Surfactant-free water-free foamable compositions, breakable foams and gels and their uses

Abstract

A substantially surface active agent free composition which includes a hydrophobic solvent, and/or a petrolatum, a paraffin wax and/or a fatty alcohol, a fatty acid and/or a wax and/or shea butter, with and without a propellant. A substantially surface active agent free composition, further comprising, a tetracycline antibiotic, or a vitamin D derivative, or one or more other active agents. A method of treatment using a substantially surface active agent free composition.

1 . (canceled) 
     
     
         2 . A surfactant free, foamable composition comprising:
 i) a carrier comprising:
 a) about 60% to about 95% by weight of the carrier of a hydrophobic solvent, wherein the hydrophobic solvent comprises oil; 
 b) about 0.1% to about 20% by weight of the carrier of at least one fatty alcohol, wherein the fatty alcohol has a carbon chain length of 14 to 22 carbons; 
 c) about 0.1% to about 20% by weight of the carrier of at least one fatty acid, at least one wax, at least one shea butter, or a mixture of two or more thereof, wherein the fatty acid has a carbon chain length of 12 to 28 carbons; 
 d) a minocycline antibiotic or a salt thereof; and 
 e) a retinoid; and 
   ii) a liquefied or compressed gas propellant,
 wherein the composition has a water activity (Aw) value of less than 0.9; 
 and wherein, upon dispensing, the composition forms a foam. 
   
     
     
         3 . The composition of  claim 2 , wherein the composition has an Aw value of less than about 0.5. 
     
     
         4 . The composition of  claim 2 , wherein the fatty alcohol is selected from the group consisting of stearyl alcohol, cetyl alcohol, behenyl alcohol, myristyl alcohol, and a mixture of any two or more thereof; and
 wherein the hydrophobic solvent is selected from the group consisting of: an avocado oil, a calendula oil, cocoglycerides, a coconut oil, a cyclomethicone, a grapeseed oil, a heavy mineral oil, a jojoba oil, a light mineral oil, a MCT oil, octyldodecanol, a peanut oil, a PPG-15 stearyl ether, a soybean oil, a wheat germ oil, and a mixture of any two or more thereof.   
     
     
         5 . The composition of  claim 2 , wherein the fatty acid comprises stearic acid. 
     
     
         6 . The composition of  claim 2 , wherein the wax comprises a combination of a beeswax and a hydrogenated castor oil, wherein the ratio of beeswax to hydrogenated castor oil is between about 1:1 and about 5:1. 
     
     
         7 . The composition of  claim 2 , wherein the composition comprises a wax and the ratio of fatty alcohol to wax is between about 4:1 and about 1:4. 
     
     
         8 . The composition of  claim 2 , wherein the composition is free of short chain alcohols. 
     
     
         9 . The composition of  claim 2 , wherein the hydrophobic solvent is a liquid oil. 
     
     
         10 . The composition of  claim 2 , wherein the composition comprises about 10% or less of petrolatum by weight of the carrier. 
     
     
         11 . The composition of  claim 2 , wherein the composition comprises a fatty acid and a fatty alcohol at a ratio of between about 1:10 and about 10:1. 
     
     
         12 . The composition of  claim 2 , wherein the fatty alcohol comprises stearyl alcohol, cetyl alcohol, or both. 
     
     
         13 . The composition of  claim 2 , wherein the fatty alcohol comprises one or more of stearyl alcohol, cetyl alcohol, behenyl alcohol, and myristyl alcohol. 
     
     
         14 . The composition of  claim 2 , wherein the minocycline antibiotic is present at about 0.5% to about 6% by weight of the carrier. 
     
