Multilayer drug delivery system with barrier against reservoir material flow

• US 8,632,800 B2
• Filed: 05/12/2006
• Issued: 01/21/2014
• Est. Priority Date: 05/13/2005
• Status: Expired due to Fees

• Current Assignee: DURECT Corporation
• Original Assignee: ALZA Corporation (Johnson & Johnson)
• Inventors: Jansen, Rolf R., Coronado, Dina J.
• Primary Examiner(s): Schnizer, Richard
• Assistant Examiner(s): Peebles, Katherine
• Application Number:
  US11/433,343
• Publication Number:
  US 20060257462A1
• Time in Patent Office: 2,811 Days
• Field of Search: 424/448, 424/447, 424/449
• US Class Current: 424/447
• CPC Class Codes: A61F 13/0203 with fluid retention members
• CPC Class Codes: A61F 2013/0296 for making transdermal patches (chemical processes excluded)
• CPC Class Codes: A61J 3/00 Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
• CPC Class Codes: A61K 31/55 having seven-membered rings, e.g. azelastine, pentylenetetrazole
• CPC Class Codes: A61K 9/7061 Polyacrylates
• CPC Class Codes: Y10T 156/1082 Partial cutting bonded sandwich [e.g., grooving or incising]

Abstract

A multilayered drug delivery system with a barrier suitable for delivery of drug through an individual'"'"'s body surface. By placing a barrier between two adjacent layers, unintended drug flow due to migration of a drug matrix between the adjacent matrix layers in the system to a patient is avoided.

Claims

1. A device for administration of a pharmaceutical agent to an individual through a body surface, comprising:

a. a reservoir having a first matrix comprising at least one pharmaceutical agent in the first matrix, the reservoir having a reservoir outer perimeter;

b. a first backing layer attached to the reservoir and substantially impermeable to the pharmaceutical agent, the first backing layer having a first backing layer outer perimeter;

c. a second matrix layer permeable to the pharmaceutical agent, the second matrix layer having a second matrix layer outer perimeter; and

d. a barrier layer disposed between the reservoir and at least part of the second matrix layer, the barrier layer having a barrier layer outer perimeter that is smaller than the second matrix layer outer perimeter, the reservoir outer perimeter being smaller than the barrier layer outer perimeter, the barrier layer being of a material that is substantially impermeable to the pharmaceutical agent wherein the barrier layer has a window through which at least one of the second matrix layer and the first backing layer can extend to attach to the other layer;

wherein at least part of the second matrix layer is disposed above the reservoir, as measured from the surface to which the device is applied.

2. The device of claim 1 wherein the second matrix layer is an adhesive, and wherein the reservoir outer perimeter and the first backing layer outer perimeter are the same size.

3. The device of claim 2 further comprising a second backing layer, wherein the second backing layer is attached to the second matrix layer and is positioned more distal from the reservoir, the second backing layer having a second backing layer outer perimeter, and wherein the first backing layer outer perimeter is smaller than the second backing layer outer perimeter.

4. The device of claim 1 wherein the second matrix layer is an adhesive that maintains the device on the body surface for at least two days, and wherein the second matrix layer is attached to the first backing layer.

5. The device of claim 1 wherein the first matrix further comprises an acrylate polymer in which the pharmaceutical agent is soluble.

6. The device of claim 1 further comprising a second backing layer,

wherein the second backing layer is attached to the second matrix layer and is positioned more distal to the reservoir,

and wherein the second matrix layer is an adhesive that maintains the device on the body surface for at least two days.

7. The device of claim 3 wherein the second matrix layer contains a second pharmaceutical agent.

8. The device of claim 1 wherein the device has an intended shelf life and the reservoir exhibits cold flow during the shelf life such that the reservoir outer perimeter enlarges during the shelf life but does not exceed the barrier layer outer perimeter.

9. The device of claim 3 further comprising a third backing layer and a third matrix layer, wherein the third backing layer is attached to the third matrix layer and is positioned more distal to the reservoir, the third matrix layer having a third matrix layer outer perimeter and the third backing layer having a third backing layer outer perimeter,

wherein the third matrix layer outer perimeter is the same size as the third backing layer outer perimeter but larger than the barrier layer outer perimeter,

and wherein the third matrix layer contains a second pharmaceutical agent and is disposed intermediate to the reservoir and the third backing layer.

10. The device of claim 3 further comprising a third matrix layer and a third backing layer, the third matrix layer having a third matrix layer outer perimeter and the third backing layer having a third backing layer outer perimeter,

wherein the third matrix having a third matrix layer outer perimeter is the same size as the third backing layer outer perimeter but smaller than the window of the barrier layer,

wherein the third matrix layer is disposed intermediate to the reservoir and the second matrix layer and can extend in the window to attach to the first backing layer,

and wherein the third matrix layer contains a second pharmaceutical agent.

11. The device of claim 3 wherein the device is made by mechanized mass production.

12. A device for administration of a pharmaceutical agent to an individual at a therapeutically effective rate through a body surface, comprising:

a. a reservoir having a first matrix comprising at least one pharmaceutical agent in the first matrix, the reservoir having a reservoir outer perimeter;

b. a first backing layer attached to the reservoir and substantially impermeable to the pharmaceutical agent, the first backing layer having a first backing layer outer perimeter;

c. a second matrix layer permeable to the pharmaceutical agent, the second matrix layer having a second matrix layer outer perimeter;

d. a second backing layer attached to the second matrix layer, the second backing layer having a second backing layer outer perimeter; and

e. a barrier layer disposed intermediate to the reservoir and at least part of the second matrix layer, the barrier layer having a barrier layer outer perimeter, the barrier layer being a material that is substantially impermeable to the pharmaceutical agent, and the barrier layer having a window through which at least one of the second matrix layer and the first backing layer can extend to attach to the other;

wherein the second backing layer outer perimeter is the same size as the second matrix layer outer perimeter but larger than the barrier layer outer perimeter,

and wherein the first backing layer outer perimeter is the same size as the reservoir outer perimeter but smaller than the barrier layer outer perimeter.