Vaccine pharmaceutical composition for oral administration and method for manufacturing vaccine pharmaceutical composition for oral administration
AssigneeNitto Denko Corporation
InventorsTakuya Shishido, Daisuke Asari, Eiji Kiyotoh, Kyohei Matsushita, Wenjing Li, Masahiro Fukasaka, Katsuyuki Okubo, Mitsuhiko Hori
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Abstract
The present invention provides a vaccine pharmaceutical composition for oral administration that enables stable storage of an influenza virus antigen and a method for producing the pharmaceutical composition. Provided is a vaccine pharmaceutical composition for oral administration containing an influenza virus antigen, an excipient, a disaccharide, and an amino acid.
Claims16
A vaccine pharmaceutical composition for oral administration comprising:
- an influenza virus antigen;
- an excipient comprising at least one selected from the group consisting of dextran, hydroxypropyl cellulose, and hydroxypropyl methylcellulose;
- a disaccharide;
- and
- an amino acid selected from the group consisting of arginine, lysine, proline, threonine, ornithine, glycine, and salts of these;
- wherein:
- a total amount of the excipient is 30 to 95% by mass relative to the mass of the solid content of the vaccine pharmaceutical composition;
- and
- the vaccine pharmaceutical composition is a dried preparation.
A method for producing a vaccine pharmaceutical composition for oral administration, comprising:
- preparing a vaccine-containing preparation solution that contains an influenza virus antigen, an excipient, a disaccharide, an amino acid, and a solvent;
- and
- drying the vaccine-containing preparation solution.
A method for producing a vaccine pharmaceutical composition for oral administration, comprising:
- preparing a vaccine-containing preparation solution that contains an influenza virus antigen, an excipient, a disaccharide, an amino acid, and a solvent;
- and
- drying the vaccine-containing preparation solution,
- wherein the vaccine-containing preparation solution is dried by lyophilization, and
- the vaccine-containing preparation solution contains 5% by mass or more of the excipient relative to the mass of the vaccine-containing preparation solution and 30% by mass or more of the excipient relative to the mass of the solid content of the vaccine-containing preparation solution.
Dependencies are inferred from the claim text.