PECVD coated pharmaceutical packaging
Inventors
Weikart, Christopher • Clark, Becky L. • Stevenson, Adam • Felts, John T.
Assignees
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Publication Number
US-11298293-B2
Publication Date
2022-04-12
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 pharmaceutical package with a thermoplastic vessel whose interior surface carries a multilayer coating set. The coating set includes a tie coating or layer, a barrier coating or layer, and a pH protective coating or layer, each having specified compositions and roles with respect to the lumen and to contact with fluid.
The tie coating or layer comprises SiO_xC_y or SiN_xC_y, and the barrier coating or layer comprises SiO_x to reduce ingress of atmospheric gas into the lumen compared to a vessel without a barrier coating or layer. The pH protective coating or layer comprises SiO_xC_y or SiN_xC_y and is positioned at the interior surface facing the lumen with an outer surface facing the interior surface of the barrier coating or layer.
A fluid having a pH greater than 5 is contained in the lumen, and the pH protective coating or layer together with the tie coating or layer are effective to keep the barrier coating or layer at least substantially undissolved as a result of attack by the fluid for a period of at least six months. The described protection is based on inhibiting erosion or dissolution of the SiO_x barrier during contact with fluid, including pH 4–8, especially pH greater than 5.
Claims Coverage
The independent claim defines a pharmaceutical package having a thermoplastic vessel interior coated with a three-layer coating set and requires performance for a fluid of pH greater than 5, with the tie and pH protective layers effective to keep the SiO_x barrier at least substantially undissolved for at least six months. The inventive features are expressed through the specific coating set composition ranges and the functional performance requirement under pH greater than 5 attack.
Multilayer coating set on a thermoplastic vessel interior surface
A pharmaceutical package comprising a vessel with a thermoplastic wall and a coating set on an interior surface, the coating set including a tie coating or layer, a barrier coating or layer, and a pH protective coating or layer configured with interior and outer surfaces facing the lumen and facing adjacent layer surfaces.
Tie layer and pH protective layer with SiO_xC_y or SiN_xC_y compositions
The tie coating or layer comprises SiO_xC_y or SiN_xC_y, and the pH protective coating or layer comprises SiO_xC_y or SiN_xC_y, positioned such that the pH protective outer surface faces the barrier coating or layer.
SiO_x barrier layer effective to reduce atmospheric gas ingress
A barrier coating or layer comprising SiO_x, having an interior surface facing the lumen and an outer surface facing the interior surface of the tie coating or layer, and being effective to reduce the ingress of atmospheric gas into the lumen compared to a vessel without a barrier coating or layer.
Performance against fluid attack for at least six months at pH greater than 5
A fluid having a pH greater than 5 contained in the lumen, wherein the pH protective coating or layer and tie coating or layer together are effective to keep the barrier coating or layer at least substantially undissolved as a result of attack by the fluid for a period of at least six months.
Across the independent claim, the coverage is centered on a trilayer coating set on a thermoplastic vessel interior, with defined composition ranges for the tie and pH protective layers and a defined SiO_x barrier layer. The claim further requires that with a fluid of pH greater than 5, the tie and pH protective layers maintain the SiO_x barrier at least substantially undissolved for at least six months, while the barrier is effective to reduce atmospheric gas ingress.
Stated Advantages
Reduces the ingress of atmospheric gas into the lumen compared to a vessel without a barrier coating or layer.
Keeps the barrier coating or layer at least substantially undissolved as a result of attack by the fluid for a period of at least six months for a fluid having pH greater than 5.
Documented Applications
A pharmaceutical package including syringe barrel, vial, and blister package forms having a vessel lumen defined by a thermoplastic wall and having the described multilayer coating set on the interior surface.
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