Foam prepared from nanoemulsions and uses

Abstract

The present invention provides a 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 oil in water nano emulsion composition includes: (a) a nano oil globule system, comprising substantially of sub-micron oil globules; (b) about 0.1% to about 5% by weight of at least one stabilizing agent, selected from the group consisting of (i) a non-ionic surfactant, (ii) an ionic surfactant, and (iii) a polymeric agent; and (c) a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the total composition, water and optional ingredients are added to complete the total mass to 100%. Upon release from an aerosol container, the foamable composition forms and expanded foam suitable for topical administration. The present invention further provides methods of treating, alleviating or preventing a disorder of the skin, body cavity or mucosal surface using such foamable compositions; and to methods of producing such foams having an improved bubble size.

1 . A foamable oil in water nano emulsion composition comprising:
 (a) A nano oil globule system, comprising substantially of sub-micron oil globules;   (b) about 0.1% to about 5% by weight of at least one stabilizing agent, selected from the group consisting of
 i. a non-ionic surfactant, 
 ii. an ionic surfactant, and 
 iii. a polymeric agent; 
   (c) water; and   (d) a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the total composition   wherein the oil, stabilizer and water are selected to provide a composition that is substantially homogenous and resistant to aging;   wherein the composition is contained in a pressurized container is substantially flowable and provides a breakable foam upon release, which is thermally stable, yet breaks under sheer force; and   wherein the bubble size of the resultant foam is significantly greater than the bubble size of the resultant foam from a composition with the same ingredients which has not been subject to nano processing.   
     
     
         2 . The foamable composition of  claim 1 , wherein the oil globule system consists of oil globules with an average diameter size in the range of about 1000 nanometers to about 10 nanometers; and the stabilizing agent consists of a polymeric agent. 
     
     
         3 . The foamable composition of  claim 2 , further comprising a non-ionic surfactant having an HLB value between 9 and 16; and/or an ionic surfactant. 
     
     
         4 . The foamable composition of  claim 2 , wherein the oil globules are discrete particles with the majority having a size ranging from about 300 to about 20 nanometers in at least one dimension. 
     
     
         5 . The foamable composition of  claim 1 , wherein:
 i. The oil globule system consists of sub-micron oil globules; and   ii. The stabilizing agent consists of a surfactant, having an HLB value or a mean HLB value between 9 and 16.   
     
     
         6 . The foamable composition of  claim 1  wherein the ratio of the surfactant to oil is high being in the range of the order of about 1:1 to about 1:10 
     
     
         7 . The foamable composition of  claim 1 , wherein the sub-micron oil globules contain at least one organic carrier selected from the group consisting of a hydrophobic organic carrier, a polar solvent, an emollient and mixtures thereof. 
     
     
         8 . The foamable composition of  claim 1 , wherein said submicron oil globules are about 50% to about 100% of the composition. 
     
     
         9 . The foamable composition of  claim 1 , wherein the sub-micron oil globules have a number-average size range, selected from (i) 40 nm to 1,000 nm. (ii) 40 nm to 500 nm; (iii) 40 nm to 200 nm; (iv) 40 nm to 100 nm (v) less than 500 nm; (vi) less than 200 nm; and (vii) less than 100 nm. 
     
     
         10 . The foamable composition of  claim 1 , wherein the sub-micron oil globules are produced by high sheer homogenization. 
     
     
         11 . The foamable composition of  claim 1 , further comprising about 0.1% to about 5% by weight of a foam adjuvant selected from the group consisting of a fatty alcohol having 15 or more carbons in their carbon chain; a fatty acid having 16 or more carbons in their 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 thereof. 
     
     
         12 . The foamable composition of  claim 1 , wherein said foamable composition is substantially alcohol-free. 
     
     
         13 . The foamable composition of  claim 1 , further containing at least one therapeutic agent. 
     
