Plaster for the treatment of dysfunctions and disorders of nail growth

• US 20040265362A1
• Filed: 08/18/2004
• Published: 12/30/2004
• Est. Priority Date: 09/04/2001
• Status: Abandoned Application

• Current Assignee: Trommsdorff GmbH & Co. KG Arzneimittel
• Original Assignee: Trommsdorff GmbH & Co. KG Arzneimittel
• Inventors: Susilo, Rudy
• Application Number:
  US10/488,915
• Publication Number:
  US 20040265362A1
• Time in Patent Office: Days
• US Class Current: 424/449
• CPC Class Codes: A61K 9/7061 Polyacrylates
• CPC Class Codes: A61P 31/10 Antimycotics
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The present invention relates to plasters for prophylaxis and/or treatment of dysfunctions or disorders of nails and/or nail growth, the use of said plasters and methods for prophylaxis and/or treatment of a dysfunction or disorder of nails and/or nail growth using said plasters. A preferred embodiment of the plaster consists of an occlusive backing layer and a contact layer attached to said backing layer. The contact layer comes in close contact with the nail and optionally with the surrounding skin. The contact layer is made of a adhesive, a skin and/or nail permeation enhancer, a therapeutically effective amount of a pharmaceutically active agent, and suitable additives.

Claims

1. Plaster for prophylaxis and/or treatment of dysfunctions or disorders of nails and/or nail growth comprising:

a layer being designed to be in close contact with the nail and optionally with the surrounding skin;

said layer comprising;

a) an adhesive;

b) at least one skin and/or nail permeation enhancer;

c) at least one therapeutically effective amount of a pharmaceutically active agent contained in said contact layer; and

d) at least one additive selected from the group comprising binders, cross linkers, softeners, solvents, fillers, and/or antioxidants.

4. Plaster according to claim 1 wherein the skin and/or nail permeation enhancer is selected from the group comprising fatty acids, fatty acid esters, fatty acid amides, fatty alcohols, 2-(2-ethoxyethoxy)-ethanol, esters of glycerol, glycerol monolaurate, propylene glycol, polyethylene glycols, unsaturated polyglycolized glycerides, saturated polyglycerides, a partial glyceride of ricinoleic acid, a-hydroxy acids, dimethylsulfoxide, decylmethylsulfoxide, pyrrolidones, salicylic acid, lactic acid, myristol, isopropyl myristate, dimethylformamide, dimethylacetamide, sodium dodecylsulfate, phospholipides, and proteolytic enzymes.

5. Plaster according to claim 1 wherein the skin and/or nail permeation enhancer is contained in the contact layer in an amount of between 0.7% to 6% by weight of the contact layer.

6. Plaster according to claim 1 wherein the additives are contained in the contact layer in an amount of between 15% to 20% by weight of the contact layer.

7. Plaster according to claim 1 wherein said pharmaceutically active agent is selected from the group comprising fluconazole (Diflucan®

), butoconazole, enilconazole, fenticonazole, sulconazole, naftifidine, clioquinol, iodoquinol, rimoprogin, griseofulvin, terbinafine (Lamisil®

, Novartis Pharma), clotrimazole, itraconazole (Sempera®

, Janssen Pharmaceutical), tioconazole, miconazole, tolnaftate, pyrogallol, econazole, isoconazole, terconazole, oxiconazole, voriconazole, amphotericin B, nystatin, tolciclate, sulbentine, ketoconazole, ciclopirox (Batrafen®

, Aventis Pharma), amorolfine, bifonazole, sodium pyrithione, salicylic acid and/or salts of these agents.

8. Plaster according to claim 1 wherein said pharmaceutically active agent is contained in the adhesive in an amount of between 0.01-5 mg per cm² plaster.

9. Plaster according to claim 1 wherein the adhesive is selected from the group comprising acrylic adhesives, rubber adhesives, and silicone adhesives.

10. Plaster according to claim 1 wherein the adhesive is contained in the plaster in an amount of between 80% to 90% by weight of the contact layer.

11. Combination therapy wherein the plaster according to claim 1 is used in combination with a systemic treatment of a dysfunction or disorder of nails and/or nail growth.

