, constipation, polyps of the colon and rectum, sexually-transmitted disease and non-sexually-transmitted vaginal and genital infectious disease.
28. Use of the foamable emulsion of claim 2, 3, 6 and 10 for the treatment of wounds, burns, cuts and ulcers.
29. The foamable emulsion of claim 2, 10 and 13, wherein said at least one active agent is antibacterial.
30. The foamable emulsion of claim 29, wherein said at least one active agent is selected from the group consisiting of: chloramphenicol, tetracyclines, synthetic and semi-synthesic penicillins, beta-lactams, quinolones, fluoroquinolnes, macrolide antibiotics, peptide antibiotics, cyclosporines, Metronidazole, free radical generating agents, iodine, chlorohexidine, benzoyl peroxide, hydrogen peroxide and any combination thereof at a therapeutically effective concentration.
31. The foamable emulsion of claim 2, 10 and 13, wherein said at least one active agent is antifungal.
32. The foamable emulsion of claim 31, wherein said at least one active agent is selected from the group of azoles, diazoles, triazoles, miconazole, fluconazole, ketoconazole, clotrimazole, itraconazole griseofulvin, ciclopirox, amorolfine, terbinafine, amphotericin B, potassium iodide, flucytosine (5FC) and any combination thereof at a therapeutically effective concentration.
33. The foamable emulsion of claim 2, 10 and 13, wherein said at least one active agent is antiviral.
34. The foamable emulsion of claim 33, wherein said at least one active agent is selected from the group consisting of vidarabine, acyclovir, gancyclovir, nucleoside-analog reverse transcriptase inhibitors, AZT (zidovudine), ddl (didanosine), ddC (zalcitabine), d4T (stavudine), 3TC (lamivudine)], non-nucleoside reverse transcriptase inhibitors, nevirapine, delavirdine, protease Inhibitors, saquinavir, ritonavir, indinavir, nelfinavir, ribavirin, amantadine, rimantadine and interferon.
35. The foamable emulsion of claim 10 and13, wherein said at least one active agent is an anti-inflammatory agent.
36. The foamable emulsion of claim 10 and 13, wherein said at least one active agent is an anti-allergic agent.
37. The foamable emulsion of claim 35 and 36, wherein said at least one active agent is selected from the group comprising corticosteroids, non-steroidal antiinflammatory drugs, anti-histamines, immunomodulating agents, immunosuppressants and any combination thereof at a therapeutically effective concentration.
38. The foamable emulsion of claim 35 wherein the anti-inflammatory agent is selected from the group comprising clobetasol proprionate, halobetasol proprionate, betamethasone diproprionate, betamethasone valerate, fluocinolone acetonide, halcinonide, betamethasone valerate, fluocinolone acetonide, hydrocortisone valerate, triamcinolone acetonide, hydrocortisone and any combination thereof at a therapeutically effective concentration.
39. The foamable emulsion of claim 35 wherein the antiinflammatory agent is a nonsteroidal antiinflammatory drug.
40. The foamable emulsion of claim 39 wherein the antiinflammatory agent is selected from the group comprisin oxicams, piroxicam, isoxicam, tenoxicam, sudoxicam, salicylates, aspirin, disalcid, benorylate, trilisate, safapryn, solprin, diflunisal, fendosal, diclofenac, fenclofenac, indomethacin, sulindac, tolmetin, isoxepac, furofenac, tiopinac, zidometacin, acematacin, fentiazac, zomepirac, clindanac, oxepinac, felbinac, ketorolac, fenamates, mefenamic, meclofenamic, flufenamic, niflumic, tolfenamic acids, propionic acid derivatives, ibuprofen, naproxen, benoxaprofen, flurbiprofen, ketoprofen, fenoprofen, fenbufen, indopropfen, pirprofen, carprofen, oxaprozin, pranoprofen, miroprofen, tioxaprofen, suprofen, alminoprofen, tiaprofenic, pyrazoles, phenylbutazone, oxyphenbutazone, feprazone, azapropazone and trimethazone.
41. The foamable emulsion of claim 36 wherein the antiallergic agent is selected from the group comprising diphenhydramine, doxepin, phrilamine maleate, chlorpheniramine and tripelennamine, phenothiazines, promethazine hydrochloride, dimethindene maleate and any combination thereof at a therapeutically effective concentration.
