Inactivated whole virion vaccine-containing microneedle array preparation and method for administering the same

Patent metadata

Field	Value
Publication number	US-10166182-B2
Application number	US-201615281325-A
Country	US
Kind code	B2
Filing date	Sep 30, 2016
Priority date	Apr 4, 2014
Publication date	Jan 1, 2019
Grant date	Jan 1, 2019

Abstract

Provided is a microneedle. The microneedle array includes a needle portion, which contains an inactivated whole virion influenza vaccine, and a sheet portion. Also provided is an administration method in which the microneedle array is administered and then administered secondly after an interval of equal to or greater than 24 hours and less than 2 months.

First claim

What is claimed is:

1. A microneedle array comprising:
a needle portion containing an inactivated whole virion influenza vaccine; and
a sheet portion,
wherein 90% by mass or more of the inactivated whole virion influenza vaccine with respect to the total mass of the vaccine is contained in a region that accounts for not more than 60% of the height of the needle portion from a tip of the needle portion; and
the height of the needle portion is equal to or greater than 50 μm and equal to or less than 2,000 μm, and
wherein the needle portion contains a water-soluble polymer, and the water-soluble polymer contains at least hydroxyethyl starch.

2. The microneedle array according to claim 1 ,
wherein the needle portion dissolves after being inserted into a body.

3. The microneedle array according to claim 1 ,
wherein the influenza vaccine is at least one kind of virus selected from the group consisting of an A/H1N1 type, an A/H3N2 type, an A/H5N1 type, and a B type.

4. The microneedle array according to claim 2 ,
wherein the influenza vaccine is at least one kind of virus selected from the group consisting of an A/H1N1 type, an A/H3N2 type, an A/H5N1 type, and a B type.

5. An administration method,
wherein the microneedle array according to claim 1 is administered to skin or mucous membrane and then administered secondly to the skin or mucous membrane after an interval of equal to or greater than 24 hours and less than 2 months.

6. An administration method,
wherein the microneedle array according to claim 2 is administered to skin or mucous membrane and then administered secondly to the skin or mucous membrane after an interval of equal to or greater than 24 hours and less than 2 months.

7. An administration method,
wherein the microneedle array according to claim 3 is administered to skin or mucous membrane and then administered secondly to the skin or mucous membrane after an interval of equal to or greater than 24 hours and less than 2 months.

Assignees

• Fujifilm Corp
• Univ Hokkaido Nat Univ Corp

Inventors

• Kuruma Koji
• Oyamada Takayoshi
• Shimada Toshio
• Sakoda Yoshihiro
• Kida Hiroshi

Classifications

• C12N2760/16234

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title

• A61K2039/545

  characterised by the dose, timing or administration schedule · CPC title

• C12N2760/16134

  Use of virus or viral component as vaccine, e.g. live-attenuated or inactivated virus, VLP, viral protein · CPC title

• A61P31/16

  for influenza or rhinoviruses · CPC title

• A61K39/12

  Viral antigens · CPC title