Glass container and glass container system

Abstract

The invention relates to a glass container for pharmaceutical compositions comprising a hollow cylinder having at least one open end, wherein at least a portion of the surface of the glass container comprises a coating having a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature rate of change of 10 °C / min, wherein the crystallization temperature range and the melting temperature range overlap at a temperature of -75 °C to -100 °C, in particular at a temperature of -80 °C.

Description

Technical Field

[0001] This invention relates to glass containers, including glass container systems comprising containers, stoppers, and / or lids, and methods for manufacturing the containers and systems. Background Technology

[0002] Pharmaceutical compositions of biological agents, such as protein and nucleic acid formulations, are prone to degradation. Complex measures are required to reduce their degradation tendency during storage or transportation. This is particularly important for aqueous compositions that allow enzymatic degradation as well as a wide range of chemical processes, including hydrolysis.

[0003] Novel and complex drug delivery systems, such as liposomes or lipid nanoparticles, increase the number of components in a composition, making it more difficult to predict and prevent potential undesirable deterioration.

[0004] Furthermore, pharmaceutical companies are under immense pressure to introduce new and robust treatment principles to the public without time to optimize or even test the long-term storage performance of their new drug products. Therefore, there has always been a need for a way to prevent degradation, or, at critical moments, a way to safely and reliably prevent degradation for a sufficient period of time, securely package and store even the most complex pharmaceutical compositions.

[0005] Freeze-drying (also known as lyophilization) has been used to address several issues. It is a well-known method that creates an environment unfavorable to enzyme activity while preventing hydrolysis. However, freeze-drying is a costly method, and finding the optimal excipients and redispersibility schemes can be difficult and time-consuming. Furthermore, freeze-drying does not produce ready-to-use compositions. Freeze-dried compositions must be redispersed before use, a process that carries the risk of human error, resulting in incomplete or incorrect dissolution, which could harm patients and reduce acceptability.

[0006] A solution to the above problems is urgently needed. Summary of the Invention

[0007] In a first aspect, the present invention relates to a glass container for a pharmaceutical composition, comprising a hollow cylinder having at least one open end. wherein at least a portion of the surface of the glass container comprises a coating having a glass transition temperature below -60°C.

[0008] It has been found that coatings with glass transition temperatures below -80°C can achieve exceptionally tight seals at very low storage temperatures. Maintaining a tight seal at such low temperatures has always been a challenge. For example, at very low temperatures, the seal of conventional silicone oil coatings can be compromised, allowing foreign matter to enter the hollow body. This foreign matter may react with or alter the components within the container or system, compromising sterility. The containers and systems of the present invention can store even the most sensitive pharmaceutical compositions, including those containing protein or nucleic acid active ingredients, at very low temperatures. By slowing down or stopping chemical and enzymatic reactions, freezing and storing pharmaceutical compositions at very low temperatures (e.g., -80°C) avoids undesirable degradation. Most importantly, storage at -80°C is suitable for ready-to-use compositions, for example, in pre-filled syringes. The inventors hypothesize that coatings with glass transition temperatures below -60°C retain sufficient elasticity at low temperatures to form a tight seal between the container surface and container closure devices such as stoppers or caps. For example, the coating may be present on at least a portion of the inner surface of the hollow cylinder to form a tight seal between the inner surface and the stopper. Additionally or alternatively, the glass container of the present invention may be configured to be closed by a lid and have a fitting surface at the open end B, said fitting surface being configured to fit tightly against the surface of the lid. Wherein, at least a portion of said fitting surface comprises the coating.

[0009] In a second aspect, the present invention relates to a glass container for a pharmaceutical composition, comprising a hollow cylinder having at least one open end. At least a portion of the surface of the glass container includes a coating having a certain hardness such that the hardness value measured on the coated surface of the glass container according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs from the hardness value measured on its uncoated surface by less than 10%.

[0010] The inventors have discovered that low-hardness coatings maintain a tight seal even at very low storage temperatures. In hardness tests, the soft, thin layer produces hardness values ​​very close to those of the substrate. In other words, the coating is softer than the substrate (i.e., the glass of the glass container). Maintaining a tight seal at such low temperatures has always been a challenge. For example, at very low temperatures, the seal of conventional silicone oil coatings is compromised, allowing foreign matter to enter the hollow body. This foreign matter may react with or alter the components within the container or system, compromising sterility. The containers and systems of the present invention can store even the most sensitive pharmaceutical compositions, including those containing protein or nucleic acid active ingredients, at very low temperatures. By slowing down or stopping chemical and enzymatic reactions, freezing and storing pharmaceutical compositions at very low temperatures (e.g., -80°C) avoids undesirable degradation. Most importantly, storage at -80°C is suitable for ready-to-use compositions, such as in pre-filled syringes. The inventors have also discovered that coatings with suitable hardness at 20°C can maintain sufficient elasticity to form a tight seal between the container surface and container closure devices such as stoppers or caps. For example, the coating may be present on at least a portion of the inner surface of the hollow cylinder to form a tight seal between the inner surface and the stopper. Additionally or alternatively, the glass container of the present invention may be configured to be closed by a lid and have a fitting surface at the open end B, said fitting surface being configured to fit tightly against the surface of the lid. Wherein, at least a portion of said fitting surface comprises the coating.

[0011] In a third aspect, the present invention relates to a glass container for a pharmaceutical composition, comprising: a hollow cylinder having at least one open end. At least a portion of the surface of the glass container is coated, and the container has container seal integrity in a standard ethanol-modified dye invasive test for at least 150 hours at -80°C. The container seal integrity in the standard ethanol-modified dye invasive test may be related to a stopper and / or a tip.

[0012] This fully ensures that glass containers with this standard ethanol-modified dye invasiveness test provide a tight seal, even under very low temperature storage conditions. The sterile composition remains sterile, and foreign matter will not leach into the composition within the container or system.

[0013] In a fourth aspect, the present invention relates to a glass container for a pharmaceutical composition, comprising a hollow cylinder having at least one open end. At least a portion of the surface of the glass container has a coating having a thickness of at least 400 nm, and the coating is cured at a temperature below 150°C, particularly at 50°C to less than 110°C.

[0014] The inventors have discovered that both coating thickness and curing temperature affect the performance of the seal at extremely low temperatures. In particular, the curing temperature should not be too high to avoid undesirable chemical reactions, such as excessive crosslinking or polymerization. In some cases, coatings cured at very high temperatures lack sufficient elasticity at low temperatures to maintain a tight seal; furthermore, slippage forces increase at high curing temperatures.

[0015] In a fifth aspect, the present invention relates to a glass container for a pharmaceutical composition, comprising a hollow cylinder having an open end A configured to receive a stopper slidable from the open end A relative to the hollow cylinder. At least a portion of the inner surface of the hollow cylinder has a coating, wherein the ratio of the total inner diameter variation along the coated portion of the inner surface to the thickness of the coating is less than 500.

[0016] The significant variation in the inner diameter of a hollow cylinder makes sealing any gaps between the plug and the inner surface of the body more difficult. Keeping the ratio low allows for a tight seal even at low temperatures. If the variation in inner diameter is not particularly small, an additional coating thickness of appropriate coating material can also help to achieve a tight seal even at low storage temperatures.

[0017] In a sixth aspect, the present invention relates to a glass container for a pharmaceutical composition, comprising a hollow cylinder having at least one open end. At least a portion of the surface of the glass container comprises a coating having a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature change rate of 10°C / min. The crystallization temperature range and the melting temperature range overlap at temperatures ranging from -75°C to -100°C, particularly at -80°C.

[0018] Not wanting to be bound by this theory, the inventors believe that both crystalline and molten portions of the coating exist within the overlap area. This is thought to impart the mechanical resistance and elasticity required for the coating to form a tight seal at low temperatures.

[0019] In a seventh aspect, the present invention relates to a glass container for a pharmaceutical composition, comprising a hollow cylinder having at least one open end. At least a portion of the surface of the glass container comprises a coating comprising one or more cross-linked polysiloxane structural units and one or more non-cross-linked polysiloxane structural units. The weight ratio of the cross-linked polysiloxane structural units to the non-cross-linked polysiloxane structural units in the coating is less than 3.00, and optionally at least 0.40.

[0020] Non-crosslinked polysiloxane structural units can help achieve the desired elasticity and cryogenic sealing properties, which is preferred for the containers and systems of the present invention. The inventors believe that crosslinked polysiloxanes provide a polymer network in which non-crosslinked polysiloxanes remain embedded, thereby creating a hybrid coating structure that combines the properties of a cured polymer network and liquid silicone oil. This is believed to contribute to achieving a tight seal at cryogenic temperatures.

[0021] According to an eighth aspect, the present invention provides a system comprising a glass container, stopper, and / or lid as described in any one of the first to seventh aspects, wherein the system has container seal integrity in a specific ethanol-modified dye invasive test for at least 150 hours at -80°C. This container seal integrity in the specific ethanol-modified dye invasive test may be related to the stopper and / or tip.

[0022] This fully ensures that systems with this specific ethanol-modified dye invasiveness test provide a tight seal, even under very low temperature storage conditions. The sterile composition remains sterile, and foreign matter will not penetrate the composition within the system.

[0023] In a ninth aspect, the present invention relates to a system comprising a glass container and a stopper as described in any one of the first to seventh aspects, wherein the ratio of the difference (I) between the average linear coefficient of thermal expansion of the material of the stopper and the material of the glass container to the thickness (II) of the coating is less than 0.5 ppm / nm.

[0024] The coefficient of thermal expansion of the stopper material can be much higher than that of the glass container. It has been found that by selecting the coating thickness based on the difference in thermal expansion coefficients between the stopper and container materials, a tight seal can be guaranteed even at very low storage temperatures.

[0025] The tenth aspect of the invention relates to a method of manufacturing a glass container according to any one of the first to seventh aspects, comprising: melting a batch of raw materials to prepare glass; forming the glass into a glass container; coating a coating composition; and curing the composition at a curing temperature below 150°C, particularly between 50°C and less than 110°C. Similarly, the seventh aspect includes a method of manufacturing a system according to the fifth or sixth aspect of the invention by adding the further step of inserting a stopper and optionally a plunger rod into a hollow cylinder.

[0026] In the eleventh aspect, the present invention relates to a glass container according to the first to fourth aspects of the invention or a system according to the eighth or ninth aspect of the invention, comprising a pharmaceutical composition.

[0027] In a twelfth aspect, the present invention relates to the use of a coating composition for preparing a coating on the surface of a glass container, wherein the coated glass container is subsequently stored for at least 150 hours at a temperature range below -60°C, particularly at a low temperature of about -80°C, wherein the coating composition comprises, by weight percentage: One or more non-crosslinkable polysiloxane compounds 2.0% to 25.0% One or more cross-linked polysiloxane compounds 0.10% to 1.50% One or more catalysts 0.03% to 0.50% One or more diluents 55.0% to 92.0%

[0028] In a thirteenth aspect, the present invention relates to the use of glass containers according to the first to seventh aspects of the invention or systems according to the eighth or ninth aspect of the invention for storing pharmaceutical compositions for at least 150 hours at temperatures below -60°C, particularly at about 80°C. Attached Figure Description

[0029] Figure 1 A coated glass container is shown.

[0030] Figure 2 The test results show the container seal integrity test for ethanol-modified dye intrusion.

[0031] Figure 3 A differential scanning calorimetry (DSC) plot of the coating according to the present invention is shown.

[0032] Figure 4 A differential scanning calorimetry (DSC) plot of the coating according to the present invention is shown.

[0033] Figure 5 Differential scanning calorimetry (DSC) plots of prior art coatings are shown.

[0034] Figure 6 Differential scanning calorimetry (DSC) plots of prior art coatings are shown.

[0035] Figure 7 Thermodynamic analysis (TMA) diagram of the coating according to the present invention is shown.

[0036] Figure 8 Thermodynamic analysis (TMA) diagram of the coating according to the present invention is shown. Detailed Implementation

[0037] As described above, some aspects of the present invention relate to a glass container for a pharmaceutical composition, comprising: a hollow cylinder having at least one open end, wherein at least a portion of the surface of the glass container includes a coating according to the invention. Generally, the glass container for a pharmaceutical composition according to the invention may include a hollow cylinder having a first open end or open end A, said open end A being configured to receive a stopper slidable relative to the hollow cylinder from said open end A. At least a portion of the inner surface of the hollow cylinder may include a coating to form a tight seal between the inner surface of the hollow cylinder and the stopper. Additionally or alternatively, the glass container according to the invention may have an open end that can be closed by a cap. In a syringe, the second open end or open end B (the first open end or open end A being the opening for receiving the stopper) is typically the tip side, i.e., the portion of the syringe to which the injection needle is attached. Open end B is typically located at the other end of the container compared to open end A. Open end A may be referred to as the "stopper side," i.e., the side into which the stopper can be inserted. The inventors have found that providing a coating on the tip side improves sealing even at extremely low temperatures.

[0038] In embodiments, the hollow cylinder described herein as part of a glass container or system may have a substantially constant inner diameter so that the stopper can substantially expel all the composition present in the cylinder. In this document, "substantially constant" means an inner diameter variation of no more than 200 μm, no more than 100 μm, or no more than 50 μm.

[0039] The coating may have a certain hardness such that the hardness value measured on the coated surface of the glass container according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs from the hardness value measured on its uncoated surface by less than 10%, less than 7.0%, less than 5.0%, or less than 3.0%. Preferably, the hardness value of the coated surface is lower than that of the uncoated surface, optionally by less than 10%, less than 7.0%, less than 5.0%, or less than 3.0%. In embodiments, the hardness value of the coated surface is at least 0.1%, at least 0.5%, at least 1.0%, or at least 2.0% lower than that of the uncoated surface. Optionally, the hardness value is a Martens hardness, and the hardness of the glass is from 3000 MPa to 3500 MPa, or from 3100 MPa to 3300 MPa. Optionally, the hardness can be measured at different indentation depths and indentation forces, wherein the indentation depth is 0.30 μm and / or the indentation force is 2 mN.

[0040] The glass container can be any type of container, including vials, syringes, or cartridges. In one embodiment, the glass container is a pre-filled syringe or cartridge.

[0041] The glass container for a pharmaceutical composition according to the invention may include a hollow cylinder having an open end A configured to receive a plug slidable from the open end A relative to the hollow cylinder, wherein at least a portion of the inner surface of the hollow cylinder includes a coating having a glass transition temperature below -60°C.

[0042] The glass container for pharmaceutical compositions according to the invention may include a hollow cylinder having an open end A configured to receive a plug slidable from the open end A relative to the hollow cylinder, wherein at least a portion of the inner surface of the hollow cylinder includes a coating having a certain hardness such that the hardness value measured on the coated surface of the glass container according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs from the hardness value measured on its uncoated surface by less than 10%.

[0043] A glass container for a pharmaceutical composition according to the present invention may include a hollow cylinder having an open end A configured to receive a stopper slidable relative to the hollow cylinder from the open end A, wherein at least a portion of the inner surface of the hollow cylinder includes a coating, and the container has container seal integrity in a standard ethanol-modified dye invasive test at -80°C for at least 150 hours. The container seal integrity in the standard ethanol-modified dye invasive test may be related to the stopper.

[0044] The glass container for a pharmaceutical composition according to the invention may include a hollow cylinder having an open end A configured to receive a plug slidable from the open end A relative to the hollow cylinder, wherein at least a portion of the inner surface of the hollow cylinder includes a coating having a thickness of at least 400 nm, and wherein the coating is cured at a temperature below 150°C.

[0045] The inventors have discovered that both coating thickness and curing temperature affect sealing performance at extremely low temperatures. In particular, curing temperatures should not be too high to avoid undesirable chemical reactions, such as excessive crosslinking or polymerization. In some cases, coatings cured at very high temperatures may not have sufficient elasticity to maintain a tight seal at low temperatures.

[0046] The glass container for pharmaceutical compositions according to the invention may have an open end B configured to be closed by a cap and having a fitting surface configured to fit tightly against the surface of the cap, wherein at least a portion of the fitting surface comprises a coating having a glass transition temperature below -60°C. Applying a coating to the tip side, even under very low temperature storage conditions, facilitates a tight seal. The sterile composition remains sterile, and foreign matter does not leach into the composition within the container or system.

[0047] The glass container for pharmaceutical compositions according to the invention may have an open end B, the open end B being configured to be closed by a lid and having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface comprises a coating having a certain hardness such that the hardness value measured on the coated surface of the glass container according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs from the hardness value measured on its uncoated surface by less than 10%.

[0048] The glass container for pharmaceutical compositions according to the invention may have an open end B, the open end B being configured to be closed by a lid and having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface comprises a coating, wherein the coating has a thickness of at least 400 nm and the coating is cured at a temperature below 150°C.

[0049] The glass container for pharmaceutical compositions according to the invention may have an open end B, said open end B being configured to be closed by a lid and having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of said fitting surface comprises a coating having a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature change rate of 10°C / min. The crystallization temperature range and the melting temperature range overlap at temperatures from -75°C to -100°C, particularly at -80°C.

[0050] The glass container for a pharmaceutical composition according to the invention may have an open end B, said open end B being configured to be closed by a lid and having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface comprises a coating comprising one or more crosslinked polysiloxane structural units and one or more non-crosslinked polysiloxane structural units. The weight ratio of the crosslinked polysiloxane structural units to the non-crosslinked polysiloxane structural units in the coating is less than 3.00, and optionally at least 0.40.

[0051] The glass container for pharmaceutical compositions according to the invention may have an open end B configured to be closed by a lid and having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface includes a coating, and the container has container seal integrity under a standard ethanol-modified dye penetration test for at least 150 hours at -80°C. This standard ethanol-modified dye penetration test container seal integrity may be tip-related. It can be reliably ensured that the glass container with a coating on the tip side and this standard ethanol-modified dye penetration test container seal integrity provides a tight seal even under very low temperature storage conditions. The sterile composition remains sterile, and foreign matter does not penetrate into the composition within the container or system.

[0052] The glass container for a pharmaceutical composition according to the invention may include a hollow cylinder having an open end A configured to receive a plug slidable relative to the hollow cylinder from the open end A, wherein at least a portion of the inner surface of the hollow cylinder has a coating, wherein the ratio of the total inner diameter variation along the coated portion of the inner surface to the thickness of the coating is less than 500.

[0053] The glass container for pharmaceutical compositions according to the invention may include a hollow cylinder having an open end A configured to receive a stopper slidable relative to the hollow cylinder from the open end A, wherein at least a portion of the inner surface of the hollow cylinder has a coating having a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature change rate of 10°C / min. The crystallization temperature range and the melting temperature range overlap at temperatures from -75°C to -100°C, particularly at -80°C.

[0054] A glass container for a pharmaceutical composition according to the present invention may include a hollow cylinder having an open end A configured to receive a stopper slidable relative to the hollow cylinder from the open end A. At least a portion of the inner surface of the hollow cylinder has a coating comprising one or more crosslinked polysiloxane structural units and one or more non-crosslinked polysiloxane structural units. The weight ratio of the crosslinked polysiloxane structural units to the non-crosslinked polysiloxane structural units in the coating is less than 3.00, and optionally at least 0.40.

[0055] A glass container for a pharmaceutical composition according to the invention may include a hollow cylinder having an open end A configured to receive a stopper slidable relative to the hollow cylinder from the open end A, wherein at least a portion of the inner surface of the hollow cylinder includes a coating. The container further includes an open end B configured to be closed by a lid and having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface includes a coating having a glass transition temperature below -60°C.

[0056] A glass container for a pharmaceutical composition according to the invention may include a hollow cylinder having an open end A configured to receive a stopper slidable relative to the hollow cylinder from the open end A, wherein at least a portion of the inner surface of the hollow cylinder includes a coating. The container also has an open end B configured to be closed by a lid and having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface includes a coating having a certain hardness such that the hardness value measured on the coated surface of the glass container according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs by less than 10% from the hardness value measured on its uncoated surface.

[0057] A glass container for pharmaceutical compositions according to the present invention may include a hollow cylinder having an open end A configured to receive a stopper slidable from the open end A relative to the hollow cylinder, wherein at least a portion of the inner surface of the hollow cylinder includes a coating, the container further having an open end B configured to be closed by a lid and having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface includes a coating, and the container having container seal integrity in a standard ethanol-modified dye invasive test for at least 150 hours at -80°C. This standard ethanol-modified dye invasive test container seal integrity may be related to the tip and the stopper.

[0058] A glass container for a pharmaceutical composition according to the present invention may include a hollow cylinder having an open end A configured to receive a stopper slidable relative to the hollow cylinder from the open end A, wherein at least a portion of the inner surface of the hollow cylinder includes a coating, and the container further has an open end B configured to be closed by a lid and having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface includes a coating. The coating has a thickness of at least 400 nm and is cured at a temperature below 150°C.

[0059] The glass container for a pharmaceutical composition according to the invention may include a hollow cylinder having an open end A configured to receive a stopper slidable relative to the hollow cylinder from the open end A, wherein at least a portion of the inner surface of the hollow cylinder includes a coating, the container further having an open end B configured to be closed by a lid and having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface includes a coating having a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature change rate of 10°C / min, wherein the crystallization temperature range and the melting temperature range overlap at temperatures from -75°C to -100°C, particularly at temperatures of -80°C.

[0060] A glass container for a pharmaceutical composition according to the invention may include a hollow cylinder having an open end A configured to receive a stopper slidable relative to the hollow cylinder from the open end A, wherein at least a portion of the inner surface of the hollow cylinder includes a coating, the container further having an open end B configured to be closed by a lid and having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface includes a coating comprising one or more crosslinked polysiloxane structural units and one or more non-crosslinked polysiloxane structural units, wherein the weight ratio of the crosslinked polysiloxane structural units to the non-crosslinked polysiloxane structural units in the coating is less than 3.00, and optionally at least 0.40. coating

[0061] The coating may be applied to the inner surface of the hollow cylinder of the glass container and / or one or more other surfaces of the glass container, wherein the other surfaces include the surface of the tip in a syringe, such as the mating surface on the tip side of the syringe. The coating and paint compositions described herein facilitate achieving a tight seal at low temperatures.

[0062] The coating thickness can be greater than 350 nm, greater than 400 nm, greater than 450 nm, or greater than 500 nm. Optionally, the coating thickness can be up to 1500 nm, up to 1250 nm, or up to 1000 nm. Appropriate coating thickness helps achieve a tight seal at low temperatures. In embodiments, the coating thickness can be from 350 nm to 1500 nm, from 400 nm to 1250 nm, or from 450 nm to 1000 nm. Optionally, the above-mentioned indices for coating thickness mean that at least 90%, at least 95%, or at least 99% of the coating area has a coating thickness within the indicated range. In a preferred embodiment, the coating thickness is greater than 400 nm, particularly at least 450 nm or at least 500 nm. Exemplary preferred ranges for coating thickness are greater than 400 nm to 1500 nm, or 450 nm to 1250 nm or 500 nm to 1000 nm.

[0063] The coating may comprise one or more organosilicon polymers. An organosilicon polymer is a polymeric material composed of monomeric units comprising silicon (Si) and carbon (C) atoms. An example of an organosilicon polymer is a polysiloxane. In embodiments, the coating comprises one or more polysiloxane structural units. A "polysiloxane structural unit" may refer to a polysiloxane structure within a macromolecule (e.g., covalently bonded to or part of a macromolecule) or the polysiloxane molecule itself. For example, a crosslinked polysiloxane structural unit is part of a polymeric network (covalently linked); while a non-crosslinked polysiloxane structural unit exists as a molecule in the coating and is not covalently linked to other molecules in the coating. Therefore, the coating may comprise crosslinked and / or non-crosslinked polysiloxane structural units. In this document, "crosslinked" means that the polysiloxane structural unit is covalently linked to the polymeric network. Specifically, the term "crosslinked" includes the preferred case where the polysiloxane structure is covalently linked to other polysiloxane structures, for example, through a polymeric backbone. Optionally, the crosslinked polysiloxane structural units are covalently bonded to other polysiloxane structures as a result of hydrosilylation. For example, the polymeric backbone can be formed by polymerizing a polysiloxane carrying polymerizable functional groups (such as vinyl groups). Conversely, "non-crosslinked" means that the polysiloxane is not covalently linked to other polysiloxane structures through the polymeric backbone, or preferably not at all covalently linked to other polysiloxanes in the coating.

[0064] In one embodiment, the crosslinked polysiloxane structural unit is crosslinked via one or more (e.g., two) terminal groups. These terminal groups may be selected from vinyl, propenyl, methacryl, styrene, and combinations thereof. In one embodiment, the coating comprises a crosslinkable polysiloxane compound and a hydrosilylation product of the crosslinkable polysiloxane compound, such as a vinyl polysiloxane compound and a polysiloxane having at least two Si-H groups. The crosslinkable polysiloxane can be crosslinked with the crosslinkable polysiloxane by reacting its multiple Si-H groups with the vinyl groups of the crosslinkable polysiloxane. This reaction may be platinum-catalyzed.

[0065] In this invention, "polysiloxane" or "polysiloxane structural unit" can refer to a polyalkylsiloxane structural unit, such as a polydialkylsiloxane structural unit. Optionally, one or more hydrocarbon groups in the polyalkylsiloxane or polydialkylsiloxane are independently selected from branched or unbranched C1 to C8 hydrocarbon groups. The hydrocarbon group can be a straight-chain hydrocarbon group. For example, the hydrocarbon group can be independently selected from methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, and octyl groups. Preferably, the hydrocarbon group is independently selected from methyl and ethyl groups.

