COLORED OR COLORABLE TOPICAL COMPOSITION FOAM

• US 20090175799A1
• Filed: 01/08/2009
• Published: 07/09/2009
• Est. Priority Date: 09/08/2006
• Status: Abandoned Application

• Current Assignee: Foamix Pharmaceuticals, Ltd. (VYNE Therapeutics, Inc.)
• Original Assignee: Foamix Pharmaceuticals, Ltd. (VYNE Therapeutics, Inc.)
• Inventors: TAMARKIN, Dov, FRIEDMAN, Doron, EINI, Meir
• Application Number:
  US12/350,642
• Publication Number:
  US 20090175799A1
• Time in Patent Office: Days
• US Class Current: 424/43
• CPC Class Codes: A61K 2800/42 Colour properties
• CPC Class Codes: A61K 2800/45 Colour indicators, e.g. pH- or Redox indicators
• CPC Class Codes: A61K 31/47 Quinolines; Isoquinolines
• CPC Class Codes: A61K 8/046 Aerosols; Foams
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin

Abstract

There is described a colored or colorable topical composition, comprising: a) a foamable base composition comprising, 1) a flowable carrier composition; 2) a color agent; wherein the color agent is effective to impart, increase, decrease or otherwise affect color of a foam produced from the foamable composition and wherein the color agent is one or more agents selected from the group consisting of a colored active agent, a colored indicator, a colored excipient, a pigment, a dye, a colorant and a coloring agent; b) a propellant at a concentration of about 3% to about 25% by weight of the total composition; wherein the base composition has a first color; and wherein the foam comprising the colored or colorable topical composition has a second color upon dispensing from an aerosol container, and wherein the first color and the second color are visually different. There is also described a method of changing color, a method of administration, a use as a diagnostic and a kit.

Claims

1. A colored or colorable topical composition, comprising:

a. a foamable base composition comprising

i. a flowable carrier composition; and

ii. a color agent comprising a coal tar; and

b. a hydrocarbon propellant;

wherein the weight ratio of the foamable base composition to the hydrocarbon propellant ranges from about 100;

3 to about 100;

25;

wherein the base composition has a first color; and

wherein the foam of the colored or colorable topical composition has a second color upon dispensing from an aerosol container, and

wherein the color intensity of the first color is greater than the color intensity of the second color.

2. The composition of claim 1, wherein the second color is off-white.

3. The composition of claim 1, wherein the hydrocarbon propellant comprises at least one short chain hydrocarbon.

4. The composition of claim 1, wherein the hydrocarbon propellant comprises propane, butane, isobutane, or any mixtures thereof.

5. The composition of claim 1, wherein the foamable base composition comprises:

a) from about 3% to about 82% by weight hydrophobic carrier;

b) polymeric agent;

c) from about 2% to about 10% by weight surfactant;

d) from about 8% to about 98% by weight polar solvent;

e) from about 1% to about 5% by weight foam adjuvant;

wherein the hydrophobic carrier comprises isopropyl myristate, a silicone oil, an essential oil, a triglyceride, or any mixtures thereof.

6. The composition of claim 1, wherein the foamable base composition comprises:

a) from about 3% to about 82% by weight hydrophobic carrier;

b) from about 0.5% to about 3% by weight polymeric agent;

c) from about 2% to about 10% by weight surfactant;

d) from about 8% to about 98% by weight polar solvent;

e) from about 1% to about 5% by weight foam adjuvant;

wherein the hydrophobic carrier comprises isopropyl myristate, a silicone oil, an essential oil, a triglyceride, or any mixtures thereof.

7. The composition of claim 1, wherein the foamable base composition is an emulsion and comprises:

a) from about 11% to about 22% by weight hydrophobic carrier;

b) from about 0.5% to about 2.3% by weight polymeric agent;

c) from about 3.0% to about 5.5% by weight surfactant;

d) from about 8% to about 16% by weight polar solvent;

e) from about 1% to about 2% by weight foam adjuvant;

f) from about 50% to about 83% by weight water;

wherein the hydrophobic carrier comprises isopropyl myristate, a silicone oil, an essential oil, a triglyceride, or any mixtures thereof.

8. The composition of claim 1, wherein the foamable base composition is non-aqueous and comprises:

a) from about 3% to about 82% by weight hydrophobic carrier, wherein the hydrophobic carrier comprises a stearyl ether, a PPG alkyl ether, a mineral oil, a petrolatum, a silicone oil, a triglyceride, an ester of a fatty acid, an unsaturated oil, a polyunsaturated oil, an essential oil, or any mixtures thereof;

b) from about 1.8% to about 3% by weight polymeric agent;

c) from about 2% to about 10% by weight surfactant;

d) from about 85% to about 98% by weight polar solvent; and

e) from about 2% to about 5% by weight foam adjuvant.

