Methods for Accelerated Return of Skin Integrity and for the Treatment of Impetigo

• US 20180147218A1
• Filed: 11/17/2017
• Published: 05/31/2018
• Est. Priority Date: 10/02/2009
• Status: Active Grant

• Current Assignee: Journey Medical Corp. (Fortress Biotech, Inc.)
• Original Assignee: Foamix Pharmaceuticals, Ltd. (VYNE Therapeutics, Inc.)
• Inventors: Tamarkin, Dov, Gazal, Elana, Keynan, Rita, Eini, Meir, Schuz, David
• Granted Patent: US 10,517,882 B2
• Time in Patent Office: Days
• CPC Class Codes: A61K 2800/31 Anhydrous
• CPC Class Codes: A61K 2800/33 Free of surfactant
• CPC Class Codes: A61K 31/137 Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
• CPC Class Codes: A61K 31/192 having aromatic groups, e.g. sulindac, 2-aryl-propionic acids, ethacrynic acid cannabinoids A61K31/658
• CPC Class Codes: A61K 31/4164 1,3-Diazoles
• CPC Class Codes: A61K 31/57 substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
• CPC Class Codes: A61K 31/573 substituted in position 21, e.g. cortisone, dexamethasone, prednisone or aldosterone
• CPC Class Codes: A61K 31/593 9,10-Secocholestane derivatives, e.g. cholecalciferol, i.e. vitamin D3
• CPC Class Codes: A61K 31/65 Tetracyclines
• CPC Class Codes: A61K 47/02 Inorganic compounds
• CPC Class Codes: A61K 47/06 Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
• CPC Class Codes: A61K 47/10 Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
• CPC Class Codes: A61K 47/12 Carboxylic acids; Salts or anhydrides thereof
• CPC Class Codes: A61K 47/24 containing atoms other than carbon, hydrogen, oxygen, halogen, nitrogen or sulfur, e.g. cyclomethicone or phospholipids
• CPC Class Codes: A61K 47/44 Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14
• CPC Class Codes: A61K 8/31 Hydrocarbons
• CPC Class Codes: A61K 8/342 Alcohols having more than seven atoms in an unbroken chain
• CPC Class Codes: A61K 8/361 Carboxylic acids having more than seven carbon atoms in an unbroken chain; Salts or anhydrides thereof
• CPC Class Codes: A61K 9/0014 Skin, i.e. galenical aspects of topical compositions non-active ingredients are additionally classified in A61K47/00; A61K9/0009, A61K9/0021, A61K9/7015, A61K9/7023 take precedence; cosmetic preparations A61K8/00, A61Q; preparations for wound dressings or bandages A61L26/00
• CPC Class Codes: A61K 9/0048 Eye, e.g. artificial tears
• CPC Class Codes: A61K 9/06 : Ointments; Bases therefor; Other semi-solid forms, e.g. creams, sticks, gels composition of ointments, creams or gels A61K47/00
• CPC Class Codes: A61K 9/12 : Aerosols; Foams A61K9/0043, A61K9/0056, A61K9/006, A61K9/0073 take precedence; spray-films A61K9/7015
• CPC Class Codes: A61K 9/122 : Foams; Dry foams edible foams A61K9/0056
• CPC Class Codes: A61K 9/124 : characterised by the propellant
• CPC Class Codes: A61P 17/10 : Anti-acne agents
• CPC Class Codes: A61Q 17/04 : Topical preparations for affording protection against sunlight or other radiation; Topical sun tanning preparations
• CPC Class Codes: A61Q 19/00 : Preparations for care of the skin
• CPC Class Codes: A61Q 19/10 : Washing or bathing preparations

Abstract

Methods of treatment and dosage regimes using hydrophobic gel or foam compositions comprising a tetracycline antibiotic for accelorating the return of skin integrity and or in treating or alleviating a disorder including impetigo, acne, rosacea, a skin disease caused by a bacteria or a tetracycline antibiotic responsive disease, wherein the foam composition or gel is administered topically to a target area on a subject having the disorder and wherein the target area comprises an area of skin, or mucosa or an eye.

Claims

1-20. -20. (canceled)

21. A method of treating or alleviating acne, comprising topically administering at least once daily an effective amount of a minocycline antibiotic foam to a target area on a patient in need thereof, wherein the target area comprises an area of skin or mucosa, and wherein the minocycline antibiotic foam is produced from a foamable composition upon addition of a liquefied or compressed gas propellant, the foamable composition comprising:

(a) 60% to 90% by weight of one or more hydrophobic oils selected from the group consisting of a mineral oil, a soybean oil, a coconut oil, a petrolatum, cyclomethicone, and a mixture of two or more thereof;

(b) a wax selected from the group consisting of a beeswax, a hydrogenated castor oil, and a mixture thereof;

(c) at least one solid fatty alcohol having a carbon chain length of 14 to 22 carbons;

(d) at least one solid fatty acid having a carbon chain length of 12 to 28 carbons; and

(e) a minocycline at about 0.2% to 10% by weight of the foam;

wherein the foamable composition does not comprise a surfactant.

