Controlled dosage drug delivery

• US 7,031,768 B2
• Filed: 06/10/2002
• Issued: 04/18/2006
• Est. Priority Date: 08/31/1998
• Status: Expired due to Term

• Current Assignee: The Tapemark Company
• Original Assignee: Birch Point Medical, Inc.
• Inventors: Anderson, Carter R., Morris, Russell L., Sembrowich, Walter L., Anderson, Clayton J.
• Primary Examiner(s): Bockelman, Mark
• Application Number:
  US10/166,157
• Publication Number:
  US 20030028170A1
• Time in Patent Office: 1,408 Days
• Field of Search: 607/2, 604/20
• US Class Current: 604/20
• 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

A planar disposable transdermal iontophoretic delivery system is disclosed which includes amounts of an oxidizable species and a reducible species connected by a common conductor forming a galvanic battery for serving as the sole source of power and control for the system, an amount of a therapeutic agent is provided to be driven through the skin of a patient solely through the use of the galvanic battery. The galvanic battery is provided with a lot-tested coulombic capacity rating to predict dosage.

Claims

1. A method of providing reliable dosage ratings for the administration of therapeutic agents in transdermal iontophoresis devices that include a reservoir for holding a therapeudic agent comprising steps of:

(a) providing a commonly manufactured lot of galvanic battery power sources each power source including

(i) an oxidizable species and a reducible species wherein said self-contained galvanic power source provides the sole source of both the power and control for dosage delivery and contains a lesser amount of a selected one of said oxidizable species and reducible species;

(ii) a common conductor for carrying said oxidizable species and said reducible species;

(b) determining by sample testing in accordance with lot size characteristics of said lot including an average charge capacity for said galvanic battery power sources of said lot to produce a tested lot;

(c) incorporating a galvanic power source from said tested lot into each said device;

(d) labeling a delivery dosage rating for said devices as verified by said average charge capacity of said tested lot.

2. A method as in claim 1 wherein said iontophoresis devices are wearable skin patches.

3. A method as in claim 2 further comprising the step of packaging said iontophoresis devices independent of a therapeutic agent to be administered.

4. A method as in claim 1 further comprising the step of packaging said iontophoresis devices independent of a therapeutic agent to be administered.

5. A method as in claim 1 including the further step of providing a circuit-interrupting switch in series with said galvanic power source in said iontophoresis devices.

6. A method as in claim 1 wherein said galvanic battery power sources have an average charge capacity ≦

60 coulombs.

7. A method of providing reliable dosage ratings for the administration of therapeutic agents in transdermal wearable skin patch iontophoresis devices that include a reservoir for holding a therapeudic agent comprising steps of:

(a) providing a commonly manufactured, relatively large lot of galvanic battery power sources each power source including

(i) an oxidizable species and a reducible species wherein said galvanic power source provides the sole source of both the power and control for dosage delivery and contains a lesser amount of said oxidizable species than said reducible species;

(ii) a common conductor for carrying said oxidizable species and said reducible species which are disposed in relation to said conductor so as to be fully consumed, said common conductor corresponding to the reduction product of said reducible species;

(b) determining by sample testing in accordance with lot size characteristics of said lot including an average charge capacity for said galvanic battery power sources of said lot to produce a tested lot;

(c) incorporating a galvanic power source from said tested lot into each said device;

(d) labeling said transdermal iontophoresis device with a delivery dosage rating for said devices as verified by said average charge capacity of said tested lot.

8. A method as in claim 7 further comprising the step of packaging said iontophoresis devices independent of a therapeutic agent to be administered.

9. A method as in claim 7 including the further step of providing a circuit-interrupting switch in series with said galvanic power source in said iontophoresis devices.

10. A method as in claim 7 comprising the further steps of applying said common conductor as a coating on a nonconductive substrate and applying said oxidizable and said reducible species as coatings on said common conductor.

11. A method as in claim 10 wherein said coatings are applied using screen printing techniques.

12. A method as in claim 7 wherein each said lot of commonly manufactured galvanic battery power sources includes at least 10,000 such sources.

