cap
The cap design with a styrene-based block copolymer protective cover and carbonate-based cap body addresses brittleness issues at low temperatures, ensuring flexibility and ease of use for vial storage.
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- TAISEI KAKO CO LTD
- Filing Date
- 2020-07-02
- Publication Date
- 2026-04-27
AI Technical Summary
Existing caps for vials storing drugs at low temperatures, such as -85°C, face issues with brittleness, as conventional protective covers are not adequately designed to maintain flexibility and durability in such conditions.
A cap design incorporating a protective cover made from a composition containing a styrene-based block copolymer with 10 to 60% styrene monomer content, along with a cap body made from a carbonate-based resin, ensuring the cover remains flexible and less prone to brittleness at low temperatures.
The solution provides a protective cover that maintains flexibility and reduces brittleness at low temperatures, facilitating easy removal and preventing contamination while ensuring the cap's structural integrity.
Smart Images

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Abstract
Description
Technical Field
[0001] The present invention relates to a composition for a protective cover and a cap.
Background Art
[0002] Conventionally, a vial that can contain a drug such as a chemical solution and whose mouth is closed with a stopper has been used. Also, a cap for sealing such a vial is known (Patent Document 1). This cap includes a cap body that can be attached to the mouth of the vial and has a through-hole for exposing the stopper, and a protective cover that is removably attached to the cap body and covers the through-hole. The cap body is formed of polypropylene (PP) or the like, and the protective cover is formed of linear low-density polyethylene (L-LDPE) or the like.
[0003] The drug contained in the vial may be taken out from the vial by piercing an injection needle into the stopper while the stopper is attached to the vial. In that case, the protective cover is removed from the cap body.
Prior Art Documents
Patent Documents
[0004]
Patent Document 1
Summary of the Invention
Problems to be Solved by the Invention
[0005] In recent years, it has been required to store a drug at a low temperature (for example, -85°C) in a vial with a cap, and a cap that is not likely to become brittle even at a low temperature may be required. However, the protective cover of such a cap has not been sufficiently studied so far.
[0006] Therefore, in view of the above-mentioned requirements, the object of the present invention is to provide a protective cover that is less likely to become brittle even at low temperatures, and a cap having said protective cover. [Means for solving the problem]
[0007] The protective cover composition according to the present invention is used to manufacture a cap that is attached to a vial whose opening is sealed with a stopper. The cap comprises a cap body that can be attached to the mouth of the vial and has a through hole that exposes the stopper, and a protective cover that is detachably attached to the cap body and covers the through hole. Used in the manufacture of the aforementioned protective cover, The material contains a styrene-based block copolymer that includes styrene monomer as a constituent unit, with the styrene monomer content being 10 to 60% by mass.
[0008] Such protective cover compositions, by containing a styrene-based block copolymer having 10 to 60% by mass of styrene monomer as a constituent unit, can provide a protective cover that is less likely to become brittle even at low temperatures.
[0009] Furthermore, the cap according to the present invention is a cap that is attached to a vial whose opening is sealed by a stopper, A cap body that can be attached to the mouth of the vial and has a through hole that exposes the stopper, The cap body is equipped with a protective cover that is detachably attached to cover the through hole, The protective cover contains a styrene-based block copolymer that includes styrene monomer as a constituent unit, with a styrene monomer content ratio of 10 to 60% by mass. [Effects of the Invention]
[0010] According to the present invention, a protective cover that is less likely to become brittle even at low temperatures, and a cap having the protective cover can be provided. [Brief explanation of the drawing]
[0011] [Figure 1] Figure 1 is a front view of a vial with the cap according to this embodiment attached thereto. [Figure 2] Figure 2 is a perspective view of a vial with the cap attached thereto. [Figure 3] Figure 3 is an exploded perspective view of a vial with the cap attached thereto. [Figure 4] Figure 4 is a plan view for explaining a cap body, a cover attachment portion, and a cover protruding portion in the cap. [Figure 5] Figure 5 is a rear view of the protective cover in the cap. [Figure 6] Figure 6 is a cross-sectional view taken along line VI-VI of FIG. 1. [Figure 7] Figure 7 is a rear view of the protective cover in the cap according to a modified example. [Figure 8] Figure 8 is a rear view of the protective cover in the cap according to a modified example. [Figure 9] Figure 9 is a rear view of the protective cover in the cap according to a modified example.
BEST MODE FOR CARRYING OUT THE INVENTION
[0012] Embodiments of the present invention will be described with reference to FIGS. 1 to 6. The cap 1 of this embodiment is a cap that is attached to a vial 2 whose mouth portion 20 is closed by a stopper 22. Further, the cap 1 of this embodiment includes a cap body 3 that is attachable to the mouth portion 20 of the vial 2 and provided with a through hole 50 for exposing the stopper 22, and a protective cover 6 that is removably attached to the cap body 3 and covers the through hole 50. The protective cover 6 is formed of the composition for the protective cover of this embodiment. Hereinafter, first, the configuration of the vial 2 will be described, and then the configurations of the cap body 3 and the protective cover 6 that constitute the cap 1 will be described.
[0013] Vial 2 is a container that holds a drug, such as a liquid drug. The liquid drug contained in vial 2 is, for example, a liquid drug that is stored and transported in a frozen state or a low-temperature state (e.g., -85°C). The mouth 20 of vial 2 is located on the top side (the upper side in FIGS. 1 and 2). Also, as shown in FIG. 3, vial 2 includes a bottle 21 that holds the liquid drug and a stopper 22 that closes the mouth 20 of vial 2. Hereinafter, the direction in which the mouth 20 extends, that is, the height direction of the mouth 20 (the vertical direction in FIGS. 1 to FIG. 3) will be simply referred to as the "height direction". Also, the side opposite to the top side in the height direction is referred to as the "lower side".