[0066] In one embodiment, the coating comprises crosslinked polydialkylsiloxane structural units and non-crosslinked polysiloxane structural units. Specifically, the coating may comprise crosslinked polydialkylsiloxane structural units and non-crosslinked polysiloxane structural units, wherein the non-crosslinked polysiloxane structural units may be one or more silicone oils, i.e., polydialkylsiloxane structural units, such as polydimethylsiloxane silicone oil.

[0067] Optionally, the weight ratio of cross-linked polysiloxane structural units to non-cross-linked polysiloxane structural units in the coating is less than 3.00, less than 2.50, less than 1.80, or less than 1.20. The weight ratio of cross-linked to non-cross-linked polysiloxane structural units in the coating can be at least 0.40, at least 0.60, or at least 0.70. In embodiments, this ratio is from 0.40 to 3.00, 0.60 to 2.50, or 0.70 to 1.80. Non-cross-linked polysiloxane structural units can help achieve the desired elasticity and cryogenic sealing function, which is preferred for containers and systems according to the invention.

[0068] The coating may comprise more than one type of non-crosslinked polysiloxane structural unit, such as at least two or at least three types. These types may differ in viscosity. In some embodiments, the coating comprises: high-viscosity non-crosslinked polysiloxane structural units with a viscosity exceeding 10,000 cSt, and / or low-viscosity non-crosslinked polysiloxane structural units with a viscosity below 10,000 cSt. It may be applied at 23°C and 10s according to DIN EN ISO 3219:1993. -1 The viscosity was measured using a coaxial cylinder system at a shear rate of [value missing]. Optionally, the viscosity of the high-viscosity non-crosslinked polysiloxane structural unit is at least 15000 cSt, and / or the viscosity of the low-viscosity non-crosslinked polysiloxane structural unit is below 5000 cSt.

[0069] In one embodiment, the coating comprises high-viscosity, non-crosslinked polysiloxane structural units, but not necessarily low-viscosity, non-crosslinked polysiloxane structural units.

[0070] The weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units. 高 :quality 低 The weight ratio can be at least 0.10, at least 0.50, at least 1.00, at least 1.50, or at least 2.00. In some embodiments, this ratio can be as high as 5.00, 4.00, or 3.00. For example, the weight ratio of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units can be from 0.10 to 5.00, 0.50 to 4.00, or 1.00 to 3.00.

[0071] Crosslinked polysiloxane structural units, low-viscosity non-crosslinked polysiloxane structural units, and / or high-viscosity non-crosslinked polysiloxane structural units may include or be composed of dialkylsiloxane monomer units, particularly dimethylsiloxane monomer units.

[0072] Optionally, the weight-average molecular weight of the low-viscosity non-crosslinked polysiloxane structural unit is from 1200 g / mol to 30000 g / mol; and / or the weight-average molecular weight of the high-viscosity non-crosslinked polysiloxane structural unit is from 15000 g / mol to 300000 g / mol. In one embodiment, the weight-average molecular weight of the high-viscosity non-crosslinked polysiloxane structural unit is from 32000 g / mol to 210000 g / mol, or from 100000 g / mol to 150000 g / mol. In one embodiment, the weight-average molecular weight of the low-viscosity non-crosslinked polysiloxane structural unit is from 5000 g / mol to 25000 g / mol, or from 10000 g / mol to 20000 g / mol.

[0073] In the embodiments, the weight-average molecular weight of the low-viscosity non-crosslinked polysiloxane structural units is at least 1200 g / mol, at least 5000 g / mol, or at least 10000 g / mol. This weight-average molecular weight can be as high as 30000 g / mol, 25000 g / mol, or 20000 g / mol.

[0074] In the embodiments, the weight-average molecular weight of the high-viscosity non-crosslinked polysiloxane structural units is at least 15,000 g / mol, at least 32,000 g / mol, or at least 100,000 g / mol. This weight-average molecular weight can be as high as 300,000 g / mol, 210,000 g / mol, or 150,000 g / mol.

[0075] Not wanting to be bound by this theory, the inventors believe that the curing temperature of the coating composition is related to achieving a tight seal. The coating can be cured at temperatures below 150°C, below 125°C, or below 110°C. Too high a curing temperature may result in low elasticity of the coating. On the other hand, too low a curing temperature may not be sufficient to achieve good sealing performance. Therefore, in the embodiments, the curing temperature can be above 50°C, above 60°C, or above 70°C. It is important to note that the curing temperature is the effective temperature of the coating composition. It should not be confused with the nominal oven temperature. The oven temperature may be much higher than the curing temperature because there may not be enough time during the curing period for the entire oven to equilibrate at the nominal temperature. Optionally, the curing temperature of the coating can be from 50°C to less than 150°C, from 60°C to less than 125°C, or from 70°C to less than 110°C. Preferably, the curing temperature range is from 50°C to less than 110°C.

[0076] In an embodiment, the coating is obtained or is possible by applying the coating composition disclosed herein to at least a portion of the surface of a container (e.g., the inner surface and / or the mating surface) and curing the coating composition on the surface, wherein the curing temperature of the coating composition is less than 150°C, particularly 50°C to less than 110°C.

[0077] Optionally, the curing temperature can be maintained for at least 10 seconds, at least 30 seconds, at least 45 seconds, or at least 60 seconds. In embodiments, the curing temperature can be maintained for up to 3000 seconds, up to 300 seconds, or up to 180 seconds. Excessive curing time may weaken elasticity and gliding force.

[0078] To achieve a suitable seal, it is generally sufficient to apply the coating to the areas requiring a tight seal, namely the contact area between the inner surface and the stopper, and / or the contact area between the mating surface and the cap. The coating may be applied to at least 25% or at least 50% of the inner surface of the hollow cylinder (area-by-area). However, the coating can also have a beneficial effect on the sliding properties of the stopper on the inner surface of the hollow cylinder. Therefore, in some embodiments, the coating is applied to at least 65% or at least 85% of the inner surface of the hollow cylinder (area-by-area). Optionally, the coating is applied to at least 90% or substantially the entire inner surface of the hollow cylinder. Optionally or additionally, the coating is applied to at least 65% or at least 85% of the mating surface of the glass container (area-by-area). Optionally, the coating is applied to at least 90% or substantially the entire mating surface.

[0079] The glass transition temperature of the coating can be below -60°C, preferably below -70°C, for example below -75°C or below -80°C. Optionally, the glass transition temperature can be above -200°C, above -150°C, above -120°C, or above -100°C. The glass transition temperature can be measured using differential scanning calorimetry (DSC) or thermodynamic analysis (TMA). An exemplary method for determining the glass transition temperature of the coating includes performing thermodynamic analysis in expansion mode, for example, using a Q400 thermodynamic analyzer from TA Instruments. According to the invention, a sample can be prepared by coating a glass container, then the coating can be scraped off with a scalpel, and thermodynamic analysis can be performed in expansion mode, i.e., measuring the relationship between the expansion or contraction of the sample and temperature. In embodiments, the glass transition temperature range of the coating is between -200°C and -60°C, -150°C and -70°C, -120°C and -75°C, or -80°C and -100°C. In one embodiment, the glass transition temperature is -80°C to -90°C.

[0080] The coating can be amorphous or partially crystalline at room temperature. Optionally, the coating has a crystallinity of less than 20% (v / v) at 20°C.

[0081] In an embodiment, the coating may have a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry (DSC) at a temperature change rate of 10°C / min. The crystallization temperature range and the melting temperature range overlap at a temperature range of -75°C to -100°C, particularly at -80°C. For example, DSC can be performed in a temperature range of -120°C to -60°C, and a suitable instrument is a DSC Q2000 (TA instrument).

[0082] Not wanting to be bound by this theory, the inventors believe that within the overlapping range, the coating has both crystalline and molten portions. This allows the coating to be considered to possess the mechanical resistance and elasticity required to form a tight seal at low temperatures. If the peak regions of crystallization and melting extend into the same temperature range, then the crystallization and melting temperature ranges are considered to overlap. For example, crystallization can begin at -55°C and end at -95°C, meaning the exothermic crystallization peak region can be from -55°C to -95°C; melting can begin at -90°C and end at -40°C, meaning the endothermic melting peak region can be from -90°C to -40°C. In this example, the overlapping temperature range is from -90°C to -55°C. This example satisfies the requirement of overlap in temperatures from -75°C to -100°C, because at least one temperature overlaps within the indicated range. Container seal integrity

[0083] Even at very low temperatures, the glass containers and systems according to the invention can maintain significant container seal integrity. Specifically, the container seal integrity under the standard ethanol-modified dye immersion test can be maintained for at least 150 hours at -80°C. This means that the seal integrity of the open end A (related to the stopper) and / or open end B (related to the tip) of the glass container or system provides a very tight seal for at least 150 hours, even at -80°C. The time here refers to the period from immersion to complete equilibrium, during which the container can undergo the appropriate tests without problems, i.e., without dye immersion.

[0084] Optionally, the container seal integrity for the standard ethanol-modified dye invasive test is at least 300 hours, at least 600 hours, or at least 1200 hours at -80°C. These times and temperatures are considered sufficient for the safe production, dispensing, and storage of pharmaceutical compositions in glass containers or systems.

[0085] The container seal integrity of the glass container according to the invention under the standard ethanol-modified dye immersion test at -80°C is at least 150 hours, at least 600 hours, or at least 1200 hours. Preferably, the container seal integrity of the glass container according to the invention under the standard ethanol-modified dye immersion test at -80°C is at least 1500 hours or at least 6000 hours. Depending on the required shelf life of the pharmaceutical product, the container seal integrity under the standard ethanol-modified dye immersion test at -80°C does not necessarily have to be very high; for example, in some embodiments, it can be up to 12000 hours, 10000 hours, or 8000 hours. The container seal integrity under the standard ethanol-modified dye immersion test may be related to the stopper and / or tip, depending on which specific interface is tested. In a preferred embodiment, both interfaces, i.e., the inner surface / stopper and the mating surface / cap, must be tested and pass the test. If only one interface is to be tested, the other open end can be sealed by melting.

[0086] The container seal integrity for a specific ethanol-modified dye invasive test according to the system of the invention is at least 150 hours, at least 600 hours, or at least 1200 hours at -80°C. Preferably, the container seal integrity for a specific ethanol-modified dye invasive test according to the system of the invention is at least 1500 hours or at least 6000 hours at -80°C. Depending on the required shelf life of the pharmaceutical product, the container seal integrity for a specific ethanol-modified dye invasive test at -80°C does not necessarily have to be very high; for example, in some embodiments, it can be as long as 12000 hours, 10000 hours, or 8000 hours. The container seal integrity for a specific ethanol-modified dye invasive test may be related to the stopper and / or tip, depending on which specific interface is being tested. In a preferred embodiment, both interfaces, namely the inner surface / stopper and the mating surface / cap, must be tested and pass the test. If only one interface is to be tested, the other open end can be sealed by melting. Structural features of containers

[0087] In general, the present invention relates to a glass container for pharmaceutical compositions, comprising: a hollow cylinder having at least one open end, i.e., an open end adapted to fill, remove, or discharge container contents. The container may be configured to receive a stopper that is slidable relative to the hollow cylinder from the open end toward another end of the container (e.g., open end B). The stopper may be used to close open end A and / or discharge the contents of the hollow cylinder through open end B. In one embodiment, the container has at least two open ends. One open end is into which a stopper can be inserted, referred to in the present invention as "open end A". The other open end may be on the other side of the container, for example, the tip side if the container is a syringe.

[0088] In one embodiment, the glass container has an open end B, optionally disposed at the other end of the container opposite to the open end A, wherein the open end B is configured to be closed by a lid. The open end B may include a conical component or a component with a conical surface, so that the open end B can be closed with a lid that is adapted to the conical shape. The conical shape may be an inner cone or an outer cone. The invention is not limited to a conical open end; other geometries are also possible, as long as they are suitable for achieving a tight seal between the open end B and the corresponding lid. The surface of the open end B is referred to as the "fitting surface," which corresponds to the surface of the lid to form a tight seal. The open end B and / or its fitting surface may be configured to fit tightly against the surface of the lid. Optionally, the fitting surface is conical.

[0089] In one embodiment, at least a portion of the open end B or its mating surface is coated with the coating described in this invention. Optionally, the coating is provided on at least 25%, at least 35%, or at least 50% of the mating surface (area-by-area). In one embodiment, the coating is provided on at least 65%, at least 75%, at least 85%, or at least 95% of the mating surface. For example, the coating is provided on substantially the entire mating surface.

[0090] This invention is not particularly limited to container volume. In one embodiment, the volume enclosed by the hollow cylinder is at least 0.10 ml, at least 0.50 ml, or at least 1.00 ml. Optionally, the volume can be as high as 1000 ml, 200 ml, 100 ml, or 25 ml. In embodiments, the volume ranges from 0.1 ml to 1000 ml, 0.50 ml to 200 ml, or 1.00 ml to 25 ml. In one embodiment, the volume enclosed by the hollow cylinder is less than 10.0 ml.

[0091] The hollow cylinder has a cavity surrounded by a glass wall, wherein the wall thickness can be at least 0.50 mm, at least 0.80 mm, or at least 1.00 mm. Optionally, the glass wall thickness can be up to 10.0 mm, 8.0 mm, 5.0 mm, or 4.0 mm. In embodiments, the glass wall thickness is from 0.50 to 10.0 mm, from 0.80 mm to 8.0 mm, or from 1.00 mm to 4.00 mm. The term "wall thickness" as used herein describes the shortest distance between the inner and outer surfaces of the hollow cylinder.

[0092] As used in this paper, the term "outer diameter" refers to the maximum distance between two points on the outer surface of a hollow cylinder, where these two points are connected by a straight line that is perpendicular to and intersects the longitudinal axis of the hollow cylinder. The term "inner diameter" refers to the maximum distance between two points on the inner surface of a hollow cylinder, where these two points are connected by a straight line that is perpendicular to and intersects the longitudinal axis of the hollow cylinder.

[0093] The hollow cylinder of the container can have a substantially constant inner diameter, meaning that the total inner diameter variation is very small. "Total inner diameter variation" refers to the difference between the maximum and minimum inner diameter of the hollow cylinder. For example, the total inner diameter variation of the hollow cylinder can be less than 200 μm, less than 100 μm, less than 50 μm, or less than 25 μm. Optionally, the total inner diameter variation can be greater than 0.01 μm, greater than 0.10 μm, or greater than 1.0 μm.

[0094] In one embodiment, the ratio of the total variation in inner diameter of the coated portion along the inner surface of the hollow cylinder to the thickness of the coating is less than 500, less than 400, less than 250, or less than 150. In another embodiment, this ratio is at least 1.0, at least 5.0, or at least 10.0. For example, this ratio can range from 1.0 to 500, 5.0 to 250, or 10.0 to 150. Loosening force and gliding force

[0095] According to various aspects of the invention, the glass container may have a standardized sliding force of no more than 5.0 N.

[0096] Sliding force represents the force required to push the stopper through a hollow cylinder, while release force represents the force required to cause the stopper to initially move through a hollow cylinder. "Standardized sliding force" (GF) is the sliding force measured under standard conditions. Similarly, "standardized release force" (BLF) is the release force measured under standard conditions. These standard conditions include a standard stopper, namely a Datwyler FM257 / 2 stopper made of brominated butyl rubber with a Shore A hardness of 52 and a density of 1.355 g / cm³. 3 Available from Datwyler Pharma Packaging International NV, located at Industrieterrein Kolmen 1519, BE-3570 Alken, Belgium. BLF and GF can be obtained in a single measurement; the test for BLF and GF can be referred to as the "BLGF" test. The loosening force or sliding force mentioned in this invention, if related to a glass container, refers to the standardized loosening force or sliding force. If uncertain, any reference to BLF or GF in relation to the system refers to the specific BLF or GF of that system. "Specific" BLF or GF refers to the loosening force or sliding force measured in the system (i.e., including the system stopper, not the standard stopper). Otherwise, the measurement performed is the same as the standard test.

[0097] The standard BLGF test is performed at room temperature (20°C) using a general-purpose testing machine. For this purpose, a standard BLGF testing apparatus with a 50N test cup can be used. The sample is fixed vertically on a Model 106 2kN general-purpose testing machine manufactured by Havre GmbH (CH-6331, Hünenberg, Switzerland).

[0098] BLF is the force required to move the stopper from its original position, and GF is the force required to keep the stopper in motion after it has been released.

[0099] The container is filled with water for injection. After filling the sample, store it immediately, or test it immediately as needed. Test the sample without a needle.

[0100] Insert the sample into the holder and move the mold toward the stopper at a rate of 20 mm / min. Once a force of 0.25 N is measured, the machine switches to a testing speed of 100 mm / min and begins recording data. The experiment ends when the measured force exceeds 35 N, at which point the far end of the hollow cylinder (usually near the open end B) has been reached.

[0101] BLF is the maximum force measured within the first 4 mm of stopper movement. GF is the test interval measured from the point of movement 4 mm to the point of reaching the distal end of the tube in the first 10 mm. According to the invention, GF is the highest sliding force measured in this experiment.

[0102] The glass container according to the invention may have a standardized BLF of no more than 12.0 N. In some embodiments, the upper limit of the standardized BLF may be limited to 9.0 N, 8.0 N, 7.0 N, 6.0 N, 5.0 N, or even 4.0 N. The standardized BLF may be at least 0.1 N, at least 0.5 N, or at least 1.0 N to prevent any accidental movement of the stopper.

[0103] In this glass container, the ratio of normalized BLF to normalized GF, BLF / GF, is greater than 1.30. Optionally, the ratio of normalized BLF to normalized GF is characterized by BLF / GF being less than or equal to 3.0, particularly even after the glass container has been stored at -80°C for 150 hours. In embodiments, for the container according to the invention, the ratio BLF / GF is greater than 1.40, greater than 1.50, or even greater than 1.60. In some embodiments, after the container according to the invention has been stored at -80°C for 150 hours (“low-temperature stored container”), the ratio BLF / GF may be less than 2.5, less than 2.2, less than 2.0, or even less than 1.9. In particular, the relative difference (BLF / GF) between the low-temperature stored container and the unstored container is also considered. -80℃ -BLF / GF0) / BLF / GF-80℃ It may be less than 10%, preferably less than 5%. This means that the effect of the freeze-thaw cycle ratio BLF / GF is very low. On the other hand, as mentioned above, a high BLF / GF ratio means that it is quite difficult to loosen the stopper from its initial position, which may be due to the interaction between the coating and the stopper. A higher BLF is beneficial for keeping the stopper in its initial position even at low temperatures, i.e., when the pharmaceutical composition expands due to freezing.

[0104] The standardized GF of the glass container according to the present invention can be less than 7.5N, less than 6.5N, less than 5.5N, less than 4.5N, less than 3.5N, or even less than 2.5N. Optionally, the relative difference (BLF) between the cryogenically stored container and the unstored container on the standardized GF can be considered. -80℃ -BLF0) / BLF -80℃ Less than 25%, less than 20%, less than 15%, less than 10%, or even less than 5%. The relative difference in GF between containers stored at low temperatures and those not stored (GF). -80℃ -GF0) / GF -80℃ Less than 25%, less than 20%, less than 15%, less than 10%, or even less than 5%. Maintaining a fairly low GLF helps to fully drain the contents of the stoppered container after cryogenic storage.

[0105] Appropriate sliding and loosening forces facilitate the use of glass containers and systems according to the invention. Generally, a tight seal corresponds to higher loosening and / or sliding forces. Some glass containers according to the invention have very low standardized loosening and sliding forces. However, sufficiently high loosening forces may help prevent unwanted movement of the stopper during storage.

[0106] Optionally, the glass container according to the invention has a standardized sliding force of at least 0.5 N.

[0107] To prevent the stopper from shifting during low-temperature storage and thus ensure a tight seal, the glass container according to the invention may have a standardized loosening force that exceeds the container's standardized sliding force by at least 30%, at least 60%, at least 100%, or at least 200%.

[0108] In one embodiment, the system according to the invention has a specific release force that is at least 600% greater than the sliding force, and the specific release force is at least 4.0 or at least 4.9.

[0109] In one embodiment, the present invention relates to the glass container or system described herein, which includes a pharmaceutical composition. The pharmaceutical composition may include more than 60 wt% water. Optionally, the pharmaceutical composition includes a protein or nucleic acid therapeutic agent. system

[0110] In some aspects, the present invention relates to a system comprising a glass container according to the invention and optionally a stopper and / or a lid. The stopper may close an open end A, and / or the lid may close an open end B.

[0111] In one embodiment, the system includes a glass container and a stopper according to various aspects of the invention, wherein the system has container seal integrity for at least 150 hours of a specific ethanol-modified dye intrusion test at -80°C.

[0112] The container seal integrity for this specific ethanol-modified dye invasive test may be related to the stopper and / or tip. "Related to the stopper" means testing the seal integrity formed by the stopper located within a hollow cylinder, i.e., the sealed open end A. "Related to the tip" means testing the seal integrity formed by the cap, which opens to the tip side, i.e., the sealed open end B. Unlike standard container seal integrity tests that rely on standard stoppers, plungers, and / or caps, the container seal integrity for this specific ethanol-modified dye invasive test is measured using the stopper and / or cap, which are part of the system being tested.

[0113] Optionally, the system may have container seal integrity for at least 300 hours, at least 600 hours, or at least 1200 hours for a specific ethanol-modified dye invasive test at -80°C. plug

[0114] The system according to the invention may include a plug.

[0115] The stopper may include a body having at least one annular protrusion and a circumferential surface. A “circumferential surface” refers to the surface of the stopper facing the inner surface of the hollow cylinder when the stopper is placed within the cylinder, for example, inserted through the open end A. This circumferential surface includes the surface of any annular protrusion. If the stopper is coated, the coated surface facing the inner surface of the hollow cylinder is part of or constitutes the circumferential surface. A “contact surface” refers to the portion of the circumferential surface that contacts the inner surface of the hollow cylinder when the stopper is inserted (e.g., at 20°C). In this invention, it may be advantageous if the stopper is uncoated. Studies have found that uncoated stoppers can form a tighter seal at low temperatures compared to coated stoppers. In one embodiment, the stopper does not include a fluoropolymer coating.

[0116] An "annular protrusion" is a portion of the stopper with a diameter greater than the average diameter measured perpendicular to the longitudinal axis of the hollow cylinder. The annular protrusion can contact the inner surface of the hollow cylinder to seal the joint between the stopper and the hollow cylinder. Any portion of the stopper not considered an "annular protrusion" if its diameter is greater than the average diameter but it does not contact the inner surface of the hollow cylinder for at least 80%, 90%, 99.9%, or 100% of the time during distal movement of the stopper. The annular protrusion helps hold the stopper in its intended position within the hollow cylinder, thereby stabilizing its orientation in the proximal-distal direction, which affects the container's BLF and GF values. Furthermore, the annular protrusion seals the joint between the stopper and the inner surface of the hollow cylinder. In one embodiment, the stopper may have two, three, or four annular protrusions. Optionally, the stopper may have exactly three annular protrusions.

[0117] Optionally, the stopper may have one or more trailing ribs. A "trailing rib" is a part of the stopper whose diameter, measured along the longitudinal axis perpendicular to the hollow cylinder, is larger than the average diameter. However, the diameter of the trailing rib is smaller than the diameter of the annular protrusion; therefore, as the stopper moves in the proximal-distal direction, the trailing rib is highly unlikely to contact the inner surface of the hollow cylinder. Thus, the trailing rib can stabilize the orientation of the stopper within the hollow cylinder without effectively sealing the joint between the stopper and the inner surface.

[0118] The stopper may be coated with a coating, which may be a polymer. In one embodiment, the coating comprises a resin, such as a fluorinated polymer, selected from the group consisting of: polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), tetrafluoroethylene (TFE), tetrafluoroethylene-perfluoroethylene copolymer, tetrafluoroethylene-hexafluoropropylene copolymer, tetrafluoroethylene-ethylene copolymer, trichlorotrifluoroethylene, polyvinylidene fluoride, polyvinyl fluoride, perfluoropropyl vinyl ether, perfluoroalkoxy polymers, and copolymers, mixtures, and combinations thereof. The coating may also be formed from a layer of polyethylene, polypropylene, parylene, polylactic acid, and copolymers, mixtures, and combinations thereof. Preferably, the coating is a polytetrafluoroethylene coating. The above coating can reduce the coefficient of friction between the circumferential surface of the stopper and the inner surface of the hollow cylinder. In an embodiment, at least the portion of the circumferential surface of the stopper in contact with the inner surface of the hollow cylinder will be coated.

[0119] The stopper may be an elastomer with a yield stress of at least 10 MPa as measured according to ISO 527-2:2012(E), and / or a low coefficient of sliding friction against steel of less than 0.23 as measured according to DIN EN ISO 8295 / 2004-10. The stopper may be made of thermoplastic elastomers and / or rubbers such as natural or synthetic rubbers. Suitable rubber materials may be selected from the group consisting of: butyl rubber, halogenated butyl rubber, acrylonitrile-butadiene rubber, isoprene rubber, chloroprene rubber, butadiene rubber, styrene-butadiene rubber, ethylene-propylene rubber, isoprene-isobutylene rubber, nitrile rubber, and combinations and mixtures thereof. In one embodiment, the stopper is made of brominated butyl rubber. In particular, the body of the stopper may be made of the rubbers and / or thermoplastic elastomers listed above.

