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Details for Patent: 6,096,333

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Details for Patent: 6,096,333

Title: Method of forming adhesive patch for applying medication to the skin
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.
Inventor(s): Rolf; David (Minneapolis, MN), Sjoblom Urmann; Elisabeth K. (Tomahawk, WI)
Assignee: LecTec Corporation (Minnetonka, MN)
Filing Date:Oct 08, 1997
Application Number:08/947,089
Claims:1. A method of forming a medication-containing adhesive patch to be applied to the skin for releasing a medication into the body of a patient comprising,

(a) providing a flexible porous backing layer in sheet form to serve as a support for the patch, said layer having a lower portion and an upper portion with an upper surface,

(b) applying an adhesive mass containing a medication to the flexible porous backing layer such that the adhesive mass penetrates into the backing layer to act as a gel matrix for the medication,

(c) providing the adhesive mass with an external exposed first portion for bonding to the skin of the patient,

(d) controlling the forming of said adhesive patch to keep the adhesive mass

(1) sufficiently fluid to penetrate the backing layer while

(2) limiting the penetration of the adhesive mass within the backing layer to said lower portion thereof such that the adhesive mass has a second portion infiltrated within only the lower portion of the porous backing layer, and

(3) maintaining said upper portion of the backing layer free of the adhesive mass,

(e) the backing layer acts as a storage location for the medication-containing adhesive such that the adhesive releases the medication into the body of the patient through an exposed surface thereof that is bonded to the patient's skin, and

(f) solidifying the adhesive mass within said lower portion of said backing layer to cause the upper surface of said porous backing layer to remain spaced apart from the gel matrix.

2. The method of claim 1 wherein the adhesive mass is solidified within the backing layer by changing the temperature of the adhesive mass after being applied to the backing layer.

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

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

5. The method of claim 1 wherein the adhesive mass comprises a hydrocolloidal gel having a pressure-sensitive surface for bonding the patch to the skin of the patient, and the hydrocolloidal gel is applied to the porous backing layer by spreading the gel 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 adhesive mass coating the backing layer to protect the adhesive coating during shipment and storage.

7. The method of claim 1 wherein,

(a) the adhesive mass is formed by admixing 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 said 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 adhesive mass is infiltrated into the porous backing layer to a depth of between about one-fourth and nine-tenths the thickness of the backing layer and 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 medication-containing adhesive mass.

10. The method of claim 1 wherein the adhesive mass is a hydrocolloidal gel and solidification is effected by heating the hydrocolloidal gel after the gel has infiltrated into the pores of the backing layer.

11. The method of claim 1 wherein the adhesive mass is formed by a knife coater to provide a pressure-sensitive surface for bonding to the skin.

12. The method of claim 1 wherein the adhesive mass is a hydrocolloidal gel coating and a liner sheet is removably applied to a pressure-sensitive surface of the hydrocolloidal gel coating to protect the same during shipment and storage.

13. The method of claim 1 wherein the adhesive mass is a hydrocolloidal gel dispersion that is formed continuously within a processing mixer and is applied as a coating in a continuous stream on a moving strip of said backing layer and a web of liner paper having a slippery release surface is applied continuously to an exposed pressure-sensitive surface of the hydrocolloidal gel coating to protect the coating during shipment and storage, and said adhesive patches are cut therefrom.

14. The method of claim 13 wherein the hydrocolloidal gel dispersion is infiltrated into the porous backing layer to a depth of between about one-fourth and nine-tenths the thickness of the backing layer and is solidified within the 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 medication-containing hydrocolloidal gel dispersion.

15. The method of claim 1 wherein a release coating is appplied to the upper surface of the backing layer.

16. A method of forming a medication-containing adhesive patch to be applied to the skin comprising,

(a) providing a flexible porous backing layer in sheet form to serve as a support for the patch, said layer having a lower portion and an upper portion with an upper surface,

(b) applying an adhesive mass containing a medication to the flexible porous backing layer such that the adhesive mass penetrates into the backing layer to act as a gel matrix for the medication,

(c) providing said patch with at least one member selected from the group consisting of karaya, spearmint oil, methyl salicylate, trolamine salicylate, camphor, menthol, emulsion adhesive, capsicum, and eucalyptus oil,

(d) providing the adhesive mass with an external exposed first portion for bonding to the skin of the patient,

(e) controlling the forming of said adhesive patch to keep the adhesive mass

(1) sufficiently fluid to penetrate the backing layer while

(2) limiting the penetration of the adhesive mass within the backing layer to said lower portion thereof such that the adhesive mass has a second portion infiltrated within only the lower portion of the porous backing layer, and

(3) maintaining said upper portion of the backing layer free of the adhesive mass,

(f) the backing layer acts as a storage location for the medication-containing adhesive such that the adhesive releases the medication for utilization by the patient, and

(g) solidifying the adhesive mass within said lower portion of said backing layer to cause the upper surface of said porous backing layer to remain spaced apart from the gel matrix.

17. The method of claim 16 wherein the adhesive mass comprises a hydrocolloidal gel having a pressure-sensitive surface for bonding the patch to the skin of the patient, and the hydrocolloidal gel is applied to the porous backing layer by spreading the gel upon a surface thereof to form a coating thereon.

18. The method of claim 16 wherein a liner sheet is removably applied to a pressure-sensitive surface of the adhesive mass to protect the adhesive during shipment and storage.

19. The method of claim 17 wherein heat is applied to cure the coating thus applied to the backing layer.

20. The method of claim 16 wherein the adhesive mass is formed continuously within a mixer and is applied as a continuous stream on a moving strip of said backing layer and a web of liner paper having a slippery release surface is applied continuously to an exposed pressure-sensitive surface of the hydrocolloidal gel coating to protect the coating during shipment and storage, and said adhesive patches are cut therefrom.

21. The method of claim 20 wherein the adhesive mass is infiltrated into the porous backing layer to a depth of between about one-fourth and nine-tenths the thickness of the backing layer and is solidified within the pores of the backing layer to unify the backing layer such that the backing layer acts as a storage location for the medication-containing adhesive.
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