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Last Updated: March 28, 2024

Claims for Patent: 7,083,781


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Summary for Patent: 7,083,781
Title:Film forming polymers, methods of use, and devices and applications thereof
Abstract: Compositions and methods for delivering active agents to the skin of a subject, including a polymer, an active ingredient and a solvent are disclosed, the compositions being capable of delivery by rolling, spreading, aerosol or in droplets and of forming a film in contact with the skin.
Inventor(s): Fotinos; Spiros (Athens, GR), Tsardaka; Ekaterini (Athens, GR), Koborozos; George (Athens, GR)
Assignee: Lavipharm S.A. (Peania Attica, GR)
Application Number:10/408,845
Patent Claims:1. A formulation, comprising: an aqueous mixture including a first polyvinyl alcohol having a viscosity in the range of from 38 to 55 cPs, a second polyvinyl alcohol having a viscosity in the range of from 13 to 27 cPs and at least one active agent selected from a pharmaceutical agent, a wound healing agent and a cosmetic agent, but not containing adhesion-promoting polymers other than polyvinyl alcohol, the mixture forming a composition, the composition when dried forming an agent releasing, water removable, peelable film when applied to a skin surface.

2. A formulation according to claim 1, wherein the pharmaceutical agent is an agent selected from the group consisting of: an anti-inflammatory, a local anesthetic, a xanthine derivative, an antihistaminic, an antifungal, an antimicrobial, an antibiotic, a cardiovascular, a hormone, an erectile dysfunction treatment, a vasodilator, an antirheumatoid, a chemotherapy, an adrenergic agonist or an adrenergic antagonist.

3. A formulation according to claim 1, wherein one or more cosmetic agents are selected from the group consisting of: anti-irritant, anti-oxidant, skin conditioning, anti-blotching, anti-aging, anti-cellulite, skin firming, eye contour, slimming, sooth, sunburn, skin lifting, anti-elastase, anti-collagenase, free radical scavenger, seboregulator, hydrative, vitamin, mineral, a-hydroxy acid, and anti-hyperpigmentation agents.

4. A formulation according to claim 1, wherein the composition is in the form of a gel.

5. A formulation according to claim 1, wherein the first polyvinyl alcohol and second polyvinyl alcohol are present at about 6 to 8% and 4 to 5%, respectively, on a wet weight basis with respect to the total composition.

6. A formulation according to claim 1, wherein the ratio of first polyvinyl alcohol to second polyvinyl alcohol is about 3:2.

7. A formulation according to claim 1 wherein the film is at least translucent.

8. A formulation according to claim 7 wherein the film is transparent.

9. A formulation according to claim 1 wherein the film is between 0.01 and 0.25mm thick.

10. A formulation according to claim 1 wherein the film is 0.03 to 0.1mm thick.

11. A method for administering a dosage of at least one active agent to a site on a subject, comprising: (i) providing a formulation, the formulation including a first polyvinyl alcohol having a viscosity in the range of from 38 to 55 cPs, a second polyvinyl alcohol having a viscosity in the range of from 13 to 27 cPs, water and at least one active agent selected from one or more of a pharmaceutical agent, a wound healing agent and a cosmetic agent; (ii) releasing from a container, a quantity of the formulation onto skin of the subject so as to form a quick-drying, agent releasing, water removable, peelable film capable of overnight adhesion and containing the active agent, wherein polymers contributing to said overnight adhesion consist of the first and second polyvinyl alcohols; and (iii) a administering the agent to the subject from the film.

12. A method according to claim 11, wherein the first polyvinyl alcohol and the second polyvinyl alcohol, each present at about 1 to 10%, on a wet weight basis with respect to the total composition.

13. A method according to claim 11, wherein the first polyvinyl alcohol and the second polyvinyl alcohol are present at about 6 to 8% and 4 to 5%, respectively, on a wet weight basis with respect to the total composition.

14. A method according to claim 11, wherein at least one agent is selected from the group consisting of: an anti-inflammatory, a local anesthetic, a xanthine derivative, an antihistaminic, an antifungal, an antimicrobial, an antibiotic, a cardiovascular, a hormone, an erectile dysfunction treatment, a vasodilator, an antirheumatoid, a chemotherapy, an adrenergic agonist, an adrenergic antagonist, an anti-irritant, an anti-oxidant, a skin conditioning, an anti-blotching, an anti-aging, an anti-cellulite, a skin firming, a eye contour, a slimming, a sunburn soothing, a skin lifting, an anti-elastase, an anti-collagenase, a free radical scavenger, a seboregulator, a hydrative, a vitamin, a mineral, an a-hydroxy acid, and an anti-hyperpigmentation agents.

