Glass vial for medical use with thin film layer

Abstract

The present invention provides a glass vial for medical use, which is provided with an opening, a mouth portion, a shoulder portion, and a chamber to be filled. The glass vial is characterized in that: the vial has a thin film layer on at least a portion of the inner wall surface; the chamber to be filled has a side surface portion and a bottom surface portion; the thickness of the thin film layer in the bottom surface portion is 5-150 times thicker than the thickness of the thin film layer in the side surface portion; and the average thickness of the thin film layer in the bottom surface portion is 100-5000 nm.

Description

Glass medical vials with a thin film layer

[0001] The present invention relates to a medical vial made of glass, and more particularly to a medical vial made of glass having a thin film layer on its inner wall surface.

[0002] Biopharmaceuticals have come to occupy a very important position in the pharmaceutical market in recent years. Biopharmaceuticals are attracting considerable attention, particularly in the treatment of cancer, autoimmune diseases, and diabetes, because they have the potential to provide therapeutic effects that could not be achieved with conventional small-molecule compounds.

[0003] Biopharmaceuticals are medicines whose main component is biomolecules, and they play a central role, especially in the fields of personalized medicine and advanced treatments.

[0004] Borosilicate glass vials are widely used for the storage and transport of biomolecules such as proteins and nucleic acids, which are the active ingredients of biopharmaceuticals.

[0005] Borosilicate glass is suitable as a container material for biopharmaceuticals due to its low expansion and high chemical resistance, but it has the problem of biomolecules adsorbing to the inner wall of the container. When biomolecules, which are the active ingredients, adsorb to the inner wall of the container, it becomes difficult to administer the drug to the patient at the intended concentration, and preparing the drug while anticipating such losses leads to increased costs. Therefore, suppressing the adsorption of active ingredients to the inner wall of the container is recognized as one of the important issues in the field of pharmaceutical formulation.

[0006] The amount of biomolecules adsorbed onto the inner wall of a medical vial basically increases in proportion to the surface area of ​​the inner wall of the vial. Therefore, it is preferable that the surface of the inner wall of a medical vial has as few irregularities as possible so that its surface area is as small as possible. However, in the case of containers made of borosilicate glass, due to the manufacturing process, numerous indentations and defects are formed on the bottom surface of the container.

[0007] These indentation defects are formed by the following mechanism: (1) Boron-derived aggregates adhere to the bottom surface of the vial during vial manufacturing; (2) A modified layer is formed in the area where the aggregates adhere; (3) The formed modified layer peels off during the washing process. This peeling off of the modified layer results in numerous defects on the bottom surface of the vial, each with a depth of approximately 0.1 to 1 μm. The increase in the surface area of ​​the vial bottom due to the occurrence of these defects leads to an increase in the amount of biomolecules adsorbed.

[0008] Therefore, as a means of avoiding the adsorption of biomolecules, the present inventors have developed a method to solve the problem of increased surface area due to peeling of the altered layer and simultaneously suppress the adsorption of biomolecules by coating the inner wall of the vial with a thin film or the like that has low adsorption properties to biomolecules (Patent Document 1).

[0009] To date, a great deal of knowledge has been accumulated regarding the technology of coating the inner walls of such containers, including studies on the coating agents themselves and coating methods, starting with Patent Document 1. However, on the other hand, the physical properties of the thin film layer formed on the inner wall of the container by the coating agent, such as the distribution of film thickness and the coefficient of friction, have not been sufficiently studied.

[0010] International Publication No. 2023 / 176479

[0011] In view of the above background, the object of the present invention is to provide a glass medical vial in which the adsorption of biomolecules is suppressed by optimizing the physical properties of a thin film layer formed on the inner wall of the medical vial.

[0012] The inventors, through diligent research into the above-mentioned problems, have discovered that by optimizing the thickness of the thin film layers on the bottom and sides of the vial, the adsorption of biomolecules can be efficiently suppressed. In addition, they have found that by optimizing the static and dynamic friction coefficients by adjusting the thickness of the thin film layer at the mouth of the vial, improvements in airtightness, prevention of cap displacement due to vibration and impact, and avoidance of distortion and damage to the container when attaching the cap to the vial can be achieved. Furthermore, they have found that by making the thickness of the thin film layer on the sides significantly smaller than that on the bottom, good visibility of the contents inside the vial can be maintained. Based on these findings, the inventors have completed the present invention by further research. That is, the present invention is as follows.

