Preparations for topical application and methods of delivering an active agent to a substrate

• US 20060083776A1
• Filed: 10/11/2005
• Published: 04/20/2006
• Est. Priority Date: 10/27/2003
• Status: Abandoned Application

• Current Assignee: Dow, Inc., Genencor International Incorporated (International Flavors & Fragrances Incorporated)
• Original Assignee: Genencor International Incorporated (International Flavors & Fragrances Incorporated)
• Inventors: Bott, Richard R., Liles, Donald T., Schalau, Gerald K. II, Brandstadt, Kurt F., Lane, Thomas H., Kollar, Csilla, Saldjeno, Mae, Murphy, Kevin P., Thomas, Xavier J.
• Application Number:
  US11/248,017
• Publication Number:
  US 20060083776A1
• Time in Patent Office: Days
• US Class Current: 424/445
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
• CPC Class Codes: A61L 15/26 Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds; Derivatives thereof A61L15/225 takes precedence
• CPC Class Codes: A61L 15/38 containing enzymes
• CPC Class Codes: A61L 15/58 Adhesives
• CPC Class Codes: C08L 83/04 Polysiloxanes

Abstract

A multi-layer dressing and controlled-release composition for topical application to a substrate include an emulsion and an active agent incorporated into the emulsion. The active agent includes a protein. A method of delivering the active agent to the substrate provides the emulsion and incorporates the active agent into the emulsion for delivery of the active agent to the substrate. Multi-layer dressings and methods particularly suited for management of wound exudate and effective debridement of wound eschar.

Claims

1. A multi-layer dressing for topical application to a substrate, said dressing comprising:

(A) a controlled-release layer formed from a controlled-release composition comprising;

(i) an oil-in-water or water-in-oil emulsion, and

(ii) an active agent incorporated into said emulsion and comprising a protein;

(B) an adhesive layer disposed adjacent said controlled-release layer; and

(C) an additional layer selected from the group of a backing layer, a cushioning layer, an absorbent layer, a second adhesive layer, and combinations thereof,

wherein the adhesive layer comprises a silicone adhesive, a non-silicone adhesive, or combinations thereof.

2. The multilayer dressing according to claim 1, wherein the non-silicone adhesive is selected from the group consisting of acrylic adhesive, rubber adhesive, and combinations thereof.

3. The multilayer dressing according to claim 2, wherein the non-silicone adhesive comprises an acrylic adhesive.

4. The multilayer dressing according to claim 3 wherein the acrylic adhesive comprises acrylic polymers and an aqueous or nonaqueous solvent.

5. The multilayer dressing according to claim 4, wherein the acrylic adhesive comprises acrylic polymers and an aqueous solvent.

6. The multilayer dressing according to claim 5, wherein the acrylic adhesive is selected from the group consisting of DC®

MG-0560, and DC®

MG-0580.

7. The multilayer dressing according to claim 4, wherein the acrylic adhesive is selected from the group consisting of DC®

MG-0610 and DC®

MG-0607.

8. The multilayer dressing according to claim 2, wherein the non-silicone adhesive comprises a rubber adhesive, said rubber adhesive comprising a styrene-butadiene copolymer.

9. The multilayer dressing according to claim 8, wherein the rubber adhesive comprises DC®

MG-0156.

10. The multilayer dressing according to claim 1 comprising a patch.

11. A multi-layer dressing for topical application to a substrate, said dressing comprising:

(A) a controlled-release layer formed from a controlled-release composition comprising;

(i) an oil-in-water or water-in-oil emulsion, and

(ii) an active agent incorporated into said emulsion and comprising a protein; and

(B) an adhesive layer disposed adjacent said controlled-release layer;

(C) an occlusive layer disposed adjacent said adhesive layer and away from said controlled release layer;

(E) an absorbent layer disposed opposite the occlusive layer from the controlled release layer; and

,

(F) optionally, at least one additional layer selected from the group of a backing layer, a cushioning layer, a second absorbent layer, a second adhesive layer, a porous adhesive layer, and combinations thereof.

12. The multilayer dressing according to claim 11, wherein an additional layer comprises a porous adhesive layer disposed adjacent the absorbent layer and between the absorbent layer and the occlusive layer.

13. The multilayer dressing according to claim 12, wherein the porous adhesive layer comprises a silicone mesh.

14. The multilayer dressing according to claim 12, wherein the porous adhesive layer comprises Mepitel®

silicone mesh.

15. The multilayer dressing according to claim 12, wherein the controlled release layer, the adhesive layer, and the occlusive layer are all substantially co-extensive in area, the area equal to C.

16. The multilayer dressing according to claim 15, wherein the porous adhesive layer and the absorbent layer are substantially co-extensive in area, the area equal to A.

