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    SERINGUE ET SON PROCÉDÉ D'ASSEMBLAGE
    5.
    发明公开
    SERINGUE ET SON PROCÉDÉ D'ASSEMBLAGE 审中-公开
    SYRINGE及其组装方法

    公开(公告)号：EP3319667A1

    公开(公告)日：2018-05-16

    申请号：EP16736209.4

    申请日：2016-07-08

    申请人： Guerbet

    发明人： CACLIN, Jérôme

    IPC分类号： A61M5/315

    CPC分类号： A61M5/31505 ,  A61M5/31501 ,  A61M2005/31506 ,  A61M2005/31508 ,  A61M2005/3151

    摘要： The invention relates to a syringe (1) comprising a body (2) delimiting a chamber (C), a piston (3) able to slide in the chamber of the body along a longitudinal axis (X1) of the syringe, and a deformable retention device (4) designed to prevent the piston from leaving the body entirely. The piston has a rod (31), a head (33) and a finger rest (32) which together are all in one piece. The retention device is mounted with force in the chamber and extends around the piston over an angular sector strictly greater than 180° when it is in the assembled position. Moreover, this retention device has external ribs (46) which, protruding, extend parallel to the longitudinal axis (X1), and which are plastically deformable when the retention device is fitted in the chamber. The invention also relates to a method for assembling this syringe.

    Process for preparing a pharmaceutical formulation of contrast agents
    7.
    发明授权
    Process for preparing a pharmaceutical formulation of contrast agents 有权
    制备造影剂药物制剂的方法

    公开(公告)号：EP2799089B9

    公开(公告)日：2017-09-06

    申请号：EP14165006.9

    申请日：2009-02-18

    申请人： GUERBET

    发明人： Meyer, Dominique ,  Corot, Claire ,  Port, Marc ,  Barbotin, Vincent ,  Bonnemain, Bruno

    IPC分类号： A61K49/10 ,  A61K51/04

    CPC分类号： A61K49/108 ,  A61K9/0019 ,  A61K31/28 ,  A61K45/06 ,  A61K47/18 ,  A61K49/106 ,  G01N33/15

    摘要： The invention relates to a process for preparing a liquid pharmaceutical formulation containing a complex of macrocyclic chelate with a lanthanide and a mol/mol amount of free macrocyclic chelate of between 0.002% and 0.4%, advantageously between 0.02% and 0.3% and very advantageously between 0.025% and 0.25%, the macrocyclic chelate advantageously being chosen from DOTA, NOTA, DOTAGA, D03A, BT-D03A, HP-D03A and PCTA, and is preferably DOTA, the said process comprising the following successive steps: b) preparation of a liquid pharmaceutical composition containing, firstly, the complex of macrocyclic chelate with a lanthanide, and, secondly, free macrocyclic chelate and/or free lanthanide; c) measurement in the pharmaceutical formulation obtained in step b) of the concentration of free macrocyclic chelate C ch1 and/or of free lanthanide C lan 1 ; d) adjustment of C ch 1 and/or of C lan 1 so as to obtain C ch 1 = Ct ch 1 and C lan 1 = 0, wherein C t ch 1 is the target concentration of free macrocyclic chelate in the final liquid pharmaceutical formulation.

    摘要翻译： 本发明涉及制备液体药物制剂的方法，所述液体药物制剂含有大环螯合物与镧系元素和摩尔/摩尔量的游离大环螯合物的复合物，其含量为0.002％至0.4％，有利地为0.02％至0.3％，非常有利地为 0.025％和0.25％，所述大环螯合物有利地选自DOTA，NOTA，DOTAGA，D03A，BT-D03A，HP-D03A和PCTA，并且优选DOTA，所述方法包括以下连续步骤：b）制备 所述液体药物组合物首先包含大环螯合物与镧系元素的复合物，其次是游离的大环螯合物和/或游离镧​​系元素; c）在步骤b）中获得的药物制剂中测量游离大环螯合物C ch1和/或游离镧​​系元素C lan 1的浓度; d）调节C ch 1和/或C lan 1以获得C ch 1 = Ct ch 1和C lan 1 = 0，其中C t ch 1是最终液体药物中游离大环螯合物的目标浓度 公式。

    Process for preparing a pharmaceutical formulation of contrast agents
    10.
    发明授权
    Process for preparing a pharmaceutical formulation of contrast agents 有权
    Verfahren zur Herstellung einer pharmazeutischen Formulierung aus Kontrastmitteln

    公开(公告)号：EP2799089B1

    公开(公告)日：2016-08-03

    申请号：EP14165006.9

    申请日：2009-02-18

    申请人： GUERBET

    发明人： Meyer, Dominique ,  Corot, Claire ,  Port, Marc ,  Barbotin, Vincent ,  Bonnemain, Bruno

    IPC分类号： A61K49/10 ,  A61K51/04

    CPC分类号： A61K49/108 ,  A61K9/0019 ,  A61K31/28 ,  A61K45/06 ,  A61K47/18 ,  A61K49/106 ,  G01N33/15

    摘要： The invention relates to a process for preparing a liquid pharmaceutical formulation containing a complex of macrocyclic chelate with a lanthanide and a mol/mol amount of free macrocyclic chelate of between 0.002% and 0.4%, advantageously between 0.02% and 0.3% and very advantageously between 0.025% and 0.25%, the macrocyclic chelate advantageously being chosen from DOTA, NOTA, DOTAGA, D03A, BT-D03A, HP-D03A and PCTA, and is preferably DOTA, the said process comprising the following successive steps: b) preparation of a liquid pharmaceutical composition containing, firstly, the complex of macrocyclic chelate with a lanthanide, and, secondly, free macrocyclic chelate and/or free lanthanide; c) measurement in the pharmaceutical formulation obtained in step b) of the concentration of free macrocyclic chelate C ch1 and/or of free lanthanide C lan 1 ; d) adjustment of C ch 1 and/or of C lan 1 so as to obtain C ch 1 = Ct ch 1 and C lan 1 = 0, wherein C t ch 1 is the target concentration of free macrocyclic chelate in the final liquid pharmaceutical formulation.

    摘要翻译： 本发明涉及制备含有大环螯合物与镧系元素络合物和摩尔/摩尔量的游离大环螯合物的液体药物制剂的方法，其中0.002％至0.4％之间，有利地在0.02％至0.3％之间，非常有利地介于 0.025％和0.25％，大环螯合物有利地选自DOTA，NOTA，DOTAGA，D03A，BT-D03A，HP-D03A和PCTA，并且优选为DOTA，所述方法包括以下连续步骤：b） 液体药物组合物首先含有大环螯合物与镧系元素的复合物，其次是游离的大环螯合物和/或游离的镧系元素; c）在步骤b）中获得的药物制剂中测量游离大环螯合物C ch1和/或游离镧​​系元素的浓度C lan 1; d）调节C ch 1和/或C lan 1，以获得C ch 1 = Ct ch 1和C lan 1 = 0，其中C t ch 1是游离大环螯合物在最终液体药物中的目标浓度 公式。