[0014] Bottle 21 is, for example, a member that holds the liquid drug (see FIG. 3). Also, bottle 21 is, for example, a bottomed cylindrical shape. Bottle 21 of the present embodiment has a bottle mouth portion 210 that is located on the top side and constitutes the mouth 20 of vial 2, and a bottle body portion 211 that is continuous with the bottle mouth portion 210 and has a larger diameter than the bottle mouth portion 210. The bottle mouth portion 210 of the present embodiment is located at the top end of the bottle mouth portion 210 and has a flange portion 212 that protrudes outward in the radial direction.
[0015] Stopper 22 is a member that seals bottle 21 and through which an injection needle is pierced when administering the liquid drug to a patient. Stopper 22 of the present embodiment is fitted inside mouth 20. Also, stopper 22 is substantially disk-shaped and has, for example, a large-diameter stopper portion 220 disposed on the top side, and a small-diameter stopper portion 221 that protrudes downward from the large-diameter stopper portion 220 and has a smaller diameter than the large-diameter stopper portion 220. Examples of the material of stopper 22 include an elastic body such as butyl rubber.
[0016] Large-diameter stopper portion 220 is a portion that is placed on the flange portion 212 of bottle mouth portion 210. It also has a lower surface 222 located on the lower side and a top surface 223 located on the top side.
[0017] Top surface 223 includes a central top surface portion 224 located at the center in the radial direction, and an outer peripheral top surface portion 225 located outside and on the top side in the radial direction with respect to the central top surface portion 224. That is, top surface 223 has a shape in which the central top surface portion 224 is one step lower than the outer peripheral top surface portion 225.
[0018] The small-diameter portion 221 of the stopper is the part that rests inside the bottle neck portion 210. The small-diameter portion 221 of the stopper extends downward from the lower surface 222 of the large-diameter portion 220 of the stopper. For example, the small-diameter portion 221 of the stopper is cylindrical.
[0019] The cap body 3 is the part that is attached to the mouth 20 of the vial 2 to prevent the stopper 22 from being removed from the bottle 21. The cap body 3 also includes a cylindrical body 4 that can be fitted onto the mouth 20 of the vial 2, and a top plate 5 provided with a through hole 50.
[0020] The cylindrical body 4 is fitted onto the mouth portion 20 of the vial 2 and covers the outer circumferential surface of the mouth portion 20. The cylindrical body 4 in this embodiment is cylindrical in shape. For example, the diameter of the cylindrical body 4 is uniform at all points in the height direction. The diameter of the cylindrical body 4 in this embodiment is approximately equal to the diameter of the bottle body portion 211 of the bottle 21. In addition, the inner surface of the cylindrical body 4 has a claw portion that engages with the lower part of the flange portion 212 of the bottle 21.
[0021] The top plate 5 is the part positioned on the top side of the cylindrical body 4. When the cylindrical body 4 is fitted onto the mouth 20 of the vial 2, the top plate 5 covers the top surface 223 of the stopper 22, for example, the outer circumference 225 of the top surface. Furthermore, as shown in Figure 4, the top plate 5 has a top plate annular portion 51 positioned around the through hole 50. In this embodiment, the top plate 5 has a top plate extension portion 52 that extends radially outward from the top plate annular portion 51. Also, the top surface of the top plate 5 is a flat surface.
[0022] The through-hole 50 is a through-hole that penetrates the top plate 5 in the thickness direction (for example, the height direction) of the top plate 5. Furthermore, as shown in Figure 6, when the cylindrical body 4 is fitted onto the mouth portion 20 of the vial 2, the through-hole 50 exposes a part of the top surface 223 of the stopper 22, for example, the central portion 224 of the top surface. In this embodiment, the through-hole 50 is located in the center of the top plate 5 (for example, in the central region centered on the cylindrical axis 4A of the cylindrical body 4).
[0023] The top plate annular portion 51 is a part provided around the through hole 50. Furthermore, the top plate annular portion 51 is, for example, an annular shape centered on the cylindrical axis 4A (see Figure 4). Specifically, the top plate annular portion 51 is the annular shape with the largest area among the imaginary annular shapes drawn on the top plate 5 centered on the cylindrical axis 4A. In this embodiment, the top plate annular portion 51 is located in the center of the top plate 5. In addition, the top plate annular portion 51 has a hole edge portion 510 as an inner end in the radial direction.
[0024] The hole rim 510 is the portion that defines the through hole 50. Furthermore, the hole rim 510 is, for example, an annular shape centered on the cylindrical axis 4A.
[0025] In this embodiment, the top plate 5 is provided with, for example, three top plate extensions 52 extending radially from the top plate annular portion 51. Each top plate extension 52 is arranged at equal intervals from each other in the circumferential direction. In other words, three openings 53 are provided on the outer periphery of the top plate 5. The three openings 53 are arranged at equal intervals from each other in the circumferential direction. Also, each top plate extension 52 has the same shape. The extension ends 520 of the top plate extensions 52 are connected to the cylindrical body 4 (for example, the edge located on the top side of the cylindrical body 4).
[0026] With the above configuration, the top plate 5 is a disc shape with a through hole 50 in the center and multiple openings 53 arranged at equal intervals in the circumferential direction around its outer edge.
[0027] The protective cover 6 is a cover that is removablely attached to the top side of the top plate 5 (see Figure 1). The protective cover 6 also includes a cover body portion 7 and a cover mounting portion 8 which is provided as mounting means 10 for attaching the protective cover 6 to the top plate 5 and is attached to the top side of the annular portion 51 of the top plate. In this embodiment, the protective cover 6 also includes a cover projection portion 9 which is provided as mounting means 10 and is located radially outward from the cover mounting portion 8.
[0028] The cover body portion 7 is the part that constitutes the end portion located on the top side of the cap 1. The cover body portion 7 also has a lower surface 70 that is positioned spaced apart from the top plate 5 when the protective cover 6 is attached to the top plate 5. In this attached state, the cover body portion 7 has a top surface 71 located on the top side. The cover body portion 7 of this embodiment has an uneven thickness and includes, for example, a central portion 72 that is located in the center and is thicker, and an outer peripheral portion 73 that is located on the outer periphery than the central portion 72 and is thinner (see Figure 2). That is, the cover body portion 7 includes a central portion 72 which is a thicker portion located on the inner periphery side, and an outer peripheral portion 73 which is a thinner portion located on the outer periphery side.
