Method of contact coating a microneedle array

• US 8,741,377 B2
• Filed: 03/27/2013
• Issued: 06/03/2014
• Est. Priority Date: 11/18/2004
• Status: Active Grant

• Current Assignee: Kindeva Drug Delivery L.P.
• Original Assignee: 3M Innovative Properties Company (3M Company)
• Inventors: Knutson, Gordon P., David, Moses M., Choi, Hannah H.
• Primary Examiner(s): SELLMAN, CACHET I
• Application Number:
  US13/851,149
• Publication Number:
  US 20130216694A1
• Time in Patent Office: 433 Days
• Field of Search: 427/430.1, 427/2.12, 427/2.3, 604/272
• US Class Current: 427/2.12
• CPC Class Codes: A61B 17/205 Vaccinating by means of needles or other puncturing devices
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles
• CPC Class Codes: B05D 1/28 performed by transfer from the surfaces of elements carrying the liquid or other fluent material, e.g. brushes, pads, rollers

Abstract

A method of coating a microneedle array by applying a coating fluid using a flexible film in a brush-like manner. A method of coating a microneedle array comprising: providing a microneedle array having a substrate and a plurality of microneedles; providing a flexible film; providing a coating solution comprising a carrier fluid and a coating material; applying the coating solution onto a first major surface of the flexible film; performing a transfer step of bringing the first major surface of the flexible film into contact with the microneedles and removing the flexible film from contact with the microneedles; and allowing the carrier fluid to evaporate.

Claims

1. A method of coating a microneedle array comprising:

providing a microneedle array having a substrate and a plurality of microneedles;

providing a coating solution comprising a carrier fluid and a coating material;

providing a coating apparatus comprising a coating substrate and a supporting member for the microneedle array, wherein at least one of the coating substrate and the microneedle array is flexibly mounted within the coating apparatus;

applying the coating solution onto a first major surface of the coating substrate to form a layer of applied coating solution having a thickness equal to or less than the height of at least one of the microneedles;

performing a transfer step of bringing the first major surface of the coating substrate into contact with the microneedles and removing the coating substrate from contact with the microneedles, thereby transferring at least a portion of the coating solution to the microneedle array; and

allowing the transferred carrier fluid to evaporate to leave a dried coating on the microneedles; and

wherein the microneedle array is moved in a linear direction with respect to the coating substrate during the transfer step and wherein the linear direction is generally perpendicular to the plane of the microneedle array.

2. A method as claimed in claim 1 wherein the coating substrate is flexibly mounted.

3. A method as claimed in claim 2 wherein the coating substrate is a flexible film.

4. A method as claimed in claim 3 wherein the microneedle array is oriented so that the microneedles are facing upward and the coating solution on the flexible film is facing downwards when it is brought into contact with the microneedles.

5. A method as claimed in claim 1 wherein more than one transfer step is performed.

6. A method as claimed in claim 1 wherein more than one transfer step is performed and in between repeated transfer steps the microneedle array is rotated with respect to the coating substrate in a plane generally parallel to the plane of the microneedle array substrate.

7. A method as claimed in claim 1 wherein the amount of coating solution transferred to the microneedles during a transfer step is between 0.1 μ

L and 10 μ

L.

8. A method as claimed in claim 1 wherein more than 50% by weight of the dried coating applied to the microneedle array is present on the microneedles.

9. A method as claimed in claim 1 wherein the dried coating material is preferentially deposited onto the microneedles.

10. A method as claimed in claim 1 wherein the dried coating material is preferentially deposited onto the upper half of the microneedles.

11. A method as claimed in claim 1 wherein the coating solution comprises a therapeutic agent.

12. A method as claimed in claim 1 wherein the coating solution comprises water.

13. A method as claimed in claim 1 wherein the coating solution comprises a vaccine, vaccine adjuvant, or mixture thereof.

14. A method as claimed in claim 11 wherein the therapeutic agent is present in the coating solution as a dispersed or suspended material.

15. A method as claimed in claim 1 wherein the microneedle array is flexibly mounted.

16. A method as claimed in claim 15 wherein the coating substrate is a fixed surface.

17. A method as claimed in claim 16 wherein an excess of coating solution is applied to the coating substrate and a doctoring step is performed to provide the layer of applied coating solution having a thickness equal to or less than the height of at least one of the microneedles.

18. A method as claimed in claim 15 wherein the coating substrate is flexibly mounted.

19. A method as claimed in claim 1 wherein at least a portion of the first major surface of the coating substrate is hydrophilic.

20. A method as claimed in claim 1 wherein the entire portion of the first major surface of the coating substrate is hydrophilic.

21. A method as claimed in claim 1 wherein the coating solution is applied to the first major surface of the coating substrate with a roll.

22. A method as claimed in claim 1 wherein the surface of the microneedles is hydrophilic.