Multilayer drug delivery system with barrier against reservoir material flow

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.

1 - 13 . (canceled) 
     
     
         14 . A method of making a device for delivery of a pharmaceutical agent to an individual through a body surface, comprising:
 cutting a reservoir and a first backing layer from a first web,
 wherein the reservoir has a first matrix comprising at least one pharmaceutical agent in the first matrix, 
 wherein the first backing layer is substantially impermeable to the pharmaceutical agent, and 
 wherein the reservoir is attached to the first backing layer and has a reservoir outer perimeter; and 
   affixing a barrier layer between the reservoir and at least part of a second matrix layer on a second web,
 wherein the second matrix layer is permeable to the pharmaceutical agent, 
 wherein the barrier layer is a material that is substantially impermeable to the pharmaceutical agent, the barrier layer having a barrier layer outer perimeter, and 
 wherein the reservoir outer perimeter is smaller than the barrier layer outer perimeter. 
   
     
     
         15 . The method of  claim 14 , further comprising:
 cutting a window in the barrier layer such that at least one of the second matrix layer and the first backing layer can extend through the window to attach to the other layer,   wherein the first backing layer is disposed between the second matrix layer and the reservoir.   
     
     
         16 . The method of  claim 15 , further comprising:
 cutting the part of the second matrix layer attached to a second backing layer from the second web,
 wherein the second backing layer has a second backing layer outer perimeter, 
 wherein the second matrix layer has a second matrix layer outer perimeter, and 
 wherein the second matrix layer outer perimeter is larger than the barrier layer outer perimeter, and 
   cutting the first web such that the first backing layer has a first backing layer outer perimeter that is smaller than the second backing layer outer perimeter.   
     
     
         17 . The method of  claim 15 , further comprising:
 feeding into a die system the first web of reservoir material and first backing layer material at a first speed; and   feeding into the die system the second web of the second matrix layer material and the second backing layer material at a second speed different than the first speed,   cutting the first web of reservoir material and first backing layer material into discrete reservoirs and first backing layers; and   attaching the discrete reservoirs and first backing layers on the second matrix layer material on the second web, such that the discrete reservoirs and first backing layers are spaced apart on the second matrix layer material on the second web.   
     
     
         18 . The method of  claim 14 , wherein the first web and the second web are mechanically cut by a machine that cuts in cycles of motion, and wherein the reservoir and the first backing layer have flush edges resulting in at least one of the first backing layer edges having material from the first matrix adhering thereto before deployment of the device on an individual. 
     
     
         19 . The method of  claim 15 , further comprising:
 cutting from a third web a third matrix layer attached to a third backing layer such that the third backing layer has a third backing layer outer perimeter, and   disposing the third matrix layer between the reservoir and the second matrix layer,
 wherein the third matrix layer has a third matrix layer outer perimeter that is the same size as the third backing layer outer perimeter, and 
 wherein the third matrix layer contains a pharmaceutical agent. 
   
     
     
         20 . The method of  claim 19 , further comprising:
 cutting a second barrier layer having a window, and   affixing the second barrier layer between the barrier layer and the reservoir,
 wherein the second barrier layer has a second barrier layer outer perimeter that is smaller than the third matrix layer outer perimeter, and 
 wherein the third matrix layer outer perimeter is smaller than the barrier layer outer perimeter. 
   
     
     
         21 . The method of  claim 20 , further comprising:
 disposing layers in the device such that the first backing layer is disposed between the reservoir and the second barrier layer, the second barrier layer is disposed between the first backing layer and the third matrix layer, the third matrix layer is disposed between the second barrier layer and the third backing layer, the third backing layer is disposed between the third matrix layer and the barrier layer, the barrier layer is disposed between the third backing layer and the second matrix layer, and the second matrix layer is disposed between the barrier layer and the second backing layer,   wherein the reservoir is for contacting the body surface, and   wherein the reservoir is most proximal to the body surface and the second backing layer is most distal to the body surface.   
     
