Foam containing benzoyl peroxide

Abstract

The present invention relates to foamable compositions for treating acne comprising benzoyl peroxide; to a therapeutic kit comprising such compositions; and to a method of treating acne using such compositions.

1 . (canceled) 
     
     
         2 . A foamable composition comprising a carrier and a liquefied or compressed gas propellant, the carrier comprising:
 i) an active agent insoluble, or partially insoluble in the carrier, wherein the active agent is homogenously dispersed in the carrier;   ii) a surface-active agent;   iii) about 0.01% to about 1% by weight of the carrier of at least one polymeric additive comprising a polyacrylic acid polymer, wherein the polymeric additive is pH sensitive;   iv) a solvent; and   v) a buffer system;   wherein the carrier has a viscosity of less than about 8000 centipoises at room temperature;   wherein the carrier is substantially waterless;   wherein the liquefied or compressed gas propellant is at a concentration of about 3% to about 25% by weight of the foamable composition and the polymeric additive together with the buffer system contributes to holding the active agent homogeneously dispersed in the foamable composition; and   wherein the composition forms a breakable foam upon dispensing in which the active agent is homogenously dispersed.   
     
     
         3 . The composition according to  claim 2 , wherein the carrier is waterless. 
     
     
         4 . The composition according to  claim 2 , wherein the carrier further comprises about 5% to about 30% by weight of a moisturizing complex. 
     
     
         5 . The composition according to  claim 2 , wherein the carrier further comprises about 5% to about 15% by weight of a moisturizing complex. 
     
     
         6 . The composition according to  claim 4 , wherein the moisturizing complex comprises glycerin and a salt of 2-pyrrolidone-5-carboxylic acid (PCA). 
     
     
         7 . The composition according to  claim 4 , wherein, in comparison with a composition without the moisturizing complex, the moisturizing complex is selected to provide at least one of the following characteristics: (a) improving the chemical stability of the active agent in the composition; (b) improving the homogeneity of the active agent in the composition; (c) improving the quality of the foam produced from the composition; and (d) improving the hydration of skin by at least about 20% within 7 hours of application of the foam produced from the composition to skin. 
     
     
         8 . The composition according to  claim 2 , wherein the polymeric additive further comprises a polymeric agent selected from the group consisting of methylcellulose, hydroxypropyl cellulose, hydroxypropyl methylcellulose, hydroxyethyl cellulose, methylhydroxyethylcellulose, hydroxyethylcarboxymethylcellulose, carboxymethylcellulose, sodium carboxymethylcellulose, xanthan gum, guar gum, carrageenan gum, locust bean gum, tragacanth gum, and a mixture of any two or more thereof. 
     
     
         9 . The composition of  claim 2 , wherein the carrier further comprises about 0.1% to about 5% by weight 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; a fatty alcohol derived from beeswax; a mixture of fatty 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; cetyl alcohol; stearyl alcohol; arachidyl alcohol; behenyl alcohol; 1-triacontanol; hexadecanoic acid; stearic acid; arachidic acid; behenic acid; octacosanoic acid; 12-hydroxy stearic acid; or a mixture of any two or more thereof. 
     
     
         10 . The composition of  claim 2 , wherein the carrier comprises a hydrophobic solvent at a concentration of about 1% to about 15% by weight of the carrier. 
     
     
         11 . The composition of  claim 10 , wherein the hydrophobic solvent is selected from the group consisting of a mineral oil, aliphatic, naphthalenic, an aromatic liquid hydrocarbon derived from petroleum, a liquid oil originating from vegetable, marine or animal source, a saturated, unsaturated or polyunsaturated oil, a corn oil, a soybean oil, a canola oil, a cottonseed oil, a coconut oil, a sesame oil, a sunflower oil, a borage seed oil, a syzigium aromaticum oil, a hempseed oil, a herring oil, a cod-liver oil, a salmon oil, a flaxseed oil, a wheat germ oil, an evening primrose oil, a polyunsaturated oil containing poly-unsaturated fatty acids, an omega-3 fatty acid, an omega-6 fatty acid, linoleic acid, linolenic acid, gamma-linoleic acid (GLA), eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), an omega-3 oil, an omega-6 oil, a liquid hydrophobic plant-derived oil, a silicone oil, a non-volatile silicone, a polyalkyl siloxane, a polyaryl siloxane, a polyalkylaryl siloxane, a polyether siloxane copolymer, a polydimethylsiloxane, a dimethicone, a poly(dimethylsiloxane)-(diphenyl-siloxane) copolymer, a cyclic or linear polydimethylsiloxane containing from about 3 to about 9, or from about 4 to about 5, silicon atoms, a volatile silicone, a cyclomethicone, and a mixture of any two or more thereof. 
     