17. The multilayer dressing according to claim 16, wherein the area A is greater than the area C and extends beyond C to form a border area, B, further wherein the porous adhesive layer contacts and adheres the dressing to the substrate.

18. A method of managing wound exudates, the method comprising:

adhering a multilayer dressing to a substrate for an effective amount of time, the multilayer dressing comprising;

(A) a controlled-release layer formed from a controlled-release composition comprising;

(i) an oil-in-water or water-in-oil emulsion, and

(ii) an active agent incorporated into said emulsion and comprising a protein; and

(B) an adhesive layer disposed adjacent said controlled-release layer;

(C) an occlusive layer disposed adjacent said adhesive layer and away from said controlled release layer;

(E) an absorbent layer disposed opposite the occlusive layer from the controlled release layer; and

,

(F) optionally, at least one additional layer selected from the group of a backing layer, a cushioning layer, a second absorbent layer, a second adhesive layer, a porous adhesive layer, and combinations thereof.

19. The method of managing wound exudates according to claim 18, wherein the occlusive layer directs the controlled release composition toward the wound.

20. The method of managing wound exudates according to claim 18, wherein the porous silicone adhesive layer directs wound exudate toward the absorbent layer.

21. The method of managing wound exudates according to claim 18, wherein the substrate comprises skin.

22. The method of managing wound exudates according to claim 18, wherein the at least one additional layer comprises a porous adhesive layer disposed adjacent the absorbent layer and between the absorbent layer and the occlusive layer.

23. The method of managing wound exudates according to claim 18, wherein the porous adhesive layer comprises a silicone mesh.

24. The method of managing wound exudates according to claim 23, wherein the porous adhesive layer comprises Mepitel®

silicone mesh.

25. The method of managing wound exudates according to claim 22, wherein the controlled release layer, the adhesive layer, and the occlusive layer are all substantially co-extensive in area, the area equal to C.

26. The method of managing wound exudates according to claim 25, wherein the porous adhesive layer and the absorbent layer are substantially co-extensive in area, the area equal to A.

27. The method of managing wound exudates according to claim 26, wherein the area A is greater than the area C and extends beyond C to form a border area, B, further wherein the porous adhesive layer contacts and adheres the dressing to the substrate.

28. A method of achieving noninvasive debridement of wound eschar, the method comprising:

adhering a multilayer dressing to a substrate, wherein the multilayer dressing comprises;

(A) a controlled-release layer formed from a controlled-release composition comprising;

(i) an oil-in-water or water-in-oil emulsion, and

(ii) an active agent incorporated into said emulsion and comprising a protein; and

(B) an adhesive layer disposed adjacent said controlled-release layer;

(C) an occlusive layer disposed adjacent said adhesive layer and away from said controlled release layer;

(E) an absorbent layer disposed opposite the occlusive layer from the controlled release layer; and

,

(F) optionally, at least one additional layer selected from the group of a backing layer, a cushioning layer, a second absorbent layer, a second adhesive layer, a porous adhesive layer, and combinations thereof.

29. The method of achieving noninvasive debridement of wound eschar according to claim 28, wherein the occlusive layer directs the controlled release composition toward the wound.

30. The method of achieving noninvasive debridement of wound eschar according to claim 28, wherein the porous silicone adhesive layer directs wound exudate toward the absorbent layer.

31. The method of achieving noninvasive debridement of wound eschar according to claim 28, wherein the substrate comprises skin.

32. The method of achieving noninvasive debridement of wound eschar according to claim 28, wherein the at least one additional layer comprises a porous adhesive layer disposed adjacent the absorbent layer and between the absorbent layer and the occlusive layer.

33. The method of achieving noninvasive debridement of wound eschar according to claim 32, wherein the porous adhesive layer comprises a silicone mesh.

34. The method of achieving noninvasive debridement of wound eschar according to claim 32, wherein the porous adhesive layer comprises Mepitel®

silicone mesh.

35. The method of achieving noninvasive debridement of wound eschar according to claim 32, wherein the controlled release layer, the adhesive layer, and the occlusive layer are all substantially co-extensive in area, the area equal to C.

36. The method of managing wound exudates according to claim 32, wherein the porous adhesive layer and the absorbent layer are substantially co-extensive in area, the area equal to A.

37. The method of achieving noninvasive debridement of wound eschar according to claim 36, wherein the area A is greater than the area C and extends beyond C to form a border area, B, further wherein the porous adhesive layer contacts and adheres the dressing to the substrate.

38. The method of achieving noninvasive debridement of wound eschar as set forth in claim 28, wherein the wound is a chronic wound.