[0013] [1] A medical vial made of glass, comprising an opening, a mouth portion, a shoulder portion, and a filling chamber, wherein the vial has a thin film layer on at least a part of its inner wall surface, the filling chamber has a side portion and a bottom portion, the thickness of the thin film layer on the bottom portion is 5 to 150 times thicker than the thickness of the thin film layer on the side portion, and the average thickness of the thin film layer on the bottom portion is 100 to 5000 nm. [2] The medical vial according to [1], wherein the average thickness of the thin film layer on the side portion is 10 to 100 nm. [3] The medical vial according to [1] or [2], wherein the inner wall surface of the mouth portion at a position 1 mm from the opening has a dynamic friction coefficient of 0.20 or less with respect to butyl rubber.

[0014] According to the present invention, it is possible to provide a glass medical vial that suppresses the adsorption of biomolecules and has good visibility. Furthermore, according to the present invention, it is possible to improve the airtightness of the glass medical vial, prevent the cap from shifting due to vibration or impact, and avoid distortion or damage to the vial when attaching the cap to the vial.

[0015] Figure 1 is a schematic diagram showing an example of a cross-section of a medical vial.

[0016] The present invention will be described in detail below.

[0017] The present invention provides a medical vial made of glass, comprising an opening, a mouth portion, a shoulder portion, and a filling chamber, wherein the vial has a thin film layer on at least a portion of its inner wall surface, the filling chamber has a side portion and a bottom portion, the thickness of the thin film layer on the bottom portion is 5 to 150 times thicker than the thickness of the thin film layer on the side portion, and the average thickness of the thin film layer on the bottom portion is 100 to 5000 nm, and the medical vial (hereinafter sometimes referred to as "the vial of the present invention") is provided.

[0018] The vial of the present invention is characterized by being made of glass. The glass used in the vial of the present invention is not particularly limited as long as it is glass that can be used for medical vials, and any type of glass may be used. Examples include, but are not limited to, borosilicate glass, aluminosilicate glass, quartz glass, and soda-lime glass. In a preferred embodiment, the glass may be borosilicate glass.

[0019] The shape of the vial of the present invention is not particularly limited as long as it is a shape adopted in general medical vials, and may be any shape. A general medical vial has an opening, a mouth, a shoulder, and a filling chamber, as illustrated in Figure 1.

[0020] The opening of the vial of the present invention may be of any shape (circular, elliptical, polygonal, etc.) and size, as long as it is configured to allow filling with a drug solution and to be sealed with a rubber stopper or cap. From the viewpoint of compatibility with automatic drug solution filling equipment and automatic capping devices, it is preferable to adopt a standardized shape and size for the opening.

[0021] In the vial of the present invention, the mouth portion refers to the portion located between the opening and the shoulder portion. The mouth portion may have any shape (circular, elliptical, polygonal, etc.) and size, as long as it can secure a rubber stopper or cap by frictional force, thereby maintaining good airtightness of the vial after sealing. It is also preferable to adopt a standardized shape and size for the mouth portion. When the term "mouth portion" is used in the context of the thickness of the thin film layer, it refers to the inner surface of the vial.

[0022] Furthermore, since the contact area between the inner surface of the vial opening and the inner surface of the rubber stopper or cap at the opening affects the fixing strength of the rubber stopper or cap, the length from the opening to the shoulder is usually 6 mm or more, preferably 7 mm or more, and more preferably 8 mm or more, but is not limited to these values. Furthermore, there is no particular upper limit, but it is usually 12 mm or less, preferably 11 mm or less, or 10 mm or less, and more preferably 9 mm or less, but is not limited to these values.

[0023] In the vial of the present invention, the shoulder portion is the part extending from the mouth to the filling chamber, and refers to the region where the diameter of the vial changes. The shoulder portion may be inclined from the mouth to the filling chamber as shown in Figure 1, or it may be horizontal. The shape and size of the shoulder portion are also not particularly limited, and any shape and size may be adopted as long as it smoothly connects the mouth and the filling chamber. When the term "shoulder portion" is used in the context of the thickness of the thin film layer, the term shall refer to the inner surface of the vial.

[0024] In the vial of the present invention, the filling chamber is the main part of the vial and refers to the part intended to maintain the drug solution filled in the vial. The shape and size of the filling chamber are also not particularly limited, and any shape and size may be adopted as long as the intended amount of drug solution can be maintained. It is preferable to adopt a standardized shape and size for the filling chamber. Furthermore, in the vial of the present invention, the filling chamber is composed of a side portion and a bottom portion. In this specification, "central region of the side portion" refers to the area 1 mm on both sides of the center line that divides the height of the filling chamber in two. When the terms "side portion," "central region of the side portion," and "bottom portion" of the filling chamber are used in the context of the thickness of the thin film layer, these terms all refer to the inner surface of the vial.

