Pharmaceutical composition

摘要

A preparation for oral administration comprising: a pregelatinized starch comprising N-[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]-(2R,3R)-2,3-tetramethylene-butyl]-(1′R,2′S,3′R,4′S)-2,3-bicyclo[2,2,1]-heptanedicarboxylmide hydrochloride (lurasidone) represented by the formula (1) as an active ingredient; a water-soluble excipient; and a water-soluble polymeric binder, the preparation exhibiting an invariant level of elution behavior even when the content of its active ingredient is varied.

主权项

1. An oral preparation comprising 20 to 120 mg of N-[4-[4-(1,2-benzisothiazol-3-yl)-1-piperazinyl]-(2R,3R)-2,3-tetramethylene-butyl]-(1′R,2′S,3′R,4′S)-2,3-bicyclo[2,2,1]heptanedicarboxylmide hydrochloride (lurasidone) of formula (1):a pregelatinized starch, a water-soluble excipient, a water-soluble polymer binder, a disintegrant, and a lubricant, wherein the content of lurasidone in the preparation is 20 to 45% (wt/wt), and the content of the pregelatinized starch in the preparation is 20 to 30% (wt/wt).