Method for producing coated container

By using capillary bridge technology to uniformly coat the inner surface of the drug container, the problem of uneven coating in existing technologies is solved, the piston sliding performance and production efficiency are improved, and drug contamination is reduced.

CN120940208APending Publication Date: 2025-11-14SCHOTT PHARMA SCHWEIZ AG
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Patent Information

Application Number
CN202510444552.X
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2024-05-14
Filing Date
2025-04-10
Publication Date
2025-11-14

AI Technical Summary

Technical Problem

Existing technologies make it difficult to uniformly coat the inner surface of drug containers, resulting in uneven piston movement, which affects the application of drug compositions and leads to low production efficiency.

Method used

By employing capillary bridge technology, a circumferential gap is left between the coating body and the inner surface of the hollow cylinder. The coating composition forms capillary bridges by moving the coating body, and is uniformly deposited on the inner surface, avoiding uneven coating caused by pressure fitting.

Benefits of technology

This method achieves a uniform coating on the inner surface of the drug container, reduces coating thickness variation, improves piston sliding performance, reduces the risk of drug contamination, and increases production efficiency.

✦ Generated by Eureka AI based on patent content.

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Abstract

The present disclosure relates to a method for manufacturing a coated container (e.g., a syringe). The present disclosure relates, inter alia, to a method of manufacturing a container having a lubricious coating on an inner surface. The present disclosure also relates to a coated container.
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Description

Technical Field

[0001] This invention relates to a method for manufacturing a coated container (e.g., a syringe). This disclosure particularly relates to a method for manufacturing a container with a lubricating coating on its inner surface. This disclosure also relates to coated containers. Background Technology

[0002] Drug containers must meet very stringent requirements, including resistance to breakage and leaks. To ensure that patients' or physicians' confidence in the quality of the drug composition contained within the container is not compromised, these containers must also be optically flawless.

[0003] Some drug containers (e.g., syringes) require smooth piston movement to expel the contents. To achieve this, a coating may be applied to the inner surface of the drug container. It is desirable that any coating applied to the contact surface between the container and the piston improves the smoothness of movement, and that any inconsistencies do not affect the smoothness of the piston's movement. The piston's movement should be very uniform; that is, it should not change abruptly along its path. Otherwise, sudden changes in sliding force could hinder the easy and painless administration of the drug composition from the container.

[0004] The demand for drug delivery systems is enormous. Simple and robust manufacturing technologies are key to facilitating the production of millions or even billions of such units. Prefilled syringes, for example, are a type of drug delivery system that has garnered significant attention in recent years. Market research indicates that the prefilled syringe market is expanding significantly. Demand for prefilled syringes is driven by a number of factors, including increased vaccine production and the adoption of self-administered biologics for the treatment of chronic diseases. According to a recent study, sales of prefilled syringes are projected to grow at approximately 9% annually, reaching approximately $9 billion by 2027.

[0005] Therefore, there is a need for drug containers and manufacturing methods that meet one or more of the above objectives. Summary of the Invention

[0006] In a first aspect, this disclosure relates to a method for manufacturing a coated container, the method comprising:

[0007] - A container comprising a hollow cylinder having a wall surrounding an inner cavity, the hollow cylinder having at least one opening.

[0008] - The coating material is inserted into the inner cavity through the opening.

[0009] - Apply a coating composition to the coated body such that the coating composition contacts at least a portion of the inner surface of the wall.

[0010] - By moving the coating body relative to the hollow cylinder, the coating composition is deposited on the deposition area of ​​the inner surface of the wall.

[0011] - The coating is withdrawn from the cavity through the opening.

[0012] The size of the coating body is such that a circumferential gap exists between the coating body and the deposition area during the deposition step.

[0013] Existing techniques for manufacturing coated containers include spraying methods. However, spraying is extremely difficult to control, making it impossible to obtain a completely uniform coating. Other methods rely on inserting a hemispherical coating body into the container, bringing it into contact with the container's inner wall. After insertion, a liquid coating composition is applied to the coating body, allowing the coating composition to distribute when the coating body is withdrawn from the container.

[0014] Compared to the "press-fit" coating process, the method of the present invention is characterized in that, during the deposition step, a circumferential gap exists between the coating body and the deposition area, specifically, the coating body does not contact the inner surface of the hollow cylinder. There is no press fit; that is, the coating body is not forced into the hollow cylinder, but rather a gap is left. This gap allows the coating composition applied to the coating body to touch or contact the inner surface of the wall and at least a portion of the coating body, thereby bridging the gap between the coating body and the inner surface, forming a so-called capillary bridge.

[0015] Compared to press-fitting, this capillary bridge facilitates coating containers in a completely different manner. The inventors hypothesize that in the former process, the coating composition flows downwards as a free-flowing film along the inner surface of a hollow cylinder. In contrast, the capillary bridge technique pulls the silicone mixture across the surface like a blanket over a bed. Thus, only a thin layer of liquid remains on the inner surface, while most of the fluid is dragged away by the moving coating. Due to the dragging force, a constant stress exists along the liquid film. This undoubtedly reduces the tendency for the coating composition to accumulate significantly compared to films prepared by press-fitting. Not wanting to be bound by this theory, the inventors believe this contributes to achieving superior coating quality through the capillary bridge technique.

[0016] In a second aspect, this disclosure relates to a coated container, optionally obtained or obtainable by the method of the first aspect, the container comprising a hollow cylinder having a wall surrounding an inner cavity, the hollow cylinder having at least one opening, wherein at least a portion of the inner surface of the wall comprises a coating, wherein...

[0017] - The average coating thickness ranges from 100 nm to 3000 nm, and

[0018] - Wherein, the total area of ​​excessive coating thickness is less than 10% of the coating area, and excessive coating thickness is defined as the area where the coating thickness is greater than twice the average coating thickness.

[0019] As described above, the method of this disclosure allows for the production of coated containers with excellent film properties. The coating thickness exhibits minimal variation, i.e., the proportion of areas with excessively large or small thicknesses is small. This results in good and uniform sliding performance for pistons used in drug containers, particularly pre-filled syringes. The uniform film thickness also reduces the tendency for the coating to rub off from the inner surface due to piston movement, as it minimizes the maximum local stress. Therefore, the coating technique used in this disclosure helps reduce potential contamination of pharmaceutical formulations in containers, especially during prolonged storage in pre-filled syringes. Attached Figure Description

[0020] Figure 1 An exemplary drug container is shown.

[0021] Figure 2 This is a schematic diagram of some of the method steps of the method disclosed herein.

[0022] Figure 3 A is a schematic diagram of the coating being inserted into the hollow cylinder by a press fit.

[0023] Figure 3 B is a schematic diagram of a coating body according to the present disclosure inserted into a hollow cylinder in the presence of a circumferential gap.

[0024] Figure 4 Figure A shows the thickness distribution of a coating applied using a press-fit technique.

[0025] Figure 4 Figure B shows the thickness distribution of a coating applied using the capillary bridge technique of this disclosure.

[0026] Figure 5 A is a schematic diagram of a coating according to this disclosure.

[0027] Figure 5 B is a schematic diagram of the capillary bridge geometry that can be obtained in the method of this disclosure. Detailed Implementation

[0028] method

[0029] In an embodiment, this disclosure relates to a method for manufacturing a coated container, the method comprising:

[0030] - A container comprising a hollow cylinder having a wall surrounding an inner cavity, the hollow cylinder having at least one opening.

[0031] - The coating material is inserted into the inner cavity through the opening.

[0032] - Apply a coating composition to the coated body such that the coating composition contacts at least a portion of the inner surface of the wall.

[0033] - By moving the coating body relative to the hollow cylinder, the coating composition is deposited on the deposition area of ​​the inner surface of the wall.

[0034] - The coating is withdrawn from the cavity through the opening.

[0035] The size of the coating body is such that a circumferential gap exists between the coating body and the inner surface during the deposition step.

[0036] The drug container and / or walls may be made partially or entirely of materials suitable for primary drug packaging. Suitable materials include glass or polymers. The glass may be silicate glass, such as borosilicate glass. The polymer may be an amorphous polymer. Transparent polymers are preferred. Suitable polymers may be selected from cyclic olefin copolymers (COC), cyclic olefin polymers (COP), polyethylene terephthalate (PET), polycarbonate (PC), polypropylene (PP), and methyl methacrylate acrylonitrile butadiene styrene polymers (MABS). These polymers have advantages such as low density, high transparency, low birefringence, extremely low water absorption, excellent water vapor barrier properties, high rigidity, high strength, high hardness, excellent biocompatibility, excellent acid and alkali resistance, and excellent melt processability.

[0037] The walls and / or drug containers can be made of polymers. Optionally, polymers with a lower density compared to glass are chosen, for example, those with a density of 0.90 g / cm³. 3 Up to 1.20 g / cm 3 Or >1.00g / cm 3 Up to 1.10 g / cm 3 The polymer. Using low-density materials can reduce transportation costs. The density can be determined using the method described in ISO 1183-1:2013-04. The wall thickness can be from 1 mm to 2.5 mm, or from 1.2 mm to 2 mm, or from 1.3 mm to 1.9 mm.