[0025] The vial of the present invention is characterized by having a thin film layer on at least a portion of its inner wall surface. In one embodiment, the vial of the present invention may have a thin film layer formed only in the filling chamber. In another embodiment, the vial of the present invention may be prepared so that, for example, a thin film layer is formed in the filling chamber, and a portion of the shoulder and mouth area does not have a thin film layer. In yet another embodiment, the vial of the present invention may be prepared so that, for example, a portion of the mouth area does not have a thin film layer, and the rest is covered with a thin film layer. In yet another embodiment, the vial of the present invention may be prepared so that a thin film layer is present in all areas of the inner wall surface of the vial of the present invention. In other words, the vial of the present invention may be prepared so that a thin film layer is present in all areas of the mouth, shoulder, and filling chamber. As described later, one of the features of the vial of the present invention is that the thickness of the thin film layer in the mouth, shoulder, and filling chamber is optimized.

[0026] In the vial of the present invention, the method for measuring the thin film layer is not particularly limited, and known methods can be used. Examples include, but are not limited to, scanning electron microscopes (SEM), stylus-type thin film step meters, optical interferometry, ellipsometry, and spectral reflectance methods. The measurement procedures for SEM and stylus-type thin film step meters are outlined below. <SEM> A vial having a thin film to be measured is broken at a desired location in liquid nitrogen. The cross-section of the broken area is observed with an SEM, and the thickness of the thin film layer is calculated from the cross-sectional image. <Stylus-type thin film step meter> A 3 mm square section is cut out from the area to be measured using a glass cutter or the like. A portion of the thin film coating on the surface of the cut-out piece is scraped off using metal tweezers to expose the glass surface. The thickness of the thin film layer is measured using a stylus-type thin film step meter.

[0027] Furthermore, in the vial of the present invention, the "thickness" of the thin film layer is defined as follows: <Bottom surface> A circle with a diameter of 5 mm is set in the center of the bottom surface, and the film thickness is measured at five locations within the circle. The arithmetic mean of these five points is taken as the thickness of the bottom surface. The five points shall be selected without bias within the region. <Side surface> The film thickness is measured at five locations within the central region of the side surface, and the arithmetic mean of these five points is taken as the thickness of the side surface. The five points shall be selected without bias within the region.

[0028] The vial of the present invention is characterized in that the thickness of the thin film layer at the bottom of the filling chamber is greater than the thickness of the thin film layer at the side of the filling chamber, and the average thickness of the thin film layer at the bottom is usually 100 to 5000 nm, preferably 100 to 4000 nm, 100 to 3000 nm, 100 to 2000 nm, 100 to 1000 nm, or 100 to 500 nm. An average thickness of 100 nm or more of the thin film layer at the bottom makes it easier to smooth out defects at the bottom and suppress the increase in protein adsorption at the bottom. On the other hand, an average thickness of 5000 nm or less of the thin film layer makes it possible to suppress excessive unevenness in the thin film layer, which can lead to the formation of steps and an increase in protein adsorption.

[0029] In one embodiment, the vial of the present invention is characterized in that the average thickness of the thin film layer on the side surface is usually 10 to 100 nm, preferably 10 to 95 nm, 10 to 90 nm, 10 to 85 nm, 13 to 80 nm, or 13 to 75 nm, more preferably 15 to 50 nm, or 20 to 40 nm. If the average film thickness on the side surface exceeds 100 nm, unevenness occurs in the thin film layer, reducing the visibility of the contents of the vial. From the viewpoint of suppressing unevenness, a thinner thin film layer is preferable, and if the average film thickness is 100 nm or less, unevenness can be reduced more effectively regardless of the coating method. On the other hand, from the viewpoint of suppressing protein adsorption, 10 nm or more is preferable.

