Pharmaceutical composition
AssigneeDainippon Sumitomo Pharma Co., Ltd.
InventorKazuyuki FUJIHARA
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Abstract
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.
Claims15
1-24. (canceled)
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 (I):
- 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).
Dependencies are inferred from the claim text.