     
         14 . The foamable composition of  claim 13 , wherein the therapeutic 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, vitamin A, a vitamin A derivative, vitamin B, a vitamin B derivative, vitamin C, a vitamin C derivative, vitamin D, a vitamin D derivative, vitamin E, a vitamin E derivative, vitamin F, a vitamin F derivative, 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, an anti-wrinkle agent, a radical scavenger, a metal oxide (e.g., titanium dioxide, zinc oxide, zirconium oxide, iron oxide), silicone oxide, an anti wrinkle agent, a skin whitening agent, a skin protective agent, a masking agent, an anti-wart agent, a refatting agent, a lubricating agent and mixtures thereof. 
     
     
         15 . The foamable composition of  claim 14 , wherein the therapeutic agent is suitable to treat a disorder, selected from a dermatological disorder, a cosmetic disorder, a gynecological disorder, a disorder of a body cavity, wound and burn. 
     
     
         16 . The foamable composition of  claim 1 , wherein the HLB or mean HLB value of said non-ionic surfactant is between about 2 and about 9. 
     
     
         17 . The foamable composition of  claim 1 , wherein the stabilizing agent is a polymeric agent selected from the group consisting of a water-soluble cellulose ether naturally-occurring polymeric material, microcrystalline cellulose, hydrophobically-modified ethoxylated urethane, and a carbomer and wherein said water-soluble cellulose ether is selected from the group consisting of methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose (Methocel), hydroxyethyl cellulose, methylhydroxyethylcellulose, methylhydroxypropylcellulose, hydroxyethylcarboxymethylcellulose, carboxymethylcellulose, carboxymethylhydroxyethylcellulose, xanthan gum, guar gum, carrageenin gum, locust bean gum and tragacanth gum. 
     
     
         18 . The foamable composition of  claim 1 , wherein surfactant is selected from the group consisting of steareth 2, steareth 21, ceteth-20, span 80, behenyl alcohol, glyceryl monostearate, PEG 40 stearate, polyoxyl 100 monostearate, methyl glucose seasquit stearate and polysorbate 80. 
     
     
         19 . The foamable composition of  claim 1 , wherein the density of the foam is selected from the group consisting of (1) less than 0.12 g/mL; (2) the range between 0.02 and 0.12; (3) the range between 0.04 and 0.10; (4) the range between 0.06 and 0.10. 
     
     
         20 . A foamable oil in water nano emulsion composition comprising:
 (a) A nano oil globule system, comprising substantially of sub-micron oil globules;   (b) about 0.1% to about 5% by weight of at least one stabilizing agent, selected from the group consisting of
 i. a non-ionic surfactant, 
 ii. an ionic surfactant, and 
 iii. a polymeric agent; 
   (c) water; and   (d) a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the total composition   wherein the oil, stabilizer and water are selected to provide a composition that is substantially homogenous and resistant to aging and wherein the viscosity of the nano emulsion is substantially reduced than the viscosity of the a macro emulsion having substaintially the same composition;   wherein the composition is contained in a pressurized container is substantially flowable and provides a breakable foam upon release, which is thermally stable, yet breaks under sheer forcea; and   wherein the bubble size of the resultant foam is significantly greater than the bubble size of the resultant foam from a composition with the same ingredients which has not been subject to nano processing.   
     
     
         21 . The foamable composition of  claim 20 , wherein the viscosity of the nano emulstion is selected from the group consisting of (1) between about 600cP and about 4000cP (2) between about 4000cP and about 200cP (3) between about 200cP and about 500cP (4) between about 500cP and about 1 cP. 
     
     
         22 . The foamable composition of  claim 20 , wherein the viscosity of the nano emulstion is between about 500cP and about 1 cP and the foam is of good or excellent quality. 
     
