Enteric hard capsule

An enteric hard capsule preparation liquid, comprising a component i, a component ii, a basic neutralizing agent acceptable pharmaceutically or as a food additive, and a solvent,

• wherein the component i is methylcellulose and/or hydroxypropyl methylcellulose having a viscosity value of 6 mPa·s or more, and
• wherein the component ii is an enteric methacrylic acid copolymer.

A method for preparing an enteric hard capsule preparation liquid, comprising a step of mixing a component i and a component ii under a condition where a basic neutralizing agent acceptable pharmaceutically or as a food additive is present in a solvent,

• wherein the component i is methylcellulose and/or hydroxypropyl methylcellulose having a viscosity value of 6 mPa·s or more, and the component ii is an enteric methacrylic acid copolymer.

A hard capsule, comprising a hard capsule film having a two-phase structure consisting of core particle phases composed of fine particles of a water-soluble polymer free of an active drug and acceptable pharmaceutically or as a food additive, and a binding phase covering surfaces of the core particles and/or binding the core particles, wherein the binding phase primarily contains a functional polymer that is different from the water-soluble polymer and can control dissolution characteristics of the core particle phases.

An enteric or sustained-release hard capsule, comprising a film containing a component I and a component II,

• wherein the component I is a water-soluble cellulose polymer prepared from a dry ingredient powder with an average particle size of 1 to 100 μm and having a lower critical solution temperature, and the component II is an enteric coating base and/or a sustained-release coating base that are water-soluble or form an aqueous dispersion of colloidal particles, and
• wherein the enteric or sustained-release hard capsule is formed through a process including at least a first step of dipping a mold pin into an enteric or sustained-release hard capsule preparation liquid maintained at a temperature close to the lower critical solution temperature of the component I, the mold pin having a surface temperature that is lower than the temperature of the preparation liquid and the preparation liquid being an aqueous dispersion containing undissolved fine particles of the component I and the component II;
• and a second step of pulling up the mold pin from the preparation liquid and drying the preparation liquid adhering to the mold pin.

An enteric hard capsule, comprising a film containing a component I and a component II,

• wherein the component I is methylcellulose and/or hydroxypropyl methylcellulose with a viscosity value of 6 mPa·s or more, and the component II is an enteric methacrylic acid copolymer, and
• wherein the enteric capsule is formed through a process including at least a first step of dipping a mold pin into an enteric hard capsule preparation liquid maintained at 30 to 65° C., the mold pin having a surface temperature that is lower than a temperature of the preparation liquid and the enteric hard capsule preparation liquid being composed of an aqueous dispersion containing undissolved fine particles of the component I and component II and further containing a basic neutralizing agent with a concentration sufficient to partially neutralize the component II, and, and a second step of pulling up the mold pin from the preparation liquid and drying the preparation liquid adhering to the mold pin.

A hard capsule preparation liquid, comprising an aqueous solvent in which fine particles of a water-soluble polymer free of an active drug and acceptable pharmaceutically or as a food additive are dispersed, and in which a functional polymer different from the water-soluble polymer is further dissolved and/or colloidal particles of a functional polymer different from the water-soluble polymer are further dispersed.