METHOD FOR TERMINAL STERILIZATION OF TRANSDERMAL DELIVERY DEVICES
    26.
    发明公开
    METHOD FOR TERMINAL STERILIZATION OF TRANSDERMAL DELIVERY DEVICES 审中-公开
    用于经皮递送装置的终端消毒的方法

    公开(公告)号:EP1885405A1

    公开(公告)日:2008-02-13

    申请号:EP06772047.4

    申请日:2006-06-01

    摘要: A method and system for providing a terminally sterilized transdermal device adapted to delivery a parathyroid hormone-based agent. A microprojection member that includes a plurality of stratum corneum-piercing microprojections is coated with PTH-based agent formulation an exposed to sufficient radiation to sterilize the microprojection member while retaining sufficient activity of the PTH-based agent. Preferably, the microprojection member is sealed in packing with an inert atmosphere and reduced moisture. The sterilizing radiation can be gamma radiation or e-beam, preferably delivered in a dose in the range of approximately 5 - 50 kGy. Also preferably, the irradiation is performed at -78.5-25°C. In preferred embodiments, the radiation is delivered at a rate greater than 3.0 kGy/hr.

    摘要翻译: 一种用于提供适于递送基于甲状旁腺激素的药剂的末端无菌透皮装置的方法和系统。 包含多个刺穿角质层的微突出物的微突出物构件涂覆有基于PTH的药物制剂,暴露于足够的辐射下以杀菌微突出物构件,同时保持基于PTH的药物的足够活性。 优选地,将微突起构件用惰性气氛和减少的湿气密封包装。 灭菌辐射可以是γ辐射或电子束,优选以约5-50kGy的剂量递送。 还优选地,照射在-78.5-25℃下进行。 在优选实施例中,辐射以大于3.0kGy / hr的速率传递。