Iontophoretic drug delivery method

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.

What is claimed is: 
     
         1 . A method of administering a therapeutic agent to a patient with an iontophoretic drug delivery system, the method comprising the steps of:
 (a) removing a drug pack component of the iontophoretic drug delivery system and an iontophoresis patch component of the iontophoretic drug delivery system from a storage package and removing one or more of the cover membranes and release liners;   (b) assembling the iontophoretic drug delivery system by combining the drug pack component and the iontophoresis patch component, the assembling step including aligning the drug pack component and the iontophoresis patch component relative to one another with an alignment structure and affixing the drug pack component and the iontophoresis patch component into permanent adhesive contact forming a transdermal iontophoresis patch that is ready to use, wherein said alignment structure is either:
 (1) a folding support structure associated with the drug pack component and the iontophoresis patch component, the folding support structure including a separator component configured to physically separate and protect the drug pack component and the iontophoresis patch component when the iontophoretic drug delivery system is present in a folded storage state; or 
 (2) a separate guide element including a raised alignment members configured to register with the drug pack component and the iontophoresis patch component for separate consecutive alignment of the drug pack component with the iontophoresis patch component; and 
   (c) applying the transdermal iontophoresis patch to the skin of the patient at a desired location.   
     
     
         2 . The method according to  claim 1  wherein the iontophoresis drug delivery system comprises a patch skin adhesive layer and the one or more release liners comprise a half release liner, and 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 the half release liner to achieve full patch adhesion. 
     
     
         3 . The method according to  claim 1 , further comprising the step of:
 unfolding the drug pack component from the iontophoresis patch component to access the separator component for removal.   
     
     
         4 . The method according to  claim 1 , further comprising the step of:
 removing the transdermal iontophoresis patch from the folding support structure prior to applying the transdermal iontophoresis patch to the skin of the patient.   
     
     
         5 . The method according to  claim 1  wherein said drug pack component includes a pair of gel pads including an anode gel pad and a cathode gel pad isolated prior to assembly by a cover membrane having low moisture permeability. 
     
     
         6 . The method according to  claim 5 , further comprising the step of:
 activating a current configured to draw the therapeutic agent from the gel pad through the skin of the patient.   
     
     
         7 . The method according to  claim 5  wherein said gel pads comprise one or more layers of non-woven polymer matrix. 
     
     
         8 . The method according to  claim 5  including an amount of therapeutic agent ion species located in gel associated with at least one of said gel pads. 
     
     
         9 . The method according to  claim 5  wherein said gel pads are fixed to a substrate layer in said drug pack by adherence of a gel material prior to assembly of said system. 
     
     
         10 . The method according to  claim 5  wherein said therapeutic agent is present in said gel in a concentration from about 0.2% to 10%. 
     
     
         11 . The method according to  claim 5  wherein said iontophoresis patch component includes electrodes comprising an anode and a cathode and a source of electric power. 
     
     
         12 . The method according to  claim 11  wherein said drug pack component comprises the gel pads and the electrodes are contained in recesses adapted to receive the gel pads of the drug pack upon assembly of the transdermal iontophoresis patch. 
     
     
         13 . The method according to  claim 5  further comprising a peripheral adhesive layer bonding the gel pad to an electrode in the transdermal iontophoresis patch. 
     
     
         14 . The method according to  claim 1  wherein said cover membrane having low moisture permeability comprises a material selected from the group consisting of metal/polymer composites and PVC. 
     
     
         15 . A method of administering a therapeutic agent to a patient with an iontophoretic drug delivery system, the method comprising the steps of:
 removing a separator component from a drug pack component having a gel pad, the separator component configured to be interposed between and thereby physically separate and protect the drug pack component and an iontophoresis patch component when the iontophoretic drug delivery system is present in a fully folded storage stage;   folding a folding support structure to align an iontophoresis patch component with the drug pack component, wherein said iontophoresis patch component is configured to align said gel pads of said drug pack component in conductive relation in an assembled state, the folding support structure is associated with the drug pack component and the iontophoresis patch component; and   applying the iontophoretic drug delivery system in the assembled state to the skin of the patient.   
     
     
         16 . The method according to  claim 15 , further comprising the step of:
 unfolding the drug pack component from the iontophoresis patch component to access the separator component for removal.   
     
     
         17 . The method according to  claim 15 , further comprising the step of:
 removing the iontophoretic drug delivery system in the assembled state from the folding support structure prior to applying the iontophoretic drug delivery system in the assembled state to the skin of the patient.   
     
     
         18 . The method according to  claim 15 , further comprising the step of:
 activating a current configured to draw the therapeutic agent from the gel pad through the skin of the patient.   
     
     
         19 . The method according to  claim 15 , wherein said drug pack component include a pair of gel pads including an anode gel pad and a cathode gel pad isolated prior to assembly by a cover membrane having low moisture permeability. 
     
     
         20 . The method according to  claim 19  wherein said gel pads comprise one or more layers of non-woven polymer matrix. 
     
     
         21 . The method according to  claim 19  including an amount of therapeutic agent ion species located in gel associated with at least one of said gel pads. 
     
     
         22 . The method according to  claim 19  wherein said gel pads are fixed to a substrate layer in said drug pack by adherence of a gel material prior to assembly of said system. 
     
     
         23 . The method according to  claim 21  wherein said therapeutic agent is present in said gel in a concentration from about 0.2% to 10%. 
     
     
         24 . The method according to  claim 15  wherein said iontophoresis patch component includes electrodes comprising an anode and a cathode and a source of electric power. 
     
     
         25 . The method according to  claim 24  wherein said drug pack component comprises the gel pads and said electrodes are contained in recesses adapted to receive said gel pads of said drug pack upon assembly of said system into said assembled state. 
     
     
         26 . The method according to  claim 15  further comprising a peripheral adhesive layer bonding the gel pad to an electrode in the assembled state. 
     
     
         27 . The method according to  claim 19  wherein said cover membrane having low moisture permeability comprises a material selected from the group consisting of metal/polymer composites and PVC.