Rate adjustable drug delivery system

• US 20020188241A1
• Filed: 06/03/2002
• Published: 12/12/2002
• Est. Priority Date: 12/30/1999
• Status: Active Grant

• Current Assignee: The Tapemark Company
• Original Assignee: Birch Point Medical, Inc.
• Inventors: Anderson, Carter R., Morris, Russell L.
• Granted Patent: US 7,016,723 B2
• Time in Patent Office: Days
• 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 transdermal iontophoretic therapeutic agent delivery system which is provided with a plurality of self-contained serially connected galvanic sources.

Claims

1. A method of providing reliable capacity-related power source and control systems for a transdermal iontophoresis delivery of a therapeutic agent, said power source and control system comprising a plurality of serially connected galvanic couple power sources, the method comprising steps of:

(a) manufacturing one or more lots of galvanic couple power sources;

(b) determining by sample testing capacity characteristics including an average charge capacity for said galvanic couple power sources of each of said one or more lots to produce tested lots;

(c) serially connecting a plurality of said galvanic couple power sources selected from one or more tested lots into a power source and control system;

(d) incorporating said power source and control system into a transdermal iontophoresis therapeutic agent delivery device as the sole source of power and delivery control; and

(e) providing a dosage rating for said agent delivery device based on the tested average power capacities of tested lots from which said plurality of galvanic power sources are taken.

2. A method as in claim 1 comprising the further step of connecting one or more additional circuit components in relation to said plurality of galvanic couple power sources in said power source and control system,

3. A method as in claim 2 comprising the further step of connecting one or more resistance devices in parallel with one or more of said plurality of galvanic power sources.

4. A method as in claim 1 wherein said plurality of galvanic power sources includes one or more sources selected to have significantly lower charge capacity than one or more others thereby producing a stepped-down dosage rate profile.

5. A method as in claim 4 further comprising the step of connecting a resistance device in parallel with one or more said plurality of galvanic power sources.

6. A method as in claim 4 comprising the further step of connecting a pair of said galvanic power sources in opposed polar relation and in parallel with a resistor device such that iontophoretic delivery current flows to deliver said therapeutic agent only after said source of lower columbic capacity is depleted.

7. A method as in claim 2 further comprising the step of connecting a switch device across one or more of said serially connected galvanic power sources.

8. A method as in claim 4 further comprising the step of connecting a switch device across said source of lesser columbic capacity.

9. A method as in claim 2 comprising the further step of connecting one or more resistance devices in series with one or more of said plurality of galvanic power sources.

10. A method as in claim 2 comprising the further step of combining said galvanic power sources and said additional circuit components in a variety of configurations to adjust potentials and/or current profiles of said power source and control systems as desired.

11. A method as in claim 1 wherein said sample testing comprises the step of reacting galvanic sources or half-cells to exhaustion.

12. A method as in claim 1 wherein said plurality of galvanic couple power sources are selected from the same tested lot.

13. A method as in claim 1 wherein said plurality of galvanic couple power sources are selected from a plurality of tested lots.

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

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

16. A method as in claim 14 further comprising the step of packaging said delivery device in a dry state.

19. A device as in claim 18 further comprising one or more additional circuit components connected in relation to said plurality of galvanic couple power sources in said power source and control system.

20. A device as in claim 18 wherein said plurality of galvanic power sources includes one or more sources selected to have significantly lower charge capacity.

21. A device as in claim 19 further comprising one or more resistance devices connected in parallel with one or more of said plurality of galvanic power sources.

22. A device as in claim 20 further comprising one or more resistance devices connected in parallel with one or more of said plurality of galvanic power sources.

23. A device as in claim 19 further comprising one or more resistance devices connected in series with one or more of said plurality of galvanic power sources.

24. A device as in claim 20 further comprising one or more resistance devices connected in series with one or more of said plurality of galvanic power sources.

25. A device as in claim 18 wherein said galvanic couple power sources are designed to be stored in a dry dormant state until time of use.

26. A device as in claim 18 wherein said device is stored in a therapeutic agent-free state until used.

27. A device as in claim 25 wherein said device is stored in a therapeutic agent-free state until used.

28. A device as in claim 18 in the form of a wearable skin patch.

29. A device as in claim 25 in the form of a wearable skin patch.

30. A device as in claim 26 in the form of a wearable skin patch.

31. A device as in claim 27 in the form of a wearable skin patch.

32. A transdermal iontophoresis therapeutic agent delivery system produced in accordance with the method of claim 1.

17. 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 plurality of galvanic couple sources, including the step of sampling and testing average power capacities of lots from which said plurality of galvanic power sources are taken and using test results to produce said rating.

18. A transdermal iontophoretic therapeutic agent delivery device comprising:

(a) a power source and control system further comprising a plurality of serially connected galvanic couple power sources, wherein said plurality of galvanic couple power sources alone provide the power for the device and the control for the rate and dosage of therapeutic agent delivered;

(b) wherein each of said plurality of galvanic couple power sources 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 corresponding manufactured lots of said plurality of galvanic couple power sources.