13. A method as in claim 12 wherein said galvanic battery power sources have an average charge capacity ≦

60 coulombs.

14. A method of providing a dosage rating for a transdermal iontophoresis therapeutic agent delivery device having a self-contained combined power source a reservoir for holding a therapeudic agent and dosage control system including a galvanic couple source, having electroactive materials disposed so as to be fully consumed, selected from a commonly manufactured relatively large lot of such sources, including the step of sampling and testing average charge capacity of a lot from which said galvanic power source is taken in accordance with lot size and using test results to produce said rating and providing said transdermal iontophoresis with said rating.

15. A transdermal iontophoretic therapeutic agent delivery device comprising:

(a) a power source and control system further comprising a galvanic couple power source, wherein said galvanic couple power source alone provides the power for the device and the control for both dosage rate and dosage amount of therapeutic agent delivered;

(b) wherein said galvanic couple power source is selected from a manufactured lot of galvanic couples of tested average charge capacity; and

(c) a label associated with said delivery device identifying the charge capacity of said delivery system based on average tested charge capacities of a corresponding commonly manufactured lot of galvanic couple power sources from which it was obtained a reservoir for holding a therapeutic agent.

16. A delivery device as in claim 15 wherein said galvanic couple power source further comprises:

(d) an oxidizable species in contact with a first delivery chamber for a therapeutic agent;

(e) a reducible species in contact with a second delivery chamber for a therapeutic agent, said reducible species being supplied in a greater amount than said oxidizable species such that said oxidizable species is first depleted; and

(f) a common electrically conductive substrate carrying said oxidizable and said reducible species which are disposed in relation to said conductor so as to be fully consumable and allowing the passage of a galvanic electric current therebetween, wherein said common conductor corresponds to the reduction product of said reducible species.

17. A delivery device as in claim 16 further comprising switch for interrupting the passage of said galvanic current.

18. A delivery device as in claim 16 wherein each said delivery chamber is provided with an amount of a hydrophilic absorbent material for retaining fluid in the chamber cavity.

19. A delivery device m as in claim 16 wherein each said delivery chamber is provided with an inlet port for admitting drug containing fluids.

20. A delivery device as in claim 16 wherein said common electrically conductive substrate is a coating on a nonconductive substrate.

21. A delivery device as in claim 20 wherein said oxidizable and said reducible species are coatings produced by screen printing.

22. A delivery device as in claim 21 wherein said common electrically conductive substrate coating is produced by screen printing.

23. A delivery device as in claim 16 wherein said oxidizable and said reducible species are coatings on said common electrically conductive substrate.

24. A delivery device as in claim 23 wherein said electrically conductive substrate is a wire.

25. A delivery device as in claim 23 further comprising a current distribution layer permeable to the passage of drug molecules overlaying the hydrophilic absorbent material and holding it in place.

26. A delivery device as in claim 23 wherein said oxidizable and said reducible species are coatings produced by screen printing.

27. A delivery device as in claim 23 wherein said common electrically conductive substrate is a coating on a non-conductive, substrate.

28. A delivery device as in claim 16 wherein said oxidizable species is selected from Mg and Zn and said reducible species is AgCl.

29. A delivery device as in claim 28 wherein said electrically conductive substrate is a silver wire.

30. A delivery device as in claim 15 wherein each said delivery chamber is provided with an amount of a hydrophilic absorbent material for retaining fluid in the chamber cavity.

31. A delivery device as in claim 30 wherein said hydrophilic absorbent material is selected from cotton, gauze and hydrophilic gels.

32. A delivery device as in claim 30 further comprising a current distribution layer permeable to the passage of drug molecules overlaying the hydrophilic absorbent material and holding it in place.

33. A delivery device as in claim 15 wherein each said delivery chamber is provided with an inlet port for admitting drug containing fluids.

34. A delivery device as in claim 30 further comprising an adhesive layer for adhering said delivery system to the skin of a patient and retaining said hydrophilic material in said chambers.

35. A delivery device as in claim 15 further comprising switch for interrupting the passage of said galvanic current.

36. A method as in claim 15 wherein said galvanic battery power sources have an average charge capacity ≦

60 coulombs.