[0038] In embodiments, the coating body is inserted and withdrawn through the same opening. In the case of a syringe, the opening is typically on the flange side. In some embodiments, the opening through which the coating body is withdrawn faces downwards. Typically, the direction of movement in the deposition step is the same as the direction of withdrawal in the withdrawal step. Therefore, in some embodiments, at least a portion of the coating composition is deposited on the deposition area by the downward movement of the coating body. During this movement, capillary bridges traverse the gap between the coating body and the inner surface of the wall, thereby depositing the coating composition very uniformly on the deposition area. In this disclosure, "deposition area" refers to a portion of the inner surface of the wall where a coating is obtained and / or formed during the coating process by depositing the coating composition. It should be understood that insertion, movement, and withdrawal of the coating body includes situations where the coating body is stationary while the container moves, or where both the coating body and the container move. In other words, the movement referred to should be understood as relative movement. In some embodiments, by the downward movement of the coating body, more than 80% (volume / volume) or substantially all of the coating composition is deposited on the deposition area.

[0039] The insertion of the coating is complete when the coating body is in its initial position. The "initial position" refers to the location where the coating composition is applied to the coating body within the cylinder. If the deposition of the coating composition occurs in a pulling motion (i.e., in the opposite direction to insertion), the initial position will be closer to the opposite end of the deposition area compared to the opening through which the coating body is inserted. If the deposition of the coating composition occurs in a pushing motion (i.e., in the insertion direction), the initial position will be closer to the end of the deposition area, adjacent to or near the opening through which the coating body is inserted. Studies have found that deposition in a pulling motion, compared to deposition in a pushing motion, results in a more uniform coating.

[0040] Optionally, the gap can be an annular gap with a substantially circular cross-section. Generally, a uniform coating is more easily obtained when both the coating body and the hollow cylinder have substantially circular cross-sections. In an embodiment, when present in a hollow cylinder, the coating body has a circumferential portion closest to the inner surface of the wall. This portion can be referred to as the “mid-latitude” of the coating body, regardless of whether the coating body is spherical. The coating body can be spherical, hemispherical, conical, or any other shape suitable for achieving the capillary bridge described herein. Generally, the coating body is preferably substantially spherical, hemispherical, or conical on the mid-latitude side of the coating body onto which the coating composition is applied. In an embodiment, the coating composition is applied to the upward-facing side of the coating body so that the coating composition can flow downward in the direction of the gap and form a capillary bridge there. In an embodiment, the coating body has a shape in which the diameter increases in the direction of the mid-latitude starting from the upward-facing side.

[0041] The circumferential clearance can be characterized by the distance D between the coating and the deposition zone during the deposition step. Distance D is defined as the average distance between the coating and the deposition zone during the deposition step. The "average distance" is calculated using the average inner diameter D of the hollow cylinder. ID Subtract the average diameter D of the coated body AB Then divide by 2, that is D AB It is the arithmetic mean of the maximum and minimum outer diameters on the outer circumference of the coated body. D ID It is the arithmetic mean of the maximum and minimum inner diameters on the inner circumference of the hollow cylinder. In each case, if D along the longitudinal axis of the container... AB Or D ID Since they are all different, they are measured separately in D. AB Or D ID D was measured at the cross-section of the coated body or hollow cylinder with the maximum value. AB and D ID But D ID This should correspond to the portion of the inner diameter corresponding to the deposition area. Optionally, the size of the circumferential gap is characterized by a distance D less than 0.10 mm. Optionally, the distance D is at least 0.005 mm, at least 0.01 mm, at least 0.02 mm, or at least 0.03 mm. It can reach a maximum of 0.10 mm, 0.08 mm, 0.06 mm, or 0.04 mm. For example, it can be in the range of 0.005 mm to 0.10 mm, 0.01 mm to 0.08 mm, or 0.02 mm to 0.04 mm.

[0042] The relative clearance dimension can be defined as D / D AB In the embodiment, D / D AB The values ​​are 0.0005 to 0.02, 0.001 to 0.01, and 0.0015 to 0.006. Optionally, D / D AB The value is at least 0.0005, at least 0.001, at least 0.0015, or at least 0.002. In some embodiments, D / D AB Maximum 0.02, maximum 0.01, maximum 0.08, maximum 0.06 or maximum 0.04.

[0043] It is useful to select a container with a hollow cylinder that meets strict geometric parameters. In embodiments, the total inner diameter variation of the cylinder in the deposition region is at most 2D, at most 1.5D, or at most D. Optionally, the total inner diameter variation is less than 0.10 mm, less than 0.08 mm, less than 0.06 mm, or less than 0.04 mm. The smaller the total inner diameter variation, the better. However, in some embodiments, providing a container with extremely small total inner diameter variation may not be economically feasible. Therefore, in embodiments, the total inner diameter variation can be at least 0.0001 mm, at least 0.001 mm, or at least 0.01 mm. For example, the total inner diameter variation can be in the range of 0.0001 mm to <0.10 mm, 0.001 mm to <0.08 mm, or 0.01 mm to <0.04 mm.

[0044] To ensure a highly uniform coating, the coated body must also meet stringent quality standards. For example, the total outer diameter variation at its latitude can be at most 2D, at most 1.5D, or at most D. Optionally, the total outer diameter variation is less than 0.20 mm, less than 0.15 mm, less than 0.10 mm, or less than 0.04 mm. The smaller the total outer diameter variation, the better. However, in some embodiments, providing a coated body with extremely small total outer diameter variation may not be economically feasible. Therefore, in embodiments, the total outer diameter variation can be at least 0.0001 mm, at least 0.001 mm, or at least 0.003 mm. For example, the total outer diameter variation can be in the range of 0.0001 mm to <0.20 mm, 0.001 mm to <0.15 mm, or 0.003 mm to <0.04 mm.

[0045] In embodiments, the coating comprises or is composed of a polymeric material. The coating may or may not have a coating. Generally, the material of the coating is not limited as long as sufficient dimensional accuracy is achieved (see above). In embodiments, at least a portion of the surface of the coating that comes into contact with the coating composition in the methods of this disclosure is made of or coated with a fluoropolymer (e.g., PTFE).

[0046] In embodiments, the coating body and / or the coating on the coating body comprises a resin, such as a fluoropolymer, selected from 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 thereof, mixtures and combinations thereof. The coating may also be formed from a layer comprising polyethylene, polypropylene, parylene, polylactic acid and copolymers thereof, mixtures and combinations thereof. PTFE coating is also an option. These coatings can reduce the coefficient of friction of the coating body surface on the inner surface of the hollow cylinder.

[0047] At least a portion of the surface of the coating, for example, a portion of the surface that contacts the capillary bridge, may have a water contact angle of at least 100° or even at least 110°. The surface may be a superhydrophobic surface.

[0048] The surface energy of the inner surface of the hollow cylinder can be at most 45 mN / m, at most 40 mN / m, or at most 35 mN / m. Optionally, the surface energy is at least 15 mN / m, at least 20 mN / m, or at least 25 mN / m. For example, the surface energy of the inner surface can be in the range of 15 mN / m to 45 mN / m, 20 mN / m to 40 mN / m, or 25 mN / m to 35 mN / m. Preferably, the surface energy of the inner surface is higher than the surface energy of the coating surface forming the capillary bridge. For example, the surface energy of the coating can be at most 25 mN / m or at most 20 mN / m. Optionally, the surface energy of the coating can be at least 10 mN / m or at least 15 mN / m. In embodiments, the surface energy of the coating surface forming the capillary bridge can be in the range of 10 mN / m to 25 mN / m or 15 mN / m to 20 mN / m. In the embodiments, the surface energy of the inner surface of the hollow cylinder is at least 40%, at least 50%, or at least 60% higher than the surface energy of the coating. According to Chapter 6.2 of DIN 55660-2:2011-12, the surface energy can be indirectly measured by calculating the value obtained from contact angle measurements using the Owens-Wendt-Rabel-Kaelble (OWRK) method. The surface energy of the coating composition may be less than the surface energy of the coating and / or the inner surface of the hollow cylinder. Optionally, the surface energy of the coating composition is less than 20 mN / m, less than 17 mN / m, or less than 15 mN / m. In the embodiments, the surface energy of the coating composition is at least 5 mN / m, at least 8 mN / m, or at least 10 mN / m. For example, the surface energy of the coating composition can be in the range of 5 mN / m to 20 mN / m, 8 mN / m to 17 mN / m, or 10 mN / m to 15 mN / m. A suitable surface energy facilitates the formation of capillary bridges.

