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

Inventors

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

Assignees

SiO2 Medical Products LLC

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Publication Number

US-12623813-B2

Patent

Publication Date

2026-05-12

Expiration Date


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 O2 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.

Core Innovation

The invention relates to an article comprising a wall having a surface, a barrier coating or layer of SiOx, and a pH protective coating of SiOxCy. The SiOx barrier coating is defined by x being from 1.5 to 2.9 and by thickness being from 2 to 1000 nm, with the outer surface facing the wall surface. The barrier coating is effective to reduce the ingress of atmospheric gas through the wall compared to an uncoated wall.

A pH protective coating of SiOxCy is provided on the barrier coating or layer and is formed by chemical vapor deposition of a precursor selected from a linear siloxane, a monocyclic siloxane, a polycyclic siloxane, a polysilsesquioxane, a silatrane, a silquasilatrane, a silproatrane, or a combination of any two or more of these precursors. The SiOxCy pH protective coating is defined by x being from about 0.5 to about 2.4 and y being from about 0.6 to about 3. Chemical vapor deposition and the selected precursors are used to form the pH protective coating on the SiOx barrier coating.

The pH protective coating is defined by spectroscopic characteristics and by erosion behavior when directly contacted by a fluid composition. An FTIR absorbance spectrum of the pH protective coating is required to have a ratio greater than 0.75 between the maximum amplitude of a Si–O–Si symmetrical stretch peak and the maximum amplitude of a Si–O–Si asymmetric stretch peak. The rate of erosion of the pH protective coating is less than 20% of the rate of erosion of the barrier coating or layer when contacted by a fluid composition having a pH of 8, and in another version the erosion rate is less than the erosion rate of the barrier coating or layer when contacted by a fluid composition with a pH at some point between 5 and 9.

Claims Coverage

The partial content includes two independent claims. Both claims focus on a wall having a SiOx barrier coating to reduce atmospheric-gas ingress, plus a SiOxCy pH protective coating with specified precursor types, FTIR ratio constraints, and improved erosion performance relative to the barrier layer.

SiOx barrier layer reducing atmospheric-gas ingress

A wall having a surface and a barrier coating or layer of SiOx with x from 1.5 to 2.9, 2 to 1000 nm thick, the barrier coating outer surface facing the wall surface, and being effective to reduce ingress of atmospheric gas through the wall compared to an uncoated wall.

SiOxCy pH protective coating formed by CVD from specified precursors

A pH protective coating of SiOxCy on the barrier coating or layer, where x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the pH protective coating being formed by chemical vapor deposition of a precursor selected from a linear siloxane, a monocyclic siloxane, a polycyclic siloxane, a polysilsesquioxane, a silatrane, a silquasilatrane, a silproatrane, or a combination of any two or more of these precursors.

FTIR Si–O–Si symmetric/asymmetric stretch ratio constraint

An FTIR absorbance spectrum of the pH protective coating having a ratio greater than 0.75 between the maximum amplitude of a Si–O–Si symmetrical stretch peak and the maximum amplitude of a Si–O–Si asymmetric stretch peak.

Erosion rate reduced relative to the SiOx barrier at pH 8

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

Erosion rate reduced relative to the SiOx barrier across pH 5 to 9

The rate of erosion of the passivation layer or pH protective coating, if directly contacted by a fluid composition having a pH at some point between 5 and 9, is less than the rate of erosion of the barrier coating or layer if directly contacted by the fluid composition.

Across the independent claims, the inventive coverage combines an SiOx barrier layer configured to reduce atmospheric-gas ingress with an SiOxCy pH protective coating formed by chemical vapor deposition from specified siloxane, silsesquioxane, and silatrane precursor types. The claims further require an FTIR-defined balance between Si–O–Si symmetrical and asymmetric stretch peak maxima, together with erosion performance showing the pH protective coating erodes more slowly than the SiOx barrier under the specified pH conditions.

Stated Advantages

Improved reduction of atmospheric-gas ingress through the wall compared to an uncoated wall.

The pH protective coating erodes more slowly than the barrier coating or layer when directly contacted by a fluid composition at the specified pH conditions.

Documented Applications

Not explicitly described in patent.

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