42. The foamable emulsion of claim 2, 10 and 13, wherein said at least one active agent is an anticancer agent.
43. The foamable emulsion of claim 2, 10 and 13, wherein the active agent is a photodynamic therapy agent.
44. The foamable emulsion of claim 2, 10 and 13, wherein said at least one active agent is a local anesthetic.
45. The foamable emulsion of claim 44, wherein said local anesthetic is selected from the group comprising benzocaine, lidocaine, bupivacaine, chlorprocaine, dibucaine, etidocaine, mepivacaine, tetracaine, dyclonine, hexylcaine, procaine, cocaine, ketamine, pramoxine, phenol
46. The foamable emulsion of claim 2, 10 and 13, wherein the active agent is a retinoid.
47. The foamable emulsion of claim 46, wherein said retinoid is selected from the group comprising retinol, retinal, all trans retinoic acid, etretinate, actiretin, isotretinoin, adapalene and tazarotene.
48. The foamable emulsion of claim 2, 10 and 13, wherein said at least one active agent is an anti-wrinkle agent.
49. The foamable emulsion of claim 2, 10 and 13, wherein said at least one active agent is selected from the group comprising ascorbic acid and its salts, ascorbyl esters of fatty acids, magnesium ascorbyl phosphate, sodium ascorbyl phosphate, ascorbyl sorbate, tocopherol, 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, propyl gallate, uric acid and its salts and alkyl esters, sorbic acid and its salts, lipoic acid, N,N-diethylhydroxylamine, amino-guanidine, sulfhydryl compounds, glutathione, dihydroxy fumaric acid and its salts, lysine pidolate, arginine pilolate, nordihydroguaiaretic acid, bioflavonoids, curcumin, lysine, methionine, proline, superoxide dismutase, silymarin, tea extract, grape skin/seed extract, melanin, and rosemary extract.
50. The foamable emulsion of claim 2, 10 and 13, wherein said at least one active agent is a self-tanning agent.
51. The foamable emulsion of claim 2, 10 and 13, wherein said at least one active agent is an anti-acne active agent.
52. The foamable emulsion of claim 51, wherein said at least one active agent is selected from the group comprising resorcinol, sulfur, salicylic acid, salicylate salts, benzoyl peroxide, retinoic acid, isotretinoin, adapalene, tazarotene, azelaic acid and azelaic acid derivatives, antibiotic agents, erythromycin and clyndamycin and zinc salts and complexes.
53. The foamable emulsion 2, 10 and 13, wherein said at least one active agent is a skin whitening agents
54. The foamable emulsion of claim 2 and 13, wherein said at least one active agent is intended for transdermal delivery.
55. The foamable emulsion of claim 1 and 10, further comprising a foam adjuvant.
56. The foamable emulsion of claim 1 and 10, wherein, upon release of the foamable emulsion, an alcohol-free foam is obtained having a specific gravity specific gravity of between about 0.01 g/mL and about 0.1 g/mL.
57. A foam, comprising:
(i) about 0.1 to 5% by weight of a composition of a surface-active agent;
(ii) about 0.1 to 5% by weight of a gelling agent;
(iii) a eutectic mixture of active agents; and (iv) water wherein the foam is alcohol-free and has a specific gravity specific gravity of between about 0.01 g/mL and about 0.1 g/mL.
58. A foam, comprising:
(i) about 0.1 to 5% by weight of a composition of a surface-active agent;
(ii) about 0.1 to 5% by weight of a gelling agent;
(iii) about 10% to 40% urea; and (iv) water wherein the foam is alcohol-free and has a specific gravity specific gravity of between about 0.01 g/mL and about 0.1 g/mL.
59. A foam, comprising:
(i) about 0.1 to 5% by weight of a composition of a surface-active agent;
(ii) about 0.1 to 5% by weight of a gelling agent;

(iii) about 10% to 30% hydroxy acid; and (iv) water wherein the foam is alcohol-free and has a specific gravity specific gravity of between about 0.01 g/mL and about 0.1 g/mL.
