Foamable composition combining a polar solvent and a hydrophobic carrier

Abstract

The present invention relates to a foamable vehicle or cosmetic or pharmaceutical composition, comprising: (1) an organic carrier, at a concentration of 10% to 70% by weight, wherein said organic carrier concurrently comprises: (i) at least one hydrophobic organic carrier, and (ii) at least one polar solvent; (2) at least one surface-active agent; (3) water; and (4) at least one liquefied or compressed gas propellant at a concentration of 3% to 25% by weight of the total composition. The present invention further provides a method of treating, alleviating or preventing a disorder of mammalian subject, comprising administering the above-mentioned compositions to an afflicted target site.

1 - 52 . (canceled) 
     
     
         53 . A foamable pharmaceutical composition comprising:
 (a) an emulsion comprising:
 (i) an organic carrier at a concentration of 10% to 70% by weight of the composition, wherein the organic carrier comprises:
 a hydrophobic solvent comprising caprylic/capric triglyceride, isopropyl myristate, and/or mineral oil; and 
 a polar solvent comprising dimethyl isosorbide and/or a short chain alcohol; 
 
 (ii) a surfactant; 
 (iii) a foam adjuvant at a concentration of about 0.01% to about 5% by weight of the composition; 
 (iv) a polymeric agent at a concentration of about 0.01% to about 5% by weight of the composition; and 
 (v) water; 
   (b) a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the composition; and   
       wherein the composition is provided in an aerosol container and upon release from the container, the composition forms a breakable foam. 
     
     
         54 . The composition of  claim 53 , wherein the short chain alcohol comprises ethanol. 
     
     
         55 . The composition of  claim 54 , wherein the polar solvent comprises ethanol at a concentration of about 15% to about 20% by weight of the composition. 
     
     
         56 . The composition of  claim 53 , wherein the polar solvent comprises dimethyl isosorbide at a concentration of about 20% by weight of the composition. 
     
     
         57 . The composition of  claim 53 , wherein the hydrophobic solvent is at a concentration of about 5% to about 30% by weight of the composition. 
     
     
         58 . The composition of  claim 53 , wherein the emulsion further comprises an emollient. 
     
     
         59 . The composition of  claim 53 , wherein the emulsion further comprises a preservative. 
     
     
         60 . The composition of  claim 53 , wherein the surfactant is at a concentration of about 0.1% to about 5% by weight of the composition. 
     
     
         61 . The composition of  claim 53 , wherein the surfactant comprises a non-ionic surfactant and an ionic surfactant, and wherein the ratio of the non-ionic surfactant to the ionic surfactant is greater than 6:1. 
     
     
         62 . The composition of  claim 53 , wherein the surfactant is selected from the group consisting of glyceryl monostearate, sorbitan stearate, polysorbate 80, PEG-40 stearate, and a mixture of two or more thereof. 
     
     
         63 . The composition of  claim 53 , wherein the foam adjuvant is at a concentration of about 0.01% to about 1% by weight of the composition. 
     
     
         64 . The composition of  claim 53 , wherein the foam adjuvant comprises a fatty alcohol having 15 or more carbons in its carbon chain; a fatty acid having 16 or more carbons in its carbon chain; a fatty alcohol derived from beeswax; a mixture of alcohols, a majority of which has at least 20 carbon atoms in their carbon chain; a fatty alcohol having a double bond; a fatty acid having a double bond; a branched fatty alcohol; a branched fatty acid; a fatty acid substituted with a hydroxyl group; and a mixture of two or more thereof. 
     
     
         65 . The composition of  claim 64 , wherein the fatty alcohol having 16 or more carbons in its carbon chain comprises stearyl alcohol. 
     
     
         66 . The composition of  claim 53 , wherein the polymeric agent is selected from a bioadhesive agent, a gelling agent, a film forming agent, and a phase change agent. 
     
     
         67 . The composition of  claim 53 , wherein the polymeric agent is selected from the group consisting of a locust bean gum, sodium caseinate, an egg albumin, a gelatin agar, a carrageenin gum, sodium alginate, a xanthan gum, a quince seed extract, a tragacanth gum, a guar gum, a starch, a chemically modified starch, a cellulose ether, an alkyl cellulose, a hydroxyalkyl cellulose, a hydroxyethyl cellulose, a hydroxypropyl cellulose, a methyl cellulose, a carboxymethyl cellulose, a methylhydroxyethylcellulose, a methylhydroxypropylcellulose, a hydroxypropyl methylcellulose, a hydroxyethylcarboxymethylcellulose, a carboxymethylhydroxyethylcellulose, a hydroxypropyl guar gum, a soluble starch, a carboxyvinyl polymer, a polyvinylpyrrolidone, a polyvinyl alcohol, a polyacrylic acid polymer, a polymethacrylic acid polymer, a polyvinyl acetate polymer, a polyvinyl chloride polymer, a polyvinylidene chloride polymer, an acrylic acid/ethyl acrylate copolymer, a carboxyvinyl polymer, a silicone dioxide, a poly(acrylic)acid, a poly(methylvinyl ether/maleic anhydride) copolymer, a chitosan, an alginic acid, a hyaluronic acid, a pectin, a karaya gum, a cyclodextrin, a chemically modified cyclodextrin, hydroxypropyl-3-cyclodextrin, a poly(N-isopropylamide), a poloxamer, and a mixture of any two or more thereof. 
     
