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
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Publication Number
US-11724860-B2
Publication Date
2023-08-15
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 a vessel that includes a thermoplastic wall having an interior surface enclosing a lumen. A barrier coating is positioned between the interior surface of the thermoplastic wall and the lumen, and the barrier coating is effective to reduce ingress of atmospheric gas into the lumen compared to a vessel without the barrier coating.
The vessel further includes a passivation or pH protective coating positioned between the barrier coating and the lumen, and the passivation or pH protective coating is effective to decrease the dissolution rate of the barrier coating. In the passivation or pH protective coating, the material comprises SiOxCy with x between 0.5 and 2.4 and y between 0.6 and 3.
An FTIR absorbance spectrum of the passivation or pH protective coating is used to define a spectral constraint. The ratio is greater than 0.75 between the maximum amplitude of the Si–O–Si symmetrical stretch peak and the maximum amplitude of the Si–O–Si asymmetrical stretch peak. The disclosed approach controls performance of the barrier coating by providing the passivation or pH protective coating that decreases dissolution and reduces atmospheric gas ingress.
Claims Coverage
The patent includes one independent claim directed to a thermoplastic vessel with an atmospheric gas barrier coating and an overlying passivation or pH protective coating. The passivation coating is defined by SiOxCy composition ranges and an FTIR peak-amplitude ratio constraint.
Thermoplastic wall with lumen
A vessel comprising a thermoplastic wall having an interior surface enclosing a lumen.
Barrier coating reducing atmospheric gas ingress
A barrier coating positioned between the interior surface of the thermoplastic wall and the lumen, effective to reduce the ingress of atmospheric gas into the lumen compared to a vessel without the barrier coating.
Passivation or pH protective coating decreasing dissolution rate
A passivation or pH protective coating positioned between the barrier coating and the lumen, effective to decrease the dissolution rate of the barrier coating.
SiOxCy composition ranges
The passivation or pH protective coating comprises SiOxCy, where x is between 0.5 and 2.4 and y is between 0.6 and 3.
FTIR Si–O–Si peak amplitude ratio constraint
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 and the maximum amplitude of the Si–O–Si asymmetrical stretch peak.
The core coverage is directed to a thermoplastic vessel having a barrier layer to reduce atmospheric gas ingress and an overlying SiOxCy passivation or pH protective coating defined by composition ranges and an FTIR ratio constraint, with the coating effective to decrease the dissolution rate of the barrier coating.
Stated Advantages
Reduces ingress of atmospheric gas into the lumen compared to a vessel without the barrier coating.
Decreases the dissolution rate of the barrier coating.
Documented Applications
Evacuated storage use cases.
Blood collection tubes.
Insulin storage.
Medical/diagnostic kits.
Pharmaceutical packages/vessels configured with filled packages and lumen contents including pH 5–9 fluids, where the vessel coatings are used to reduce barrier dissolution and extend shelf life.
Use of the disclosed vessel structure for pH-protective behavior for pH 5–9, including pH 8, fluids to reduce erosion or dissolution and improve stability.
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