60. A foam, comprising:
(i) about 5 to 50% by weight of composition of a liquid, non-volatile hydrophobic solvent;
(ii) about 0.1 to 5% by weight of a composition of a surface-active agent;
(iii) about 0.1 to 5% by weight of a gelling agent, comprising an amphiphilic copolymer; and (iv) an active component selected from the group consisting of one or more of urea, a hydroxy acid, a eutectic mixture of active agents and a therapeutic enhancer;
wherein the foam is alcohol-free and has a specific gravity specific gravity of between about 0.01 g/mL and about 0.1 g/mL.
61. Use of the foam of claim 1, 10, 57, 58, 59 and 60 for treating a disorder selected from the group consisting of skin, mucosal membrane, ear channel, vaginal, rectal and penile urethra disorders.
62. Use of the foam of claim 1, 10, 57, 58, 59 and 60 for treating a disorder selected from the group consisting of contact dermatitis, atopic dermatitis, seborrheic dermatitis, nummular dermatitis, chronic dermatitis of the hands and feet, generalized exfoliative dermatitis, stasis dermatitis; lichen simplex chronicus; diaper rash; bacterial Infections including cellulitis, acute lymphangitis, lymphadenitis, erysipelas, cutaneous abscesses, necrotizing subcutaneous infections, staphylococcal scalded skin syndrome, folliculitis, furuncles, hidradenitis suppurativa, carbuncles, paronychial infections, erythrasma;
fungal infections including dermatophyte infections, yeast infections; parasitic infections, scabies, pediculosis, creeping eruption; viral infections, disorders of hair follicles and sebaceous glands, acne, rosacea, perioral dermatitis, hypertrichosis, hirsutism, male pattern baldness, alopecia areata, alopecia universalis and alopecia totalis; pseudofolliculitis barbae, keratinous cyst, scaling papular diseases, psoriasis, pityriasis rosea, lichen planus, pityriasis rubra pilaris, benign tumors, moles, dysplastic nevi, skin tags, lipomas, angiomas, pyogenic granuloma, seborrheic keratoses, dermatofibroma, keratoacanthoma, keloid;
malignant tumors, basal cell carcinoma, squamous cell carcinoma, malignant melanoma, paget's disease of the nipples, kaposi's sarcoma; reactions to sunlight, sunburn, photosensitivity; Bullous Diseases including pemphigus, bullous pemphigoid, dermatitis herpetiformis, linear Immunoglobulin A disease, vitiligo, albinism, postinflammatory hypopigmentation, hyperpigmentation, melasma, chloasma, drug-induced hyperpigmentation, postinflammatory hyperpigmentation, ichthyosis, keratosis pilaris, calluses, corns, actinic keratosis;
pressure Sores, disorders of sweating, erythema multiforme, erythema nodosum, granuloma annulare, non-dermatological disorders, which respond to topical /
transdermal delivery of an active agent, localized pain, joint pain; muscle pain, back pain, rheumatic pain, arthritis, ostheoarthritis, acute soft tissue injuries and sports injuries, conditions, which respond to hormone therapy, hormone replacement therapy, transdermal nicotine administration, pelvic pain, premenstrual syndrome (PMS), mittelschmerz, dysmenorrhea, endometriosis, ectopic pregnancy, ovarian cysts and masses, acute pelvic inflammatory disease, pelvic congestion syndrome, vulvodynia, vulvovaginal infections, bacterial vaginosis, candidal vaginitis, trichomonas vaginalis, herpes simplex, genital ulcers and warts, pelvic inflammatory disease (PID), cervicitis, acute and chronic salp;ngitis, endometriosis, gynecological neoplasms, endometrial Cancer, ovarian cancer, cervical cancer, vulvar cancer, vaginal cancer, fallopian tube cancer, gestational trophoblastic disease, benign tumors; sexually transmitted diseases;
sexual dysfunction disorders that respond to pharmacological therapy, sexual arousal disorder, female orgasmic disorder, dyspareunia and vaginismus, anal abscess/fistula, anal cancer, anal warts, crohn's disease, haemorrhoids, perianal thrush, anal fissures, fecal incontinence, constipation, polyps of the colon and
63 rectum, sexually-transmitted disease and non-sexually-transmitted vaginal and genital infectious disease.

