Composite material for a pharmaceutical packaging, method for the production thereof, and use of the composite material
A composite material for a pharmaceutical packaging is provided that includes a substrate and a protective layer. The substrate has a contact region in contact with the protective layer. The contact region includes a contact area between the substrate and the protective layer and a region of the substrate close to the surface. The substrate is made of glass or of a cyclic olefin polymer or a cyclic olefin copolymer, while the protective layer is made of ceramic material. The substrate in the contact region is different from the substrate outside the contact region.
1. A composite material for a pharmaceutical packaging, comprising:
a substrate; and
a protective layer comprising hydrogenated oxidized silicon carbide (SiC:OH) and/or nitrided oxidized hydrogenated silicon carbide (SiC:OHN), the substrate has a contact region in contact with the protective layer, the contact region comprising a contact area between the substrate and the protective layer and a region of the substrate, the region of the substrate being defined by a lateral extension along the contact area and a vertical extension in a depth direction perpendicular to the contact area, the substrate being made of a material selected from the group consisting of glass, cyclic olefin polymer, and cyclic olefin copolymer, the protective layer being made of a ceramic material, wherein the substrate in the contact region has a difference from the substrate outside the contact region.
2. The composite material as claimed in claim 1 , wherein the material of the substrate is glass selected from the group consisting of hydrolytic class I to V and borosilicate glass of hydrolytic class I.
3. The composite material as claimed in claim 1 , wherein the difference of the substrate in the contact region from the substrate outside the contact region is selected from the group consisting of a surface roughness, a chemical composition, a surface energy, and a chemical etching rate.
4. The composite material as claimed in claim 1 , wherein the protective layer is attached to the contact area of the substrate by van der Waals forces and/or covalently.
5. The composite material as claimed in claim 1 , wherein the protective layer has a structure selected from the group consisting of amorphous, partially crystalline, and crystalline.
6. The composite material as claimed in claim 1 , wherein the protective layer is free of silicon dioxide (SiO2), at least in a portion thereof.
7. The composite material as claimed in claim 1 , wherein the protective layer comprises a first sub-layer facing the substrate and a second sub-layer facing away from the substrate.
8. The composite material as claimed in claim 7 , wherein the second sub-layer has a composition different from that of the first sub-layer.
9. The composite material as claimed in claim 7 , further comprising a content of an element selected from the group consisting of nitrogen, oxygen, carbon and combinations thereof of the second sub-layer that is different from that of the first sub-layer.
10. The composite material as claimed in claim 7 , wherein the first sub-layer has a carbon content c 1 (C) of c 1 (C)≥40% and/or a nitrogen content c 1 (N) of c 1 (N)≥0.01%, or c 1 (N)≥0.05%.
11. The composite material as claimed in claim 7 , wherein the second sub-layer has a nitrogen content c 2 (N) of c 2 (N)≥0.1% and/or an oxygen content c 2 (O) of c 2 (O)≥5%.
12. The composite material as claimed in claim 7 , wherein the second sub-layer has a density of an element selected from the group consisting of nitrogen, oxygen, carbon, and combinations thereof of >1.7 g/cm3 and/or has a thickness less than a thickness of the first sub-layer.
13. The composite material as claimed in claim 1 , wherein the protective layer has a ratio alpha of carbon content to silicon content in a range of 0.8<alpha<7 and/or a ratio beta of nitrogen content to silicon content in a range of 0<beta<3.
14. The composite material as claimed in claim 1 , wherein the composite material is configured for use as a device selected from the group consisting of a container for a medical product, a container for a pharmaceutical product, a hollow tube, a hollow container, a pharmaceutical packaging, a vial, a syringe, a cartridge, and an ampoule, and wherein the protective layer is sufficient to prevent delamination of glass from interaction with a liquid solution.
15. The composite material as claimed in claim 1 , wherein the composite material is configured as a hollow body for use with a product selected from the group consisting of products including alkaline based drugs, products including protein-based drugs, products including surface active agents, non-buffered drug solutions, acidic formulations, neutral formulations, alkaline formulations, acidic formulations that include a surface active agent, acidic formulations that include a surfactant, neutral formulations that include a surface active agent, neutral formulations that include a surfactant, alkaline formulations that include a surface active agent, alkaline formulations that include a surfactant, solutions with polysorbate, solutions including sugar, and solutions including sugar alcohol.
16. A composite material for a pharmaceutical packaging, comprising:
a substrate; and
a protective layer, the substrate has a contact region in contact with the protective layer, the contact region comprising a contact area between the substrate and the protective layer and a region of the substrate, the region of the substrate being defined by a lateral extension along the contact area and a vertical extension in a depth direction perpendicular to the contact area, the substrate being made of a material selected from the group consisting of glass, cyclic olefin polymer, and cyclic olefin copolymer, the protective layer being made of a ceramic material, wherein the substrate in the contact region has a difference from the substrate outside the contact region, wherein the protective layer comprises a first sub-layer facing the substrate and a second sub-layer facing away from the substrate, and wherein the second sub-layer has a content that varies continuously as a function of a distance from the first sub-layer.
17. The composite material as claimed in claim 16 , wherein the content of the second sub-layer that is in contact with the first sub-layer is the same as a content of the first sub-layer.
18. A composite material for a pharmaceutical packaging, comprising:
a substrate; and
a protective layer, the substrate has a contact region in contact with the protective layer, the contact region comprising a contact area between the substrate and the protective layer and a region of the substrate, the region of the substrate being defined by a lateral extension along the contact area and a vertical extension in a depth direction perpendicular to the contact area, the substrate being made of a material selected from the group consisting of glass, cyclic olefin polymer, and cyclic olefin copolymer, the protective layer being a ceramic crystalline coating, wherein the substrate in the contact region comprises, but the substrate outside the contact region does not comprise, a chemical element of glass selected from a group consisting of Na, B, Al, K, Ca, Mg, Ba, Cl, a combination of Si and O, and any combinations thereof.