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.

1 . (canceled) 
     
     
         2 . A composition comprising a carrier and a propellant, the carrier comprising:
 i) a surface-active agent;   ii) about 2% to about 75% by weight of the carrier of a liquid non-volatile hydrophobic solvent;   iii) a gelling agent;   iv) an active component selected from the group consisting of a urea, a hydroxy acid, a hydroxy acid salt, and a mixture of any two or more thereof; and   v) water,   
       wherein a breakable foam forms upon dispensing the composition. 
     
     
         3 . The composition of  claim 2 , comprising a hydroxy acid and a hydroxy acid salt. 
     
     
         4 . The composition of  claim 2 , wherein the surface-active agent is present at about 0.1% to about 8% by weight of the carrier. 
     
     
         5 . The composition of  claim 2 , wherein the surfactant comprises a glycerol ester, a polyoxyethylene alkyl ether, or a mixture thereof. 
     
     
         6 . The composition of  claim 5 , wherein the surfactant is selected from the group consisting of glyceryl monostearate, steareth-2, steareth-21, and mixtures of any two or more thereof. 
     
     
         7 . The composition of  claim 2 , wherein the hydrophobic solvent is selected from the group consisting of a vegetable oil, a marine oil, a mineral oil, an emollient, a silicone oil, a plant-derived therapeutic oil, and mixtures of any two or more thereof. 
     
     
         8 . The composition of  claim 7 , wherein the hydrophobic solvent comprises caprylic/capric triglycerides and or octyldodecanol. 
     
     
         9 . The composition of  claim 2 , further comprising a volatile silicone oil. 
     
     
         10 . The composition of  claim 2 , wherein the hydrophobic solvent is about 5% to about 50% by weight of the carrier. 
     
     
         11 . The composition of  claim 2 , wherein the carrier further comprises a foam adjuvant at about 0.1% to about 5% by weight of the carrier. 
     
     
         12 . The composition of  claim 2 , wherein the gelling agent is present in an amount of about 0.01% to about 5.0% by weight of the carrier. 
     
     
         13 . The composition of  claim 12 , wherein the gelling agent is selected from the group consisting 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 microcrystalline cellulose, 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 acrylates (a pemulen), a carbopol, and mixtures of any two or more thereof. 
     
     
         14 . The composition of  claim 2 , wherein the carrier further comprising a therapeutic enhancer selected from the group consisting of a polyhydric alcohol, propylene glycol, butylene glycol, glycerol, pentaerythritol, sorbitol, mannitol, an oligosaccharide, dimethyl isosorbide, a 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. 
     
     
         15 . The composition of  claim 2 , wherein the carrier further comprises a humectant, a moisturizer, a preservative, a pH adjusting agent, or a mixture of any two or more thereof. 
     
     
         16 . The composition of  claim 2 , wherein the liquefied or compressed gas propellant is at a concentration of about 3% to about 18% by weight of the carrier. 
     
     
         17 . The composition of  claim 2 , wherein the carrier further comprises a polar solvent. 
     
     
         18 . The composition of  claim 2 , wherein the active component comprises a urea, a hydroxy acid, and a hydroxy acid salt. 
     
     
         19 . The composition of  claim 18 , wherein the carrier further comprises a foam adjuvant and a gelling agent. 
     
     
         20 . The composition of  claim 18 , wherein the carrier further comprises a polar solvent and or a therapeutic enhancer. 
     
     
         21 . The composition of  claim 18 , wherein the carrier further comprises a humectant, a moisturizer, a preservative, a pH adjusting agent, or a mixture of any two or more thereof. 
     
     
         22 . A composition comprising a carrier and a propellant, the carrier comprising:
 i) a surface active agent comprising a non-ionic surface-active agent;   ii) about 2% to about 75% by weight of the carrier of a liquid non-volatile hydrophobic solvent;   iii) a gelling agent;   iv) an active component selected from the group consisting of a urea, a hydroxy acid, a hydroxy acid salt, and a mixture of any two or more thereof; and   v) water,   
       wherein at least 50% of the surface active agent comprises a non-ionic surface active agent if an ionic surface active agent is present; and 
       wherein a breakable foam forms upon dispensing the composition. 
     
