Claims for Patent: 8,435,498

Summary for Patent: 8,435,498

Title:	Penetrating pharmaceutical foam
Abstract:	The invention relates to an alcohol-free cosmetic or pharmaceutical foam composition comprising water, a hydrophobic solvent, a surface-active agent, a gelling agent, an active component selected from the group of urea, hydroxy acid and a therapeutic enhancer and a propellant. The foam further comprises active agents and excipients with therapeutic properties having enhanced skin penetration.
Inventor(s):	Tamarkin; Dov (Maccabim, IL), Friedman; Doron (Karmei Yosef, IL), Eini; Meir (Ness Ziona, IL)
Assignee:	Foamix Ltd. (Rehovot, IL)
Application Number:	12/752,718
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 8,435,498
Patent Claims:	1. A method of skin or mucosal surface application comprising spreading or collapsing a breakable thermally stable foam by mechanical force at or about a target site of a subject, the breakable thermally stable foam obtained by dispensing a foamable emulsion composition comprising (i) about 0.1 to about 5% by weight of a surface-active agent; (ii) about 5 to about 50% by weight of a liquid, non-volatile hydrophobic solvent; (iii) about 0.1 to about 5% by weight of a gelling agent; and (iv) a component selected from the group consisting of urea, a hydroxy acid, a therapeutic enhancer, and mixtures of two or more thereof; (v) water; and (vi) a liquefied or a compressed gas propellant; wherein the foamable emulsion composition contains no more than 7.5% by weight methyl alcohol, ethyl alcohol, isopropyl alcohol, butyl alcohol, or mixtures thereof. 2. The method of claim 1, wherein the foam has a specific gravity of between about 0.01 g/mL and about 0.1 g/mL. 3. The method of claim 1, wherein the surface-active agent has an HLB in the range of about 9 to 14. 4. The method of claim 1, wherein the surface-active agent is a non-ionic surfactant. 5. The method of claim 1, wherein the gelling agent comprises an amphiphilic copolymer. 6. The method of claim 1, wherein the component consists of about 1% to about 50% by weight of urea. 7. The method of claim 1, wherein the component consists of about 10% to about 20% by weight of urea. 8. The method of claim 1, wherein the component consists of about 20% to about 50% by weight of urea. 9. The method of claim 1, wherein the component consists of about 1% to about 30% by weight of at least one hydroxy acid. 10. The method of claim 1, wherein the component consists of about 1% to about 10% by weight of at least one hydroxy acid. 11. The method of claim 1, wherein the component consists of a combination of about 1% to about 50% by weight of urea and about 1% to about 30% by weight of at least one hydroxy acid. 12. The method of claim 1, wherein the component consists of at about 1% to about 30% by weight of at least one therapeutic enhancer selected from the group consisting of propylene glycol, butylene glycols, glycerol, pentaerythritol, sorbitol, mannitol, oligosaccharides, dimethyl isosorbide, monooleate of ethoxylated glycerides (with 8 to 10 ethylene oxide units), polyethylene glycol 200-600, transcutol (diethylene glycol monoethyl ether), glycofurol (tetrahydrofurfuryl alcohol), PEG ether, and a cyclodextrin. 13. The method of claim 1, wherein the component comprises at least one humectant or moisture-retaining agent. 14. The method of claim 1, wherein the composition further comprises a foam adjuvant. 15. The method of claim 1, wherein the composition further comprises a therapeutically effective concentration of at least one active agent. 16. The method of claim 15, wherein the active agent is at least one agent selected from the group consisting of an antibacterial agent, an anti-fungal agent, an anti-viral agent, an anti-inflammatory agent, a steroid, a corticosteroid, anti-histamine, a nonsteroidal anti-inflammatory agent, an immonumodulating agent, an immunosuppressant, an anti-allergic agent, a local anesthetic agent, a keratolytically active agent, a retinoid, an insecticide, an insect repellent, an anti-cancer drug, a photodynamic therapy agent, an active agents for burns, wounds, cuts and ulcers, an anti-acne active agent, an anti-wrinkle active agent, an anti-atrophy active agent, an anti-oxidant, a radical scavenger, a self-tanning active agent, a skin lightening or whitening agent, an agent suitable for the treatment of a hair growth disorder, a humectant, a moisture-retaining agent, a hydroxy acid, and an agent for treating cellulite. 