Design and Manufacture of Nonelectronic, Active-Infusion Patch and Device for Transdermal Delivery Across Skin

• US 20150238433A1
• Filed: 09/23/2013
• Published: 08/27/2015
• Est. Priority Date: 10/01/2012
• Status: Active Grant

• Current Assignee: Hong Kong University of Science and Technology
• Original Assignee: Hong Kong University of Science and Technology
• Inventors: Yeung, King Lun, Poon, Ho Yee Timothy, Wong, Wai Kit, Kwan, Siu Ming, Chau, Li Yin, Lee, Ming Hung Thomas, Chow, Albert Hee Lum
• Granted Patent: US 10,548,854 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61K 31/196 the amino group being directly attached to a ring, e.g. anthranilic acid, mefenamic acid, diclofenac, chlorambucil
• CPC Class Codes: A61K 38/28 Insulins
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/703 characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
• CPC Class Codes: A61K 9/7084 Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

Transdermal patches and devices for delivery of therapeutic drug and/or cosmetic formulations through an intact or porated skin barrier are described. Active-infusion delivers controlled dosing over a period of time to provide long-term efficacy. Methods and devices for preparing active-infusion patches for controlled dose delivery by nonelectronic means and methods of skin poration that is safe and painless are described.

Claims

1. A transdermal patch device comprising:

a body piece having a proximal side and a distal side;

an activator access in the body piece;

an actuator compartment within the body piece and operably connected with the activator access;

a drug reservoir at a proximal side of the body piece, a distal side of the drug reservoir adjacent a proximal side of the actuator compartment; and

a transdermal drug delivery zone at a proximal side of the drug reservoir;

wherein in an initial, pre-activated state, actuator within the actuator compartment is isolated from an activator;

wherein, upon initiation by a user, an activator transits through the activator access into the actuator compartment and contacts the actuator, causing the actuator to swell, whereby the actuator expands in a proximal direction and thereby transmits force to the distal side of the drug reservoir, whereby a drug in the drug reservoir is forced through the transdermal drug delivery zone and out of the device.

2. A transdermal patch according to claim 1, wherein the activator access comprises an activator compartment within the body piece.

3. A transdermal patch according to claim 1, wherein the activator access comprises an injector port.

4. A transdermal patch according to claim 2, further comprising:

an opening in the body piece;

a turnable cover within the body piece and having a distal side accessible through the opening in the body piece;

an insert in operable communication with the proximal side of the turnable cover, where the activator compartment and the actuator compartment are formed of the insert; and

at least one trigger mechanism on the turnable cover by which a user can initiate open connection between the actuator compartment and the activator compartment.

5. A transdermal patch according to claim 4, further comprising at least one breakable gate on the insert.

6. A transdermal patch according to claim 5, wherein the trigger mechanism is a break trigger that opens the at least one breakable gate when the turnable cover is rotated, whereby open connection is initiated between the actuator compartment and the activator compartment.

7. A transdermal patch according to claim 4, further comprising at least one slot within the actuator compartment.

8. A transdermal patch according to claim 7, wherein the trigger mechanism is a switchable gate on the turnable cover that opens and closes the slot when the turnable cover is rotated, whereby open connection is initiated between the actuator compartment and the activator compartment.

9. A transdermal patch according to claim 4, wherein the turnable cover further comprises a lock accessible through the opening in the body piece.

10. A transdermal patch according to claim 9, further comprising a key for removably engaging with the lock to rotate the turnable cover.

11. A transdermal patch according to claim 2, further comprising a body piece overlay in which the drug reservoir is disposed.

12. A transdermal patch according to claim 11, further comprising a drug port operably connected to the drug reservoir in the body piece overlay.

13. A transdermal patch according to claim 12, wherein the drug port is sealable.

14. A transdermal patch according to claim 11, further comprising at least one arm on the insert and at least one block on the body piece overlay, wherein the block engages with the arm to inhibit the insert from being rotated.

15. A transdermal patch according to claim 11, further comprising a membrane between the actuator compartment and the drug reservoir.

16. A transdermal patch, according to claim 11, further comprising a microneedle plate adjacent to the drug delivery zone.

17. A transdermal patch according to claim 16, wherein the microneedle plate comprises plastic, metal, ceramic, silicon, glass, or zeolite.

18. A transdermal patch device according to claim 14, further comprising one or more alignment structures on at least one of the body piece, the body piece overlay, or the insert.

19. A transdermal patch according to claim 4, further comprising a coating that forms a seal between two or more adjacent components within the transdermal patch.

20. A transdermal patch according to claim 19, wherein the coating comprises a silicon-based material.