Method for making disposable and/or replenishable transdermal drug applicators

• US 4,856,188 A
• Filed: 10/07/1987
• Issued: 08/15/1989
• Est. Priority Date: 10/12/1984
• Status: Expired due to Term

• Current Assignee: Drug Delivery Systems Incorporated
• Original Assignee: Drug Delivery Systems Incorporated
• Inventors: Sibalis, Dan
• Primary Examiner(s): Goldberg, Howard N.
• Assistant Examiner(s): Arbes, Carl J.
• Application Number:
  US07/105,889
• Time in Patent Office: 678 Days
• Field of Search: 29/825, 29/877, 128/640, 128/841, 128/798, 604/20, 156/235, 156/280, 156/299
• US Class Current: 29/877
• 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

Applicators for the electrophoretic and/or electroosmotic deposition of a medicament across the skin and into the blood stream. The applicator includes a plurality of drug reservoir electrodes, a battery, a plurality of folded members each having an electrically conductive coating on a flexible, non-conductive substrate in electrical contact with the battery and the drug reservoir electrodes, electrical current conditioning means, and a cover adhesively secured to the applicator.

Claims

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

a. providing a release coated substrate;

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

c. laminating an open cell foam material to said substrate over said occlusive adhesive dam material so as to cause said dam material to penetrate and fill the full thickness of said open cell foam; and

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

2. The method of manufacturing a transdermal drug applicator which is electrically activated according to claim 1, 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.

3. The method of manufacturing a transdermal drug applicator which is electrically activated, according to claim 1, 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.

4. The method of manufacturing a transdermal drug reservoir for an electrically powered transdermal drug applicator, comprising the steps of:

a. providing a web substrate continuously fed from rolled stock material; and

b. applying to said substrate a plurality of drug reservoirs and occlusive dam material in a continuous or repeated pattern;

whereby replaceable/disposable drug reservoirs are formed with said dam material disposed between said drug reservoirs.

5. The method according to claim 4, wherein two drug reservoirs assemblies are combined in an aligned back-to-back fashion to form a single transdermal drug applicator.

6. The method according to claim 4, wherein said drug reservoirs form a quilt pattern of multiple drug reservoirs.

7. The method according to claim 4, wherein web material is provided to reinforce said drug reservoirs.

8. The method according to claim 4, wherein a semi-permeable membrane is provided in juxtaposition to said drug reservoir.

9. The method of manufacturing a transdermal drug reservoir for an electrically powered transdermal drug applicator, comprising the steps of:

a. providing a web substrate continuously fed from rolled stock material;

b. laminating to said substrate a foam material forming drug reservoirs, as well as

occlusive dam material between said drug reservoirs so as to occupy the full depth of said foam material; and

c. filling said drug reservoirs with one or more drug/gel mixtures.

10. The method of claim 9, wherein said web substrate comprises a release liner which is discarded when said drug reservoir is employed transdermally.

11. The method of claim 9, further comprising the step of laminating together two drug reservoirs to form a thicker drug reservoir.

12. The method of claim 11, wherein said two drug reservoirs are separated by reinforcing means.

13. The method of claim 11, wherein said two drug reservoirs are separated by a semipermeable membrane.

14. The method of manufacturing a transdermal drug reservoir for an electrically powered transdermal drug applicator, comprising the steps of:

a. providing a release coated substrate;

b. laminating a foam material to said substrate so as to form drug reservoir compartments as well as

occlusive dam material between said drug reservoirs;

c. filing said drug reservoir compartments with one or more drug/gel mixtures.

15. The method according to claim 14, further comprising the step of laiminating together two drug reservoirs with a reinforcing material disposed between the two drug reservoirs.

16. The method according to claim 14, further comprising the step of laminating together two drug reservoirs with a semipermeable membrane disposed between the two drug reservoirs.