Details for Patent: 9,713,643

Title:	Foamable carriers
Abstract:	The invention relates to an alcohol-free cosmetic or therapeutic foam carrier comprising water, a hydrophobic organic carrier, a foam adjuvant agent, a surface-active agent and a gelling agent. The cosmetic or therapeutic foam carrier does not contain aliphatic alcohols, making it non-irritating and non-drying. The alcohol-free foam carrier is suitable for inclusion of both water-soluble and oil soluble therapeutic and cosmetic agents.
Inventor(s):	Friedman; Doron (Karmei Yosef, IL), Besonov; Alex (Rehovot, IL), Tamarkin; Dov (Maccabim, IL), Eini; Meir (Ness Ziona, IL)
Assignee:	Foamix Pharmaceuticals Ltd. (Rehovot, IL)
Filing Date:	May 08, 2014
Application Number:	14/272,551
Claims:	1. A composition comprising a foamable composition and a liquefied or compressed gas propellant, the foamable composition comprising: i) a surface-active agent; ii) about 2% to about 75% by weight of the foamable composition of an organic solvent selected from the group consisting of an emollient, a polar solvent, an oil, and a mixture of any two or more thereof; iii) a stabilizer comprising about 0.01% to about 5% by weight of the foamable composition of at least one polymeric agent and about 0.1% to about 5% by weight of the foamable composition of at least one foam adjuvant; iv) water; and v) an active agent selected from the group consisting of an anti-parasitic agent, an antifungal agent, an antiviral agent, a corticosteroid, an anticancer agent, an estrogen, and a mixture of any two or more thereof; wherein the combined amount of the foam adjuvant, surface active agent, and poymeric agent is less than about 8% by weight of the foamable composition; wherein upon release from a foam dispenser, a foam is produced; and wherein the foam remains stable as a foam for at east 60 seconds at 37.degree. C. 2. The composition of claim 1, wherein the liquefied or compressed gas propellant is present at about 3% to about 25% by weight of the foamable composition. 3. The composiUon of claim 1, wherein the oil comprises an essential oil. 4. The composition of claim 1, wherein the foamable composition comprises a micro-emulsion. 5. The composition of claim 1, wherein the foamable composition comprises nano-particles. 6. The composition of claim 1, wherein the surface-active agent is present at less than about 2% by weight of the foamable composition. 7. The composition of claim 1, wherein the polymeric agent is present at less than about 1% by weight of the foamable composition. 8. The composition of claim 1, wherein the foamable composition does not include petrolatum. 9. The composition of claim 1, wherein the foamable composition comprises less than about 2% by weight of the foamable composition of one or more lower alcohols having up to 5 carbon atoms in their carbon chain skeleton. 10. The composition of claim 1, wherein the 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, an ionic surface-active agent, and a mixture of any two or more thereof. 11. The composition of claim 10, wherein when a non-ionic surface-active agent and at least one other surface-active agent is present, the ratio of non-ionic surface-active agent to other surface-active agent is greater than 6:1. 12. The composition of claim 11, wherein the composition is an emulsion and the droplet diameter is about 200 nanometers (nm) to about 400 nm. 13. The composition of claim 11, wherein the foamable composition comprises more than about 50% by weight of the foamable composition of a potent solvent. 14. The composition of claim 1, wherein the surface-active agent is a non ionic surface-active agent. 15. The composition of claim 1, wherein the combined amount of the foam adjuvant, surface active agent, and polymeric agent is less than about 5% by weight of the foamable composition. 16. The composition of claim 1, wherein the polymeric agent is less than 1% by weight of the foamable composition. 17. The composition of claim 1, wherein the organic solvent is about 5% to about 10% by weight of the foamable composition, about 10% to about 20% by weight of the foamable composition, or 11.4% to 48.4% by weight of the foamable composition. 18. The composition of claim 1, wherein the composition is an emulsion and the droplet diameter is approximately 100 nanometers (nm) or less. 19. The composition of claim 1, wherein the emollient comprises diisopropyl adipate and the oil comprises mineral oil. 20. The composition of claim 1, wherein if an ionic surface active agent is present, at least 50% of the surface active agent comprises a non-ionic surface active agent. 