2. Plaster for prophylaxis and/or treatment of dysfunctions or disorders of nails and/or nail growth comprising:

a) a backing layer; and

b) a contact layer attached to said backing layer and being designed to be in close contact with the nail and optionally with the surrounding skin;

said contact layer comprising;

aa) an adhesive;

bb) at least one skin and/or nail permeation enhancer;

cc) at least one therapeutically effective amount of a pharmaceutically active agent contained in said contact layer; and

dd) at least one additive selected from the group comprising binders, cross linkers, softeners, solvents, fillers, and/or antioxidants.

3. Plaster according to claim 2 wherein said backing layer is an occlusive backing layer.

12. Use of the plaster for the transdermal and/or transnail prophylaxis and/or treatment of a dysfunction or disorder of nails and/or nail growth by adhesively securing to the nail and optionally the surrounding skin of said nail the plaster comprising:

a layer being designed to be in close contact with the nail and optionally with the surrounding skin;

said layer comprising;

a) an adhesive;

b) at least one skin and/or nail permeation enhancer;

c) at least one therapeutically effective amount of a pharmaceutically active agent contained in said contact layer; and

d) at least one additive selected from the group comprising binders, cross linkers, softeners, solvents, fillers, and/or antioxidants.

15. Use of the plaster according to claim 12 wherein the skin and/or nail permeation enhancer is selected from the group comprising fatty acids, fatty acid esters, fatty acid amides, fatty alcohols, 2-(2-ethoxyethoxy)-ethanol, esters of glycerol, glycerol monolaurate, propylene glycol, polyethylene glycols, unsaturated polyglycolized glycerides, saturated polyglycerides, a partial glyceride of ricinoleic acid, a-hydroxy acids, dimethylsulfoxide, decylmethylsulfoxide, pyrrolidones, salicylic acid, lactic acid, myristol, isopropyl myristate, dimethylformamide, dimethylacetamide, sodium dodecylsulfate, phospholipides, and proteolytic enzymes.

16. Use of the plaster according to claim 12 wherein the skin and/or nail permeation enhancer is contained in the contact layer in an amount of between 0.7% to 6% by weight of the contact layer.

17. Use of the plaster according to claim 12 wherein the additives are contained in the contact layer in an amount of between 15% to 20% by weight of the contact layer.

18. Use of the plaster according to claim 12 wherein said pharmaceutically active agent is selected from the group comprising fluconazole (Diflucan®

), butoconazole, enilconazole, fenticonazole, sulconazole, naftifidine, clioquinol, iodoquinol, rimoprogin, griseofulvin, terbinafine (Lamisil®

, Novartis Pharma), clotrimazole, itraconazole (Sempera@, Janssen Pharmaceutical), tioconazole, miconazole, tolnaftate, pyrogallol, econazole, isoconazole, terconazole, oxiconazole, voriconazole, amphotericin B, nystatin, tolciclate, sulbentine, ketoconazole, ciclopirox (Batrafen®

, Aventis Pharma), amorolfine, bifonazole, sodium pyrithione, salicylic acid and/or salts of these agents.

19. Use of the plaster according to claim 12 wherein said pharmaceutically active agent is contained in the adhesive in an amount of between 0.01-5 mg per cm² plaster.

20. Use of the plaster according to claim 12 wherein the adhesive is selected from the group comprising acrylic adhesives, rubber adhesives, and silicone adhesives.

21. Use of the plaster according to claim 12 wherein the adhesive is contained in the plaster in an amount of between 80% to 90% by weight of the contact layer.

22. Use of the plaster according to claim 12 in combination with a systemic treatment of a dysfunction or disorder of nails and/or nail growth, especially of onychomycosis, onychocryptosis, nail psoriasis, melanonychia striata, white line disease, eczema, chronic onychia, discolored nails, thickened nails, and other forms of onychodystrophy.

13. Use of the plaster for the transdermal and/or transnail prophylaxis and/or treatment of a dysfunction or disorder of nails and/or nail growth by adhesively securing to the nail and optionally the surrounding skin of said nail the plaster comprising:

a) a backing layer; and

b) a contact layer attached to said backing layer and being designed to be in close contact with the nail and optionally with the surrounding skin;

said contact layer comprising;

aa) an adhesive;

bb) at least one skin and/or nail permeation enhancer;

cc) at least one therapeutically effective amount of a pharmaceutically active agent contained in said contact layer; and

dd) at least one additive selected from the group comprising binders, cross linkers, softeners, solvents, fillers, and/or antioxidants.