     
         15 . The composition of  claim 2 , wherein the hydrophobic solvent comprises alexandria laurel tree oil, an almond oil, an essential oil, an unsaturated or polyunsaturated oil, an apricot stone oil, an avocado oil, a barley oil, a basil oil, a borage seed oil, a calendula oil, a camphor oil, a canelle nut tree oil, a canola oil, a cardamom oil, a carrot oil, a castor oil, a citronella oil, a clary sage oil, a clove oil, a coconut oil, a cod-liver oil, a corn oil, a cotton oil, a cottonseed oil, a cypress oil, an epoxy-modified silicone oil, an ester oil, an evening primrose oil, a fatty acid-modified silicone oil, a flaxseed oil, a fluoro group-modified silicone oil, a frankincense oil, a ginger oil, a grape seed oil, a grapefruit oil, a groundnut oil, a hazelnut oil, a heavy mineral oil, a hempseed oil, a herring oil, hydrocarbon oils, a hyssop oil, a jasmine oil, a jojoba oil, a lavender oil, a lemon oil, a light mineral oil, a lucerne oil, a maize germ oil, a maleated soybean oil, a mandarin oil, a manuka oil, a marjoram oil, a marrow oil, a MCT oil, a millet oil, a mineral oil, a myrrh oil, a neroli oil, a nutmeg oil, oils from animal origin, oils of plant origin, an olive oil, a palm oil, a passionflower oil, a peanut oil, a petitgrain oil, a polyether group-modified silicone oil, a poppy oil, a rapeseed oil, a rosehip oil, a rye oil, a safflower oil, a sage oil, a salmon oil, a sesame oil, a silicone oil, a soya oil, a soybean oil, a sunflower oil, a sweet almond oil, a sysymbrium oil, a syzigium aromaticum oil, a tangerine oil, a tea tree oil, unsaturated or polyunsaturated oils, a vanilla oil, a verbena oil, a walnut oil, a wheat germ oil, or a mixture of any two or more thereof. 
     
     
         16 . The composition of  claim 2 , wherein the hydrophobic solvent comprises
 (i) a diglyceride, capric/caprylic triglycerides, glycereth triacetate, glycerol triheptanoate, glyceryl oleate, glyceryl trioctanoate, liquid triglycerides, or a wheat germ glyceride;   (ii) a PPG alkyl ether, a PPG-10 cetyl ether, a PPG-10 oleyl ether, a PPG-11 stearyl ether, a PPG-12 butyl ether, a PPG-14 butyl ether, a PPG-15 butyl ether, a PPG-15 stearyl ether, a PPG-16 butyl ether, a PPG-17 butyl ether, a PPG-18 butyl ether, a PPG-2 butyl ether, a PPG-2 methyl ether, a PPG-20 butyl ether, a PPG-20 oleyl ether, a PPG-22 butyl ether, a PPG-23 oleyl ether, a PPG-24 butyl ether, a PPG-26 butyl ether, a PPG-28 cetyl ether, a PPG-3 methyl ether, a PPG-3 myristyl ether, a PPG-30 butyl ether, a PPG-30 cetyl ether, a PPG-30 isocetyl ether, a PPG-30 oleyl ether, a PPG-33 butyl ether, a PPG-37 oleyl ether, a PPG-4 butyl ether, a PPG-4 lauryl ether, a PPG-4 myristyl ether, a PPG-40 butyl ether, a PPG-5 butyl ether, a PPG-50 cetyl ether, a PPG-50 oleyl ether, a PPG-52 butyl ether, a PPG-53 butyl ether, a PPG-7 lauryl ether, a PPG-9 butyl ether, or a PPG-9-13 butyl ether;   (iii) benzyl laurate, benzyl myristate, benzyl