[0120] The main body can be coated with the aforementioned resin. The thickness of the stopper coating can be less than 1 mm, particularly 0.5 μm to 200 μm, particularly 10 μm to 125 μm, or 30 μm to 100 μm. It has been proven that the above thicknesses are easy to apply and sufficient to achieve the desired effect against friction.

[0121] The water contact angle of the circumferential surface of the stopper can be at least 100°, or even at least 110°. The circumferential surface of the stopper can be superhydrophobic. Using a superhydrophobic stopper in the container of the present invention helps to obtain a favorable BLGF value because of its low coefficient of sliding friction and low adhesion tendency.

[0122] The circumferential surface of the plug and the inner surface of the hollow cylinder can at least partially contact each other at the contact area. This contact area is sometimes referred to as the sealing area. In an embodiment, the contact area will be at least 8 mm. 2 The maximum is 48mm 2 The contact area can be 8mm. 2 -48mm 2 10mm 2 -40mm 2 15mm 2 -30mm 2 or 16mm 2 -24mm 2 In cases with multiple annular protrusions, each protrusion contributes to increasing the contact area. A minimal contact area will help achieve a proper seal. If the contact area is too large, the BLGF value may increase excessively.

[0123] This system may include a stopper with a Shore A hardness not exceeding 70. The Shore A hardness can be tested using the ISO 7619-1 (2012-02, 1-second indentation) method. The Shore A hardness can be at least 35, at least 40, or at least 45. Optionally, it can be up to 65 or up to 60. In embodiments, the Shore A hardness can be 35 to 70, 40 to 65, or 45 to 60.

[0124] The density of the stopper can be at least 1.200 g / cm³. 3 At least 1.250 g / cm³ 3 or at least 1.300 g / cm 3 Optionally, the density can be up to 1.450 g / cm³. 3 The maximum value is 1.400 g / cm³. 3 Or at most 1.385 g / cm³ 3 In the embodiment, the density is 1.200 g / cm³. 3 Up to 1.450 g / cm 3 1.250g / cm 3 Up to 1.400 g / cm 3 or 1.300g / cm 3 Up to 1.385 g / cm 3 .

[0125] To ensure a tight seal, the compression deformation of the plug is at most 20%, less than 18%, or less than 16%. Optionally, the compression deformation can be at least 5%, at least 7%, or at least 10%. The compression deformation can be measured according to ISO 815-1 (2016-09). Optionally, the compression deformation is 5% to 20%, 7% to 18%, or 10% to 16%.

[0126] In one embodiment, the present invention relates to a system comprising: a glass container having an open end B, wherein the open end B is optionally disposed at the other end of the container relative to an open end A, the open end B being closed by a lid and having a fitting surface configured to fit tightly against the surface of the lid. cover

[0127] The system may include a cap with a Shore A hardness not exceeding 80. The Shore A hardness can be tested using the ISO 7619-1 (2012-02, 1-second indentation) method. The Shore A hardness can be at least 50, at least 55, or at least 60. Optionally, it can be up to 75 or up to 70. In embodiments, the Shore A hardness can be 50 to 80, 55 to 75, or 60 to 70.

[0128] The density of the lid can be at least 1.300 g / cm³.3 At least 1.330 g / cm³ 3 or at least 1.350 g / cm 3 Optionally, the density may be at most 1.500 g / cm³, at most 1.450 g / cm³, or at most 1.400 g / cm³. In an embodiment, the density is 1.300 g / cm³. 3 Up to 1.500 g / cm 3 1.330g / cm 3 Up to 1.450 g / cm 3 or 1.350g / cm 3 Up to 1.400 g / cm 3 .

[0129] To ensure a tight seal, the compression deformation of the lid is at most 18%, less than 16%, or less than 14%. Optionally, the compression deformation can be at least 5%, at least 7%, or at least 10%. The compression deformation can be measured according to ISO 815-1 (2016-09). Optionally, the compression deformation is 5% to 18%, 7% to 16%, or 10% to 14%.

[0130] The cap may be a rigid needle cap, a rigid cap (as described in EP 3569272A1), or a pointed cap. The cap may be made of a polymeric material. The polymeric material may be a rubber. In one embodiment, the polymeric material is a synthetic isoprene-bromobutyl mixture. The cap may have an elastomer with a yield stress of at least 10 MPa as measured according to ISO 527-2:2012(E), and / or a low coefficient of sliding friction against steel of less than 0.23 as measured according to DIN EN ISO 8295 / 2004-10. The cap may be made of a thermoplastic elastomer and / or rubbers such as natural or synthetic rubbers. Suitable rubber materials may be selected from the group consisting of: butyl rubber, halogenated butyl rubber, acrylonitrile-butadiene rubber, isoprene rubber, chloroprene rubber, butadiene rubber, styrene-butadiene rubber, ethylene-propylene rubber, isoprene-isobutylene rubber, nitrile rubber, and combinations and mixtures thereof. In one embodiment, the cap is made of synthetic isoprene-bromobutyl rubber. Specifically, the body of the cap may be made of the rubbers and / or thermoplastic elastomers listed above. In one embodiment, the cap material has a higher density or Shore A hardness than the stopper. Optionally, the cap material has lower compressive strength compared to the stopper material.

[0131] This invention includes a system in which at least a portion of the mating surfaces are coated with the coating described herein. For a suitable sealing effect, it is often sufficient to apply the coating to the areas requiring a tight seal. Therefore, at least 25%, or at least 50%, of the mating surfaces (area-by-area) is coated. In some embodiments, at least 65%, or at least 85%, of the mating surfaces (area-by-area) is coated. Optionally, the coating is applied to substantially the entire mating surface.

[0132] This invention includes a system comprising a glass container and a stopper as described herein, wherein the ratio of the difference (I) in the average linear thermal expansion coefficients of the materials of the stopper and the glass container to the coating thickness (II) is less than 0.5 ppm / nm. In some embodiments, this ratio is less than 0.45 ppm / nm, less than 0.35 ppm / nm, or less than 0.30 ppm / nm. Optionally, this ratio can be at least 0.01 ppm / nm, at least 0.05 ppm / nm, or at least 0.10 ppm / nm. The average linear thermal expansion coefficient can be measured between 20°C and 300°C. The ratio of the difference (I) in the average linear thermal expansion coefficients of the materials of the stopper and the glass container to the coating thickness (II) can be from 0.01 ppm / nm to less than 0.5 ppm / nm, from 0.05 ppm / nm to less than 0.45 ppm / nm, or from 0.10 ppm / nm to less than 0.30 ppm / nm.

[0133] The ratio of the plug's uncompressible outer diameter to the inner diameter of the hollow cylinder is greater than 1.100 or greater than 1.185. Generally, a higher ratio results in a tighter seal. However, an excessively high ratio can significantly increase the loosening force and sliding force. Optionally, this ratio is limited to not exceeding 1.400, 1.350, or 1.300.

[0134] In one embodiment, the system includes a syringe with a peg-shaped needle and a rigid needle cap.

[0135] In one embodiment, the system includes a syringe with a rigid cap as disclosed in EP 3569272 A1. EP 3569272 A1 is incorporated herein by reference and is as if fully set forth herein. The rigid cap can be attached to the syringe using a Luer lock adapter.

[0136] In one embodiment, the system includes a syringe with a tip cap. Glass composition

[0137] This invention does not specifically limit the glass element. Preferably, the glass is borosilicate glass, aluminosilicate glass, lithium-aluminosilicate (LAS) glass, and more preferably borosilicate glass.

[0138] In one embodiment, the glass composition comprises, by mass percentage: SiO2: 30% to 98%, preferably 50% to 90%, more preferably 70.0% to 74.0%; and / or B2O3: 0% to 30%, preferably 3% to 20%, more preferably 7.0% to 16.0%; and / or Al2O3: 0% to 30%, preferably 1% to 15%, more preferably 3.0% to 6.5%; and / or X₂O: 0% to 30%, preferably 1% to 15%, more preferably 2.0% to 7.2%, wherein X is selected from Na, K, Li, preferably, X is Na and / or K; and / or YO: 0% to 30%, preferably 0.1% to 5%, more preferably 0.5% to 1.0%, wherein Y is selected from Ca, Mg, Ba, and preferably, Y is Ca and / or Mg.

[0139] More preferably, the composition of the glass, by mass percentage, includes: SiO2: 30% to 98%, preferably 50% to 90%, more preferably 70.0% to 74.0%; B2O3: 0% to 30%, preferably 3% to 20%, more preferably 7.0% to 16.0%; Al2O3: 0% to 30%, preferably 1% to 15%, more preferably 3.0% to 6.5%; X₂O: 0% to 30%, preferably 1% to 15%, more preferably 2.0% to 7.2%, wherein X is selected from Na, K, and Li, preferably, X is Na and / or K; and YO: 0% to 30%, preferably 0.1% to 5%, more preferably 0.5% to 1.0%, wherein Y is selected from Ca, Mg, Ba, and preferably, Y is Ca and / or Mg.

[0140] In another preferred embodiment, the glass composition, by mass percentage, comprises: SiO2: 20% to 98%, preferably 40% to 75%, more preferably 50% to 65%; and / or B2O3: 0% to 30%, preferably 1% to 15%, more preferably 3% to 9%; and / or Al2O3: 0% to 30%, preferably 10% to 20%, more preferably 13% to 18%; and / or X2O: 0% to 30%, preferably 0% to 5%, more preferably 0% to 3%, wherein X is selected from Na, K, Li, preferably, X is Na and / or K; and / or YO: 0% to 50%, preferably 0.1% to 40%, more preferably 10% to 35%, wherein Y is selected from Ca, Mg, Ba, and preferably, Y is Ca and / or Mg.

[0141] More preferably, the composition of the glass, by mass percentage, includes: SiO2: 20% to 98%, preferably 40% to 75%, more preferably 50% to 65%; B2O3: 0% to 30%, preferably 1% to 15%, more preferably 3% to 9%; Al2O3: 0% to 30%, preferably 10% to 20%, more preferably 13% to 18%; X₂O: 0% to 30%, preferably 0% to 5%, more preferably 0% to 3%, wherein X is selected from Na, K, and Li, preferably X is Na and / or K; and YO: 0% to 50%, preferably 0.1% to 40%, more preferably 10% to 35%, wherein Y is selected from Ca, Mg, Ba, and preferably, Y is Ca and / or Mg.

[0142] The present invention does not specifically limit the volume of the glass container. Preferably, the full-mouth volume of the container is 0.1 ml to 1000 ml, more preferably 0.5 ml to 500 ml, more preferably 1 ml to 250 ml, more preferably 2 ml to 30 ml, more preferably 2 ml to 15 ml, more preferably about 1 ml, 2 ml, 3 ml, 4 ml, 5 ml, 6 ml, 7 ml, 8 ml, 9 ml, 10 ml, 11 ml, 12 ml, 13 ml, 14 ml or 15 ml, more preferably 5 ml to 15 ml.

[0143] In one embodiment, the glass composition of the glass container comprises 50 wt% to 90 wt% SiO2 and 3 wt% to 25 wt% B2O3.

[0144] In one embodiment, the glass of the glass container has a glass composition comprising aluminosilicate, the glass composition optionally comprising 55 wt% to 75 wt% SiO2 and 11.0 wt% to 25.0 wt% Al2O3.

[0145] In one embodiment, the glass composition of the glass container comprises 70 wt% to 81 wt% SiO2, 1 wt% to 10 wt% Al2O3, 6 wt% to 14 wt% B2O3, 3 wt% to 10 wt% Na2O, 0 wt% to 3 wt% K2O, 0 wt% to 1 wt% Li2O, 0 wt% to 3 wt% MgO, 0 wt% to 3 wt% CaO, and 0 wt% to 5 wt% BaO.

[0146] In one embodiment, the glass composition of the glass container comprises 72 wt% to 82 wt% SiO2, 5 wt% to 8 wt% Al2O3, 3 wt% to 6 wt% B2O3, 2 wt% to 6 wt% Na2O, 3 wt% to 9 wt% K2O, 0 wt% to 1 wt% Li2O, 0 wt% to 1 wt% MgO, and 0 wt% to 1 wt% CaO.

[0147] In one embodiment, the glass composition of the glass container comprises 60 wt% to 78 wt% SiO2, 7 wt% to 15 wt% B2O3, 0 wt% to 4 wt% Na2O, 3 wt% to 12 wt% K2O, 0 wt% to 2 wt% Li2O, 0 wt% to 2 wt% MgO, 0 wt% to 2 wt% CaO, 0 wt% to 3 wt% BaO, and 4 wt% to 9 wt% ZrO2.

[0148] In one embodiment, the glass composition of the glass container comprises 50 wt% to 70 wt% SiO2, 10 wt% to 26 wt% Al2O3, 1 wt% to 14 wt% B2O3, 0 wt% to 15 wt% MgO, 2 wt% to 12 wt% CaO, 0 wt% to 10 wt% BaO, 0 wt% to 2 wt% SrO, 0 wt% to 8 wt% ZnO, and 0 wt% to 2 wt% ZrO2.

[0149] In one embodiment, the glass composition of the glass container comprises 55 wt% to 70 wt% SiO2, 11 wt% to 25 wt% Al2O3, 0 wt% to 10 wt% MgO, 1 wt% to 20 wt% CaO, 0 wt% to 10 wt% BaO, 0 wt% to 8.5 wt% SrO, 0 wt% to 5 wt% ZnO, 0 wt% to 5 wt% ZrO2, and 0 wt% to 5 wt% TiO2.

[0150] In one embodiment, the glass composition of the glass container comprises 65% to 72 wt% SiO2, 11% to 17 wt% Al2O3, 0.1% to 8 wt% Na2O, 0% to 8 wt% K2O, 3% to 8 wt% MgO, 4% to 12 wt% CaO, and 0% to 10 wt% ZnO.

[0151] In one embodiment, the glass composition of the glass container comprises 64% to 78 wt% SiO2, 4% to 14 wt% Al2O3, 0% to 4 wt% B2O3, 6% to 14 wt% Na2O, 0% to 3 wt% K2O, 0% to 10 wt% MgO, 0% to 15 wt% CaO, 0% to 2 wt% ZrO2, and 0% to 2 wt% TiO2.

[0152] In one embodiment, the average linear coefficient of thermal expansion (CTE) of the glass in the glass container, measured over a temperature range of 20°C to 300°C, is 3.0 × 10⁻⁶. -6 / K to 8.0*10 -6 Between / K, or 3.5*10 -6 / K to 7.0*10 -6 Between / K, or 4.0*10 -6 / K to 6.0*10 -6 Between / K. Of course, CTE can be less than 5.2*10. -6 / K or less than 5.1*10 -6 / K. In some embodiments, the CTE is limited to no more than 6.9*10. -6 / K or no more than 5.9*10 -6 / K. CTE can be measured according to DIN ISO 7991:1987. Manufacturing method

[0153] A method for manufacturing glass containers and / or systems according to the present invention may include:

[0154] Melt a batch of raw materials to produce glass;

[0155] The glass is used to form a glass container; and

[0156] The coating composition is applied and cured at a curing temperature below 150°C.

[0157] The coating composition may contain or consist of the components required to obtain the coating described in this invention. The coating composition may contain one or more organosilicon substances, such as polymers or oligomers. For example, the coating composition may include polysiloxane structural units or compounds. The polysiloxane compound of the coating composition may include crosslinkable and / or non-crosslinkable polysiloxane compounds. In one embodiment, the polysiloxane compound is a polyalkylsiloxane compound, such as a polydialkylsiloxane compound. Optionally, one or more alkyl groups in the polyalkylsiloxane or polydialkylsiloxane are independently selected from C1 to C8 alkyl groups, whether branched or unbranched. Additionally, the coating composition may include a catalyst and / or a diluent.

[0158] A polysiloxane compound is considered "crosslinkable" if it contains one or more (especially two) polymerizable or crosslinkable groups under the curing conditions of the present invention, particularly at a curing temperature below 150°C and a curing time of less than 3000 seconds. A polysiloxane compound is considered "non-crosslinkable" if it does not contain any polymerizable or crosslinkable groups under the curing conditions of the present invention, particularly at a curing temperature below 150°C and a curing time of less than 3000 seconds.

[0159] In one embodiment, the coating composition comprises: - one or more crosslinkable polydialkylsiloxane compounds; and - One or more non-crosslinkable polysiloxane compounds.

[0160] Optionally, the coating composition comprises: - One or more crosslinkable polydialkylsiloxane compounds; - one or more non-crosslinkable polysiloxane compounds; and - One or more cross-linked polysiloxane compounds. Cross-linked polysiloxane compounds

[0161] The crosslinked polysiloxane compound is suitable for reacting with a crosslinkable polysiloxane compound under the conditions described in this invention (especially under the conditions of curing temperature below 150°C and curing time less than 3000 seconds), preferably by hydrosilylation, thereby forming a polysiloxane network.

[0162] Crosslinked polysiloxane compounds may include alkylsiloxane monomer units, such as dialkylsiloxane monomer units. Optionally, one or more alkyl groups of the monomer in the crosslinked polysiloxane compound are independently selected from C1 to C8 alkyl groups, whether branched or unbranched. The alkyl group may be a straight-chain alkyl group. For example, the alkyl group may be independently selected from methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, and octyl groups. Preferably, the alkyl group is independently selected from methyl and ethyl groups.

[0163] In some embodiments, the crosslinked polysiloxane compound is a polysiloxane having Si-H groups. In one example embodiment, the crosslinked polysiloxane compound is a copolymer having dimethylsiloxane and methylhydrosiloxane monomer units. In this case, it has been found advantageous to use copolymers having the following structure (m is an integer greater than or equal to 1, n is an integer greater than or equal to 1; n can be greater than or equal to 2):

[0164] Optionally, the crosslinked polysiloxane is a copolymer, particularly having dialkylsiloxane and alkylhydrosiloxane monomer units. The alkyl group in the alkylhydrosiloxane monomer unit can be selected from branched or unbranched C1 to C8 alkyl groups. The alkyl group can be a straight-chain alkyl group. For example, the alkyl group can be independently selected from methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, and octyl groups. Preferably, the alkyl group is independently selected from methyl and ethyl groups.

[0165] In the coating composition, the content of crosslinked polysiloxane can be from 0.10 wt% to 1.50 wt%, from 0.10 wt% to 1.00 wt%, or from 0.10 wt% to 0.60 wt%. In the examples, the concentration of crosslinked polysiloxane in the coating composition should not exceed 1.50 wt%, 1.00 wt%, or 0.60 wt%. Preferably, the minimum amount is 0.10 wt%. Non-crosslinkable polysiloxane compounds

[0166] The coating composition may include one or more types of non-crosslinked polysiloxane compounds, such as at least two or at least three types. These types may differ in viscosity. In some embodiments, the coating comprises: a high-viscosity non-crosslinked polysiloxane compound with a viscosity greater than 10,000 cSt, and / or a low-viscosity non-crosslinked polysiloxane compound with a viscosity less than 10,000 cSt. It may be applied at 23°C and 10s according to DIN EN ISO 3219:1993. -1 The viscosity was determined using a coaxial cylinder system at a shear rate of [value missing]. Optionally, the viscosity of the high-viscosity non-crosslinkable polysiloxane compound was at least 15000 cSt, and / or the viscosity of the low-viscosity non-crosslinkable polysiloxane compound was below 5000 cSt.

[0167] The weight ratio (by mass) of low-viscosity non-crosslinkable polysiloxane compounds to high-viscosity non-crosslinkable polysiloxane compounds. 高 :quality 低 The weight ratio can be at least 0.10, at least 0.50, at least 1.00, at least 1.50, or at least 2.00. In some embodiments, this ratio can be as high as 5.00, 4.00, or 3.00. For example, the weight ratio of a low-viscosity non-crosslinkable polysiloxane compound to a high-viscosity non-crosslinkable polysiloxane compound can range from 0.10 to 5.00, 0.50 to 4.00, or 1.00 to 3.00.

[0168] Optionally, the weight-average molecular weight of the low-viscosity non-crosslinkable polysiloxane compound is from 1200 g / mol to 30000 g / mol; and / or the weight-average molecular weight of the high-viscosity non-crosslinkable polysiloxane compound is from 15000 g / mol to 300000 g / mol. In one embodiment, the weight-average molecular weight of the high-viscosity non-crosslinkable polysiloxane compound is from 32000 g / mol to 210000 g / mol, or from 100000 to 150000 g / mol. In one embodiment, the weight-average molecular weight of the low-viscosity non-crosslinkable polysiloxane compound is from 5000 g / mol to 25000 g / mol, or from 10000 g / mol to 20000 g / mol.

[0169] In the embodiments, the weight-average molecular weight of the low-viscosity non-crosslinkable polysiloxane compound is at least 1200 g / mol, at least 5000 g / mol, or at least 10000 g / mol. This weight-average molecular weight can be as high as 30000 g / mol, 25000 g / mol, or 20000 g / mol.

[0170] In the embodiments, the weight-average molecular weight of the high-viscosity non-crosslinkable polysiloxane structural unit is at least 15,000 g / mol, at least 32,000 g / mol, or at least 100,000 g / mol. This weight-average molecular weight can be as high as 300,000 g / mol, 210,000 g / mol, or 150,000 g / mol.

[0171] In particular, polydimethylsiloxane is suitable for use as a non-crosslinkable polysiloxane compound. Crosslinkable polysiloxane compounds

[0172] Crosslinkable polysiloxane compounds can be crosslinked via one or more, preferably via two, terminal groups. In particular, the terminal groups can have double bonds, allowing them to undergo a hydride reaction, for example, under the conditions of the present invention (particularly a curing temperature below 150°C and a curing time of less than 3000 seconds). The terminal groups can be selected from vinyl, acrylonitrile, methacrylonitrile, styrene, and combinations thereof.

[0173] In one embodiment, the crosslinkable polysiloxane compound and the crosslinked polysiloxane compound can form a hydrosilylation product under the conditions of the present invention (particularly at a curing temperature below 150°C and a curing time of less than 3000 seconds). A suitable crosslinkable polysiloxane compound is a vinyl-polysiloxane compound. The crosslinked polysiloxane can be crosslinked with the crosslinkable polysiloxane by reacting multiple Si-H groups with the vinyl groups of the crosslinkable polysiloxane. This reaction can be platinum-catalyzed.

[0174] Crosslinkable polysiloxane compounds may include alkylsiloxane monomer units, such as dialkylsiloxane monomer units. Optionally, one or more alkyl groups of the monomer in the crosslinkable polysiloxane compound are independently selected from branched or unbranched C1 to C8 alkyl groups. The alkyl group may be a straight-chain alkyl group. For example, the alkyl group may be independently selected from methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, and octyl groups. Preferably, the alkyl group is independently selected from methyl and ethyl groups. diluent

[0175] The coating composition may also include one or more diluents. The diluent according to the invention can be a Si-containing solvent in which both crosslinkable and non-crosslinkable polysiloxane compounds are soluble. To ensure good solubility of the polysiloxane compound, a non-polar solvent can be used as the diluent. In this case, it has been found advantageous to use an organosilicon compound with up to six silicon atoms as the diluent.

[0176] Example diluents include: - Cyclic organosilicones, such as: octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane, dodecylcyclohexasiloxane, tetramethylcyclotetrasiloxane, and pentamethylcyclopentasiloxane; - Hexamethyldisiloxane (HMDSO); -Octamethyltrisiloxane; and -Decamethyltetrasiloxane.

[0177] In particular, mixtures of one or more of the above-mentioned substances can also be used as diluents. Catalyst / Inhibitor

[0178] The coating composition may also include a catalyst for the crosslinking reaction of compounds in a multi-component system. Soluble platinum-containing catalysts, such as chloroplatinic acid, can be used. Karstedt catalysts may also be used.

[0179] In some embodiments, the coating composition includes at least one inhibitor to prevent spontaneous reactions in the composition. This facilitates the treatment of the composition up to the initiation of coating application. The inhibitor can form a reversible complex with the catalyst, thereby preventing spontaneous crosslinking reactions in the composition. Coating composition

[0180] In one embodiment, the coating composition includes a high-viscosity non-crosslinkable polysiloxane compound, but does not necessarily include a low-viscosity non-crosslinkable polysiloxane compound.

[0181] In one embodiment, the coating composition comprises the following components: One or more non-crosslinkable polysiloxane compounds One or more cross-linked polysiloxane compounds One or more catalysts One or more diluents

[0182] In one embodiment, the coating composition comprises the following components by weight percentage: One or more non-crosslinkable polysiloxane compounds 2.0% to 25.0% One or more cross-linked polysiloxane compounds 0.10% to 1.50% One or more catalysts 0.001% to 0.50% One or more diluents 55.0% to 92.0%

[0183] In some embodiments, the weight ratio of the crosslinkable polysiloxane compound to the crosslinkable polysiloxane compound is at least 0.01, at least 0.015, or at least 0.02. Optionally, this ratio should not exceed 0.5, 0.4, 0.2, or 0.1. In some embodiments, the ratio ranges from 0.01 to 0.5, 0.015 to 0.4, or 0.02 to 0.2. The present invention considers that the weight ratio of the crosslinkable polysiloxane compound to the crosslinkable polysiloxane compound is related to adjusting the glass transition temperature and the crystallization and melting properties of the coating.

