METHOD FOR PREPARATION OF A HIGH CONCENTRATION LIQUID FORMULATION OF AN ANTIBODY
    61.
    发明申请
    METHOD FOR PREPARATION OF A HIGH CONCENTRATION LIQUID FORMULATION OF AN ANTIBODY 审中-公开
    制备高浓度液体制剂抗体的方法

    公开(公告)号:US20140120086A1

    公开(公告)日:2014-05-01

    申请号:US14068074

    申请日:2013-10-31

    申请人: Takeda GmbH

    IPC分类号: A61K39/395

    摘要: The present invention provides a method for preparation of a high concentration liquid formulation (HCLF) of an antibody or a fragment thereof. The present invention also relates to a method for stabilizing an anti-CD20 antibody or a fragment thereof in a liquid pharmaceutical formulation. Furthermore, the present invention relates to a liquid pharmaceutical formulation of a veltuzumab antibody or a fragment thereof comprising at least 155 mg/mL of a veltuzumab antibody or a fragment thereof.

    摘要翻译: 本发明提供了制备抗体或其片段的高浓度液体制剂(HCLF)的方法。 本发明还涉及在液体药物制剂中稳定抗CD20抗体或其片段的方法。 此外,本发明涉及veltuzumab抗体或其片段的液体药物制剂,其包含至少155mg / mL的veltuzumab抗体或其片段。

    Process for the preparation of roflumilast
    65.
    发明授权
    Process for the preparation of roflumilast 有权
    罗氟司特的制备方法

    公开(公告)号:US08618142B2

    公开(公告)日:2013-12-31

    申请号:US13860264

    申请日:2013-04-10

    申请人: Takeda GmbH

    IPC分类号: A61K31/44

    摘要: A composition comprising: roflumilast having a purity of greater than or equal to 99% by weight, and N-(3,5-dichloropyrid-4-yl)-3-cyclopropylmethoxy-4-hydroxybenzamide present (relative to roflumilast) in an amount greater than zero and less than 0.1% by weight.

    摘要翻译: 一种组合物,其包含:具有大于或等于99重量%的纯度的罗氟司特和存在(相对于罗氟司特)的N-(3,5-二氯吡啶-4-基)-3-环丙基甲氧基-4-羟基苯甲酰胺 大于零且小于0.1重量%。

    Compliance monitor and method
    67.
    发明授权
    Compliance monitor and method 有权
    合规监测和方法

    公开(公告)号:US08464707B2

    公开(公告)日:2013-06-18

    申请号:US10572316

    申请日:2004-09-22

    IPC分类号: A61M11/00

    摘要: A compliance monitor (20) is attachable to or forms part of a drug delivery device, such as an inhaler (2). The monitor comprises a flexible portion (38) to enable a switch which is actuated by a user when delivering a dose of medicament. The monitor further comprises a sensor for sensing whether the device is properly positioned in contact with or relative to the user's body for administration of the medicament. For example, where the device is an inhaler and the sensor a temperature sensor, temperature variations caused by insertion of an inhaler mouthpiece into the user's mouth indicate whether the dose has been delivered into the patient's mouth. A memory in the compliance monitor stores a compliance record indicating whether or not the device was properly positioned each time a dose was delivered.

    摘要翻译: 合规监视器(20)可附接到或形成药物输送装置(例如吸入器(2))的一部分。 显示器包括柔性部分(38),以使得能够在递送一定剂量的药物时由用户致动的开关。 监视器还包括传感器,用于感测装置是否适当地定位成与使用者的身体接触或相对于使用者的身体施用,用于施用药物。 例如,在设备是吸入器并且传感器是温度传感器的情况下,由将吸入器接口插入使用者口腔而引起的温度变化表示剂量是否已被输送到患者的口中。 合规性监视器中的存储器存储指示每次发送剂量时设备是否正确定位的合规记录。