TRILAYER COATED PHARMACEUTICAL PACKAGING WITH LOW OXYGEN TRANSMISSION RATE

摘要

An article is described including an article surface and a coating set comprising an optional tie coating or layer, a barrier coating or layer, and a pH protective layer. The respective coatings or layers can be applied by chemical vapor deposition of a polysiloxane or polysilazane precursor in the presence of oxygen. Examples of such an article are a prefilled thermoplastic syringe or thermoplastic pharmaceutical vial with a coated interior portion containing a pharmaceutical preparation or other fluid with a pH of 4 to 8, alternatively 5 to 9. The barrier coating or layer prevents oxygen from penetrating into the thermoplastic syringe or vial. The tie coating or layer, if present, and the pH protective coating or layer protect the barrier layer from the contents of the syringe or vial.

主权项

1. A vessel comprising:
a thermoplastic wall:
defining a lumen,having an interior surface facing the lumen, andhaving a first oxygen transmission rate respecting ingress of oxygen; a coating set on the interior surface, comprising:
optionally, a tie coating or layer having an interior surface facing the lumen and an outer surface facing the wall interior surface;a barrier coating or layer having an outer surface facing the wall interior surface and, if present, the interior surface of the tie coating or layer;and a pH protective coating or layer having an interior surface facing the lumen and an outer surface facing the interior surface of the barrier coating or layer;in which the barrier coating or layer is effective to provide a second oxygen transmission rate lower than the first oxygen transmission rate; a fluid having a pH from 3 to 9 contained in the lumen; and a closure closing the vessel to provide a closed pharmaceutical package; in which the coating set on the interior surface is effective to maintain the second oxygen transmission rate lower than the first oxygen transmission rate for at least six months of contact between the fluid in the lumen and the pH protective coating or layer.