FORMYCON AG;SIO2 MEDICAL PRODUCTS, INC.;KLINGE BIOPHARMA GMBH
发明人:
Carsten Brockmeyer,Christopher Weikart,Murray Stephen Bennett,Jean-Pierre Giraud,Thomas Strungmann
申请号:
US16615969
公开号:
US20200237997A1
申请日:
2018.05.24
申请国别(地区):
US
年份:
2020
代理人:
摘要:
A pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist, for example Ranibizumab, inside the package. A nonlimiting example of the package can be a syringe, cartridge, or vial, 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. Optionally, the package further comprises a bag, a blister, a pouch or any other vessel. Stability performance of the VEGF-antagonist packaged in the coated COP vessel comparable to or better than glass was obtained. The said pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist is suitable for sterilization (such as for surface and/or terminal sterilization) with sterilization gas residuals being minimal and/or lower than required by ISO 10993-7.