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

• US 5,976,101 A
• Filed: 06/07/1995
• Issued: 11/02/1999
• Est. Priority Date: 08/18/1983
• Status: Expired due to Fees

• Current Assignee: Drug Delivery Systems Incorporated
• Original Assignee: Drug Delivery Systems Incorporated
• Inventors: Sibalis, Dan
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US08/474,251
• Time in Patent Office: 1,609 Days
• Field of Search: 604/20, 607/115, 607/149, 607/152, 424/447-449, 29/877
• US Class Current: 604/20
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• 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
• 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
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing
• CPC Class Codes: Y10T 29/4921 with bonding

Abstract

An electrically/battery powered transdermal drug applicator comprising a flexible non-conductive substrate with a plurality of conductive coated areas, the conductive coated areas forming drug reservoir electrodes, and a plurality of drug reservoirs separated by occlusive adhesive dams and in electrical contact with said drug reservoir electrodes. The battery is connected to the electrodes of the drug reservoirs and said applicator including electrical current conditioning means, with a conformal cover adhesively secured to said transdermal drug applicator and with a release liner covering and protecting said plurality of drug reservoirs until use.

Claims

1. A method of manufacturing a transdermal drug applicator which is electrically activated, comprising the steps of:

a. applying conductive coated areas to one surface of a substrate for use in said drug applicator;

b. folding said conductive coated areas so as to provide electrical conductors leading to the other surface of the substrate;

c. applying at least one occlusive adhesive dam to a surface of another substrate;

d. adding at least one drug reservoir to said surface of said another substrate in areas not occupied by said occlusive adhesive dam;

e. applying at least one drug reservoir to a portion of at least one of said electrical conductors; and

f. joining together said substrate and said another substrate to form a construction in which said drug reservoirs and said occlusive adhesive dam are contained between said substrates.

3. The method of manufacturing a transdermal drug applicator which is electrically activated according to claim 1, wherein at least one of conductive material comprise carbon powder.

4. The method of manufacturing a transdermal drug applicator which is electrically activated according to claim 3, wherein said carbon powder contains a depolarizing agent.

5. The method of manufacturing a transdermal drug applicator which is electrically activated according to claim 3, wherein at least one of said conductive coated areas comprise a noble metal.

6. The method of manufacturing a transdermal drug applicator which is electrically activated according to claim 1, further comprising the step of forming one electrode of a first cell of a battery by extending one of said conductive material and forming at least one additional separate electrode of a further cell of said battery using the same conductive material.

7. The method of manufacturing a transdermal drug applicator which is electrically activated, according to claim 6, further comprising the step of forming a plurality of negative battery electrodes on said substrate;

and electrically connecting the last negative battery electrode to a conductive surface on said substrate.

8. The method of manufacturing a transdermal drug applicator which is electrically activated according to claim 6, further comprising the step of interconnecting the battery cell electrodes in series by means of a conductive adhesive.

9. The method of manufacturing a transdermal drug applicator which is electrically activated according to claim 8, further comprising the step of folding said substrate along a plurality of fold lines so as to form individual battery cells, and placing in between the cell electrodes a gelled battery electrolyte impregnated thermoplastic separator and heat sealing the periphery of said cells.

10. The method of manufacturing a transdermal drug applicator which is electrically activated according to claim 9, further comprising the step of adding an electronic current conditioning means in series with said battery, and the drug reservoir electrode not connected to said battery.

11. The method of manufacturing a transdermal drug applicator which is electrically activated according to claim 10, wherein all of the electrical connections within said drug applicator are made by the use of conductive flexible adhesives.

2. The method of manufacturing an electrically activated transdermal drug applicator, comprising the steps of:

a. applying a conductive material to one surface of a first substrate;

b. folding the conductive material away from itself to create a first conductive surface and a second, opposed conductive surface;

c. applying at least one occlusive adhesive dam to a surface of a second substrate;

d. adding at least one drug reservoir to the surface of the second substrate in areas not occupied by the occlusive adhesive dam;

e. applying at least one drug reservoir to a portion of at least one of the conductive surfaces of the first substrate; and

f. joining together the first and second substrates whereby the drug reservoirs and the occlusive adhesive dam are contained between the substrates.

12. The method of manufacturing a transdermal drug applicator which is electrically activated according to claim 2, further comprising the step of applying an adhesive coating to the opposite surface of said substrate.

13. The method of manufacturing a transdermal drug applicator of claim 2 further comprising the step of applying a conformal cover having an adhesive coated surface over the folded substrate so as to enclose and protect said transdermal drug applicator.

14. The method of manufacturing a transdermal drug applicator of claim 2 wherein portions of the conductive material are folded by about 180°

.

15. The method of manufacturing a transdermal drug applicator of claim 2 wherein said surface of said another substrate contains a coated release agent thereon.

16. A method for making a replaceable disposable drug reservoir for an electrically powered transdermal drug applicator, comprising the steps of:

a. providing a substrate;

b. depositing on said substrate occlusive adhesive dam material to define a plurality of drug reservoir compartments;

c. laminating an open cell foam material to said substrate over said occlusive adhesive dam material; and

d. filling said plurality of drug reservoir compartments with drug mixtures.

17. A transdermal drug applicator which is electrically powered, comprising:

a flexible, non-conductive substrate having a plurality of conductive coated areas, said conductive coated areas forming drug reservoir electrodes, battery electrodes and interconnections;

a plurality of drug reservoirs separated by occlusive adhesive dams and in electrical contact with said drug reservoir electrodes and;

a battery connected in series with the electrodes of the drug reservoir.

18. A method for making a replaceable disposable drug reservoir for an electrically powered transdermal drug applicator, comprising the steps of:

a. providing a substrate;

b. depositing occlusive adhesive dam material on the substrate to define a plurality of drug reservoir compartments;

c. laminating a foam material to the substrate over the occlusive adhesive dam material; and

d. filling at least one of the plurality of drug reservoir compartments with a drug mixture.

19. The method of manufacturing a transdermal drug applicator which is electrically activated according to claim 18, further comprising the step of laminating together said replaceable drug reservoir with another drug reservoir and the lamination comprising a reinforcing scrim between the two drug reservoir layers.

20. The method of manufacturing a transdermal drug applicator which is electrically activated, according to claim 18, further comprising the step of laminating together said replaceable drug reservoir with another drug reservoir and the lamination comprising a semipermeable membrane between the two drug reservoir layers.

21. An electrically powered transdermal drug applicator comprising:

a flexible non-conductive substrate having a plurality of conductive areas forming drug reservoir electrodes, battery electrodes and interconnections;

a plurality of drug reservoirs separated by occlusive adhesive dams, the drug reservoirs in electrical contact with the drug reservoir electrodes; and

a battery connected in series with the drug reservoirs.

22. The transdermal drug applicator which is electrically powered according to claim 21, wherein some of the conductive areas interconnecting the drug reservoir electrodes are of a predetermined resistance so as to perform the function of a current limiting resistor.

23. The electrically powered transdermal drug applicator of claim 21 wherein the battery is in series with electrical current conditioning means.

24. The electrically powered transdermal drug applicator of claim 21 further comprising a conformable cover adhesively secured to the drug applicator.

25. The electrically powered transdermal drug applicator of claim 21 further comprising a release liner covering and protecting the drug reservoirs until use.