63. A method of treating, alleviating or preventing a dermatological or mucosal disorder, comprising:
applying a foamable composition to a surfacing having a dermatological or mucosal disorder in need of treatment, said foam composition comprising:
(i) about 5 to 50% by weight of composition of a liquid, non-volatile hydrophobic solvent;
(ii) about 0.1 to 5% by weight of a composition of a surface-active agent;
(iii) about 0.1 to 5% by weight of a gelling agent,;
(iv) an active component selected from the group consisting of urea, hydroxyl acid, a eutectic mixture of active agents and a therapeutic enhances; and (vii) a liquefied gas propellant at a concentration of about 3% to about 18% by weight of the total composition, wherein the composition is alcohol-free and has a specific gravity specific gravity of between about 0.01 g/mL and about 0.1 g/mL.
64. A method of treating, alleviating or preventing a dermatological or mucosal disorder, comprising:
applying a foamable composition to a surfacing having a dermatological or mucosal disorder in need of treatment, said foam composition comprising:
(i) about 0.1 to 5% by weight of a composition of a surface-active agent;
(ii) about 0.1 to 5% by weight of a gelling agent (iii) a eutectic mixture of active agents;
wherein the foam is alcohol-free and has a specific gravity specific gravity of between about 0.01 g/mL and about 0.1 g/mL.
65. A method of treating, alleviating or preventing a dermatological or mucosal disorder, comprising:
applying a foamable composition to a surfacing having a dermatological or mucosal disorder in need of treatment, said foam composition comprising:
(i) about 0.1 to 5% by weight of a composition of a surface-active agent;
(ii) about 0.1 to 5% by weight of a gelling agent;
(iii) about 10% to 40% urea;
wherein the foam is alcohol-free and has a specific gravity specific gravity of between about 0.01 g/mL and about 0.1 g/mL.
66. A method of treating, alleviating or preventing a dermatological or mucosal disorder, comprising:
applying a foamable composition to a surfacing having a dermatological or mucosal disorder in need of treatment, said foam composition comprising:
(i) about 0.1 to 5% by weight of a composition of a surface-active agent;
(ii) about 0.1 to 5% by weight of a gelling agent;
(iii) about 1 % to 30% hydroxy acid;
wherein the foam is alcohol-free and has a specific gravity specific gravity of between about 0.01 g/mL and about 0.1 g/mL.
67. The method of claim 63, 64, 65 and 66, wherein said gelling agent comprises an amphiphilic copolymer;
68. The method of claim 63, wherein said active component consists of about 1% to about 50% urea.
69. The methd of claim 68, wherein said active component consists of about 10% to about 20% urea.
70. The method of claim 68, wherein said active component consists of about 20% to about 50% urea.
71. The method of claim 63, wherein said active component consists of about 1 % to about 30% hydroxy acid.
72. The method of claim 71, wherein said active component consists of about 1 % to about 10% hydroxy acid.
73. The method of claim 71, wherein said active component consists of about 10% to about 30% hydroxy acid.
74. The method of claim 63, wherein said active component consists of a combination of about 1 % to about 50% urea and about 1 % to about 30%
hydroxy acid.
75. The method of claim 63, wherein said active component consists of at about 1 % to about 10% of a therapeutic enhancer.
76. The method of claim 63, wherein said active component consists of about 10% to about 30% therapeutic enhancer.
77. The method of claim 75 and 76, wherein said therapeutic enhancer is selected from the group consisting of propylene glycol, butylene glycols, glycerol, pentaerythritol, sorbitol, mannitol, oligosaccharides, dimethyl isosorbide, monooleate of ethoxylated glycerides having about 8 to 10 ethylene oxide units, polyethylene glycol 200-600, transcutol, glycofurol and cyclodextrins
78. The method of claim 63, 64, 65, 66, 67, 68, 71, 75, 76 and 77 further comprising a therapeutically effective concentration of at least one active agent.
79. The method of claim 63, 64, 65, 66 and 67 wherein the ratio between the surface active agent and the hydrophobic solvent is between about 1:8 and about 1:16.
80. The method of claim 63, 64, 65, 66 and 67 wherein the ratio between the surface active agent and the hydrophobic solvent is between about 1:16 and about 1:32.
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US20050075407A1 (en) 2005-04-07
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