25. The composition of claim 1, further comprising as an additional component an anti-perspirant, an anti-static agent, a buffering agent, a bulking agent, a chelating agent, a colorant, a conditioner, a deodorant, a diluent, a dye, an emollient, fragrance, a humectant, an occlusive agent, a penetration enhancer, a perfuming agent, a permeation enhancer, a pH-adjusting agent, a preservative, a skin penetration enhancer, a sunscreen, a sun blocking agent, a sunless tanning agent, a vitamin, or any mixtures thereof.

9. A colored or colorable topical composition, comprising:

a foamable base composition comprising a color agent comprising a coal tar, wherein the base composition is an oil in water emulsion and wherein the hydrophobic phase of the oil in water emulsion is present in the base composition at a concentration of at least about 5%; and

a hydrocarbon propellant

wherein the weight ratio of the foamable base composition to the hydrocarbon propellant ranges from about 100;

3 to about 100;

25;

wherein the base composition has a first color; and

wherein the foam of the colored or colorable topical composition has a second color upon dispensing from a pressurized container, and

wherein the color intensity of the first color is greater than the color intensity of the second color.

10. The composition of claim 9, wherein the second color is off-white

11. The composition of claim 9, wherein the coal tar is provided as a coal tar extract or tincture dissolved in all or part of the polar solvent.

12. The composition of claim 9 wherein the hydrophobic phase of the oil in water emulsion is present in the base composition at a concentration of at least about 10%.

13. The composition of claim 9, wherein the hydrophobic phase of the oil in water emulsion comprises isopropyl myristate.

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

15. The composition of claim 14, wherein the silicone oil comprises dimethicone, cyclomethicone, polyalkyl siloxane, polyaryl siloxane, polyalkylaryl siloxane, polyether siloxane copolymer, poly(dimethylsiloxane)-(diphenyl-siloxane) copolymer, or any mixtures thereof.

16. The composition of claim 9, wherein the hydrophobic phase of the oil in water emulsion comprises a triglyceride.

17. The composition of claim 9, wherein the base composition comprises:

a) from about 11% to about 22% by weight hydrophobic carrier;

b) from about 0.5% to about 2.3% by weight polymeric agent;

c) from about 3.0% to about 5.5% by weight surfactant;

d) from about 8% to about 16% by weight polar solvent;

e) from about 1% to about 2% by weight foam adjuvant; and

f) from about 50% to about 83% by weight water.

18. The composition of claim 17, wherein the hydrophobic carrier comprises isopropyl myristate, a silicone oil, a triglyceride, an essential oil, octyl dodecanol, lanolin or any mixtures thereof.

19. The composition of claim 17, wherein the polar solvent comprises a short chain alcohol, glycerol, propylene glycol or any mixtures thereof.

20. The composition of claim 19, wherein the short chain alcohol comprises ethanol.

21. The composition of claim 17, wherein the surfactant comprises of ceteareth 20, glyceryl stearate, PEG 40 stearate, polysorbate 60, laureth-4, emulgin B2 or any mixtures thereof.

22. The composition of claim 17, wherein the foam adjuvant comprises a fatty alcohol having 15 or more carbons in the carbon chain, a fatty acid having 16 or more carbons in the carbon chain, or any mixtures thereof.

23. The composition of claim 17, wherein the polymeric agent comprises hypromellose, xanthan gum, methocel K100, carboxymethylcellulose or any mixtures thereof.

24. The composition of claim 17, wherein the hydrophobic carrier comprises at least two of isopropyl myristate, a triglyceride or silicone oil;

wherein the polymeric agent comprises hypromellose K100M or xanthan gum; and

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

26. A method of treating, alleviating or preventing a disorder, comprising:

administering topically to a surface having the disorder, a foamed composition comprising;

a. a foamable base composition comprising

i. a flowable carrier composition; and

ii. a color agent comprising a coal tar; and

b. a hydrocarbon propellant;

wherein the weight ratio of the foamable base composition to the hydrocarbon propellant ranges from about 100;

3 to about 100;

25;

wherein the base composition has a first color; and

wherein the foam of the colored or colorable topical composition has a second color upon dispensing from an aerosol container, and

wherein the color intensity of the first color is greater than the color intensity of the second color.

27. The method of claim 26, wherein the second color is off-white.

28. The method of claim 26, wherein the hydrocarbon propellant comprises at least one short chain hydrocarbon.

29. The claim of claim 26, wherein the hydrocarbon propellant comprises propane, butane, isobutane, or any mixtures thereof.

30. The method of claim 26, wherein the foamable base composition comprises:

a) from about 3% to about 82% by weight hydrophobic carrier;

b) from about 0.5% to about 3% by weight polymeric agent;

c) from about 2% to about 10% by weight surfactant;

d) from about 8% to about 98% by weight polar solvent;

e) from about 1% to about 5% by weight foam adjuvant;

wherein the hydrophobic carrier comprises isopropyl myristate, a silicone oil, an essential oil, a triglyceride, or any mixture thereof.

