System and method for controlling rate of electrokinetic delivery of a drug

• US 4,808,152 A
• Filed: 01/05/1987
• Issued: 02/28/1989
• Est. Priority Date: 08/18/1983
• Status: Expired due to Term

• Current Assignee: Drug Delivery Systems Incorporated
• Original Assignee: Drug Delivery Systems Incorporated
• Inventors: Sibalis, Dan
• Primary Examiner(s): Coven, Edward M.
• Assistant Examiner(s): SHAY, RANDY CITRIN
• Application Number:
  US07/000,554
• Time in Patent Office: 785 Days
• Field of Search: 128/783, 128/798, 128/799, 128/802, 128/803, 604/20, 29/825, 29/874, 29/876, 29/877, 29/878
• US Class Current: 604/20
• 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 1/0444 Membrane
• CPC Class Codes: A61N 1/0448 Drug reservoir
• CPC Class Codes: Y10T 29/49117 Conductor or circuit manufacturing

Abstract

This invention relates to a system and method for controlling the rate of electrokinetic delivery of a drug or drugs through the skin (42) or mucous membrane of a human or animal being by way of a drug reservoir (12) having a pair of electrodes (16,18) positioned in the reservoir (12) that are connected to first (22A) and second (22B) power sources. The first (22A) and second (22B) power sources can be optionally directed to the electrodes (16, 18) to add to or subtract from the second (22B) power source so as to cause variations in the drug reservoir (12) in accordance with the type of drug being administered. The system can include computer (62) directed controls (66) programmed for the particular drug. With such pre-programmed variations in the drug reservoir (12), control of the rate of drug delivery through the skin (42) can be regulated or pre-set by prescription.

Claims

1. A system for selectively controlling the rate of delivery of a medicament or drug through the skin or mucous membrane of a human or animal by electrokinetic action, comprising, in combination:

drug reservoir means containing a drug, said drug reservoir means adapted to be in electrical contact with the skin at a first skin contact, said drug reservoir means retaining the drug and being capable of passing an electrical current through the drug wherein the drug is passed through the skin by electrokinetic action at said first skin contact,

a pair of spaced first and second electrodes positioned in said drug reservoir means, said first and second electrodes being spaced apart from said first skin contact,

electrode means in electrical contact with the skin at a second skin contact spaced from said skin contact, said electrode means being for passing and receiving current to and from said second skin contact,

a first electrical circuit, formed when the system is mounted on the skin, extending between said first and second electrodes, between said second electrode and said electrode means through the skin wherein the skin acts as an electrical conductor, and said electrode means and said first electrode, said first electrical circuit including a bypass electrical circuit extending between a junction positioned on said first electrical circuit and said second electrode, said junction being positioned between said electrode means and said first electrode, wherein said bypass electrical circuit bypasses said first electrode.

a second electrical circuit extending in parallel between said first and second electrodes,

first power means positioned in said first electrical circuit between said electrode means and said junction, said first power means being for generating a first electrical current through said first circuit,

second power means positioned in said second electrical circuit adapted to pass a second electrical current through said second circuit, and

means for passing a selected current between said first and second electrodes in accordance with the dosage and type of drug in said reservoir means, said means for passing a selected current including at least one of a plurality of the following options;

(a) selectively passing only said first current in said first circuit;

(b) selectively passing only said second current in said second circuit;

(c) selectively inactivating said bypass circuit;

(d) selectively using only said bypass circuit;

(e) selectively positioning the polarity of said first power means; and

(f) selectively positioning the polarity of said first power means;

whereby a predetermined rate of electrokinetic delivery of said drug is attained.

2. A system in accordance with claim 1, further including a control system adapted to selectively operate said means for passing a selected current.

3. A system in accordance with claim 2, wherein said control system includes switch means positioned at said junction on said first circuit adapted to selectively activate or deactivate said bypass circuit and simultaneously to deactivate or activate, respectively, said first circuit between said junction and said first electrode.

4. A system according to claim 3, wherein said control system includes a computer system positioned proximate said first and second circuits, said computer system including signal circuits connected to said means for passing a selected current, computer originated output controls aligned with said signal circuits, and computer programming input circuitry capable of instructing said computer relative to operating said output controls.

5. A system according to claim 4, further including switch means positioned on said circuit path for deactivating said second electrical circuit, said switch means including switch means signal circuit connected to said output controls of said computer said computer programming input circuitry being capable of instructing said computer relative to said switch means signal circuit.

6. A system according to claim 3, wherein said reservoir means includes a semi-permeable membrane capable of passing the drug extending across said reservoir means generally between said first and second electrodes and forming first and second reservoirs, said first and second reservoirs being distal and proximate respectively to the skin of the patient, and said first drug being in generally concentrated form in said first reservoir and being in generally diluted form in said second reservoir.