21. The composition of claim 1, wherein the combined amount of the foam adjuvant, surface active agent, and polymeric agent is selected from the group consisting of about 0.7% by weight of the foamable composition, about 1.7% by weight of the foamable composition, about 2% by weight of the foamable composition, about 2.6% by weight of the foamable composition, about 3.4% by weight of the foamabis composition, about 5% by weight of the foamable composition, about 5.7% by weight of the foamable composition, about 5.8% by weight of the foamable composition, about 6.3% by weight of the foamable composition, about 6.6% by weight of the foamable composition, about 6.7% by weight of the foamable composition, about 6.8% by weight of the foamable composition, about 7.1% by weight of the foamable composition, about 7.2% by weight of the foamable composition, about 7.5% by weight of the foamable composition and less than any of the aforesaid amounts. 22. The composition of claim 21, wherein the surface active agent is present at about 0.1% to about 5% by weight of the foamable composition. 23. The composition of claim 21, wherein the combined amount of the foam adjuvant, surface active agent, and polymeric agent is about 6.3% or less than about 6.3% by weight of the foamable composition. 24. The composition of claim 21, wherein the at least one polymeric agent is selected from the group consisting of a bioadhesive agent, a gelling agent, a film forming agent, and a phase change agent. 25. The composition of claim 24, wherein the polymeric agent is selected from the group consisfing of a locust bean gum, sodium alginate, sodium caseinate, egg albumin, a gelatin agar, a carrageenin gum, a xanthan gum, a quince seed extract, a tragacanth gum, a guar gum, a starch, a chemically modified starch, cellulose ethers, a hydroxyethyl cellulose, a methyl cellulose, a carboxymethyl cellulose, a hydroxy propylmethyl cellulose, a hydroxypropyl guar gum, a soluble starch, cationic celluloses, cationic guars, carboxyvinyl polymers, a polyvinylpyrrolidone, a polyvinyl alcohol polyacrylic acid polymers, polymethacrylic acid polymers, polyvinyl acetate polymers, polyvinyl chloride polymers, polyvinylidene chloride polymers, acrylic acid/ethyl acrylate copolymers, crosslinked copolymers of acrylic acid and C10-C30 alkyl acrylate (pemulen), carboxyvinyl polymers, a carbopol, a hydroxypropyl cellulose, and a mixture of any two or more thereof. 26. The composition of claim 25, wherein the foam adjuvant is selected from the group consisting of a fatty alcohol having 15 or more carbons in its carbon chain; a fatty acid having 16 or more carbons in its carbon chain; fatty alcohols, derived from beeswax and including a mixture of alcohols, a majority of which has at least 20 carbon atoms in their carbon chain; a fatty alcohol having at least one double bond; a fatty acid having at least one double bond; a branched fatty alcohol; a branched fatty acid; a fatty acid substituted with a hydroxyl group; cetyl alcohol; stearyl alcohol; arachidyl alcohol; behenyl alcohol; 1-triacontanol; hexadecanoic acid; stearic acid; arachidic acid; behenic acid; octacosanoic acid; 12-hydroxy stearic acid; and a mixture of any two or more thereof. 27. The composition of claim 26, wherein the foam adjuvant is about 0.4% to about 2.5% by weight of the foamable composition. 28. The composition of claim 26, wherein the corticosteroid is selected from the group consisting of hydrocortisone, hydrocortisone acetate, desonide, betamethasone valerate, clobetasone-17-butyrate, flucinonide, fluocinolone acetonide, alcometasone dipropionate, mometasone furoate, prednicarbate, triamcinolone acetonide, betamethasone-17-benzoate, methylprednisolone aceponate, betamethasone dipropionate, halcinonide, triamcinolone acetonide, halobetasol, clobetasol-17-propionate, and a mixture of any two or more thereof. 29. The composition of claim 26, wherein the antifungal agent is an azole selected from the group consisting of clotrimazole, econazole, fluconazole, ketoconazole, itraconazole, miconazole, and a mixture of any two or more thereof. 