Trilayer coated blood collection tube with low oxygen transmission rate
View Patent ↗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 thermoplastic syringe, vial, or blood collection tube 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, vial, or blood collection tube. The tie coating or layer, if present, and the pH protective coating or layer protect the barrier layer from the contents of the syringe, vial, or blood collection tube.
1. A blood collection tube comprising:
a thermoplastic wall:
defining a lumen,
having an interior surface facing the lumen, and
having a first oxygen transmission rate respecting ingress of oxygen;
a coating set on the interior surface applied by PECVD, comprising:
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 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 pH protective coating or layer comprises SiO x C y , wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3;
in which the barrier coating or layer is effective to provide a second oxygen transmission rate lower than the first oxygen transmission rate; and
a closure closing the blood collection tube;
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 a fluid having a pH from 5 to 9 in the lumen and the pH protective coating or layer.
2. The blood collection tube of claim 1 , in which the fluid having a pH from 5 to 9 is a 0.2% aqueous solution of polysorbate-80, maintained at pH 8 with a phosphate buffer.
3. The blood collection tube of claim 2 , in which the thermoplastic wall comprises a polyester, polyethylene terephthalate (PET), polyethylene naphthalate (PEN), a polyolefin, cyclic olefin polymer (COP), cyclic olefin copolymer (COC), polypropylene (PP), or a polycarbonate.
4. The blood collection tube of claim 2 , in which the tie coating or layer is between 5 and 50 nm thick.
5. The blood collection tube of claim 2 , in which the barrier coating or layer is from 2 to 1000 nm thick.
6. The blood collection tube of claim 2 , in which the pH protective coating or layer as applied is between 10 and 1000 nm thick.
7. The blood collection tube of claim 2 , in which the tie coating or layer comprises SiO x C y wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3.
8. The blood collection tube of claim 2 , in which the barrier coating or layer comprises SiO x , wherein x is from 1.5 to 2.9.
9. The blood collection tube of claim 2 , in which the calculated shelf life (total Si/Si dissolution rate) is more than six months.
10. The blood collection tube of claim 2 , in which the calculated shelf life is more than six months at a storage temperature of 4° C.
11. The blood collection tube of claim 2 , in which the lumen is evacuated, defining an evacuated blood collection tube.