PHARMACEUTICAL COMPOSITION FOR MODIFIED USE

摘要

A pharmaceutical composition for modified release, comprising (1) (R)-2-(2-aminothiazol-4-yl)-4′-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide, or a pharmaceutically acceptable salt thereof, (2) at least one additive which ensures penetration of water into the pharmaceutical composition and which has a solubility such that the volume of water required for dissolving 1 g of the additive is 10 mL or less, and (3) a hydrogel-forming polymer having an average molecular weight of approximately 100,000 or more, or a viscosity of 12 mPa·s or more at a 5% aqueous solution at 25° C. is disclosed.

主权项

1. A pharmaceutical composition for modified release, comprising
(1) 10 mg to 200 mg of (R)-2-(2-aminothiazol-4-yl)-4′-[2-[(2-hydroxy-2-phenylethyl)amino]ethyl]acetic acid anilide, or a pharmaceutically acceptable salt thereof, (2) at least one additive which ensures penetration of water into the pharmaceutical composition and which has a solubility such that the volume of water required for dissolving 1 g of the additive is 10 mL or less, and (3) a hydrogel-forming polymer having an average molecular weight of approximately 100,000 to 5,000,000, or a viscosity of 12 mPa·s at a 5% aqueous solution at 25° C. to 7500 mPa·s at a 1% aqueous solution at 25° C., wherein the hydrogel-forming polymer is present in an amount of 1% by weight to 40% by weight with respect to the total weight of the pharmaceutical composition; and wherein a drug dissolution rate from the pharmaceutical composition is 75% or less after 1.5 hours, and 75% or more to 100% or less after 7 hours from the beginning of a dissolution test.