     
         23 . A foamable oil in water nano emulsion composition comprising:
 (a) A nano oil globule system, comprising substantially of sub-micron oil globules;   (b) about 0.1% to about 5% by weight of at least one stabilizing agent comprising a carbomer polymeric agent, and a second stabilizing agent selected from the group consisting of
 i. a non-ionic surfactant, 
 ii. an ionic surfactant, and 
 iii. a polymeric agent; 
   (c) water; and   (d) a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the total composition   wherein the oil, stabilizer and water are selected to provide a composition that is substantially homogenous and resistant to aging and wherein the viscosity of the pre foam formulation remains substantially high after it has been subject to nano processing;   wherein the composition is contained in a pressurized container is substantially flowable and provides a breakable foam upon release, which is thermally stable, yet breaks under sheer force; and   wherein the bubble size of the resultant foam is significantly greater than the bubble size of the resultant foam from a composition with the same ingredients which has not been subject to nano processing.   
     
     
         24 . A foamable oil in water nano emulsion composition comprising:
 (a) a nano oil globule system, comprising substantially of sub-micron oil globules;   (b) about 0.1% to about 5% by weight of at least one stabilizing agent, selected from the group consisting of
 i. a non-ionic surfactant, 
 ii. an ionic surfactant, and 
 iii. a polymeric agent; and 
 (c) water; 
   wherein the oil, stabilizer and water are selected to provide a composition that is substantially homogenous and resistant to aging;   wherein the composition prior to addition of propellant is translucent with a blue tint;   wherein if the composition is contained in a pressurized container and further comprises a liquefied hydrocarbon gas propellant at a concentration of about 3% to about 35% by weight of the total composition it is substantially flowable and provides a breakable foam upon release, which is thermally stable, yet breaks under sheer force; and   wherein the bubble size of the resultant foam is significantly greater than the bubble size of the resultant foam from a composition with the same ingredients which has not been subject to nano processing.   
     
     
         25 . A method of treating, alleviating or preventing a disorder of the skin, body cavity or mucosal surface, wherein said disorder involves insufficient hydration of skin or a mucosal surface as one of its etiological factors, comprising:
 administering topically to a subject having said disorder, a foamed composition comprising:   (a) a nano oil globule system, comprising substantially of sub-micron oil globules;   (b) about 0.1% to about 5% by weight of at least one stabilizing agent, selected from the group consisting of
 i. a non-ionic surfactant, 
 ii. an ionic surfactant, and 
 iii. a polymeric agent; 
   (c) water; and   (d) a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the total composition   wherein the oil, stabilizer and water are selected to provide a composition that is substantially homogenous and resistant to aging;   wherein the composition is contained in a pressurized container is substantially flowable and provides a breakable foam upon release, which is thermally stable, yet breaks under sheer force; and   wherein the bubble size of the resultant foam is significantly greater than the bubble size of the resultant foam from a composition with the same ingredients which has not been subject to nano processing.   
     
     
         26 . The method of  claim 25 , wherein the composition further comprises an active agent effective to treat a disorder and wherein the disorder is selected from the group consisting of a vaginal disorder, a vulvar disorder, an anal disorder, a disorder of a body cavity, an ear disorder, a disorder of the nose, a disorder of the respiratory system, a bacterial infection, fungal infection, viral infection, dermatosis, dermatitis, parasitic infections, disorders of hair follicles and sebaceous glands, scaling papular diseases, benign tumors, malignant tumors, reactions to sunlight, bullous diseases, pigmentation disorders, disorders of cornification, pressure sores, disorders of sweating, inflammatory reactions, xerosis, ichthyosis, allergy, burn, wound, cut, chlamydia infection, gonorrhea infection, hepatitis B, herpes, HIV/AIDS, human papillomavirus (HPV), genital warts, bacterial vaginosis, candidiasis, chancroid, granuloma Inguinale, lymphogranloma venereum, mucopurulent cervicitis (MPC), molluscum contagiosum, nongonococcal urethritis (NGU), trichomoniasis, vulvar disorders, vulvodynia, vulvar pain, yeast infection, vulvar dystrophy, vulvar intraepithelial neoplasia (VIN), contact dermatitis, osteoarthritis, joint pain, hormonal disorder, pelvic inflammation, endometritis, salpingitis, oophoritis, genital cancer, cancer of the cervix, cancer of the vulva, cancer of the vagina, vaginal dryness, dyspareunia, anal and rectal disease, anal abscess/fistula, anal cancer, anal fissure, anal warts, Crohn's disease, hemorrhoids, anal itch, pruritus ani, fecal incontinence, constipation, polyps of the colon and rectum. 
     