[0029] The lower surface 70 of this embodiment includes a central lower surface 700 located in the center and an outer lower surface 701 located further outward than the central lower surface 700 (see Figure 6). In this lower surface 70, the outer lower surface 701 has a shape that is located higher up than the central lower surface 700. A cover mounting portion 8 is positioned between the central lower surface 700 and the outer lower surface 701.
[0030] The top surface 71 of this embodiment includes a central top surface 710 located in the center and an outer peripheral top surface 711 located outside the central top surface 710.
[0031] The central top surface 710 includes a recessed portion 712 that is recessed on the lower side and a convex portion 713 that protrudes on the upper side. In this central top surface 710, the recessed portion 712 is located closer to the center than the convex portion 713. The central top surface 710 also includes an auxiliary convex portion 714 that protrudes on the upper side and is located outside the convex portion 713. The recessed portion 712 is circular in shape (see Figure 2). The auxiliary convex portion 714 is annular, for example, a circular annular shape. The convex portion 713 is annular, for example, a circular annular shape. In this embodiment, the convex portion 713 is located at a position corresponding to the cover mounting portion 8 (a position that overlaps with the cover mounting portion 8 when viewed from the height direction) (see Figure 6).
[0032] The outer periphery top surface 711 is the outer edge of the top surface 71 of the cover body 7, and includes an edge portion 715 that protrudes upward. The edge portion 715 is annular, for example, circular (see Figure 2).
[0033] The mounting means 10 of this embodiment is a cover mounting portion 8 formed in an annular shape around the through hole 50, as shown in Figure 5. The cover mounting portion 8 is continuous and uninterrupted around the entire circumference. For example, the cover mounting portion 8 is annular. The cover mounting portion 8 is cylindrical and has an inner circumferential surface 80 and an outer circumferential surface 81. The inner and outer diameters of the cover mounting portion 8 in this embodiment are substantially uniform at all points in the height direction, and the thickness of the cover mounting portion 8 in the radial direction is constant.
[0034] The cover mounting portion 8 is attached to the cap body 3. The cover mounting portion 8 also protrudes from the lower surface 70 of the cover body portion 7 toward the top side of the top plate ring portion 51 of the top plate 5, and is configured to attach to both the lower surface 70 of the cover body portion 7 and the top side of the top plate ring portion 51 (see Figure 6).
[0035] In this embodiment, the cover mounting portion 8 is positioned at the boundary between the central portion 72 and the outer peripheral portion 73 of the cover body portion 7. Furthermore, the cover mounting portion 8 in this embodiment is attached to the annular portion 51 of the top plate 5 (see Figure 4). Specifically, the cover mounting portion 8 is attached to the hole edge portion 510 of the top plate 5 concentrically with the through hole 50. That is, the central axis of the cover mounting portion 8 coincides with the central axis of the through hole 50.
[0036] The cover projection 9, like the cover mounting portion 8, protrudes from the lower surface 70 of the cover body 7 toward the top side of the top plate annular portion 51 of the top plate 5 (see Figure 6). In this embodiment, the cover projection 9 is located on the outer peripheral portion 73, which is a thin-walled portion of the cover body 7. The lower surface of the cover projection 9 in this embodiment is flush with the lower surface of the cover mounting portion 8.
[0037] The protective cover 6 of this embodiment is provided with four cover projections 9 (see Figure 5). Each cover projection 9 is arranged at equal intervals in the circumferential direction. That is, multiple cover projections 9 are arranged radially.
[0038] The cover projection 9 of this embodiment is connected to the cover mounting portion 8, for example, to the outer circumferential surface 81 of the cover mounting portion 8. Specifically, the cover projection 9 extends radially outward from the outer circumferential surface 81 of the cover mounting portion 8. The cover projection 9 does not reach the outer edge of the cover body portion 7, but extends to an intermediate position radially outward of the cover body portion 7. That is, the cover projection 9 has an inner diameter end portion 93 that is continuous with the cover mounting portion 8, and an outer diameter end portion 94 that is located radially outward midway. The cover projection 9 of this embodiment is continuous without interruption from the inner diameter end portion 93 to the outer diameter end portion 94.
[0039] For example, each cover projection 9 is a straight rib. The width of the cover projection 9 in the direction perpendicular to the extension direction is uniform. The dimensions of each cover projection 9 provided on the protective cover 6 in the longitudinal direction may be equal or different. In the protective cover 6 of this embodiment, the longitudinal dimension of one of the four cover projections 9, the first cover projection 91, is shorter than the longitudinal dimensions of the other three second cover projections 92.
[0040] The cover projection 9 is attached to at least the top plate annular portion 51 of the top plate 5 (see Figure 4). In this embodiment, at least one of the cover projection 9 extends from the top plate annular portion 51 to the top plate extension portion 52. Specifically, the first cover projection 91 is attached only to the top plate annular portion 51, while the second cover projection 92 extends from the top plate annular portion 51 to the top plate extension portion 52, and is also attached to the top plate annular portion 51 and the top plate extension portion 52.
[0041] In the cap 1 of this embodiment, one opening 53 of the top plate 5 is positioned between adjacent long cover projections 9 (for example, the second cover projection 92) in the circumferential direction.
[0042] In the cap 1 described above, the cover mounting portion 8, which extends downward from the lower surface 70 of the cover body portion 7, is attached to the top side of the cap body 3. As a result, the lower surface 70 of the cover body portion 7 is separated from the top plate 5, and a gap C is created around the cover mounting portion 8 (see Figure 6). That is, a gap C is created between the protective cover 6 and the cap body 3.
