Pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist
Inventors
Brockmeyer, Carsten • Weikart, Christopher • Bennett, Murray Stephen • Giraud, Jean-Pierre • Strungmann, Thomas
Assignees
Klinge Biopharma GmbH • Formycon AG • SiO2 Medical Products LLC
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Publication Number
US-11666632-B2
Publication Date
2023-06-06
Expiration Date
Abstract
A pre-filled pharmaceutical package comprising a liquid formulation of a VEGF-antagonist, for example Ranibizumab, in a pre-filled pharmaceutical package, for example a syringe, cartridge, or vial, made in part or in whole of a thermoplastic polymer, coated on the interior with a tie coating or layer, a barrier coating or layer, a pH protective coating or layer, and optionally a lubricity coating or layer. Stability performance of the VEGF-antagonist packaged in the coated COP vessel comparable to or better than glass was obtained.
Core Innovation
The invention provides a pre-filled pharmaceutical package that includes a liquid formulation of a VEGF-antagonist and a cyclic olefin polymer wall that encloses a lumen. The interior surface of the wall is engineered with multiple SiO x C y H z-containing coating layers and additional functional coatings positioned along the lumen surface stack, and a closure is provided to close the lumen. The VEGF antagonist is Aflibercept.
The coating architecture includes a tie coating or layer of SiO x C y H z on the wall interior surface, followed by a barrier coating or layer of SiO x. A pH protective coating or layer of SiO x C y H z is positioned between the barrier coating or layer and the lumen, and a lubricity coating or layer positioned between the pH protective coating or layer and the lumen includes atomic proportions SiO x C y H z and is designed to provide lubricity at the lumen interface.
The claimed package uses specified compositional ranges for x, y, and z as measured by X-ray photoelectron spectroscopy (XPS) for the tie coating or layer and pH protective coating or layer, and as measured by XPS for the barrier coating or layer. The z parameter for the tie coating or layer and the pH protective coating or layer is measured by at least one of Rutherford backscattering spectrometry (RBS) or hydrogen forward scattering (HFS). The lubricity coating or layer also has defined atomic proportions SiO x C y H z with x, y, and z measured by XPS and by at least one of RBS or HFS.
Claims Coverage
The document includes one explicitly identified independent claim directed to a pre-filled pharmaceutical package with a cyclic olefin polymer wall, a multi-layer SiO x-based interior coating system, a lumen containing a VEGF-antagonist formulation, and a closure sealing the lumen. The independent claim specifies that the VEGF antagonist is Aflibercept.
Multi-layer SiOxCyHz interior coating on a cyclic olefin polymer wall
A pre-filled pharmaceutical package with a wall comprising a cyclic olefin polymer enclosing at least a portion of a lumen, having a tie coating or layer on the wall interior surface comprising SiO x C y H z, a barrier coating or layer of SiO x positioned between the tie coating or layer and the lumen, a pH protective coating or layer comprising SiO x C y H z positioned between the barrier coating or layer and the lumen, and a lubricity coating or layer positioned between the pH protective coating or layer and the lumen, wherein the lubricity coating or layer has atomic proportions SiO x C y H z.
Compositional constraints for coating layers measured by XPS and RBS/HFS
The tie coating or layer has x, y, and z ranges measured by XPS and at least one of RBS or HFS, the barrier coating or layer has an x range measured by XPS, the pH protective coating or layer has x, y, and z ranges measured by XPS and at least one of RBS or HFS, and the lubricity coating or layer has atomic proportions SiO x C y H z with x and y measured by XPS and z measured by at least one of RBS or HFS.
Lumen containing a VEGF-antagonist formulation with closure sealing
A liquid formulation of a VEGF-antagonist in the lumen, and a closure closing the lumen, wherein the VEGF antagonist is Aflibercept.
Overall, the independent claim centers on a cyclic olefin polymer pre-filled container whose lumen interior is defined by a tie layer, a SiO x barrier layer, a pH protective SiO x C y H z layer, and a lubricity SiO x C y H z layer with specified compositional ranges, while sealing the lumen containing an Aflibercept VEGF-antagonist formulation.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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