     
         27 . A method of promoting the penetration of an active agent into the surface layers of the skin and mucosal membranes, comprising: apply a foamable composition to the surface layers of a stem or mucosal membrane, the foamable composition comprising:
 (a) a nano oil globule system, comprising substantially of sub-micron oil globules;   (b) about 0.1% to about 5% by weight of at least one stabilizing agent, selected from the group consisting of
 i. a non-ionic surfactant, 
 ii. an ionic surfactant, and 
 iii. a polymeric agent; 
   (c) water; and   (d) a liquefied or compressed gas propellant at a concentration of about 3% to about 25% by weight of the total composition   wherein the oil, stabilizer and water are selected to provide a composition that is substantially homogenous and resistant to aging;   wherein the composition is contained in a pressurized container is substantially flowable and provides a breakable foam upon release, which is thermally stable, yet breaks under sheer force; and   wherein the bubble size of the resultant foam is significantly greater than the bubble size of the resultant foam from a composition with the same ingredients which has not been subject to nano processing.   
     
     
         28 . The method of  claim 27 , wherein the 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, vitamin A, a vitamin A derivative, vitamin B, a vitamin B derivative, vitamin C, a vitamin C derivative, vitamin D, a vitamin D derivative, vitamin E, a vitamin E derivative, vitamin F, a vitamin F derivative, 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, an anti-wrinkle agent, a radical scavenger, a metal oxide (e.g., titanium dioxide, zinc oxide, zirconium oxide, iron oxide), silicone oxide, an anti wrinkle agent, a skin whitening agent, a skin protective agent, a masking agent, an anti-wart agent and a refatting agent. 
     
     
         29 . A method of treating, alleviating or preventing a disorder of the skin, body cavity or mucosal surface, wherein said disorder involves insufficient hydration of skin or a mucosal surface as one of its etiological factors, comprising:
 administering topically to a subject having said disorder, a foamed composition comprising:   (a) a nano oil globule system, comprising substantially of sub-micron oil globules;   (b) about 0.1% to about 5% by weight of at least one stabilizing agent, selected from the group consisting of
 i. a non-ionic surfactant, 
 ii. an ionic surfactant, and 
 iii. a polymeric agent; and 
   (c) water;   wherein the oil, stabilizer and water are selected to provide a composition that is substantially homogenous and resistant to aging;   wherein the composition prior to addition of propellant is translucent with a blue tint;   wherein if the composition is contained in a pressurized container and further comprises a liquefied hydrocarbon gas propellant at a concentration of about 3% to about 35% by weight of the total composition it is substantially flowable and provides a breakable foam upon release, which is thermally stable, yet breaks under sheer force; and   wherein the bubble size of the resultant foam is significantly greater than the bubble size of the resultant foam from a composition with the same ingredients which has not been subject to nano processing.   
     
     
         30 . The method of  claim 29 , wherein the composition further comprises an active agent effective to treat a disorder and wherein the disorder is selected from the group consisting of a vaginal disorder, a vulvar disorder, an anal disorder, a disorder of a body cavity, an ear disorder, a disorder of the nose, a disorder of the respiratory system, a bacterial infection, fungal infection, viral infection, dermatosis, dermatitis, parasitic infections, disorders of hair follicles and sebaceous glands, scaling papular diseases, benign tumors, malignant tumors, reactions to sunlight, bullous diseases, pigmentation disorders, disorders of cornification, pressure sores, disorders of sweating, inflammatory reactions, xerosis, ichthyosis, allergy, burn, wound, cut, chlamydia infection, gonorrhea infection, hepatitis B, herpes, HIV/AIDS, human papillomavirus (HPV), genital warts, bacterial vaginosis, candidiasis, chancroid, granuloma Inguinale, lymphogranloma venereum, mucopurulent cervicitis (MPC), molluscum contagiosum, nongonococcal urethritis (NGU), trichomoniasis, vulvar disorders, vulvodynia, vulvar pain, yeast infection, vulvar dystrophy, vulvar intraepithelial neoplasia (VIN), contact dermatitis, osteoarthritis, joint pain, hormonal disorder, pelvic inflammation, endometritis, salpingitis, oophoritis, genital cancer, cancer of the cervix, cancer of the vulva, cancer of the vagina, vaginal dryness, dyspareunia, anal and rectal disease, anal abscess/fistula, anal cancer, anal fissure, anal warts, Crohn's disease, hemorrhoids, anal itch, pruritus ani, fecal incontinence, constipation, polyps of the colon and rectum. 
     