     
         12 . The composition of  claim 2 , wherein a pH of the buffer system is lower than a pH of the carrier measured before adding the buffer system. 
     
     
         13 . The composition of  claim 2 , wherein the buffer system is selected from the group consisting of citric acid, sodium citrate, lactic acid, ammonium lactate, and a mixture of any two or more thereof. 
     
     
         14 . The composition of  claim 2 , wherein the surface-active agent comprises about 0.1% to about 5% by weight of the carrier of a non ionic surface-active agent, wherein the non ionic surface-active agent is selected from the group consisting of steareth-21, steareth-2, steareth 20, polysorbate 80, polysorbate 60, polysorbate 20, ceteth 20, PEG 40-stearate, PEG 100-stearate, PEG-30 dipolyhydroxystearate, sorbitan stearate, sorbitan palmitate, sorbitan laurate, sorbitan monooleate, glyceryl stearate, laureth 4, ceteareth 20, macrogol cetostearyl ether, ceteth 2, sucrose distearate, polyoxyethylene (100) stearate, and a mixture of any two or more thereof. 
     
     
         15 . The composition of  claim 14 , wherein the surface-active agent comprises two or more of glyceryl stearate, polysorbate 60, and PEG 40 stearate. 
     
     
         16 . The composition of  claim 2 , wherein the active agent is selected from the group consisting of benzoyl peroxide, imiquimod, acyclovir, zinc oxide, titanium oxide, an antibiotic, a corticosteroid, a steroidal anti-inflammatory agent, a non-steroidal anti-inflammatory agent, an immunosuppressive agent, an immunomodulator, an immunoregulating agent, a hormonal agent, an androgen, an estrogen, a prostaglandin, an antiandrogen agent, a testosterone inhibitor, a dihydrotestosterone inhibitor, an anti biotic agent, an antifungal agent, an antiviral agent, an antiparasitic 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, a keratolytic agent, urea, a urea derivative, an alpha hydroxyl acid, lactic acid, glycolic acid, a beta-hydroxy acid, a protein, a peptide, a neuropeptide, an 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, an organo-metallic compound, an organo-boron compound, an organo-berrilium compound, talc, carbon, an anti wrinkle agent, a skin whitening agent, a skin protective agent, a masking agent, an anti-wart agent, a lubricating agent, an anti-seborrhea agent, coal tar, anthralin, and a mixture of any two or more thereof. 
     
     
         17 . The composition of  claim 2 , wherein the carrier further comprises a concentration of about 2% to about 50% by weight of the carrier of at least one organic carrier selected from the group consisting of an organic polar solvent, an emollient, and a mixture thereof. 
     
     
         18 . The foamable composition of  claim 17 , wherein the organic polar solvent is at a concentration of about 1% to about 25% by weight of the carrier, and wherein the organic polar solvent is selected from the group consisting of a polyol, glycerol, propylene glycol, hexylene glycol, diethylene glycol, a propylene glycol, an n-alkanol, terpenes, di-terpenes, tri-terpenes, terpen-ols, limonene, terpene-ol, 1-menthol, dioxolane, ethylene glycol, a sulfoxide, dimethylsulfoxide, dimethylformanide, methyl dodecyl sulfoxide, dimethylacetamide, monooleate of ethoxylated glycerides with 8 to 10 ethylene oxide units, azone (1-dodecylazacycloheptan-2-one), 2-(n-nonyl)-1,3-dioxolane, isopropyl myristate, isopropyl palmitate, ethyl acetate, butyl acetate, methyl proprionate, capric/caprylic triglyceride, octylmyristate, dodecyl-myristate, lauryl alcohol, lauric acid, lauryl lactate, a ketone, an amide, acetamide oleates, triolein, an alkanoic acid, caprylic acid, a lactam compound, an alkanol, a dialkylamino acetate, a polyethylene glycol, PEG 200, PEG 300, PEG 400, PEG600, PEG 4000, PEG 6000, PEG 10000, and a mixture of any two or more thereof. 
     
     
         19 . The composition of  claim 2 , wherein the carrier has a viscosity of less than about 7000 centipoises, less than about 6000 centipoises, or less than about 5000 centipoises, at room temperature. 
     
     
         20 . The composition of  claim 2 , wherein viscosity of the carrier with the propellant is lower than viscosity of the carrier without the propellant, and wherein the ratio between the viscosity of the carrier with the propellant to and the viscosity of the carrier without the propellant is between about 19:20 to about 1:10, between about 4:5 to about to about 1:10, between about 3:4 to about 1:5, or between about 19:20 to about 2:5. 
     
     
         21 . A method of treating a skin disorder, the method comprising administering a foam produced from the foamable composition according to  claim 2  topically onto the skin of a subject having said disorder.