30. The composition of claim 26, 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, polyoxyethylene (20) stearate, polyoxyethylene (40) stearate, polyoxyethylene (100) stearate, a polyoxyethylene alkyl ether, a polyoxyethylene cetyl ether, polyoxyethylene (23) cetyl ether, polyoxyethylene (2) cetyl ether, polyoxyethylene (10) cetyl ether, isoceteth-20, a sucrose ester, a partial ester of sorbitol, an anhydride of a partial ester of sorbitol, sorbitan monolaurate, sorbitan stearate, a monoglyceride, glyceryl monostearate, a diglyceride, a lecithin, sodium methyl cocoyl taurate, sodium methyl oleoyl taurate, sodium lauryl sulfate, triethanolamine lauryl sulfate, a betaine, cocamidopropyl betaine, and a mixture of any two or more thereof. 31. The composition of claim 20, wherein the composition is suitable for the treatment of a disorder of a body cavity or a mucosal surface, wherein the disorder is selected from the group consisting of psoriasis, atopic dermatitis, a fungal infection, a viral infection, vaginal dryness, dyspareunia, HIV, a sexually transmitted disease, post-surgical adhesions, a hormonal deficiency, a parasitic infection, a cancer, and a combination of any two or more thereof. 32. The composition of claim 30, wherein the foam remains stable as a foam for at least 2 or 3 minutes at 37.degree. C. 33. The composition of claim 30, further comprising an excipient selected from the group consisting of a stabilizing agent, an antioxidant, a humectant, a preservative, a colorant, an odorant, and a mixture of any two or more thereof. 34. The composition of claim 30, wherein the composition is an emulsion and the droplet diameter is about 200 nanometers (nm) to about 400 nm. 35. The composition of claim 30, wherein the total amount of the foam adjuvant, polymeric agent, and surface active agent is about 1.4% to about 3.5% by weight of the foamable composition. 36. The composition of claim 30, wherein the active agent comprises a mometasone, acyclovir, or estradiol. 37. The composition of claim 36, wherein the oil comprises a vegetable oil, wherein the polar solvent comprises propylene glycol, wherein the polymeric agent comprises a hydroxypropyl methylcellulose, a xanthan gum or both, wherein the foam adjuvant comprises stearyl alcohol, wherein the surface-active agent is selected from the group consisting of a glycerol ester, a polyoxyethylene fatty acid ester, a polysorbate, and a mixture of any two or more thereof, wherein the oil is present at about 5% to about 20% by weight of the foamable composition, wherein the foamable composition further comprises oleyl alcohol. 38. The composition of claim 30, wherein the active agent comprises an antifungal agent, wherein the oil comprises light mineral oil, wherein the emollient comprises diisopropyl adipate, wherein the polar solvent comprises propylene glycol, wherein the polymeric agent comprises a hydroxypropyl cellulose, wherein the foam adjuvant comprises cetostearyl alcohol, wherein the surface-active agent comprises a polyoxyethylene alkyl ether wherein the oil is present at about 5% to about 20% by weight of the foamable composition. 39. The composition of claim 30, wherein the foamable composition comprises more than about 50% by weight of the foamable composition of a potent solvent. 40. The composition of claim 39, wherein the potent solvent is selected from the group consisting of polyethylene glycol, propylene glycol, hexylene glycol, butane-diol and isomers thereof, glycerol, benzyl alcohol, dimethyl sulfoxide, ethyl oleate, ethyl caprylate, dimethylacetamide, N-methylpyrrolidone, N-hydroxyethylpyrrolidone, polyvinylpyrrolidone, isosorbide derivatives, dimethyl isosorbide, glycofurol, ethoxydiglycol, and a mixture of any two or more thereof. 41. A composition comprising a foamable composition and a liquefied or compressed gas propellant, the foamable composition comprising: i) a surface-active agent; ii) about 70% to about 99% by weight of the foamable composition of a hydrophobic organic solvent; iii) a stabilizer selected from the group consisting of about 0.01% to about 5% by weight of the foamable composition of a polymeric agent and about 0.1% to about 5% by weight of the foamable composition of a foam adjuvant; wherein upon release from a foam dispenser, a foam is produced; and wherein the foam remains stable as a foam for at least 60 seconds at 37.degree. C. 42. The composition of claim 41, wherein the foam remains stable as a foam for at least 2 or 3 minutes at 37.degree. C. 43. The composition of claim 42, wherein the foamable composition further comprises an active agent, and wherein the active agent is selected from the group consisting of an antibiotic, an antibacterial, an antifungal, an antiviral, an antiinflammatory, an anesthetic, an analgesic, an antiallergic, an antiproliferative, an azole, a dicarboxylic acid, a steroid, and a mixture of any two or more thereof. 