Sensation modifying topical composition foam

Patent metadata

Field	Value
Publication number	US-9320705-B2
Application number	US-35065009-A
Country	US
Kind code	B2
Filing date	Jan 8, 2009
Priority date	Oct 25, 2002
Publication date	Apr 26, 2016
Grant date	Apr 26, 2016

Abstract

This invention relates to foamable compositions that are capable of producing a sensation or sensation modifying effect upon application on a body surface. More particularly the invention relates to foamable pharmaceutical, therapeutic and cosmetic compositions, comprising an active agent, having a sensation or sensation modifying affect on a body surface, upon application. More particularly, the invention relates to foamable compositions comprising: (a) a foamable carrier; (b) at least one sensation or sensation modifying agent, selected from the group of a cooling agent; a warming agent; a relaxing or soothing agent; stimulating or refreshing agent; or mixtures thereof and (c) a propellant at a concentration of about 3% to about 45% by weight of the total composition. The foamable carrier can be an emollient emulsion foamable vehicle, a foamable gel vehicle and can also be a substantially non aqueous foamable vehicle.

First claim

The invention claimed is:

1. A topical composition, comprising a foamable base composition and a hydrocarbon propellant,
wherein the foamable base composition is an oil in water emulsion comprising:
i. about 6% to about 22% by weight of the foamable base composition of a hydrophobic solvent comprising a non-volatile hydrophobic solvent selected from the group consisting of at least two of isopropyl myristate, a triglyceride and a silicone oil;
ii. about 0.5% to about 3% by weight of the foamable base composition of a sensation or sensation modifying agent;
iii. a coal tar;
iv. about 0.1% to about 5% by weight of the foamable base composition of a polymeric agent, wherein the polymeric agent is selected from the group consisting of a locust bean gum, sodium alginate, sodium caseinate, an egg albumin, a gelatin agar, a carrageenan gum, a xanthan gum, a tragacanth gum, a guar gum, a cationic guar, a hydroxypropyl guar gum, a starch, an amine-bearing polymer, a chitosan, an alginic acid, a hyaluronic acid, a chemically modified starch, a carboxyvinyl polymer, a polyvinylpyrrolidone, a polyvinyl alcohol, a polyacrylic acid polymer, a polymethacrylic acid polymer, a polyvinyl acetate, a polyvinyl chloride polymer, a polyvinylidene chloride polymer, a methylcellulose, a hydroxypropyl cellulose, a hydroxypropyl methylcellulose, a hydroxyethyl cellulose, methylhydroxyethylcellulose, a hydroxyethyl carboxymethylcellulose, a carboxymethyl cellulose, a cationic cellulose, PEG 1000, PEG 4000, PEG 6000, PEG 8000, a sodium carboxymethyl cellulose, a microcrystalline cellulose, a polyacrylate and mixtures of any two or more thereof; and
v. about 40% to about 90% by weight of the foamable base composition of water;

wherein the hydrocarbon propellant is selected from the group consisting of butane, propane, isobutane, isobutene and mixtures of any two or more thereof;
wherein the weight ratio of the foamable base composition to the hydrocarbon propellant ranges from about 100:3 to about 100:25;
wherein the topical composition is stored in a pressurized container and upon release expands to form a non-crackling short term stable foam that breaks under mechanical force;
wherein the foam produces at least one prolonged sensation at a delivery site upon dispensing from an aerosol container for a period of at least about 5 minutes; and
wherein the prolonged sensation is not primarily due to the propellant or an exothermic reaction.

2. The composition of claim 1 , wherein the foam neutralizes, ameliorates or hides one or more undesired properties or negative sensation effect of said coal tar extract.

3. The composition of claim 1 , wherein the hydrocarbon propellant is a mixture of propane, butane, and isobutane.

4. The composition of claim 1 , wherein the sensation or sensation modifying agent is selected from the group consisting of menthol, an isomer of menthol, a menthol derivative, 4-Methyl-3-(1-pyrrolidinyl)-2[5H]-furanone, WS-23, icilin, icilin unilever analog, 5-methyl-4-(1-pyrrolidinyl)-3-[2H]-furanone, 4,5-dimethyl-3-(1-pyrrolidinyl)-2[5H]-furanone, isopulegol, 3-(1-menthoxy)propane-1,2-diol, 3-(1-menthoxy)-2-methylpropane-1,2-diol, p-menthane-2,3-diol, p-menthane-3,8-diol, 6-isopropyl-9-methyl-1,4-dioxas-piro[4,5]decane-2-methanol, menthyl succinate, menthyl succinate alkaline earth metal salts, trimethylcyclohexanol, N-ethyl-2-isopropyl-5-methylcyclohexanecarb-oxamide, Japanese mint ( Mentha arvensis ) oil, peppermint oil, menthone, menthone glycerol ketal, menthyl lactate, 3-(1-menthoxy)ethan-1-ol, 3-(1-menthoxy)propan-1-ol, 3-(1-menthoxy)butan-1-ol, 1-menthylacetic acid N-ethylamide, 1-menthyl-4-hydroxypentanoate, 1-menthyl-3-hydroxybutyrate, N,2,3-trimethyl-2-(1-methylethyl)-butanamide, spearmint oil, and mixtures of any two or more thereof.