[0030] One of the features of the vial of the present invention is that the thickness of the thin film layer at the bottom of the filling chamber is 5 to 150 times thicker than the thickness of the thin film layer at the side of the filling chamber. In one embodiment, the thickness of the thin film layer at the bottom of the filling chamber is usually 5 times or more, preferably 6 times or more, 7 times or more, or 8 times or more, and more preferably 9 times or more, than the thickness of the thin film layer at the side of the filling chamber, but is not limited to these. Also in one embodiment, the thickness of the thin film layer at the bottom of the filling chamber is usually 150 times or less, preferably 100 times or less, 50 times or less, or 25 times or less, and more preferably 15 times or less, than the thickness of the thin film layer at the side of the filling chamber, but is not limited to these. In one embodiment, the thickness of the thin film layer at the bottom of the filling chamber is usually 5 to 150 times thicker, preferably 6 to 100 times thicker, 7 to 50 times thicker, or 8 to 25 times thicker, and more preferably 9 to 15 times thicker, than the thickness of the thin film layer at the side of the filling chamber, but is not limited to these.

[0031] In one embodiment, the vial of the present invention is characterized in that the thickness of the thin film layer at the bottom of the filling chamber and the thickness of the thin film layer at the side of the filling chamber are in the following combinations: [Bottom (nm)]:[Side (nm)] (1) 100-5000: 10-100 (2) 100-4000: 10-90 (3) 100-3000: 10-85 (4) 100-2000: 13-75 (5) 100-1000: 15-50 (6) 100-500: 20-40

[0032] The thickness of the thin film layer in the vial of the present invention can be adjusted by any method. For example, as shown in the examples described later, a method can be used in which the coating solution for the thin film layer is filled to a different depth and applied multiple times. Alternatively, methods such as adjusting the orientation of the vial when the coating solution dries (i.e., whether the bottom or the opening is facing downwards when drying), adjusting the viscosity of the coating solution, or using a spray coat can be used, but are not limited to these.

[0033] In another embodiment, the vial of the present invention is characterized in that the inner wall surface of the mouth at a position 1 mm from the opening has a dynamic friction coefficient of 0.20 or less with respect to butyl rubber. Preferably, the dynamic friction coefficient is 0.10 or more. After filling the vial with pharmaceuticals, a rubber stopper may be inserted into the mouth. If the dynamic friction coefficient is within the above range, excessive load on the mouth when inserting the rubber stopper can be prevented, thus preventing damage to the vial. The dynamic friction coefficient can be adjusted by the roughness of the glass surface, the presence or absence of a thin film layer, the location of the layer formation, and the film thickness.

[0034] The coefficient of friction can be measured using methods that are already known. Examples include the inclined plate method and the measurement method using a tribometer, but are not limited to these. An example of a method for measuring the coefficient of friction is the measurement method specified in the Japanese Industrial Standards "Plastics - Film and sheeting - Determination of the coefficients of friction" (K 7125:1999 (ISO 8295:1995)), but are not limited to these.

[0035] In the vial of the present invention, since the film thickness of the thin film layer is a technical essence, the substance constituting the thin film layer may be any substance as long as it does not adversely affect the active ingredient dissolved or dispersed in the filled chemical solution. However, from the perspective of imparting further high added value to the vial, the substance constituting the thin film layer (i.e., the coating agent) is, for example, a coating agent for preventing the interaction between the chemical solution or the active ingredient contained in the chemical solution and the surface of the glass, a coating agent for stabilizing the active ingredient or suppressing the adsorption to the surface of the glass, a coating agent having functions such as a coating agent for preventing delamination of the glass surface by the chemical solution, etc., may be used alone or in combination.

[0036] Examples of the coating agent used in the vial of the present invention include, but are not limited to, Lipidure-CR300, Lipidure-CM5206, Lipidure-CR2001, Lipidure-NH01 (manufactured by NOF Corporation), prevelex AP01, prevelex CC1, prevelex CC2 (manufactured by Nissan Chemical Industries, Ltd.), Biosurfine-AWP (manufactured by Toyo Synthetic Industry Co., Ltd.), and SEC ONE SURFACE (manufactured by Toyobo Co., Ltd.). In a preferred embodiment, the coating agent constituting the thin film layer includes a coating agent containing the copolymer used in the following examples, and coating agents disclosed in WO2019 / 151265, WO2019 / 198374, WO2023 / 176479, JP2024-084216, Japanese Patent Application No. 2023-141324, and Japanese Patent Application No. 2023-181367, etc., but is not limited thereto.

[0037] The present invention will be described more specifically in the following examples, but the present invention is not limited by these examples.

[0038] Test Example 1: The bottom and side surfaces of a glass vial were coated with a coating agent so as to have the film thickness shown in Table 1 below. An aqueous solution containing a protein (Fibrinogen or IgG) was filled into the obtained glass vial, allowed to stand under certain conditions, and then the amount of the protein adsorbed on the inner wall surface of the glass vial was measured. The coating of the glass vial and the measurement of the amount of the protein adsorbed on the inner wall of the glass vial were carried out according to the following procedure.