palmitate, bis dimer dilinoleate, butyl myristate, butyl stearate, propyl myristate, propylene glycol dicaprate, propylene glycol dicaprylate, propylene glycol myristyl ether acetate, propylene glycol ricinoleate, stearyl caprate, stearyl propionate, tocopheryl acetate, tocopheryl linoleate, triisocetyl citrate, decyl oleate, diethylhexyl adipate, diethylhexyl malate, diethylhexyl succinate, diisopropyl adipate, diisopropyl dimerate, diisopropyl sebacate, diisosteary dimer dilinoleate, diisostearyl fumerate, dioctyl malate, dioctyl sebacate, disopropyl adipate, dodecyl oleate, ester derivatives of lanolic acid, ethylhexyl hydroxystearate, ethylhexyl palmitate, ethylhexyl pelargonate, ethylhexyl stearate, hexyl laurate, isoamyl laurate, isocetyl behenate, isocetyl lanolate, isocetyl palmitate, isocetyl salicylate, isocetyl stearate, isocetyl stearoyl stearate, isodecyl oleate, isododecane, isohexadecane, isohexadecanol, isopropyl isostearate, isopropyl lanolate, isopropyl laurate, isopropyl myristate, isopropyl palmitate, isopropyl stearate, isosteary citrate, isosteary salicylate, isosteary tartarate, isostearyl behenate, isostearyl erucate, isostearyl glycolate, isostearyl isostearate, isostearyl lactate, isostearyl linoleate, isostearyl linolenate, isostearyl malate, isostearyl palmitate, lauryl lactate, myristyl lactate, myristyl myristate, myristyl propionate, neopentylglycol dicaprate, neopentylglycol dicaprylate/dicaprate, octyl palmitate, octyl stearate, octyldodecyl behenate, octyldodecyl hydroxystearate, octyldodecyl myristate, octyldodecyl stearoyl stearate, oleyl erucate, oleyl lactate, oleyl oleate, or pentaerythrityl tetrastearate;   (iv) alkyl benzoate, alkyl octanoate, C12-C15 alkyl benzoate, C12-C15 alkyl octanoate, stearyl heptanoate, tridecyl ethyl hexanoate, tridecyl isononanoate, a cetearyl ethyl hexanoate, cetearyl isononanoate, cetearyl octanoate, cetyl ethyl hexanoate, cetyl octanoate, diethyleneglycol diethylhexanoate, diethyleneglycol diisononanoate, diethyleneglycol dioctanoate, diethylhexanoate, ethylhexyl cocoate, ethylhexyl ethyl hexanoate, ethylhexyl isononanoate, isocetearyl octanoate, isodecyl ethylhexanoate, isodecyl isononanoate, isohexyl decanoate, isononyl isononanoate, isononyl octanoate, isostearyl isononanoate, isostearyl neopentanoate, isotridecyl isononanoate, or myristyl neopentanoate;   (v) a caprylyl methicone, cetyl dimethicone, stearyl dimethicone, a cyclohexasiloxane, a cyclomethicone, cyclopentasiloxane, a cyclotetrasiloxane, dimethicone, dimethyl polysiloxane, methylphenylpolysiloxane, PEG/PPG 18/18 dimethicone, phenyl trimethicone, a poly-diphenyl-siloxane copolymer, a polyalkyl siloxane, a polyalkylaryl siloxane, a polyaryl siloxane, or a polyether siloxane copolymer;   (vi) an acetylated lanolin alcohol, a liquid paraffin, octyldodecanol, a polyalphaolefin, a polyisobutylene, a polyolefin, or a synthetic isoalkane; or (vii) a mixture of any two or more thereof.   
     