[0049] In embodiments, the coating body includes one or more conduits adapted to deliver a coating composition through the coating body. One or more conduits are useful because it is not necessary to place a certain amount of coating composition within the hollow cylinder before inserting the coating body. Instead, the coating body can be inserted and properly positioned within the lumen before applying the coating composition. In embodiments, one or more conduits terminate at or near the tip of the coating body. The tip of the coating body is typically its uppermost portion when the coating composition is applied. The coating composition can flow from here to and across the circumferential gap, forming a capillary bridge. Therefore, the step of applying a coating composition to the coating body can include delivering the coating composition through one or more conduits. Typically, one or more conduits will terminate above the mid-latitude of the coating body, thereby allowing the coating composition to flow downwards on the coating body. Applying a coating composition to the coating body can include delivering the coating composition to the very top of the coating body, thereby allowing the coating composition to flow downwards on the coating body. In embodiments, the coating body includes at least two, at least three, at least four, or at least six conduits. Optionally, the number of conduits can be up to 24, up to 20, up to 16, or up to 12. For example, the coating may include 1 to 24, 2 to 20, 4 to 16, or 6 to 12 conduits. The conduits may be disposed on the coating in a manner that supports uniform distribution of the coating composition.

[0050] Applying a coating composition to a coating body may include: delivering the coating composition to a portion of the coating body and allowing the coating composition to form a capillary bridge between the coating body and the inner surface of the wall.

[0051] As described above, the coating composition is applied to the coating body such that it contacts at least a portion of the inner surface of the wall. This requires the coating composition to be close enough to the inner surface of the wall to span a circumferential gap. In an embodiment, the circumferential gap is sized such that the coating composition forms capillary bridges spanning the circumferential gap during the deposition step. If the gap is small enough to allow the formation of capillary bridges during the deposition step, particularly throughout the entire deposition step, a very uniform coating can be obtained. On the other hand, if the gap is too small, the coating body may inadvertently contact the inner surface of the deposition area, thereby affecting the uniform deposition of the coating composition.

[0052] In one embodiment, the volume of the coating composition initially applied to the coating body is sufficient to span the gap throughout the deposition step. In another embodiment, during the deposition step, one or more volumes of the coating composition are applied to the coating body, for example, to supplement the volume of the coating composition, such that the capillary bridge remains intact throughout the deposition step.

[0053] In the embodiments, the total volume of the coating composition initially and optionally applied to the coating body during the deposition step is at least 2 μl, at least 5 μl, at least 10 μl, at least 25 μl, or at least 50 μl. Optionally, this volume can be up to 200 μl, up to 100 μl, or up to 90 μl. Of course, the exact volume of the coating composition depends on the deposition area and the desired coating thickness. For example, the total volume of the coating composition can be from 2 μl to 200 μl or from 5 μl to 100 μl.

[0054] In embodiments, the movement rate of the coating body during the deposition of the coating composition is no greater than the flow rate of the coating composition in the direction of movement of the coating body. As described above, the coating body moves relative to the hollow cylinder during the deposition of the coating composition. During this step, the capillary bridge should remain intact to achieve the most uniform effect. If the coating body moves too quickly, a significant portion of the coating composition may revert to a free-flowing state, risking the formation of fine streams on the inner surface. These streams can remain on the inner surface, causing significant non-uniformity. Optionally, the movement rate of the coating body is at least 2 mm / s, at least 4 mm / s, at least 5 mm / s, or at least 10 mm / s. In embodiments, the movement rate is at most 50 mm / s, at most 30 mm / s, at most 20 mm / s, or at most 15 mm / s. For example, the movement rate of the coating body is in the range of 2 mm / s to 50 mm / s, 5 mm / s to 30 mm / s, or 10 mm / s to 15 mm / s.

[0055] In an embodiment, the method may further include a step of air rinsing the container after depositing the coating composition on the deposition area. Air rinsing facilitates the evaporation of the diluent in the coating composition and helps to smooth the coating.

[0056] Alternatively or additionally, the method may include the step of depositing a coating composition on a deposition area followed by curing the coating composition to obtain a cured coating. Curing can be used to crosslink and / or polymerize crosslinkable or polymerizable compounds in the coating composition to form a coating. Furthermore, curing also facilitates the evaporation of diluents from the coating composition.

[0057] A coating composition can be applied to achieve the desired coating thickness. The average coating thickness can be greater than 100 nm, 200 nm, 300 nm, 400 nm, or 450 nm. Optionally, the average coating thickness can be up to 3000 nm, up to 2500 nm, up to 2000 nm, up to 1500 nm, up to 1000 nm, or up to 850 nm. A suitable coating thickness facilitates sealing at low temperatures. In embodiments, the average coating thickness can be from 100 nm to 3000 nm, 200 nm to 2000 nm, 300 nm to 1500 nm, or 400 nm to 1000 nm. Optionally, the average coating thickness is present over at least 90%, at least 95%, or at least 99% of the coated area. In embodiments, the average coating thickness is greater than 400 nm, particularly at least 450 nm or at least 500 nm. An exemplary preferred range for the average coating thickness is >400nm to 1500nm, 450nm to 1250nm, or 450nm to 850nm.

[0058] The coating composition can be deposited on at least 25% or at least 50% of the inner surface (by area) of the hollow cylinder. The coating can have a beneficial effect on the sliding properties of the piston on the inner surface of the hollow cylinder. Therefore, in some embodiments, the coating composition is deposited on at least 65% or at least 85% of the inner surface (by area) of the hollow cylinder. Optionally, the coating composition is deposited on at least 90% or substantially all of the inner surface of the hollow cylinder.

[0059] As used herein, "curing temperature" refers to the effective temperature at which the coating is 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 polymerizing polymerizable groups, such as polymerizable end groups. The coating may be cured at curing temperatures below 150°C, below 125°C, or below 110°C. Excessively high curing temperatures may result in a brittle coating. On the other hand, excessively low curing temperatures may also fail to achieve satisfactory performance. Therefore, in the 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. Oven temperatures may be much higher than the curing temperature because there may not be sufficient time for the entire oven to equilibrate to the nominal temperature during curing. Alternatively, the coating may be cured at temperatures from 50°C to below 150°C, 60°C to below 125°C, or 70°C to below 110°C. The preferred range is 50°C to <110°C. In the embodiments, curing does not involve the application of plasma.

[0060] The curing temperature is maintained for a sufficient time to achieve the desired degree of curing. Optionally, the curing temperature may be maintained for at least 2 seconds, at least 3 seconds, at least 4 seconds, or at least 5 seconds. In the embodiments, the curing temperature is maintained for a maximum of 300 seconds, a maximum of 100 seconds, or a maximum of 20 seconds.

[0061] After curing, the average coating thickness can range from 100 nm to 3000 nm. Alternatively or additionally, after curing, the total area of ​​excessive coating thickness is less than 10% of the coating area, and excessive coating thickness is defined as an area where the coating thickness is greater than two, 1.50, or 1.20 times the average coating thickness. After curing, the coating may contain one or more silicone polymers.

[0062] In some embodiments, the method further includes the step of obtaining a coated container of the present disclosure. In other embodiments, the method further includes the step of obtaining a container having a coating, as described in more detail below.

[0063] The coating composition can be cured at curing temperatures below 150°C, below 125°C, or below 110°C. Excessively high curing temperatures may result in a brittle coating. Conversely, excessively low curing temperatures may not provide sufficient mechanical resistance for the coating. Therefore, in the embodiments, curing temperatures 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 and should not be confused with the nominal oven temperature. Oven temperatures may be much higher than the curing temperature because there may not be sufficient time for the entire oven to equilibrate to the nominal temperature during curing. Alternatively, the coating can be cured at temperatures from 50°C to below 150°C, 60°C to below 125°C, or 70°C to below 110°C. The preferred range is 50°C to <110°C.

[0064] In embodiments, the coating can be obtained by applying the coating composition disclosed herein onto at least a portion of the container surface (e.g., the inner surface) and curing the coating composition on the surface.

[0065] This disclosure is not particularly limited to container volume. In embodiments, 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 up to 1000 ml, up to 200 ml, up to 100 ml, or up to 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 embodiments, the volume enclosed by the hollow cylinder is less than 10.0 ml.

[0066] The hollow cylinder has an inner cavity surrounded by walls, wherein the wall thickness is at least 0.50 mm, at least 0.80 mm, or at least 1.00 mm. Optionally, the wall thickness can be a maximum of 10.0 mm, a maximum of 8.0 mm, a maximum of 5.0 mm, or a maximum of 4.0 mm. In embodiments, the wall thickness is in the range of 0.50 mm to 10.0 mm, 0.80 mm to 8.0 mm, or 1.00 mm to 4.00 mm. As used herein, the term "wall thickness" refers to the shortest distance between the inner and outer surfaces of the hollow cylinder.

[0067] 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, connected by a straight line perpendicular to and intersecting the longitudinal axis of the cylinder. The term "inner diameter" refers to the maximum distance between two points on the inner surface of a hollow cylinder, connected by a straight line perpendicular to and intersecting the longitudinal axis of the cylinder.

[0068] In a first specific embodiment, the method includes:

[0069] - A container comprising a hollow cylinder having a wall surrounding an inner cavity and having at least one opening is provided.

[0070] - Insert the coating material into the inner cavity through the opening.

[0071] - Apply a coating composition to the coated body such that the coating composition contacts at least a portion of the inner surface of the wall.

[0072] - A coating composition is deposited on the deposition area of ​​the inner surface of the wall by moving the coating body relative to the hollow cylinder.