[0039] [Preparation of Coating Agent] The coating agent was prepared as follows.

[0040] (Monomer) KBM503: 3-methacryloxypropyltrimethoxysilane (CH ２ =C(CH ３ )-COO-(CH ２ ), molecular weight 248.4, "KBM-503" manufactured by Shin-Etsu Silicone Co., Ltd.). HEMA: Hydroxyethyl methacrylate (CH ３ =C(CH ３ )-COO-CH ３ CH ２ =C(CH ３ )-COO-CH ２ CH ２ O-H, molecular weight 130.14). MEA: Methoxyethyl acrylate (CH ２ =CH-COO-CH ２ CH ２ O-CH ３ , molecular weight of 130.14).

[0041] (Polymerization Initiator) AIBN: 2,2'-(azobisisobutyronitrile) VPE0201: An azo-based polymerization initiator having a polyoxyethylene chain (a compound having a structure in which n5 is 45 to 46 and n6 is 6 to 14 in the following formula (PI), molecular weight 2240, "VPE-0201" manufactured by Fujifilm Wako Pure Chemical Corporation).

[0042]

[0043] Methoxypropanol and diacetone alcohol were mixed in a mixed solvent at a ratio of 85:15 (mass ratio). In this mixed solvent, each component was dissolved in a ratio of KBM503:HEMA:MEA:VPE0201 = 10:35:35:20 (mass%) to a solid content concentration of 20% by mass. The resulting solution was placed in a pressure-resistant glass bottle, sealed, and polymerized by heating at 80°C for 24 hours to obtain a copolymer solution with a solid content concentration of 20% by mass.

[0044] [Preparation of coating solution] To 0.5 g of the obtained copolymer solution with a solid content of 20% by mass, 0.9 g of a mixed solvent prepared by mixing methoxypropanol and diacetone alcohol in a mass ratio of 85:15 and 0.6 g of a 0.1% by mass aqueous solution of nitric acid were added, and the mixture was stirred at 50°C for 16 hours. Then, 3 g of the mixed solvent prepared by mixing methoxypropanol and diacetone alcohol in a mass ratio of 85:15 was added to obtain a coating solution with a solid content of 2% by mass.

[0045] [Coating Glass Vials] (1) To coat only the bottom surface, fill the glass vial with the prepared coating solution from the bottom surface up to 1 / 3 of the height of the filling chamber. (2) Dispense the coating solution filled in the glass vial with a pipette. (3) With the bottom of the vial facing down, heat the vial at 100-250°C for 30 minutes to fix the coating agent to the bottom surface of the vial. (4) Repeat steps (1) to (3) to adjust the thickness of the coating layer on the bottom surface of the vial. (5) To coat the sides, fill the glass vial with the coating solution up to the shoulder. (6) Dispense the coating solution filled in the glass vial with a pipette. (7) With the bottom of the vial facing down, heat the vial at 100-250°C for 30 minutes to fix the coating agent to the sides of the vial. (8) Repeat steps (5) to (7) as needed, adjusting the height to which the coating liquid is filled in step (5), and adjusting the thickness of the coating layer on the side of the vial.

[0046] [Measurement of the amount of protein adsorbed on the inner wall of a glass vial] (1) Add 1 mL of a 1 mg / mL protein (Fibrinogene or IgG) solution to a coated glass vial. (2) Seal the glass vial with a rubber stopper and let it stand at room temperature (23-25°C) for 1 hour. (3) Pipette the protein solution out of the vial. (4) Add 4 mL of washing solution (physiological saline solution in which Tween 20 (Sigma Aldrich) is dissolved at 0.05% by mass) to the empty vial and manually drain it. (5) With the vial opening facing vertically downwards, tap it 10 times against a Kimtowel to remove the liquid. (6) Repeat steps (4) and (5) four times. (7) Add 1 mL of TMB peroxidase (KPL, 5120-0053, SeraCare Life Sciences) to the glass vial as a colorimetric reagent and let stand for 7 minutes. (8) Add 0.5 mL of 1 mol / L sulfuric acid to the glass vial to stop the color development. (9) Transfer 150 μL of the solution in the glass vial to a 96-well TCPS plate and measure the absorbance of light at 450 nm using a microplate reader (CYTATION 5, BioTek). (10) Based on the obtained absorbance, use a calibration curve created using protein solutions of known concentrations and the surface area of ​​the vial that was in contact with the protein solution to determine the amount of protein in the reagent (ng / mm³). ２ Calculate the result.