     
         31 . A method of promoting the penetration of an active agent into the surface layers of the skin and mucosal membranes, comprising: apply a foamable composition to the surface layers of a stem or mucosal membrane, the foamable composition comprising:
 (a) a nano oil globule system, comprising substantially of sub-micron oil globules;   (b) about 0.1% to about 5% by weight of at least one stabilizing agent, selected from the group consisting of
 i. a non-ionic surfactant, 
 ii. an ionic surfactant, and 
 iii. a polymeric agent; and 
   (c) water;   wherein the oil, stabilizer and water are selected to provide a composition that is substantially homogenous and resistant to aging;   wherein the composition prior to addition of propellant is translucent with a blue tint;   wherein if the composition is contained in a pressurized container and further comprises a liquefied hydrocarbon gas propellant at a concentration of about 3% to about 35% by weight of the total composition it is substantially flowable and provides a breakable foam upon release, which is thermally stable, yet breaks under sheer force; and   wherein the bubble size of the resultant foam is significantly greater than the bubble size of the resultant foam from a composition with the same ingredients which has not been subject to nano processing.   
     
     
         32 . The method of  claim 31 , wherein the 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, vitamin A, a vitamin A derivative, vitamin B, a vitamin B derivative, vitamin C, a vitamin C derivative, vitamin D, a vitamin D derivative, vitamin E, a vitamin E derivative, vitamin F, a vitamin F derivative, 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, an anti-wrinkle agent, a radical scavenger, a metal oxide (e.g., titanium dioxide, zinc oxide, zirconium oxide, iron oxide), silicone oxide, an anti wrinkle agent, a skin whitening agent, a skin protective agent, a masking agent, an anti-wart agent and a refatting agent. 
     
     
         33 . The foamable oil in water nano emulsion composition of  claim 1  for use as a medicament or in the manufacture of a medicament. 
     
     
         34 . A method of producing a foam having improved foam bubble size comprising:
 i. preparing a pre foam oil in water emulsion formulation, wherein the pre foam oil comprises (a) oil globules; (b) about 0.1% to about 5% by weight of at least one stabilizing agent selected from the group consisting of a non-ionic surfactant, an ionic surfactant, and a polymeric agent; and (c) water;   ii. subjecting the pre foam formulation to high pressure mechanical stress to produce a nano emulsion;   iii. storing the nano emulsion in a sealed pressurized container that further comprises a liquefied hydrocarbon gas propellant at a concentration of about 3% to about 25% by weight of the total composition and having an outlet capable of releasing the pressurized product as a foam; and   iv. releasing the foam;
 wherein the bubble size of the resultant foam is significantly greater than the bubble size of a resultant foam from the pre foam oil in water emulsion formulation stored in a sealed pressurized container that further comprises a liquefied hydrocarbon gas propellant at a concentration of about 3% to about 25% by weight of the total composition and having an outlet capable of releasing the pressurized product as a foam. 
   
     
     
         35 . The method of  claim 34 , wherein the nano emulsion comprises oil globules having an average diameter size in the range of about 1000 nanometers to about 10 nanometers; and wherein the stabilizing agent consists of a polymeric agent. 
     
     
         36 . The method of  claim 34 , wherein the resulting foam consists of sub-micron oil globules; and wherein the stabilizing agent consists of a surfactant having an HLB value or a mean HLB value between 9 and 16. 
     
