Coated packaging
Inventors
Weikart, Christopher • Clark, Becky L. • Stevenson, Adam • Felts, John T.
Assignees
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Publication Number
US-11344473-B2
Publication Date
2022-05-31
Expiration Date
Abstract
A vessel has an interior surface facing a lumen. The interior surface includes a tie coating or layer, a barrier coating or layer, and a pH protective coating or layer. The tie coating or layer can comprise SiOxCy or SiNxCy, where x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3. The barrier coating or layer can comprise SiOx, wherein x is from 1.5 to 2.9. The barrier coating or layer reduces the ingress of atmospheric gas into the lumen. The pH protective coating or layer can comprise SiOxCy or SiNxCy, as well. In an embodiment, in the presence of a fluid composition contained in the lumen and having a pH between 5 and 9, the calculated shelf life of the package can be more than six months at a storage temperature of 4° C.
Core Innovation
The invention provides a coated thermoplastic vessel having an interior surface enclosing at least a portion of a lumen, where the interior surface includes a trilayer coating set comprising a tie coating or layer, a barrier coating or layer, and a pH protective coating or layer. The tie coating or layer comprises SiOxCyHz or SiNxCyHz and is positioned between the thermoplastic wall and the barrier layer, and the barrier coating or layer comprises SiOx and is positioned between the tie coating or layer and the lumen.
The pH protective coating or layer comprises SiOxCyHz or SiNxCyHz and is positioned between the barrier layer and the lumen. The pH protective layer is defined using an FTIR absorbance spectrum criterion based on a ratio greater than 0.9 between the maximum amplitude of Si-O-Si symmetrical and asymmetric stretch peaks, and in some claims by an ATR O-parameter less than 0.4.
The vessel is characterized by a silicon dissolution rate, determined under a defined potassium phosphate buffer diluted in water for injection at pH 8 and containing polysorbate-80, that is less than 170 ppb/day. The trilayer architecture is used to reduce atmospheric gas ingress while maintaining barrier function and limiting silicon dissolution and/or erosion behaviors under exposure relevant to pharmaceutical environments.
Claims Coverage
Independent claim coverage centers on a thermoplastic vessel with three inventive features: a tie coating or layer, a SiOx barrier coating or layer, and a pH protective coating or layer, together with structural characterization and a silicon dissolution-rate limitation. Dependent claims further refine the coating composition, FTIR and ATR measurements, erosion relationships, deposition method, vessel type, and shelf-life.
Trilayer coated thermoplastic vessel with tie, barrier, and pH protective layers
A vessel comprising a thermoplastic wall enclosing at least a portion of a lumen; a tie coating or layer comprising SiOxCyHz or SiNxCyHz positioned between the thermoplastic wall interior surface and the lumen; a barrier coating or layer of SiOx positioned between the tie coating or layer and the lumen; and a pH protective coating or layer of SiOxCyHz or SiNxCyHz positioned between the barrier coating or layer and the lumen.
FTIR-based pH protective coating spectral ratio criterion
The pH protective coating or layer has an FTIR absorbance spectrum with a ratio greater than 0.9 between the maximum amplitude of the Si-O-Si symmetrical stretch peak and the maximum amplitude of the Si-O-Si asymmetric stretch peak.
Silicon dissolution rate limitation under defined buffered polysorbate-containing condition
The silicon dissolution rate from the vessel, measured using a potassium phosphate buffer diluted in water for injection, adjusted to pH 8, and containing polysorbate-80 surfactant, is less than 170 ppb/day.
Prefilled syringe implementation with pH greater than 5 pharmaceutical composition and shelf life
A prefilled syringe in which the interior syringe barrel includes the tie coating or layer, the barrier coating or layer, and the pH protective coating or layer, where a seated plunger includes a pharmaceutical composition having pH greater than 5 in the lumen, and the syringe has a shelf life of at least six months.
FTIR-derived pH protective O-parameter constraint
The pH protective coating or layer has an O-parameter, measured by attenuated total reflection, less than 0.4 based on intensity at 1253 cm-1 relative to the maximum intensity within 1000 to 1100 cm-1.
Relative pH protective erosion rate limit under pH greater than 5 exposure
The rate of erosion of the pH protective coating or layer contacted by a fluid in the lumen with pH greater than 5 is less than 20% of the rate of erosion of the barrier coating or layer under the same conditions.
PECVD formed coatings
At least one of the tie coating or layer, the barrier coating or layer, or the pH protective coating or layer is formed using plasma enhanced chemical vapor deposition (PECVD).
Tie coating thickness range
The tie coating or tie layer has an average thickness between 5 and 200 nm.
The claim set centers on a trilayer interior coating structure for a thermoplastic vessel that combines a tie layer, a SiOx barrier layer, and a pH protective SiOxCyHz or SiNxCyHz layer. The pH protective layer is constrained by FTIR spectral ratios and, in dependent claims, ATR O-parameter and erosion-rate relationships. The vessel is further required to exhibit low silicon dissolution under a defined buffered, polysorbate-containing test condition, and specific embodiments include PECVD formation and prefilled syringe use with a shelf-life minimum.
Stated Advantages
Low silicon dissolution rate from the vessel under a defined buffered, polysorbate-containing condition.
Reduction of atmospheric gas ingress.
Improved performance for pharmaceutical storage, supported by shelf-life performance.
Reduced erosion of the pH protective coating layer relative to the barrier coating layer under pH greater than 5 conditions.
Reduces blood clotting and platelet activation in blood collection tube contexts.
Prevents insulin precipitation in storage contexts.
Documented Applications
A prefilled syringe with an interior syringe barrel coated with the tie coating, barrier coating, and pH protective coating, in which the lumen contains a pharmaceutical composition having pH greater than 5 and the syringe has a shelf life of at least six months.
A blood collection tube context in which the coatings reduce blood clotting and platelet activation.
An insulin storage context in which the coatings prevent insulin precipitation.
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