[0184] Optionally, the weight ratio of the crosslinkable polysiloxane compound to the non-crosslinkable polysiloxane compound in the coating composition is less than 3.00, less than 2.50, less than 1.80, or less than 1.20. In the coating, the weight ratio of the crosslinkable polysiloxane compound to the non-crosslinkable polysiloxane compound can be at least 0.40, at least 0.60, or at least 0.70. In embodiments, this ratio ranges from 0.40 to 3.00, 0.60 to 2.50, or 0.70 to 1.80. The non-crosslinkable polysiloxane compound helps achieve the desired elasticity and cryogenic sealing properties, which are preferred for containers and systems according to the invention.

[0185] In one embodiment, the coating composition comprises the following components by weight percentage:

[0186] In one embodiment, the coating composition comprises the following components by weight percentage:

[0187] In one embodiment, the coating composition comprises the following components by weight percentage:

[0188] In one embodiment, the coating composition comprises the following components by weight percentage: More specific coating compositions

[0189] Crosslinked polysiloxane structural units, low-viscosity non-crosslinked polysiloxane structural units, and / or high-viscosity non-crosslinked polysiloxane structural units may include or be composed of dialkylsiloxane monomer units, particularly dimethylsiloxane monomer units.

[0190] In some embodiments, the crosslinkable polysiloxane is a vinyl-functionalized polysiloxane, and / or the crosslinkable polysiloxane compound is a polysiloxane having Si-H groups. According to one example embodiment, it comprises a vinyl-functionalized polydimethylsiloxane as the crosslinkable polysiloxane compound, and / or a copolymer having dimethylsiloxane and methylhydrosiloxane monomer units as the crosslinkable polysiloxane compound. In this case, it has been found advantageous to use copolymers having the following structure (m is an integer greater than or equal to 1, n is an integer greater than or equal to 1; n can be 2 or more):

[0191] In a more specific variant, the coating composition includes the following components:

[0192] In a more specific variant, the coating composition comprises the following components by weight percentage:

[0193] In a more specific variant, the coating composition comprises the following components by weight percentage:

[0194] In a more specific variant, the coating composition comprises the following components by weight percentage:

[0195] In a more specific variant, the coating composition comprises the following components by weight percentage:

[0196] In a more specific variant, the coating composition comprises the following components by weight percentage:

[0197] Optionally, the crosslinkable polysiloxane structural unit, the low-viscosity non-crosslinkable polysiloxane structural unit, and / or the high-viscosity non-crosslinkable polysiloxane structural unit may include a dialkylsiloxane monomer unit, particularly a dimethylsiloxane monomer unit. The crosslinkable polysiloxane structural unit may be crosslinked via one or more polymerizable end groups.

[0198] The coating composition can be applied using conventional methods known in the art. In one embodiment, the method includes coating at least a portion of a glass container with the coating composition, such as wiping, dipping, spraying (e.g., ultrasonic spraying), or curtain coating. In a preferred embodiment, the coating composition can be applied using a wiping process.

[0199] The coating composition can be applied to achieve the desired coating thickness. The coating thickness can be greater than 250 nm, greater than 300 nm, greater than 400 nm, greater than 450 nm, or greater than 500 nm. Optionally, the coating thickness can be up to 1500 nm, 1250 nm, or 1000 nm. Appropriate coating thickness contributes to achieving a tight seal at low temperatures. In embodiments, the coating thickness can be from 250 nm to 1500 nm, from 300 nm to 1250 nm, or from 400 nm to 1000 nm. Optionally, the above-mentioned indices for coating thickness mean that at least 90%, at least 95%, or at least 99% of the coating area has a coating thickness within the indicated range. In a preferred embodiment, the coating thickness is greater than 400 nm, particularly at least 450 nm or at least 500 nm. Exemplary preferred ranges for coating thickness are greater than 400 nm to 1500 nm, or 450 nm to 1250 nm, or 500 nm to 1000 nm.

[0200] To achieve a suitable sealing effect, it is generally sufficient to apply the coating composition to the areas requiring a tight seal, namely the contact area between the inner surface and the stopper, and / or the contact area between the mating surface and the cap (the sealing area). The coating composition may be applied (area-by-area) to at least 25% or at least 50% of the inner surface of the hollow cylinder. However, this coating may also have a beneficial effect on the sliding properties of the stopper on the inner surface of the hollow cylinder. Therefore, in some embodiments, the coating composition is applied (area-by-area) to at least 65% or at least 85% of the inner surface of the hollow cylinder. Optionally, the coating composition is applied to at least 90% or substantially the entire inner surface of the hollow cylinder. In some embodiments, the coating composition is applied (area-by-area) to at least 65% or at least 85% of the mating surface of the glass container. Optionally, the coating composition is applied to at least 90% or substantially the entire mating surface.

[0201] The term "curing temperature" as used here refers to the effective temperature at which the coating can be cured. The curing temperature is not the nominal temperature in the oven, which may be higher than the effective temperature of the coating during curing. Curing may include polymerizable polymerizable groups, such as polymerizable end groups. The coating can be cured at curing temperatures below 150°C, below 125°C, or below 110°C. Too high a curing temperature may result in low elasticity of the coating. On the other hand, too low a curing temperature may not be sufficient to achieve good sealing performance. Therefore, in embodiments, the curing temperature may be above 50°C, above 60°C, or above 70°C. It is important to note that the curing temperature is the effective temperature of the coating composition. It should not be confused with the nominal oven temperature. The oven temperature may be much higher than the curing temperature because there may not be enough time during the curing period for the entire oven to equilibrate at the nominal temperature. Optionally, the curing temperature of the coating may be from 50°C to less than 150°C, from 60°C to less than 125°C, or from 70°C to less than 110°C. Preferably, the curing temperature range is from 50°C to less than 110°C. In a preferred embodiment, curing does not involve the application of plasma.

[0202] The curing temperature can be maintained for a sufficient time to achieve the desired degree of curing. Optionally, the curing temperature can be maintained for at least 10 seconds, at least 30 seconds, at least 45 seconds, or at least 60 seconds. In embodiments, the curing temperature is maintained for up to 3000 seconds, up to 300 seconds, or up to 180 seconds.

[0203] The present invention also relates to the use of the coating composition as described above for preparing a coating on the surface of a glass container, wherein the coated glass container is subsequently stored for at least 150 hours in a low temperature range below -60°C, particularly at a low temperature of about -80°C. Optionally, the coated glass container is stored for at least 600 hours or at least 1200 hours. In one embodiment, the glass container is stored for at least 1500 hours or at least 6000 hours. Depending on the required shelf life of the pharmaceutical product, the glass container may be stored for up to 12000 hours, up to 10000 hours, or up to 8000 hours. Preferably, the glass container is the glass container described in this invention.

[0204] The coatings detailed here can be obtained using the methods described above. Specific Implementation

[0205] The following examples are more specific disclosures that are expected to perform particularly well.

[0206] In one specific embodiment, the glass container for a pharmaceutical composition according to the present invention comprises a hollow cylinder having at least one open end, wherein the glass container comprises a coating on at least 90% of the inner surface of the hollow cylinder, the coating having a glass transition temperature below -60°C. The coating has a thickness of at least 450 nm and comprises cross-linked polysiloxane structural units and non-cross-linked polysiloxane structural units. Optionally, the ratio of the total inner diameter variation of the coated portion along the inner surface of the hollow cylinder to the coating thickness is less than 250; and the average linear coefficient of thermal expansion (CTE) of the glass, measured in the range of 20°C to 300°C, is less than 5.2 × 10⁻⁶. -6 / K.

[0207] In one specific embodiment, the glass container for a pharmaceutical composition according to the invention comprises a hollow cylinder having at least one open end, wherein the glass container comprises a coating on at least 90% of the inner surface of the hollow cylinder, the coating having a certain hardness such that the hardness value measured on the coated surface of the glass container according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs from the hardness value measured on its uncoated surface by less than 10%. The coating has a thickness of at least 450 nm and comprises cross-linked polysiloxane structural units and non-cross-linked polysiloxane structural units. Optionally, the ratio of the total inner diameter variation of the coated portion along the inner surface of the hollow cylinder to the coating thickness is less than 250; and the average linear coefficient of thermal expansion (CTE) of the glass, measured in the range of 20°C to 300°C, is less than 5.2 × 10⁻⁶. -6 / K.

[0208] In one specific embodiment, the glass container for a pharmaceutical composition according to the invention comprises a hollow cylinder having at least one open end, wherein the glass container comprises a coating on at least 90% of the inner surface of the hollow cylinder, the container having container seal integrity under a standard ethanol-modified dye invasive test at -80°C for at least 150 hours. The coating has a thickness of at least 450 nm and comprises cross-linked polysiloxane structural units and non-cross-linked polysiloxane structural units. Optionally, the ratio of the total inner diameter variation of the coated portion along the inner surface of the hollow cylinder to the coating thickness is less than 250; and the average linear coefficient of thermal expansion (CTE) of the glass, measured in the range of 20°C to 300°C, is less than 5.2 × 10⁻⁶. -6 / K.

[0209] In one specific embodiment, the glass container for a pharmaceutical composition according to the invention comprises a hollow cylinder having at least one open end, wherein the glass container comprises a coating on at least 90% of the inner surface of the hollow cylinder, the coating being cured at a temperature below 150°C, particularly at a temperature between 50°C and 110°C, wherein the coating thickness is at least 450 nm, and the coating comprises cross-linked polysiloxane structural units and non-cross-linked polysiloxane structural units, wherein, optionally, the ratio of the total inner diameter variation of the coated portion along the inner surface of the hollow cylinder to the coating thickness is less than 250; and wherein, the average linear coefficient of thermal expansion (CTE) of the glass, measured in the range of 20°C to 300°C, is less than 5.2 × 10⁻⁶. -6 / K.

[0210] In one specific embodiment, the glass container for a pharmaceutical composition according to the invention comprises a hollow cylinder having at least one open end, wherein the glass container comprises a coating on at least 90% of the inner surface of the hollow cylinder, the coating having a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature change rate of 10°C / min, wherein the crystallization temperature range and the melting temperature range overlap at temperatures from -75°C to -100°C, particularly at -80°C, wherein the thickness of the coating is at least 450 nm, and the coating comprises crosslinked polysiloxane structural units and non-crosslinked polysiloxane structural units, wherein, optionally, the ratio of the total inner diameter variation of the coated portion along the inner surface of the hollow cylinder to the coating thickness is less than 250; and wherein, the average linear coefficient of thermal expansion (CTE) of the glass, measured in the range of 20°C to 300°C, is less than 5.2 × 10⁻⁶. -6 / K.

[0211] In one specific embodiment, the glass container for a pharmaceutical composition according to the invention comprises a hollow cylinder having at least one open end, wherein at least a portion of the surface of the glass container comprises a coating comprising one or more crosslinked polysiloxane structural units and one or more non-crosslinked polysiloxane structural units. The weight ratio of the crosslinked polysiloxane structural units to the non-crosslinked polysiloxane structural units in the coating is less than 3.00, and optionally at least 0.40. The coating thickness is at least 450 nm, and optionally, the ratio of the total inner diameter variation along the inner surface of the coated portion of the hollow cylinder to the coating thickness is less than 250; and the average linear coefficient of thermal expansion (CTE) of the glass, measured in the range of 20°C to 300°C, is less than 5.2 × 10⁻⁶. -6 / K.

[0212] In one specific embodiment, the glass container for a pharmaceutical composition according to the invention comprises a hollow cylinder having at least one open end, wherein at least a portion of the sealing surface of the glass container comprises a coating having a glass transition temperature below -60°C, wherein the coating has a thickness of at least 450 nm, and the coating comprises cross-linked polysiloxane structural units and non-cross-linked polysiloxane structural units, wherein the weight ratio of the cross-linked polysiloxane structural units to the non-cross-linked polysiloxane structural units in the coating is at least 0.70 and less than 3.00; and the coating comprises high-viscosity non-cross-linked polysiloxane structural units with a viscosity exceeding 10000 cSt, wherein, optionally, the coating is cured at a temperature below 150°C, particularly at a temperature between 50°C and less than 110°C.

[0213] In one specific embodiment, the glass container for a pharmaceutical composition according to the invention comprises a hollow cylinder having at least one open end, wherein at least a portion of the sealing surface of the glass container comprises a coating having a certain hardness such that the hardness value measured on the coated surface of the glass container according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs from the hardness value measured on its uncoated surface by less than 10%. The coating has a thickness of at least 450 nm and comprises cross-linked polysiloxane structural units and non-cross-linked polysiloxane structural units. In this coating, the weight ratio of cross-linked polysiloxane structural units to non-cross-linked polysiloxane structural units is at least 0.70 and less than 3.00; and the coating includes high-viscosity non-cross-linked polysiloxane structural units with a viscosity exceeding 10,000 cSt. Optionally, the coating is cured at a temperature below 150°C, particularly at a temperature between 50°C and less than 110°C.

[0214] In one specific embodiment, the glass container for a pharmaceutical composition according to the invention comprises a hollow cylinder having at least one open end, wherein at least a portion of the sealing surface of the glass container comprises a coating, the container having container seal integrity under a standard ethanol-modified dye invasive test at -80°C for at least 150 hours. The coating has a thickness of at least 450 nm and comprises cross-linked polysiloxane structural units and non-cross-linked polysiloxane structural units. The weight ratio of the cross-linked polysiloxane structural units to the non-cross-linked polysiloxane structural units in the coating is at least 0.70 and less than 3.00; and the coating comprises high-viscosity non-cross-linked polysiloxane structural units with a viscosity exceeding 10000 cSt. Optionally, the coating is cured at temperatures below 150°C, particularly at temperatures between 50°C and less than 110°C.

[0215] In one specific embodiment, the glass container for a pharmaceutical composition according to the invention comprises a hollow cylinder having at least one open end, wherein at least a portion of the sealing surface of the glass container comprises a coating having a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature change rate of 10°C / min, wherein the crystallization temperature range and the melting temperature range overlap at a temperature of -75°C to -100°C, particularly at a temperature of -80°C, wherein the thickness of the coating is at least 450 nm, and the coating comprises crosslinked polysiloxane structural units and non-crosslinked polysiloxane structural units, wherein the weight ratio of the crosslinked polysiloxane structural units to the non-crosslinked polysiloxane structural units in the coating is at least 0.70 and less than 3.00; and the coating comprises high-viscosity non-crosslinked polysiloxane structural units with a viscosity exceeding 10000 cSt, wherein, optionally, the coating is cured at a temperature below 150°C, particularly at a temperature of 50°C to less than 110°C.

[0216] In one specific embodiment, the glass container for a pharmaceutical composition comprises a hollow cylinder having at least one open end, wherein at least a portion of the surface of the glass container comprises a coating having a glass transition temperature below -60°C and a certain hardness, thereby conforming to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 states that the hardness value measured on the coated surface of the glass container differs from the hardness value measured on its uncoated surface by less than 10%; and the container has container seal integrity after a standard ethanol-modified dye intrusion test at -80°C for at least 150 hours, wherein the coating thickness is at least 400 nm, and the coating is cured at a temperature less than 150°C, particularly between 50°C and 110°C, wherein the coating has a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature change rate of 10°C / min, wherein the crystallization temperature range and the melting temperature range overlap at a temperature of -75°C to -100°C, particularly at -80°C, and wherein the coating comprises one or more crosslinked polysiloxane structural units and one or more non-crosslinked polysiloxane structural units. In this coating, the weight ratio of cross-linked polysiloxane structural units to non-cross-linked polysiloxane structural units is less than 3.00, and optionally at least 0.40.

[0217] Alternatively, a coating according to a specific embodiment can be obtained by curing the following coating composition for less than 180 seconds at a curing temperature of less than 150°C, preferably at a curing temperature of 50°C to less than 110°C: One or more non-crosslinkable polysiloxane compounds 2.0% to 25.0% One or more cross-linked polysiloxane compounds 0.10% to 1.50% One or more catalysts 0.03% to 0.50% One or more diluents 55.0% to 92.0%

[0218] Alternatively, a coating according to a specific embodiment can be obtained by curing the following coating composition for less than 180 seconds at a curing temperature of less than 150°C, preferably at a curing temperature of 50°C to less than 110°C:

[0219] In one specific embodiment, the system according to the invention comprises: a glass container, particularly a glass container according to one of the specific embodiments; and a stopper and / or a lid, wherein the system has container seal integrity tested for at least 150 hours at -80°C using a specific ethanol-modified dye intrusion test.

[0220] In one specific embodiment, the system according to the invention comprises: a glass container, particularly a glass container according to one of the specific embodiments; and a stopper, wherein the ratio of the difference (I) between the average linear coefficient of thermal expansion of the material of the stopper and the material of the glass container to the thickness (II) of the coating is less than 0.5 ppm / nm, wherein the system has container seal integrity under a specific ethanol-modified dye intrusion test at -80°C for at least 150 hours. Container seal integrity in ethanol-modified dye invasive test

[0221] Now refer to Figure 2 This paper describes the container seal integrity test for ethanol-modified dye intrusion.

[0222] Figure 2 An apparatus 200 for determining the seal integrity of a container at different stages of ethanol-modified dye intrusion is schematically shown. The apparatus 200 includes an immersion apparatus 270 and a container 201 used in conjunction with the immersion apparatus 270.

[0223] Container 201 is a glass container, such as the glass container according to the invention, comprising a hollow cylinder 210 with two openings, namely, an opening end A 212-1 and an opening end B 212-2 disposed on different sides of the glass container. Each opening 212-1, 212-2 is sealed by a sealing device plug 230-1 or a lid 230-2. The container volume 205 of the glass container 201 is defined by a portion of the inner wall of the container body 210 and the inner surface of each sealing device 230-1, 230-2.

[0224] For standard ethanol-modified dye intrusion container seal integrity tests, the stopper is a Datwyler FM257, and the cap is a West W7025 Luer lock SRC rigid cap (as described in EP3569272A1). For specific ethanol-modified dye intrusion container seal integrity tests, the stopper is the stopper of the system under test, and the cap (if any) is the cap of the system under test.

[0225] In the example shown, glass container 201 is a medical syringe or medicine cartridge. The same test can be performed on other types of glass containers. The proximal open end A 212-1 of the container is sealed by a stopper-like closure device 230-1. The distal open end B 212-2 of the container is located at the top of container 201 and is sealed by a cap-like closure device 230-2.

[0226] To achieve this test objective, container volume 205 is filled with air at a pressure of 1 atm and sealed using a suitable sealing device. Immersion equipment 270 includes immersion device 272. Immersion device 272 is provided with a reservoir containing ambient liquid 274. Immersion device 272 also includes conditioning facilities for adjusting and maintaining the temperature of ambient liquid 274 according to the test protocol.

[0227] At the start of the test, container volume 205 is completely filled with air. Additionally, the temperature of both container 201 and the gas within container volume 205 can be adjusted to 20°C. The ambient liquid 274 is adjusted to -80°C; ambient liquid 274 is ethanol containing a fluorescent dye (fluorescein disodium, 1 g / L).

[0228] like Figure 2 As shown in b), in the next step, container 201 can be completely immersed in ambient liquid 274. When immersed in ambient liquid 274, the temperature of container 201 will gradually approach at least -80°C. The absolute heat capacity of container 201 is very small relative to the absolute heat capacity of ambient liquid 274. Thus, the temperature change of ambient liquid 274 is minimal, given that container 201 is not immersed in it. When the temperature of container 201 decreases due to immersion in ambient liquid 274, the temperature of the gas in container volume 205 will decrease accordingly. Therefore, the gas in container volume 205 will contract, and the gas pressure in container volume 205 will drop below ambient pressure.

[0229] The container 201 is kept in the ambient liquid 274 for at least a predetermined period of time, which begins when the container is fully immersed in the ambient liquid 274 and ends when the container 201 is removed from the ambient liquid 274 and equilibrates with room temperature (preferably 20°C).

[0230] Figure 2c) This schematically illustrates two possible outcomes after removing container 201 from ambient liquid 274. In example i), the amount of ambient liquid L can be detected within container volume 205. Specifically, the amount L of ambient liquid 274 has exceeded the boundary of the tip region in container 201. This indicates that there is a leak in the tip region of container 201 under the conditions of the previous stages a) and b). In example ii), no ambient liquid 274 is detected in container 201. This indicates that container 201 is well-sealed under the conditions of the previous stages a) and b).

[0231] If no ambient liquid is detected inside the container, including between the annular protrusions of the stopper or between the closure and the coated surface, the container is considered to have passed the test. Example Exemplary container

[0232] Now refer to the attached diagram, Figure 1 A glass container 1 according to an exemplary embodiment is shown, which is a syringe 3 for injecting pharmaceuticals or cosmetics. The syringe 3 is made of glass and includes a glass wall 5 surrounding a cavity. The container includes a hollow cylinder 7 and a fitting surface 18 on which an injection needle or cap can be placed, for example. A stopper 12 is inserted into the cylindrical portion and can slide axially by pressure from a push rod 13. The cylindrical portion is provided with an operable flange 15 at the inlet end of the stopper 12, i.e., the open end A.

[0233] The inner surface of the glass container 1 is provided with a coating 10, specifically referring to the inner surface of the hollow cylinder 7. In this example, the coating 10 covers an area of ​​the inner surface of the hollow cylinder 7, on which the stopper 12 can slide when the syringe is emptied or used for removal. Coating composition

[0234] Multiple sets of glass syringes (Schott SyriQ 1.0ml long, Fiolux Clear) were coated with a coating composition. The coating composition used is as follows.

[0235] The glass syringe is coated using a spray method. The coating is then cured at high temperature in an oven. During the curing process, the diluent evaporates, and the crosslinkable polysiloxane forms a network during the hydrosilylation reaction. Coating thickness

[0236] Coatings of varying thicknesses were applied to glass syringes and cured at 70°C for 60 seconds. The coatings were applied to the inner surface of the syringe barrel and the mating surface of the syringe tip. Then, both open ends were sealed. Open end A was sealed using a Datwyler FM257 stopper, and open end B was sealed using a West W7025 tip cap. As described above, the samples were tested in a container seal integrity test for ethanol-modified dye intrusion. Samples F and G used the latest silicone oil (DuPont). D360), with viscosities of 1000 cSt and 12500 cSt respectively. Coating thickness 1000nm 800nm 500nm 400nm 200nm 800nm 800nm CCI Test pass pass pass Not passed Not passed Not passed Not passed Curing temperature

[0237] The coatings of compositions A (samples H and I) and B (samples J and K) were cured at different curing temperatures for 60 seconds, and the standardized release force and sliding force were tested. The coating thickness was 80 nm. Curing temperature 40℃ 70℃ 40℃ 70℃ BLF 7.4±0.29N 7.6±0.21N 7.4±0.32N 4.9±0.41N GF 1.0±0.08N 1.0±0.03N 3.5±0.79N 2.8±0.33N DSC measurement

[0238] Differential scanning calorimetry (DSC) was performed on the cured coating sample, and the cured coating was scraped off the glass (according to DIN 51007:2019). The experiment was conducted on a DSC Q2000 (TA instrument) with a temperature change rate of 10 °C / min and a range of -120 °C to -60 °C. The experiment could be repeated twice to confirm the measurement results.

[0239] The results of composition A are as follows Figure 3 As shown, the exothermic crystallization peak is at -72.52℃, extending from -90℃ to -60℃. The endothermic melting peak is at -42.11℃, extending from -90℃ to -30℃. These two peaks overlap within a temperature range including -80℃.

[0240] The results of composition B are as follows Figure 4 As shown, the exothermic crystallization peak is at -73.48℃, extending from -93℃ to -65℃. The endothermic melting peak extends from -90℃ to -50℃ and above. These two peaks overlap within a temperature range including -80℃.

[0241] Figure 5 Results for a new silicone oil with a viscosity of 1000 cSt are shown. The exothermic crystallization peak is at -84.06 °C, extending from -100 °C to -70 °C. The endothermic melting peak extends from -70 °C to -50 °C and above. There is no overlap between these two peaks in the temperature range including -80 °C.

[0242] Figure 6Results for a new silicone oil with a viscosity of 12500 cSt are shown. The exothermic crystallization peak is at -80.25 °C, extending from -88 °C to -73 °C. The endothermic melting peak extends from -60 °C to -40 °C and above. There is no overlap between these two peaks in the temperature range including -80 °C. Glass transition temperature

[0243] To determine the glass transition temperature, thermodynamic analysis was performed using a Q400 thermodynamic analyzer on a TA instrument in expansion mode. Sample preparation was performed using the same method as for DSC testing. The glass transition temperature of composition A was -81.50℃, and that of composition B was -94.96℃. The results are as follows: Figure 7 and Figure 8 As shown. project

[0244] The following items relate to useful embodiments of the invention. These items and features can be combined with all other features and embodiments of the invention.

