EP1974724A3 — Oral preparations with good disintegration

USPTO Abstract

The present invention provides an oral preparation with good disintegration, which comprises a granule, said granule being obtainable by granulating with spraying an aqueous suspension containing a slightly water-soluble active ingredient and a water-soluble polymer binder to a mixture of a sugar alcohol and a first disintegrant wherein: (1) the slightly water-soluble active ingredient is N-[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]-(2R,3R)-2,3-tetramethylenebutyl]-(1'R,2'S,3'R,4'S)-2,3-bicyclo[2.2.1]-heptanedicarboximide hydrochloride; (2) the sugar alcohol is D-mannitol; (3) the water-soluble polymer binder is one or more members selected from hydroxypropylcellulose, hydroxypropylmethylcellulose, polyvinylpyrrolidone, and polyvinyl alcohol; and (4) the first disintegrant is one or more members selected from corn starch, microcrystalline cellulose, low substituted hydroxypropylcellulose, carmellose, carmellose calcium, carmellose sodium, croscarmellose sodium, carboxymethyl starch sodium, and crosspovidone.