17. The method of claim 1, wherein the ratio between the surface active agent and the hydrophobic solvent is between about 1:8 and about 1:16. 18. The method of claim 1, wherein the ratio between the surface active agent and the hydrophobic solvent is between about 1:16 and about 1:32. 19. The method of claim 1, wherein the emulsion is an oil in water emulsion. 20. The method of claim 6, wherein the skin or mucosal surface application is for ameliorating a skin or mucosal disorder selected from the group consisting of one or more of pain, wounds, burns, cuts, ulcers, ear channel disorders, vaginal disorders, rectal disorders, penile disorders, and urethra disorders. 21. The method of claim 9, wherein the skin or mucosal surface application is for ameliorating a skin or mucosal disorder selected from the group consisting of one or more of pain, wounds, burns, cuts, ulcers, ear channel disorders, vaginal disorders, rectal disorders, penile disorders, and urethra disorders. 22. The method of claim 15, wherein the skin or mucosal application is for ameliorating a disorder that is known to be responsive to the at least one active agent, wherein the disorder is selected from the group consisting of contact dermatitis, atopic dermatitis, seborrheic dermatitis, nummular dermatitis, chronic dermatitis of the hands or feet, generalized exfoliative dermatitis, stasis dermatitis, diaper rash, bacterial infections, cellulitis, fungal infections, parasitic infections, scabies, pediculosis, viral infections, disorders of hair follicles, disorders of sebaceous glands, acne, rosacea, perioral dermatitis, psoriasis, basal cell carcinoma, squamous cell carcinoma, melanoma reactions to sunlight, sunburn, photosensitivity, bullous diseases, vitiligo, hyperpigmentation, ichthyosis, actinic keratosis, pressure sores, disorders of sweating, non-dermatological disorders which respond to topical or transdermal delivery of an active agent, localized pain, joint pain, muscle pain, back pain, ostheoarthritis, conditions which respond to hormone therapy, pelvic pain, vulvovaginal infections, bacterial vaginosis, candidal vaginitis, trichomonas vaginalis, herpes simplex, genital ulcers, genital warts, sexually transmitted diseases, sexual dysfunction disorders that respond to pharmacological topical therapy, erectile dysfunction, anal fistula, anal warts, haemorrhoids, and anal fissures. 23. A method of skin or mucosal surface application comprising spreading or collapsing a breakable thermally stable foam by mechanical force at or about a target site of a subject, the breakable thermally stable foam obtained by dispensing a foamable emulsion composition comprising: about 0.1 to about 5% by weight of a surface-active agent, wherein the surface active agent comprises one or more of a polysorbate, a polyoxyethylene fatty acid ester, a poly(oxyethylene) alkyl ether, a sucrose ester, a partial ester of sorbitol, a sorbitol anhydride, isoceteth-20, sodium methyl cocoyl taurate, sodium methyl oleoyl taurate, sodium lauryl sulfate, triethanolamine lauryl sulfate, a betaine, a mono-, di- or tri-ester of sucrose with food fatty acids (sucrose esters), a monoglyceride, a diglyceride, polyoxyethylene (20) sorbitan monostearate, polyoxyethylene (20) sorbitan monooleate, polyoxyethylene (8) stearate, polyoxyethylene (20) stearate, polyoxyethylene (100) stearate, a polyoxyethylene cetyl ether, a polyoxyethylene palmityl ether, a polyethylene oxide hexadecyl ether, polyoxyethylene (2) cetyl ether, polyoxyethylene (10) cetyl ether, sorbitan monolaurate, isoceteth-20, cocamidopropyl betaine, and polyoxyethylene 40 stearate; (ii) about 0.1 to about 5% by weight of a gelling agent; (iii) a therapeutic enhancer and a component selected from the group consisting of urea, hydroxyl acid, an active agent, and combinations of two or more thereof; (iv) water; and (v) a liquefied or a compressed gas propellant; wherein the composition contains no more than 7.5% by weight methyl alcohol, ethyl alcohol, isopropyl alcohol, butyl alcohol, or mixtures thereof. 24. The method of claim 15, wherein the skin or mucosal surface application is for ameliorating a disorder selected from the group consisting of one or more of pain, wounds, burns, cuts, ulcers, ear channel disorders, vaginal disorders, rectal disorders, penile disorders, and urethra disorders.