| 摘要 |
<P>PROBLEM TO BE SOLVED: To provide slightly-soluble active pharmaceutical ingredient powder having improved solubility and stability; especially, to provide high-purity form I crystal powder especially of candesartan cilexetil in which the average particle size is comparatively small and particles having a particle size of ≥100 μm are not contained substantially (high solubility), and increase of a desethyl body is small (high stability), concerning candesartan cilexetil; and to provide a simple method for producing the same. <P>SOLUTION: Small-particle powder of slightly-soluble active pharmaceutical ingredient powder is produced by a production method including a step in which powder containing aimed crystalline large particles is supplied, and a crushing step in which, assuming that D90 of the powder containing large particles is D1 (m) and D90 of small-particle powder obtained after crushing is D2 (m), the powder containing large particles is crushed with a workload whose value of ä(1/D2)-(1/D1)} is 10-50 (1/m), to thereby obtain small-particle powder not containing substantially particles having the particle size of ≥100 μm which disturb improvement of solubility. <P>COPYRIGHT: (C)2013,JPO&INPIT |
