Moisturizing Foam Containing Lanolin

Abstract

The present invention provides a highly tolerable, hydrating lanolin containing foamable composition for administration to the skin, body surface, body cavity or mucosal surface, e.g., the mucosa of the nose, mouth, eye, ear, respiratory system, vagina or rectum. The foamable composition includes lanolin, a surface-active agent, about 0.01% to about 5% by weight of at least one polymeric additive selected from the group consisting of a bioadhesive agent, a gelling agent, a film forming agent and a phase change agent, water, and a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the total composition.

What is claimed is: 
     
         1 .- 20 . (canceled) 
     
     
         21 . A hydrating foamable composition comprising an emulsion, the emulsion comprising:
 i) a hydrating component comprising an emollient, a humectant, or a mixture thereof;   ii) about 0.1% to about 5% of a surface-active agent by weight of the emulsion;   iii) about 0.01% to about 5% by weight of the emulsion of at least one polymeric additive selected from the group consisting of a bioadhesive agent, a gelling agent, a film forming agent, a phase change agent, a water-soluble cellulose ether, a naturally-occurring polymeric material, and mixtures of two or more thereof;   iv) water; and   v) optionally at least one therapeutic agent; and
 a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the hydrating foamable composition; 
   
       wherein upon release from a pressurized container the composition expands to form a foam that collapses upon application of shear force but does not immediately collapse upon exposure to skin temperature. 
     
     
         22 . The foamable composition of  claim 21 , further comprising at least one organic carrier selected from the group consisting of a hydrophobic organic carrier, a polar solvent, and mixtures of two or more thereof, wherein the at least one organic carrier is present in an amount selected from the group consisting of (i) about 2% to about 5% by weight of the emulsion; (ii) about 5% to about 10% by weight of the emulsion; (iii) about 10% to about 20% by weight of the emulsion; and (iv) about 20% to about 50% by weight of the emulsion. 
     
     
         23 . The foamable composition of  claim 21 , further comprising about 0.1% to about 5% by weight of the emulsion of a foam adjuvant 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; and a fatty acid substituted with a hydroxyl group; and mixtures of any two or more thereof. 
     
     
         24 . The foamable composition of  claim 21 , wherein the foamable composition is substantially free of short chain alcohols. 
     
     
         25 . The foamable composition of  claim 21 , wherein the hydrating component comprises a lanolin selected from the group consisting of:
 i) lanolin, wool fat, lanolin wax, and a synthetic lanolin;   ii) a synthetic lanolin comprising at least one of cholesterol, isocholesterol, and analogs, derivatives, salts, and esters thereof;   iii) an oil-soluble hydrophobic derivative of lanolin;   iv) a synthetic lanolin comprising at least one of cholesterol and isocholesterol covalently linked with an organic moiety;   v) a synthetic lanolin comprising at least one of cholesterol and isocholesterol covalently linked with an aliphatic acid;   vi) a lanolin acid;   vii) an ester of lanolin acid with an aliphatic alcohol;   viii) a compound selected from the group consisting of acetylated lanolin, isopropyl lanolate, and cetyl lanolate; and   ix) mixtures of any two or more thereof.   
     
     
         26 . The foamable composition of  claim 25 , wherein the concentration range of lanolin is selected from the group of (i) between about 5% and about 12% by weight of the emulsion; and (ii) between about 12% and about 24% by weight of the emulsion. 
     
     
         27 . The foamable composition of  claim 21 , wherein the surface active agent is non ionic and the concentration of the non-ionic surface active agent is less than about 2% by weight of the emulsion. 
     
     
         28 . The foamable composition of  claim 21 , wherein the surface-active agent comprises a combination of at least one non-ionic surfactant having HLB of less than 9 and at least one non-ionic surfactant having HLB of equal or more than 9, wherein the ratio between the at least one non-ionic surfactant having HLB of less than 9 and the at least one non-ionic surfactant having HLB of equal or more than 9, is between 1:8 and 8:1. 
     
