Injection molded microneedle array and method for forming the microneedle array

• US 9,545,507 B2
• Filed: 04/27/2011
• Issued: 01/17/2017
• 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): Stigell, Theodore
• Assistant Examiner(s): STILES, AMBER R.
• Application Number:
  US13/641,507
• Publication Number:
  US 20130144217A1
• Time in Patent Office: 2,092 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61K 38/1793 for cytokines; for lymphokines; for interferons
• CPC Class Codes: A61K 38/191 Tumor necrosis factors [TNF], e.g. lymphotoxin [LT], i.e. TNF-beta
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/7023 Transdermal patches and similar drug-containing composite devices, e.g. cataplasms galenical aspects of iontophoretic devices A61K9/0009; microneedle arrays A61K9/0021; buccal patches A61K9/006
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 2037/003 having a lumen
• CPC Class Codes: A61M 2037/0038 having a channel at the side surface
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 2037/0061 Methods for using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: A61P 37/06 Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: B29C 2059/023 Microembossing
• CPC Class Codes: B29C 59/002 Component parts, details or accessories; Auxiliary operations
• CPC Class Codes: B29C 59/026 of layered or coated substantially flat surfaces
• CPC Class Codes: B29K 2995/0056 Biocompatible, e.g. biopolymers or bioelastomers
• CPC Class Codes: B29L 2031/7544 Injection needles, syringes
• CPC Class Codes: B29L 2031/756 Microarticles, nanoarticles
• CPC Class Codes: Y10T 156/10 Methods of surface bonding and/or assembly therefor
• CPC Class Codes: Y10T 156/1039 Surface deformation only of sandwich or lamina [e.g., embossed panels]
• CPC Class Codes: Y10T 156/1057 : Subsequent to assembly of laminae

Abstract

Disclosed are injection molded devices including microneedles on a substrate base. The microneedles may include a plurality of nano-sized structures fabricated thereon. The molds used to form the microneedles are assembled from a plurality of mold segments, each defining portions of the microneedles. Upon assembly of the multiple mold segments, microneedle negative cavities are formed. The molds may be used in an injection molding process to form microneedle arrays. Devices may be utilized for interacting with a component of the dermal connective tissue.

Claims

1. An injection molded microneedle array comprising:

a substrate;

a plurality of microneedles extending from a surface of the substrate;

a plurality of nanostructures and microstructures on a surface and projecting directly outward therefrom of at least one of the microneedles in a predetermined pattern,

wherein at least a portion of the microstructures have a cross-sectional dimension of greater than about 500 nanometers and less than about 10 micrometers and a height of from about 20 nanometers to about 1 micrometer, and, wherein at least a portion of the nanostructures have a cross-sectional dimension of less than about 500 nanometers and greater than about 5 nanometers, wherein at least one of the microneedies defines a channel; and

wherein the substrate, the pluraiity of microneedles and the plurality of nanostructures are all portions of an injection molded construct.

2. The injection molded microneedle array of claim 1, 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 plurality of nanostructures.

3. A transdermal patch comprising the injection molded microneedle array of claim 1.

4. The transdermal patch of claim 3, further comprising a reservoir for holding a drug compound.

5. The transdermal patch of claim 4, further comprising a rate control membrane in fluid communication with the reservoir.

6. The transdermal patch of claim 5, further comprising a release member that is generally impermeable to the drug compound and positioned adjacent to the rate control membrane.

7. The transdermal patch of claim 3, wherein the drug compound has a molecular weight between about 20 kDa and about 250 kDa.

8. The injection molded microneedle array of claim 1, wherein at least a portion of the nanostructures have a center-to-center spacing of from about 50 nanometers to about 1 micrometer.

9. The injection molded microneedle array of claim 1, wherein at least a portion of the nanostructures have a height of from about 10 nanometers to about 1 micrometer.

10. The injection molded microneedle array of claim 1, wherein at least a portion of the nanostructures have an aspect ratio of from about 0.2 to about 5.

11. The injection molded microneedle array of claim 1, wherein the pattern has a fractal dimension of greater than about 1.

12. The injection molded microneedle array of claim 1, wherein at least a portion of the nanostructures have a cross-sectional dimension of from about 100 to about 300 nanometers.

13. The injection molded microneedle array of claim 1, wherein the nanostructures have approximately the same cross-sectional dimension.

14. The injection molded microneedle array of 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 about 1:

1 and about 1;

4.

15. The injection molded microneedle array of claim 1, wherein at least a portion of the nanostructures have an equidistant spacing.

16. The injection molded microneedle array of claim 1, wherein the channel has a cross-sectional dimension of from about 1 to about 100 micrometers.

17. The injection molded microneedle array of claim 16, wherein the channel has a length of from about 10 to about 800 micrometers.

18. The injection molded microneedle array of claim 1, wherein the array contains a base having an aperture, wherein the aperture is in at least partial alignment with the channel of a microneedle.

19. The injection molded microneedle array of claim 4, wherein the reservoir is removably connected to the array.

20. The injection molded microneedle array of claim 1, wherein the nanostructures are in the form of pillars.

21. The injection molded microneedle array of claim 1, wherein at least a portion of the nanostructures have an aspect ratio of from about 0.5 to about 3.5.

22. The injection molded microneedle array of claim 1, wherein at least a portion of the nanostructures have a cross-sectional dimension of from about 20 to about 400 nanometers and at least a portion of the microstructures have a cross-sectional dimension of from about 600 nanometers to about 1.5 micrometers.

23. The injection molded microneedle array of claim 1, wherein at least a portion of the microstructures have an aspect ratio of from about0.2 to about 5.

24. The injection molded microneedle array of claim 1, wherein the cross-sectional dimension of the microstructures is greater than the height of the microstructures.

25. The injection molded microneedle array of claim 24, wherein at least a portion of the microstructures have an aspect ratio of from about 0.15 to 1.

26. The injection molded microneedle array of claim 1, wherein at least a portion of the nanostructures have a height greater than a cross-sectional dimension.