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-11884446-B2
Publication Date
2024-01-30
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 prefilled syringe in which a syringe barrel lumen is defined at least in part by a thermoplastic wall. A lubricity coating of SiOxCy is provided with an inner surface facing the lumen and an outer surface facing the interior surface of the thermoplastic wall, and the lubricity coating has a lower frictional resistance than an uncoated surface of the thermoplastic wall.
The lumen contains a fluid composition comprising a botulinum toxin, wherein the fluid composition has a pH between 4 and 10. A plunger tip is positioned in the lumen and is slidable along the interior surface of the wall, and a cap or needle shield is provided at a distal end of the syringe barrel.
The lubricity coating composition is defined by w, x, and y in which w is 1, x is from about 0.5 to about 2.4, and y is from about 0.6 to about 3. The prefilled syringe is characterized such that the shelf life of the prefilled syringe is more than six months at a storage temperature of 4°C.
Claims Coverage
Independent claim clm-00001 defines 3 inventive features in a prefilled syringe with a thermoplastic barrel, a specific SiOxCy lubricity coating, a botulinum toxin fluid composition at defined pH, and a shelf life requirement at 4°C.
SiOxCy lubricity coating on a thermoplastic barrel lumen
A lubricity coating of SiOxCy is disposed in the lumen with an inner surface facing the lumen and an outer surface facing the interior surface of the thermoplastic wall, the lubricity coating having a lower frictional resistance than an uncoated surface of the thermoplastic wall, wherein w is 1, x is from about 0.5 to about 2.4, and y is from about 0.6 to about 3.
Botulinum toxin fluid composition at pH 4 to 10
The fluid composition contained in the lumen comprises a botulinum toxin and has a pH between 4 and 10.
Prefilled syringe performance defined by shelf life at 4°C
The shelf life of the prefilled syringe is more than six months at a storage temperature of 4°C.
Overall claim coverage centers on a prefilled syringe using a defined SiOxCy lubricity coating on a thermoplastic barrel lumen to reduce friction, while containing a botulinum toxin fluid at pH 4 to 10 and achieving a shelf life of more than six months at 4°C.
Stated Advantages
Lower frictional resistance than an uncoated surface of the thermoplastic wall.
Shelf life more than six months at a storage temperature of 4°C.
Documented Applications
Not explicitly described in patent.
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