[0043] In the cap 1 of this embodiment, the cover mounting portion 8 of the protective cover 6 is positioned on the hole edge portion 510 of the annular portion 51 of the top plate of the cap body 3, so the gap C is provided so as to surround the cover mounting portion 8 (see Figure 4). Specifically, the gap C is a region located radially outward from the outer peripheral surface 81 of the cover mounting portion 8 in Figure 5, and is provided in a region other than the region to which the cover projection 9 extends.
[0044] In the cap 1 of this embodiment, it is important that the protective cover 6 contains a styrene-based block copolymer in which styrene monomer is included as a constituent unit, and the content ratio of the styrene monomer is 10 to 60% by mass. In this embodiment, it is preferable that the cap body 3 contains a carbonate-based resin.
[0045] Examples of carbonate resins included in the cap body 3 include aromatic carbonate resins and aliphatic carbonate resins. Examples of the aromatic carbonate resin include polymers of aromatic dihydroxy compounds and phosgene (COCl2), and polymers of aromatic dihydroxy compounds and diester carbonates. Polymers of aromatic dihydroxy compounds and phosgene can be obtained by methods such as interfacial polymerization between aromatic dihydroxy compounds and phosgene. Polymers of aromatic dihydroxy compounds and diester carbonates can be obtained by transesterification reactions between aromatic dihydroxy compounds and diester carbonates. Examples of aromatic dihydroxy compounds include bisphenol A, dimethylbisphenol A, bisphenol Z, and 1,1-bis(4-hydroxyphenyl)-3,3,5-trimethylcyclohexane. Examples of diester carbonates include diphenyl carbonate. As the carbonate resin, conventionally known carbonate resins can be used, as long as they do not impair the effects of the present invention. The mass-average molecular weight of the carbonate resin is preferably 10,000 or more, more preferably 20,000 or more. While there is no particular upper limit to the mass-average molecular weight of the carbonate resin, it is preferably 1,000,000 or less. In this embodiment, the mass-average molecular weight can be measured by gel permeation chromatography (GPC) and determined by converting it to polystyrene equivalent. In addition to carbonate resin, the cap body 3 may also contain other materials known as materials for the cap body 3, to the extent that they do not impair the effects of the present invention. The embrittlement temperature of the cap body 3 is preferably -70°C or lower, more preferably -100°C or lower. In this embodiment, the embrittlement temperature can be measured according to JIS K7216-1980.
[0046] The cap body 3 contains a carbonate-based resin, preferably 51 to 100% by mass, more preferably 80 to 100% by mass.
[0047] The protective cover 6 is formed from the protective cover composition of this embodiment. That is, the protective cover 6 has the same composition ratio as the protective cover composition of this embodiment. The protective cover composition of this embodiment is important because it contains a styrene-based block copolymer (component A) which contains styrene monomer as a constituent unit, with a styrene monomer content ratio of 10 to 60% by mass. Furthermore, the protective cover composition of this embodiment preferably contains an olefin resin (component B). Additionally, the protective cover composition of this embodiment preferably contains a lubricant (component C).
[0048] <Component A (styrene-based block copolymer with a styrene monomer content of 10-60% by mass)> Component A is a styrene-based block copolymer, and the styrene monomer content ratio (also simply called the "styrene content ratio") in the styrene-based block copolymer is 10 to 60% by mass. The styrene content ratio of 10 to 60% by mass makes the protective cover 6 less likely to become brittle even at low temperatures (e.g., -85°C), allows the protective cover 6 to adhere well to the cap body, and enables the protective cover to be removed from the cap body with moderate force. The styrene-based block copolymer is preferably an elastomer.
[0049] Component A is not particularly limited as long as its styrene content is between 10 and 60% by mass. Component A is a block copolymer having, for example, one or more polymer blocks X mainly composed of structural units derived from a styrene skeleton-containing compound, preferably two or more from the viewpoint of mechanical properties, and one or more polymer blocks Y mainly composed of structural units derived from a conjugated diene compound. Examples of component A include block copolymers having structures such as XY, XYX, YXYX, and XYXYX. Furthermore, hydrogenated block copolymers having the above structure, or mixtures thereof, can also be preferably used as component A. In other words, component A is a concept that includes hydrogenated materials.
[0050] Hydrogenated styrene-based block copolymers having the above structure are obtained by adding hydrogen to the carbon-carbon double bonds in the styrene-based block copolymer having the above structure to convert them into carbon-carbon single bonds. The above hydrogenation can be carried out by known methods, for example, by hydrogenating the styrene-based block copolymer having the above structure using a hydrogenation catalyst in an inert solvent.
[0051] The styrene skeleton-containing compound is a polymerizable monomer having a polymerizable carbon-carbon double bond and an aromatic ring. Examples of the styrene skeleton-containing compound include styrene, t-butylstyrene, α-methylstyrene, divinylbenzene, 1,1-diphenylstyrene, N,N-diethyl-p-aminoethylstyrene, p-3-butylstyrene, and alkylstyrene in which at least one C1-C8 alkyl group is bonded to a benzene ring. Among these, styrene and alkylstyrene in which at least one C1-C8 alkyl group is bonded to a benzene ring are preferred. One or more of these can be used as the styrene skeleton-containing compound.
[0052] The above-mentioned conjugated diene compound is a polymerizable monomer having a structure in which two carbon-carbon double bonds are connected by one carbon-carbon single bond. Examples of the above-mentioned conjugated diene compound include 1,3-butadiene, isoprene (2-methyl-1,3-butadiene), 2,3-dimethyl-1,3-butadiene, and chloroprene (2-chloro-1,3-butadiene). Among these, 1,3-butadiene and isoprene are preferred. One or more of these can be used as the above-mentioned conjugated diene compound.
[0053] From the viewpoint of low-temperature characteristics (cold resistance), it is important that the styrene content of the styrene-based block copolymer (a concept that includes hydrogenated materials), which is component A of the protective cover 6, is 10 to 60% by mass, and preferably 20 to 50% by mass. Furthermore, from the viewpoint of adhesion to the cap body and ease of removal from the cap body, the styrene content of the styrene-based block copolymer (a concept that includes hydrogenated materials), which is component A, is preferably 10 to 60% by mass, and more preferably 20 to 50% by mass.