     
         37 . The method of  claim 34 , wherein the ratio of the surfactant to oil is high being in the range of the order of about 1:1 to about 1:10. 
     
     
         38 . The method of  claim 36 , wherein the sub-micron oil globules contain at least one organic carrier selected from the group consisting of a hydrophobic organic carrier, a polar solvent, an emollient and mixtures thereof. 
     
     
         39 . The method of  claim 34 , wherein the resulting foam consists of submicron oil globules which are about 50% to about 100% of the foam composition. 
     
     
         40 . The method of  claim 34 , wherein the resulting foam consists of sub-micron oil globules have a number-average size range, selected from (i) 40 nm to 1,000 nm. (ii) 40 nm to 500 nm; (iii) 40 nm to 200 nm; (iv) 40 nm to 100 nm (v) less than 500 nm; (vi) less than 200 nm; and (vii) less than 100 nm. 
     
     
         41 . The method of  claim 34 , wherein the pre foam further comprises about 0.1% to about 5% by weight of a foam adjuvant selected from the group consisting of a fatty alcohol having 15 or more carbons in their carbon chain; a fatty acid having 16 or more carbons in their 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 thereof. 
     
     
         42 . The method of  claim 34 , wherein the pre foam is substantially alcohol-free. 
     
     
         43 . The method of  claim 34 , wherein the pre foam further comprises at least one therapeutic agent. 
     
     
         44 . The method of  claim 43 , wherein the therapeutic 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, vitamin A, a vitamin A derivative, vitamin B, a vitamin B derivative, vitamin C, a vitamin C derivative, vitamin D, a vitamin D derivative, vitamin E, a vitamin E derivative, vitamin F, a vitamin F derivative, 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, an anti-wrinkle agent, a radical scavenger, a metal oxide (e.g., titanium dioxide, zinc oxide, zirconium oxide, iron oxide), silicone oxide, an anti wrinkle agent, a skin whitening agent, a skin protective agent, a masking agent, an anti-wart agent, a refatting agent, a lubricating agent and mixtures thereof. 
     
     
         45 . The method of  claim 44 , wherein the therapeutic agent is suitable to treat a disorder, selected from a dermatological disorder, a cosmetic disorder, a gynecological disorder, a disorder of a body cavity, wound and burn. 
     
     
         46 . The method of  claim 34 , wherein the stabilizing agent is a polymeric agent selected from the group consisting of a water-soluble cellulose ether naturally-occurring polymeric material, microcrystalline cellulose, hydrophobically-modified ethoxylated urethane, and a carbomer; and wherein said water-soluble cellulose ether is selected from the group consisting of methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose (Methocel), hydroxyethyl cellulose, methylhydroxyethylcellulose, methylhydroxypropylcellulose, hydroxyethylcarboxymethylcellulose, carboxymethylcellulose, carboxymethylhydroxyethylcellulose, xanthan gum, guar gum, carrageenin gum, locust bean gum and tragacanth gum. 
     
     
         47 . The method of  claim 34 , wherein the non-ionic surfactant is selected from the group consisting of steareth 2, steareth 21, ceteth-20, span 80, behenyl alcohol, glyceryl monostearate, PEG 40 stearate, polyoxyl 100 monostearate, methyl glucose seasquit stearate and polysorbate 80. 
     
     
         48 . The method of  claim 34 , wherein the density of the nano emulsion is selected from the group consisting of (1) less than 0.12 g/mL; (2) the range between 0.02 and 0.12; (3) the range between 0.04 and 0.10; (4) the range between 0.06 and 0.10. 
     
     
         49 . The method of  claim 34 , wherein the viscosity of the nano emulsion is selected from the group consisting of (1) between about 6000cP and about 400cP (2) between about 4000cP and about 2000cP (3) between about 200cP and about 500cP (4) between about 500cP and about 1cP. 
     
     
         50 . The method of  claim 34 , wherein the viscosity of the nano emulsion is between about 500cP and about 1 cP and the foam is of good or excellent quality.