44. The composition of claim 43, wherein the steroid is an anti-inflammatory steroid selected from the group consisting of hydrocortisone, hydrocortisone acetate, desonide, betamethasone valerate, clobetasone-17-butyrate, flucinonide, fluocinolone acetonide, alcometasone dipropionate, mometasone furoate, prednicarbate, triamcinolone acetonide, betamethasone-17-benzoate, methylprednisolone aceponate, betamethasone dipropionate, halcinonide, triamcinolone acetonide, halobetasol, clobetasol-17-propionate, and a mixture of any two or more thereof. 45. The composition of claim 43, wherein the azole is selected from the group consisting of azoles, diazoles, triazoles, pyrazoles, and a mixture of any two or more thereof. 46. The composition of claim 43, wherein the azole is selected from the group consisting of clotrimazole, econazole, fluconazole, ketoconazole, itraconazole, metronidazole, miconazole, and a mixture of any two or more; and wherein the antiinfiammatory agent is selected from the group consisting of phenylbutazone, oxyphenbutazone, feprazone, azapropazone, trimethazone, and a mixture of any two or more thereof. 47. A composition comprising, an active agent, a foamable composition, and a liquefied or compressed gas propellant, the foamable composition comprising: i) about 2% to about 75% by weight of the foamable composition of an organic solvent selected from the group consisting of an emollient, a polar solvent, an oil, and a mixture thereof; ii) a stabilizer selected from the group consisting of about 0.01% to about 5% by weight of the foamable composition of at least one polymeric agent, about 0.1% to about 5% by weight of the foamable composition of at least one foam adjuvant, and a mixture thereof; iii) water; iv) an active agent selected from the group consisting of an anti-parasitic agent, an antifungal agent, an antiviral agent, a corticosteroid, an anticancer agent, an estrogen, and a mixture of any two or more thereof; and v) optionally, a surfactant; wherein the combined amount of the foam adjuvant, polymeric agent, and surface active agent, if present, is less than about 8% by weight of the foamable composition; wherein upon release from a foam dispenser, a foam is produced; and wherein the foam remains stable as a foam for at least 60 seconds at 37.degree. C. 48. The composition of claim 47, wherein the combined amount of the foam adjuvant, surface active agent, and polymeric agent is less than about 5% by weight of the foamable composition. 49. A composition comprising an active agent, a foamable composition and a liquefied or compressed gas propellant, the foamable composition comprising: i) about 0.1% to about 5% by weight of the foamable composition of a surface-active agent; ii) about 2% to about 75% by weight of the foamable composition of an organic solvent selected from the group consisting of an emollient, a polar solvent, an oil, and a mixture thereof; iii) a stabilizer selected from the group consisting of about 0.01 % to about 5% by weight of the foamable composition of at least one film forming or mucoadhesive agent, at least one foam adjuvant, and a mixture thereof; iv) water; and v) an active agent selected from the group consisting of an anti-parasitic agent, an antifungal agent, an antiviral agent, a corticosteroid, an anticancer agent, an estrogen, and a mixture of any two or more thereof; wherein the surface-active agent is selected from the group consisting of a non ionic surface-active agent, an amphoteric surface-active agent, and a mixture thereof; wherein the combined amount of the foam adjuvant, surface active agent, and polymeric agent is less than about 8% by weight of the foamable composition; wherein upon release from a foam dispenser, a foam is produced; and wherein the foam remains stable as a foam for at least 60 seconds at 37.degree. C. 50. The composition of claim 49, wherein the total amount of the stabilizer and surface active agent is about 1.4% to about 3.5% by weight of the foamable composition. 51. The composition of claim 49, wherein the composition is an emulsion and the droplet diameter is approximately 100 nanometers (nm) or less. 52. The composition of claim 49, wherein the combined amount of the foam adjuvant, surface active agent, and polymeric agent is less than about 5% by weight of the foamable composition.