Controlled release transdermal drug delivery

• US 20100114008A1
• Filed: 01/11/2010
• Published: 05/06/2010
• Est. Priority Date: 04/29/2002
• Status: Active Grant

• Current Assignee: Kevin S. Marchitto, Stephen T. Flock
• Original Assignee: Kevin S. Marchitto, Stephen T. Flock
• Inventors: Marchitto, Kevin S., Flock, Stephen T.
• Granted Patent: US 7,912,538 B2
• Time in Patent Office: Days
• US Class Current: 604/20
• CPC Class Codes: A61M 35/00 Devices for applying media, e.g. remedies, on the human body devices for handling toiletry or cosmetic substances A45D; absorbent pads, e.g. swabs, A61F13/15
• CPC Class Codes: A61N 1/30 Apparatus for iontophoresis, i.e. transfer of media in ionic state by an electromotoric force into the body, or cataphoresis

Abstract

Provided herein is a device for controlling the release of a substance at a site of interest in a biological membrane comprising a means of monitoring a physiological state at the site of interest; and a means of releasing a variable amount of the substance to the site of interest where the amount varies in response to the status of the monitored physiological state. Also provided are methods of using the device.

Claims

1. A device for controlling the release of a substance at a site of interest on a biological membrane comprising:

means for ablating or altering the biological membrane at the site of interest;

means of monitoring a physiological state at the site of interest;

means of releasing a variable amount of the substance to the site of interest;

said amount varying in response to the status of the monitored physiological state; and

means for housing the device.

2. The device of claim 1, wherein the means for ablating or altering the biological membrane comprises:

an energy delivery system, said system delivering laser energy, electromagnetic energy, mechanical energy, heat energy, or energy in the form of ions, neutral particles or a plasma.

3. The device of claim 1, wherein the means to monitor the physiological state comprises:

at least one first active electrode comprising an anode in electrical contact at the site of interest;

a second return electrode comprising a cathode in electrical contact distal to the first electrode at the site of interest;

an optional electrically conductive fluid interface between the first and second electrodes and the site of interest on the biological membrane; and

a controller to monitor an electrical current between the first electrode and the second electrode, said controller further comprising a microprocessor.

4. The device of claim 3, wherein the first electrode(s) and the second electrode comprise a galvanic cell.

5. The device of claim 1, wherein the means to monitor the physiological state comprises:

at least one probe further comprising an electrical sensor, a chemical sensor or a mechanical sensor, said sensor located at the tip of the probe(s) and the sensor in contact with the site of interest; and

a controller to monitor the probe(s), said controller further comprising a microprocessor.

6. The device of claim 1, wherein the means of releasing the variable amount of the substance comprises:

a patch comprising;

a reservoir to contain the substance; and

a release mechanism located between the reservoir and the site of interest;

said mechanism operably connected to a controller;

wherein operation of the mechanism by the controller releases the substance from the reservoir to the site of interest or collects the substance in the reservoir from the site of interest.

7. The device of claim 6, further comprising a permeable membrane located between the release mechanism and the site of interest, wherein the permeable membrane is in contact with the site of interest or in contact with a fluid at the site of interest.

8. The device of claim 6, wherein the release mechanism is a valve, a membrane or an electronic pump device.

9. The device of claim 8, wherein the electronic pump device is an electrophoretic device.

10. The device of claim 1, wherein the biological membrane is the skin.

11. The device of claim 10, wherein the skin has an ablated or altered stratum corneum at the site of interest.

12. The device of claim 1, wherein the physiological state comprises an electrical property or a chemical property of the site of interest.

13. The device of claim 12, wherein the electrical property is impedance, conductivity or resistance.

14. The device of claim 12, wherein the chemical property is one or more ion levels at the site of interest.

15. The device of claim 14, wherein the chemical property is the level of lipids, proteins or carbohydrates at the site of interest. compound.

16. The device of claim 1, wherein the substance is a pharmaceutical

17. The device of claim 16, wherein the pharmaceutical compound is nitroglycerin, an anti-nauseant, an antibiotic, a hormone, a steroidal antinflammatory agent, a non-steroid antiinflammatory agent, a chemotherapeutic agent, an anti-cancer agent, an immunogen, an anti-viral agent or an anti-fungal agent.

18. The device of claim 17, wherein the anti-nauseant is scopolamine.

19. The device of claim 17, wherein the antibiotic is tetracycline, streptomycin, sulfa drugs, kanamycin, neomycin, penicillin, or chloramphenicol.

20. The device of claim 17, wherein the hormone is LHRH, parathyroid hormone, growth hormone, gonadotropins, insulin, ACTH, somatostatin, prolactin, placental lactogen, melanocyte stimulating hormone, thyrotropin, parathyroid hormone, calcitonin, enkephalin, or angiotensin.

21. The device of claim 1, wherein the substance is a diagnostic material.

22. A method to control the release of a substance at a site of interest in a biological membrane comprising the steps of:

contacting the site of interest with the device of claim 1;

ablating or altering the biological membrane at the site of interest;

monitoring a physiological state at the site of interest;

applying an algorithm to evaluate the physiological state;

operating a release mechanism in the device of claim 1 in response to the value obtained for the physiological state; and

releasing the substance to the site of interest or collecting the substance from the site of interest thereby controlling the release of the substance at the site of interest.

23. The method of claim 22, wherein the value obtained for the physiological state is compared to a control value of the physiological state.

24. The method of claim 23, wherein the control value of the physiological state is obtained from the same individual or within a group of individuals.