     
         17 . The composition of  claim 2 , wherein the minocycline is present at about 3% by weight of the carrier. 
     
     
         18 . The composition of  claim 2 , wherein the composition comprises at least one fatty alcohol, at least one fatty acid, and at least one wax. 
     
     
         19 . The composition of  claim 2 , wherein the ratio of fatty alcohol to fatty acid is about 1:7 to about 16:3. 
     
     
         20 . The composition of  claim 2 , wherein the composition is free of polymeric agent. 
     
     
         21 . The composition of  claim 2 , wherein the retinoid comprises adapalene and/or tazarotene. 
     
     
         22 . The composition of  claim 2 , wherein the retinoid comprises adapalene. 
     
     
         23 . The composition of  claim 2 , wherein the composition is free of petrolatum. 
     
     
         24 . The composition of  claim 2 , wherein the composition is flowable. 
     
     
         25 . The composition of  claim 2 , wherein the composition comprises a wax selected from the group consisting a beeswax, a hydrogenated castor oil, a paraffin wax, a wax that is solid at room temperature, and a mixture of any two or more thereof. 
     
     
         26 . A surfactant free foamable composition comprising:
 i) a carrier comprising:
 a) about 60% to about 95% by weight of the carrier of a hydrophobic solvent, wherein the hydrophobic solvent comprises oil; 
 b) about 0.1% to about 20% by weight of the carrier of at least one fatty alcohol, wherein the fatty alcohol has a carbon chain length of 14 to 22 carbons; 
 c) about 0.1% to about 20% by weight of the carrier of at least one fatty acid, at least one wax, at least one shea butter, or a mixture of two or more thereof, wherein the fatty acid has a carbon chain length of 12 to 28 carbons; 
 d) a minocycline antibiotic or a salt thereof; and 
 e) a retinoid; and 
   ii) a liquefied or compressed gas propellant;
 wherein the composition is essentially waterless; 
 and wherein, upon dispensing, the composition forms a foam. 
   
     
     
         27 . The composition of  claim 26 , wherein the minocycline antibiotic is present at about 0.5% to about 6% by weight of the carrier. 
     
     
         28 . The composition of  claim 26 , wherein the minocycline antibiotic is present at about 3% by weight of the carrier. 
     
     
         29 . The composition of  claim 26 , wherein the composition comprises at least one fatty alcohol, at least one fatty acid, and at least one wax. 
     
     
         30 . The composition of  claim 26 , wherein the composition is free of petrolatum. 
     
     
         31 . The composition of  claim 26 , wherein the retinoid comprises adapalene and/or tazarotene. 
     
     
         32 . The composition of  claim 26 , wherein the retinoid comprises adapalene. 
     
     
         33 . The composition of  claim 26 , wherein the composition is free of polymeric agent. 
     
     
         34 . The composition of  claim 26 , wherein the composition comprises a wax selected from the group consisting a beeswax, a hydrogenated castor oil, a paraffin wax, a wax that is solid at room temperature, and a mixture of any two or more thereof. 
     
     
         35 . A method of treating acne vulgaris in a subject in need thereof, comprising administering a foam produced from the foamable composition of  claim 2  to the subject. 
     
     
         36 . The method of  claim 35 , wherein the composition is administered at least once daily. 
     
     
         37 . The method of  claim 35 , wherein the composition is administered at least once daily, and the minocycline is present at about 3% by weight of the carrier. 
     
     
         38 . The method of  claim 35 , wherein the composition comprises at least one fatty alcohol, at least one fatty acid, and at least one wax. 
     
     
         39 . The method of  claim 35 , wherein the composition is free of polymeric agent. 
     
     
         40 . The method of  claim 35 , wherein the retinoid comprises adapalene and/or tazarotene. 
     
     
         41 . The method of  claim 35 , wherein the retinoid comprises adapalene. 
     
     
         42 . A method of treating acne vulgaris in a subject in need thereof, comprising administering a foam produced from the foamable composition of  claim 26  to the subject. 
     
     
         43 . The method of  claim 42 , wherein the minocycline antibiotic is present at about 0.5% to about 6% by weight of the carrier. 
     
     
         44 . The method of  claim 42 , wherein the minocycline antibiotic is present at about 3% by weight of the carrier. 
     
     
         45 . The method of  claim 42 , wherein the composition comprises at least one fatty alcohol, at least one fatty acid, and at least one wax. 
     
     
         46 . The method of  claim 42 , wherein the composition is free of polymeric agent. 
     
     
         47 . The method of  claim 42 , wherein the retinoid comprises adapalene and/or tazarotene. 
     
     
         48 . The method of  claim 42 , wherein the retinoid comprises adapalene. 
     
     
         49 . A surfactant free, foamable composition comprising:
 i) a carrier comprising:
 a) about 60% to about 95% by weight of the carrier of a hydrophobic solvent, wherein the hydrophobic solvent comprises oil; 
 b) about 0.1% to about 20% by weight of the carrier of at least one fatty alcohol, wherein the fatty alcohol has a carbon chain length of 14 to 22 carbons; 
 c) about 0.1% to about 20% by weight of the carrier of at least one fatty acid, at least one wax, at least one shea butter, at least one additional fatty alcohol, or a mixture of two or more thereof, wherein the fatty acid has a carbon chain length of 12 to 28 carbons, and wherein the fatty alcohol has a carbon chain length of 14 to 22 carbons; 
 d) a minocycline antibiotic or a salt thereof; and 
 e) a retinoid; and 
   ii) a liquefied or compressed gas propellant,
 wherein the composition has a water activity (Aw) value of less than 0.9; 
 and wherein, upon dispensing, the composition forms a foam.