Method of contact coating a microneedle array

• US 8,057,842 B2
• Filed: 11/18/2005
• Issued: 11/15/2011
• 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., Choi, Hye-Ok, David, Moses M.
• Primary Examiner(s): Meeks; Timothy
• Assistant Examiner(s): SELLMAN, CACHET I
• Application Number:
  US11/718,474
• Publication Number:
  US 20080051699A1
• Time in Patent Office: 2,188 Days
• Field of Search: 427 21- 231, 604/46, 604/239, 604/272, 604/21, 604/22
• US Class Current: 427/2.1
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61M 2037/0023 Drug applicators using microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

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. Also, a method of coating a microneedle array by applying a coating solution onto a first major surface of a 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 and 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.

Claims

1. 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;

coating the microneedle array with coating solution by bringing the first major surface of the flexible film into contact with the microneedles and removing the flexible film from contact with the microneedles, wherein the flexible film and the microneedle array define an angle of flexure during the coating step that is between 5 and 15 degrees; and

allowing the carrier fluid to evaporate from the microneedle array to leave a dried coating on the microneedle array.

2. A method as claimed in claim 1 wherein the flexible film is moved in a linear direction across the microneedles while the coating solution on the flexible film is in contact with the microneedles.

3. A method as claimed in claim 2 wherein the linear direction is generally parallel to the plane of the microneedle array.

4. A method as claimed in claim 3 wherein more than one coating step is performed and in between repeated coating steps the microneedle array is rotated with respect to the flexible film in a plane generally parallel to the plane of the microneedle array substrate.

5. A method as claimed in claim 2 wherein the linear direction is generally perpendicular to the plane of the microneedle array.

6. A method as claimed in claim 1 wherein more than one coating step is performed.

7. A method as claimed in claim 1 wherein the amount of coating solution coated on the microneedles during the coating 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 is present on the microneedles.

9. A method as claimed in claim 1 wherein the amount of the dried coating per unit surface area will be greater on the microneedles than on the substrate.

10. A method as claimed in claim 1 wherein the dried coating 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 11 wherein the therapeutic agent is present in the coating solution as a dispersed or suspended material.

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

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

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

16. A method as claimed in claim 1 wherein the surface of the microneedles is coated with a thin film of diamond-like glass.

17. 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 the coating substrate is flexibly mounted within the coating apparatus and wherein at least a portion of the first major surface of the coating substrate is hydrophilic;

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.

18. A method as claimed in claim 17 wherein the coating substrate is a flexible film.

19. A method as claimed in claim 18 wherein the first major surface of the coating substrate has a leading edge and a trailing edge and wherein the trailing edge of the flexible film is brought into contact with the microneedles during the transfer step.

20. A method as claimed in claim 18 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.

21. A method as claimed in claim 17 wherein the coating substrate is flexibly mounted.

22. A method as claimed in claim 17 wherein the entire portion of the first major surface of the coating substrate is hydrophilic.

23. A method as claimed in claim 17 wherein the coating solution is applied to the first major surface of the coating substrate with a roll.

24. A method as claimed in claim 17 wherein the coating solution is applied to the first major surface of the coating substrate with a pickup plate.

25. A method as claimed in claim 17 wherein the coating solution is applied to the first major surface of the coating substrate with an extrusion die.

26. 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;

coating the microneedle array with coating solution by bringing the first major surface of the flexible film into contact with the microneedles and removing the flexible film from contact with the microneedles, wherein the flexible film is moved in a linear direction across the microneedles while the coating solution on the flexible film is in contact with the microneedles; and

allowing the carrier fluid to evaporate from the microneedle array to leave a dried coating on the microneedle array.

27. A method of coating a microneedle array comprising:

providing a microneedle array having a substrate and a plurality of microneedles, wherein the surface of the microneedles is coated with a thin film of diamond-like glass;

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;

coating the microneedle array with coating solution by bringing the first major surface of the flexible film into contact with the microneedles and removing the flexible film from contact with the microneedles;

allowing the carrier fluid to evaporate from the microneedle array to leave a dried coating on the microneedle array.