TRANSMUCOSAL DRUG DELIVERY DEVICE AND METHOD INCLUDING MICRONEEDLES

• US 20110087195A1
• Filed: 10/08/2009
• Published: 04/14/2011
• Est. Priority Date: 10/08/2009
• Status: Active Grant

• Current Assignee: Xerox Corporation (Xerox Holdings Corp.)
• Original Assignee: Palo Alto Research Center, Inc. (Xerox Holdings Corp.)
• Inventors: Uhland, Scott, Peeters, Eric
• Granted Patent: US 9,017,310 B2
• Time in Patent Office: Days
• US Class Current: 604/515
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

Devices and methods for transmucosal drug delivery are provided. A device includes a housing configured for intralumenal deployment into a human or animal subject; a drug-dispensing portion which contains at least one drug; and a plurality of microneedles extending, or being extendable from, the housing, the plurality of microneedles being configured to disrupt at least one region of a mucosal barrier adjacent the housing at a selected time after being intralumenally deployed in the human or animal subject. The device is operable to dispense the drug from the housing to a region of the mucosal barrier disrupted by the plurality of microneedles.

Claims

1. An intralumenal device for transmucosal drug delivery comprising:

a housing configured for intralumenal deployment into a human or animal subject;

a drug-dispensing portion which contains at least one drug; and

a plurality of microneedles extending, or being extendable from, the housing, the plurality of microneedles being configured to disrupt at least one region of a mucosal barrier adjacent the housing at a selected time after being intralumenally deployed in the human or animal subject,

wherein the device is operable to dispense the drug from the housing to a region of the mucosal barrier disrupted by the plurality of microneedles.

2. The device of claim 1, wherein the housing is configured for intravaginal deployment.

3. The device of claim 1, wherein the drug comprises a protein or peptide.

4. The device of claim 1, wherein the drug comprises a hormone or steroid.

5. The device of claim 1, further comprising a receiver adapted to receive power or control signals from a transmitting device when the device is intralumenally deployed in the human or animal subject.

6. The device of claim 1, further comprising a controller configured to actuate the release of the at least one drug from the housing after the plurality of microneedles penetrate the mucosal barrier.

7. The device of claim 1, wherein the drug dispensing portion comprises a positive displacement element for actively dispensing the drug from the housing, the positive displacement element being selected from the group consisting of a mechanical displacement element, an osmotic swelling displacement element, a gas-volume displacement element, a magnetically-induced phase transformation element, a thermally-induced phase transformation element, a piezoelectric actuator, an electrostatically-induced compression element, an actuatable dispensing valve with a static pressure head, and a combination thereof.

8. The device of claim 1, further comprising an actuator configured to move the plurality of microneedles from a first position to a second position in which the plurality of microneedles penetrate the mucosal barrier at the selected time.

9. The device of claim 8, wherein the microneedles are contained within the housing in the first position.

10. The device of claim 8, wherein a controller is configured to actuate the release of the at least one drug after the plurality of microneedles are actuated to the second position.

11. The device of claim 1, further comprising a dissolvable coating or a moveable covering configured to expose the microneedles at the selected time.

12. The device of claim 11, wherein a controller is configured to actuate the release of the at least one drug after the plurality of microneedles are exposed.

13. A method for local transmucosal delivery of a drug to a human or animal subject comprising:

deploying a drug delivery device within a mucosal tissue lumen;

penetrating the mucosal tissue with a plurality of microneedles that extend from, or are extendable from, the drug delivery device at a selected time after the drug delivery device is deployed in the lumen; and

dispensing from the device a drug such that the drug is delivered through the plurality of microneedles into the mucosal tissue or is delivered to the region of the mucosal tissue that is disrupted by the microneedles.

14. The method of claim 13, wherein the lumen comprises the vagina, uterus, or rectum of the human or animal subject.

15. The method of claim 13, wherein the drug comprises a protein or peptide.

16. The method of claim 13, wherein the drug is dispensed from the drug delivery device via a positive displacement process.

17. The method of claim 16, wherein the positive displacement process comprises mechanical displacement, osmotic swelling displacement, gas-volume displacement, magnetically-induced phase transformation, thermally-induced phase transformation, piezoelectric actuation, electrostatically-induced compression, static pressure head displacement through an actuatable dispensing valve, or a combination thereof.

18. The method of claim 13, wherein penetrating the mucosal tissue comprises moving a plurality of microneedles from a first position to a second position in which the plurality of microneedles penetrate the mucosal barrier.

19. The method of claim 13, wherein penetrating the mucosal tissue comprises dissolving a dissolvable coating or moving a moveable covering to expose the microneedles at the selected time.

20. An intravaginal device for transmucosal drug delivery comprising:

a housing configured for intravaginal deployment into a human or animal subject;

a plurality of microneedles extending from, or extendable from, the housing configured to penetrate a region of the mucosal barrier adjacent to the housing at a selected time after being intravaginally deployed in the human or animal subject, and

a drug dispenser comprising a drug repository containing at least one drug and a positive displacement element adapted to dispense the at least one drug from the housing through plurality of microneedles or onto the region of the mucosal tissue disrupted by the microneedles.

21. The device of claim 20, further comprising a controller configured to control the actuation of the positive displacement element.

22. The device of claim 20, wherein the positive displacement element is selected from the group consisting of a mechanical displacement element, an osmotic swelling displacement element, a gas-volume displacement element, a magnetically-induced phase transformation element, a thermally-induced phase transformation element, and a combination thereof.

23. The device of claim 20, wherein the drug comprises a protein or peptide.

24. The device of claim 20, further comprising an actuator configured to move the plurality of microneedles from a first position to a second position in which the plurality of microneedles penetrate the mucosal barrier at the selected time.

25. The device of claim 20, further comprising a dissolvable coating or a moveable covering configured to expose the microneedles at the selected time.