[0073] - The coating is withdrawn from the inner cavity through the opening.

[0074] The dimensions of the coating body are such that a circumferential gap exists between the coating body and the inner surface during the deposition step.

[0075] in,

[0076] The wall is made of polymers, such as COC or COP;

[0077] By moving the coating body downwards, at least a portion of the coating composition is deposited on the deposition area;

[0078] The coating body includes one or more conduits adapted to deliver the coating composition through the coating body; and

[0079] The size of the circumferential gap is characterized by a distance D of less than 0.10 mm between the coating body and the deposition area during the deposition step.

[0080] In the second specific embodiment 2, the method includes:

[0081] - A container comprising a hollow cylinder having a wall surrounding an inner cavity and having at least one opening is provided.

[0082] - Insert the coating material into the inner cavity through the opening.

[0083] - Apply a coating composition to the coated body such that the coating composition contacts at least a portion of the inner surface of the wall.

[0084] - A coating composition is deposited on the deposition area of ​​the inner surface of the wall by moving the coating body relative to the hollow cylinder.

[0085] - The coating is withdrawn from the inner cavity through the opening.

[0086] The dimensions of the coating body are such that a circumferential gap exists between the coating body and the inner surface during the deposition step.

[0087] in,

[0088] The wall is made of polymers, such as COC or COP;

[0089] By moving the coating body downwards, at least a portion of the coating composition is deposited on the deposition area;

[0090] The coating body includes one or more conduits adapted to deliver the coating composition through the coating body;

[0091] The size of the circumferential gap is characterized by the distance D between the coating body and the deposition area, which is less than 0.10 mm, during the deposition step;

[0092] The total volume of the coating composition applied to the coated body is 5 μl to 100 μl; and

[0093] During the deposition of the coating composition, the movement rate of the coated body is not greater than the flow rate of the coating composition in the direction of movement of the coated body.

[0094] In a third specific embodiment, the method includes:

[0095] - A container comprising a hollow cylinder having a wall surrounding an inner cavity and having at least one opening is provided.

[0096] - Insert the coating material into the inner cavity through the opening.

[0097] - Apply a coating composition to the coated body such that the coating composition contacts at least a portion of the inner surface of the wall.

[0098] - A coating composition is deposited on the deposition area of ​​the inner surface of the wall by moving the coating body relative to the hollow cylinder.

[0099] - The coating is withdrawn from the inner cavity through the opening.

[0100] The dimensions of the coating body are such that a circumferential gap exists between the coating body and the inner surface during the deposition step.

[0101] in,

[0102] The wall is made of polymers, such as COC or COP;

[0103] By moving the coating body downwards, at least a portion of the coating composition is deposited on the deposition area;

[0104] The coating body includes one or more conduits adapted to deliver the coating composition through the coating body;

[0105] The size of the circumferential gap is characterized by the distance D between the coating body and the deposition area, which is less than 0.10 mm, during the deposition step;

[0106] The total volume of the coating composition applied to the coated body is 5 μl to 100 μl; and

[0107] During the deposition of the coating composition, the movement rate of the coated body is not greater than the flow rate of the coating composition in the direction of movement of the coated body;

[0108] The coating composition contains polysiloxane structural units or compounds.

[0109] In the fourth specific embodiment, the method includes:

[0110] - A container comprising a hollow cylinder having a wall surrounding an inner cavity and having at least one opening is provided.

[0111] - Insert the coating material into the inner cavity through the opening.

[0112] - Apply a coating composition to the coated body such that the coating composition contacts at least a portion of the inner surface of the wall.

[0113] - A coating composition is deposited on the deposition area of ​​the inner surface of the wall by moving the coating body relative to the hollow cylinder.

[0114] - The coating is withdrawn from the inner cavity through the opening.

[0115] The dimensions of the coating body are such that a circumferential gap exists between the coating body and the inner surface during the deposition step.

[0116] in,

[0117] The wall is made of polymers, such as COC or COP;

[0118] By moving the coating body downwards, at least a portion of the coating composition is deposited on the deposition area;

[0119] The coating body includes one or more conduits adapted to deliver the coating composition through the coating body;

[0120] The size of the circumferential gap is characterized by the distance D between the coating body and the deposition area, which is less than 0.10 mm, during the deposition step;

[0121] Initially and optionally during the deposition step, the total volume of the coating composition applied to the coated body is from 5 μl to 100 μl;

[0122] During the deposition of the coating composition, the movement rate of the coated body is not greater than the flow rate of the coating composition in the direction of movement of the coated body;

[0123] The coating composition contains polysiloxane structural units or compounds; and

[0124] The surface energy of the inner surface is higher than the surface energy of the surface of the coating that forms the capillary bridge.

[0125] In a fifth specific embodiment, the method includes:

[0126] - A container comprising a hollow cylinder having a wall surrounding an inner cavity and having at least one opening is provided.

[0127] - Insert the coating material into the inner cavity through the opening.

[0128] - Apply a coating composition to the coated body such that the coating composition contacts at least a portion of the inner surface of the wall.

[0129] - A coating composition is deposited on the deposition area of ​​the inner surface of the wall by moving the coating body relative to the hollow cylinder.

[0130] - The coating is withdrawn from the inner cavity through the opening.

[0131] The dimensions of the coating body are such that a circumferential gap exists between the coating body and the inner surface during the deposition step.

[0132] in,

[0133] The walls are made of glass;

[0134] By moving the coating body downwards, at least a portion of the coating composition is deposited on the deposition area;

[0135] The coating body includes one or more conduits adapted to deliver the coating composition through the coating body; and

[0136] The size of the circumferential gap is characterized by a distance D of less than 0.10 mm between the coating body and the deposition area during the deposition step.

[0137] In a sixth specific embodiment, the method includes:

[0138] - A container comprising a hollow cylinder having a wall surrounding an inner cavity and having at least one opening is provided.

[0139] - Insert the coating material into the inner cavity through the opening.

[0140] - Apply a coating composition to the coated body such that the coating composition contacts at least a portion of the inner surface of the wall.

[0141] - A coating composition is deposited on the deposition area of ​​the inner surface of the wall by moving the coating body relative to the hollow cylinder.

[0142] - The coating is withdrawn from the inner cavity through the opening.

[0143] The dimensions of the coating body are such that a circumferential gap exists between the coating body and the inner surface during the deposition step.

[0144] in,

[0145] The walls are made of glass;

[0146] By moving the coating body downwards, at least a portion of the coating composition is deposited on the deposition area;

[0147] The coating body includes one or more conduits adapted to deliver the coating composition through the coating body;

[0148] The size of the circumferential gap is characterized by the distance D between the coating body and the deposition area, which is less than 0.10 mm, during the deposition step;

[0149] The total volume of the coating composition applied to the coated body is 5 μl to 100 μl; and

[0150] During the deposition of the coating composition, the movement rate of the coated body is not greater than the flow rate of the coating composition in the direction of movement of the coated body.

[0151] In the seventh specific embodiment, the method includes:

[0152] - A container comprising a hollow cylinder having a wall surrounding an inner cavity and having at least one opening is provided.

[0153] - Insert the coating material into the inner cavity through the opening.

[0154] - Apply a coating composition to the coated body such that the coating composition contacts at least a portion of the inner surface of the wall.

[0155] - A coating composition is deposited on the deposition area of ​​the inner surface of the wall by moving the coating body relative to the hollow cylinder.

[0156] - The coating is withdrawn from the inner cavity through the opening.

[0157] The dimensions of the coating body are such that a circumferential gap exists between the coating body and the inner surface during the deposition step.

[0158] in,

[0159] The walls are made of glass;

[0160] By moving the coating body downwards, at least a portion of the coating composition is deposited on the deposition area;

[0161] The coating body includes one or more conduits adapted to deliver the coating composition through the coating body;

[0162] The size of the circumferential gap is characterized by the distance D between the coating body and the deposition area, which is less than 0.10 mm, during the deposition step;

[0163] The total volume of the coating composition applied to the coated body is 5 μl to 100 μl; and

[0164] During the deposition of the coating composition, the movement rate of the coated body is not greater than the flow rate of the coating composition in the direction of movement of the coated body;

[0165] The coating composition contains polysiloxane structural units or compounds.

[0166] In the eighth specific embodiment, the method includes:

[0167] - A container comprising a hollow cylinder having a wall surrounding an inner cavity and having at least one opening is provided.

[0168] - Insert the coating material into the inner cavity through the opening.

[0169] - Apply a coating composition to the coated body such that the coating composition contacts at least a portion of the inner surface of the wall.

[0170] - A coating composition is deposited on the deposition area of ​​the inner surface of the wall by moving the coating body relative to the hollow cylinder.

[0171] - The coating is withdrawn from the inner cavity through the opening.

[0172] The dimensions of the coating body are such that a circumferential gap exists between the coating body and the inner surface during the deposition step.