[0245] Item 1: The present invention relates to a glass container for a pharmaceutical composition, comprising a hollow cylinder having at least one open end, wherein at least a portion of the surface of the glass container comprises a coating having a crystallization temperature range and a melting temperature range determined by differential scanning calorimetry at a temperature change rate of 10°C / min, wherein the crystallization temperature range and the melting temperature range overlap at a temperature of -75°C to -100°C, particularly at a temperature of -80°C.

[0246] Item 2: The glass container according to Item 1, wherein the coating thickness is 250 nm or more, 300 nm or more, 400 nm or more, 450 nm or more, or 500 nm or more.

[0247] Item 3: The glass container according to Item 1 or Item 2, wherein the glass transition temperature of the coating is below -60°C, preferably below -70°C, for example below -75°C, or below -80°C.

[0248] Item 4: A glass container according to any one or more of the preceding items, wherein the hardness of the coating is such that the hardness value measured on the coated surface of the glass container according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs from the hardness value measured on its uncoated surface by less than 10%, less than 7.0%, less than 5.0%, or less than 3.0%, and / or at least 0.1%, at least 0.5%, at least 1.0%, or at least 2.0%.

[0249] Item 5: A glass container according to any one or more of the preceding items, wherein the container has container seal integrity tested for at least 150 hours or at least 600 hours at -80°C using a standard ethanol-modified dye invasive test.

[0250] Item 6: A glass container according to any one or more of the preceding items, wherein the coating is cured at a temperature below 150°C or below 110°C, and / or at a temperature above 50°C or above 60°C.

[0251] Item 7: A glass container according to any one or more of the preceding items, wherein the hollow cylinder has an open end A configured to receive a plug that can slide relative to the hollow cylinder from the open end A; wherein at least a portion of the inner surface of the hollow cylinder has a coating.

[0252] Item 8: A glass container according to any one or more of the preceding items, wherein the container has an open end B configured to be closed by a lid, the open end B having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface includes a coating.

[0253] Item 9: A glass container according to any one or more of the preceding items, wherein the coating comprises one or more cross-linked polysiloxane structural units and one or more non-cross-linked polysiloxane structural units, wherein the weight ratio of the cross-linked polysiloxane structural units to the non-cross-linked polysiloxane structural units in the coating is less than 3.00, and optionally at least 0.40.

[0254] Item 10: A glass container according to any one or more of the preceding items, wherein the coating comprises at least two non-crosslinked polysiloxane structural units with different viscosities.

[0255] Item 11: A glass container according to any one or more of the preceding items, wherein at least a portion of the inner surface of the hollow cylinder has a coating, wherein the ratio of the total inner diameter variation along the portion of the inner surface with the coating to the thickness of the coating is less than 500.

[0256] Item 12: A glass container according to any one or more of the preceding items, wherein the container is a syringe or cartridge, for example, a pre-filled syringe or cartridge.

[0257] Item 13: A glass container according to any one or more of the preceding items, wherein the coating thickness is up to 1500 nm, up to 1250 nm or up to 1000 nm.

[0258] Item 14: A glass container according to any one or more of the preceding items, wherein the thickness of the coating is greater than 400 nm to 1500 nm, 450 nm to 1250 nm, or 500 nm to 1000 nm.

[0259] Item 15: A glass container according to any one or more of the preceding items, wherein the coating comprises a polyalkylsiloxane structural unit such as a polydialkylsiloxane structural unit.

[0260] Item 16: The glass container according to Item 15, wherein one or more alkyl groups in the polyalkylsiloxane or polydialkylsiloxane are independently selected from branched or unbranched C1 to C8 alkyl groups.

[0261] Item 17: A glass container according to any one or more of the preceding items, wherein the weight ratio of the cross-linked polysiloxane structural units to the non-cross-linked polysiloxane structural units in the coating is less than 3.00, less than 2.50, less than 1.80, or less than 1.20.

[0262] Item 18: A glass container according to any one or more of the preceding items, wherein the weight ratio of the cross-linked polysiloxane structural units to the non-cross-linked polysiloxane structural units in the coating is at least 0.40, at least 0.60, or at least 0.70.

[0263] Item 19: A glass container according to any one or more of the preceding items, wherein the weight ratio of the cross-linked polysiloxane structural units to the non-cross-linked polysiloxane structural units in the coating is 0.40 to 3.00, 0.60 to 2.50, or 0.70 to 1.80.

[0264] Item 20: A glass container according to any one or more of the preceding items, wherein the coating comprises:

[0265] - High-viscosity, non-crosslinked polysiloxane structural units with a viscosity exceeding 10,000 cSt, and / or

[0266] - Low-viscosity, non-crosslinked polysiloxane structural units with a viscosity below 10,000 cSt.

[0267] Item 21: The glass container according to Item 20, wherein,

[0268] - The viscosity of the high-viscosity non-crosslinked polysiloxane structural unit is at least 15000 cSt, and / or

[0269] - The viscosity of low-viscosity, non-crosslinked polysiloxane structural units is below 5000 cSt.

[0270] Item 22: A glass container according to Item 20 or Item 21, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 The value is at least 0.10, at least 0.50, at least 1.00, at least 1.50, or at least 2.00.

[0271] Item 23: A glass container according to Items 20, 21, or 22, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 Up to 5.00, up to 4.00 or up to 3.00.

[0272] Item 24: A glass container according to any one or more of items 20 to 23, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 The values ​​range from 0.10 to 5.00, 0.50 to 4.00, or 1.00 to 3.00.

[0273] Item 25: A glass container according to any one or more of items 20 to 24, wherein, - Crosslinked polysiloxane structural units, -Low viscosity non-crosslinked polysiloxane structural units, and / or - High-viscosity non-crosslinked polysiloxane structural units -Including dialkylsiloxane monomer units, particularly dimethylsiloxane monomer units.

[0274] Item 26: A glass container according to any one or more of items 9 to 25, wherein the crosslinked polysiloxane structural units are crosslinked via one or more polymeric end groups.

[0275] Item 27: A glass container according to any one or more of items 9 to 26, wherein the polymeric end group is selected from vinyl, propylene, methacryl, styrene, and combinations thereof.

[0276] Item 28: A glass container according to any one or more of the foregoing items, wherein the coating can be obtained by or through the following means:

[0277] Applying the coating composition to at least a portion of the surface of the container, and

[0278] The coating composition is cured on the surface.

[0279] The curing temperature of the coating composition is below 150°C or below 125°C, and optionally, the curing temperature is maintained for at least 10 seconds and at most 3000 seconds.

[0280] Item 29: The glass container according to Item 28, wherein the curing temperature is maintained for at least 45 seconds and at most 180 seconds.

[0281] Item 30: A glass container according to Item 28 or 29, wherein the coating composition has the following components by weight percentage: One or more non-crosslinkable polysiloxane compounds 2.0% to 25.0% One or more cross-linked polysiloxane compounds 0.10% to 1.50% One or more catalysts 0.03% to 0.50% One or more diluents 55.0% to 92.0%

[0282] Item 31: A glass container according to Item 28 or 29, wherein the coating composition has the following components by weight percentage:

[0283] Item 32: A glass container according to Item 28 or 29, wherein the coating composition has the following components by weight percentage:

[0284] Item 33: A glass container according to any one or more of the preceding items, wherein the glass of the glass container comprises 50 wt% to 90 wt% SiO2 and 3 wt% to 25 wt% B2O3.

[0285] Item 34: A glass container according to any one or more of the preceding items, wherein the glass of the glass container comprises 55 wt% to 75 wt% SiO2 and 11.0 wt% to 25.0 wt% Al2O3.

[0286] Item 35: The glass container according to Item 33, wherein the glass of the glass container comprises 70 wt% to 81 wt% SiO2, 1 wt% to 10 wt% Al2O3, 6 wt% to 14 wt% B2O3, 3 wt% to 10 wt% Na2O, 0 wt% to 3 wt% K2O, 0 wt% to 1 wt% Li2O, 0 wt% to 3 wt% MgO, 0 wt% to 3 wt% CaO and 0 wt% to 5 wt% BaO.

[0287] Item 36: The glass container according to Item 33, wherein the glass of the glass container comprises 72 wt% to 82 wt% SiO2, 5 wt% to 8 wt% Al2O3, 3 wt% to 6 wt% B2O3, 2 wt% to 6 wt% Na2O, 3 wt% to 9 wt% K2O, 0 wt% to 1 wt% Li2O, 0 wt% to 1 wt% MgO and 0 wt% to 1 wt% CaO.

[0288] Item 37: The glass container according to Item 33, wherein the glass of the glass container comprises 60 wt% to 78 wt% SiO2, 7 wt% to 15 wt% B2O3, 0 wt% to 4 wt% Na2O, 3 wt% to 12 wt% K2O, 0 wt% to 2 wt% Li2O, 0 wt% to 2 wt% MgO, 0 wt% to 2 wt% CaO, 0 wt% to 3 wt% BaO, and 4 wt% to 9 wt% ZrO2.

[0289] Item 38: A glass container according to any one of items 1 to 32, wherein the glass of the glass container comprises 50 wt% to 70 wt% SiO2, 10 wt% to 26 wt% Al2O3, 1 wt% to 14 wt% B2O3, 0 wt% to 15 wt% MgO, 2 wt% to 12 wt% CaO, 0 wt% to 10 wt% BaO, 0 wt% to 2 wt% SrO, 0 wt% to 8 wt% ZnO, and 0 wt% to 2 wt% ZrO2.

[0290] Item 39: The glass container according to Item 34, wherein the glass of the glass container comprises 55 wt% to 70 wt% SiO2, 11 wt% to 25 wt% Al2O3, 0 wt% to 10 wt% MgO, 1 wt% to 20 wt% CaO, 0 wt% to 10 wt% BaO, 0 wt% to 8.5 wt% SrO, 0 wt% to 5 wt% ZnO, 0 wt% to 5 wt% ZrO2 and 0 wt% to 5 wt% TiO2.

[0291] Item 40: The glass container according to Item 34, wherein the glass of the glass container comprises 65 wt% to 72 wt% SiO2, 11 wt% to 17 wt% Al2O3, 0.1 wt% to 8 wt% Na2O, 0 wt% to 8 wt% K2O, 3 wt% to 8 wt% MgO, 4 wt% to 12 wt% CaO and 0 wt% to 10 wt% ZnO.

[0292] Item 41: A glass container according to any one or more of items 1 to 32, wherein the glass of the glass container comprises 64 wt% to 78 wt% SiO2, 4 wt% to 14 wt% Al2O3, 0 wt% to 4 wt% B2O3, 6 wt% to 14 wt% Na2O, 0 wt% to 3 wt% K2O, 0 wt% to 10 wt% MgO, 0 wt% to 15 wt% CaO, 0 wt% to 2 wt% ZrO2 and 0 wt% to 2 wt% TiO2.

[0293] Item 42: A glass container according to at least one of the preceding items, wherein at least 25% or at least 50% of the inner surface of the hollow cylinder is provided with a coating.

[0294] Item 43: A glass container according to at least one of the preceding items, wherein at least 65% or at least 85% of the inner surface of the hollow cylinder is provided with a coating.

[0295] Item 44: A glass container according to at least one of the preceding items, wherein a coating is provided on all the inner surfaces of the substantially hollow cylinder.

[0296] Item 45: A glass container according to any one or more of items 8 to 44, wherein at least 25% or at least 50% of the mating surfaces are coated.

[0297] Item 46: A glass container according to any one or more of items 8 to 45, wherein at least 65% or at least 85% of the mating surfaces are coated.

[0298] Item 47: A glass container according to any one or more of items 8 to 46, wherein substantially all mating surfaces are coated.

[0299] Item 48: A glass container according to any one or more of items 8 to 47, wherein the mating surface has a conical shape.

[0300] Item 49: A glass container according to at least one of the preceding items, wherein the volume enclosed by the hollow cylinder is from 0.1 ml to 1000 ml.

[0301] Item 50: A glass container according to at least one of the preceding items, wherein the volume enclosed by the hollow cylinder is less than 10.0 ml.

[0302] Item 51: A glass container according to at least one of the preceding items.

[0303] The hollow cylinder has an inner cavity surrounded by a glass wall, the thickness of which is between 0.50 mm and 10.0 mm.

[0304] Item 52: A glass container according to at least one of the preceding items.

[0305] The hollow cylinder has an inner cavity surrounded by a glass wall, the thickness of which is between 1.00 mm and 4.00 mm.

[0306] Item 53: A glass container according to at least one of the preceding items, wherein the ratio of the total inner diameter variation along the portion having a coating on the inner surface to the thickness of the coating is less than 250 or less than 150.

[0307] Item 54: A glass container according to at least one of the preceding items, wherein the total inner diameter variation of the hollow cylinder is less than 200 μm, less than 100 μm, or less than 50 μm.

[0308] Item 55: A glass container according to at least one of the preceding items, wherein the crystallinity of the coating at 20°C is less than 20%.

[0309] Item 57: A glass container according to at least one of the preceding items, having a standardized sliding force (GF) of less than 7.5 N, less than 6.5 N, less than 5.5 N, less than 4.5 N, less than 3.5 N, or less than 2.5 N.

[0310] Item 58: A glass container according to at least one of the preceding items has a normalized sliding force (GF) of at least 0.5 N.

[0311] Item 59: A glass container according to at least one of the preceding items, wherein the ratio of its normalized loose force (BLF) to its normalized force (GF) is greater than 1.30, greater than 1.40, greater than 1.50, or greater than 1.60.

[0312] Item 60: A glass container according to at least one of the preceding items, wherein the ratio of normalized loose force (BLF) to normalized GF, BLF / GF, is less than 3.0.

[0313] Item 61: A glass container according to at least one of the preceding items, wherein the standardized loosening force exceeds the standardized sliding force of the container by at least 30%, at least 60%, at least 100%, or at least 200%.

[0314] Item 62: A glass container according to at least one of the preceding items, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units with a weight-average molecular weight of 1200 g / mol to 30000 g / mol, 5000 g / mol to 25000 g / mol, or 10000 g / mol to 20000 g / mol.

[0315] Item 63: A glass container according to at least one of the preceding items, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units having a weight-average molecular weight of at least 1200 g / mol, at least 5000 g / mol, or at least 10000 g / mol.

[0316] Item 64: A glass container according to at least one of the preceding items, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units with a weight-average molecular weight of up to 30,000 g / mol, up to 25,000 g / mol, or up to 20,000 g / mol.

[0317] Item 65: A glass container according to at least one of the preceding items, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units with a weight-average molecular weight of 15,000 g / mol to 300,000 g / mol, 32,000 g / mol to 210,000 g / mol, or 100,000 g / mol to 150,000 g / mol.

[0318] Item 66: A glass container according to at least one of the preceding items, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units having a weight-average molecular weight of at least 15,000 g / mol, at least 32,000 g / mol, or at least 100,000 g / mol.

[0319] Item 67: A glass container according to at least one of the preceding items, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units with a weight-average molecular weight of up to 300,000 g / mol, up to 210,000 g / mol, or up to 150,000 g / mol.

[0320] Item 68: The present invention relates to a glass container for a pharmaceutical composition, comprising a hollow cylinder having at least one open end; wherein at least a portion of the surface of the glass container comprises a coating, the hardness of which is such that the hardness value measured on the coated surface of the glass container according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs from the hardness value measured on its uncoated surface by less than 10%.

[0321] Item 69: A glass container according to Item 68, wherein the hardness of the coating is such that the hardness value measured on the coated surface of the glass container according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs from the hardness value measured on its uncoated surface by less than 7.0%, less than 5.0%, or less than 3.0%, and / or at least 0.1%, at least 0.5%, at least 1.0%, or at least 2.0%.

[0322] Item 70: A glass container according to Item 68 or 69, wherein the coating thickness is 250 nm or more, 300 nm or more, 400 nm or more, 450 nm or more, or 500 nm or more.

[0323] Item 71: A glass container according to any one or more of items 68 to 70, wherein the glass transition temperature of the coating is below -60°C, preferably below -70°C, for example below -75°C, or below -80°C.

[0324] Item 72: A glass container according to any one or more of items 68 to 71, wherein the container has container seal integrity tested for at least 150 hours or at least 600 hours at -80°C using a standard ethanol-modified dye invasive test.

[0325] Item 73: A glass container according to any one or more of items 68 to 72, wherein the coating is cured at a temperature below 150°C or below 110°C, and / or at a temperature above 50°C or above 60°C.

[0326] Item 74: A glass container according to any one or more of items 68 to 73, wherein the hollow cylinder has an open end A configured to receive a plug that can slide relative to the hollow cylinder from the open end A; wherein at least a portion of the inner surface of the hollow cylinder has a coating.

[0327] Item 75: A glass container according to any one or more of items 68 to 74, wherein the container has an open end B configured to be closed by a lid, the open end B having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface includes a coating.

[0328] Item 76: A glass container according to any one or more of items 68 to 75, wherein the coating comprises one or more crosslinked polysiloxane structural units and one or more non-crosslinked polysiloxane structural units, wherein the weight ratio of the crosslinked polysiloxane structural units to the non-crosslinked polysiloxane structural units in the coating is less than 3.00, and optionally at least 0.40.

[0329] Item 77: A glass container according to any one or more of items 68 to 76, wherein the coating comprises at least two non-crosslinked polysiloxane structural units with different viscosities.

[0330] Item 78: A glass container according to any one or more of items 68 to 77, wherein at least a portion of the inner surface of the hollow cylinder has a coating, wherein the ratio of the total inner diameter variation along the coated portion of the inner surface to the thickness of the coating is less than 500.

[0331] Item 79: A glass container according to any one or more of items 68 to 78, wherein the container is a syringe or cartridge, for example, a pre-filled syringe or cartridge.

[0332] Item 80: A glass container according to any one or more of items 68 to 79, wherein the coating thickness is up to 1500 nm, up to 1250 nm or up to 1000 nm.

[0333] Item 81: A glass container according to any one or more of items 68 to 80, wherein the coating thickness is greater than 400 nm to 1500 nm, 450 nm to 1250 nm, or 500 nm to 1000 nm.

[0334] Item 82: A glass container according to any one or more of items 68 to 81, wherein the coating comprises polyalkylsiloxane structural units such as polydialkylsiloxane structural units.

[0335] Item 83: The glass container according to Item 82, wherein one or more alkyl groups in the polyalkylsiloxane or polydialkylsiloxane are independently selected from C1 to C8 alkyl groups, whether branched or unbranched.

[0336] Item 84: A glass container according to any one or more of items 68 to 83, wherein the weight ratio of the cross-linked polysiloxane structural units to the non-cross-linked polysiloxane structural units in the coating is less than 3.00, less than 2.50, less than 1.80, or less than 1.20.

[0337] Item 85: A glass container according to any one or more of items 68 to 84, wherein the weight ratio of cross-linked polysiloxane structural units to non-cross-linked polysiloxane structural units in the coating is at least 0.40, at least 0.60, or at least 0.70.

[0338] Item 86: A glass container according to any one or more of items 68 to 85, wherein the weight ratio of cross-linked polysiloxane structural units to non-cross-linked polysiloxane structural units in the coating is 0.40 to 3.00, 0.60 to 2.50, or 0.70 to 1.80.

[0339] Item 87: A glass container according to any one or more of items 68 to 86, wherein the coating comprises: - High-viscosity non-crosslinked polysiloxane structural units with a viscosity exceeding 10,000 cSt, and / or - low-viscosity non-crosslinked polysiloxane structural units with a viscosity below 10,000 cSt.

[0340] Item 88: The glass container according to Item 87, wherein, - The viscosity of the high-viscosity non-crosslinked polysiloxane structural unit is at least 15,000 cSt, and / or - the viscosity of the low-viscosity non-crosslinked polysiloxane structural unit is below 5,000 cSt.

[0341] Item 89: A glass container according to Item 87 or Item 88, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 The value is at least 0.10, at least 0.50, at least 1.00, at least 1.50, or at least 2.00.

[0342] Item 90: A glass container according to Items 87, 88, or 89, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 Up to 5.00, up to 4.00 or up to 3.00.

[0343] Item 91: A glass container according to any one or more of items 87 to 90, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 The values ​​are 0.10 to 5.00, 0.50 to 4.00, or 1.00 to 3.00.

[0344] Item 92: A glass container according to any one or more of items 87 to 91, wherein - cross-linked polysiloxane structural units, -Low viscosity non-crosslinked polysiloxane structural units, and / or - High-viscosity non-crosslinked polysiloxane structural units This includes dialkylsiloxane monomer units, particularly dimethylsiloxane monomer units.

[0345] Item 93: A glass container according to any one or more of items 76 to 92, wherein the crosslinked polysiloxane structural units are crosslinked via one or more polymeric end groups.

[0346] Item 94: A glass container according to any one or more of items 76 to 93, wherein the polymeric end group is selected from vinyl, acrylonitrile, methacrylonitrile, styrene and combinations thereof.

[0347] Item 95: A glass container according to any one or more of items 68 to 94, wherein the coating can be obtained by or through the following means:

[0348] Applying the coating composition to at least a portion of the surface of the container, and

[0349] The coating composition is cured on the surface.

[0350] The curing temperature of the coating composition is below 150°C or below 125°C, and optionally, the curing temperature is maintained for at least 10 seconds and at most 3000 seconds.

[0351] Item 96: The glass container according to Item 95, wherein the curing temperature is maintained for at least 45 seconds and at most 180 seconds.

[0352] Item 97: A glass container according to Item 95 or 96, wherein the coating composition has the following components by weight percentage: One or more non-crosslinkable polysiloxane compounds 2.0% to 25.0% One or more cross-linked polysiloxane compounds 0.10% to 1.50% One or more catalysts 0.03% to 0.50% One or more diluents 55.0% to 92.0%

[0353] Item 98: A glass container according to Item 95 or 96, wherein the coating composition has the following components by weight percentage: One or more non-crosslinkable polysiloxane compounds 8.0% to 15.0% One or more cross-linked polysiloxane compounds 0.10% to 1.00% One or more catalysts 0.03% to 0.50% One or more diluents 55.0% to 82.0%

[0354] Item 99: A glass container according to Item 95 or 96, wherein the coating composition has the following components by weight percentage:

[0355] Item 100: A glass container according to any one or more of items 68 to 99, wherein the glass of the glass container comprises 50 wt% to 90 wt% SiO2 and 3 wt% to 25 wt% B2O3.

[0356] Item 101: A glass container according to any one or more of items 68 to 100, wherein the glass of the glass container comprises 55 wt% to 75 wt% SiO2 and 11.0 wt% to 25.0 wt% Al2O3.

[0357] Item 102: A glass container according to Item 100, wherein the glass of the glass container comprises 70 wt% to 81 wt% SiO2, 1 wt% to 10 wt% Al2O3, 6 wt% to 14 wt% B2O3, 3 wt% to 10 wt% Na2O, 0 wt% to 3 wt% K2O, 0 wt% to 1 wt% Li2O, 0 wt% to 3 wt% MgO, 0 wt% to 3 wt% CaO, and 0 wt% to 5 wt% BaO.

[0358] Item 103: A glass container according to Item 100, wherein the glass of the glass container comprises 72 wt% to 82 wt% SiO2, 5 wt% to 8 wt% Al2O3, 3 wt% to 6 wt% B2O3, 2 wt% to 6 wt% Na2O, 3 wt% to 9 wt% K2O, 0 wt% to 1 wt% Li2O, 0 wt% to 1 wt% MgO and 0 wt% to 1 wt% CaO.

[0359] Item 104: A glass container according to Item 100, wherein the glass of the glass container comprises 60 wt% to 78 wt% SiO2, 7 wt% to 15 wt% B2O3, 0 wt% to 4 wt% Na2O, 3 wt% to 12 wt% K2O, 0 wt% to 2 wt% Li2O, 0 wt% to 2 wt% MgO, 0 wt% to 2 wt% CaO, 0 wt% to 3 wt% BaO, and 4 wt% to 9 wt% ZrO2.

[0360] Item 105: A glass container according to any one of items 68 to 99, wherein the glass of the glass container comprises 50 wt% to 70 wt% SiO2, 10 wt% to 26 wt% Al2O3, 1 wt% to 14 wt% B2O3, 0 wt% to 15 wt% MgO, 2 wt% to 12 wt% CaO, 0 wt% to 10 wt% BaO, 0 wt% to 2 wt% SrO, 0 wt% to 8 wt% ZnO, and 0 wt% to 2 wt% ZrO2.

[0361] Item 106: The glass container according to Item 101, wherein the glass of the glass container comprises 55 wt% to 70 wt% SiO2, 11 wt% to 25 wt% Al2O3, 0 wt% to 10 wt% MgO, 1 wt% to 20 wt% CaO, 0 wt% to 10 wt% BaO, 0 wt% to 8.5 wt% SrO, 0 wt% to 5 wt% ZnO, 0 wt% to 5 wt% ZrO2 and 0 wt% to 5 wt% TiO2.

[0362] Item 107: The glass container according to Item 101, wherein the glass of the glass container comprises 65 wt% to 72 wt% SiO2, 11 wt% to 17 wt% Al2O3, 0.1 wt% to 8 wt% Na2O, 0 wt% to 8 wt% K2O, 3 wt% to 8 wt% MgO, 4 wt% to 12 wt% CaO and 0 wt% to 10 wt% ZnO.