     
         68 . The composition of  claim 53 , wherein the liquefied or compressed gas propellant comprises propane and/or butane. 
     
     
         69 . The composition of  claim 53 , wherein:
 (a) the emulsion comprises:
 (i) a hydrophobic solvent comprising caprylic/capric triglyceride at a concentration of about 30% by weight of the composition; 
 (ii) a polar solvent comprising dimethyl isosorbide at a concentration of about 20% by weight of the composition; 
 (iii) a surfactant comprising glyceryl monostearate and sorbitant stearate at a combined concentration of about 4% by weight of the composition; 
 (iv) a foam adjuvant comprising stearyl alcohol at a concentration of about 1% by weight of the composition; 
 (v) a polymeric agent comprising xanthan gum and hydroxypropyl methylcellulose at a combined concentration of about 0.3% by weight of the composition; and 
 (vi) water; 
   (b) a liquefied or compressed gas propellant comprising propane and butane at a concentration of about 8% by weight of the composition.   
     
     
         70 . The composition of  claim 53 , wherein:
 (a) the emulsion comprises:
 (i) a hydrophobic solvent comprising mineral oil and isopropyl myristate at a combined concentration of about 9.24% by weight of the composition; 
 (ii) a polar solvent comprising ethanol at a concentration of about 15% by weight of the composition; 
 (iii) a surfactant comprising glyceryl monostearate, polysorbate 80, and PEG-40 stearate at a combined concentration of about 3.37% by weight of the composition; 
 (iv) a foam adjuvant comprising stearyl alcohol at a concentration of about 0.77% by weight of the composition; 
 (v) a polymeric agent comprising xanthan gum and hydroxypropyl methylcellulose at a combined concentration of about 0.46% by weight of the composition; and 
 (vi) water; 
   (b) a liquefied or compressed gas propellant comprising propane and butane at a concentration of about 8% by weight of the composition.   
     
     
         71 . The composition of  claim 53 , wherein:
 (a) the emulsion comprises:
 (i) a hydrophobic solvent comprising mineral oil and isopropyl myristate at a combined concentration of about 8.64% by weight of the composition; 
 (ii) a polar solvent comprising ethanol at a concentration of about 20% by weight of the composition; 
 (iii) a surfactant comprising glyceryl monostearate, polysorbate 80, and PEG-40 stearate at a combined concentration of about 3.24% by weight of the composition; 
 (iv) a foam adjuvant comprising stearyl alcohol at a concentration of about 0.72% by weight of the composition; 
 (v) a polymeric agent comprising xanthan gum and hydroxypropyl methylcellulose at a combined concentration of about 0.44% by weight of the composition; and 
 (vi) water; 
   (b) a liquefied or compressed gas propellant comprising propane and butane at a concentration of about 8% by weight of the composition.   
     
     
         72 . The composition of  claim 53 , wherein the breakable foam has a density of about 0.04 g/mL to about 0.12 g/mL. 
     
     
         73 . The composition of  claim 53 , wherein the weight ratio between the polar solvent and the hydrophobic solvent is between about 1:4 and about 4:1. 
     
     
         74 . The composition of  claim 53 , wherein the emulsion further comprises an active agent. 
     
     
         75 . A method of treating, alleviating, or preventing a disorder, comprising topically administrating a breakable foam produced from the composition of  claim 74 . 
     
     
         76 . The method of  claim 75 , wherein the disorder is a steroid-responsive inflammation, a viral infection, a fungal infection, a bacterial infection, a parasite infestation, a pigment disorder, a dermatosis, psoriasis, atopic dermatitis, herpes, seborrhea, dandruff, acne, rosacea, osteoarthritis, a joint pain, or eczema. 
     
     
         77 . The method of  claim 75 , wherein the active agent is hydrocortisone acetate, betamethasone valerate, clobetasol proprionate, acyclovir, ciclopirox, clindomycine, azelaic acid, metronidazole, diclofenac, or tachrolimus.