Controlled release transdermal drug delivery

• US 20030204163A1
• Filed: 04/24/2003
• Published: 10/30/2003
• Est. Priority Date: 04/29/2002
• Status: Active Grant

• Current Assignee: Rocky Mountain Biosystems, Inc.
• Original Assignee: Rocky Mountain Biosystems, Inc.
• Inventors: Marchitto, Kevin S., Flock, Stephen T.
• Granted Patent: US 7,647,099 B2
• Time in Patent Office: Days
• US Class Current: 604/65
• 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 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 said substance to the site of interest;

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

2. The device of claim 1, wherein said means to monitor said 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 said first electrode at the site of interest; and

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

3. The device of claim 1, wherein said means to monitor said 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 said probe(s) and said sensor in contact with the site of interest; and

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

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

a reservoir to contain said substance; and

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

said mechanism operably connected to a controller;

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

5. The device of claim 4, further comprising a permeable membrane located between said release mechanism and said site of interest, wherein said permeable membrane is in contact with said site of interest or in contact with a fluid at said site of interest.

6. The device of claim 4, wherein said release mechanism is a valve, a membrane or an electronic pump device.

7. The device of claim 6, wherein said electronic pump device is an electrophoretic device.

8. The device of claim 1, wherein said device is in a patch.

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

10. The device of claim 9, wherein the skin has an ablated or altered stratum corneum at the site of interest.

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

12. The device of claim 11, wherein said electrical property is impedance or conductivity.

13. The device of claim 1, wherein said chemical property is hydration or one or more ion levels at the site of interest.

14. The device of claim 13, wherein said chemical property is the level of lipids, proteins or carbohydrates at the site of interest.

15. The device of claim 1, wherein said substance is a pharmaceutical compound.

16. The device of claim 15, wherein said pharmaceutical compound is selected from the group consisting of 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.

17. The device of claim 16, wherein said anti-nauseant is scopolamine.

18. The device of claim 16, wherein said antibiotic is tetracycline, streptomycin, sulfa drugs, kanamycin, neomycin, penicillin, or chloramphenicol.

19. The device of claim 16, wherein said LHRH, hormone is parathyroid hormone, growth hormone, gonadotropins, insulin, ACTH, somatostatin, prolactin, placental lactogen, melanocyte stimulating hormone, thyrotropin, parathyroid hormone, calcitonin, enkephalin, or angiotensin.

20. The device of claim 1, wherein said substance is a diagnostic material.

21. 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;

monitoring a physiological state at the site of interest;

applying an algorithm to evaluate said physiological state;

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

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

22. The method of claim 21, wherein said value obtained for said physiological state is compared to a control value of said physiological state.

23. The method of claim 22, wherein said control value of said physiological state is obtained from the same individual or within a group of individuals.

45. 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 24;

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

monitoring a physiological state at the site of interest;

applying an algorithm to evaluate said physiological state;

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

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

46. The method of claim 45, wherein said value obtained for said physiological state is compared to a control value of said physiological state.

47. The method of claim 46, wherein said control value of said physiological state is obtained from the same individual or within a group of individuals.

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

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

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

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

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

a means for housing said device.

25. The device of claim 24, wherein said means for ablating or altering said 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.

26. The device of claim 24, wherein said means to monitor said 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 said first electrode at the site of interest;

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

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

27. The device of claim 26, wherein said first electrode(s) and said second electrode comprise a galvanic cell.

28. The device of claim 24, wherein said means to monitor said 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 said probe(s) and said sensor in contact with said site of interest; and

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

29. The device of claim 24, wherein said means of releasing the variable amount of said substance comprises:

a patch, said patch comprising;

a reservoir to contain said substance; and

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

said mechanism operably connected to a controller;

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

30. The device of claim 29, further comprising a permeable membrane located between said release mechanism and said site of interest, wherein said permeable membrane is in contact with said site of interest or in contact with a fluid at said site of interest.

31. The device of claim 29, wherein said release mechanism is a valve, a membrane or an electronic pump device.

32. The device of claim 31, wherein said electronic pump device is an electrophoretic device.

33. The device of claim 24, wherein the biological membrane is the skin.

34. The device of claim 33, wherein the skin has an ablated or altered stratum corneum at the site of interest.

35. The device of claim 24, wherein said physiological state comprises an electrical property or a chemical property of the site of interest.

36. The device of claim 35, wherein said electrical property is impedance, conductivity or resistance.

37. The device of claim 35, wherein said chemical property is one or more ion levels at the site of interest.

38. The device of claim 37, wherein said chemical property is the level of lipids, proteins or carbohydrates at the site of interest.

39. The device of claim 24, wherein said substance is a pharmaceutical compound.

40. The device of claim 39, wherein said pharmaceutical compound is selected from the group consisting of 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.

41. The device of claim 40, wherein said anti-nauseant is scopolamine.

42. The device of claim 40, wherein said antibiotic is tetracycline, streptomycin, sulfa drugs, kanamycin, neomycin, penicillin, or chloramphenicol.

43. The device of claim 40, wherein said hormone is LHRH, parathyroid hormone, growth hormone, gonadotropins, insulin, ACTH, somatostatin, prolactin, placental lactogen, melanocyte stimulating hormone, thyrotropin, parathyroid hormone, calcitonin, enkephalin, or angiotensin.

44. The device of claim 24, wherein said substance is a diagnostic material.