22. The method of claim 21, wherein the concentration of the propellant is 3% to 25% by weight of the foamable composition.

23. The method of claim 21, wherein the minocycline antibiotic is present in a free base form, a salt form, a hydrate form, or a complex form.

24. The method of claim 21, wherein the concentration of the minocycline antibiotic is 1 to 4% by weight of the foamable composition.

25. The method of claim 21, wherein the minocycline antibiotic is minocycline hydrochloride, and wherein the concentration of minocycline hydrochloride is about 3% to about 4% by weight of the foamable composition.

26. The method of claim 21, wherein the minocycline antibiotic foam is administered for at least three weeks.

27. The method of claim 21, wherein the minocycline antibiotic foam is administered for up to sixteen weeks.

28. The method of claim 21, wherein minocycline antibiotic foam is administered for six to twelve weeks.

29. The method of claim 21, wherein the at least one solid fatty alcohol is selected from the group consisting of myristyl alcohol, cetostearyl alcohol, stearyl alcohol, behenyl alcohol, and a mixture of two or more thereof.

30. The method of claim 21, wherein the least one solid fatty acid having a carbon chain length of 12 to 28 carbons comprises stearic acid.

31. The method of claim 21, wherein the foamable composition further comprises fumed silica.

32. The method of claim 21, wherein the minocycline antibiotic is micronized.

33. The method of claim 21, wherein the composition further comprises an additional active agent.

34. The method of claim 33, wherein the additional active agent comprises a retinoid.

35. A method of restoring skin integrity or accelerating restoration of an area of broken skin or mucosa due to acne, comprising topically administering at least once daily an effective amount of a minocycline antibiotic foam to the area of broken skin or mucosa, wherein the minocycline antibiotic foam is produced from a foamable composition upon addition of a liquefied or compressed gas propellant, the foamable composition comprising:

(a) 60% to 90% by weight of one or more hydrophobic oils selected from the group consisting of a mineral oil, a soybean oil, a coconut oil, a petrolatum, cyclomethicone, and a mixture of two or more thereof;

(b) a wax selected from the group consisting of a beeswax, a hydrogenated castor oil, and a mixture thereof;

(c) at least one solid fatty alcohol having a carbon chain length of 14 to 22 carbons;

(d) at least one solid fatty acid having a carbon chain length of 12 to 28 carbons; and

(e) a minocycline at about 0.2% to 10% by weight of the foam;

wherein the foamable composition does not comprise a surfactant.

36. The method of claim 35, wherein the solid fatty acid is stearic acid and the liquefied or compressed gas propellant is 3% to 25% by weight of the foamable composition.

37. The method of claim 35, wherein the minocycline antibiotic is minocycline hydrochloride present at a concentration of about 4% by weight of the foamable composition.

38. The method of claim 35, wherein the restoration of the skin or mucosa integrity is achieved within twelve weeks.

39. The method of claim 35, wherein the restoration of the skin or mucosa integrity is achieved within six weeks.

40. The method of claim 35, wherein the restoration of the skin or mucosa integrity is achieved within three weeks.

41. The method of claim 35, wherein the restoration of the skin or mucosa integrity is indicated by the presence of visible, normal cutaneous topographic features.

42. The method of claim 35, wherein the least one solid fatty acid having a carbon chain length of 12 to 28 carbons comprises stearic acid.

43. A method for healing of an infected acne lesion without scaring, comprising topically administering at least once daily an effective amount of a minocycline antibiotic foam to an infected acne lesion, wherein the minocycline antibiotic foam is produced from a foamable composition upon addition of a liquefied or compressed gas propellant, the foamable composition comprising:

(a) 60% to 90% by weight of one or more hydrophobic oils selected from the group consisting of a mineral oil, a soybean oil, a coconut oil, a petrolatum, cyclomethicone, and a mixture of two or more thereof;

(b) a wax selected from the group consisting of a beeswax, a hydrogenated castor oil, and a mixture thereof;

(c) at least one solid fatty alcohol having a carbon chain length of 14 to 22 carbons;

(d) at least one solid fatty acid having a carbon chain length of 12 to 28 carbons; and

(e) a minocycline at about 0.2% to 10% by weight of the foam;

wherein the foamable composition does not comprise a surfactant.

44. The method of claim 43, wherein the least one solid fatty acid having a carbon chain length of 12 to 28 carbons comprises stearic acid.

45. The method of claim 43, wherein the healing is characterized by one or more of a return to normal cutaneous topographic features, closing of broken skin or damaged mucosa, and return of skin integrity.

46. The method of claim 43, wherein the healing is achieved within twelve weeks.

47. The method of claim 43, wherein the healing is achieved within six weeks.

48. The method of claim 43, wherein the healing is achieved within three weeks.