Claims for Patent: 10,946,101

Summary for Patent: 10,946,101

Title:	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.
Inventor(s):	Tamarkin; Dov (Maccabim, IL), Gazal; Elana (Rehovot, IL), Papiashvili; Irakliy (Ashkelon, IL), Hazot; Yohan (Rehovot, IL), Schuz; David (Gimzu, IL), Keynan; Rita (Rehovot, IL)
Assignee:	Vyne Therapeutics Inc. (Bridgewater, NJ)
Application Number:	16/235,986
Patent Claims:	1. A method of treating rosacea, consisting of administering a surfactant free foam composition, obtained from a foamable composition dispensed from a container, to a subject in need thereof, wherein the foamable composition consists of: i) a carrier consisting of: a) about 60% to about 95% by weight of the carrier of a hydrophobic solvent; 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 mixtures of two or more thereof, wherein the fatty acid has a carbon chain length of 12 to 28 carbons, and the wax is selected from the group consisting of 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; and d) one active agent, wherein the one active agent is minocycline or a salt thereof; and ii) a liquefied or compressed gas propellant; wherein the foamable composition comprises 15% or less of petrolatum by weight of the carrier; wherein the foamable composition is essentially waterless; wherein the foamable composition is free of polymeric agent; wherein, upon dispensing, the foamable composition forms a foam; and wherein the subject in need thereof has rosacea. 2. The method of claim 1, 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 grape seed oil, a heavy mineral oil, a jojoba oil, a light mineral oil, medium chain triglyceride (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. 3. The method of claim 1, wherein the hydrophobic solvent is selected from the group consisting of an avocado oil, a calendula oil, cocoglycerides, a coconut oil, a cyclomethicone, a grape seed oil, a heavy mineral oil, a jojoba oil, a light mineral oil, medium chain triglyceride (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. 4. The method of claim 1, wherein the fatty acid comprises stearic acid. 5. The method of claim 1, wherein the foamable composition comprises at least one fatty alcohol and at least one wax, or at least one fatty alcohol and at least one fatty acid, or at least one fatty alcohol, at least one fatty acid, and at least one wax. 6. The method of claim 1, 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 method of claim 1, wherein the ratio of fatty alcohol to wax is between about 4:1 and about 1:4. 8. The method of claim 1, wherein the foamable composition is free of short chain alcohols. 9. The method of claim 1, wherein the hydrophobic solvent is a liquid oil. 10. The method of claim 1, wherein the foamable composition comprises about 10% or less of petrolatum by weight of the carrier. 11. The method of claim 1, wherein the foamable composition comprises a fatty acid and a fatty alcohol at a ratio of between about 1:10 and about 10:1. 12. The method of claim 1, wherein the fatty alcohol comprises stearyl alcohol, cetyl alcohol, or both. 13. The method of claim 1, wherein the fatty alcohol comprises one or more of stearyl alcohol, cetyl alcohol, behenyl alcohol, or myristyl alcohol. 14. The method of claim 1, wherein the minocycline antibiotic is present at about 0.5% to about 6% by weight of the carrier. 15. The method of claim 1, wherein the hydrophobic solvent is selected from the group consisting of an 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, medium chain triglyceride (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, and a mixture of any two or more thereof. 16. The method of claim 1, 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 palm itate, 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 method of claim 1, wherein the foamable composition is administered at least once daily. 18. The method of claim 1, wherein the foamable composition is administered at least once daily and the minocycline is present at about 3% by weight of the carrier. 19. The method of claim 1, wherein the foamable composition is administered at least once daily and the minocycline is present at about 1.5% by weight of the carrier. 20. The method of claim 1, wherein the foamable composition comprises at least one fatty alcohol, at least one fatty acid, and at least one wax. 21. The method of claim 1, wherein the ratio of fatty alcohol to fatty acid is about 1:7 to about 16:3. 22. The method of claim 1, wherein the ratio of fatty alcohol to fatty acid is about 3:17 to about 2:1. 23. The method of claim 1, wherein the foamable composition is free of petrolatum. 24. The method of claim 1, wherein the salt of minocycline is minocycline hydrochloride.