Passivation, pH protective or lubricity coating for pharmaceutical package, coating process and apparatus

Patent metadata

Field	Value
Publication number	US-11724860-B2
Application number	US-202117484944-A
Country	US
Kind code	B2
Filing date	Sep 24, 2021
Priority date	Nov 11, 2011
Publication date	Aug 15, 2023
Grant date	Aug 15, 2023

Abstract

A method for providing a passivation layer or pH protective coating on a substrate surface by PECVD is provided, the method comprising generating a plasma from a gaseous reactant comprising polymerizing gases. The lubricity, passivation, pH protective, hydrophobicity, and/or barrier properties of the passivation layer or pH protective coating are set by setting the ratio of the O 2 to the organosilicon precursor in the precursor feed, and/or by setting the electric power used for generating the plasma. In particular, a passivation layer or pH protective coating made by the method is provided. Pharmaceutical packages coated by the method and the use of such packages protecting composition contained in the vessel against mechanical and/or chemical effects of the surface of the package without a passivation layer or pH protective coating material are also provided.

First claim

The invention claimed is:

1. A vessel comprising:
a thermoplastic wall having an interior surface enclosing a lumen;
a barrier coating positioned between the interior surface of the thermoplastic wall and the lumen, and supported by the thermoplastic wall, the barrier coating being effective to reduce the ingress of atmospheric gas into the lumen compared to a vessel without the barrier coating; and
a passivation or pH protective coating positioned between the barrier coating and the lumen, and supported by the thermoplastic wall, the passivation or pH protective coating being effective to decrease the dissolution rate of the barrier coating;
in which the passivation or pH protective coating comprises SiO x C y , in which x is between 0.5 and 2.4 and y is between 0.6 and 3, and
an FTIR absorbance spectrum of the passivation or pH protective coating has a ratio greater than 0.75 between:
the maximum amplitude of the Si—O—Si symmetrical stretch peak between about 1000 and 1040 cm-1, and
the maximum amplitude of the Si—O—Si assymmetric stretch peak between about 1060 and about 1100 cm-1.

2. The vessel of claim 1 , wherein the FTIR absorbance spectrum of the passivation or pH protective coating has a ratio greater than 0.9 between:
the maximum amplitude of the Si—O—Si symmetrical stretch peak between about 1000 and 1040 cm-1, and
the maximum amplitude of the Si—O—Si assymmetric stretch peak between about 1060 and about 1100 cm-1.

3. The vessel of claim 1 , in which the barrier coating comprises SiO x , in which x is between 1.5 and 2.9.

4. The vessel of claim 1 , in which the thermoplastic wall comprises or consists essentially of a polyolefin, a cyclic olefin polymer, a cyclic olefin copolymer, a polyester, a polycarbonate, polylactic acid, or a combination or copolymer of these.

5. The vessel of claim 1 , wherein the vessel is a syringe barrel, a cartridge, a vial, or a blister package.

6. The vessel of claim 1 , wherein the barrier coating is from 2 nm to 1000 nm thick.

7. The vessel of claim 1 , wherein the passivation or pH protective coating is from 10 nm to 1000 nm thick.

8. The vessel of claim 1 , wherein the passivation or pH protective coating is at least coextensive with the barrier coating.

9. The vessel of claim 1 , wherein the passivation or pH protective coating is applied by PECVD.

10. The vessel of claim 1 , wherein the barrier coating is applied by PECVD.

11. The vessel of claim 1 , wherein the passivation or pH protective coating has an O-parameter of less than 0.4, measured with attenuated total reflection (ATR) as:

O
⁢

-

⁢
Parameter

=

Intensity
⁢

⁢
at
⁢

⁢
1253
⁢

⁢

cm

-
1

Maximum
⁢

⁢
intensity
⁢

⁢
in
⁢

⁢
the
⁢

⁢
range
⁢

⁢
1000
⁢

⁢
to
⁢

⁢
1100
⁢

⁢

cm

-
1

.

12. The vessel of claim 11 , wherein the passivation or pH protective coating has an N-parameter of less than 0.7, measured with attenuated total reflection (ATR) as:

N
⁢

-

⁢
Parameter

=

Intensity
⁢

⁢
at
⁢

⁢
840
⁢

⁢

cm

-
1

Intensity
⁢

⁢
at
⁢

⁢
799
⁢

⁢

cm

-
1

.

13. The vessel of claim 1 , wherein the rate of erosion of the passivation or pH protective coating, if directly contacted by a fluid composition having a pH of 8, is less than 20% the rate of erosion of the barrier coating, if directly contacted by the same composition under the same conditions.

14. The vessel of claim 13 , wherein the rate of erosion of the passivation or pH protective coating, if directly contacted by a fluid composition having a pH of 8, is less than 10% the rate of erosion of the barrier coating, if directly contacted by the same composition under the same conditions.

15. The vessel of claim 14 , wherein the rate of erosion of the passivation or pH protective coating, if directly contacted by a fluid composition having a pH of 8, is less than 7% the rate of erosion of the barrier coating, if directly contacted by

Assignees

• Sio2 Medical Products Inc

Inventors

• Felts John T
• Fisk Thomas E
• Abrams Robert S
• Ferguson John
• Freedman Jonathan R
• Pangborn Robert J
• Sagona Peter J
• Weikart Christopher

Classifications

• B65D25/04

  Partitions · CPC title

• B65D25/14 Primary

  Linings or internal coatings (of containers made by folding or erecting blanks made of paper B65D5/56 {; linings for domestic water storage heaters F24H1/183}) · CPC title

• A61M5/3129

  Syringe barrels (A61M5/3205 and A61M5/50 take precedence) · CPC title

• C23C16/045

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

• C23C16/30 Primary

  Deposition of compounds, mixtures or solid solutions, e.g. borides, carbides, nitrides · CPC title