[0054] Examples of the styrene-based block copolymers include styrene-butadiene-styrene block copolymer (SBS) and styrene-isoprene-styrene block copolymer (SIS). Examples of hydrogenated styrene-based block copolymers include styrene-ethylene-butene copolymer (SEB), styrene-ethylene-propylene copolymer (SEP), styrene-ethylene-butene-styrene copolymer (SEBS), styrene-ethylene-propylene-styrene copolymer (SEPS), and styrene-ethylene-ethylene-propylene-styrene copolymer (SEEPS). The listed styrene-based block copolymers can be used individually or as a mixture of two or more.
[0055] The mass-average molecular weight of component A, a styrene-based block copolymer (a concept that includes hydrogenated materials), is preferably 50,000 to 500,000. More preferably, it is 80,000 to 450,000, and even more preferably, 100,000 to 400,000. Within this range, good processability and moldability are obtained. In this specification, the mass-average molecular weight can be determined by measuring it by gel permeation chromatography (GPC) and converting it to polystyrene equivalent.
[0056] The protective cover 6 contains, preferably, 50 to 100% by mass, and more preferably, 70 to 100% by mass, a styrene-based block copolymer which is component A.
[0057] <Component B (Olefin-based resin)> Component B is an olefin resin. Furthermore, component B improves the fluidity of the protective cover composition of this embodiment, enhances its moldability, and is effective in adjusting its hardness.
[0058] Examples of component B include ethylene resins, propylene resins, and 1-butene resins. Examples of ethylene-based resins include homopolymers and copolymers of ethylene. Examples of homopolymers include low-density polyethylene, linear low-density polyethylene, and high-density polyethylene. Examples of copolymers include copolymers of ethylene with other α-olefins (e.g., propylene, 1-butene, 1-hexene, 4-methyl-1-pentene, 1-octene, etc.). Examples of propylene-based resins include propylene homopolymers and copolymers. Examples of such copolymers include random copolymers and block copolymers of propylene with other α-olefins (e.g., ethylene, 1-butene, 1-hexene, 4-methyl-1-pentene, 1-octene, etc.). Among these, ethylene-based resins and propylene-based resins are preferably used.
[0059] When component B is included in the protective cover composition of this embodiment, the amount of component B is preferably 200 parts by mass or less, more preferably 5 to 100 parts by mass, and even more preferably 8 to 80 parts by mass, relative to 100 parts by mass of component A. By having 200 parts by mass or less of component B, the protective cover is more likely to maintain its strength at low temperatures. Note that component B may not be included in the protective cover composition of this embodiment.
[0060] <Component C (Lubricant)> Component C is a lubricant. The protective cover composition of this embodiment preferably contains component C from the viewpoint of adhesion between the protective cover and the cap body, and the ease of peeling the protective cover from the cap body.
[0061] The aforementioned component C is not particularly limited, and examples of component C include paraffinic lubricants, hydrocarbon resin lubricants, fatty acid lubricants, fatty acid amide lubricants, fatty acid ester lubricants, fatty acid ketone lubricants, and silicone lubricants. Among these, fatty acid amide lubricants are preferably used.
[0062] The amount of component C is preferably 0.1 to 3 parts by mass, and more preferably 0.3 to 1 part by mass, relative to 100 parts by mass of component A. When component C is within this range, a good balance is achieved between the adhesion between the protective cover and the cap body, and the peelability of the protective cover from the cap body.
[0063] <Other ingredients> In addition to the components described above, the protective cover composition for caps of the present invention may also contain, to the extent that it does not impair the properties of the present invention, other polymer components, rubber softeners, anti-blocking agents, heat stabilizers, antioxidants, UV absorbers, colorants, thickeners, anti-aging agents, fillers, and the like.
[0064] Furthermore, the cap 1 is integrally molded by insert molding or two-color molding. For example, after the cap body 3 is molded by injection molding, the cap body 3 is inserted into a protective cover injection molding die for molding the protective cover 6, and the protective cover 6 is molded by injection molding. Alternatively, after molding the protective cover 6, the protective cover 6 may be inserted into a mold for molding the cap body 3, and the cap body 3 may be molded by injection molding.
[0065] Such a cap 1 is attached to the vial 2 as follows: First, the liquid drug is placed in the bottle 21 of the vial 2, and with the stopper 22 fitted inside the mouth 20 of the vial 2, the stopper 22 is pressed downwards, that is, the stopper 22 is sealed and attached to the bottle 21. Furthermore, with the cap body 3 fitted outside the mouth 20 of the vial 2, the protective cover 6 is pressed downwards, that is, the cap 1 is sealed and attached to the vial 2. Note that the sealing of the stopper 22 and cap 1 is performed, for example, using an automatic capping device.
[0066] Furthermore, when removing the protective cover 6 of the cap 1 attached to vial 2, insert your fingers into the gap between the cover body 7 and the cap body 3 and pinch the outer circumference 73. Because the outer circumference 73 of the cover body 7 is thin, it bends easily (peels easily), making it easy to start peeling off the cover body 7. If you continue peeling the cover body 7 toward the center in the radial direction, for example, by grasping (pinching) the peeled outer circumference 73 and pulling it up, the cover mounting portion 8 will peel off. If a cover projection 9 is provided, the cover projection 9 will peel off continuously from the outer diameter end 94 to the inner diameter end 93, and then the cover mounting portion 8 will peel off from the inner diameter end 93 of the cover projection 9, and the central portion 72 of the cover body 7 will also peel off. In other words, the cover projection 9 is the part that causes the cover mounting portion 8 to peel off. Because the central part 72 of the main body of the cover 7 is thick and difficult to bend, the cover mounting part 8 will peel off all at once.
