LYOPHILIZED FORMULATION CONTAINING CEPHALOSPORIN HAVING CATECHOL GROUP, AND METHOD FOR PRODUCING SAME

    公开(公告)号:EP4190332A1

    公开(公告)日:2023-06-07

    申请号:EP21850852.1

    申请日:2021-07-28

    摘要: The present invention relates to a method for manufacturing a lyophilized formulation which comprises a compound represented by Formula (I):

    or its pharmaceutically acceptable salt, wherein the water content is controlled and the reconstitution time is short; and a lyophilized formulation.
    With a method for manufacturing a lyophilized formulation comprising at least the following steps:
    1) a step of cooling a liquid comprising the compound represented by Formula (I) or its pharmaceutically acceptable salt in a chamber of a lyophilizer to a predetermined cooling temperature, and
    2) a step of introducing ice crystals into the chamber,
    and a lyophilized formulation having a specific surface area of 0.6 to 1.1 m 2 /g, the water content can be 0.5% or less, and the reconstitution time can be 30 seconds or less.