     
         23 . The composition of  claim 22 , wherein the active agent comprises a urea, and wherein the urea is present at about 1% to about 50% by weight of the carrier. 
     
     
         24 . The composition of  claim 22 , wherein the active agent comprises a hydroxy acid, and wherein the hydroxy acid is present at about 1% to about 30% by weight of the carrier. 
     
     
         25 . The composition of  claim 22 , wherein the active agent comprises a hydroxy acid salt, and wherein the hydroxy acid salt is present at about 1% to about 30% by weight of the carrier. 
     
     
         26 . The composition of  claim 22 , wherein the ionic surface-active agent is selected from the group consisting of a cationic surface-active agent, an amphoteric surface-active agent, an anionic surface-active agent, a zwitterionic-surface active agent, and mixtures of any two or more thereof. 
     
     
         27 . The composition of  claim 22 , wherein the carrier further comprises a foam adjuvant, a polar solvent, a therapeutic enhancer, a humectant, a moisturizer, a preservative, a pH adjusting agent, or a mixture of any two or more thereof. 
     
     
         28 . The composition of  claim 27 , wherein the foam adjuvant comprises a fatty alcohol having 15 or more carbons in its carbon chain. 
     
     
         29 . The composition of  claim 28 , wherein the fatty alcohol comprises cetyl alcohol or stearyl alcohol or a mixture thereof. 
     
     
         30 . The composition of  claim 27 , wherein the combined amount of surface-active agent, gelling agent and foam adjuvant is less than about 8% by weight of the carrier or less than about 5% by weight of the carrier. 
     
     
         31 . The composition of  claim 22 , wherein if an ionic surface active agent is present then the ratio of non-ionic surface active agent to ionic surface active agent is greater than 6:1. 
     
     
         32 . The composition of  claim 27 , wherein the hydrophobic solvent comprises a vegetable oil and or an emollient, wherein the foam adjuvant comprises a fatty alcohol and or a fatty acid, wherein the gelling agent comprises a polymeric agent, and wherein the non-ionic surface active agent comprises a glycerol ester, a polyoxyethylene alkyl ether, or a mixture of two or more thereof. 
     
     
         33 . The composition of  claim 32 , wherein the hydrophobic solvent comprises caprylic/capric triglycerides, octyldodecanol, or mixtures thereof; the foam adjuvant comprises cetyl alcohol, stearyl alcohol, or mixtures thereof; the gelling agent comprises a gum, a cellulose ether, or a mixture thereof; and the non-ionic surface active agent comprises glyceryl monostearate, steareth-2, steareth-21, and mixtures of any two or more thereof. 
     
     
         34 . The composition of  claim 22 , wherein the carrier comprises:
 a) from about 12% to about 44% hydrophobic solvent by weight of the carrier;   b) from about 0% to about 40% urea by weight of the carrier, or when hydroxy acid is 0%, from about 6% to about 40% urea by weight of the carrier;   c) from about 0% to about 10% hydroxy acid by weight of the carrier, or when urea is 0%, from about 4% to about 10% hydroxyl acid by weight of the carrier;   d) from about 0.5% to about 1.1% gelling agent by weight of the carrier;   e) from about 0.5% to about 7.5% surfactant by weight of the carrier;   f) from about 0% to about 1% foam adjuvant by weight of the carrier;   g) from about 0% to about 20% therapeutic enhancer by weight of the carrier; and   
       wherein the non-ionic surface active agent has a HLB or an average HLB of about 3.8 to about 15. 
     
     
         35 . A method of skin or mucosal surface application and or treatment comprising spreading or collapsing a foam of  claim 22  at or about a target site of a subject having a skin or mucosal disorder. 
     
     
         36 . The method of  claim 35 , wherein the disorder is selected from the group consisting of dry skin, scaly skin, xerosis, ichthyosis, dermatitis, eczema, psoriasis, keratoses, calluses, and hyperkeratotic skin.