Details for Patent: 8,741,265

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 (Ness Ziona, IL), Friedman; Doron (Karmei Yosef, IL), Eini; Meir (Ness Ziona, IL)
Assignee:	Foamix Ltd. (Rehovot, IL)
Filing Date:	Mar 04, 2013
Application Number:	13/784,085
Claims:	1. A foamable composition comprising a carrier and a liquefied or a compressed gas propellant, the carrier comprising: i) about 0.1% to about 5% by weight of the carrier of a surface-active agent; ii) about 2% to about 75% by weight of the carrier of a liquid, non-volatile hydrophobic solvent; iii) about 0.01% to about 5% by weight of the carrier of a gelling agent; and iv) water, wherein the surface active agent is selected from the group consisting of polysorbate, a polyoxyethylene fatty acid ester, a polyoxyethylene alkyl ether, a sucrose ester, a partial ester of sorbitol, a partial ester of sorbitol anhydride, 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, Myrj 45 (Polyoxyethylene (8) Stearate), Myrj 49 (polyoxyethylene (20) stearate), Myrj 59 (polyoxyethylene (100) stearate), a polyoxyethylene cetyl ether, a polyoxyethylene palmityl ether, a polyethylene oxide hexadecyl ether, Brij 52 (polyoxyethylene (2) cetyl ether), Brij 56 (polyoxyethylene (10) cetyl ether), sorbitan monolaurate, isoceteth-20, cocamidopropyl betaine, and Myrj 52 (polyoxyethylene 40 stearate); wherein a breakable foam forms upon dispensing the foamable composition. 2. The foamable composition of claim 1, wherein the carrier further comprises a therapeutically effective amount of at least one active agent. 3. The foamable composition of claim 1, wherein the liquefied or compressed gas propellant is at a concentration of about 3% to about 18% by weight of the carrier. 4. The foamable composition of claim 1, wherein the carrier is an oil in water emulsion. 5. The foamable composition of claim 1, wherein the carrier further comprises about 1% to about 30% by weight of the carrier of a therapeutic enhancer. 6. The foamable composition of claim 5, wherein the therapeutic enhancer is selected from the group consisting of a polyhydric alcohol, propylene glycol, butylene glycol, glycerol, pentaerythritol, sorbitol, mannitol, an oligosaccharide, dimethyl isosorbide, monooleate of ethoxylated glycerides (with 8 to 10 ethylene oxide units), a polyethylene glycol 200-600, transcutol (diethylene glycol monoethyl ether), glycofurol (tetrahydrofurfuryl alcohol PEG ether), a cyclodextrin, and mixtures of any two or more thereof. 7. The foamable composition of claim 1, wherein the breakable foam has a specific gravity of between about 0.01 g/mL and about 0.1 g/mL. 8. The foamable composition of claim 1, wherein the carrier further comprises a foam adjuvant. 9. The foamable composition of claim 1, wherein the hydrophobic solvent is selected from the group consisting of vegetable oil, marine oil, mineral oil, an emollient, silicone oil, a plant-derived therapeutic oil, and mixtures of any two or more thereof. 10. The foamable composition of claim 2, wherein the active agent is 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 immunomodulating 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 agent 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, an agent for treating cellulite, and mixtures of any two or more thereof. 11. The foamable composition of claim 1, wherein the ratio between the surface active agent and the hydrophobic solvent is between about 1:8 and about 1:16. 12. The foamable composition of claim 1, wherein the ratio between the surface active agent and the hydrophobic solvent is between about 1:16 and about 1:32. 13. The foamable composition of claim 1, wherein the carrier contains no more than 7.5% by weight of the carrier of methyl alcohol, ethyl alcohol, isopropyl alcohol, butyl alcohol, or mixtures thereof. 14. A foamable composition comprising a carrier and a liquefied or a compressed gas propellant, the carrier comprising: i) about 0.1% to about 5% by weight of the carrier of a surface-active agent; ii) 0.01% to about 5% by weight of the carrier of a gelling agent; iii) a therapeutic enhancer selected from the group consisting of a polyhydric alcohol, propylene glycol, butylene glycol, glycerol, pentaerythritol, sorbitol, mannitol, an oligosaccharide, dimethyl isosorbide, monooleate of ethoxylated glycerides (with 8 to 10 ethylene oxide units), a polyethylene glycol 200-600, transcutol (diethylene glycol monoethyl ether), glycofurol (tetrahydrofurfuryl alcohol PEG ether), a cyclodextrin, and mixtures of any two or more thereof; and iv) water, wherein a breakable foam forms upon dispensing the foamable composition. 15. The foamable composition of claim 14, wherein the liquefied or compressed gas propellant is at a concentration of about 3% to about 18% by weight of the carrier. 16. The foamable composition of claim 14, wherein the carrier further comprises a therapeutically effective amount of at least one active agent. 17. The foamable composition of claim 14, wherein the active agent is 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 immunomodulating 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 agent 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, an agent for treating cellulite, and mixtures of any two or more thereof. 18. A foamable composition comprising a carrier and a liquefied or a compressed gas propellant, the carrier comprising: i) about 0.1% to about 5% by weight of the carrier of a surface-active agent; ii) about 2% to about 75% by weight of the carrier of a liquid, non-volatile hydrophobic solvent; iii) about 0.01% to about 5% by weight of the carrier of a gelling agent; iv) a foam adjuvant; and iv) water, wherein a breakable foam forms upon dispensing the foamable composition. 19. The foamable composition of claim 18, 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, a zwitterionic-surface active agent, and mixtures of any two or more thereof. 20. A foamable composition comprising a carrier and a liquefied or a compressed gas propellant, the carrier comprising: i) about 0.1% to about 5% by weight of the carrier of a surface-active agent; ii) about 2% to about 75% by weight of the carrier of a liquid, non-volatile hydrophobic solvent; iii) about 0.01% to about 5% by weight of the carrier of a gelling agent; and iv) water, wherein the ratio of surface active agent to hydrophobic solvent is about 1:8 to about 1:16; and wherein a breakable foam forms upon dispensing the foamable composition. 21. The foamable composition of claim 18, wherein the surface-active agent is a non-ionic surfactant. 22. The foamble composition of claim 18, wherein the carrier further comprises a therapeutically effective amount of at least one active agent. 23. The foamble composition of claim 22, wherein the active agent is 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 immunomodulating 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 agent 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, an agent for treating cellulite, and mixtures of any two or more thereof. 24. The foamable composition of claim 20, wherein the 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. 25. The foamble composition of claim 20, wherein the hydrophobic solvent is about 20% to about 50% by weight of the carrier. 26. The foamble composition of claim 20, wherein the hydrophobic solvent is 10% to about 20% by weight of the carrier. 27. The foamble composition of claim 20, wherein the carrier further comprises a therapeutically effective amount of at least one active agent. 28. The foamble composition of claim 27, wherein the active agent is 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 immunomodulating 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 agent 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, an agent for treating cellulite, and mixtures of any two or more thereof.