[0067] With the cap 1 described above, a cover mounting portion 8 is provided projecting from the lower surface 70 of the cover body portion 7 of the protective cover 6 toward the top side of the top plate ring portion 51. Therefore, when the protective cover 6 is attached to the cap body 3, the lower surface 70 of the cover body portion 7 is separated from the top plate 5, creating a gap C around the cover mounting portion 8. As a result, the user can easily grasp the protective cover 6 by placing their fingers through this gap C and work with it, and can easily peel the protective cover 6 off the cap body 3. Moreover, because the cover mounting portion 8 is ring-shaped, when the protective cover 6 is attached to the cap body 3, the cover mounting portion 8 extending ring-shaped from the lower surface 70 of the cover body portion 7 surrounds the through hole 50 of the cap body 3, sealing the portion exposed from the through hole 50 of the stopper 22 and preventing contamination. Furthermore, since the top surface of the top plate 5 of the cap body 3 is a flat surface without irregularities, it is easy to wipe with an alcohol swab after peeling off the protective cover 6, and no lint is produced, making it hygienic.
[0068] In the cap 1 of this embodiment, the cover projection 9 is positioned below the cover body 7 and radially outward from the cover mounting portion 8. Therefore, for example, when transporting multiple caps 1 packed in a box or bag, even if the end of the protective cover 6 of another cap 1 tries to enter the gap C between the protective cover 6 and the top plate 5 of the cap body 3 of one cap 1, the cover projection 9 can prevent this intrusion. This prevents the protective cover 6 of one cap 1 from being pried open by another cap 1.
[0069] Furthermore, in the cap 1 of this embodiment, the cover projection 9 extends continuously with the cover mounting portion 8 on the radially outer side of the cover mounting portion 8. Therefore, when peeling the protective cover 6 from the cap body 3, the peeling force is transmitted sequentially from the cover projection 9 to the cover mounting portion 8, allowing the protective cover 6 to be peeled off smoothly.
[0070] Furthermore, in the cap 1 of this embodiment, the top plate annular portion 51 is positioned in the center of the top plate 5, so a uniform gap C is provided around the cover mounting portion 8. Therefore, the protective cover 6 can be easily peeled off the cap body 3 regardless of which area of the outer periphery of the protective cover 6 is placed with a finger.
[0071] In the cap 1 of this embodiment, the top plate annular portion 51 has a hole edge portion 510 that defines the through hole 50, and the cover mounting portion 8 is attached to this hole edge portion 510. Therefore, the distance from the periphery of the protective cover 6 to the cover mounting portion 8, that is, the gap C arranged around the cover mounting portion 8, is sufficiently large, so when the protective cover 6 is peeled off, the outer periphery 73 of the cover body portion 7 is easily peeled back, the force applied to the cover mounting portion 8 increases, and this makes it easier to peel the protective cover 6 from the cap body 3.
[0072] Furthermore, in the cap 1 of this embodiment, the protruding portion 713 on the top surface of the protective cover 6 (for example, the top surface 71 of the cover body portion 7) is provided in an area corresponding to the cover mounting portion 8. Therefore, the portion of the protective cover 6 that rests on the top side of the annular portion 51 of the top plate has the cover mounting portion 8 and the protruding portion 713, making the thickness of the protective cover 6 thicker in this area. As a result, even if the protruding portion 713 is pressed against the top plate when the cap 1 is used to cap the vial 2, the protective cover 6 is less likely to be damaged.
[0073] Furthermore, in the cap 1 of this embodiment, the cover projections 9 are spaced equally in the circumferential direction, that is, uniformly arranged in the circumferential direction. Therefore, even if the end of the protective cover 6 of another cap 1 tries to get into the gap C between the protective cover 6 and the top plate 5 of the cap body 3, this intrusion can be efficiently prevented, thus preventing the caps 1 from getting stuck together or the protective cover 6 from accidentally peeling off.
[0074] Furthermore, in the cap 1 of this embodiment, an edge portion 715 that protrudes upward is provided as the outer peripheral edge of the top surface 71 of the cover body portion 7. Therefore, for example, when transporting multiple caps 1 packed in a box or bag, even if the end of one cap 1 tries to get into the gap C between the protective cover 6 of another cap 1 and the top plate 5 of the cap body 3, the outer peripheral portion 73 of the cover body portion 7 is thick, making it difficult for the cap to get into the gap C. Furthermore, if the height from the outer lower surface 701 to the top of the edge portion 715 is greater than the height of the cover mounting portion 8 or the height of the gap C, intrusion can be more effectively prevented.
[0075] Furthermore, in the cap 1 of this embodiment, the central top surface 710 has an auxiliary protruding portion 714 that protrudes upward and is positioned outside the protruding portion 713, so that the force to peel off the protective cover 6 is transmitted smoothly, and the strength of the protective cover 6 itself can be adjusted.
[0076] The protective cover composition of this embodiment is used to manufacture a cap that is fitted onto a vial whose opening is sealed with a stopper. Specifically, the protective cover composition of this embodiment is used to manufacture the protective cover. The protective cover composition of this embodiment contains a styrene-based block copolymer in which styrene monomer is included as a constituent unit, and the styrene monomer content ratio is 10 to 60% by mass.
[0077] Furthermore, the protective cover composition and cap according to the present invention are not limited to the embodiments described above. Also, the protective cover composition and cap according to the present invention are not limited by the effects described above. Moreover, the protective cover composition and cap according to the present invention can be modified in various ways without departing from the spirit of the present invention.
[0078] In the above embodiment, the mounting means 10 included a cover mounting portion 8 and a cover projection portion 9 that projected toward the top side of the top plate annular portion 51 of the top plate 5 from the lower surface 70 of the cover body portion 7, but it may also include only the cover mounting portion 8. In this case, for example, the protective cover 6 may include the cover body portion 7 and the annular cover mounting portion 8. Even in this case, when the protective cover 6 is attached to the cap body 3, the user can easily put their fingers on the protective cover 6 through the gap C around the cover mounting portion 8 and easily peel the protective cover 6 off the cap body 3. Moreover, because the cover mounting portion 8 is annular, when the protective cover 6 is attached to the cap body 3, the cover mounting portion 8 surrounds the through hole 50 of the cap body 3, thereby sealing the portion of the stopper 22 that is exposed from the through hole 50.
