Method of forming adhesive patch for applying medication to the skin

• US 6,361,790 B1
• Filed: 07/31/2000
• Issued: 03/26/2002
• Est. Priority Date: 03/30/1994
• Status: Expired due to Term

• Current Assignee: Endo Pharmaceuticals Incorporated (Endo International PLC)
• Original Assignee: LecTec Corporation
• Inventors: Sjoblom Urmann, Elisabeth K., Rolf, David
• Primary Examiner(s): Dodson, Shelley A.
• Assistant Examiner(s): Williamson, Michael A.
• Application Number:
  US09/629,783
• Time in Patent Office: 603 Days
• Field of Search: 424/443, 424/445-9, 602/49-51, 514/953, 514/964, 514/965
• US Class Current: 424/443
• CPC Class Codes: A61F 13/00995 for mechanical treatments
• CPC Class Codes: A61F 2013/00646 Medication patches, e.g. transcutaneous
• CPC Class Codes: A61K 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• CPC Class Codes: A61K 9/7061 Polyacrylates

Abstract

A non-occlusive medication patch to be applied to the skin includes a porous self-supporting backing layer to give the patch the required integrity and strength by acting as a supporting framework for other components, and a flexible hydrophilic pressure-sensitive adhesive reservoir comprising a natural or synthetic polymer for the sustained release of medication to be absorbed topically through the skin into the body of a patient. The reservoir has two portions: first, an external coating layer with an exposed lower skin-contacting surface that forms a pressure-sensitive bond with the skin, and second, an upper internal portion which infiltrates the porous backing and becomes solidified therein after being applied so that the reservoir and the backing are unified, enabling the backing itself to act as a storage location for the medication-containing reservoir. The medication within the reservoir migrates over time from within the backing through the lower coating layer and passes through the skin to provide sustained release of the medication into the body of a patient.

Claims

1. A method of forming a medication-containing adhesive patch that can be applied to the skin of a patient, the method comprising the steps of:

(a) providing a backing layer having an upper portion and a lower portion, the backing layer comprising flexible, porous, and water insoluble material selected from;

non-woven fabric, cellulose fiber, woven fabric, polymeric material, open-cell plastic foam, or a combination thereof;

wherein the backing layer is non-occlusive, is in a sheet form, and serves as a support for the patch;

(b) applying a hydrogel to the backing layer such that the hydrogel penetrates between about one-fourth to about nine-tenths the thickness of the backing layer, wherein the hydrogel comprises a polymer, a hydrophilic humectant, a medicament, and a hydrophilic adhesive substance;

(c) limiting the penetration of the hydrogel within the backing layer to the lower portion of the backing layer; and

(d) maintaining the upper portion of the backing layer essentially free of the hydrogel;

thereby providing a medication-containing adhesive patch that can be applied to the skin of a patient.

2. The method of claim 1 wherein the hydrogel is solidified within the backing layer after the hydrogel is applied to the backing layer.

3. The method of claim 2 wherein the solidification of the hydrogel is effected by heating the hydrogel.

4. The method of claim 1 wherein the hydrogel is chilled when applied to the backing layer.

5. The method of claim 1 wherein the hydrogel is applied to the backing layer by spreading the hydrogel upon a surface thereof to form a coating thereon.

6. The method of claim 5 wherein a liner sheet is removably applied to the pressure-sensitive surface of the hydrogel coating the backing layer, to protect the hydrogel coating during shipment and storage.

7. The method of claim 1 wherein,

(a) the hydrogel is a dispersion of a natural or synthetic hydrophilic polymer and a liquid, and

(b) the dispersion is continuously formed by mixing and is applied as a continuous stream onto the backing layer to form a coating thereon.

8. The method of claim 7 wherein heat is applied to cure the coating thus applied to the backing layer.

9. The method of claim 1 wherein the hydrogel is solidified within pores of the backing layer to unify the backing layer and the coating such that the backing layer acts as a storage location for the hydrogel.

10. The method of claim 1 wherein the polymer comprises a natural gum, a synthetic saccharide, a cellulose, a synthetic polymer, or a combination thereof.

11. The method of claim 1 wherein the hydrophillic humectant comprises a polyhydric alcohol.

12. The method of claim 1 wherein the medicament is trolamine salicylate, methyl salicylate, menthol, camphor, eucalyptus oil, spearmint oil, hydrocortisone, benzocaine, lidocaine, ibuprofen, salicylic acid, capsicum, or a combination thereof.

13. The method of claim 1 wherein the hydrophilic adhesive substance comprises a resin emulsion adhesive, an acrylic ester copolymer, a vinyl acetate resin, or a combination thereof.

14. The method of claim 1 wherein the backing layer is treated with a sizing material, a release coating, or a combination thereof.