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    • 33. 发明申请
    • Method for terminal sterilization of transdermal delivery devices
    • 透皮给药装置终末灭菌方法
    • US20060280644A1
    • 2006-12-14
    • US11446530
    • 2006-06-01
    • Scott SellersYuh-Fun Maa
    • Scott SellersYuh-Fun Maa
    • A61L2/00
    • A61K9/0021A61K41/0019A61L2/081A61L2/087A61L2/206A61M37/00A61M37/0015A61M2037/0046A61M2037/0061
    • A method and system for providing a terminally sterilized transdermal influenza vaccine delivery device. A microprojection member having a plurality of stratum corneum-piercing microprojections is coated with an influenza vaccine-formulation and exposed to sufficient radiation to sterilize the microprojection member while retaining sufficient potency of the influenza vaccine. Preferably, the microprojection member is sealed in packaging, such as a foil pouch. Also preferably, a retainer ring and adhesive are included within the packaging. The sterilizing radiation can be gamma radiation or e-beam, preferably delivered in a dose in the range of approximately 7-21 kGy. Also preferably, the irradiation is performed from −78.5-25° C. In preferred embodiments, the radiation is delivered at a rate greater than 3.0 kGy/hr.
    • 一种用于提供终末灭菌的经皮流感疫苗递送装置的方法和系统。 具有多个角质层穿孔微突出物的微突出物构件涂覆有流感疫苗制剂并且暴露于足够的辐射以在保持足够的流感疫苗的效力的同时对微突出物构件进行灭菌。 优选地,微喷射构件被密封在包装中,例如箔袋。 还优选地,保持环和粘合剂包括在包装内。 灭菌辐射可以是γ辐射或电子束,优选以约7-21kGy的剂量递送。 还优选地,照射从-78.5-25℃进行。在优选的实施方案中,以大于3.0kGy / hr的速率递送辐射。