[0363] Item 108: A glass container according to any one or more of items 68 to 99, wherein the glass of the glass container comprises 64 wt% to 78 wt% SiO2, 4 wt% to 14 wt% Al2O3, 0 wt% to 4 wt% B2O3, 6 wt% to 14 wt% Na2O, 0 wt% to 3 wt% K2O, 0 wt% to 10 wt% MgO, 0 wt% to 15 wt% CaO, 0 wt% to 2 wt% ZrO2 and 0 wt% to 2 wt% TiO2.

[0364] Item 109: A glass container according to at least one of items 68 to 108, wherein at least 25% or at least 50% of the inner surface of the hollow cylinder is provided with a coating.

[0365] Item 110: A glass container according to at least one of items 68 to 109, wherein at least 65% or at least 85% of the inner surface of the hollow cylinder is provided with a coating.

[0366] Item 111: A glass container according to at least one of items 68 to 110, wherein a coating is provided on all the inner surfaces of the substantially hollow cylinder.

[0367] Item 112: A glass container according to any one or more of items 75 to 111, wherein at least 25% or at least 50% of the mating surfaces are coated.

[0368] Item 113: A glass container according to any one or more of items 75 to 112, wherein at least 65% or at least 85% of the mating surfaces are coated.

[0369] Item 114: A glass container according to any one or more of items 75 to 113, wherein substantially all mating surfaces are coated.

[0370] Item 115: A glass container according to any one or more of items 75 to 114, wherein the mating surface has a conical shape.

[0371] Item 116: A glass container according to at least one of items 68 to 115, wherein the volume enclosed by the hollow cylinder is from 0.1 ml to 1000 ml.

[0372] Item 117: A glass container according to at least one of items 68 to 116, wherein the volume enclosed by the hollow cylinder is less than 10.0 ml.

[0373] Item 118: A glass container according to at least one of items 68 to 117,

[0374] The hollow cylinder has an inner cavity surrounded by a glass wall, the thickness of which is between 0.50 mm and 10.0 mm.

[0375] Item 119: A glass container according to at least one of items 68 to 118,

[0376] The hollow cylinder has an inner cavity surrounded by a glass wall, the thickness of which is between 1.00 mm and 4.00 mm.

[0377] Item 120: A glass container according to at least one of items 68 to 119, wherein the ratio of the total inner diameter variation along the portion having a coating on the inner surface to the thickness of the coating is less than 250 or less than 150.

[0378] Item 121: A glass container according to at least one of items 68 to 120, wherein the total inner diameter variation of the hollow cylinder is less than 200 μm, less than 100 μm, or less than 50 μm.

[0379] Item 122: A glass container according to at least one of items 68 to 121, wherein the crystallinity of the coating at 20°C is less than 20%.

[0380] Item 123: A glass container according to at least one of items 68 to 122, wherein the normalized sliding force (GF) is less than 7.5 N, less than 6.5 N, less than 5.5 N, less than 4.5 N, less than 3.5 N, or less than 2.5 N.

[0381] Item 124: A glass container according to at least one of items 68 to 123, wherein the normalized sliding force (GF) is at least 0.5 N.

[0382] Item 125: A glass container according to at least one of items 68 to 124, wherein the ratio of normalized loose force (BLF) to normalized force (GF) is greater than 1.30, greater than 1.40, greater than 1.50, or greater than 1.60.

[0383] Item 126: A glass container according to at least one of items 68 to 125, wherein the ratio of normalized loose force (BLF) to normalized GF, BLF / GF, is less than 3.0.

[0384] Item 127: A glass container according to at least one of items 68 to 126, wherein the standardized loosening force exceeds the standardized sliding force of the container by at least 30%, at least 60%, at least 100%, or at least 200%.

[0385] Item 128: A glass container according to at least one of items 68 to 127, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units with a weight-average molecular weight of 1200 g / mol to 30000 g / mol, 5000 g / mol to 25000 g / mol, or 10000 g / mol to 20000 g / mol.

[0386] Item 129: A glass container according to at least one of items 68 to 128, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units having a weight-average molecular weight of at least 1200 g / mol, at least 5000 g / mol, or at least 10000 g / mol.

[0387] Item 130: A glass container according to at least one of items 68 to 129, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units with a weight-average molecular weight of up to 30,000 g / mol, up to 25,000 g / mol, or up to 20,000 g / mol.

[0388] Item 131: A glass container according to at least one of items 68 to 130, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units with a weight-average molecular weight of 15,000 g / mol to 300,000 g / mol, 32,000 g / mol to 210,000 g / mol, or 100,000 g / mol to 150,000 g / mol.

[0389] Item 132: A glass container according to at least one of items 68 to 131, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units having a weight-average molecular weight of at least 15,000 g / mol, at least 32,000 g / mol, or at least 100,000 g / mol.

[0390] Item 133: A glass container according to at least one of items 68 to 132, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units with a weight-average molecular weight of up to 300,000 g / mol, up to 210,000 g / mol, or up to 150,000 g / mol.

[0391] Item 134: A glass container according to at least one of items 68 to 133, wherein the coating has a crystallization temperature range and a melting temperature range determined by differential scanning calorimetry at a temperature change rate of 10°C / min, wherein the crystallization temperature range and the melting temperature range overlap at a temperature of -75°C to -100°C, particularly at a temperature of -80°C.

[0392] Item 135, the present invention relates to a glass container for a pharmaceutical composition, comprising: a hollow cylinder having at least one open end; wherein at least a portion of the surface of the glass container is coated, and the container has container seal integrity under a standard ethanol-modified dye invasive test at -80°C for at least 150 hours.

[0393] Item 136: A glass container according to Item 135, wherein the hardness of the coating is such that the hardness value measured on the coated surface of the glass container according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs from the hardness value measured on its uncoated surface by less than 10%, less than 7.0%, less than 5.0%, or less than 3.0%, and / or at least 0.1%, at least 0.5%, at least 1.0%, or at least 2.0%.

[0394] Item 137: A glass container according to Item 135 or Item 136, wherein the coating thickness is 250 nm or more, 300 nm or more, 400 nm or more, 450 nm or more, or 500 nm or more.

[0395] Item 138: A glass container according to any one or more of items 135 to 137, wherein the glass transition temperature of the coating is below -60°C, preferably below -70°C, for example below -75°C, or below -80°C.

[0396] Item 139: A glass container according to any one or more of items 135 to 138, wherein the container has container seal integrity after a standard ethanol-modified dye invasive test at -80°C for at least 600 hours.

[0397] Item 140: A glass container according to any one or more of items 135 to 139, wherein the coating is cured at a temperature below 150°C or below 110°C, and / or at a temperature above 50°C or above 60°C.

[0398] Item 141: A glass container according to any one or more of items 135 to 140, wherein the hollow cylinder has an open end A configured to receive a plug slidable relative to the hollow cylinder from the open end A; wherein at least a portion of the inner surface of the hollow cylinder has a coating.

[0399] Item 142: A glass container according to any one or more of items 135 to 141, wherein the container has an open end B configured to be closed by a lid, the open end B having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface includes a coating.

[0400] Item 143: A glass container according to any one or more of items 135 to 142, wherein the coating comprises one or more crosslinked polysiloxane structural units and one or more non-crosslinked polysiloxane structural units, wherein the weight ratio of the crosslinked polysiloxane structural units to the non-crosslinked polysiloxane structural units in the coating is less than 3.00, and optionally at least 0.40.

[0401] Item 144: A glass container according to any one or more of items 135 to 143, wherein the coating comprises at least two non-crosslinked polysiloxane structural units with different viscosities.

[0402] Item 145: A glass container according to any one or more of items 135 to 144, wherein at least a portion of the inner surface of the hollow cylinder has a coating, wherein the ratio of the total inner diameter variation along the coated portion of the inner surface to the thickness of the coating is less than 500.

[0403] Item 146: A glass container according to any one or more of items 135 to 145, wherein the container is a syringe or cartridge, for example, a pre-filled syringe or cartridge.

[0404] Item 147: A glass container according to any one or more of items 135 to 146, wherein the coating thickness is up to 1500 nm, up to 1250 nm or up to 1000 nm.

[0405] Item 148: A glass container according to any one or more of items 135 to 147, wherein the coating thickness is greater than 400 nm to 1500 nm, 450 nm to 1250 nm, or 500 nm to 1000 nm.

[0406] Item 149: A glass container according to any one or more of items 135 to 148, wherein the coating comprises polyalkylsiloxane structural units such as polydialkylsiloxane structural units.

[0407] Item 150: A glass container according to Item 149, wherein one or more alkyl groups in the polyalkylsiloxane or polydialkylsiloxane are independently selected from branched or unbranched C1 to C8 alkyl groups.

[0408] Item 151: A glass container according to any one or more of items 135 to 150, wherein the weight ratio of the cross-linked polysiloxane structural units to the non-cross-linked polysiloxane structural units in the coating is less than 3.00, less than 2.50, less than 1.80, or less than 1.20.

[0409] Item 152: A glass container according to any one or more of items 135 to 151, wherein the weight ratio of the crosslinked polysiloxane structural units to the non-crosslinked polysiloxane structural units in the coating is at least 0.40, at least 0.60, or at least 0.70.

[0410] Item 153: A glass container according to any one or more of items 135 to 152, wherein the weight ratio of cross-linked polysiloxane structural units to non-cross-linked polysiloxane structural units in the coating is 0.40 to 3.00, 0.60 to 2.50, or 0.70 to 1.80.

[0411] Item 154: A glass container according to any one or more of items 135 to 153, wherein the coating comprises: - High-viscosity non-crosslinked polysiloxane structural units with a viscosity exceeding 10,000 cSt, and / or - low-viscosity non-crosslinked polysiloxane structural units with a viscosity below 10,000 cSt.

[0412] Item 155: The glass container according to Item 154, wherein, - The viscosity of the high-viscosity non-crosslinked polysiloxane structural unit is at least 15,000 cSt, and / or - the viscosity of the low-viscosity non-crosslinked polysiloxane structural unit is below 5,000 cSt.

[0413] Item 156: A glass container according to Item 154 or Item 155, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 The value is at least 0.10, at least 0.50, at least 1.00, at least 1.50, or at least 2.00.

[0414] Item 157: A glass container according to Items 154, 155, or 156, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高:quality 低 Up to 5.00, up to 4.00 or up to 3.00.

[0415] Item 158: A glass container according to any one or more of items 154 to 157, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 The values ​​are 0.10 to 5.00, 0.50 to 4.00, or 1.00 to 3.00.

[0416] Item 159: A glass container according to any one or more of items 154 to 158, wherein,

[0417] Cross-linked polysiloxane structural units, -Low viscosity non-crosslinked polysiloxane structural units, and / or - High-viscosity non-crosslinked polysiloxane structural units This includes dialkylsiloxane monomer units, particularly dimethylsiloxane monomer units.

[0418] Item 160: A glass container according to any one or more of items 143 to 159, wherein the crosslinked polysiloxane structural units are crosslinked via one or more polymeric end groups.

[0419] Item 161: A glass container according to any one or more of items 143 to 160, wherein the polymeric end group is selected from vinyl, acrylonitrile, methacrylonitrile, styrene and combinations thereof.

[0420] Item 162: A glass container according to any one or more of items 135 to 161, wherein the coating can be obtained by or through the following means:

[0421] Applying the coating composition to at least a portion of the surface of the container, and

[0422] The coating composition is cured on the surface.

[0423] The curing temperature of the coating composition is below 150°C or below 125°C, and optionally, the curing temperature is maintained for at least 10 seconds and at most 3000 seconds.

[0424] Item 163: The glass container according to Item 162, wherein the curing temperature is maintained for at least 45 seconds and at most 180 seconds.

[0425] Item 164: A glass container according to Item 162 or Item 163, wherein the coating composition has the following components by weight percentage: One or more non-crosslinkable polysiloxane compounds 2.0% to 25.0% One or more cross-linked polysiloxane compounds 0.10% to 1.50% One or more catalysts 0.03% to 0.50% One or more diluents 55.0% to 92.0%

[0426] Item 165: A glass container according to Item 162 or Item 163, wherein the coating composition has the following components by weight percentage: One or more non-crosslinkable polysiloxane compounds 8.0% to 15.0% One or more cross-linked polysiloxane compounds 0.10% to 1.00% One or more catalysts 0.03% to 0.50% One or more diluents 55.0% to 82.0%

[0427] Item 166: A glass container according to Item 162 or Item 163, wherein the coating composition has the following components by weight percentage:

[0428] Item 167: A glass container according to any one or more of items 135 to 166, wherein the glass of the glass container comprises 50 wt% to 90 wt% SiO2 and 3 wt% to 25 wt% B2O3.

[0429] Item 168: A glass container according to any one or more of items 135 to 167, wherein the glass of the glass container comprises 55 wt% to 75 wt% SiO2 and 11.0 wt% to 25.0 wt% Al2O3.

[0430] Item 169: A glass container according to Item 167, wherein the glass of the glass container comprises 70 wt% to 81 wt% SiO2, 1 wt% to 10 wt% Al2O3, 6 wt% to 14 wt% B2O3, 3 wt% to 10 wt% Na2O, 0 wt% to 3 wt% K2O, 0 wt% to 1 wt% Li2O, 0 wt% to 3 wt% MgO, 0 wt% to 3 wt% CaO, and 0 wt% to 5 wt% BaO.

[0431] Item 170: A glass container according to Item 167, wherein the glass of the glass container comprises 72 wt% to 82 wt% SiO2, 5 wt% to 8 wt% Al2O3, 3 wt% to 6 wt% B2O3, 2 wt% to 6 wt% Na2O, 3 wt% to 9 wt% K2O, 0 wt% to 1 wt% Li2O, 0 wt% to 1 wt% MgO and 0 wt% to 1 wt% CaO.

[0432] Item 171: A glass container according to Item 167, wherein the glass of the glass container comprises 60 wt% to 78 wt% SiO2, 7 wt% to 15 wt% B2O3, 0 wt% to 4 wt% Na2O, 3 wt% to 12 wt% K2O, 0 wt% to 2 wt% Li2O, 0 wt% to 2 wt% MgO, 0 wt% to 2 wt% CaO, 0 wt% to 3 wt% BaO, and 4 wt% to 9 wt% ZrO2.

[0433] Item 172: A glass container according to any one of items 135 to 166, wherein the glass of the glass container comprises 50 wt% to 70 wt% SiO2, 10 wt% to 26 wt% Al2O3, 1 wt% to 14 wt% B2O3, 0 wt% to 15 wt% MgO, 2 wt% to 12 wt% CaO, 0 wt% to 10 wt% BaO, 0 wt% to 2 wt% SrO, 0 wt% to 8 wt% ZnO, and 0 wt% to 2 wt% ZrO2.

[0434] Item 173: A glass container according to Item 168, wherein the glass of the glass container comprises 55 wt% to 70 wt% SiO2, 11 wt% to 25 wt% Al2O3, 0 wt% to 10 wt% MgO, 1 wt% to 20 wt% CaO, 0 wt% to 10 wt% BaO, 0 wt% to 8.5 wt% SrO, 0 wt% to 5 wt% ZnO, 0 wt% to 5 wt% ZrO2 and 0 wt% to 5 wt% TiO2.

[0435] Item 174: A glass container according to Item 168, wherein the glass of the glass container comprises 65 wt% to 72 wt% SiO2, 11 wt% to 17 wt% Al2O3, 0.1 wt% to 8 wt% Na2O, 0 wt% to 8 wt% K2O, 3 wt% to 8 wt% MgO, 4 wt% to 12 wt% CaO and 0 wt% to 10 wt% ZnO.

[0436] Item 175: A glass container according to any one or more of items 135 to 166, wherein the glass of the glass container comprises 64 wt% to 78 wt% SiO2, 4 wt% to 14 wt% Al2O3, 0 wt% to 4 wt% B2O3, 6 wt% to 14 wt% Na2O, 0 wt% to 3 wt% K2O, 0 wt% to 10 wt% MgO, 0 wt% to 15 wt% CaO, 0 wt% to 2 wt% ZrO2 and 0 wt% to 2 wt% TiO2.

[0437] Item 176: A glass container according to at least one of items 135 to 175, wherein at least 25% or at least 50% of the inner surface of the hollow cylinder is provided with a coating.

[0438] Item 177: A glass container according to at least one of items 135 to 176, wherein at least 65% or at least 85% of the inner surface of the hollow cylinder is coated.

[0439] Item 178: A glass container according to at least one of items 135 to 177, wherein all inner surfaces of the hollow cylinder are coated.

[0440] Item 179: A glass container according to any one or more of items 142 to 178, wherein at least 25% or at least 50% of the mating surfaces are coated.

[0441] Item 180: A glass container according to any one or more of items 142 to 179, wherein at least 65% or at least 85% of the mating surfaces are coated.

[0442] Item 181: A glass container according to any one or more of items 142 to 180, wherein substantially all mating surfaces are coated.

[0443] Item 182: A glass container according to any one or more of items 142 to 181, wherein the mating surface has a conical shape.

[0444] Item 183: A glass container according to at least one of items 135 to 182, wherein the volume enclosed by the hollow cylinder is from 0.1 ml to 1000 ml.

[0445] Item 184: A glass container according to at least one of items 135 to 183, wherein the volume enclosed by the hollow cylinder is less than 10.0 ml.

[0446] Item 185: A glass container according to at least one of items 135 to 184, wherein the hollow cylinder has an inner cavity surrounded by a glass wall with a wall thickness between 0.50 mm and 10.0 mm.

[0447] Item 186: A glass container according to at least one of items 135 to 185, wherein the hollow cylinder has an inner cavity surrounded by a glass wall with a wall thickness between 1.00 mm and 4.00 mm.

[0448] Item 187: A glass container according to at least one of items 135 to 186, wherein the ratio of the total inner diameter variation along the portion having a coating on the inner surface to the thickness of the coating is less than 250 or less than 150.

[0449] Item 188: A glass container according to at least one of items 135 to 187, wherein the total inner diameter variation of the hollow cylinder is less than 200 μm, less than 100 μm, or less than 50 μm.

[0450] Item 189: A glass container according to at least one of items 135 to 188, wherein the crystallinity of the coating at 20°C is less than 20%.

[0451] Item 190: A glass container according to at least one of items 135 to 189, having a normalized sliding force (GF) of less than 7.5 N, less than 6.5 N, less than 5.5 N, less than 4.5 N, less than 3.5 N, or less than 2.5 N.

[0452] Item 191: A glass container according to at least one of items 135 to 190, wherein the normalized sliding force (GF) is at least 0.5 N.

[0453] Item 192: A glass container according to at least one of items 135 to 191, wherein the ratio of normalized loose force (BLF) to normalized force (GF) is greater than 1.30, greater than 1.40, greater than 1.50, or greater than 1.60.

[0454] Item 193: A glass container according to at least one of items 135 to 192, wherein the ratio of normalized loose force (BLF) to normalized GF, BLF / GF, is less than 3.0.

[0455] Item 194: A glass container according to at least one of items 135 to 193, wherein the standardized loosening force exceeds the standardized sliding force of the container by at least 30%, at least 60%, at least 100%, or at least 200%.

[0456] Item 195: A glass container according to at least one of items 135 to 194, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units with a weight-average molecular weight of 1200 g / mol to 30000 g / mol, 5000 g / mol to 25000 g / mol, or 10000 g / mol to 20000 g / mol.

[0457] Item 196: A glass container according to at least one of items 135 to 195, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units having a weight-average molecular weight of at least 1200 g / mol, at least 5000 g / mol, or at least 10000 g / mol.

[0458] Item 197: A glass container according to at least one of items 135 to 196, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units with a weight-average molecular weight of up to 30,000 g / mol, up to 25,000 g / mol, or up to 20,000 g / mol.

[0459] Item 198: A glass container according to at least one of items 135 to 197, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units with a weight-average molecular weight of 15,000 g / mol to 300,000 g / mol, 32,000 g / mol to 210,000 g / mol, or 100,000 g / mol to 150,000 g / mol.

[0460] Item 199: A glass container according to at least one of items 135 to 198, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units having a weight-average molecular weight of at least 15,000 g / mol, at least 32,000 g / mol, or at least 100,000 g / mol.

[0461] Item 200: A glass container according to at least one of items 135 to 199, wherein the coating comprises high-viscosity, non-crosslinked polysiloxane structural units with a weight-average molecular weight of up to 300,000 g / mol, up to 210,000 g / mol, or up to 150,000 g / mol.

[0462] Item 201: A glass container according to at least one of items 135 to 200, wherein the coating has a crystallization temperature range and a melting temperature range determined by differential scanning calorimetry at a temperature change rate of 10°C / min, wherein the crystallization temperature range and the melting temperature range overlap at a temperature of -75°C to -100°C, particularly at a temperature of -80°C.

[0463] Item 202: The present invention relates to a glass container for a pharmaceutical composition, comprising a hollow cylinder having at least one open end, wherein at least a portion of the surface of the glass container comprises a coating, wherein the glass transition temperature of the coating is below -60°C.

[0464] Item 203: A glass container according to Item 202, wherein the hardness of the coating is such that the hardness value measured on the coated surface of the glass container according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs from the hardness value measured on its uncoated surface by less than 10%, less than 7.0%, less than 5.0%, or less than 3.0%, and / or at least 0.1%, at least 0.5%, at least 1.0%, or at least 2.0%.

[0465] Item 204: A glass container according to Item 202 or Item 203, wherein the coating thickness is 250 nm or more, 300 nm or more, 400 nm or more, 450 nm or more, or 500 nm or more.

[0466] Item 205: A glass container according to any one or more of items 202 to 204, wherein the glass transition temperature of the coating is below -70°C, for example below -75°C, or below -80°C.

[0467] Item 206: A glass container according to any one or more of items 202 to 205, wherein the container has container seal integrity tested for at least 150 hours or at least 600 hours at -80°C using a standard ethanol-modified dye invasive test.

[0468] Item 207: A glass container according to any one or more of items 202 to 206, wherein the coating is cured at a temperature below 150°C or below 110°C, and / or at a temperature above 50°C or above 60°C.

[0469] Item 208: A glass container according to any one or more of items 202 to 207, wherein the hollow cylinder has an open end A configured to receive a plug that can slide relative to the hollow cylinder from the open end A; wherein at least a portion of the inner surface of the hollow cylinder has a coating.

[0470] Item 209: A glass container according to any one or more of items 202 to 208, wherein the container has an open end B configured to be closed by a lid, the open end B having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface includes a coating.

[0471] Item 210: A glass container according to any one or more of items 202 to 209, wherein the coating comprises one or more crosslinked polysiloxane structural units and one or more non-crosslinked polysiloxane structural units, wherein the weight ratio of the crosslinked polysiloxane structural units to the non-crosslinked polysiloxane structural units in the coating is less than 3.00, and optionally at least 0.40.

[0472] Item 211: A glass container according to any one or more of items 202 to 210, wherein the coating comprises at least two non-crosslinked polysiloxane structural units with different viscosities.

[0473] Item 212: A glass container according to any one or more of items 202 to 211, wherein at least a portion of the inner surface of the hollow cylinder has a coating, wherein the ratio of the total inner diameter variation along the coated portion of the inner surface to the thickness of the coating is less than 500.

[0474] Item 213: A glass container according to any one or more of items 202 to 212, wherein the container is a syringe or cartridge, for example, a pre-filled syringe or cartridge.

[0475] Item 214: A glass container according to any one or more of items 202 to 213, wherein the coating thickness is up to 1500 nm, up to 1250 nm or up to 1000 nm.

[0476] Item 215: A glass container according to any one or more of items 202 to 214, wherein the coating thickness is greater than 400 nm to 1500 nm, 450 nm to 1250 nm, or 500 nm to 1000 nm.

[0477] Item 216: A glass container according to any one or more of items 202 to 215, wherein the coating comprises polyalkylsiloxane structural units such as polydialkylsiloxane structural units.

[0478] Item 217: The glass container according to Item 216, wherein one or more alkyl groups in the polyalkylsiloxane or polydialkylsiloxane are independently selected from C1 to C8 alkyl groups, whether branched or unbranched.

[0479] Item 218: A glass container according to any one or more of items 202 to 217, wherein the weight ratio of the cross-linked polysiloxane structural units to the non-cross-linked polysiloxane structural units in the coating is less than 3.00, less than 2.50, less than 1.80, or less than 1.20.

[0480] Item 219: A glass container according to any one or more of items 202 to 218, wherein the weight ratio of the cross-linked polysiloxane structural units to the non-cross-linked polysiloxane structural units in the coating is at least 0.40, at least 0.60, or at least 0.70.

[0481] Item 220: A glass container according to any one or more of items 202 to 219, wherein the weight ratio of cross-linked polysiloxane structural units to non-cross-linked polysiloxane structural units in the coating is 0.40 to 3.00, 0.60 to 2.50, or 0.70 to 1.80.

[0482] Item 221: A glass container according to any one or more of items 202 to 220, wherein the coating comprises: - High-viscosity non-crosslinked polysiloxane structural units with a viscosity exceeding 10,000 cSt, and / or - low-viscosity non-crosslinked polysiloxane structural units with a viscosity below 10,000 cSt.

[0483] Item 222: The glass container according to Item 221, wherein, - The viscosity of the high-viscosity non-crosslinked polysiloxane structural unit is at least 15,000 cSt, and / or - the viscosity of the low-viscosity non-crosslinked polysiloxane structural unit is below 5,000 cSt.