5. The composition of claim 1 , wherein the short term stable foam is stable at the delivery site for at least one minute.

6. The composition of claim 1 , wherein the coal tar is provided as a coal tar extract or tincture.

7. The composition of claim 1 , wherein the hydrophobic solvent of the oil in water emulsion is present at a concentration of at least about 10% by weight of the foamable composition.

8. The composition of claim 1 , wherein the hydrophobic solvent of the oil in water emulsion comprises isopropyl myristate.

9. The composition of claim 1 , wherein the hydrophobic solvent of the oil in water emulsion comprises a silicone oil.

10. The composition of claim 9 , wherein the silicone oil is selected from the group consisting of a dimethicone, a polyalkyl siloxane, a polyaryl siloxane, a polyalkylaryl siloxane, a polyether siloxane copolymer, a poly(dimethylsiloxane)-(diphenyl-siloxane) copolymer and mixtures of any two or more thereof.

11. The composition of claim 1 , wherein the hydrophobic solvent of the oil in water emulsion comprises a triglyceride.

12. The composition of claim 6 , wherein the foamable base composition comprises:
a) from about 0.5% to about 4% by weight of the foamable base composition of at least one polymeric agent;
b) from about 2.0% to about 8.5% by weight of the foamable base composition of a surfactant;
c) from about 3% to about 25% by weight of the foamable base composition of a polar solvent;
d) from 0% to about 2% by weight of the foamable base composition of a foam adjuvant; and
e) from about 49% to about 88.5% by weight of the foamable base composition of water; and
wherein the polar solvent range includes polar solvent present in the coal tar extract.

13. The composition of claim 12 , wherein the sensation modifying agent is a cooling agent comprising menthol, an isomer of menthol, a menthol derivative, 4-Methyl-3-(1-pyrrolidinyl)-2[5H]-furanone, WS-23, icilin, icilin unilever analog, 5-methyl-4-(1-pyrrolidinyl)-3-[2H]-furanone, 4,5-dimethyl-3-(1-pyrrolidinyl)-2[5H]-furanone, isopulegol, 3-(1-menthoxy)propane-1,2-diol, 3-(1-menthoxy)-2-methylpropane-1,2-diol, p-menthane-2,3-diol, p-menthane-3,8-diol, 6-isopropyl-9-methyl-1,4-dioxas-piro[4,5]decane-2-methanol, menthyl succinate, menthyl succinate alkaline earth metal salts, trimethylcyclohexanol, N-ethyl-2-isopropyl-5-methylcyclohexanecarb-oxamide, Japanese mint ( Mentha arvensis ) oil, peppermint oil, menthone, menthone glycerol ketal, menthyl lactate, 3-(1-menthoxy)ethan-1-ol, 3-(1-menthoxy)propan-1-ol, 3-(1-menthoxy)butan-1-ol, 1-menthylacetic acid N-ethylamide, 1-menthyl-4-hydroxypentanoate, 1-menthyl-3-hydroxybutyrate, N,2,3-trimethyl-2-(1-methylethyl)-butanamide, spearmint oil and mixtures of any two or more thereof.

14. The composition of claim 12 , wherein the hydrophobic solvent further comprises a solvent selected from the group consisting of an essential oil, octyl dodecanol, lanolin, and mixtures of any two or more thereof.

15. The composition of claim 12 , wherein the polar solvent is selected from the group consisting of a short chain alcohol, glycerol, propylene glycol and mixtures of any two or more thereof.

16. The composition of claim 15 , wherein the short chain alcohol is ethanol.

17. The composition of claim 12 , wherein the surfactant is selected from the group consisting of ceteareth 20, glyceryl stearate, PEG 40 stearate, polysorbate 60, laureth-4 and mixtures of any two or more thereof.

18. The composition of claim 12 , wherein the foam adjuvant is selected from the group consisting of a fatty alcohol having 15 or more carbons in the carbon chain, a fatty acid having 16 or more carbons in the carbon chain and mixtures of any two or more thereof.

19. The composition of claim 12 , whe

Assignees

• Tamarkin Dov
• Eini Meir
• Friedman Doron
• Zlatkis Ella
• Schuz David
• Berman Tal
• Foamix Pharmaceuticals Ltd

Inventors

• Tamarkin Dov
• Eini Meir
• Friedman Doron
• Zlatkis Ella
• Schuz David
• Berman Tal

Classifications

• A61K8/345

  containing more than one hydroxy group · CPC title

• A61Q19/007

  Preparations for dry skin · CPC title

• A61K8/34

  Alcohols · CPC title

• A61Q17/02

  containing insect repellants · CPC title

• A61K8/736

  Chitin; Chitosan; Derivatives thereof · CPC title