     
         29 . The foamable composition of  claim 21 , wherein the polymeric agent is selected from the group consisting of methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, methylhydroxyethylcellulose, methylhydroxypropylcellulose, hydroxyethylcarboxymethylcellulose, carboxymethylcellulose, carboxymethylhydroxyethylcellulose, xanthan gum, guar gum, carrageenan gum, locust bean gum, tragacanth gum, and mixtures of any two or more thereof. 
     
     
         30 . The foamable composition of  claim 21 , comprising a therapeutic agent selected from the group consisting of an anti-infective, an antibiotic, an antibacterial agent, an antifungal agent, an antiviral agent, an antiparasitic agent, a steroidal antiinflammatory agent, an immunosuppressive agent, an immunomodulator, an immunoregulating agent, a hormonal agent, a vitamin A, a vitamin A derivative, a vitamin B, a vitamin B derivative, a vitamin C, a vitamin C derivative, a vitamin D, a vitamin D derivative, a vitamin E, a vitamin E derivative, a vitamin F, a vitamin F derivative, a vitamin K, a vitamin K derivative, a wound healing agent, a disinfectant, an anesthetic, an antiallergic agent, an alpha hydroxyl acid, lactic acid, glycolic acid, a beta-hydroxy acid, a protein, a peptide, a neuropeptide, a allergen, an immunogenic substance, a haptene, an oxidizing agent, an antioxidant, a dicarboxylic acid, azelaic acid, sebacic acid, adipic acid, fumaric acid, a retinoid, an antiproliferative agent, an anticancer agent, a photodynamic therapy agent, benzoyl chloride, calcium hypochlorite, magnesium hypochlorite, an anti-wrinkle agent, a radical scavenger, a metal, silver, a metal oxide, titanium dioxide, zinc oxide, zirconium oxide, iron oxide, silicone oxide, talc, carbon, a skin whitening agent, a skin protective agent, a masking agent, an anti-wart agent, a refatting agent, a lubricating agent, and mixtures of any two or more thereof. 
     
     
         31 . The composition of  claim 21 , wherein the hydrating component is selected from the group consisting of a lanolin, a beeswax, a mineral oil, a MCT oil, isopropyl myristate (IPM), and isopropyl palmitate (IPP). 
     
     
         32 . The composition of  claim 25 , wherein the hydrating component is at least about 5% by weight of the emulsion and comprises a combination of a lanolin and a component selected from the group consisting of a beeswax, a mineral oil, a MCT oil, isopropyl myristate (IPM) isopropyl palmitate (IPP), and mixtures of any two or more thereof. 
     
     
         33 . A hydrating foamable composition comprising an emulsion, the emulsion comprising:
 i) a hydrating component comprising a humectant;   ii) about 0.1% to about 5% of a surface-active agent by weight of the emulsion;   iii) about 0.01% to about 5% by weight of the emulsion of at least one polymeric additive selected from the group consisting of a bioadhesive agent, a gelling agent, a film forming agent, a phase change agent, a water-soluble cellulose ether, a naturally-occurring polymeric material, and mixtures of two or more thereof;   iv) water; and   v) optionally at least one therapeutic agent; and
 a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the hydrating foamable composition; 
   wherein upon release from a pressurized container the composition expands to form a foam that collapses upon application of shear force but does not immediately collapse upon exposure to skin temperature.   
     
     
         34 . The foamable composition of  claim 33 , further comprising at least one organic carrier selected from the group consisting of a hydrophobic organic carrier, a polar solvent, an emollient, and mixtures of two or more thereof, wherein the at least one organic carrier is present in an amount selected from the group consisting of (i) about 2% to about 5% by weight of the emulsion; (ii) about 5% to about 10% by weight of the emulsion; (iii) about 10% to about 20% by weight of the emulsion; and (iv) about 20% to about 50% by weight of the emulsion. 
     
