Patent ID: 7727553
Filing Date: 2010-06-01
Classification: A61K

Abstract:
1. A rapidly disintegrating oral preparation comprising: i) granules, said granules comprising: a water-soluble excipient selected from either one or both of lactose and mannitol; a first disintegrant selected from one or more of corn starch, microcrystalline cellulose, low substituted hydroxypropylcellulose, carmellose, carmellose calcium, carmellose sodium, croscarmellose sodium, carboxymethyl starch sodium and crosspovidone; a water-soluble polymer binder selected from one or more of hydroxypropylcellulose, hydroxypropylmethylcellulose, polyvinylpyrrolidone, and partially saponified polyvinyl alcohol; and an active ingredient that 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; and ii) a second disintegrant selected from one or more of lactose, anhydrous dibasic calcium phosphate, dibasic calcium phosphate, microcrystalline cellulose, low substituted hydroxypropylcellulose, carmellose, carmellose calcium, carmellose sodium, croscarmellose sodium, carboxymethyl starch sodium, and crosspovidone; wherein said granules are mixed in said second disintegrant, and wherein said active ingredient is contained in an amount of 5 to 40 mg, and wherein said water-soluble excipient is contained an amount of 200 to 2000% by weight of the active ingredient, and wherein said first disintegrant is contained in an amount of 5 to 300% by weight to the weight of the active ingredient, and wherein said water-soluble polymer binder is contained in an amount of about 1 to 5% by weight to the total weight of said preparation, and wherein said second disintegrant is contained in amount of 20 to 1200% by weight to the weight of the granule.