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SPARINGLY SOLUBLE ACTIVE PHARMACEUTICAL INTERMEDIATE WITH IMPROVED SOLUBILITY AND STABILITY, AND METHOD FOR PRODUCING THE SAME
SPARINGLY SOLUBLE ACTIVE PHARMACEUTICAL INTERMEDIATE WITH IMPROVED SOLUBILITY AND STABILITY, AND METHOD FOR PRODUCING THE SAME
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机译:具有改善的溶解度和稳定性的难溶的活性药物中间体,及其制备方法
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摘要
PROBLEM TO BE SOLVED: To provide a sparingly soluble active pharmaceutical intermediate with improved solubility and stability, especially in candesartan cilexetil, Form I crystalline powder of candesartan cilexetil, whose particle size is relatively small and contains essentially no particles having a particle size of 100 μm or more (high solubility), and which shows little increase in the amount of desethyl compound (high stability) and has high purity, and to provide a simple method for producing the same.;SOLUTION: The fine particle powder of sparingly soluble active pharmaceutical intermediate of the present invention is produced by a production method comprising: a step of feeding powder containing large particles having a desired crystal form; and a pulverization step of obtaining the small particle powder containing essentially no particles having a particle size of 100 μm or more, which inhibit improvement of solubility, by pulverizing the powder containing large particles with a work volume such that, when D90 of the powder containing large particles is denoted by D1 (m) and D90 of the small particle powder by D2 (m), a value of {(1/D2)-(1/D1)} is 10 to 50 (1/m).;SELECTED DRAWING: None;COPYRIGHT: (C)2016,JPO&INPIT
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