[0173] in,

[0174] The walls are made of glass;

[0175] By moving the coating body downwards, at least a portion of the coating composition is deposited on the deposition area;

[0176] The coating body includes one or more conduits adapted to deliver the coating composition through the coating body;

[0177] The size of the circumferential gap is characterized by the distance D between the coating body and the deposition area, which is less than 0.10 mm, during the deposition step;

[0178] Initially and optionally during the deposition step, the total volume of the coating composition applied to the coated body is from 5 μl to 100 μl;

[0179] During the deposition of the coating composition, the movement rate of the coated body is not greater than the flow rate of the coating composition in the direction of movement of the coated body;

[0180] The coating composition contains polysiloxane structural units or compounds; and

[0181] The surface energy of the inner surface is higher than the surface energy of the surface of the coating that forms the capillary bridge.

[0182] Coating composition

[0183] The coating composition may contain or consist of the components required to obtain the coating described in this disclosure. 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 embodiments, the polysiloxane compound is a polyalkylsiloxane compound, such as a polydialkylsiloxane compound. Optionally, one or more alkyl groups in the polyalkylsiloxane or polydialkylsiloxane may be independently selected from branched or unbranched C1 to C8 alkyl groups. Furthermore, the coating composition may include a catalyst and / or a diluent.

[0184] A polysiloxane compound is considered "crosslinkable" if it includes one or more (especially two) groups that are polymerizable or crosslinkable under the curing conditions disclosed herein (especially when the curing temperature is below 150°C and the curing time is less than 3000 seconds). A polysiloxane compound is considered "non-crosslinkable" if it does not include any chemical structures that are polymerizable or crosslinkable under the curing conditions disclosed herein (especially when the curing temperature is below 150°C and the curing time is less than 3000 seconds).

[0185] In the embodiments, the coating composition includes:

[0186] - One or more crosslinkable polydialkylsiloxane compounds; and

[0187] - One or more non-crosslinkable polysiloxane compounds.

[0188] Optionally, the coating composition includes:

[0189] - One or more crosslinkable polydialkylsiloxane compounds;

[0190] - One or more non-crosslinkable polysiloxane compounds; and

[0191] - One or more cross-linked polysiloxane compounds.

[0192] Cross-linked polysiloxane compounds

[0193] The crosslinked polysiloxane compound is suitable for reacting with the crosslinkable polysiloxane compound under the conditions of this disclosure (especially when the curing temperature is below 150°C and the curing time is less than 3000 seconds), preferably in a hydrosilylation reaction, to form a polysiloxane network.

[0194] 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 may be independently selected from branched or unbranched C1 to C8 alkyl groups. The alkyl group may be linear alkyl. For example, the alkyl group may be independently selected from methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, and octyl. Optionally, the alkyl group may be independently selected from methyl and ethyl.

[0195] In some embodiments, the crosslinked polysiloxane compound is a polysiloxane having Si-H groups. In an exemplary 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 2 or greater):

[0196]

[0197] Optionally, the crosslinked polysiloxane is a copolymer, particularly a copolymer 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 linear. For example, the alkyl group can be independently selected from methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, and octyl. Optionally, the alkyl group can be independently selected from methyl and ethyl.

[0198] Crosslinked polysiloxanes may be present in the coating composition at concentrations of 0.10 to 1.50 wt%, 0.10 to 1.00 wt%, or 0.10 to 0.60 wt%. In the examples, the concentration of crosslinked polysiloxanes 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%.

[0199] Non-crosslinkable polysiloxane compounds

[0200] The coating composition may contain more than one type, such as at least two or three types of non-crosslinkable polysiloxane compounds. These types may differ in viscosity. In some embodiments, the coating comprises a high-viscosity non-crosslinkable polysiloxane compound with a viscosity greater than 10,000 cSt, and / or a low-viscosity non-crosslinkable polysiloxane compound with a viscosity of 10,000 cSt or lower. The viscosity of the polysiloxane compound can be determined according to DIN EN ISO 3219:1993 using a coaxial cylinder system at 23°C in 10s. -1 The shear rate was determined. Optionally, the viscosity of the high-viscosity non-crosslinkable polysiloxane compound was at least 15,000 cSt, and / or the viscosity of the low-viscosity non-crosslinkable polysiloxane compound was 5,000 cSt or lower.

[0201] The weight ratio (mass) of low-viscosity non-crosslinkable polysiloxane compounds to high-viscosity non-crosslinkable polysiloxane compounds high mass low The 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, the ratio can range from a maximum of 5.00, a maximum of 4.00, or a maximum of 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.

[0202] Optionally, the low-viscosity non-crosslinkable polysiloxane compound has a weight-average molecular weight of 1200 to 30000 g / mol, and / or the high-viscosity non-crosslinkable polysiloxane compound has a weight-average molecular weight of 15000 to 300000 g / mol. In examples, the high-viscosity non-crosslinkable polysiloxane compound has a weight-average molecular weight of 32000 to 210000 g / mol or 100000 to 150000 g / mol. In examples, the low-viscosity non-crosslinkable polysiloxane compound has a weight-average molecular weight of 5000 to 25000 g / mol or 10000 to 20000 g / mol.

[0203] In the embodiments, the low-viscosity, non-crosslinkable polysiloxane compound has a weight-average molecular weight of at least 1200 g / mol, at least 5000 g / mol, or at least 10000 g / mol. The weight-average molecular weight range can be up to 30000 g / mol, up to 25000 g / mol, or up to 20000 g / mol.

[0204] In the examples, the high-viscosity, non-crosslinkable polysiloxane compound has 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. The weight-average molecular weight range can be up to 300,000 g / mol, up to 210,000 g / mol, or up to 150,000 g / mol. The weight-average molecular weight can be determined by gel permeation chromatography (GPC).

[0205] Polydimethylsiloxane is particularly suitable for use as a non-crosslinkable polysiloxane compound.

[0206] Crosslinkable polysiloxane compounds

[0207] Crosslinkable polysiloxane compounds can be crosslinked via one or more (preferably two) end groups. In particular, the end groups may have double bonds, making them suitable for hydrosilylation reactions, for example, under the conditions of this disclosure (especially at curing temperatures below 150°C and curing times of less than 3000 seconds). The end groups may be selected from vinyl, acryloyl, methacryl, styrene, and combinations thereof.

[0208] In the embodiments, crosslinkable polysiloxane compounds and crosslinked polysiloxane compounds can form hydrogenated silylation reaction products under the conditions of this disclosure (particularly at curing temperatures below 150°C and curing times of less than 3000 seconds). Suitable crosslinkable polysiloxane compounds are vinyl-polysiloxane compounds. Crosslinkable polysiloxanes can be crosslinked by reacting multiple Si-H groups with the vinyl groups of the crosslinkable polysiloxane. This reaction can be a platinum-catalyzed reaction.

[0209] 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 may be independently selected from branched or unbranched C1 to C8 alkyl groups. The alkyl group may be linear alkyl. For example, the alkyl group may be independently selected from methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, and octyl. Optionally, the alkyl group may be independently selected from methyl and ethyl.

[0210] diluent

[0211] The coating composition may further comprise one or more diluents. In the context of this disclosure, the diluent may be a silicone-containing solvent in which both crosslinkable and non-crosslinkable polysiloxane compounds are soluble. To ensure good solubility of the polysiloxane compound, a nonpolar solvent may be used as the diluent. In this case, it has been found useful to use an organosilicon compound having up to six silicon atoms as the diluent.

[0212] Examples of diluents include:

[0213] - Cyclic organosilicones, such as: octamethylcyclotetrasiloxane, decamethylcyclopentasiloxane, dodecylcyclohexasiloxane, tetramethylcyclotetrasiloxane, pentamethylcyclopentasiloxane;

[0214] - Hexamethyldisiloxane (HMDSO);

[0215] -Octamethyltrisiloxane;

[0216] -Decamethyltetrasiloxane.

[0217] Mixtures, especially mixtures containing one or more of the above substances, can also be used as diluents.

[0218] The coating composition is a liquid. In the examples, the viscosity of the coating composition is 1.0 to 50 mPas, 2.0 to 25 mPas, or 3.0 to 15 mPas. Optionally, the viscosity of the coating composition can be at least 1.0 mPas, at least 2.0 mPas, at least 3.0 mPas, or at least 3.5 mPas. For example, the viscosity range of the coating composition can be up to 50 mPas, up to 25 mPas, or up to 15 mPas. The viscosity of the coating composition can be determined according to DIN EN ISO 3219:1993 using a coaxial cylinder system at 25°C in 16.8 s. -1 The shear rate was determined.

[0219] Catalyst / Inhibitor

[0220] The coating composition may also include a catalyst for the crosslinking reaction of compounds in a multi-component system. A soluble platinum-containing catalyst, such as chloroplatinic acid, can be used. A Karstedt catalyst can also be used.

[0221] In some embodiments, the coating composition includes at least one inhibitor to prevent spontaneous reactions in the composition. This is advantageous for processing the composition up to the coating. The inhibitor can form a reversible complex with the catalyst, thereby preventing spontaneous crosslinking reactions of the composition.