     
         35 . A method of treating or alleviating insufficient hydration of skin, a body cavity or a mucosal surface, comprising:
 administering topically to skin, a body cavity or a mucosal surface a foam that collapses upon application of shear force but does not immediately collapse upon exposure to skin temperature, wherein the foam is obtained by releasing from a pressurized container a foamable composition comprising an emulsion comprising:   i) a hydrating component comprising an emollient, a humectant, or mixture thereof;   ii) about 0.1% to about 5% of a non-ionic surface-active agent by weight of the emulsion;   iii) about 0.01% to about 5% by weight of the emulsion of at least one polymeric additive selected from the group consisting of a bioadhesive agent, a gelling agent, a film forming agent, a phase change agent, a water-soluble cellulose ether, a naturally-occurring polymeric material, and mixtures of two or more thereof; and   iv) water; and
 a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the hydrating foamable composition; 
 wherein the non-ionic surface-active agent comprises a combination of at least one non-ionic surfactant having HLB of less than 9 and at least one non-ionic surfactant having HLB of equal or more than 9, wherein the ratio between the at least one non-ionic surfactant having HLB of less than 9 and the at least one non-ionic surfactant having HLB of equal or more than 9, is between 1:8 and 8:1. 
   
     
     
         36 . The method of  claim 35 , wherein the hydrating component comprises a lanolin selected from the group consisting of:
 i) lanolin, wool fat, lanolin wax, and a synthetic lanolin;   ii) a synthetic lanolin comprising at least one of cholesterol, isocholesterol, and analogs, derivatives, salts, and esters thereof;   iii) an oil-soluble hydrophobic derivative of lanolin;   iv) a synthetic lanolin comprising at least one of cholesterol and isocholesterol covalently linked with an organic moiety;   v) a synthetic lanolin comprising at least one of cholesterol and isocholesterol covalently linked with an aliphatic acid;   vi) a lanolin acid;   vii) an ester of lanolin acid with an aliphatic alcohol;   viii) a compound selected from the group consisting of acetylated lanolin, isopropyl lanolate, and cetyl lanolate; and   ix) mixtures of any two or more thereof.   
     
     
         37 . The method of  claim 35 , wherein the composition further comprises at least about 5% by weight of the emulsion of a lanolin and about 0.1% to about 5% by weight of the emulsion of a foam adjuvant 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; and mixtures of any two or more thereof. 
     
     
         38 . The method of  claim 35 , wherein the composition further comprises an additional active agent effective to treat a disorder of skin, a body cavity or a mucosal surface. 
     
     
         39 . The method of  claim 35 , wherein the foamable composition further comprises an organic carrier consisting of at least one therapeutically active oil. 
     
     
         40 . The method of  claim 38 , wherein the additional active agent is selected from the group consisting of an anti-infective, an antibiotic, an antibacterial agent, an antifungal agent, an antiviral agent, an antiparasitic agent, an steroidal antiinflammatory agent, an immunosuppressive agent, an immunomodulator, an immunoregulating agent, a hormonal agent, a vitamin A, a vitamin A derivative, a vitamin B, a vitamin B derivative, a vitamin C, a vitamin C derivative, a vitamin D, a vitamin D derivative, a vitamin E, a vitamin E derivative, a vitamin F, a vitamin F derivative, a vitamin K, a vitamin K derivative, a wound healing agent, a disinfectant, an anesthetic, an antiallergic agent, an alpha hydroxyl acid, lactic acid, glycolic acid, a beta-hydroxy acid, a protein, a peptide, a neuropeptide, a allergen, an immunogenic substance, a haptene, an oxidizing agent, an antioxidant, a dicarboxylic acid, azelaic acid, sebacic acid, adipic acid, fumaric acid, a retinoid, an antiproliferative agent, an anticancer agent, a photodynamic therapy agent, benzoyl chloride, calcium hypochlorite, magnesium hypochlorite, an anti-wrinkle agent, a radical scavenger, a metal, silver, a metal oxide, titanium dioxide, zinc oxide, zirconium oxide, iron oxide, silicone oxide, talc, carbon, a skin whitening agent, a skin protective agent, a masking agent, an anti-wart agent, a refatting agent, a lubricating agent, and mixtures of any two or more thereof. 
     
     
         41 . The method of  claim 35 , wherein the surface active agent is non ionic and the concentration of the nonionic surface active agent is less than about 2% by weight of the emulsion. 
     
     
         42 . The method of  claim 35 , wherein the hydrating component is selected from the group consisting of a lanolin, beeswax, mineral oil, MCT oil, isopropyl myristate (IPM) isopropyl palmitate (IPP), and mixtures of any two or more thereof.