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-11148856-B2
Publication Date
2021-10-19
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 or layer of SiOx, where x is between 1.5 and 2.9, is positioned between the interior surface and the lumen and is supported by the thermoplastic wall, and the barrier coating is effective to reduce the ingress of atmospheric gas into the lumen compared to a vessel without the barrier coating or layer.
The vessel also includes a passivation layer or pH protective coating of SiOxCy, where x is between 0.5 and 2.4 and y is between 0.6 and 3. This layer is positioned between the barrier coating and the lumen and is supported by the thermoplastic wall, and the passivation layer or pH protective coating is effective to decrease the silicon dissolution rate from the vessel.
The document addresses silicon dissolution or erosion and atmospheric gas ingress that negatively impact performance during storage of fluids in pharmaceutical packages or vessels. It further describes PECVD-formed SiOx barrier coatings and SiOxCy or SiNxCy passivation or pH protective layers associated with controlling organosilicon precursor chemistry for improved barrier and passivation performance.
Claims Coverage
The claims coverage centers on a thermoplastic vessel with two functional coating layers: an SiOx barrier layer to reduce atmospheric gas ingress and an SiOxCy passivation or pH protective layer to decrease silicon dissolution rate. The inventive features are defined by composition ranges for x and y and are supported by dependent-claim performance constraints.
Vessel with dual-layer SiOx barrier and SiOxCy passivation
A vessel comprising a thermoplastic wall having an interior surface enclosing a lumen; a barrier coating or layer of SiOx, in which x is between 1.5 and 2.9, positioned between the interior surface of the thermoplastic wall and the lumen and supported by the thermoplastic wall, the barrier coating or layer being effective to reduce the ingress of atmospheric gas into the lumen compared to a vessel without the barrier coating or layer; and a passivation layer or pH protective coating of SiOxCy, in which x is between 0.5 and 2.4 and y is between 0.6 and 3, positioned between the barrier coating or layer and the lumen and supported by the thermoplastic wall, the passivation layer or pH protective coating being effective to decrease the silicon dissolution rate from the vessel.
pH-conditioned lumen fluid
A fluid is contained in the lumen and has a pH greater than 5.
Time-dependent passivation-layer thickness
The passivation layer or pH protective coating contacting the fluid is between 20 and 700 nm thick two years after the fluid is disposed in the vessel.
Shelf-life and minimum passivation thickness at shelf-life end
The fluid-containing vessel has a minimum shelf life of at least one year when determined at 4°C, and the passivation layer or pH protective coating is at least 80 nm thick at the end of the shelf life.
Relative passivation erosion versus barrier layer
A fluid composition with pH 8 directly contacts the passivation layer or pH protective coating and has an erosion rate that is less than 20% of the erosion rate of a barrier coating or layer under the same conditions.
The claims coverage is centered on a thermoplastic vessel that combines an SiOx barrier layer and an SiOxCy passivation or pH-protective layer. Dependent claim coverage further specifies lumen-fluid pH greater than 5, time-dependent passivation-layer thickness after two years, shelf life at 4°C with a minimum passivation thickness at shelf-life end, and reduced passivation erosion relative to the barrier layer for a pH 8 fluid.
Stated Advantages
Reduces the ingress of atmospheric gas into the lumen compared to a vessel without the barrier coating or layer.
Decreases the silicon dissolution rate from the vessel.
The erosion rate of the passivation layer or pH protective coating is less than 20% of the erosion rate of a barrier coating or layer for a pH 8 fluid.
Documented Applications
Pharmaceutical vessel use including evacuation storage, blood collection tubes, and insulin storage.
Pharmaceutical packages and vessels configured to protect against silicon dissolution or erosion and gas ingress during storage of fluids, including syringes, vials, and tubing.
Fluid-containing vessels where a fluid in the lumen has pH greater than 5, including fluids at pH 8.
Contexts involving biologics, blood, and insulin compatibility and improved shelf life, including calculated shelf life at 4°C.
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