FIELD: medicine; pharmaceuticals.
SUBSTANCE: invention relates to the field of medicine and pharmaceuticals, namely, to pharmaceutical packaging pre-filled with an ophthalmic medicinal product, providing for: 1) a container comprising a thermoplastic wall made of a cyclic olefin polymer (COP), having an inner surface, an outer surface and a set of coatings on the inner and outer surfaces of the wall, and the set of coatings comprises: a binding coating or layer on the inner surface or outer surface and a pH-protecting coating or layer containing SiOxCyHz, wherein x is from 0.5 to 2.4, y is from 0.6 to 3 and z is from 2 to 9; barrier coating or layer of SiOx, wherein х is from 1.5 to 2.9; 2) located in the cavity, liquid composition suitable for intravitreal injection, based on an ophthalmic medicinal product that is a vascular endothelial growth factor (VEGF) antagonist; and 3) closure.
EFFECT: obtaining a container containing a liquid composition of a VEGF antagonist, with a coating that effectively ensures that the liquid composition contains less than 50 particles with a size of more than 10 μm and less than 5 particles with a size of more than 25 μm after storage for three months at 25°C and a relative humidity of 60 % or 40°C and a relative humidity of 75%.
40 cl, 39 dwg, 6 tbl, 2 ex.
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Authors
Dates
2021-07-14—Published
2016-11-18—Filed