[0079] Furthermore, the mounting means 10 may include a cover mounting portion or a cover projection portion that protrudes from the top side of the top plate annular portion 51 of the top plate 5 toward the bottom surface 70 of the cover body portion 7. This cover mounting portion is configured to attach both the top side of the top plate annular portion 51 of the top plate 5 and the bottom surface 70 of the cover body portion 7.
[0080] In the protective cover 6 of the above embodiment, four cover protrusions 9 were provided, but it is sufficient to provide at least one cover protrusion 9. For example, as shown in Figure 7, it is conceivable that six cover protrusions 9 may be provided. Multiple cover protrusions 9 extend radially. Furthermore, the cover protrusions 9 include a first cover protrusion 91 which has a short length in the longitudinal direction and a second cover protrusion 92 which has a long length in the longitudinal direction.
[0081] Furthermore, in the protective cover 6 of the above embodiment, the cover projection 9 extended linearly outward in the radial direction, but it may also extend in a curved or meandering manner outward in the radial direction. Also, as shown in Figure 8, the cover projection 9 may extend in a direction other than outward in the radial direction. For example, it is conceivable that a cover projection 9 extending in a different direction may extend from a cover projection 9 extending in the radial direction. Specifically, it is conceivable that an auxiliary projection 920 may extend in a branch-like manner from a longer second cover projection 92 as another cover projection 9. With such a branch-like auxiliary projection 920, even if the end of the protective cover 6 of one cap 1 tries to enter the gap C between the protective cover 6 and the top plate 5 of the cap body 3 of one cap 1, the cover projection 9 can reliably prevent this intrusion.
[0082] The auxiliary protrusion 920 extends from a position between the inner diameter end 93 and the outer diameter end 94 of the second cover protrusion 92 in a direction intersecting the direction in which the second cover protrusion 92 extends. Specifically, the auxiliary protrusion 920 extends from the second cover protrusion 92 to both sides in the width direction of the second cover protrusion 92 (for example, in a direction perpendicular to the longitudinal direction of the second cover protrusion 92).
[0083] Furthermore, in the protective cover 6 of the above embodiment, the width of the cover projection 9 was uniform, but this width may be non-uniform. For example, as shown in Figure 9, the width of the cover projection 9 may be narrower towards the outer radial end. That is, the cover projection 9 may have a tapered shape. Specifically, the width of the cover projection 9 may be narrower towards the inner radial end 93 and wider towards the outer radial end 94. With a cover projection 9 having such a tapered shape, the force required to start peeling off the protective cover 6 may be small. Also, since the width of the cover projection 9 gradually widens as it moves outward in the radial direction, the force required to peel off the protective cover 6 is easily transmitted smoothly.
[0084] Furthermore, in the protective cover 6 of the above embodiment, the cover projection 9 extended continuously with the cover mounting portion 8, but it may be discontinuous with the cover mounting portion 8.
[0085] In the protective cover 6 of the above embodiment, the cover mounting portion 8 was cylindrical, but it may have a different shape, such as an elliptical tube or a rectangular tube. Also, the cover mounting portion 8 may be a double annular shape or multiple overlapping annular shapes.
[0086] Furthermore, although the cover mounting portion 8 was projected downward from the lower surface 70 of the cover body portion 7, it is sufficient for it to project downward along the lower surface 70. For example, the cover mounting portion 8 may project downward from the lower surface 70 of the cover body portion 7 in a curved manner, or it may project downward at an angle from the lower surface 70. When the cover mounting portion 8 projects downward at an angle from the lower surface 70 of the cover body portion 7, the cover mounting portion 8 will be tapered cylindrical in shape.
[0087] In the protective cover 6 of the above embodiment, the lower surface 70 of the cover body 7 had a shape in which the outer peripheral lower surface 701 was positioned higher than the central lower surface 700. Furthermore, the outer peripheral edge of the outer peripheral lower surface 701 may have a shape in which it protrudes downward more than other parts. In this case, for example, when transporting multiple caps 1 packed in a box or bag, even if the end of the protective cover 6 of one cap 1 tries to enter the gap C between the protective cover 6 and the cap body 3 of one cap 1, the outer peripheral edge of the outer peripheral lower surface 701 of the cover body 7 can prevent this intrusion.
[0088] In the cap body 3 of the above embodiment, the top plate 5 was disc-shaped with a through hole 50 in the center and openings 53 arranged at equal intervals around the outer circumference. However, as long as the through hole 50 is provided, the shape of the other parts is not specified. For example, in the top plate 5 of the above embodiment, three top plate extensions 52 extended from the top plate annular portion 51. However, at least one other top plate extension 52 may extend from the annular portion 51.
[0089] In the above embodiment, the drug contained in vial 2 was a drug solution, but it may also be a lyophilized drug, for example. In this case, when using a lyophilized drug, it can be returned to a liquid state by adding a diluent or solvent before being administered to the patient. [Examples]
[0090] Next, the present invention will be described in more detail with reference to test examples (examples and comparative examples). The following examples are provided to further illustrate the present invention and do not limit its scope.