[0484] Item 223: A glass container according to Item 221 or Item 222, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 The value is at least 0.10, at least 0.50, at least 1.00, at least 1.50, or at least 2.00.

[0485] Item 224: A glass container according to Items 221, 222, or 223, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 Up to 5.00, up to 4.00 or up to 3.00.

[0486] Item 225: A glass container according to any one or more of items 221 to 224, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 The values ​​are 0.10 to 5.00, 0.50 to 4.00, or 1.00 to 3.00.

[0487] Item 226: A glass container according to any one or more of items 221 to 225, wherein, - Cross-linked polysiloxane structural units, -Low viscosity non-crosslinked polysiloxane structural units, and / or - High-viscosity non-crosslinked polysiloxane structural units This includes dialkylsiloxane monomer units, particularly dimethylsiloxane monomer units.

[0488] Item 227: A glass container according to any one or more of items 210 to 226, wherein the crosslinked polysiloxane structural units are crosslinked via one or more polymeric end groups.

[0489] Item 228: A glass container according to any one or more of items 210 to 227, wherein the polymeric end group is selected from vinyl, acrylonitrile, methacrylonitrile, styrene and combinations thereof.

[0490] Item 229: A glass container according to any one or more of items 202 to 228, wherein the coating can be obtained by or through the following means:

[0491] Applying the coating composition to at least a portion of the surface of the container; and

[0492] Curing the coating composition on the surface;

[0493] The curing temperature of the coating composition is below 150°C or below 125°C, and optionally, the curing temperature is maintained for at least 10 seconds and at most 3000 seconds.

[0494] Item 230: A glass container according to Item 229, wherein the curing temperature is maintained for at least 45 seconds and at most 180 seconds.

[0495] Item 231: A glass container according to Item 229 or Item 230, wherein the coating composition has the following components by weight percentage: One or more non-crosslinkable polysiloxane compounds 2.0% to 25.0% One or more cross-linked polysiloxane compounds 0.10% to 1.50% One or more catalysts 0.03% to 0.50% One or more diluents 55.0% to 92.0%

[0496] Item 232: A glass container according to Item 229 or Item 230, wherein the coating composition has the following components by weight percentage: One or more non-crosslinkable polysiloxane compounds 8.0% to 15.0% One or more cross-linked polysiloxane compounds 0.10% to 1.00% One or more catalysts 0.03% to 0.50% One or more diluents 55.0% to 82.0%

[0497] Item 233: A glass container according to Item 229 or Item 230, wherein the coating composition has the following components by weight percentage:

[0498] Item 234: A glass container according to any one or more of items 202 to 233, wherein the glass of the glass container comprises 50 wt% to 90 wt% SiO2 and 3 wt% to 25 wt% B2O3.

[0499] Item 235: A glass container according to any one or more of items 202 to 234, wherein the glass of the glass container comprises 55 wt% to 75 wt% SiO2 and 11.0 wt% to 25.0 wt% Al2O3.

[0500] Item 236: A glass container according to Item 234, wherein the glass of the glass container comprises 70 wt% to 81 wt% SiO2, 1 wt% to 10 wt% Al2O3, 6 wt% to 14 wt% B2O3, 3 wt% to 10 wt% Na2O, 0 wt% to 3 wt% K2O, 0 wt% to 1 wt% Li2O, 0 wt% to 3 wt% MgO, 0 wt% to 3 wt% CaO, and 0 wt% to 5 wt% BaO.

[0501] Item 237: A glass container according to Item 234, wherein the glass of the glass container comprises 72 wt% to 82 wt% SiO2, 5 wt% to 8 wt% Al2O3, 3 wt% to 6 wt% B2O3, 2 wt% to 6 wt% Na2O, 3 wt% to 9 wt% K2O, 0 wt% to 1 wt% Li2O, 0 wt% to 1 wt% MgO and 0 wt% to 1 wt% CaO.

[0502] Item 238: A glass container according to Item 234, wherein the glass of the glass container comprises 60 wt% to 78 wt% SiO2, 7 wt% to 15 wt% B2O3, 0 wt% to 4 wt% Na2O, 3 wt% to 12 wt% K2O, 0 wt% to 2 wt% Li2O, 0 wt% to 2 wt% MgO, 0 wt% to 2 wt% CaO, 0 wt% to 3 wt% BaO, and 4 wt% to 9 wt% ZrO2.

[0503] Item 239: A glass container according to any one of items 202 to 233, wherein the glass of the glass container comprises 50 wt% to 70 wt% SiO2, 10 wt% to 26 wt% Al2O3, 1 wt% to 14 wt% B2O3, 0 wt% to 15 wt% MgO, 2 wt% to 12 wt% CaO, 0 wt% to 10 wt% BaO, 0 wt% to 2 wt% SrO, 0 wt% to 8 wt% ZnO, and 0 wt% to 2 wt% ZrO2.

[0504] Item 240: A glass container according to Item 235, wherein the glass of the glass container comprises 55 wt% to 70 wt% SiO2, 11 wt% to 25 wt% Al2O3, 0 wt% to 10 wt% MgO, 1 wt% to 20 wt% CaO, 0 wt% to 10 wt% BaO, 0 wt% to 8.5 wt% SrO, 0 wt% to 5 wt% ZnO, 0 wt% to 5 wt% ZrO2 and 0 wt% to 5 wt% TiO2.

[0505] Item 241: A glass container according to Item 235, wherein the glass of the glass container comprises 65 wt% to 72 wt% SiO2, 11 wt% to 17 wt% Al2O3, 0.1 wt% to 8 wt% Na2O, 0 wt% to 8 wt% K2O, 3 wt% to 8 wt% MgO, 4 wt% to 12 wt% CaO and 0 wt% to 10 wt% ZnO.

[0506] Item 242: A glass container according to any one or more of items 202 to 233, wherein the glass of the glass container comprises 64 wt% to 78 wt% SiO2, 4 wt% to 14 wt% Al2O3, 0 wt% to 4 wt% B2O3, 6 wt% to 14 wt% Na2O, 0 wt% to 3 wt% K2O, 0 wt% to 10 wt% MgO, 0 wt% to 15 wt% CaO, 0 wt% to 2 wt% ZrO2 and 0 wt% to 2 wt% TiO2.

[0507] Item 243: A glass container according to at least one of items 202 to 242, wherein at least 25% or at least 50% of the inner surface of the hollow cylinder is provided with a coating.

[0508] Item 244: A glass container according to at least one of items 202 to 243, wherein at least 65% or at least 85% of the inner surface of the hollow cylinder is coated.

[0509] Item 245: A glass container according to at least one of items 202 to 244, wherein a coating is provided on all the inner surfaces of the substantially hollow cylinder.

[0510] Item 246: A glass container according to any one or more of items 210 to 245, wherein at least 25% or at least 50% of the mating surfaces are coated.

[0511] Item 247: A glass container according to any one or more of items 210 to 246, wherein at least 65% or at least 85% of the mating surfaces are coated.

[0512] Item 248: A glass container according to any one or more of items 210 to 247, wherein substantially all mating surfaces are coated.

[0513] Item 249: A glass container according to any one or more of items 210 to 248, wherein the mating surface has a conical shape.

[0514] Item 250: A glass container according to at least one of items 202 to 249, wherein the volume enclosed by the hollow cylinder is from 0.1 ml to 1000 ml.

[0515] Item 251: A glass container according to at least one of items 202 to 250, wherein the volume enclosed by the hollow cylinder is less than 10.0 ml.

[0516] Item 252: A glass container according to at least one of items 202 to 251, wherein the hollow cylinder has an inner cavity surrounded by a glass wall with a wall thickness between 0.50 mm and 10.0 mm.

[0517] Item 253: A glass container according to at least one of items 202 to 252, wherein the hollow cylinder has an inner cavity surrounded by a glass wall with a wall thickness between 1.00 mm and 4.00 mm.

[0518] Item 254: A glass container according to at least one of items 202 to 253, wherein the ratio of the total inner diameter variation along the portion having a coating on the inner surface to the thickness of the coating is less than 250 or less than 150.

[0519] Item 255: A glass container according to at least one of items 202 to 254, wherein the total inner diameter variation of the hollow cylinder is less than 200 μm, less than 100 μm, or less than 50 μm.

[0520] Item 256: A glass container according to at least one of items 202 to 255, wherein the crystallinity of the coating at 20°C is less than 20%.

[0521] Item 257: A glass container according to at least one of items 202 to 256, wherein the normalized sliding force (GF) is less than 7.5 N, less than 6.5 N, less than 5.5 N, less than 4.5 N, less than 3.5 N, or less than 2.5 N.

[0522] Item 258: A glass container according to at least one of items 202 to 257, wherein the normalized sliding force (GF) is at least 0.5 N.

[0523] Item 259: A glass container according to at least one of items 202 to 258, wherein the ratio of normalized loose force (BLF) to normalized force (GF) is greater than 1.30, greater than 1.40, greater than 1.50, or greater than 1.60.

[0524] Item 260: A glass container according to at least one of items 202 to 259, wherein the ratio of normalized loose force (BLF) to normalized GF, BLF / GF, is less than 3.0.

[0525] Item 261: A glass container according to at least one of items 202 to 260, wherein the standardized loosening force exceeds the standardized sliding force of the container by at least 30%, at least 60%, at least 100%, or at least 200%.

[0526] Item 262: A glass container according to at least one of items 202 to 261, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units with a weight-average molecular weight of 1200 g / mol to 30000 g / mol, 5000 g / mol to 25000 g / mol, or 10000 g / mol to 20000 g / mol.

[0527] Item 263: A glass container according to at least one of items 202 to 262, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units having a weight-average molecular weight of at least 1200 g / mol, at least 5000 g / mol, or at least 10000 g / mol.

[0528] Item 264: A glass container according to at least one of items 202 to 263, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units with a weight-average molecular weight of up to 30,000 g / mol, up to 25,000 g / mol, or up to 20,000 g / mol.

[0529] Item 265: A glass container according to at least one of items 202 to 264, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units with a weight-average molecular weight of 15,000 g / mol to 300,000 g / mol, 32,000 g / mol to 210,000 g / mol, or 100,000 g / mol to 150,000 g / mol.

[0530] Item 266: A glass container according to at least one of items 202 to 265, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units having a weight-average molecular weight of at least 15,000 g / mol, at least 32,000 g / mol, or at least 100,000 g / mol.

[0531] Item 267: A glass container according to at least one of items 202 to 266, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units with a weight-average molecular weight of up to 300,000 g / mol, up to 210,000 g / mol, or up to 150,000 g / mol.

[0532] Item 268: A glass container according to at least one of items 202 to 267, wherein the coating has a crystallization temperature range and a melting temperature range determined by differential scanning calorimetry at a temperature change rate of 10°C / min, wherein the crystallization temperature range and the melting temperature range overlap at a temperature of -75°C to -100°C, particularly at a temperature of -80°C.

[0533] Item 269: The present invention relates to a glass container for a pharmaceutical composition, comprising a hollow cylinder having at least one open end, wherein at least a portion of the surface of the glass container has a coating having a thickness of at least 400 nm, and the coating is cured at a temperature below 150°C, particularly at 50°C to less than 110°C.

[0534] Item 270: A glass container according to Item 269, wherein the hardness of the coating is such that the hardness value measured on the coated surface of the glass container according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs from the hardness value measured on its uncoated surface by less than 10%, less than 7.0%, less than 5.0%, or less than 3.0%, and / or at least 0.1%, at least 0.5%, at least 1.0%, or at least 2.0%.

[0535] Item 271: A glass container according to Item 269 or Item 270, wherein the coating thickness is 250 nm or more, 300 nm or more, 400 nm or more, 450 nm or more, or 500 nm or more.

[0536] Item 272: A glass container according to any one or more of items 269 to 271, wherein the glass transition temperature of the coating is below -60°C, below -70°C, for example below -75°C, or below -80°C.

[0537] Item 273: A glass container according to any one or more of items 269 to 272, wherein the container has container seal integrity tested for at least 150 hours or at least 600 hours at -80°C using a standard ethanol-modified dye invasive test.

[0538] Item 274: A glass container according to any one or more of items 269 to 273, wherein the coating is cured at a temperature below 150°C or below 110°C, and / or cured at a temperature above 50°C or above 60°C.

[0539] Item 275: A glass container according to any one or more of items 269 to 274, wherein the hollow cylinder has an open end A configured to receive a plug that can slide relative to the hollow cylinder from the open end A; wherein at least a portion of the inner surface of the hollow cylinder has a coating.

[0540] Item 276: A glass container according to any one or more of items 269 to 275, wherein the container has an open end B configured to be closed by a lid, the open end B having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface includes a coating.

[0541] Item 277: A glass container according to any one or more of items 269 to 276, wherein the coating comprises one or more crosslinked polysiloxane structural units and one or more non-crosslinked polysiloxane structural units, wherein the weight ratio of the crosslinked polysiloxane structural units to the non-crosslinked polysiloxane structural units in the coating is less than 3.00, and optionally at least 0.40.

[0542] Item 278: A glass container according to any one or more of items 269 to 277, wherein the coating comprises at least two non-crosslinked polysiloxane structural units with different viscosities.

[0543] Item 279: A glass container according to any one or more of items 269 to 278, wherein at least a portion of the inner surface of the hollow cylinder has a coating, wherein the ratio of the total inner diameter variation along the coated portion of the inner surface to the thickness of the coating is less than 500.

[0544] Item 280: A glass container according to any one or more of items 269 to 279, wherein the container is a syringe or cartridge, for example, a pre-filled syringe or cartridge.

[0545] Item 281: A glass container according to any one or more of items 269 to 280, wherein the coating thickness is up to 1500 nm, up to 1250 nm or up to 1000 nm.

[0546] Item 282: A glass container according to any one or more of items 269 to 281, wherein the coating thickness is greater than 400 nm to 1500 nm, 450 nm to 1250 nm, or 500 nm to 1000 nm.

[0547] Item 283: A glass container according to any one or more of items 269 to 282, wherein the coating comprises polyalkylsiloxane structural units such as polydialkylsiloxane structural units.

[0548] Item 284: A glass container according to Item 283, wherein one or more alkyl groups in the polyalkylsiloxane or polydialkylsiloxane are independently selected from C1 to C8 alkyl groups, whether branched or unbranched.

[0549] Item 285: A glass container according to any one or more of items 269 to 284, wherein the weight ratio of the cross-linked polysiloxane structural units to the non-cross-linked polysiloxane structural units in the coating is less than 3.00, less than 2.50, less than 1.80, or less than 1.20.

[0550] Item 286: A glass container according to any one or more of items 269 to 285, wherein the weight ratio of the cross-linked polysiloxane structural units to the non-cross-linked polysiloxane structural units in the coating is at least 0.40, at least 0.60, or at least 0.70.

[0551] Item 287: A glass container according to any one or more of items 269 to 286, wherein the weight ratio of cross-linked polysiloxane structural units to non-cross-linked polysiloxane structural units in the coating is 0.40 to 3.00, 0.60 to 2.50, or 0.70 to 1.80.

[0552] Item 288: A glass container according to any one or more of items 269 to 287, wherein the coating comprises: - High-viscosity non-crosslinked polysiloxane structural units with a viscosity exceeding 10,000 cSt, and / or - low-viscosity non-crosslinked polysiloxane structural units with a viscosity below 10,000 cSt.

[0553] Item 289: The glass container according to Item 288, wherein, - The viscosity of the high-viscosity non-crosslinked polysiloxane structural unit is at least 15,000 cSt, and / or - the viscosity of the low-viscosity non-crosslinked polysiloxane structural unit is below 5,000 cSt.

[0554] Item 290: A glass container according to Item 288 or 299, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 The value is at least 0.10, at least 0.50, at least 1.00, at least 1.50, or at least 2.00.

[0555] Item 291: A glass container according to Items 287, 289, or 290, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 Up to 5.00, 4.00 or 3.00.

[0556] Item 292: A glass container according to any one or more of items 287 to 291, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 The values ​​are 0.10 to 5.00, 0.50 to 4.00, or 1.00 to 3.00.

[0557] Item 293: A glass container according to any one or more of items 287 to 292, wherein, - Crosslinked polysiloxane structural units, -Low viscosity non-crosslinked polysiloxane structural units, and / or - High-viscosity non-crosslinked polysiloxane structural units This includes dialkylsiloxane monomer units, particularly dimethylsiloxane monomer units.

[0558] Item 294: A glass container according to any one or more of items 277 to 293, wherein the crosslinked polysiloxane structural units are crosslinked via one or more polymeric end groups.

[0559] Item 295: A glass container according to any one or more of items 277 to 294, wherein the polymeric end group is selected from vinyl, propylene, methacryl, styrene and combinations thereof.

[0560] Item 296: A glass container according to any one or more of items 269 to 295, wherein the coating can be obtained by or through the following means:

[0561] Applying the coating composition to at least a portion of the surface of the container; and

[0562] Curing the coating composition on the surface;

[0563] The curing temperature of the coating composition is below 150°C or below 125°C, and optionally, the curing temperature is maintained for at least 10 seconds and at most 3000 seconds.

[0564] Item 297: The glass container according to Item 298, wherein the curing temperature is maintained for at least 45 seconds and at most 180 seconds.

[0565] Item 298: A glass container according to Item 296 or 297, wherein the coating composition has the following components by weight percentage: One or more non-crosslinkable polysiloxane compounds 2.0% to 25.0% One or more cross-linked polysiloxane compounds 0.10% to 1.50% One or more catalysts 0.03% to 0.50% One or more diluents 55.0% to 92.0%

[0566] Item 299: A glass container according to Item 296 or 297, wherein the coating composition has the following components by weight percentage: One or more non-crosslinkable polysiloxane compounds 8.0% to 15.0% One or more cross-linked polysiloxane compounds 0.10% to 1.00% One or more catalysts 0.03% to 0.50% One or more diluents 55.0% to 82.0%

[0567] Item 300: A glass container according to Item 296 or 297, wherein the coating composition has the following components by weight percentage:

[0568] Item 301: A glass container according to any one or more of items 269 to 300, wherein the glass of the glass container comprises 50 wt% to 90 wt% SiO2 and 3 wt% to 25 wt% B2O3.

[0569] Item 302: A glass container according to any one or more of items 269 to 301, wherein the glass of the glass container comprises 55 wt% to 75 wt% SiO2 and 11.0 wt% to 25.0 wt% Al2O3.

[0570] Item 303: A glass container according to Item 301, wherein the glass of the glass container comprises 70 wt% to 81 wt% SiO2, 1 wt% to 10 wt% Al2O3, 6 wt% to 14 wt% B2O3, 3 wt% to 10 wt% Na2O, 0 wt% to 3 wt% K2O, 0 wt% to 1 wt% Li2O, 0 wt% to 3 wt% MgO, 0 wt% to 3 wt% CaO, and 0 wt% to 5 wt% BaO.

[0571] Item 304: A glass container according to Item 301, wherein the glass of the glass container comprises 72 wt% to 82 wt% SiO2, 5 wt% to 8 wt% Al2O3, 3 wt% to 6 wt% B2O3, 2 wt% to 6 wt% Na2O, 3 wt% to 9 wt% K2O, 0 wt% to 1 wt% Li2O, 0 wt% to 1 wt% MgO and 0 wt% to 1 wt% CaO.

[0572] Item 305: A glass container according to Item 301, wherein the glass of the glass container comprises 60 wt% to 78 wt% SiO2, 7 wt% to 15 wt% B2O3, 0 wt% to 4 wt% Na2O, 3 wt% to 12 wt% K2O, 0 wt% to 2 wt% Li2O, 0 wt% to 2 wt% MgO, 0 wt% to 2 wt% CaO, 0 wt% to 3 wt% BaO, and 4 wt% to 9 wt% ZrO2.

[0573] Item 306: A glass container according to any one of items 269 to 300, wherein the glass of the glass container comprises 50 wt% to 70 wt% SiO2, 10 wt% to 26 wt% Al2O3, 1 wt% to 14 wt% B2O3, 0 wt% to 15 wt% MgO, 2 wt% to 12 wt% CaO, 0 wt% to 10 wt% BaO, 0 wt% to 2 wt% SrO, 0 wt% to 8 wt% ZnO, and 0 wt% to 2 wt% ZrO2.

[0574] Item 307: A glass container according to Item 302, wherein the glass of the glass container comprises 55 wt% to 70 wt% SiO2, 11 wt% to 25 wt% Al2O3, 0 wt% to 10 wt% MgO, 1 wt% to 20 wt% CaO, 0 wt% to 10 wt% BaO, 0 wt% to 8.5 wt% SrO, 0 wt% to 5 wt% ZnO, 0 wt% to 5 wt% ZrO2 and 0 wt% to 5 wt% TiO2.

[0575] Item 308: A glass container according to Item 302, wherein the glass of the glass container comprises 65 wt% to 72 wt% SiO2, 11 wt% to 17 wt% Al2O3, 0.1 wt% to 8 wt% Na2O, 0 wt% to 8 wt% K2O, 3 wt% to 8 wt% MgO, 4 wt% to 12 wt% CaO and 0 wt% to 10 wt% ZnO.

[0576] Item 309: A glass container according to any one or more of items 269 to 300, wherein the glass of the glass container comprises 64 wt% to 78 wt% SiO2, 4 wt% to 14 wt% Al2O3, 0 wt% to 4 wt% B2O3, 6 wt% to 14 wt% Na2O, 0 wt% to 3 wt% K2O, 0 wt% to 10 wt% MgO, 0 wt% to 15 wt% CaO, 0 wt% to 2 wt% ZrO2 and 0 wt% to 2 wt% TiO2.

[0577] Item 310: A glass container according to at least one of items 269 to 309, wherein the coating is disposed on at least 25% or at least 50% of the inner surface of the hollow cylinder.

[0578] Item 311: A glass container according to at least one of items 269 to 310, wherein at least 65% or at least 85% of the inner surface of the hollow cylinder is coated.

[0579] Item 312: A glass container according to at least one of items 269 to 311, wherein all the inner surfaces of the substantially hollow cylinder are coated.

[0580] Item 313: A glass container according to any one or more of items 277 to 312, wherein at least 25% or at least 50% of the mating surfaces are coated.

[0581] Item 314: A glass container according to any one or more of items 277 to 313, wherein at least 65% or at least 85% of the mating surfaces are coated.

[0582] Item 315: A glass container according to any one or more of items 277 to 313, wherein substantially all mating surfaces are coated.

[0583] Item 316: A glass container according to any one or more of items 277 to 315, wherein the mating surface has a conical shape.

[0584] Item 317: A glass container according to at least one of items 269 to 316, wherein the volume enclosed by the hollow cylinder is from 0.1 ml to 1000 ml.

[0585] Item 318: A glass container according to at least one of items 269 to 317, wherein the volume enclosed by the hollow cylinder is less than 10.0 ml.

[0586] Item 319: A glass container according to at least one of items 269 to 318, wherein the hollow cylinder has an inner cavity surrounded by a glass wall with a wall thickness between 0.50 mm and 10.0 mm.

[0587] Item 320: A glass container according to at least one of items 269 to 319, wherein the hollow cylinder has an inner cavity surrounded by a glass wall with a wall thickness between 1.00 mm and 4.00 mm.

[0588] Item 321: A glass container according to at least one of items 269 to 320, wherein the ratio of the total inner diameter variation along the portion having a coating on the inner surface to the thickness of the coating is less than 250 or less than 150.

[0589] Item 322: A glass container according to at least one of items 269 to 321, wherein the total inner diameter variation of the hollow cylinder is less than 200 μm, less than 100 μm, or less than 50 μm.

[0590] Item 323: A glass container according to at least one of items 269 to 322, wherein the crystallinity of the coating at 20°C is less than 20%.

[0591] Item 324: A glass container according to at least one of items 269 to 323, wherein the normalized sliding force (GF) is less than 7.5 N, less than 6.5 N, less than 5.5 N, less than 4.5 N, less than 3.5 N, or less than 2.5 N.

[0592] Item 325: A glass container according to at least one of items 269 to 324, wherein the normalized sliding force (GF) is at least 0.5 N.

[0593] Item 326: A glass container according to at least one of items 269 to 325, wherein the ratio of normalized loose force (BLF) to normalized force (GF) is greater than 1.30, greater than 1.40, greater than 1.50, or greater than 1.60.

[0594] Item 327: A glass container according to at least one of items 269 to 326, wherein the ratio of normalized loose force (BLF) to normalized GF, BLF / GF, is less than 3.0.

[0595] Item 328: A glass container according to at least one of items 269 to 327, wherein the standardized loosening force exceeds the standardized sliding force of the container by at least 30%, at least 60%, at least 100%, or at least 200%.

[0596] Item 329: A glass container according to at least one of items 269 to 328, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units with a weight-average molecular weight of 1200 g / mol to 30000 g / mol, 5000 g / mol to 25000 g / mol, or 10000 g / mol to 20000 g / mol.

[0597] Item 330: A glass container according to at least one of items 269 to 329, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units having a weight-average molecular weight of at least 1200 g / mol, at least 5000 g / mol, or at least 10000 g / mol.

[0598] Item 331: A glass container according to at least one of items 269 to 330, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units with a weight-average molecular weight of up to 30,000 g / mol, up to 25,000 g / mol, or up to 20,000 g / mol.