31. The method of claim 26, wherein the foamable base composition is an emulsion and comprises:

a) from about 11% to about 22% by weight hydrophobic carrier;

b) from about 0.5% to about 2.3% by weight polymeric agent;

c) from about 3.0% to about 5.5% by weight surfactant;

d) from about 8% to about 16% by weight polar solvent;

e) from about 1% to about 2% by weight foam adjuvant;

f) from about 50% to about 83% by weight water;

wherein the hydrophobic carrier comprises isopropyl myristate, a silicone oil, an essential oil, a triglyceride, or any mixture thereof.

32. The method of claim 26, wherein the flowable carrier is non-aqueous and comprises:

a) from about 3% to about 82% by weight hydrophobic carrier, comprises a stearyl ether, a PPG alkyl ether, a mineral oil, a petrolatum, a silicone oil, a triglyceride, an ester of a fatty acid, an unsaturated oil, a polyunsaturated oil or an essential oil;

b) from about 1.8% to about 3% by weight polymeric agent;

c) from about 2% to about 10% by weight surfactant;

d) from about 85% to about 98% by weight polar solvent; and

e) from about 2% to about 5% by weight foam adjuvant.

49. The method of claim 26 wherein the disorder comprises a disorder associated with hyperkeratinization, dandruff, seborrheic dermatitis, or psoriasis.

33. A method of treating, alleviating or preventing a disorder, comprising:

administering topically to a body surface having the disorder, a foamed composition comprising;

a foamable base composition comprising a color agent comprising a coal tar, wherein the base composition is an oil in water emulsion and wherein the hydrophobic phase of the oil in water emulsion is present in the base composition at a concentration of at least about 5%; and

a hydrocarbon propellant;

wherein the weight ratio of the foamable base composition to the hydrocarbon propellant ranges from about 100;

3 to about 100;

25;

wherein the base composition has a first color; and

wherein the foam of the foamed composition has a second color upon dispensing from a pressurized container, and

wherein the color intensity of the first color is greater than the color intensity of the second color.

34. The method of claim 33, wherein the second color is off-white.

35. The method of claim 33, wherein the coal tar is provided as a coal tar extract or tincture dissolved in all or part of the polar solvent.

36. The method of claim 33, wherein the hydrophobic phase of the oil in water emulsion is present in the base composition at a concentration of at least about 10%.

37. The method of claim 33, wherein the hydrophobic base of the oil in the water emulsion comprises isopropyl myristate.

38. The method of claim 33, wherein the hydrophobic phase of the oil in water emulsion comprises a silicone oil.

39. The method of claim 38, wherein the silicone oil comprises dimethicone, cyclomethicone, polyalkyl siloxane, polyaryl siloxane, polyalkylaryl siloxane, polyether siloxane copolymer, poly(dimethylsiloxane)-(diphenyl-siloxane) copolymer, or any mixtures thereof.

40. The method of claim 33, wherein the hydrophobic phase of the oil in water emulsion comprises a triglyceride.

41. The method of claim 33, wherein the base composition comprises:

a) from about 11% to about 22% by weight hydrophobic carrier;

b) from about 0.5% to about 2.3% by weight polymeric agent;

c) from about 3.0% to about 5.5% by weight surfactant;

d) from about 8% to about 16% by weight polar solvent;

e) from about 1% to about 2% by weight foam adjuvant; and

f) from about 50% to about 83% by weight water.

42. The method of claim 41, wherein the hydrophobic carrier comprises isopropyl myristate, a silicone oil, a triglyceride, an essential oil, octyl dodecanol, lanolin or any mixtures thereof.

43. The method of claim 41, wherein the polar solvent comprises short chain alcohol, glycerol, propylene glycol or any mixtures thereof.

44. The method of claim 41, wherein the short chain alcohol comprises ethanol.

45. The method of claim 41, wherein the surfactant comprises ceteareth 20, glyceryl stearate, PEG 40 stearate, polysorbate 60, laureth-4, emulgin B2 or any mixtures thereof.

46. The method of claim 41, wherein the foam adjuvant comprises a fatty alcohol having 15 or more carbons in the carbon chain, a fatty acid having 16 or more carbons in the carbon chain, or any mixtures thereof.

47. The method of claim 41, wherein the polymeric agent comprises hypromellose, xanthan gum, methocel K100, carboxymethylcellulose or any mixtures thereof.

48. The method of claim 41, wherein the hydrophobic carrier comprises at least two of isopropyl myristate, a triglyceride and silicone oil;

wherein the polymeric agent comprises hypromellose K100M or xanthan gum; and

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