Granted Patent B2

US 9,320,705 · App. 12/350,650 · Granted Apr 26, 2016

Abstract

Claims (81)

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 , wherein the polymeric agent is selected from the group consisting of a hypromellose, a xanthan gum, a carboxymethylcellulose and mixtures of any two or more thereof.

20. The composition of claim 12 ,

wherein the polymeric agent comprises a hypromellose or a xanthan gum; and

wherein the polar solvent comprises a short chain alcohol and glycerin.

21. A method of treating or alleviating a disorder selected from the group consisting of hyperkeratinization, eczema, dandruff, seborrheic dermatitis, psoriasis, atopic dermatitis, and dermatitis, comprising administering topically to a delivery site having the disorder, a foam produced from a composition comprising a foamable base composition and a hydrocarbon propellant,

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.

22. The method of claim 21 , wherein the hydrocarbon propellant comprises propane, butane, and isobutane.

23. The method of claim 21 , 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.

24. The method of claim 21 , wherein the short term stable foam is stable at the delivery site for at least one minute.

25. The method of claim 21 , wherein the coal tar is provided as a coal tar extract or tincture.

26. The method of claim 21 , 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 base composition.

27. The method of claim 21 , wherein the hydrophobic solvent of the oil in water emulsion comprises isopropyl myristate.

28. The method of claim 21 , wherein the hydrophobic solvent of the oil in water emulsion comprises a silicone oil.

29. The method of claim 28 , 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.

30. The method of claim 21 , wherein the hydrophobic solvent of the oil in water emulsion comprises a triglyceride.

31. The method of claim 25 , wherein the foamable base composition comprises:

a) from about 0.5% to about 4% by weight of foamable base composition of at least one polymeric agent;

b) from about 2% to about 8.5% by weight of foamable base composition of a surfactant;

c) from about 3% to about 25% by weight of foamable base composition of a polar solvent;

d) from about 0% to about 2% by weight of foamable base composition of a foam adjuvant; and

e) from about 49% to about 88.5% by weight of foamable base composition of water;

wherein the polar solvent range includes polar solvent present in the coal tar extract.

32. The method of claim 31 , 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.

33. The method of claim 31 , wherein the hydrophobic solvent further comprises a solvent selected from the group consisting of an essential oil, octyl dodecanol, a lanolin or any and mixtures of any two or more thereof.

34. The method of claim 31 , 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.

35. The method of claim 34 , wherein the short chain alcohol is ethanol.

36. The method of claim 31 , 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.

37. The method of claim 31 , 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.

38. The method of claim 31 , wherein the polymeric agent is selected from the group consisting of hypromellose, xanthan gum, carboxymethylcellulose and mixtures of any two or more thereof.

39. The method of claim 31 ,

wherein the polymeric agent comprises hypromellose or xanthan gum; and

wherein the polar solvent comprises a short chain alcohol and glycerin.

40. A composition according to claim 1 , wherein said foamable base composition further comprises a cyclomethicone.

41. A method according to claim 21 , wherein said foamable base composition further comprises a cyclomethicone.

42. The composition of claim 1 , further comprising a foam adjuvant.

43. The composition of claim 6 , wherein the extract or tincture is about 2% to about 20% by weight of the foamable composition.

44. The composition of claim 25 , wherein the extract or tincture is about 2% to about 20% by weight of the foamable composition.

Assignments (8)