Foamable iodine compositions

• US 8,119,106 B2
• Filed: 07/08/2009
• Issued: 02/21/2012
• 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:
  US12/499,609
• Publication Number:
  US 20090317338A1
• Time in Patent Office: 958 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 method of treating or alleviating a dermal or mucosal condition selected from the group consisting of wounds, burns, infections, ulcers and combinations thereof, comprising

a. releasing an effective amount of non-irritating foamable composition from an aerosol container comprising:

i. about 0.1% to about 5% by weight of iodine;

ii. about 80% to about 99.6% by weight of at least one solvent;

iii. about 0.1% to about 5% by weight of at least one foam adjuvant,

wherein the at least one foam adjuvant is selected from a fatty alcohol, a fatty acid and a hydroxy fatty acid and mixtures thereof;

iv. about 0.1% to about 5% by weight of at least one surface active agent; and

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

97 to about 25;

75, and

wherein upon release, 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;

b. applying the breakable foam to an afflicted surface having a dermatological or mucosal disorder; and

c. collapsing the breakable foam by applying a gentle rub, wherein the collapsed foam is absorbed into the afflicted surface without chaffing of the surface.

2. The method of claim 1, wherein the composition is provided in a plastic or glass dispenser.

3. The method of claim 1 wherein the iodine is selected from native iodine and complexed iodine.

4. The method of claim 3 wherein the complexed iodine is selected from cadexomer-iodine, diiodhydrin, domiodol, hydriodic acid, iodinated glycerol, iodoform, and povidone-iodine.

5. The method of claim 1, wherein the at least one solvent comprises water.

6. The method of claim 5, further comprising a water miscible organic solvent.

7. The method of claim 6, wherein the water miscible organic solvent is selected from a polyhydroxy solvent and a poly-ethoxylated compound.

8. The method of claim 7, 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.

9. The method of claim 7, wherein the poly-ethoxylated compound is selected from the group consisting of polyethylene glycol, tetrahydrofurfuryl alcohol and polyethyleneglycol.

10. The method of claim 6, having a water to water miscible organic solvent ratio of about 1:

10 to about 10;

1.

11. The method 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, nonionic surface active agents, zwitterionic surface active agents, amphoteric surface active agents, ampholytic surface active agents and mixtures thereof.

12. The method of claim 11, wherein the at least one surface-active agent is a mixture of a non-ionic surface-active agent and an ionic surface-active agent.

13. The method of claim 12, 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.

14. The method of claim 12, wherein the non-ionic surface acting agent to ionic surface active agent weight ratio is in the range of about 2:

1 to about 1;

2.

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

16. The method of claim 1, wherein the at least one foam adjuvant concentration is between about 0.4% and about 2.5% of the composition.

17. The method of claim 1, wherein the infection is selected from a bacterial infection, a fungal infection and a viral infection.

18. The method of claim 17, wherein the bacterial infection is selected from cellulitis, acute lymphangitis, lymphadenitis, erysipelas, cutaneous abscesses, necrotizing subcutaneous infections, staphylococcal scalded skin syndrome, furuncles, impetigo, hidradenitis suppurativa, carbuncles, paronychial infections and erythrasma.

19. The method of claim 18, wherein the bacterial infection is selected from a dermatophyte infections and a yeast infection.

20. The method of claim 1, wherein the condition is related to radiation or radioisotope exposure.

21. The method of claim 1, wherein the condition is related to chemical or biological warfare.

22. The method of claim 1, wherein the composition further comprises about 0.1% to about 5% by weight of at least one gelling agent.

23. The method of claim 22, wherein the at least one gelling agent comprises naturally-occurring polymeric materials, chemically modified starches, semi-synthetic polymeric materials, synthetic polymeric materials, acrylic acid/ethyl acrylate copolymers and carboxyvinyl polymers.

24. The method of claim 22, wherein the at least one gelling agent comprises locust bean gum, guar gum, sodium alginate, sodium caseinate, egg albumin, gelatin agar, carrageenin gum, sodium alginate, xanthan gum, quince seed extract, tragacanth gum, starch, a cellulose ether, hydroxypropyl guar gum, soluble starch, cationic cellulose, 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 a mixture thereof.

25. The method of claim 22, wherein the at least one gelling agent comprises hydroxypropylmethyl cellulose, hydroxyethyl cellulose, methyl cellulose, carboxymethyl cellulose, or a mixture thereof.