Details for Patent: 9,492,412

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 (Macabim, IL), Friedman; Doron (Karmei Yosef, IL), Eini; Meir (Ness Ziona, IL)
Assignee:	Foamix Pharmaceuticals Ltd. (Rehovot, IL)
Filing Date:	Apr 22, 2014
Application Number:	14/258,700
Claims:	1. A foamable composition comprising a carrier and a liquefied or a compressed gas propellant, the carrier comprising: i) a surface-active agent, wherein the surface-active agent is a non-ionic surface-active agent, an ionic surface-active agent, or mixtures thereof, wherein the surface-active agent is selected from the group consisting of a 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, 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, polyoxyethylene (40) stearate, and mixtures of any two or more thereof; ii) about 2% to about 75% by weight of the carrier of a liquid, non-volatile hydrophobic solvent, wherein the hydrophobic solvent is a mixture of octyldodecanol and isopropyl myristate; iii) a foam adjuvant; and iv) water; wherein a breakable foam forms upon dispensing of 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 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, an anti-histamine, a nonsteroidal anti-inflammatory agent, an immunomodulating agent, an immunosuppressant, an anti-allergic agent, a local anesthetic 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, an agent for treating cellulite, and mixtures of any two or more thereof. 4. 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. 5. The foamable composition of claim 1, wherein the surface-active agent is a mixture of the non-ionic surface-active agent and the ionic surface-active agent. 6. The foamable composition of claim 5, wherein the ratio of the non-ionic surface-active agent to the ionic surface-active agent is between 1:1to 20:1. 7. The foamable composition of claim 1, wherein the surface-active agent is a non-ionic surface-active agent. 8. The foamable composition of claim 1, wherein the surface-active agent is present at about 0.3% to about 6.25% by weight of the carrier. 9. The foamable composition of claim 1, wherein the carrier is an oil-in-water emulsion. 10. The foamable composition of claim 1, wherein the carrier further comprises a preservative, a pH adjusting agent, or a mixture thereof. 11. The foamable composition of claim 1, wherein the carrier further comprises about 2% to about 30% by weight of the carrier of a therapeutic enhancer. 12. The foamable composition of claim 11, 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, diethylene glycol monoethyl ether, glycofurol, a cyclodextrin, and mixtures of any two or more thereof. 13. The foamable composition of claim 12, wherein therapeutic enhancer is contained in the foamable composition in an amount from about 2% to about 10% by weight of the carrier. 14. The foamable composition of claim 1, wherein the breakable foam has a specific gravity of between about 0.01 and about 0.1. 15. The foamable composition of claim 1, wherein the carrier further comprises a gelling agent at a concentration of less than 1% by weight of the carrier. 16. The foamable composition of claim 15, wherein the gelling agent is a carbomer, a hypromellose, or mixtures thereof. 17. The foamable composition of claim 15, wherein the ratio between the foam adjuvant and the hydrophobic solvent is selected from a group consisting of about 1:12, about 1:24, about 1:44, about 1:60, about 1:25, and about 1:220. 18. The foamable composition of claim 1, wherein the hydrophobic solvent is included at a concentration of 5% to about 10% or 10% to about 20% by weight of the carrier. 19. 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 or is between about 1:16 and about 1:32. 20. The foamable composition of claim 1, wherein the surface-active agent is about 0.1% to about 5% by weight of the carrier. 21. The foamable composition of claim 1, wherein the ratio between the surface-active agent and the hydrophobic solvent is selected from a group consisting of about 3:8, about 2:7, about 2:5, about 2:13, about 1:5, about 1:6, about 1:8, about 1:16, about 1:32, about 1:36, between about 1:8 and about 1:16, and between about 1:16, about 1:32. 22. The foamable composition of claim 1, wherein the ratio between the gelling agent and the hydrophobic solvent is selected from a group consisting of about 1:10, about 1:16 about 2:15, about 1:24, about 1:20, about 1:55, about 1:41, and about 1:50. 23. The foamable composition of claim 1, wherein the ratio between the gelling agent and the surface-active agent is selected from a group consisting of about 1:3, about 3:10, about 1:7, about 3:28, about 1:10, about 1:5, about 1:8, and about 2:1. 24. The foamable composition of claim 1, further comprising a gelling agent. 25. The foamable composition of claim 24, wherein the carrier further comprises a therapeutically effective amount of at least one active agent. 26. The foamable composition of claim 25, wherein the active agent is selected from the group consisting of an anti-fungal agent, an anti-viral agent, a steroid, a corticosteroid, an anti-histamine, an immunomodulating agent, an immunosuppressant, an anti-allergic agent, a local anesthetic agent, an insecticide, an insect repellent, an anti-cancer drug, a photodynamic therapy agent, an active agent for burns, wounds, cuts and ulcers, 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, an agent for treating cellulite, and mixtures of any two or more thereof.