# US 11,077,290 B2 · Method for producing microneedle device

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- Number: US 11,077,290 B2
- Document ID: US11077290B2
- Status: Granted
- Kind: B2
- Application number: 16/488,450
- Filed: 2018-02-20
- Published: 2019-12-19
- Granted: 2021-08-03
- Earliest claimed: 2017-02-24
- Assignees: Hisamitsu Pharmaceutical Co., Inc.
- Applicants: Hisamitsu Pharmaceutical Co., Inc.
- Inventors: Toru Kobayashi; Toshiyuki Matsudo; Shinpei Nishimura; Seiji Tokumoto; Tetsuji Kuwahara
- Web page: https://patentgrep.com/patent/US11077290B2

## CPC

- A61M 37/0015: {by using microneedles}
- A61M 2037/0053: {Methods for producing microneedles}
- A61M 2205/0238: the material being a coating or protective layer
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

A method for producing a microneedle device having a coating on the microneedles comprises a step A of drying a precursor composition containing a biologically active substance and a first solvent to obtain -a freeze-dried composition, a step B of mixing the freeze-dried composition with a second solvent to obtain a coating composition, and a step C of applying the coating composition to the microneedles and drying the same, wherein the precursor composition further contains a thickener, or a thickener is added when the freeze-dried composition and the second solvent are mixed.

## Claims

### Claim 1

A method for producing a microneedle device having a coating on microneedles comprising:
a step A of drying a precursor composition containing a biologically active substance and a first solvent to obtain a freeze-dried composition,
a step B of mixing the freeze-dried composition with a second solvent to obtain a coating composition, and
a step C of applying the coating composition to the microneedles and consequently drying, wherein
the precursor composition further contains a thickener, or a thickener is added when the freeze-dried composition and the second solvent are mixed;
wherein the second solvent is used in a reduced amount compared to if the freeze-dried composition was not required for preparation of the coating composition.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the step C is dip coating.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the freeze-dried composition has a bulk volume of 3 to 110 times the volume of the second solvent.

### Claim 4 (depends on 3)

The method according to claim 3, wherein the coating composition has a viscosity of 1000 to 25000 cps.

### Claim 5 (depends on 3)

The method according to claim 3, wherein the freeze-dried composition has a density of 6 to 140 mg/mL.

### Claim 6 (depends on 3)

The method according to claim 3, wherein, in the step B, the freeze-dried composition and the second solvent are mixed using a planetary centrifugal mixer.

### Claim 7 (depends on 3)

The method according to claim 3, wherein the step C is dip coating.

### Claim 8 (depends on 1)

The method according to claim 1, wherein the coating composition has a viscosity of 1000 to 25000 cps.

### Claim 9 (depends on 8)

The method according to claim 8, wherein the freeze-dried composition has a density of 6 to 140 mg/mL.

### Claim 10 (depends on 8)

The method according to claim 8, wherein, in the step B, the freeze-dried composition and the second solvent are mixed using a planetary centrifugal mixer.

### Claim 11 (depends on 8)

The method according to claim 8, wherein the step C is dip coating.

### Claim 12 (depends on 1)

The method according to claim 1, wherein the freeze-dried composition has a density of 6 to 140 mg/mL.

### Claim 13 (depends on 12)

The method according to claim 12, wherein, in the step B, the freeze-dried composition and the second solvent are mixed using a planetary centrifugal mixer.

### Claim 14 (depends on 12)

The method according to claim 12, wherein the step C is dip coating.

### Claim 15 (depends on 1)

The method according to claim 1, wherein, in the step B, the freeze-dried composition and the second solvent are mixed using a planetary centrifugal mixer.

### Claim 16 (depends on 15)

The method according to claim 15, wherein the step C is dip coating.