Disposable and/or replenishable transdermal drug applicators and methods of manufacturing same

• US 4,883,457 A
• Filed: 06/05/1987
• Issued: 11/28/1989
• Est. Priority Date: 08/18/1983
• Status: Expired due to Term

• Current Assignee: Drug Delivery Systems Incorporated
• Original Assignee: Drug Delivery Systems Incorporated
• Inventors: Sibalis, Dan
• Primary Examiner(s): Hindenburg, Max
• Assistant Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US07/058,527
• Time in Patent Office: 907 Days
• Field of Search: 128/798, 128/802, 128/803, 604/20
• US Class Current: 604/20
• CPC Class Codes: A61M 37/00 Other apparatus for introducing media into the body for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30; Percutany, i.e. introducing medicines into the body by diffusion through the skin salt baths A61H33/04
• CPC Class Codes: A61N 1/0436 Material of the electrode
• CPC Class Codes: A61N 1/044 Shape of the electrode
• CPC Class Codes: A61N 1/0448 Drug reservoir

Abstract

Applicators for the electrophoretic and/or electro-osmostic dispensing of a medicament across the skin and into the bloodstream of a patient. Each applicator includes two electrodes in electrical contact with the skin with at least one of the electrodes being a drug reservoir, at least one battery, a flexible, non-conductive substrate having an electrically conductive coating extending to electrical contact with each electrode and to the terminals of the battery, the substrate being folded into at least two layers, a cover adhesively secured to the applicator, and a release liner covering and protecting the drug reservoir or reservoirs until use.

Claims

1. A transdermal drug applicator for application to the skin of a patient which is electrically powered, comprising:

a flexible, non-conductive substrate having conductive coated areas which together form a single flexible member said flexible substrate defining first and second surfaces, and said conductive coated areas being on said first surface and forming drug reservoir electrodes, said flexible member being folded at about 180 degrees at each of two opposite ends to form top side and bottom side portions with the conductive coated areas providing electrical conductors between said top side and said bottom side portions, a plurality of separated drug reservoirs in electrical contact with said drug reservoir electrodes at said bottom side portions, a power source, including an electrical circuit, connected to said conductors at said top side portions for providing current to said plurality of drug reservoirs via said conductors and drug reservoir electrodes, electrical current conditioning means in said circuit with said power source and said drug reservoir electrodes, and a covering for said drug applicator enveloping and enclosing said flexible member, said power source and current conditioning means, and said plurality of drug reservoirs leaving a side of said drug reservoirs free for application.

2. The transdermal drug applicator according to claim 1, wherein said power source is a reusable battery and said cover forms an aperture to receive said reusable power source, said reusable power source having positive and negative terminals adapted to be in electrical contact with said conductive areas so as to form an electrical circuit when said reusable battery is positioned in said aperture.

3. The transdermal drug applicator according to claim 2 further including a programmable control means connected to said reusable power source so as to make a reusable power and control unit adapted to be removably placed in said applicator at said aperture.

4. The transdermal drug applicator according to claim 3, wherein said power source includes a pair of positive and negative sheet electrodes.

5. The transdermal drug applicator according to claim 4, wherein said pair of positive and negative sheet electrodes are zinc and carbon electrodes, respectively.

6. The transdermal drug applicator according to claim 1, wherein said drug reservoirs include gels.

7. The transdermal drug applicator according to claim 6, wherein said gels are reinforced by scrims.

8. The transdermal drug applicator according to claim 2, wherein said drug reservoirs include open cell foam material impregnated with gels.

9. The transdermal drug applicator according to claim 8, further including a semi-permeable membrane in juxtaposition to said drug reservoirs, said semi-permeable membrane having seals so as to define particular drug zones.

10. The transdermal drug applicator according to claim 9, wherein said drug zones contain drugs of different compositions from each other.

11. The transdermal drug applicator according to claim 9, wherein said drug zones contain drugs of different concentrations from each other.

12. The transdermal drug applicator according to claim 1, further including another substrate containing thereon a coated release agent, and said plurality of drug reservoirs being positioned with their free sides in juxtaposition with said release agent of said another substrate.

13. A transdermal drug applicator according to claim 12, wherein said topside portions of said coated areas are joined to terminals of said power source so as to create an electrical circuit when said applicator is applied to the skin.

14. The transdermal drug applicator according to claim 1, wherein some of the conductors are of a predetermined resistance so as to perform the function of a current limiting resistor.

15. The transdermal drug applicator according to claim 1, wherein at least one of said drug reservoir electrodes of one of said plurality of drug reservoirs comprises graphite.

16. The transdermal drug applicator according to claim 15, wherein said plurality of drug reservoirs have opposed inner and outer sides with the outer sides adapted to make contact with the sun of patent upon application, and said at least one electrode mode of graphite is in electrical contact with said inner side of said one drug reservoir.

17. The transdermal drug applicator according to claim 1, further including an adhesive layer on the other side of said non-conductive substrate for firmly securing the folded opposite ends of said non-conductive substrate to itself.

18. The transdermal drug applicator according to claim 1, further including a conductive adhesive at opposite end portions of said conductive coated areas for removably securing said plurality of drug reservoirs to said conductive coated areas.

19. The transdermal drug applicator according to claim 1, further including spacer means having cutouts, and being disposed between said non-conductive substrate and said covering for locating in said cutouts said current conditioning means and said power source.

20. The transdermal drug applicator according to claim 19, including a non-conductive liner having a plurality of perforations juxtaposed on both sides of said spacer means, and said perforations arranged in line with said current conditioning means and said power source.

21. The transdermal drug applicator according to claim 20, including conductive adhesives extending through said perforations for maintaining electrical contact with said current conditioning means and said power source.

22. The transdermal drug applicator according to claim 2, wherein said power source is a plurality of electrically connected batteries.

23. The transdermal drug applicator according to claim 22, wherein said batteries and current conditioning means together with predetermined printed circuit layouts in said applicator and said conductive adhesives form said electrical circuit of the drug applicator.

24. The applicator drug applicator according to claim 23, wherein said predetermined printed circuit layers are formed by a conductive paint.

25. The transdermal drug applicator according to claim 23, wherein said predetermined printed circuit layouts are formed on said liner.

26. The transdermal drug applicator according to claim 20, further including apertures in said spacer means, said liners and said non-conductive substrate forming in registry at least one window in said transdermal drug applicator.

27. The transdermal drug applicator according to claim 1, wherein said electrical circuit includes indicator means in said electrical circuit.