Methods for accelerated return of skin integrity and for the treatment of impetigo

• US 9,849,142 B2
• Filed: 03/14/2013
• Issued: 12/26/2017
• 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
• Primary Examiner(s): Barham, Bethany
• Assistant Examiner(s): Anthopolos, Peter
• Application Number:
  US13/831,396
• Publication Number:
  US 20130225536A1
• Time in Patent Office: 1,748 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 accelerating 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. A method of treating or alleviating impetigo comprising topically administering an effective amount of a tetracycline antibiotic foam to a target area on a mammal in need thereof, wherein the target area comprises an area of skin or mucosa, and wherein the tetracycline antibiotic foam is produced from a foamable composition comprising:

(a) 60% to 90% by weight of at least one hydrophobic oil;

(b) a wax selected from the group consisting of a beeswax, a hydrogenated castor oil, a paraffin wax, a plant wax, an animal wax, a polyethylene wax, and a mixture of two or more thereof;

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

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

(e) a tetracycline antibiotic selected from the group consisting of tetracycline, oxytetracycline, demeclocycline, doxycycline, lymecycline, meclocycline, methacycline, minocycline, rolitetracycline, chlorotetracycline, tigecycline, and a mixture of two or more thereof; and

(f) a liquefied or compressed gas propellant; and

wherein the foamable composition does not comprise a surfactant.

2. The method of claim 1, wherein the concentration of the liquefied or compressed gas propellant is 3% to 25% by weight of the foamable composition.

3. The method of claim 1, wherein the wax is selected from the group consisting of a beeswax, a hydrogenated castor oil, and a mixture thereof.

4. The method of claim 1, wherein the tetracycline antibiotic is present in a free base form, a salt form, a hydrate form, or a complex form.

5. The method of claim 4, wherein the tetracycline antibiotic is minocycline hydrochloride, and wherein the concentration of minocycline hydrochloride is 0.2% to 10% by weight of the foamable composition.

6. The method of claim 4, wherein the tetracycline antibiotic is doxycycline hyclate, and wherein the concentration of doxycycline hyclate is 0.2% to 10% by weight of the foamable composition.

7. The method of claim 1, wherein the tetracycline antibiotic foam is administered twice daily.

8. The method of claim 1, wherein the hydrophobic oil is selected from the group consisting of a mineral oil, a soybean oil, a coconut oil, cyclomethicone, and a mixture of two or more thereof.

9. The method of claim 1, 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.

10. The method of claim 1, wherein the foamable composition does comprise the optional at least one solid fatty acid having a carbon chain length of 12 to 28 carbons.

11. The method of claim 10, wherein the least one solid fatty acid having a carbon chain length of 12 to 28 carbons is stearic acid.

12. The method of claim 1, wherein the foamable composition further comprises fumed silica.

13. The method of claim 1, wherein the mammal is a human.

14. The method of claim 1, wherein tetracycline antibiotic foam is administered at least once daily.

15. The method of claim 1, wherein the tetracycline antibiotic is micronized.

16. The method of claim 1, wherein the concentration of tetracycline antibiotic is 0.2 to 10% by weight of the foamable composition.