PECVD coated pharmaceutical packaging
Inventors
Weikart, Christopher • Clark, Becky L. • Stevenson, Adam • Felts, John T.
Assignees
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Publication Number
US-12239606-B2
Publication Date
2025-03-04
Expiration Date
Abstract
An article or vessel is described including a vessel surface and a coating set comprising at least one tie coating, at least one barrier coating, and at least one pH protective coating. For example, the coating set can comprise a tie coating, a barrier coating, a pH protective coating and a second barrier coating; and in the presence of a fluid composition, the fluid contacting surface is the barrier coating or layer. The respective coatings can be applied by PECVD of a polysiloxane precursor. Such vessels can have a coated interior portion containing a fluid with a pH of 4 to 8. The barrier coating prevents oxygen from penetrating into the thermoplastic vessel, and the tie coating and pH protective coating together protect the barrier layer from the contents of the vessel. The second barrier coating is comparable to glass surface if needed.
Core Innovation
The invention relates to a vessel having a thermoplastic wall enclosing a lumen and a trilayer coating set formed by a tie coating, a barrier coating, and a pH protective coating. The tie coating comprises SiOxCy or SiNxCy and is positioned on the lumen-facing side of the barrier coating. The barrier coating comprises SiOx and is effective to reduce the ingress of atmospheric gas into the lumen compared to a vessel without the barrier coating.
A pH protective coating comprising SiOxCy or SiNxCy is positioned between the contents of the lumen and the barrier coating, with an interior surface facing the lumen and an outer surface facing the interior surface of the barrier coating. The passivation or pH protective coating is effective to decrease the dissolution rate of the barrier coating in the presence of a fluid composition having a pH between 5 and 9 in the lumen.
The layered arrangement targets reliability of the gas barrier while addressing pH-related loss mechanisms that affect the barrier. The coating system is associated with reduced barrier erosion or dissolution, reduced pinhole formation after alkaline or chemical attack, and calculated shelf life outcomes under defined pH conditions, including storage at 4°C.
Claims Coverage
The independent claim covers a vessel with a thermoplastic wall and a trilayer coating set configured for reduced gas ingress and decreased barrier dissolution in lumen fluids having pH between 5 and 9. One inventive feature is identified.
Trilayer coated thermoplastic-wall vessel for gas-barrier and pH-dissolution control
A vessel comprising a thermoplastic wall having an interior surface enclosing a lumen; a tie coating comprising SiOxCy or SiNxCy; a barrier coating effective to reduce ingress of atmospheric gas into the lumen compared to a vessel without the barrier coating; and a pH protective coating comprising SiOxCy or SiNxCy, the pH protective coating being effective to decrease the dissolution rate of the barrier coating in the presence of a fluid composition having a pH between 5 and 9 in the lumen.
The core inventive concept is a trilayer coating architecture on a thermoplastic-wall lumen that combines an SiOx-based atmospheric gas barrier with a SiOxCy or SiNxCy tie layer and a lumen-side SiOxCy or SiNxCy pH protective passivation layer.
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 in the presence of a fluid composition having a pH between 5 and 9 in the lumen.
Improves oxygen barrier reliability by addressing pH-related barrier loss and reducing pinhole formation after alkaline or chemical attack.
Provides a calculated shelf life of more than six months when stored at 4°C under lumen fluid conditions having pH between 5 and 9.
Documented Applications
Pharmaceutical packaging vessels including vials, syringes, and blister packs, having a lumen containing a fluid composition with pH between 5 and 9, where improved gas barrier reliability and decreased barrier dissolution are desired.
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