IMPROVED METHOD OF MAPPING GLYCANS OF GLYCOPROTEINS IN SERUM SAMPLES
    5.
    发明公开
    IMPROVED METHOD OF MAPPING GLYCANS OF GLYCOPROTEINS IN SERUM SAMPLES 审中-公开
    血清样本中糖蛋白甘露糖的改进方法

    公开(公告)号:EP3169999A1

    公开(公告)日:2017-05-24

    申请号:EP15738920.6

    申请日:2015-07-17

    申请人: Hexal AG

    IPC分类号: G01N33/50

    摘要: The present invention relates to a method for analyzing glycans of a recombinant glycoprotein in a liquid sample of a mammal. Specifically the method comprises a step of affinity purifying the recombinant glycoprotein from the sample, enzymatically releasing a glycan containing fragment from the immobilized glycoprotein, adding a reference standard containing isotopically labeled glycans, fluorescently label the glycans and analyzing the glycans using LC-MS. The present invention also relates to a method further comprising analyzing the glycans of the immobilized recombinant glycoprotein fragment, further comprising a pre-clearing step of the liquid sample, and releasing the glycans from the immobilized recombinant glycoprotein fragment. The methods allow for the use of a small sample volume and the possibility to operate with high throughput, such as in a 96-well plate sample preparation and are therefore suited to measure pharmacodynamics parameters of a recombinant glycoprotein in a mammal in clinical or pre-clinical studies.

    摘要翻译: 本发明涉及一种分析哺乳动物液体样品中重组糖蛋白聚糖的方法。 具体而言,该方法包括亲和纯化来自样品的重组糖蛋白,从固定的糖蛋白酶促释放含聚糖片段,添加含有同位素标记的聚糖的参考标准物,荧光标记聚糖并使用LC-MS分析聚糖的步骤。 本发明还涉及一种方法,其进一步包括分析固定的重组糖蛋白片段的聚糖,还包括液体样品的预清除步骤,并从固定化的重组糖蛋白片段释放聚糖。 这些方法允许使用小的样品体积和以高通量操作的可能性,例如在96孔板样品制备中,因此适合于测量哺乳动物中临床或预测的重组糖蛋白的药效学参数, 临床研究。

    TRANSDERMAL THERAPEUTIC SYSTEM COMPRISING BUPRENORPHINE
    7.
    发明授权
    TRANSDERMAL THERAPEUTIC SYSTEM COMPRISING BUPRENORPHINE 有权
    丁丙诺啡透皮治疗系统

    公开(公告)号:EP2640389B1

    公开(公告)日:2014-12-31

    申请号:EP11784951.3

    申请日:2011-11-17

    申请人: Hexal AG

    摘要: The invention is concerned with a transdermal therapeutic system (TTS) comprising buprenorphine and a method of manufacturing such a TTS. The transdermal therapeutic system is used for the transdermal administration of buprenorphine and analogues thereof. In particular, the invention relates to the use of a transdermal therapeutic system (TTS) for analgesic purposes. The TTS according to the invention comprises a transdermal drug delivery composition comprising buprenorphine and an adhesive component, which is a mixture of a crosslinked and a non-crosslinked acrylic polymer and a penetration enhancer comprising a keto acid.

    Orodispersible film compositions
    9.
    发明公开
    Orodispersible film compositions 审中-公开
    Schmelzfilmzusammensetzungen

    公开(公告)号:EP2732813A1

    公开(公告)日:2014-05-21

    申请号:EP12007710.2

    申请日:2012-11-14

    申请人: Hexal AG

    发明人: Kohr, Thomas

    IPC分类号: A61K9/70 A61K47/44 A61K31/485

    摘要: The present invention relates to an orodispersible film composition comprising a therapeutically effective amount of at least one active pharmaceutical ingredient, a gelling agent, at least one flavoring agent selected from natural citrus fruit derived oil or a mixture of two or more natural citrus fruit derived oils, wherein said composition does not comprise an artificial flavoring agent. The present invention also relates to a method of preparation of said composition, and an orodispersible film comprising said composition. The orodispersible film composition is particularly useful as a medicament.

    摘要翻译: 本发明涉及包含治疗有效量的至少一种活性药物成分,胶凝剂,至少一种选自天然柑橘类水果衍生油的调味剂或两种或多种天然柑橘类水果衍生油的混合物的可分散膜组合物 其中所述组合物不包含人造调味剂。 本发明还涉及所述组合物的制备方法和包含所述组合物的可分散膜。 可分散的膜组合物特别可用作药物。