Foamable compositions

• US 8,486,375 B2
• Filed: 02/20/2012
• Issued: 07/16/2013
• Est. Priority Date: 04/28/2003
• Status: Active Grant

• Current Assignee: VYNE Therapeutics, Inc.
• Original Assignee: Foamix Ltd. (VYNE Therapeutics, Inc.)
• Inventors: Tamarkin, Dov, Friedman, Doron, Eini, Meir
• Primary Examiner(s): Haghighatian, Mina
• Application Number:
  US13/400,337
• Publication Number:
  US 20120195836A1
• Time in Patent Office: 512 Days
• Field of Search: 424/45, 424/400, 424/51, 424/78.06, 424/78.07, 514/945, 514/928, 514/887, 514/828
• US Class Current: 424/45
• CPC Class Codes: A61K 33/18 Iodine; Compounds thereof
• 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 17/02 for treating wounds, ulcers, burns, scars, keloids, or the like
• 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: A61P 31/00 Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
• CPC Class Codes: A61P 31/04 Antibacterial agents
• CPC Class Codes: A61P 31/10 Antimycotics
• CPC Class Codes: A61P 31/12 Antivirals

Abstract

The present invention is related to a foamable composition of matter comprising iodine, water, a foam adjuvant, a surface-active agent and a gelling agent. This foamable composition, which may be provided in a propellant free foaming device, or alternatively may further comprise a propellant, evolves into foam, which is effective in the topical treatment and prevention of various skin disorders.

Claims

1. A non-irritating foamable composition in an aerosol container comprising:

a carrier composition comprising;

a. about 80% to about 99.6% by weight of the carrier composition of a solvent comprising water and a water miscible organic solvent;

b. about 0.1% to about 5% by weight of the carrier composition of at least one foam adjuvant, wherein the at least one foam adjuvant is selected from a fatty alcohol, a fatty acid, a hydroxy fatty acid, and mixtures thereof;

c. about 0.1% to about 5% by weight of the carrier composition of at least one surface active agent; and

a liquefied or compressed gas propellant wherein the weight ratio of the propellant to the carrier composition is about 3;

97 to about 25;

75;

wherein upon release from the container, the foamable composition forms a thermally stable breakable foam having a specific gravity of between about 0.02 g/mL and about 0.35 g/mL.

2. The foamable composition of claim 1, wherein the water miscible organic solvent is selected from the group consisting of a polyhydroxy solvent and a poly-ethoxylated compound.

3. The composition of claim 2, wherein the polyhydroxy solvent is selected from the group consisting of ethylene glycol, propylene glycol, glycerol, butanediols and isomers thereof, pentaerythritol, sorbitol, mannitol, dimethyl isosorbide, polyethylene glycol, polypropylene glycol, diethylene glycol monoethyl ether, and mixtures thereof;

and, wherein the poly-ethoxylated compound is selected from the group consisting of polyethylene glycol, tetrahydrofurfuryl alcohol, and polyethyleneglycol.

4. The composition of claim 1, wherein the water to water miscible organic solvent ratio is in the range of about 1:

10 to about 10;

1.

5. The composition of claim 1, further comprising an iodine.

6. The composition of claim 1, having a specific gravity of about 0.02 gr/ml to about 0.35 gr/ml.

7. The composition of claim 1, wherein the at least one surface active agent is selected from the group consisting of anionic surface active agents, cationic surface active agents, non-ionic surface active agents, zwitterionic surface active agents, amphoteric surface active agents, ampholytic surface active agents, and mixtures thereof.

8. The composition of claim 7, wherein the at least one surface active agent is a mixture of a non-ionic surface active agent and an ionic surface active agent.

9. The composition of claim 8, wherein the non-ionic surface active agent to ionic surface active agent weight ratio is in the range of about 4:

1 to about 1;

4.

10. The composition of claim 8, wherein the non-ionic surface acting agent to ionic surface acting agent weight ratio is in the range of about 2:

1 to about 1;

2.

11. The composition of claim 7, wherein the at least one surface active agent has a HLB value higher than about 8.

12. The composition of claim 1, wherein the at least one foam adjuvant is present at about 0.4% to about 2.5% by weight of the carrier composition.

13. The composition of claim 1, wherein the at least one surface active agent is a non-ionic surface active agent.

14. The composition of claim 8, wherein the ratio of non-ionic to ionic surface active agent is about 3:

2.

15. The composition of claim 8, wherein the ionic surface active agent comprises a zwitterionic surface active agent and the ratio of zwitterionic to non-ionic surface active agent is about 1:

2.

16. The composition of claim 8, wherein the ionic surface active agent comprises an anionic surface active agent and the amount of anionic surface active agent is about the same as or is less than the amount of non-ionic surface active agent.

17. The composition of claim 1, further comprising about 0.1% to about 5% by weight of at least one gelling agent.

18. The composition of claim 17, wherein the at least one gelling agent comprises one or more of a naturally-occurring polymeric material, a chemically modified starch, a semi-synthetic polymeric material, a synthetic polymeric material, an acrylic acid/ethyl acrylate copolymer, or a carboxyvinyl polymers.

19. The composition of claim 17, wherein the at least one gelling agent comprises a locust bean gum, a guar gum, sodium alginate, sodium caseinate, an egg albumin, a gelatin agar, a carrageenin gum, a xanthan gum, a quince seed extract, a tragacanth gum, a starch, a cellulose ether, a hydroxypropyl guar gum, a soluble starch, a cationic cellulose, a cationic guar, a carboxyvinyl polymer, polyvinylpyrrolidone, polyvinyl alcohol, a polyacrylic acid polymer, a polymethacrylic acid polymer, a polyvinyl acetate polymer a, a polyvinyl chloride polymer, a polyvinylidene chloride polymer, a polyalkenyl polyether cross-linked polymer of acrylic acid, or any mixture of two or more thereof

20. The composition of claim 17, wherein the at least one gelling agent comprises a hydroxypropylmethyl cellulose, a hydroxyethyl cellulose, a methyl cellulose, a carboxymethyl cellulose, or any mixture of two or more thereof.

21. The composition of claim 5, wherein the iodine is selected from native iodine and complexed iodine or comprises both.

22. The composition of claim 21, wherein the complexed iodine is selected from the group consisting of cadexomeriodine, diiodhydrin, domiodol, hydriodic acid, iodinated glycerol, iodoform, povidone-iodine, and mixtures of any two or more thereof.