Trilayer coated pharmaceutical packaging with low oxygen transmission rate

Patent metadata

Field	Value
Publication number	US-9937099-B2
Application number	US-201514751435-A
Country	US
Kind code	B2
Filing date	Jun 26, 2015
Priority date	Mar 11, 2013
Publication date	Apr 10, 2018
Grant date	Apr 10, 2018

Abstract

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.

First claim

The invention claimed is:

1. A vessel 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, 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, 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;

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 in the lumen having a pH from 3 to 9 and the pH protective coating or layer.

2. A vessel 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, 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 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;

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.

3. The vessel 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 vessel of claim 2 , in which the vessel comprises a sample collection tube, a syringe barrel, a vial, a blister package, an ampoule, a cartridge, an injection pen, a bottle, a pouch, a pump, a sprayer, a stopper, a needle, a plunger, a cap, a stent, a catheter, an implant, a plastic-coated vial, a plastic coated syringe, a plastic coated ampoule, a plastic coated bottle, or any other type of container or conduit for a fluid.

5. The vessel of claim 2 , comprising the tie coating or layer, in which the tie coating or layer is between 5 and 50 nm thick.

6. The vessel of claim 2 , in which the barrier coating or layer is from 2 to 1000 nm thick.

7. The vessel of claim 2 , in which the pH protective coating or layer as applied is between 10 and 1000 nm thick.

8. The vessel of claim 2 , comprising the tie coating or layer, 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.

9. The vessel of claim 2 , in which the barrier coating or layer comprises SiO x , wherein x is from 1.5 to 2.9.

10. The vessel of claim 2 , comprising the tie coating or layer, in which the tie coating or layer is applied by PECVD.

11. The vessel of claim 2 , in which the barrier coating or layer is applied by PECVD.

12. The vessel of claim 2 , in which the pH protective coating or layer is applied by PECVD.

13. The vessel of claim 2 , in which the fluid has a pH between 5 and 9.

14. The vessel of claim 2 , in which the fluid composition is an aqueous liquid.

15. The vessel of claim 2 , in which the calculated shelf life of the vessel (total Si/Si dissolution rate) is more than six months.

16. The vessel of claim 2 , in which the fluid contained in the lumen has a pH between 5 and 9; wherein the calculated shelf life of the package is more than six months at a storage temperature of 4° C.

Assignees

• Sio2 Medical Products Inc

Inventors

• Weikart Christopher
• Clark Becky L
• Stevenson Adam
• Felts John T

Classifications

• A61M2205/0238

  the material being a coating or protective layer · CPC title

• C23C16/045

  Coating cavities or hollow spaces, e.g. interior of tubes; Infiltration of porous substrates · CPC title

• A61M3/0216

  Pressure · CPC title

• A61J1/00

  Containers specially adapted for medical or pharmaceutical purposes (capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00) · CPC title

• A61J1/2096

  Combination of a vial and a syringe for transferring or mixing their contents · CPC title