7. A system in accordance with claim 6, said electrode means being another reservoir means containing a second drug, said electrode means including a third electrode positioned in said another reservoir means, said third electrode being in electrical contact with said first power means, said another reservoir means being capable of passing electrical current between said third electrode and said second skin contact.

8. A system according to claim 7, wherein said another reservoir means includes a semi-permeable membrane capable of passing said second drug extending across said reservoir forming third and fourth reservoirs, said third and fourth reservoirs being distal and proximate respectively to the skin of the patient, and said second drug being in generally concentrated form in said third reservoir and being in generally diluted form in said fourth reservoir.

9. A system according to claim 7, wherein said first, second and third electrodes are made of an electrically conductive and permeable non-metallic membrane containing a depolarizing agent.

10. A system according to claim 7, wherein said first, second and third electrodes are made of metal.

11. A system according to claim 10, further including coatings for said first, second and third electrodes, said coating being a depolarizing agent.

12. A system according to claim 11, wherein said depolarizing agent is manganese dioxide (MnO₂).

13. A system according to claim 12, further including outer layers over said coatings for said first, second and third electrodes, said outer layers being made of a semi-permeable membrane material capable of keeping said first and second drugs from contact with said depolarizing agent.

14. A system according to claim 1, further including first and second current conditioning means positioned in said first and second electrical circuits, respectively.

15. A system according to claim 14, wherein said first and second current conditioning means include a constant current device and a first timer in series and a second constant current device and a second timer in series.

16. A method of controlling the rate of electrokinetic delivery of a predetermined drug through the skin by means of a transdermal applicator comprising the following steps:

(a) providing a first electrical circuit path through the skin having at least one reservoir containing two electrodes and a third electrode spaced from said reservoir;

(b) providing a second electrical circuit path in said reservoir interconnected to said first and second electrodes;

(c) providing at least one electrical power source positioned in either of said first or second electrical circuits; and

(d) controlling the rate of delivery of said drug by establishing a selected current in accordance with any one of the following options;

1. establishing only a first current in said first circuit path;

2. establishing only a second current in said second circuit path;

3. establishing an electrical path in said first circuit with said first electrode;

4. establishing a bypass electrical path in said first circuit with said second electrode bypassing said first electrode;

18. The method according to claim 16, including a second power source in the other of said first or second electrical circuit paths.

17. establishing the polarity of the said at least one power source;

whereby a predetermined rate of electrokinetic delivery of said rug is attained.

19. The method according to claim 17, further including another drug reservoir positioned about said third electrode.

21. The method according to claim 19, including sealing said reservoir.

22. The method according to claim 19, including providing first and second current conditioning means in said first and second electrical circuits respectively.

20. A method for manufacturing a drug applicator capable of selectively controlling the rate of delivery of a medicament or drug through the skin or mucous membrane of a human or animal patient by electrokinetic action, comprising the following steps:

(a) providing a reservoir for containing a predetermined drug and placing spaced first and second electrodes in said reservoir, one side of said reservoir being provided with a permeable membrane, said first and second electrodes being spaced proximate to and distal respectively from aid membrane, charging said drug in said reservoir;

(b) providing a third electrode spaced from said reservoir;

(c) providing a first electrical circuit path portion extending from said third electrode with a junction spaced from said first electrode with a first predetermined power means, the polarity of said first power means being oriented with drug current requirements;

(d) providing a second electrical circuit having a parallel circuit path with said first and second electrodes with second power means, the polarity of said second power means being oriented with drug current requirements; and

(e) providing either a first electrical path between said junction and said first electrode or a second electrical path between said junction and said second electrode in accordance with the current requirement of said predetermined drug.

23. A method for manufacturing a drug applicator capable of selectively controlling the rate of delivery of a medicament or drug through the skin or mucous membrane of a human or animal patient by electrokinetic action, comprising the following steps:

(a) providing a reservoir for containing a predetermined drug and placing spaced first and second electrodes in said reservoir, one side of said reservoir being provided with a permeable membrane, said first and second electrodes being spaced proximate to and distal respectively from said membrane, charging said drug in said reservoir;

(b) providing a third electrode spaced from said reservoir;

(c) providing a first electrical circuit path portion extending from said third electrode with a junction spaced from said first electrode with a first predetermined power means, the polarity of said first power means being oriented with drug current requirements;

(d) providing a second electrical circuit having a parallel circuit path with said first and second electrodes with second electrodes with second power means, the polarity of said second power means being oriented with drug current requirements; and

(e) providing switch means for selecting either a first electrical path between said junction and said first electrode or a second electrical path between said junction said second electrode in accordance with the current requirement of said predetermined drug.