[0599] Item 332: A glass container according to at least one of items 269 to 331, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units with a weight-average molecular weight of 15,000 g / mol to 300,000 g / mol, 32,000 g / mol to 210,000 g / mol, or 100,000 g / mol to 150,000 g / mol.

[0600] Item 333: A glass container according to at least one of items 269 to 332, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units having a weight-average molecular weight of at least 15,000 g / mol, at least 32,000 g / mol, or at least 100,000 g / mol.

[0601] Item 334: A glass container according to at least one of items 269 to 333, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units with a weight-average molecular weight of up to 300,000 g / mol, up to 210,000 g / mol, or up to 150,000 g / mol.

[0602] Item 335: A glass container according to at least one of items 269 to 334, wherein the coating has a crystallization temperature range and a melting temperature range determined by differential scanning calorimetry at a temperature change rate of 10°C / min, wherein the crystallization temperature range and the melting temperature range overlap at a temperature of -75°C to -100°C, particularly at a temperature of -80°C.

[0603] Item 336: The present invention relates to a glass container for a pharmaceutical composition, comprising a hollow cylinder having at least one open end, wherein at least a portion of the surface of the glass container comprises a coating comprising one or more crosslinked polysiloxane structural units and one or more non-crosslinked polysiloxane structural units, wherein the weight ratio of the crosslinked polysiloxane structural units to the non-crosslinked polysiloxane structural units in the coating is less than 3.00, and optionally at least 0.40.

[0604] Item 337: A glass container according to Item 336, wherein the hardness of the coating is such that the hardness value measured on the coated surface of the glass container according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs from the hardness value measured on its uncoated surface by less than 10%, less than 7.0%, less than 5.0%, or less than 3.0%, and / or at least 0.1%, at least 0.5%, at least 1.0%, or at least 2.0%.

[0605] Item 338: A glass container according to Item 336 or Item 337, wherein the coating thickness is 250 nm or more, 300 nm or more, 400 nm or more, 450 nm or more, or 500 nm or more.

[0606] Item 339: A glass container according to any one or more of items 336 to 338, wherein the glass transition temperature of the coating is below -60°C, below -70°C, for example below -75°C, or below -80°C.

[0607] Item 340: A glass container according to any one or more of items 336 to 339, wherein the container has container seal integrity tested for at least 150 hours or at least 600 hours at -80°C using a standard ethanol-modified dye invasive test.

[0608] Item 341: A glass container according to any one or more of items 336 to 340, wherein the coating is cured at a temperature below 150°C or below 110°C, and / or cured at a temperature above 50°C or above 60°C.

[0609] Item 342: A glass container according to any one or more of items 336 to 341, wherein the hollow cylinder has an open end A configured to receive a plug that can slide relative to the hollow cylinder from the open end A; wherein at least a portion of the inner surface of the hollow cylinder has a coating.

[0610] Item 343: A glass container according to any one or more of items 336 to 342, wherein the container has an open end B configured to be closed by a lid, the open end B having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface includes a coating.

[0611] Item 344: A glass container according to any one or more of items 336 to 343, wherein the coating comprises one or more crosslinked polysiloxane structural units and one or more non-crosslinked polysiloxane structural units, wherein the weight ratio of the crosslinked polysiloxane structural units to the non-crosslinked polysiloxane structural units in the coating is less than 3.00, and optionally at least 0.40.

[0612] Item 345: A glass container according to any one or more of items 336 to 344, wherein the coating comprises at least two non-crosslinked polysiloxane structural units with different viscosities.

[0613] Item 346: A glass container according to any one or more of items 336 to 345, wherein at least a portion of the inner surface of the hollow cylinder has a coating, wherein the ratio of the total inner diameter variation along the coated portion of the inner surface to the thickness of the coating is less than 500.

[0614] Item 347: A glass container according to any one or more of items 336 to 346, wherein the container is a syringe or cartridge, for example, a pre-filled syringe or cartridge.

[0615] Item 348: A glass container according to any one or more of items 336 to 347, wherein the coating thickness is up to 1500 nm, up to 1250 nm or up to 1000 nm.

[0616] Item 349: A glass container according to any one or more of items 336 to 348, wherein the coating thickness is greater than 400 nm to 1500 nm, 450 nm to 1250 nm, or 500 nm to 1000 nm.

[0617] Item 350: A glass container according to any one or more of items 336 to 349, wherein the coating comprises polyalkylsiloxane structural units such as polydialkylsiloxane structural units.

[0618] Item 351: A glass container according to Item 350, wherein one or more alkyl groups in the polyalkylsiloxane or polydialkylsiloxane are independently selected from C1 to C8 alkyl groups, whether branched or unbranched.

[0619] Item 352: A glass container according to any one or more of items 336 to 351, wherein the weight ratio of the cross-linked polysiloxane structural units to the non-cross-linked polysiloxane structural units in the coating is less than 3.00, less than 2.50, less than 1.80, or less than 1.20.

[0620] Item 353: A glass container according to any one or more of items 336 to 352, wherein the weight ratio of the crosslinked polysiloxane structural units to the non-crosslinked polysiloxane structural units in the coating is at least 0.40, at least 0.60, or at least 0.70.

[0621] Item 354: A glass container according to any one or more of items 336 to 353, wherein the weight ratio of cross-linked polysiloxane structural units to non-cross-linked polysiloxane structural units in the coating is 0.40 to 3.00, 0.60 to 2.50, or 0.70 to 1.80.

[0622] Item 355: A glass container according to any one or more of items 336 to 354, wherein the coating comprises: - High-viscosity non-crosslinked polysiloxane structural units with a viscosity exceeding 10,000 cSt, and / or - low-viscosity non-crosslinked polysiloxane structural units with a viscosity below 10,000 cSt.

[0623] Item 356: The glass container according to Item 355, wherein, - The viscosity of high-viscosity non-crosslinked polysiloxane structural units is at least 15,000 cSt, and / or - the viscosity of low-viscosity non-crosslinked polysiloxane structural units is below 5,000 cSt.

[0624] Item 357: A glass container according to any one or more of items 336 to 356, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 The value is at least 0.10, at least 0.50, at least 1.00, at least 1.50, or at least 2.00.

[0625] Item 358: A glass container according to any one or more of items 336 to 357, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 Up to 5.00, up to 4.00, or up to 3.00.

[0626] Item 359: A glass container according to any one or more of items 336 to 358, wherein the weight ratio (by mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units is... 高 :quality 低 The values ​​are 0.10 to 5.00, 0.50 to 4.00, or 1.00 to 3.00.

[0627] Item 360: A glass container according to any one or more of items 336 to 359, wherein,

[0628] Cross-linked polysiloxane structural units, -Low viscosity non-crosslinked polysiloxane structural units, and / or - High-viscosity non-crosslinked polysiloxane structural units This includes dialkylsiloxane monomer units, particularly dimethylsiloxane monomer units.

[0629] Item 361: A glass container according to any one or more of items 336 to 360, wherein the crosslinked polysiloxane structural units are crosslinked via one or more polymeric end groups.

[0630] Item 362: The glass container according to Item 361, wherein the polymeric end group is selected from vinyl, acrylonitrile, methacrylonitrile, styrene and combinations thereof.

[0631] Item 363: A glass container according to any one or more of items 336 to 362, wherein the coating can be obtained by or through the following means:

[0632] Applying the coating composition to at least a portion of the surface of the container; and

[0633] Curing the coating composition on the surface;

[0634] The curing temperature of the coating composition is below 150°C or below 125°C, and optionally, the curing temperature is maintained for at least 10 seconds and at most 3000 seconds.

[0635] Item 364: A glass container according to Item 363, wherein the curing temperature is maintained for at least 45 seconds and at most 180 seconds.

[0636] Item 365: A glass container according to Item 363 or 364, wherein the coating composition has the following components by weight percentage: One or more non-crosslinkable polysiloxane compounds 2.0% to 25.0% One or more cross-linked polysiloxane compounds 0.10% to 1.50% One or more catalysts 0.03% to 0.50% One or more diluents 55.0% to 92.0%

[0637] Item 366: A glass container according to Item 363 or 364, wherein the coating composition has the following components by weight percentage: One or more non-crosslinkable polysiloxane compounds 8.0% to 15.0% One or more cross-linked polysiloxane compounds 0.10% to 1.00% One or more catalysts 0.03% to 0.50% One or more diluents 55.0% to 82.0%

[0638] Item 367: A glass container according to Item 363 or 364, wherein the coating composition has the following components by weight percentage:

[0639] Item 368: A glass container according to any one or more of items 336 to 367, wherein the glass of the glass container comprises 50 wt% to 90 wt% SiO2 and 3 wt% to 25 wt% B2O3.

[0640] Item 369: A glass container according to any one or more of items 336 to 368, wherein the glass of the glass container comprises 55 wt% to 75 wt% SiO2 and 11.0 wt% to 25.0 wt% Al2O3.

[0641] Item 370: A glass container according to Item 368, wherein the glass of the glass container comprises 70 wt% to 81 wt% SiO2, 1 wt% to 10 wt% Al2O3, 6 wt% to 14 wt% B2O3, 3 wt% to 10 wt% Na2O, 0 wt% to 3 wt% K2O, 0 wt% to 1 wt% Li2O, 0 wt% to 3 wt% MgO, 0 wt% to 3 wt% CaO, and 0 wt% to 5 wt% BaO.

[0642] Item 371: A glass container according to Item 368, wherein the glass of the glass container comprises 72 wt% to 82 wt% SiO2, 5 wt% to 8 wt% Al2O3, 3 wt% to 6 wt% B2O3, 2 wt% to 6 wt% Na2O, 3 wt% to 9 wt% K2O, 0 wt% to 1 wt% Li2O, 0 wt% to 1 wt% MgO and 0 wt% to 1 wt% CaO.

[0643] Item 372: A glass container according to Item 368, wherein the glass of the glass container comprises 60 wt% to 78 wt% SiO2, 7 wt% to 15 wt% B2O3, 0 wt% to 4 wt% Na2O, 3 wt% to 12 wt% K2O, 0 wt% to 2 wt% Li2O, 0 wt% to 2 wt% MgO, 0 wt% to 2 wt% CaO, 0 wt% to 3 wt% BaO, and 4 wt% to 9 wt% ZrO2.

[0644] Item 373: A glass container according to any one of items 336 to 367, wherein the glass of the glass container comprises 50 wt% to 70 wt% SiO2, 10 wt% to 26 wt% Al2O3, 1 wt% to 14 wt% B2O3, 0 wt% to 15 wt% MgO, 2 wt% to 12 wt% CaO, 0 wt% to 10 wt% BaO, 0 wt% to 2 wt% SrO, 0 wt% to 8 wt% ZnO, and 0 wt% to 2 wt% ZrO2.

[0645] Item 374: A glass container according to Item 369, wherein the glass of the glass container comprises 55 wt% to 70 wt% SiO2, 11 wt% to 25 wt% Al2O3, 0 wt% to 10 wt% MgO, 1 wt% to 20 wt% CaO, 0 wt% to 10 wt% BaO, 0 wt% to 8.5 wt% SrO, 0 wt% to 5 wt% ZnO, 0 wt% to 5 wt% ZrO2 and 0 wt% to 5 wt% TiO2.

[0646] Item 374, the glass container according to Item 369, wherein the glass of the glass container comprises 65 wt% to 72 wt% SiO2, 11 wt% to 17 wt% Al2O3, 0.1 wt% to 8 wt% Na2O, 0 wt% to 8 wt% K2O, 3 wt% to 8 wt% MgO, 4 wt% to 12 wt% CaO and 0 wt% to 10 wt% ZnO.

[0647] Item 375: A glass container according to any one or more of items 336 to 367, wherein the glass of the glass container comprises 64 wt% to 78 wt% SiO2, 4 wt% to 14 wt% Al2O3, 0 wt% to 4 wt% B2O3, 6 wt% to 14 wt% Na2O, 0 wt% to 3 wt% K2O, 0 wt% to 10 wt% MgO, 0 wt% to 15 wt% CaO, 0 wt% to 2 wt% ZrO2 and 0 wt% to 2 wt% TiO2.

[0648] Item 376: A glass container according to at least one of items 336 to 375, wherein at least 25% or at least 50% of the inner surface of the hollow cylinder is provided with a coating.

[0649] Item 377: A glass container according to at least one of items 366 to 376, wherein at least 65% or at least 85% of the inner surface of the hollow cylinder is coated.

[0650] Item 378: A glass container according to at least one of items 336 to 377, wherein a coating is provided on all the inner surfaces of the substantially hollow cylinder.

[0651] Item 379: A glass container according to any one or more of items 336 to 378, wherein at least 25% or at least 50% of the mating surfaces are coated.

[0652] Item 380: A glass container according to any one or more of items 336 to 379, wherein at least 65% or at least 85% of the mating surfaces are coated.

[0653] Item 381: A glass container according to any one or more of items 336 to 380, wherein substantially all mating surfaces are coated.

[0654] Item 382: A glass container according to any one or more of items 336 to 381, wherein the mating surface has a conical shape.

[0655] Item 383: A glass container according to at least one of items 336 to 382, ​​wherein the volume enclosed by the hollow cylinder is from 0.1 ml to 1000 ml.

[0656] Item 384: A glass container according to at least one of items 336 to 383, wherein the volume enclosed by the hollow cylinder is less than 10.0 ml.

[0657] Item 385: A glass container according to at least one of items 336 to 384, wherein the hollow cylinder has an inner cavity surrounded by a glass wall with a wall thickness between 0.50 mm and 10.0 mm.

[0658] Item 386: A glass container according to at least one of items 336 to 385, wherein the hollow cylinder has an inner cavity surrounded by a glass wall with a wall thickness between 1.00 mm and 4.00 mm.

[0659] Item 387: A glass container according to at least one of items 336 to 386, wherein the ratio of the total inner diameter variation along the portion having a coating on the inner surface to the thickness of the coating is less than 250 or less than 150.

[0660] Item 388: A glass container according to at least one of items 336 to 387, wherein the total inner diameter variation of the hollow cylinder is less than 200 μm, less than 100 μm, or less than 50 μm.

[0661] Item 389: A glass container according to at least one of items 336 to 388, wherein the crystallinity of the coating at 20°C is less than 20%.

[0662] Item 390: A glass container according to at least one of items 336 to 389, having a normalized sliding force (GF) of less than 7.5 N, less than 6.5 N, less than 5.5 N, less than 4.5 N, less than 3.5 N, or less than 2.5 N.

[0663] Item 391: A glass container according to at least one of items 336 to 390, wherein the normalized sliding force (GF) is at least 0.5 N.

[0664] Item 392: A glass container according to at least one of items 336 to 391, wherein the ratio of normalized loose force (BLF) to normalized force (GF) is greater than 1.30, greater than 1.40, greater than 1.50, or greater than 1.60.

[0665] Item 393: A glass container according to at least one of items 336 to 392, wherein the ratio of normalized loose force (BLF) to normalized GF, BLF / GF, is less than 3.0.

[0666] Item 394: A glass container according to at least one of items 336 to 393, wherein the standardized loosening force exceeds the standardized sliding force of the container by at least 30%, at least 60%, at least 100%, or at least 200%.

[0667] Item 395: A glass container according to at least one of items 336 to 394, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units with a weight-average molecular weight of 1200 g / mol to 30000 g / mol, 5000 g / mol to 25000 g / mol, or 10000 g / mol to 20000 g / mol.

[0668] Item 396: A glass container according to at least one of items 336 to 395, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units having a weight-average molecular weight of at least 1200 g / mol, at least 5000 g / mol, or at least 10000 g / mol.

[0669] Item 397: A glass container according to at least one of items 336 to 396, wherein the coating comprises low-viscosity, non-crosslinked polysiloxane structural units with a weight-average molecular weight of up to 30,000 g / mol, up to 25,000 g / mol, or up to 20,000 g / mol.

[0670] Item 398: A glass container according to at least one of items 336 to 397, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units with a weight-average molecular weight of 15,000 g / mol to 300,000 g / mol, 32,000 g / mol to 210,000 g / mol, or 100,000 g / mol to 150,000 g / mol.

[0671] Item 398: A glass container according to at least one of items 336 to 397, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units having a weight-average molecular weight of at least 15,000 g / mol, at least 32,000 g / mol, or at least 100,000 g / mol.

[0672] Item 399: A glass container according to at least one of items 336 to 398, wherein the coating comprises high-viscosity non-crosslinked polysiloxane structural units with a weight-average molecular weight of up to 300,000 g / mol, up to 210,000 g / mol, or up to 150,000 g / mol.

[0673] Item 400: A glass container according to at least one of items 336 to 399, wherein the coating has a crystallization temperature range and a melting temperature range determined by differential scanning calorimetry at a temperature change rate of 10°C / min, wherein the crystallization temperature range and the melting temperature range overlap at a temperature of -75°C to -100°C, particularly at a temperature of -80°C.

[0674] According to claim 401, the present invention relates to a system comprising a glass container, stopper and / or lid as described in at least one of the preceding claims, wherein the system has container seal integrity under a specific ethanol-modified dye intrusion test at -80°C for at least 150 hours.

[0675] Item 402: The system according to Item 401, which has container seal integrity under a specific ethanol-modified dye intrusion test for at least 600 hours or at least 1200 hours at -80°C.

[0676] Item 403: The system according to Item 401 or Item 402, wherein the Shore A hardness of the plug is not greater than 70.

[0677] Item 404: A system according to at least one of items 401 to 403, wherein the Shore A hardness of the stopper is at least 40.

[0678] Item 405: A system according to at least one of items 401 to 404, wherein the density of the plug is at least 1.200 g / cm³. 3 .

[0679] Item 406: A system according to at least one of items 401 to 405, wherein the density of the stopper is at most 1.450 g / cm³. 3 .

[0680] Item 407: A system according to at least one of items 401 to 406, wherein the compression deformation of the plug is at least 10%.

[0681] Item 408: A system according to at least one of items 401 to 407, wherein the compression deformation of the plug is at most 20%.

[0682] Item 409: A system according to at least one of items 401 to 408, wherein the ratio between the difference (I) of the average linear coefficient of thermal expansion of the stopper material and the glass container material and the thickness (II) of the coating is less than 0.5 ppm / nm.

[0683] Item 410: A system according to at least one of items 401 to 409, wherein the ratio of the uncompressed outer diameter of the plug to the inner diameter of the hollow cylinder is greater than 1.100 or greater than 1.185.

[0684] Item 411: A system according to at least one of items 401 to 410, wherein the release force is at least 30% greater than the gliding force, and the release force is at least 4.9.

[0685] Item 412: A system according to at least one of items 401 to 411, wherein a glass container has an open end B, which is optionally disposed at the opposite end of the container relative to the open end A, the open end B being closed by a lid, the open end B having a fitting surface configured to fit tightly against the surface of the lid.

[0686] Item 413: The system according to Item 412, wherein at least a portion of the mating surface is coated with a coating present on at least a portion of the inner surface of the hollow cylinder.

[0687] Item 414: A system according to at least one of items 401 to 411, comprising an injector having a rigid cap, a tip cap, or a rigid needle cap for a post needle.

[0688] Item 415, the present invention relates to a system comprising a glass container, a stopper and / or a lid as described in at least one of the preceding items, wherein the ratio between the difference (I) of the average linear coefficient of thermal expansion of the material of the stopper and the material of the glass container and the degree of coating (II) is less than 0.5 ppm / nm.

[0689] Item 416: The system according to Item 415 has container seal integrity tested for a specific ethanol-modified dye intrusion at -80°C for at least 150 hours, at least 600 hours, or at least 1200 hours.

[0690] Item 417: The system according to Item 415 or Item 416, wherein the Shore A hardness of the plug is not greater than 70.

[0691] Item 418: A system according to at least one of items 415 to 417, wherein the Shore A hardness of the stopper is at least 40.

[0692] Item 419: A system according to at least one of items 415 to 418, wherein the density of the plug is at least 1.200 g / cm³. 3 .

[0693] Item 420: A system according to at least one of items 415 to 419, wherein the density of the stopper is at most 1.450 g / cm³. 3 .

[0694] Item 421: A system according to at least one of items 415 to 420, wherein the compression deformation of the plug is at least 10%.

[0695] Item 422: A system according to at least one of items 415 to 421, wherein the compression deformation of the plug is at most 20%.

[0696] Item 423: A system according to at least one of items 415 to 422, wherein the ratio between the difference (I) of the average linear coefficient of thermal expansion of the stopper material and the glass container material and the thickness (II) of the coating is less than 0.5 ppm / nm.

[0697] Item 424: A system according to at least one of items 415 to 423, wherein the ratio of the uncompressed outer diameter of the plug to the inner diameter of the hollow cylinder is greater than 1.100 or greater than 1.185.

[0698] Item 425: A system according to at least one of items 415 to 424, wherein the release force is at least 30% greater than the gliding force, and the release force is at least 4.9.

[0699] Item 426: A system according to at least one of items 415 to 425, wherein a glass container has an open end B, which is optionally disposed at the opposite end of the container relative to an open end A, the open end B being closed by a lid, the open end B having a fitting surface configured to fit tightly against the surface of the lid.

[0700] Item 427: The system according to Item 426, wherein at least a portion of the mating surface is coated with a coating present on at least a portion of the inner surface of the hollow cylinder.

[0701] Item 428: A system according to at least one of items 415 to 427, comprising an injector with a post needle having a rigid cap, a tip cap, or a rigid needle cap.

Claims

1. A glass container for a pharmaceutical composition, comprising a hollow cylinder having at least one open end, wherein, At least a portion of the surface of the glass container includes a coating having a crystallization temperature range and a melting temperature range determined using differential scanning calorimetry at a temperature change rate of 10°C / min, wherein the crystallization temperature range and the melting temperature range overlap at a temperature of -75°C to -100°C, and wherein the container has container seal integrity as determined by a specific ethanol-modified dye intrusion test at -80°C for at least 150 hours.

2. The glass container according to claim 1, wherein, The coating thickness is above 250 nm.

3. The glass container according to claim 1, wherein, The crystallization temperature range and the melting temperature range overlap at a temperature of -80°C.

4. The glass container according to claim 1, wherein, The coating thickness is 300 nm or more.

5. The glass container according to claim 1, wherein, The coating has a thickness of 400 nm or more.

6. The glass container according to claim 1, wherein, The coating has a thickness of 450 nm or more.

7. The glass container according to claim 1, wherein, The coating has a thickness of 500 nm or more.

8. The glass container according to claim 1 or 2, wherein, The glass transition temperature of the coating is below -60°C.

9. The glass container according to claim 1 or 2, wherein, The glass transition temperature of the coating is below -70°C.

10. The glass container according to claim 1 or 2, wherein, The glass transition temperature of the coating is below -75°C.

11. The glass container according to claim 1 or 2, wherein, The glass transition temperature of the coating is below -80°C.

12. The glass container according to any one of the preceding claims, wherein, The coating has a hardness such that the hardness value measured on the coated surface of the glass container according to DIN EN ISO 14577-1:2015-11 and DIN EN ISO 14577-4:2017-04 differs by less than 10% from the hardness value measured on its uncoated surface.

13. The glass container according to any one of the preceding claims, wherein, The container has container seal integrity tested for at least 150 hours at -80°C for a standard ethanol-modified dye invasiveness test.

14. The glass container according to any one of the preceding claims, wherein, The container has container seal integrity tested for at least 600 hours under a standard ethanol-modified dye invasive test at -80°C.

15. The glass container according to any one of the preceding claims, wherein, The coating Curing at temperatures below 150°C, and / or Curing occurs at temperatures above 50°C.

16. The glass container according to any one of the preceding claims, wherein, The coating Curing at temperatures below 125°C, and / or Curing occurs at temperatures above 60°C.

17. The glass container according to any one of the preceding claims, wherein, The hollow cylinder has an open end A configured to receive a plug that can slide relative to the hollow cylinder from the open end A; wherein at least a portion of the inner surface of the hollow cylinder has the coating.

18. The glass container according to any one of the preceding claims, wherein, The container has an open end B configured to be closed by a lid, the open end B having a fitting surface configured to fit tightly against the surface of the lid, wherein at least a portion of the fitting surface includes the coating.

19. The glass container according to any one of the preceding claims, wherein, The coating comprises one or more cross-linked polysiloxane structural units and one or more non-cross-linked polysiloxane structural units, wherein the weight ratio of the cross-linked polysiloxane structural units to the weight of the non-cross-linked polysiloxane structural units in the coating is less than 3.00 and at least 0.

40.

20. The glass container according to any one of the preceding claims, wherein, The coating comprises at least two non-crosslinked polysiloxane structural units with different viscosities.

21. The glass container according to any one of the preceding claims, wherein, At least a portion of the inner surface of the hollow cylinder has the coating, wherein the ratio of the total inner diameter variation along the portion of the inner surface with the coating to the thickness of the coating is less than 500.

22. Use of a coating composition for preparing a coating on the surface of a glass container, wherein, The coated glass container is then stored at a temperature below -60°C for at least 150 hours, wherein the coating composition comprises, by weight percentage:

23. The use according to claim 22, wherein, The coated glass container was then stored at a low temperature of -80°C for at least 150 hours.

24. The use according to claim 22, wherein, The coating composition has the following components by weight percentage: or 25. The use according to any one of claims 22 to 24, wherein, The glass container is the container according to any one of claims 1 to 21.

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