Method for producing a liquid pharmaceutical preparation

    公开(公告)号:US10064961B2

    公开(公告)日:2018-09-04

    申请号:US15500685

    申请日:2015-06-15

    Abstract: A method for producing a liquid pharmaceutical preparation which contains a complex consisting of DOTA and gadolinium and a base such as L-lysine or meglumine, includes the following steps: a) An aqueous solution containing free DOTA, free gadolinium and a base such as L-lysine or meglumine is produced. b) The yield of free DOTA and free gadolinium is determined in the solution obtained according to step a). c) Free gadolinium and/or free DOTA is added in order to adjust a stoichiometric excess of free DOTA in the solution. d) The complexation is executed at an increased temperature. e) Additional base such as L-lysine or meglumine is added in order to adjust the pH value. f) The final volume of the preparation is adjusted.

    COMPOSITIONS OF TOLPERISONE
    10.
    发明申请
    COMPOSITIONS OF TOLPERISONE 有权
    妥尔酮组合物

    公开(公告)号:US20160367540A1

    公开(公告)日:2016-12-22

    申请号:US15225182

    申请日:2016-08-01

    Abstract: The present disclosure relates to tolperisone, or a pharmaceutically acceptable salt or hydrate thereof, with 10 ppm 2-methyl-1-(4-methylphenyl)-propenone (4-MMPPO) or less, methods of producing the same, as well as compositions related thereto. The disclosure further relates to methods of treating a subject with tolperisone under conditions that limit exposure of the subject to tolerable levels of 4-MMPPO.

    Abstract translation: 本公开内容涉及具有10ppm 2-甲基-1-(4-甲基苯基) - 丙烯酮(4-MMPPO)或更少的甲苯哌嗪或其药学上可接受的盐或水合物,其制备方法以及组合物 相关。 本公开进一步涉及在将受试者的暴露限制为可耐受水平的4-MMPPO的条件下用甲苯哌酮治疗受试者的方法。

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