     
         22 . The method of  claim 15 , further comprising:
 cutting from a third web a third matrix layer attached to a third backing layer,
 wherein the third backing layer has a third backing layer outer perimeter, 
   disposing the third matrix layer between the reservoir and the second matrix layer,
 wherein the third matrix layer has a third matrix layer outer perimeter that is the same size as the third backing layer outer perimeter, and 
 wherein the third matrix layer outer perimeter is smaller than the window; and 
   affixing one of at least part of the third matrix layer and at least part of the first backing layer to at least part of the other layer through the window,
 wherein the third matrix layer contains a pharmaceutical agent. 
   
     
     
         23 . The method of  claim 15 , further comprising:
 cutting to provide a frame shape to the barrier layer, and   attaching the framed shaped barrier layer to the second matrix layer on the second web.   
     
     
         24 . The method of  claim 15 , further comprising:
 positioning the device in a protective pouch; and   sealing the protective pouch to enclose the device.   
     
     
         25 . The method of  claim 14 , wherein the second matrix layer contains a pharmaceutical agent. 
     
     
         26 . The method of  claim 14 , further comprising:
 cutting the barrier layer from a web having a barrier layer material.   
     
     
         27 . The method of  claim 15 , further comprising:
 cutting from a third web a third matrix layer attached to a third backing layer,
 wherein the third matrix layer has a third matrix layer outer perimeter, 
 wherein the third matrix layer outer perimeter is larger than the second matrix layer outer perimeter; 
   cutting a second barrier layer having a window,
 wherein the second barrier layer outer perimeter is smaller than the third matrix layer outer perimeter, 
 wherein the second barrier layer is larger than the second matrix layer outer perimeter; 
   disposing the third matrix layer on the side of the second matrix layer more distal from the reservoir; and   disposing the second barrier layer between the third matrix layer and the second matrix layer,
 wherein the second matrix layer contains a pharmaceutical agent. 
   
     
     
         28 . A method of making a device for delivery of a pharmaceutical agent to an individual through a body surface, comprising:
 cutting a reservoir and a first backing layer from a first web,
 wherein the reservoir has a first matrix comprising at least one pharmaceutical agent in the first matrix, 
 wherein the first backing layer is substantially impermeable to the pharmaceutical agent, and 
 wherein the reservoir is attached to the first backing layer and has a reservoir outer perimeter; 
   cutting a second matrix layer from a second web having a second matrix material permeable to the at least one pharmaceutical agent;   cutting a barrier layer from a web having a barrier material that is substantially impermeable to the at least one pharmaceutical agent,
 wherein the barrier layer having has a barrier layer outer perimeter, and a window smaller than the reservoir outer perimeter; and 
   affixing the barrier layer between the reservoir and at least part of the second matrix layer,
 wherein the reservoir outer perimeter is smaller than the barrier layer outer perimeter. 
   
     
     
         29 . A method of making a device for delivery of a pharmaceutical agent to an individual through a body surface, comprising:
 cutting a reservoir and a first backing layer from a first web,
 wherein the reservoir has a first matrix comprising at least one pharmaceutical agent in the first matrix, 
 wherein the first backing layer is substantially impermeable to the at least one pharmaceutical agent, 
 wherein the reservoir is attached to the first backing layer and has a reservoir outer perimeter, and 
 wherein the first backing layer has a first backing layer outer perimeter that is the same size as the reservoir outer perimeter; 
   cutting a second matrix layer and a second backing layer from a second web,
 wherein the second matrix layer is permeable to the at least one pharmaceutical agent, 
 wherein the second backing layer has a second backing layer outer perimeter, and 
 wherein the second matrix layer has a second matrix layer outer perimeter that is the same size as the second backing layer outer perimeter; 
   cutting a barrier layer from a web having a barrier material that is substantially impermeable to the at least one pharmaceutical agent,
 wherein the barrier layer has a barrier layer outer perimeter, 
 wherein the barrier layer outer perimeter is smaller than the second matrix layer outer perimeter, and 
 wherein the barrier layer has a window smaller than the reservoir layer outer perimeter; and 
   affixing the barrier layer between the reservoir and at least part of the second matrix layer,
 wherein the reservoir outer perimeter is smaller than the barrier layer outer perimeter.