14. Use according to claim 13 wherein said backing layer is an occlusive backing layer.

23. Method for the transdermal and/or transnail prophylaxis and/or treatment of a dysfunction or disorder of nails and/or nail growth by adhesively securing to the nail and optionally the surrounding skin of said nail the plaster comprising:

a layer being designed to be in close contact with the nail and optionally with the surrounding skin;

said layer comprising;

a) an adhesive;

b) at least one skin and/or nail permeation enhancer;

c) at least one therapeutically effective amount of a pharmaceutically active agent contained in said contact layer; and

d) at least one additive selected from the group comprising binders, cross linkers, softeners, solvents, fillers, and/or antioxidants.

26. Method according to claim 23 wherein the skin and/or nail permeation enhancer is selected from the group comprising fatty acids, fatty acid esters, fatty acid amides, fatty alcohols, 2-(2-ethoxyethoxy)-ethanol, esters of glycerol, glycerol monolaurate, propylene glycol, polyethylene glycols, unsaturated polyglycolized glycerides, saturated polyglycerides, a partial glyceride of ricinoleic acid, a-hydroxy acids, dimethylsulfoxide, decylmethylsulfoxide, pyrrolidones, salicylic acid, lactic acid, myristol, isopropyl myristate, dimethylformamide, dimethylacetamide, sodium dodecylsulfate, phospholipides, and proteolytic enzymes.

27. Method according to claim 23 wherein the skin and/or nail permeation enhancer is contained in the contact layer in an amount of between 0.7% to 6% by weight of the contact layer.

28. Method according to claim 23 wherein the additives are contained in the contact layer in an amount of between 15% to 20% by weight of the contact layer.

29. Method according to claim 23 wherein said pharmaceutically active agent is selected from the group comprising fluconazole (Diflucan®

), butoconazole, enilconazole, fenticonazole, sulconazole, naftifidine, clioquinol, iodoquinol, rimoprogin, griseofulvin, terbinafine (Lamisil®

, Novartis Pharma), clotrimazole, itraconazole (Sempera®

, Janssen Pharmaceutical), tioconazole, miconazole, tolnaftate, pyrogallol, econazole, isoconazole, terconazole, oxiconazole, voriconazole, amphotericin B, nystatin, tolciclate, sulbentine, ketoconazole, ciclopirox (Batrafen®

, Aventis Pharma), amorolfine, bifonazole, sodium pyrithione, salicylic acid and/or salts of these agents.

30. Method according to claim 23 wherein said pharmaceutically active agent is contained in the adhesive in an amount of between 0.01-5 mg per cm² plaster.

31. Method according to claim 23 wherein the adhesive is selected from the group comprising acrylic adhesives, rubber adhesives, and silicone adhesives.

32. Method according to claim 23 wherein the adhesive is contained in the plaster in an amount of between 80% to 90% by weight of the contact layer.

33. Method according to claim 23 in combination with a systemic treatment of a dysfunction or disorder of nails and/or nail growth, especially of onychomycosis, onychocryptosis, nail psoriasis, melanonychia striata, white line disease, eczema, chronic onychia, discolored nails, thickened nails, and other forms of onychodystrophy.

24. Method for the transdermal and/or transnail prophylaxis and/or treatment of a dysfunction or disorder of nails and/or nail growth by adhesively securing to the nail and optionally the surrounding skin of said nail the plaster comprising:

a) a backing layer; and

b) a contact layer attached to said backing layer and being designed to be in close contact with the nail and optionally with the surrounding skin;

said contact layer comprising;

aa) an adhesive;

bb) at least one skin and/or nail permeation enhancer;

cc) at least one therapeutically effective amount of a pharmaceutically active agent contained in said contact layer; and

dd) at least one additive selected from the group comprising binders, cross linkers, softeners, solvents, fillers, and/or antioxidants.

25. Method according to claim 24 wherein said backing layer is an occlusive backing layer.