Method Of Coating Microneedle

• US 20100280457A1
• Filed: 10/18/2007
• Published: 11/04/2010
• Est. Priority Date: 05/15/2007
• Status: Active Grant

• Current Assignee: Hisamitsu Pharmaceutical Company Incorporated
• Original Assignee: Hisamitsu Pharmaceutical Company Incorporated
• Inventors: Matsudo, Toshiyuki, Tokumoto, Seiji, Kuwahara, Tetsuji
• Granted Patent: US 8,771,781 B2
• Time in Patent Office: Days
• US Class Current: 604/173
• 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: B81B 2201/055 Microneedles
• CPC Class Codes: B81B 2203/0361 Tips, pillars
• CPC Class Codes: B81C 1/00206 Processes for functionalising a surface, e.g. provide the surface with specific mechanical, chemical or biological properties

Abstract

The present invention provides a method of coating microneedles by which the microneedles mounted on a microneedle device are coated accurately and easily in a mass-producible manner. In this method, a microneedle device (22) with a plurality of microneedles (21) is mounted on a table (23), while a mask plate (25) with a plurality of apertures (24) is fixed to a frame member (26), and a coating solution (27) is drawn in the direction of arrow A on the mask plate (25) using a spatula (28) to fill the apertures (24) with the coating solution. The microneedles (21) are inserted in the apertures (24) before or after the filling of the apertures (24) with the coating solution (27) to coat the microneedles (21).

Claims

1. A method of coating microneedles comprising the steps of filling a coating solution on a mask plate having apertures into the apertures using a filling means, and inserting microneedles of a microneedle device to the apertures filled with the coating solution to coat the microneedles.

3. The method of coating microneedles according to claim 1, wherein the filling means is a spatula.

4. The method of coating microneedles according to claim 3, wherein a coating amount to the microneedle is adjusted by changing at least one of

a. an opening diameter of the apertures formed on the mask plate,

b. a viscosity of the coating solution,

c. a clearance between the mask plate and the microneedle basal surface,

d. a spatula pressure,

e. a speed of spatula stroke,

f. a thickness of the mask plate, and

g. an attack angle between the spatula and the mask plate.

5. The method of coating microneedles according to claim 4, wherein the opening diameter of the apertures formed on the mask plate is 100 μ

m² to 90000 μ

m², which exceeds a cross sectional area of the microneedle at a lower end of the apertures when inserting the microneedle.

6. The method of coating microneedles according to claim 4, wherein the viscosity of the coating solution is 500 cps to 60000 cps.

7. The method of coating microneedles according to claim 4, wherein the clearance between the mask plate and the microneedle basal surface is 0 to 500 μ

m.

8. The method of coating microneedles according to claim 4, wherein the spatula pressure is 0.001 to 0.4 MPa.

9. The method of coating microneedles according to claim 4, wherein the speed of spatula stroke is 2 to 800 mm/sec.

10. The method of coating microneedles according to claim 3, wherein the thickness of the mask plate is 10 to 500 μ

m.

11. The method of coating microneedles according to claim 4, wherein the attack angle between the spatula and the mask plate is 65°

to 90°

.

12. The method of coating microneedles according to claim 1, wherein the steps are carried out at a relative humidity of 70.0 to 100% RH.

13. The method of coating microneedles according to claim 1, wherein the coating solution contains a high molecular carrier compatible with a high molecular physiologically active substance.

14. The method of coating microneedles according to claim 13, wherein the high molecular carrier is a polysaccharide.

15. The method of coating microneedles according to claim 14, wherein the polysaccharide is one or more selected from the group consisting of pullulan, hydroxypropylcellulose and hyaluronic acid.

16. A microneedle device comprising microneedles coated by the coating method of claim 1.

19. The method of coating microneedles according to claim 12, wherein the coating solution contains a high molecular carrier compatible with a high molecular physiologically active substance.

2. A method of coating microneedles comprising the steps of inserting microneedles of a microneedle device to apertures formed on a mask plate, and filling a coating solution on the mask plate into the apertures using a filling means to coat the microneedles.

17. The method of coating microneedles according to claim 2, wherein the filling means is a spatula.

18. The method of coating microneedles according claim 2, wherein the steps are carried out at a relative humidity of 70.0 to 100% RH.

20. A microneedle device comprising microneedles coated by the coating method of claim 2.