15. A method according to claim 11 wherein the film is at least translucent.

16. A method according to claim 15 wherein the film is transparent.

17. A method according to claim 11 wherein the film is between 0.01 and 0.25 mm thick.

18. A method according to claim 11 wherein the film is between 0.03 and 0.1 mm thick.

19. A method according to claim 11 wherein administering includes percutaneous absorption of the agent.

20. A method for administering a dosage of at least one active agent to a subject, comprising: (i) applying to a skin surface of the subject, an amount of a formulation containing water, a first polyvinyl alcohol having a viscosity in the range of from 38 to 55 cPs, a second polyvinyl alcohol having a viscosity in the range of from 13 to 27 cPs and the active agent selected from one or more of a pharmaceutical agent, a wound healing agent and a cosmetic agent but not containing adhesion-promoting polymers other than to polyvinyl alcohol; (ii) allowing the formulation to dry on the skin to form a peelable, water-removable agent-releasing film containing the active agent; and (iii) administering the dosage of the active agent to the subject from the wet formulation and then from the film.

21. A method according to claim 20, wherein the formulation is administered from a container selected from the group consisting of: an aerosol can, an atomizer, a jar having an apical manual pump, a rollette and a tube container.

22. A method according to claim 21, wherein the formulation is administered in a controlled dosage.

23. A method according to claim 20 wherein the film is at least translucent.

24. A method according to claim 23 wherein the film is transparent.

25. A method according to claim 20 wherein the film is between 0.01 and 0.25 mm thick.

26. A method according to claim 20 wherein the film is between 0.03 and 0.1 mm thick.

27. A method according to claim 20 wherein administering is performed by percutaneous absorption of the active agent.

28. An active agent delivery system comprising: a peelable agent-releasing film dried on the skin of a subject so as to be at least translucent, the film administering a dosage of active agent contained in the film into the subject through percutaneous absorption, wherein the film was made from a first polyvinyl alcohol having a viscosity in the range of from 38 to 55 cPs and a second polyvinyl alcohol having a viscosity in the range of from 13 to 27 cPs but not from adhesion-promoting polymers besides polyvinyl alcohol.

29. The active agent delivery system of claim 28 wherein the film has a thickness between 0.01 to 0.25 mm.

30. The active agent delivery system of claim 28 wherein the film has a thickness between 0.03 and 0.1 mm.

31. The active agent delivery system of claim 28 wherein the active agent is a pharmaceutical agent.

32. The active agent delivery system of claim 28 wherein the active agent is a wound healing agent.

33. The active agent delivery system of claim 28 wherein the film is transparent.

34. A method for administering a dosage of at least one active agent to a subject, comprising: (i) applying to a skin surface of the subject, an amount of a gel formulation containing water, a first polyvinyl alcohol having a viscosity in the range of from 38 to 55 cPs, a second polyvinyl alcohol having a viscosity in the range of from 13 to 27 cPs and the active agent selected from one or more of a pharmaceutical agent, a wound healing agent and a cosmetic agent; (ii) allowing the gel formulation to dry on the skin to form a peelable, water-removable, agent-releasing film capable of overnight adhesion and containing the active agent wherein polymers contributing to said overnight adhesion consist of the first and second polyvinyl alcohols; and (iii) administering by percutaneous absorption, the dosage of the active agent to the subject from the gel and then from the film.

35. A formulation, comprising: an aqueous mixture including a first polyvinyl alcohol having a viscosity in the range of from 38 to 55 cPs, a second polyvinyl alcohol having a viscosity in the range of from 13 to 27 cPs and at least one active agent selected from a pharmaceutical agent, a wound healing agent and a cosmetic agent, the mixture forming a composition, the composition when dried forming an agent releasing, water removable, peelable film capable of overnight adhesion when applied to a skin surface wherein polymers contributing to said overnight adhesion consist of said first and second polyvinyl alcohols.

36. An active agent delivery system comprising: a peelable agent-releasing film dried on the skin of a subject so as to be capable of overnight adhesion and at least translucent, the film administering a dosage of active agent contained in the film into the subject, wherein the film was made from a first polyvinyl alcohol having a viscosity in the range of from 38 to 55 cPs and a second polyvinyl alcohol having a viscosity in the range of from 13 to 27 cPs wherein polymers contributing to said overnight adhesion consist of said first and second polyvinyl alcohols.

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