[0047] The results are shown in Table 1. Note that the "adsorption inhibition effect" in Table 1 is indicated in three stages: A, B, and C (A: excellent, B: good, C: acceptable).

[0048]

[0049] As shown in Table 1, when the thickness of the coating film on the bottom surface was 50 nm or more, the adsorption of proteins to the inner wall of the container was effectively suppressed. Furthermore, an acceptable level of adsorption suppression was confirmed when the thickness of the coating film on the bottom surface was up to approximately 6000 nm.

[0050] Test Example 2 The sides of glass vials were coated with the coating solution prepared in Test Example 1 to achieve the film thickness shown in Table 2 below. The film thickness on the bottom surface was 200 nm in all cases. The resulting glass vials were filled with an aqueous solution containing either Fibrinogen or IgG. Fibrinogen was purchased from Merck Co., Ltd., and IgG (goat anti-mouse IgG(H+L)-HRP complex 1706516) was purchased from Bio-Rad Laboratories. The concentrations of each protein in the aqueous solution were 1 mg / mL (Fibrinogen) and 10 μL / 80 mL (IgG). After filling the glass vials with each protein solution, the Fibrinogen was allowed to stand at 37°C for 30 minutes. The IgG was allowed to stand at room temperature (23-25°C) for 1 hour. Next, the amount of protein adsorbed onto the inner wall surface of the glass vial was measured. The coating of the glass vial and the measurement of the amount of protein adsorbed onto the inner wall of the glass vial were the same as those performed in Test Example 1. In addition, the visibility of the glass vial was measured. In this specification, "visibility" is defined as the ease with which white aggregates of fibrinogen are visible when a vial containing fibrinogen solution is shaken at 1,000 rpm for 3 hours to generate white aggregates of fibrinogen inside the vial. The evaluation of visibility was performed by a trained expert panel under the following conditions.

[0051] [Conditions] Illuminance: 2700 lux Light type: White fluorescent lamp Background: Black Temperature: Room temperature (20-25°C) Humidity: 20-60% Test time: 5-10 seconds

[0052] [Evaluation of Visibility] A vial with a thin film layer was filled with fibrinogen solution (1 mg / mL). Next, the vial containing the fibrinogen solution was shaken at 1,000 rpm for 3 hours to generate white fibrinogen aggregates inside the vial. After that, the inside of the vial was visually observed from a position 30 cm horizontally away from the vial. The evaluation criteria were as follows:

[0053] A: White aggregates are clearly visible. B: White aggregates are clearly visible. C: White aggregates are almost invisible.

[0054] The results are shown in Table 2. The "percentage of adsorption inhibition (%)" was calculated as follows: Percentage of adsorption inhibition (%) = 100 - [percentage of adsorption in each vial], where the amount of protein adsorbed in the uncoated vial was set to 100%.

[0055]

[0056] As shown in Table 2, it was demonstrated that when the film thickness at the bottom and the film thickness at the sides of the vial have a specific ratio, both adsorption suppression and visibility are good.

[0057] According to the present invention, it is possible to provide a glass medical vial that suppresses the adsorption of biomolecules and has good visibility. Furthermore, according to the present invention, it is possible to improve the airtightness of the glass medical vial, prevent the cap from shifting due to vibration or impact, and avoid distortion or damage to the vial when attaching the cap to the vial. Therefore, the present invention is extremely useful, for example, in the field of biopharmaceutical manufacturing.

[0058] This application is based on Japanese Patent Application No. 2024-223881 (filing date: December 19, 2024), the contents of which are fully incorporated herein.

[0059] 1. Medical vial 2. Opening 3. Mouth 4. Shoulder 5. Filling chamber (side) 6. Filling chamber (bottom)

Claims

A glass medical vial comprising an opening, a mouth portion, a shoulder portion, and a filling chamber, wherein, The vial has a thin film layer on at least a portion of its inner wall surface, The filling chamber has a side portion and a bottom portion, The thickness of the thin film layer on the bottom surface is 5 to 150 times thicker than the thickness of the thin film layer on the side surface, and A medical vial characterized in that the average thickness of the thin film layer at the bottom surface is 100 to 5000 nm. 　 The medical vial according to claim 1, wherein the average thickness of the thin film layer on the side surface is 10 to 100 nm. 　 A medical vial according to claim 1 or 2, wherein the inner wall surface of the opening at a position 1 mm from the opening has a dynamic friction coefficient of 0.20 or less with respect to butyl rubber.

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