Controlled dosage drug delivery

• US 20030028170A1
• Filed: 06/10/2002
• Published: 02/06/2003
• Est. Priority Date: 08/31/1998
• Status: Active Grant

• Current Assignee: The Tapemark Company
• Original Assignee: Birch Point Medical, Inc.
• Inventors: Anderson, Carter R., Morris, Russell L., Sembrowich, Walter L., Anderson, Clayton J.
• Granted Patent: US 7,031,768 B2
• Time in Patent Office: Days
• US Class Current: 604/501
• 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 a reliable dosage designation for the dosage of a therapeutic agent delivered by transdermal iontophoresis devices comprising steps of:

(a) providing a 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 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 the capacity characteristics of said lot including an average charge capacity for said lot of galvanic battery power sources 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 verified by the tested average power capacity of said corresponding tested lot.

2. A method as in claim 1 wherein said delivery device is a wearable skin patch.

3. A method as in claim 1 further comprising the step of packaging said delivery device in a dry state.

4. A method as in claim 2 further comprising the step of packaging said delivery device in a dry state.

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

6. A method of providing a reliable dosage designation for the dosage of a therapeutic agent delivered by transdermal iontophoresis devices comprising steps of:

(a) providing a 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 so as to be fully consumed, said common conductor corresponding to the reduction product of said reducible species;

(b) determining by sample testing the capacity characteristics of said lot including an average charge capacity for said lot of galvanic battery power sources 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 verified by the tested average power capacity of said corresponding tested lot.

7. A method as in claim 6 wherein said delivery device is a wearable skin patch.

8. A method as in claim 6 further comprising the step of packaging said delivery device in a dry state.

9. A method as in claim 7 further comprising the step of packaging said delivery device in a dry state.

10. A method as in claim 6 including the further step of providing a switch in series with said galvanic power source.

33. A method as in claim 7 comprising the further steps of applying said common conductor as a coating on a non-conductive substrate and applying said oxidizable and said reducible species as coating on said common conductor.

34. A method as in claim 33 wherein said coatings are applied using screen printing techniques.

35. A method as in claim 34 wherein said delivery device is a wearable skin patch.

11. A method of providing a dosage rating for a transdermal iontophoresis therapeutic agent delivery device having a self-contained combined power source and dosage control system including a galvanic couple source, having electroactive materials disposed so as to be fully consumed, selected from a manufactured 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 and using test results to produce said rating.

12. 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 the rate and dosage of therapeutic agent delivered;

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

(c) a label associated with said delivery device identifying the capacity of said delivery system based on the average tested capacities of the corresponding manufactured lot of galvanic couple power sources.

13. A delivery device as in claim 12 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; and

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

14. A delivery system as in claim 13 wherein said oxidizable and said reducible species are coatings on said common electrically conductive substrate.

15. A delivery system as in claim 13 wherein said oxidizable species is selected from Mg and Zn and said reducible species is AgCl.

16. A delivery system as in claim 14 wherein said electrically conductive substrate is a wire.

17. A delivery system as in claim 15 wherein said electrically conductive substrate is a silver wire.

18. A delivery system as in claim 12 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 system as in claim 18 wherein said hydrophilic absorbent material is selected from cotton, gauze and hydrophilic gels.

20. A delivery system as in claim 18 further comprising a current distribution layer permeable to the passage of drug molecules overlaying the hydrophilic absorbent material and holding it in place.

21. A delivery system as in claim 12 wherein each said delivery chamber is provided with an inlet port for admitting drug containing fluids.

22. A delivery system as in claim 18 further comprising an adhesive layer for adhering said delivery system to the skin of a patient and retaining said hydrophilic material in said chambers.

23. A delivery system as in claim 12 further comprising switch for interrupting the passage of said galvanic current.

24. A delivery system as in claim 13 further comprising switch for interrupting the passage of said galvanic current.

25. A delivery system as in claim 13 wherein each said delivery chamber is provided with an amount of a hydrophilic absorbent material for retaining fluid in the chamber cavity.

26. A delivery system as in claim 14 further comprising a current distribution layer permeable to the passage of drug molecules overlaying the hydrophilic absorbent material and holding it in place.

27. A delivery system as in claim 13 wherein each said delivery chamber is provided with an inlet port for admitting drug containing fluids.

28. A delivery system as in claim 14 wherein said oxidizable and said reducible species are coatings produced by screen printing.

29. A delivery system as in claim 13 wherein said common electrically conductive substrate is a coating on a non-conductive substrate.

30. A delivery system as in claim 14 wherein said common electrically conductive substrate is a coating on a non-conductive substrate.

31. A delivery system as in claim 29 wherein said oxidizable and said reducible species are coatings produced by screen printing.

32. A delivery system as in claim 31 wherein said common electrically conductive substrate coating is produced by screen printing.