NOVEL AMORPHOUS FORMS OF PITAVASTATIN CALCIUM
To provide methods of producing novel amorphous forms of pitavastatin calcium, the novel amorphous forms, and pharmaceutical compositions containing the amorphous forms.SOLUTION: Novel amorphous forms having characteristic peaks in X-ray powder diffraction patterns are produced by adding a non-solve...
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Main Authors | , , , |
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Format | Patent |
Language | English Japanese |
Published |
28.02.2019
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Subjects | |
Online Access | Get full text |
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Summary: | To provide methods of producing novel amorphous forms of pitavastatin calcium, the novel amorphous forms, and pharmaceutical compositions containing the amorphous forms.SOLUTION: Novel amorphous forms having characteristic peaks in X-ray powder diffraction patterns are produced by adding a non-solvent to an organic solvent solution of (3R,5S)-7-[2-cyclopropyl-4-(4-fluorophenyl)quinolin-3-yl]-3,5-dihydroxy-6(E)-heptanoic acid hemicalcium salt or lyophilizing an aqueous solution of the salt.SELECTED DRAWING: None
【課題】ピタバスタチンカルシウムの新規なアモルファス形態の製造方法、新規なアモルファス形態、及び該アモルファス形態を含む医薬組成物を提供する。【解決手段】(3R,5S)−7−[2−シクロプロピル−4−(4−フルオロフェニル)キノリン−3−イル]−3,5−ジヒドロキシ−6(E)−ヘプテン酸ヘミカルシウム塩の有機溶剤溶液に非溶剤を加えるか、又は上記塩の水溶液を凍結乾燥することにより、X線粉末回折図形において特徴的なピークを有する新規なアモルファス形態を製造する。【選択図】なし |
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Bibliography: | Application Number: JP20180223591 |