STERILIZABLE PHARMACEUTICAL PACKAGE FOR OPHTHALMIC FORMULATIONS
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United States of America Patent
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Issued Date -
Mar 7, 2024
app pub date -
Oct 31, 2023
filing date -
Nov 18, 2015
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Abstract
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.
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