Iontophoretic Drug Delivery Packaging

Abstract

The present invention relates generally to iontophoretic drug delivery systems for transdermal delivery of therapeutic agents and, more particularly, to packaging such systems for long shelf life and easy assembly for use. The system package includes an iontophoretic skin worn patch component that accommodates a power source, electronics, electrodes and a drug pack component that carries a therapeutic agent which is contained as a separate sealed component. The packaged system further provides for ease of assembly at the time of use.

1 - 24 . (canceled) 
     
     
         25 . A drug pack component for assembly into an iontophoretic drug delivery system comprising:
 (a) a carrier substrate;   (b) one or more gel pads adhered to said substrate;   (c) a cover membrane of a material of low moisture permeability spaced from and enclosing said one or more gel pads; and   (d) an amount of a gel material absorbed in said one or more gel pads with at least one of said pads containing an amount of a therapeutic agent.   
     
     
         26 . A drug pack as in  claim 25  further comprising an occlusive ring on an exposed surface of each of said one or more gel pads. 
     
     
         27 . A drug pack as in  claim 26  wherein said occlusive ring matches the periphery of a corresponding electrode. 
     
     
         28 . A drug pack as in  claim 25  wherein said gel pads comprise laminated non-woven polymer matrices. 
     
     
         29 . A drug pack as in  claim 28  wherein said matrices contain perforations. 
     
     
         30 . A drug pack as in  claim 25  wherein the viscosity of said gel is at least 8,000 centipoises. 
     
     
         31 . A drug pack as in  claim 25  wherein said gel material comprises a material selected from the group consisting of HPMC, PVP, PEO, and PVA and combinations thereof. 
     
     
         32 . A drug pack as in  claim 31  wherein the viscosity of said gel is at least 8,000 centipoises. 
     
     
         33 . A drug pack as in  claim 31  wherein said gel comprises HPMC. 
     
     
         34 . A drug pack as in  claim 33  wherein the viscosity of said gel is at least 8,000 centipoises. 
     
     
         35 . A drug pack as in  claim 25  wherein said gel pads include one or more materials selected from the group consisting of cotton, polypropylene, polyethylene and a polyester. 
     
     
         36 . A drug pack as in  claim 35  wherein said gel pads include polypropylene. 
     
     
         37 . A drug pack as in  claim 29  wherein said gel pads include polypropylene. 
     
     
         38 . A drug pack as in  claim 35  wherein said gel pads comprise laminated, non-woven materials. 
     
     
         39 . A drug pack as in  claim 25  wherein said cover membrane having low moisture permeability comprises a material selected from the group consisting of metal/polymer composites and PVC. 
     
     
         40 . A drug pack as in  claim 39  wherein said cover membrane comprises an aluminum/nylon composite material. 
     
     
         41 . A method of assembling a drug pack comprising:
 (a) placing one or more gel pads in recesses in spaced cavities in a shaped lid member;   (b) dispensing an amount of gel onto each said one or more gel pads such that the height of the gel extends beyond the depth of each corresponding cavity;   (c) applying a generally flat carrier substrate layer to said lid member contacting the gel, and sealing the substrate layer to said lid member; and   (d) allowing said gel to cause each said gel pad to adhere to said substrate layer and be drawn away from a corresponding cavity as said gel is absorbed into each pad, providing a clearance between said cover membrane and said gel pads.   
     
     
         42 . A method as in  claim 39  wherein step (c) is accomplished prior to said gel soaking through said pads. 
     
     
         43 . A method of storing an iontophoretic drug delivery system comprising:
 storing a drug pack component and an iontophoresis patch as separate entities in a common package for assembly prior to use wherein said drug pack component and said iontophoresis patch are configured to combine when superimposed to form a self-contained wearable drug delivery system.   
     
     
         44 . A method of using a prepackaged iontophoresis drug delivery system including drug pack and iontophoresis patch comprising:
 (a) removing the system drug pack and iontophoresis components from a storage package and removing necessary cover membranes and release liners;   (b) assembling the system by combining said drug pack and said iontophoresis using an alignment structure in a manner that brings them into permanent adhesive contact forming a transdermal iontophoresis patch that is ready to use; and   (c) applying the transdermal iontophoresis patch to the skin of a patient at a desired location.   
     
     
         45 . A method as in  claim 44  wherein step (b) includes the use of a guide element. 
     
     
         46 . A method as in  claim 44  wherein about one half of the patch skin adhesive layer is exposed initially when the patch is applied to the skin followed by removal of a half release liner to achieve full patch adhesion.