Christopher Weikart,Murray Stephen Bennett,Jean-Pierre Giraud
申请号:
US16616310
公开号:
US20200171244A1
申请日:
2018.05.24
申请国别(地区):
US
年份:
2020
代理人:
摘要:
A liquid formulation of an ophthalmic drug in a pre-filled pharmaceutical package, for example a syringe, cartridge, vial or any other vessel made in part or in whole of a thermoplastic polymer, coated on the interior with a tie coating or layer, a barrier coating or layer, a pH protective coating or layer, and optionally a lubricity coating or layer. A blister, a pouch, a bag, a tray or a tub may encompass as a secondary packaging the syringe, vial, cartridge, tube or any other vessel. The package is suitable for sterilization (e.g., surface and/or terminal sterilization) with sterilization gas residuals being minimal and/or lower than required by ISO 10993-7; and/or the stability of the ophthalmic drug is maintained, during a prolonged time period following the sterilization. The sterilization gas may be EO, propylene oxide, chlorine dioxide, nitrogen dioxide, or vaporized hydrogen peroxide (VHP), among others.