CRYSTAL HABIT OF QUINOLINE DERIVATIVE AND PREPARATION METHOD FOR CRYSTALLINE POWDER THEREOF

    公开(公告)号:EP3816161A1

    公开(公告)日:2021-05-05

    申请号:EP19826745.2

    申请日:2019-06-24

    摘要: The present application relates to the field of pharmaceutical technology, specifically to the crystal habit and crystalline powder preparation of quinoline derivatives, and more specifically, to the crystal habit and crystalline powder preparation of anlotinib dihydrochloride. The compound of formula II disclosed herein is a crystalline powder with a flaky crystal habit having a specific surface area ≥ 10 m 2 /g and a particle-size distribution of X 50 ≤ 50 µm and/or X 90 ≤ 500 µm, such that a large specific surface area is provided without reducing the particle size of the drug by a physical method under the condition of a broad particle-size distribution, and the drug can rapidly dissolving. In addition to excellent dissolution property, the crystalline powder is also beneficial to industrial manufacturing, featuring simplified process and cost-efficiency.