[0222] Coating composition

[0223] In the embodiments, the coating composition includes a high-viscosity, non-crosslinkable polysiloxane compound, but does not necessarily include a low-viscosity, non-crosslinkable polysiloxane compound.

[0224] In the embodiments, the coating composition includes the following components:

[0225] One or more crosslinkable polysiloxane compounds One or more non-crosslinkable polysiloxane compounds One or more cross-linked polysiloxane compounds One or more catalysts One or more diluents

[0226] In the embodiments, the coating composition comprises the following components by weight percentage:

[0227]

[0228]

[0229] 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.

[0230] 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. The weight ratio of the crosslinkable polysiloxane compound to the non-crosslinkable polysiloxane compound in the coating composition may be at least 0.40, at least 0.60, or at least 0.70. In some embodiments, this ratio is in the range of 0.40 to 3.00, 0.60 to 2.50, or 0.70 to 1.80.

[0231] In the embodiments, the coating composition comprises the following components by weight percentage:

[0232]

[0233] In the embodiments, the coating composition comprises the following components by weight percentage:

[0234]

[0235] In the embodiments, the coating composition comprises the following components by weight percentage:

[0236]

[0237]

[0238] In the embodiments, the coating composition comprises the following components by weight percentage:

[0239]

[0240] More specific coating compositions

[0241] Crosslinked polysiloxane structural units, low-viscosity non-crosslinked polysiloxane structural units, and / or high-viscosity non-crosslinked polysiloxane structural units may contain or be composed of dialkylsiloxane monomer units (especially dimethylsiloxane monomer units).

[0242] In some embodiments, the crosslinkable polysiloxane is a vinyl-functionalized polysiloxane; and / or the crosslinkable polysiloxane compound is a polysiloxane having Si-H groups. An exemplary embodiment 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 greater):

[0243]

[0244] In more specific variations, the coating composition includes the following components:

[0245]

[0246] In more specific variations, the coating composition comprises the following components by weight percentage:

[0247]

[0248] In more specific variations, the coating composition comprises the following components by weight percentage:

[0249]

[0250] In more specific variations, the coating composition comprises the following components by weight percentage:

[0251]

[0252]

[0253] In more specific variations, the coating composition comprises the following components by weight percentage:

[0254]

[0255] In more specific variations, the coating composition comprises the following components by weight percentage:

[0256]

[0257] 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.

[0258] Coated containers

[0259] In an embodiment, this disclosure relates to a coated container. The coating described in detail herein can be obtained by the methods described above. The coated container can be obtained by or can be obtained by the methods of this disclosure. The coated container includes a hollow cylinder having a wall surrounding an inner cavity, the hollow cylinder having at least one opening, wherein at least a portion of the inner surface of the wall includes a coating.

[0260] The average coating thickness can range from 100 nm to 3000 nm.

[0261] Optionally, the total area of ​​excessive coating thickness is less than 10% of the coating area. Excessive coating thickness is defined as an area where the coating thickness is greater than twice, greater than 1.5 times, or greater than 1.20 times the average coating thickness. In some embodiments, the total area of ​​excessive coating thickness is less than 7%, 5%, or 3% of the coating area.

[0262] In an embodiment, the coating comprises one or more silicone-based polymers.

[0263] In some useful embodiments, the total area of ​​insufficient coating thickness is less than 5% of the coating area, and insufficient coating thickness is defined as a region with a coating thickness of less than 100 nm or less than 50 nm. The total area of ​​insufficient coating thickness is less than 3% or 2% of the coating area.

[0264] The coated container of this disclosure may have a coating comprising 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.

[0265] The coating can be applied to the inner surface of the hollow cylinder of the container. The average thickness of the coating can be greater than 100 nm, 200 nm, 300 nm, 400 nm, or 450 nm. Optionally, the average thickness of the coating can be up to 3000 nm, up to 2000 nm, up to 1500 nm, up to 1000 nm, or up to 850 nm. A suitable coating thickness facilitates sealing at low temperatures. In embodiments, the average coating thickness can be from 100 nm to 3000 nm, 200 nm to 2000 nm, 300 nm to 1500 nm, or 400 nm to 1000 nm. Optionally, the average coating thickness is present on at least 90%, at least 95%, or at least 99% of the coated area. In embodiments, the average coating thickness is greater than 400 nm, particularly at least 450 nm or at least 500 nm. An exemplary preferred range for the average coating thickness is >400nm to 1500nm, 450nm to 1250nm, or 450nm to 850nm.

[0266] In embodiments, the hollow cylinder that forms part of the container as described in this disclosure may have a substantially constant inner diameter so that the piston can substantially expel all the composition present within the hollow cylinder. In this case, "substantially constant" includes an inner diameter variation of no more than 200 μm, no more than 100 μm, or no more than 50 μm.

[0267] The container can be any type of container, including vials, syringes, or cartridges. In this embodiment, the container is a syringe or cartridge.

[0268] The coating may comprise one or more organosilicon polymers. An organosilicon polymer is a polymer material composed of monomer units consisting of silicon (Si) and carbon (C) atoms. An example of an organosilicon polymer is a polysiloxane. In an embodiment, the coating comprises one or more polysiloxane structural units. A "polysiloxane structural unit" may refer to a polysiloxane structure within a larger molecule (e.g., covalently bonded to a larger molecule, or a portion thereof) or the polysiloxane molecule itself. For example, a crosslinked polysiloxane structural unit is part of a polymer network (covalently linked), while a non-crosslinked polysiloxane structural unit exists in the coating as a molecule, not covalently linked to other molecules in the coating. Therefore, the coating may comprise crosslinked and / or non-crosslinked polysiloxane structural units. In this context, "crosslinked" means that the polysiloxane structural unit is covalently linked to the polymer network. Specifically, the term "crosslinked" includes the preferred case where the polysiloxane structure is covalently linked to other polysiloxane structures (e.g., via the polymer backbone). Optionally, the crosslinked polysiloxane structural units are covalently bonded to other polysiloxane structures due to a hydrosilylation reaction. The polymer backbone can be formed, for example, by polymerizing a polysiloxane carrying polymerizable functional groups (such as vinyl groups). In contrast, "non-crosslinked" means that the polysiloxane is not covalently linked to other polysiloxane structures via the polymer backbone, or is not covalently linked to other polysiloxanes in the coating at all.

[0269] In embodiments, the crosslinked polysiloxane structural units are crosslinked via one or more (e.g., two) end groups. The end groups may be selected from vinyl, acryloyl, methacrylate, styrene, and combinations thereof. In embodiments, the coating comprises a crosslinkable polysiloxane compound and a hydrosilylation reaction 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 by reacting its multiple Si-H groups with the vinyl group of the crosslinkable polysiloxane. This reaction may be platinum-catalyzed.

[0270] In this disclosure, "polysiloxane" or "polysiloxane structural unit" may refer to a polyalkylsiloxane structural unit, such as a polydialkylsiloxane structural unit. Optionally, one or more alkyl groups in the polyalkylsiloxane or polydialkylsiloxane may be independently selected from branched or unbranched C1 to C8 alkyl groups. The alkyl group may be linear. For example, the alkyl group may be independently selected from methyl, ethyl, propyl, butyl, pentyl, hexyl, heptyl, and octyl. For example, the alkyl group may be independently selected from methyl and ethyl.

[0271] In an embodiment, the coating comprises cross-linked polydialkylsiloxane structural units and non-cross-linked polysiloxane structural units. Specifically, the coating may comprise cross-linked polydialkylsiloxane structural units and non-cross-linked polysiloxane structural units, wherein the non-cross-linked polysiloxane structural units may be one or more silicone oils, i.e., polydialkylsiloxane structural units, such as polydimethylsiloxane silicone oil.

[0272] Optionally, the weight ratio of crosslinked polysiloxane structural units to non-crosslinked 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 crosslinked polysiloxane structural units to non-crosslinked polysiloxane structural units in the coating may be at least 0.40, at least 0.60, or at least 0.70. In some embodiments, this ratio is in the range of 0.40 to 3.00, 0.60 to 2.50, or 0.70 to 1.80.

[0273] The coating may comprise at least one type, such as at least two types, or at least three types of non-crosslinked polysiloxane structural units. These types may differ in viscosity. In some embodiments, the coating comprises high-viscosity non-crosslinked polysiloxane structural units with a viscosity greater than 10,000 cSt, and / or low-viscosity non-crosslinked polysiloxane structural units with a viscosity of 10,000 cSt or lower. The viscosity of the polysiloxane structural units can be determined according to DIN EN ISO 3219:1993 using a coaxial cylindrical system at 23°C in 10s. -1 The shear rate was determined. 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 5000 cSt or lower.

[0274] In the embodiments, the coating comprises high-viscosity non-crosslinked polysiloxane structural units, but does not necessarily include low-viscosity non-crosslinked polysiloxane structural units.

[0275] The weight ratio (mass) of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units. high mass low The 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, the ratio can range from a maximum of 5.00, a maximum of 4.00, or a maximum of 3.00. For example, the weight ratio of low-viscosity non-crosslinked polysiloxane structural units to high-viscosity non-crosslinked polysiloxane structural units can range from 0.10 to 5.00, 0.50 to 4.00, or 1.00 to 3.00.

