Microneedle deposition method

• US 9,993,423 B2
• Filed: 10/20/2011
• Issued: 06/12/2018
• Est. Priority Date: 10/20/2011
• Status: Active Grant

• Current Assignee: CosMED Pharmaceutical Co., Ltd.
• Original Assignee: CosMED Pharmaceutical Co., Ltd.
• Inventors: Quan, Ying-shu, Kamiyama, Fumio
• Primary Examiner(s): Hall, Deanna K
• Application Number:
  US14/352,397
• Publication Number:
  US 20140257189A1
• Time in Patent Office: 2,427 Days
• Field of Search: 604173
• CPC Class Codes: A61K 9/0021 Intradermal administration, e.g. through microneedle arrays, needleless injectors mechanical aspects A61M
• CPC Class Codes: A61K 9/08 Solutions composition of solutions A61K47/00
• CPC Class Codes: A61M 2037/0046 Solid microneedles
• CPC Class Codes: A61M 2037/0053 Methods for producing microneedles
• CPC Class Codes: A61M 37/0015 by using microneedles

Abstract

The present invention provides a microneedle array which holds a drug only in the microneedle portions, and a method of manufacturing the same.

The microneedle array 2A which holds the drug only on the tips of the microneedles can be manufactured by the microneedle deposition method, i.e. a) the microneedle array 2 is prepared using an water-soluble polymer as a base material; b) a drug solution 1 to be applied to the tips of the microneedle array 2 is prepared; and c) the tips of the microneedle array 2 are contacted with the drug solution 1 for a short time. When the drug solution 1 is a water solution, the biodegradable polymer is of water-soluble, and in addition to the drug, the biodegradable polymer is dissolved in the solution at high concentration, the applied drug is integrated with the microneedle so that only the drug does not fall away during insertion.

Claims

1. A microneedle deposition method of manufacturing a microneedle array in which a drug is deposited on tips thereof by the following steps:

a) the microneedle array is prepared using a water-soluble polymer as a base material;

b) a drug solution to be applied to the tips of the microneedle array is prepared; and

c) the tips of the microneedle array are contacted with the drug solution for 0.01 to 5 seconds;

wherein

in addition to the drug, a water-soluble polymer is dissolved in the drug solution, characterized in that a main component of the drug solution is water,

the water soluble polymer in the drug solution and the base material of the microneedle array are compatible with each other, and

the tips of the microneedle array are partially dissolved when they are contacted with the drug solution, thereby incorporating the drug integrally with the water-soluble polymer in the tips of the microneedle array and creating a concentration gradient of the drug in the tips of the microneedle array such that there is no boundary surface between the original tips of the microneedle array and the drug solution.

2. The microneedle deposition method according to claim 1 characterized in that the water-soluble polymer in the drug solution and the water-soluble polymer as the base material of the microneedle array contain at least one common component.

3. The microneedle deposition method according to claim 1 characterized in that a main component of the water-soluble polymer in the drug solution and a main component of the water-soluble polymer as the base material of the microneedle array are the same.

4. The microneedle deposition method according to claim 1 characterized in that the water-soluble polymer contained in the drug solution and the water-soluble polymer as the base material of the microneedle array are the same.

5. The microneedle deposition method according to claim 1 characterized in that viscosity of the drug solution ranges 1.0 dPa·

s to 90 dPa·

s.

6. The microneedle deposition method according to claim 1 characterized in that the drug solution further comprises an organic solvent.

7. The microneedle deposition method according to claim 1 characterized in that a needle length of the microneedle is 100-2000 microns.

8. The microneedle deposition method according to claim 1 characterized in that the drug is any one of PTH, interferon, insulin, exendin-4, exendin derivative, EGF, FGF, botulinum toxin, various antigen proteins or virus fragments.

9. The microneedle deposition method according to claim 1 characterized in that the water-soluble polymer is any one or more selected from hyaluronic acid, dextrin, dextran, carboxymethyl cellulose, chondroitin sulfate, proteoglycan, polyacrylic acid (salt), polyvinyl pyrrolidone, and polyvinyl alcohol.