Device for delivery of rheumatoid arthritis medication

• US 10,029,082 B2
• Filed: 12/14/2016
• Issued: 07/24/2018
• Est. Priority Date: 04/28/2010
• Status: Active Grant

• Current Assignee: Sorrento Therapeutics Inc.
• Original Assignee: Kimberly-Clark Worldwide Incorporated (Kimberly-Clark Corporation)
• Inventors: Ross, Russell Frederick
• Primary Examiner(s): STILES, AMBER R.
• Application Number:
  US15/378,097
• Publication Number:
  US 20170157380A1
• Time in Patent Office: 587 Days
• CPC Class Codes: A61L 31/00 Materials for other surgical articles , e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices shape or structure of stent-grafts A61F2/07, of stents A61F2/82, of surgical gloves A61B42/00, of surgical drapes A61B46/00, of occluding devices A61B17/12022
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61M 5/158 Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
• CPC Class Codes: A61P 19/02 for joint disorders, e.g. arthritis, arthrosis
• CPC Class Codes: A61P 29/00 Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
• CPC Class Codes: Y10T 29/49 Method of mechanical manufacture

Abstract

Devices for delivering a rheumatoid arthritis drug across a dermal barrier are provided. The devices include microneedles for penetrating the stratum corneum and also include structures fabricated on a surface of the microneedles to form a nanotopography. A random or non-random pattern of structures may be fabricated such as a complex pattern including structures of differing sizes and/or shapes. The pattern of structures on the surface of the microneedles may include nano-sized structures.

Claims

1. A device for delivery of a rheumatoid arthritis drug across a dermal barrier, the device comprising:

a microneedle and a plurality of nanostructures fabricated on a surface of the microneedle to project outward from the surface of the microneedle, the nanostructures being arranged in a predetermined pattern, wherein at least a portion of the nanostructures have a cross-sectional dimension of less than 500 nanometers and greater than 5 nanometers, a height of from 10 nanometers to 1 micrometer, and an aspect ratio of from 0.2 to 5, and wherein the microneedle further contains a channel; and

a reservoir that is in fluid communication with the channel of the microneedle and that contains a rheumatoid arthritis drug.

2. The device of claim 1, wherein the pattern further includes microstructures, wherein the nanostructures have a cross-sectional dimension smaller than the microstructures.

3. The device of claim 2, further comprising second nanostructures having a cross-sectional dimension less than the cross-sectional dimension of the microstructures and greater than the cross-sectional dimension of the first nanostructures.

4. The device of claim 1, wherein at least a portion of the nanostructures have a cross-sectional dimension of less than 400 nanometers and greater than 10 nanometers.

5. The device of claim 1, wherein at least a portion of the nanostructures have a center-to-center spacing of from 50 nanometers to 1 micrometer.

6. The device of claim 1, wherein at least a portion of the nanostructures have a height of from 100 nanometers to 700 nanometers micrometer.

7. The device of claim 1, wherein at least a portion of the nanostructures have an aspect ratio of from 0.5 to 3.5.

8. The device of claim 1, wherein the rheumatoid arthritis drug is a disease-modifying antirheumatic drug.

9. The device of claim 8, wherein the rheumatoid arthritis drug is a protein therapeutic.

10. The device of claim 9, wherein the rheumatoid arthritis drug is a TNF-α

blocker or an IL-1 blocker.

11. The device of claim 1, wherein the rheumatoid arthritis drug is an anti-inflammatory drug.

12. The device of claim 1, wherein the rheumatoid arthritis drug is an analgesic.

13. The device according to claim 1, wherein the pattern has a fractal dimension of greater than 1 and up to 5.

14. The device according to claim 1, wherein at least a portion of the nanostructures have a cross-sectional dimension of from 100 to 300 nanometers.

15. The device according to claim 1, wherein the nanostructures have approximately the same cross-sectional dimension.

16. The device according to claim 1, wherein the ratio of the cross sectional dimension of two adjacent nanostructures to the center-to-center spacing between those two structures is between 1:

1 and 1;

4.

17. The device according to claim 1, wherein at least a portion of the nanostructures have an equidistant spacing.

18. The device according to claim 1, wherein at least a portion of the nanostructures are in the form of pillars.

19. The device according to claim 1, wherein the channel has a cross-sectional dimension of from 1 to 100 micrometers.

20. The device according to claim 19, wherein the channel has a length of from 10 to 800 micrometers.

21. The device according to claim 1, wherein the device contains a microneedle array that contains the microneedle.

22. The device according to claim 21, wherein the array contains a base having an aperture, wherein the aperture is in at least partial alignment with the channel of the microneedle.

23. The device according to claim 22, wherein the reservoir is attached to a substrate upon which the array is located.

24. The device according to claim 22, wherein the reservoir is removably connected to the array.

25. A method for delivering a rheumatoid arthritis drug across a dermal barrier, the method comprising:

penetrating the stratum corneum with a microneedle having a surface on which a plurality of nanostructures are fabricated in a predetermined pattern to project outward from the surface of the microneedle, wherein at least a portion of the nanostructures have a cross-sectional dimension of less than 500 nanometers and greater than 5 nanometers, a height of from 10 nanometers to 1 micrometer and an aspect ratio of from 0.2 to 5, and, wherein the microneedle further contains a channel;

transporting a rheumatoid arthritis drug from a reservoir through the channel of the microneedle and across the stratum corneum.

26. The method according to claim 25, wherein the rheumatoid arthritis drug has a molecular weight greater than 100 kDa and up to 200 kDa.