[0276] 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).

[0277] Optionally, the weight-average molecular weight of the low-viscosity non-crosslinked polysiloxane structural units is from 1200 to 30000 g / mol, and / or the weight-average molecular weight of the high-viscosity non-crosslinked polysiloxane structural units is from 15000 to 300000 g / mol. In examples, the weight-average molecular weight of the high-viscosity non-crosslinked polysiloxane structural units is from 32000 to 210000 g / mol or from 100000 to 150000 g / mol. In examples, the weight-average molecular weight of the low-viscosity non-crosslinked polysiloxane structural units is from 5000 to 25000 g / mol or from 10000 to 20000 g / mol.

[0278] 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. The weight-average molecular weight may be at most 30000 g / mol, at most 25000 g / mol, or at most 20000 g / mol.

[0279] In the embodiments, the high-viscosity non-crosslinked polysiloxane compound has 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. The weight-average molecular weight can be at most 300,000 g / mol, at most 210,000 g / mol, or at most 150,000 g / mol.

[0280] The glass transition temperature of the coating can be -60°C or lower, optionally -70°C or lower, for example -75°C or lower or -80°C or lower. Alternatively, 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 thermomechanical analysis (TMA). An exemplary method for determining the glass transition temperature of the coating includes performing thermomechanical analysis in expansion mode (e.g., using a Q400 thermomechanical analyzer from TA Instruments). A sample can be prepared by coating a container according to this disclosure, scraping off the coating with a doctor blade, and performing thermomechanical analysis in expansion mode (i.e., measuring the expansion or contraction of the sample as a function of temperature). The glass transition temperature of the coating is in the range of -200°C to -60°C, -150°C to -70°C, -120°C to -75°C, or -80°C to -100°C. In the embodiments, the glass transition temperature is -80°C to -90°C.

[0281] 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.

[0282] In this embodiment, the crystallization temperature range and melting temperature range of the coating can be determined using differential scanning calorimetry (DSC) at a temperature change rate of 10 °C / min, wherein the crystallization temperature range and melting temperature range overlap within a temperature range of -75 °C to -100 °C (especially -80 °C). For example, DSC can be performed within a temperature range of -120 °C to -60 °C. A suitable instrument is the DSC Q2000 (TAInstruments).

[0283] The inventors do not wish to be bound by this theory; they assume that both crystalline and molten portions of the coating exist within the overlap range. It is assumed that the coating possesses good mechanical resistance. If the crystalline and molten peak regions extend into the same temperature range, the crystalline 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 range may be between -55°C and -95°C; melting can begin at -90°C and end at -40°C, meaning the endothermic melting peak range may be between -90°C and -40°C. In this example, the overlapping temperature range is -90°C to -55°C. This example satisfies the requirement of temperature overlap between -75°C and -100°C because at least one temperature overlaps within the specified range.

[0284] Generally, this disclosure relates to a container for pharmaceutical compositions comprising a hollow cylinder. The container may be configured to receive a piston that is slidable relative to the hollow cylinder from an open end of the container to another end. In one embodiment, the container has at least two open ends. One open end can be used to insert the piston. The other open end may be located on the opposite side of the container, for example, on the tip side in the case of a syringe.

[0285] This disclosure is not particularly limited to container volume. In embodiments, the volume of the hollow cylinder is at least 0.10 ml, at least 0.50 ml, or at least 1.00 ml. Alternatively, the volume can be up to 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 20 ml, or 1.00 ml to 25 ml. In embodiments, the volume of the hollow cylinder is less than 10.0 ml.

[0286] The hollow cylinder has an inner cavity surrounded by walls, wherein the wall thickness is at least 0.50 mm, at least 0.80 mm, or at least 1.00 mm. Optionally, the wall thickness can be at most 10.0 mm, at most 8.0 mm, at most 5.0 mm, or at most 4.0 mm. In embodiments, the wall thickness is from 0.50 mm to 10.0 mm, from 0.80 mm to 8.0 mm, or from 1.00 mm to 4.00 mm. As used herein, the term "wall thickness" refers to the shortest distance between the inner and outer surfaces of the hollow cylinder.

[0287] 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, connected by a straight line perpendicular to and intersecting the longitudinal axis of the cylinder. The term "inner diameter" refers to the maximum distance between two points on the inner surface of a hollow cylinder, connected by a straight line perpendicular to and intersecting the longitudinal axis of the cylinder.

[0288] The hollow cylinder of the container can have a substantially constant inner diameter. This means that the total inner diameter variation is very small. "Total inner diameter variation" is the difference between the maximum inner diameter of the hollow cylinder and the minimum inner diameter of the same hollow cylinder. Optionally, the total inner diameter variation is less than 0.10 mm, less than 0.08 mm, less than 0.06 mm, or less than 0.04 mm. The smaller the total inner diameter variation, the better. However, in some embodiments, providing a container with extremely small total inner diameter variation may not be economically feasible. Therefore, in embodiments, the total inner diameter variation can be at least 0.0001 mm, at least 0.001 mm, or at least 0.01 mm. For example, the total inner diameter variation can be in the range of 0.0001 mm to <0.10 mm, 0.001 mm to <0.08 mm, or 0.01 mm to <0.04 mm.

[0289] According to various aspects of this disclosure, the standardized sliding force of the container does not exceed 5.0 N. Sliding force represents the force required to push the piston within the hollow cylinder, while release force represents the force required to induce the initial movement of the piston within the hollow cylinder. "Standardized sliding force" is the sliding force (GF) measured under standard conditions. Similarly, "standardized release force" is the release force (BLF) measured under standard conditions. Standard conditions include a standard piston, namely a Detweller FM257 / 2 piston made of brominated butyl rubber with a hardness of 52 Shore A and a density of 1.355 g / cm³, available from Detweller Pharmaceutical Packaging International (NV, 1519 Kolmen Industrial Zone, Alken, Belgium, BE-3570). BLF and GF can be measured simultaneously. The testing of BLF and GF may be referred to as the "BLGF" test. Any reference to "release force" or "sliding force" herein refers to the standardized release force or sliding force.

[0290] The standardized BLGF test was performed at room temperature (i.e., 20°C) on a universal testing machine. To achieve this, a standardized BLGF testing apparatus with a 50N test cup was used. The samples were fixed vertically in a 2kN universal testing machine (model 106, from TesT AG, CH-6331, Hulenburg, Switzerland).

[0291] BLF is the force required to move the piston from its original position. GF is the force required to keep the piston moving after it has loosened.

[0292] The containers are filled with water for injection. After filling, the samples are either stored immediately or tested immediately, depending on the purpose of the test. The samples are tested without a needle.

[0293] Insert the sample into the fixture and move the pressure head toward the piston at a speed of 20 mm / min. Once a force of 0.25 N is measured, the machine switches to a test rate of 100 mm / min and begins recording data. The experiment ends when the measured force exceeds 35 N (which typically occurs when the force reaches the far end of the hollow cylinder).

[0294] BLF is the maximum force measured within the first 4 mm of piston movement. GF is measured within a test range that begins after 4 mm of movement and ends 10 mm before reaching the distal end of the hollow cylinder. According to this disclosure, GF is the highest sliding force measured in this experiment.

[0295] The container disclosed herein may exhibit a normalized BLF not exceeding 12.0 N. In some embodiments, the normalized BLF may be limited to an upper limit of 9.0 N, 8.0 N, 7.0 N, 6.0 N, 5.0 N, or even 4.0 N. The normalized 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 piston.

[0296] The ratio of the normalized BLF to the normalized GF of the container, BLF / GF, is greater than 1.30. Optionally, the ratio of normalized BLF to normalized GF is characterized by BLF / GF ≤ 3.0. In embodiments, for the container of this disclosure, the ratio BLF / GF is >1.40, >1.50, or even >1.60. In some embodiments, the ratio BLF / GF may be <2.5, <2.2, <2.0, or even <1.9.

[0297] The standardized GF of the container disclosed herein can be <7.5N, <6.5N, <5.5N, <4.5N, <3.5N, or even <2.5N.

[0298] Appropriate sliding and loosening forces are related to the ease of use of the containers of this disclosure. However, a sufficiently high loosening force may help to suppress unwanted piston movement during storage. Optionally, the containers according to this disclosure have a standardized sliding force of at least 0.5 N.

[0299] In order to ensure a tight seal by suppressing piston movement during cryogenic storage, the container of this disclosure may have a standardized loosening force that exceeds the container’s standard sliding force by at least 30%, at least 60%, at least 100%, or at least 200%.

[0300] In embodiments, this disclosure relates to containers containing pharmaceutical compositions as described herein. The pharmaceutical composition may contain more than 60 wt% water. Optionally, the pharmaceutical composition contains a protein or nucleic acid therapeutic agent.