[0091] (Example test) After molding the cap body by injection molding, the cap body was inserted into a protective cover injection molding die for molding a protective cover, and the protective cover was molded by injection molding using a protective cover composition to produce the caps of the example and comparative example. However, in test examples 8 and 9, the protective cover did not adhere to the cap body, so the cap could not be manufactured. The protective cover (composition for the protective cover) and the cap body were manufactured to have the compositions shown in Table 1 and below. The cap was also manufactured to have the shape shown in Table 1 and below, and to be sized to fit onto a vial (capacity: 10 mL). <Composition of the protective cover> (A) Styrene-based block copolymer (styrene content: 10-60% by mass) (A-1) SBS: Styrene-butadiene-styrene block copolymer (styrene content: 40% by mass) (TR-2000, manufactured by JSR Corporation) (A-2) SEBS: Styrene-ethylene-butene-styrene block copolymer (styrene content: 33% by mass) (Septon 8006, manufactured by Kuraray Co., Ltd.) SEPS: Styrene-ethylene-propylene-styrene block copolymer (styrene content: 65% by mass) (Septon 2104, manufactured by Kuraray Co., Ltd.) • PS: Polystyrene (Toyo Styrofoam GP G200C, manufactured by Toyo Styrofoam Co., Ltd.) (B) Olefin resin (B-1) HDPE: High-density polyethylene (Novatec HD HJ490, manufactured by Nippon Polyethylene Co., Ltd.) (B-2) Random PP: Random polypropylene (Novatec PP FW4BT, manufactured by Nippon Polypropylene Co., Ltd.) ·(C)Lubricant (C-1) Fatty acid amide lubricant (isostearyl amide) (INCROSLIP SL, manufactured by Croder) L-LDPE: Linear low-density polyethylene PC: Carbonate resin <Composition of the cap body> PC: Carbonate resin • PP: Polypropylene <Cap shape> A: Shape shown in Figures 1-6 B: The shape shown in Figures 1-4 of International Publication No. 2015 / 029580
[0092] (DuPont impact test (temperature conditions: -85°C, 23°C)) The caps were subjected to impact using a DuPont impact testing machine (JIS K5600-5-3:1999), and the condition of the protective cover on the caps was visually inspected. Specifically, the caps were first laid flat at -85°C or 23°C for 30 minutes. Immediately afterward, a stamping die (round, radius: 6 mm) was placed on top of the cap's protective cover, and a 300 g weight was dropped onto the die from a height of 500 mm. The condition of the cap's protective cover was then visually evaluated according to the following criteria. ○: No change. ×: Cracks and chips were observed. The results are shown in Table 1 below.
[0093] (Peel test 1) A cap was attached to a vial (capacity: 10 mL) whose opening was sealed with a rubber stopper. Next, the protective cover was manually removed from the capped vial and evaluated according to the following criteria. ○: The protective cover peeled off cleanly without requiring much force. ×: The protective cover is chipped or partially attached to the cap. (It required considerable force to remove the protective cover.) The results are shown in Table 1 below.
[0094] (Peel test 2) A cap was attached to a vial (capacity: 10 mL) whose opening was sealed with a rubber stopper. Next, I made two holes in the protective cover and threaded wires through these holes to attach it. Then, a vial with a cap was placed in the push-pull gauge, and the protective cover was pulled from the capped vial with a wire (speed: 60 mm / min). The maximum force required to detach the protective cover (also called the "flip-off force") was read. This measurement was performed five times. The average, maximum, and minimum values of the flip-off force are shown in Table 1 below.
[0095] [Table 1]
[0096] As shown in Table 1, in Test Examples 1 to 7, which used protective cover compositions within the scope of the present invention, the protective cover did not change even when subjected to impact at -85°C, compared to Test Examples 8 to 11. In other words, a protective cover composition within the scope of the present invention can provide a protective cover that is less likely to become brittle even at low temperatures.
[0097] Furthermore, in Test Example 4, the flip-off force was smaller compared to Test Example 1. This indicates that the protective cover, by containing a lubricant, becomes more easily detached from the cap body. [Explanation of Symbols]
[0098] 1...Cap, 2...Vial, 3...Cap body, 4...Cylinder, 5...Top plate, 6...Protective cover, 7...Cover body part, 8...Cover mounting part, 9...Cover projection, 10...Mounting means, 20...Mouth part, 21...Bottle, 22...Stopper, 50...Through hole, 51...Top plate annular part, 52...Top plate extension part, 53...Opening, 70...Bottom surface, 71...Top surface, 72...Center part, 73...Outer circumference part, 80...Inner circumference surface, 81...Outer circumference surface, 90...Cover projection, 91...First cover projection, 92...Second cap 210...Bar protrusion, 211...Bottle mouth, 212...Bottle body, 220...Large diameter stopper, 221...Small diameter stopper, 222...Bottom surface, 223...Top surface, 224...Center of top surface, 225...Outer circumference of top surface, 510...Hole edge, 520...Extended end, 700...Center bottom surface, 701...Outer circumference bottom surface, 710...Center top surface, 711...Outer circumference top surface, 712...Recessed area, 713...Convex part, 714...Auxiliary convex part, 715...Edge part, 920...Auxiliary protrusion, 4A...Cylindrical shaft, C...Gap
Claims
1. A cap that is fitted onto a vial whose opening is sealed with a stopper, The system comprises a cap body that can be attached to the mouth of the vial and has a through hole that exposes the stopper, and a protective cover that is detachably attached to the cap body and covers the through hole, The protective cover composition comprising the aforementioned protective cover is The material contains a styrene-based block copolymer that includes styrene monomer as a constituent unit, wherein the styrene monomer content is 10 to 60% by mass, and the styrene-based block copolymer is a styrene-butadiene-styrene block copolymer. It further contains a fatty acid amide-based lubricant as a lubricant, The amount of the lubricant added is 0.1 to 3 parts by mass per 100 parts by mass of the styrene-based block copolymer, in a cap.
2. The cap according to claim 1, wherein the protective cover composition contains an olefin resin.
3. The cap according to claim 2, wherein the protective cover composition contains 200 parts by mass or less of the olefin resin per 100 parts by mass of the styrene-based block copolymer.
4. The cap according to claim 2 or 3, wherein the protective cover composition contains at least one of an ethylene resin and a propylene resin as the olefin resin.
5. The cap according to any one of claims 1 to 4, wherein the cap body contains a carbonate resin.
Citation Information
Patent Citations
Exposure controller of cameras
JP1979079029A
Cap for vial
WO2015029580A1
Elastomer composition and medical container stopper formed by molding same
WO2017150714A1