METHOD FOR TERMINAL STERILIZATION OF TRANSDERMAL DELIVERY DEVICES

摘要

A method and system for providing a terminally sterilized transdermal natriuretic peptide delivery device. A microprojection member having a plurality of stratum corneum-piercing microprojections is coated with a natriuretic peptide- formulation an exposed to sufficient radiation to sterilize the microprojection member while retaining sufficient activity of the natriuretic peptide. 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 14 - 21 IcGy. Also preferably, the irradiation is performed at -78.5 - 250C. hi preferred embodiments, the radiation is delivered at a rate greater than 3.0 kGy/hr.