Trilayer coated pharmaceutical packaging with low oxygen transmission rate

• US 9,937,099 B2
• Filed: 06/26/2015
• Issued: 04/10/2018
• Est. Priority Date: 03/11/2013
• Status: Active Grant

• Current Assignee: SiO2 Medical products Inc.
• Original Assignee: SiO2 Medical products Inc.
• Inventors: Weikart, Christopher, Clark, Becky L., Stevenson, Adam, Felts, John T.
• Primary Examiner(s): AUGHENBAUGH, WALTER
• Application Number:
  US14/751,435
• Publication Number:
  US 20150290080A1
• Time in Patent Office: 1,019 Days
• Field of Search: 428 367
• CPC Class Codes: A61J 1/00 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 Class Codes: A61J 1/05 for collecting, storing or administering blood, plasma or medical fluids multiple bags systems for separating or storing blood components A61M1/0209; Infusion or perfusion containers
• CPC Class Codes: A61J 1/06 Ampoules or carpules syringe ampoules or carpules A61M5/28
• CPC Class Codes: A61J 1/062 Carpules
• CPC Class Codes: A61J 1/065 Rigid ampoules, e.g. glass ampoules
• CPC Class Codes: A61J 1/1425 Snap-fit type
• CPC Class Codes: A61J 1/1468 Containers characterised by specific material properties
• CPC Class Codes: A61J 1/2096 Combination of a vial and a syringe for transferring or mixing their contents
• CPC Class Codes: A61M 2005/3131 specially adapted for improving sealing or sliding
• CPC Class Codes: A61M 2205/0238 the material being a coating or protective layer
• CPC Class Codes: A61M 3/00 Medical syringes, e.g. enemata; Irrigators A61M5/00 takes precedence; pistons A61M5/315
• CPC Class Codes: A61M 3/0204 Physical characteristics of the irrigation fluid, e.g. conductivity or turbidity
• CPC Class Codes: A61M 3/0208 before use
• CPC Class Codes: A61M 3/0212 after use
• CPC Class Codes: A61M 3/0216 Pressure
• CPC Class Codes: A61M 3/022 Volume; Flow rate
• CPC Class Codes: A61M 5/3129 Syringe barrels A61M5/3205 and A61M5/50 take precedence
• CPC Class Codes: B32B 1/00 Layered products having a non-planar shape
• CPC Class Codes: B32B 1/08 Tubular products
• CPC Class Codes: C23C 16/0272 Deposition of sub-layers, e.g. to promote the adhesion of the main coating
• CPC Class Codes: C23C 16/045 : Coating cavities or hollow spaces, e.g. interior of tubes; Infiltration of porous substrates
• CPC Class Codes: C23C 16/401 : containing silicon
• CPC Class Codes: C23C 16/45523 : Pulsed gas flow or change of composition over time
• CPC Class Codes: Y10T 428/1383 : Vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit is sandwiched between layers [continuous layer]

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.

Claims

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_xC_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_xC_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.