[0301] Example

[0302] Exemplary container

[0303] Now refer to the attached diagram, Figure 1 A container 1, i.e., a syringe 3 for administering pharmaceuticals or cosmetics, is shown in an exemplary embodiment. The syringe 3 is made of a polymer and includes a wall 5 surrounding an inner cavity. The container includes a hollow cylinder 7, an opening 4, and a nesting surface 18, on which an injection needle or cap can be placed, for example,. A piston 12 is inserted into the cylindrical portion and can slide axially by pressure on a push rod 13. The syringe 3 has a flange 15 for operation.

[0304] A coating 10 is provided on the inner surface of container 1 (specifically, the inner surface of hollow cylinder 7). In this example, the coating 10 covers the inner surface area of ​​hollow cylinder 7, within which piston 12 can slide when the syringe is emptied or used for aspiration.

[0305] Coating composition

[0306] The table below shows two exemplary coating compositions that are useful in the methods disclosed herein.

[0307]

[0308] Coating thickness

[0309] Figure 2The pressure fitting technique is illustrated. A coating body 20 is inserted into a drug container 1 (here, a syringe), the drug container 1 having an opening 4 and a hollow cylinder 7. A coating composition 8 is applied to the coating body 20. The coating body 20 is in direct physical contact with the inner surface of the container. The coating composition 8 is deposited in the deposition area on the inner surface, while the coating body 20 moves relative to the hollow cylinder 7, in this case, moving downwards, leaving a layer of coating composition 8 on the inner surface. When it reaches the opening 4 of the container 1, the coating body 20 is withdrawn from the container 1. This yields a product with... Figure 4 The coating thickness distribution shown in Figure A is for a coated container 1.

[0310] 3.A shows a coating 20 inserted into a hollow cylinder 7 with a wall 5 according to a press-fit technique, while Figure 3 Figure B shows a coating body 20 inserted into a hollow cylinder 7, wherein a circumferential gap 22 exists between the coating body 20 and the inner surface of the hollow cylinder 7. The coating body 20 also includes a conduit 23 through which a coating composition can be applied to the coating body, such that the coating composition flows toward the mid-latitude line of the coating body 20.

[0311] Figure 5 A shows an exemplary coating 20 with a mid-latitude line 24 and a hemispherical portion of the coating 20 above the mid-latitude line 24, wherein h k is the height of the capillary bridges on the surface of the coated body, and hw is the height of the capillary bridges on the inner surface of the hollow cylinder. Figure 5 Figure B shows a geometric diagram of the capillary bridge 25 that can be formed between the coating body 20 and the inner surface. D represents the size of the gap spanned by the capillary bridge; R1 is the radius of curvature of the coating body; θ1 is the contact angle between the coating composition and the coating body; θ2 is the contact angle between the coating composition and the inner surface of the hollow cylinder; l is the azimuth radius; r is the meridional radius; β describes the position of the three-phase contact line on the particle surface. The height of the liquid meniscus is h.

[0312] Comparative experiments were conducted in which the coating was applied via press-fit technique and using the capillary bridge technique of this disclosure (i.e., using... Figure 2 Another coating is applied using the same method as shown, but with a smaller diameter coating body, thus forming capillary bridges. The coating compositions and containers are identical for both methods. This experiment uses... A 1ml 1g LL syringe. The syringe is made of COC with an inner surface energy of approximately 30mN / m. The coating is a hemispherical PTFE head with a surface energy of approximately 18mN / m. The coating composition has a surface energy of 13mN / m and a viscosity of approximately 4mPas. The syringe barrel has an inner diameter of 6.5mm. The diameter at the mid-latitude of the coating is 6.4mm.

[0313] Figure 4Figure A shows the thickness analysis of the coating produced according to the press-fit method. Figure 4 Figure B illustrates the thickness analysis of a coating produced according to the method of this disclosure. It is evident that... Figure 4 The coating of component B is very uniform, with an average thickness of 730 nm. The total area with excessively thick coatings is less than 5% of the total coating area. The total area with insufficiently thick coatings (<100 nm) is less than 5% of the total coating area.

[0314] Figure 4 The layer thickness distributions shown in Figures A and B were measured using the RapID Layer Explorer measurement device. LayerExplorer RapID is a computer-aided device with an integrated interferometer. A camera is also connected for positioning. RapID can measure the average film thickness on the inner side of transparent, hollow cylinders (especially glass and plastic-based materials). It can also measure other cylindrical primary packaging materials, such as cartridges.

[0315] Using the principle of white light reflection, coating thickness is measured at multiple points on the coating (e.g., at least 240 or 480 points distributed across the coating area) (each point 1mm × 1mm). By measuring multiple points on the coating, the coating distribution within the hollow cylinder can be quantitatively determined. The associated measurement mode is called the BI mode (coating height > 100nm). RapID can also be used to measure lower (> 20nm) coating heights. Measurements are performed using a laser as the light source. This measurement method is called the UT mode (similar to ultrathin). The coating height is measured starting 5mm above the flange, with any 1mm point measured to the conical side. Using these settings, there are 49 measurement points along the cylinder. After measuring the entire length, the stage automatically rotates by a given angle and begins measuring a new line again. In this example, the stage rotation is always maintained at 30°, meaning 12 × 49 points = 588 points. Any image represented is based on 588 single measurements. The RapID software represents the data as 2D pseudocolor and converts it to 3D elevation or height profiles. The coating thickness is expressed in grayscale (see...). Figure 4 (AB). Black indicates a layer thickness of 2000 nm, and white indicates 0 nm or no measurement. The RapID analyzer is used for layers thicker than 50 nm and treats any layer thinner than 50 nm as non-existent. However, with special settings on the RapID device, layer thicknesses as low as 20 nm can also be measured.

Claims

1. A method for manufacturing a coated container, the method comprising: - A container comprising a hollow cylinder having a wall surrounding an inner cavity, the hollow cylinder having at least one opening. - The coating material is inserted into the inner cavity through the opening. - Apply a coating composition to the coated body such that the coating composition contacts at least a portion of the inner surface of the wall. - By moving the coating body relative to the hollow cylinder, the coating composition is deposited on the deposition area of ​​the inner surface of the wall. - The coating is withdrawn from the cavity through the opening. The dimensions of the coating body are such that a circumferential gap exists between the coating body and the inner surface of the wall during the deposition step.

2. The method according to claim 1, wherein, The circumferential gap is sized such that, during the deposition step, the coating composition forms a capillary bridge spanning the circumferential gap.

3. The method according to claim 1 or 2, wherein, The size of the circumferential gap is characterized by a distance D of less than 0.10 mm between the coating and the deposition area during the deposition step, and preferably... Wherein, the distance D is 0.005mm to 0.08mm, or 0.01mm to 0.04mm.

4. The method according to any one of the preceding claims, wherein, The wall comprises or is composed of polymeric materials or glass.

5. The method according to any one of the preceding claims, wherein, The coating composition comprises, by weight percentage: 。 6. The method according to any one of the preceding claims, wherein, During the deposition of the coating composition, the movement rate of the coating body is not greater than the flow rate of the coating composition in the direction of movement of the coating body.

7. The method according to any one of the preceding claims further includes the following steps: - After depositing the coating composition on the deposition area, the container is air-rinsed, and / or - After depositing the coating composition on the deposition area, the coating composition is cured to obtain a cured coating.

8. The method according to any one of claims 3 to 7, wherein, - The total inner diameter variation of the cylinder in the deposition region is at most 2D, and / or - The total outer diameter of the coated body varies by a maximum of 2D.

9. The method according to any one of the preceding claims, wherein, - The coating body includes one or more conduits adapted to deliver the coating composition through the coating body, and optionally, the step of coating the coating body with the coating composition includes delivering the coating composition through the one or more conduits, and / or - Applying a coating composition to the coating body comprises: conveying the coating composition to a portion of the coating body above the mid-latitude line, thereby allowing the coating composition to flow downwards on the coating body; and / or - Applying a coating composition to the coating body includes: delivering the coating composition to a portion of the coating body and allowing the coating composition to form a capillary bridge between the coating body and the inner surface of the wall.

10. The method according to any one of claims 7 to 9, wherein, After curing, - Average coating thickness of 100 nm to 3000 nm, and / or - The total area of ​​excessive coating thickness is less than 10% of the coating area, and excessive coating thickness is defined as the area where the coating thickness is greater than twice the average coating thickness.

11. The method according to any one of claims 7 to 10, wherein, After curing, the coating contains one or more silicone organic polymers.

12. A coated container, optionally obtained or obtainable by the method of any one of the preceding claims, the container comprising a hollow cylinder having a wall surrounding an inner cavity, the hollow cylinder having at least one opening, wherein, At least a portion of the inner surface of the wall includes a coating, wherein, - The average coating thickness ranges from 100 nm to 3000 nm, and - Wherein, the total area of ​​excessive coating thickness is less than 10% of the coating area, and excessive coating thickness is defined as the area where the coating thickness is greater than twice the average coating thickness.

13. The coated container according to claim 12, wherein, The coating comprises one or more silicone organic polymers.

14. The coated container according to claim 12 or 13, wherein, The total area of ​​insufficient coating thickness is less than 5% of the coating area, and insufficient coating thickness is defined as a region with a coating thickness of less than 100 nm.