Iontophoretic Drug Delivery Packaging

• US 20120022431A1
• Filed: 09/03/2009
• Published: 01/26/2012
• Est. Priority Date: 09/05/2008
• Status: Active Grant

• Current Assignee: Teva Pharmaceuticals International GmbH (Teva Pharmaceutical Industries Limited)
• Original Assignee: Travanti Pharma Inc. (Teikoku Seiyaku)
• Inventors: Krinke, Todd A.
• Granted Patent: US 9,492,650 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61N 1/0428 Specially adapted for iontophoresis, e.g. AC, DC or including drug reservoirs
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0448 Drug reservoir
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis
• CPC Class Codes: A61N 1/303 Constructional details electrodes for external use A61N1/0428
• CPC Class Codes: A61N 1/325 for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body electrodes for external use A61N1/0428

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.

Claims

1. An iontophoretic drug delivery system for pre-use assembly comprising:

(a) a drug pack component comprising one or more gel pads;

(b) an iontophoresis patch component;

(c) wherein said iontophoresis patch component is configured to align with one or more gel pads of said drug pack component in conductive relation in an assembled state; and

(d) an alignment structure to assist in assembling said components, wherein when said alignment structure is selected from;

(1) a folding support structure associated with said drug pack component and said iontophoresis patch component, said folding support structure comprises a separator component configured to physically separate and protect said drug pack and iontophoresis patch components when said iontophoretic drug delivery system is present in a folded storage stage; and

(2) a guide element for separate consecutive alignment of said drug pack with iontophoresis patch component.

2. An iontophoretic drug delivery system as in claim 1 wherein said alignment structure comprises a multi-panel folding support structure associating said drug pack component, said iontophoresis patch component and said separator component.

3. An iontophoretic drug delivery system as in claim 2 wherein said drug pack component and said iontophoresis patch component are provided on separate conjoined panels of said folding support structure.

4. An iontophoretic drug delivery system as in claim 2 wherein said folding support structure assumes one folded configuration for storage and a different folded configuration for assembly of said system.

5. An iontophoretic drug delivery system as in claim 2 wherein said support structure comprises four conjoined folding panels.

6. An iontophoretic drug delivery system as in claim 1 wherein said drug pack component and said iontophoresis patch component are provided on separate support structures and wherein said alignment structure comprises a guide element associated with at least one of said support structures.

7. An iontophoretic drug delivery system as in claim 3 wherein said support structures are connected.

8. An iontophoretic drug delivery system as in claim 6 wherein said guide element includes raised alignment members and said support structures include corresponding openings to receive said alignment members.

9. An iontophoretic drug delivery system as in claim 5 wherein one of said support structures is attached to said guide element prior to assembly of said system.

10. An iontophoretic drug delivery system as in claim 1 wherein said drug pack component comprises gel pads including an anode gel pad and a cathode gel pad isolated prior to assembly by a cover membrane having low moisture permeability.

11. An iontophoretic drug delivery system as in claim 10 wherein said gel pads comprise one or more layers of non-woven polymer matrix.

12. An iontophoretic drug delivery system as in claim 10 including an amount of therapeutic agent ion species located in gel associated with at least one of said gel pads.

13. An iontophoretic drug delivery system as in claim 1 including an amount of therapeutic species in said iontophoresis patch.

14. An iontophoretic drug delivery system as in claim 10 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.

15. An iontophoretic drug delivery system as in claim 12 wherein said therapeutic agent is present in said gel in a concentration from about 0.2% to 10%.

16. An iontophoretic drug delivery system as in claim 1 wherein said iontophoresis patch component includes electrodes comprising an anode and a cathode and a source of electric power.

17. An iontophoretic drug delivery system as in claim 16 wherein said drug pack component comprises 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.

18. An iontophoretic drug delivery system as in claim 1 further comprising a peripheral adhesive layer bonding said gel pads to said electrodes in said assembled state.

19. An iontophoretic drug delivery system as in claim 10 wherein said cover membrane having low moisture permeability comprises a material selected from the group consisting of metal/polymer composites and PVC.

24. An iontophoretic drug delivery system as in claim 16 wherein said patch further comprises a half release liner covering a portion of a skin adhesive.

20. An iontophoretic drug delivery system packaged for easy assembly comprising:

(a) a drug pack component containing an anode gel pad and a cathode gel pad removably carried on a first support structure and isolated by a membrane having a low moisture permeability prior to assembly;

(b) an iontophoresis patch component including an anode electrode and a cathode electrode and a source of electric power, said patch being removably carried on a second support structure;

(c) wherein said iontophoresis patch component includes shaped recesses associate with said anode and said cathode configured to receive said anode and cathode gel pads respectively, in conductive relation in an assembled state;

(d) wherein said first support structure and said second support structure are selected from the group consisting of conjoined folding panels including separator protector panels for folded storage and separate members for assembly with a guide element; and

(e) and amount of therapeutic ion species located in at least one of said anode gel pad, said cathode gel pad and said iontophoresis patch.

21. An iontophoretic drug delivery system as in claim 20 further comprising a peripheral adhesive layer bonding said gel pads to said electrodes in said assembled state.

22. An iontophoretic drug delivery system comprising:

(a) a drug pack component comprising one or more gel pads;

(b) an iontophoretic patch component;

(c) an alignment structure to assist in assembling said components comprising a multi-panel folding support structure having a panel associated with each said drug pack component;

(d) wherein said iontophoresis patch component is configured to align with one or more gel pads of said drug pack component in conductive relation when said alignment structure is folded in an assembled state; and

(e) wherein said drug pack component and said iontophoresis patch component and separator panels are inside a folded structure and have a panel interposed therebetween as folded in a packaged or stored state.

23. An iontophoretic drug delivery system as in claim 22 wherein a folded storage configuration is secured by a releasable adhesive.

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.

42. A method as in claim 39 wherein step (c) is accomplished prior to said gel soaking through said pads.

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.

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.