Foamable vehicles and pharmaceutical compositions comprising aprotic polar solvents and uses thereof

• US 9,884,017 B2
• Filed: 06/30/2017
• Issued: 02/06/2018
• Est. Priority Date: 04/28/2009
• Status: Active Grant

• Current Assignee: Journey Medical Corp. (Fortress Biotech, Inc.)
• Original Assignee: Foamix Pharmaceuticals, Ltd. (VYNE Therapeutics, Inc.)
• Inventors: Tamarkin, Dov, Schuz, David, Berman, Tal, Hazot, Yohan
• Primary Examiner(s): LOVE, TREVOR M
• Application Number:
  US15/639,114
• Publication Number:
  US 20170360705A1
• Time in Patent Office: 221 Days
• CPC Class Codes: A61K 2800/31 Anhydrous
• CPC Class Codes: A61K 47/14 Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
• CPC Class Codes: A61K 47/20 containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
• CPC Class Codes: A61K 47/26 Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
• CPC Class Codes: A61K 47/38 Cellulose; Derivatives thereof
• CPC Class Codes: A61K 8/046 Aerosols; Foams
• CPC Class Codes: A61K 8/46 containing sulfur A61K8/44 takes precedence
• 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 9/122 Foams; Dry foams edible foams A61K9/0056
• CPC Class Codes: A61P 17/00 Drugs for dermatological disorders
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: A61Q 19/00 Preparations for care of the skin

Abstract

The present invention teaches a foamable pharmaceutical and cosmetic compositions comprising an aprotic polar solvent; foam compositions and uses thereof.

Claims

1. A foamable composition formulated for skin delivery of an active agent comprising:

a minocycline in a therapeutically effective amount of about 1 to about 5% by weight of the composition;

a short chain alcohol comprising ethanol;

about 12% to about 30% by weight of the composition of a protic polar solvent comprising propylene glycol;

a polymeric agent comprising a cellulose ether;

a modulating agent comprises an antioxidizing agent;

a metal;

an essential oil;

wherein the foamable composition is surfactant free;

and wherein the composition is waterless and essentially free of fatty alcohol.

2. The foamable composition according to claim 1, wherein the minocycline is a minocycline hydrochloride.

3. The foamable composition according to claim 1, wherein the therapeutically effective amount is about 1%.

4. The foamable composition according to claim 1, wherein the therapeutically effective amount is about 4%.

5. The foamable composition according to claim 1, wherein the short chain alcohol is present in an amount of at least 55% by weight of the composition.

6. The foamable composition according to claim 1, wherein the cellulose ether is a hydroxypropyl cellulose.

7. The foamable composition according to claim 1, wherein the modulating agent is present in an amount ranging from about 0.1% to about 10% by weight of the composition.

8. The foamable composition according to claim 7, wherein the modulating agent is present in an amount ranging from about 1% to about 5% by weight of the composition.

9. The foamable composition according to claim 1, wherein the cellulose ether is present in an amount ranging from about 0.5% to about 1% by weight of the composition.

10. The foamable composition according to claim 1, wherein:

the minocycline is minocycline hydrochloride; and

the cellulose ether is a hydroxypropyl cellulose.

11. The foamable composition according to claim 10, wherein:

the ethanol is present in an amount of at least 55% by weight of the composition;

the hydroxypropyl cellulose is present in an amount of about 0.5% to about 1% by weight of the composition; and

the modulating agent is present in an amount ranging from about 0.1% to about 10% by weight of the composition.

12. The foamable composition according to claim 11, wherein the therapeutically effective amount is about 1% by weight of the composition.

13. The foamable composition according to claim 11, wherein the therapeutically effective amount is about 4% by weight of the composition.

14. The foamable composition according to claim 1, wherein the liquefied or compressed gas propellant is present in an amount ranging from about 3% to about 25% by weight of the composition.