PTP Packaging Materials

Abstract

The present invention provides a PTP (Press-Through Packaging) package that allows medication to be pushed out of the pocket without contamination, and also allows multiple medications to be removed at once by peeling off the lid. [Solution] A PTP packaging material comprising a container material 20 and a lid material 30, wherein the container material has a storage section 40 for storing a drug 50, and the lid material is constructed by laminating a base layer 31, an adhesive layer 32, a metal layer 33, and a heat seal layer 34 in this order, the base layer being made of a resin film, and the base layer of the lid material has a notch 60 formed in the depth direction from the outer surface of the lid material within the area corresponding to the storage section, and the notch has one of the following shapes when the diameter of the storage section is D: (1) at least two straight lines with a length of 0.4 to 1.2 times D, (2) a single curve with a length of 2.1 to 3.8 times D and whose ends are not connected, or (3) a shape consisting of two or more lines with at least one end of the line not connected to another line.

Description

Technical Field

[0001] The present invention relates to a PTP packaging material provided with a lid material having a cut portion.

Background Art

[0002] A press-through pack package (hereinafter referred to as "PTP") is widely used for individually packaging pharmaceuticals and the like. Generally, it includes a container material for containing a drug and a lid material for covering the container material. When taking out the drug, it is common to break through the lid material by pushing in the accommodation portion of the container material from below. When taking out the drug (tablets, etc.) filled in the container material of a conventional PTP, the lid material including an aluminum foil is broken by pushing out the drugs one by one from the pockets of the container sheet to take out the contents. In this case, in hospitals, dispensing pharmacies, etc., since they handle dozens to hundreds of drugs a day, it is burdensome to push out the drugs one by one, and there is a desire to easily take out a plurality of drugs at once.

[0003] For the purpose of solving the above problems, a package composed of a bottom material provided with an accommodation portion and a lid material in which a paper base material and an aluminum foil layer are laminated is developed. By adjusting the peel strength between the bottom material and the lid material and providing partial cuts in the paper base material of the lid material, the drug can be pushed out and taken out, and the lid can be peeled off to easily take out the drugs at once.

Prior Art Documents

Patent Documents

[0004]

Patent Document 1

Summary of the Invention

Problems to be Solved by the Invention

[0005] Conventional PTP packaging can produce fragments of aluminum foil from the lid when the medication is dispensed, and there is a problem that the aluminum may tear when attempting to peel off the lid, making it difficult to properly remove it. In the packaging material described in Patent Document 1, the base layer is made of paper to prevent the lid from tearing when peeling it from the base material, but there is a risk that the paper may tear when the medication is dispensed from the container, and that foreign matter may be mixed into the dispensed medication.

[0006] Therefore, the objective of this invention is to provide a PTP packaging that allows drugs to be pushed out of the pocket without contamination of the drugs with foreign matter, and also allows multiple drugs to be removed at once by peeling off the lid material. [Means for solving the problem]

[0007] This invention provides a means to solve the above problem in a PTP packaging material comprising a container material and a lid material. Specifically, the lid material is constructed by laminating a base layer, an adhesive layer, a metal layer, and a heat seal layer in this order, the base layer being made of a resin film, and a notch is provided in the base layer within the area corresponding to the storage portion. When the diameter of the storage portion for storing the drug is D, the notch has one of the following shapes: (1) at least two straight lines with a length of 0.4 to 1.2 times the diameter of D, (2) a single curve with a length of 2.1 to 3.8 times the diameter of D, and whose ends are not connected, or (3) a shape consisting of two or more lines, with at least one end of the line not connected to another line. By providing a notch of this specific size and shape, the drug can be pushed out of the pocket without contamination and the lid material can be properly peeled off. [Effects of the Invention]

[0008] According to this invention, the lid material is constructed by laminating a base layer, an adhesive layer, a metal layer, and a heat-seal layer in that order. Since the base layer is made of a resin film, it is possible to peel it off and remove the medication all at once, and it is also possible to suppress the inclusion of foreign matter when the medication is pushed out. Furthermore, by providing notches of a specific shape and size in the base layer of the lid material, the lid material can be reliably broken with little force and the medication can be removed. Moreover, since the notches are formed exclusively in the base layer and not in the metal layer, the necessary barrier properties are maintained during transportation and storage, resulting in excellent technical effects. [Brief explanation of the drawing]

[0009] [Figure 1] This is a schematic perspective view of a PTP packaging material according to one embodiment of the invention, as seen from the container material side. [Figure 2] This is a schematic perspective view of a PTP packaging material according to one embodiment of the invention, as seen from the lid side. [Figure 3] This figure shows the main cross-sectional structure of the containment section of the PTP packaging material. [Figure 4] This is a plan view of the lid material of the aforementioned PTP packaging material, showing that an X-shaped cutout has been formed in the area corresponding to the storage portion. [Figure 5] This is a plan view of the lid material of the aforementioned PTP packaging material, showing a state in which a Y-shaped cutout is formed in the area corresponding to the storage portion. [Figure 6] This is a plan view of the lid material of the aforementioned PTP packaging material, showing that an S-shaped cutout has been formed in the area corresponding to the storage portion. [Modes for carrying out the invention]

[0010] One embodiment of the present invention is a PTP packaging material used for individually packaging pharmaceuticals, and as shown in Figures 1 and 2, it is mainly composed of a container material 20 and a lid material 30, forming a PTP packaging material 10.

[0011] The PTP packaging material 10 has a structure in which the drug 50 is contained inside the container material 20, and the opening of this containment section 40 is sealed with a lid material 30.

[0012] The container material 20 has one or more storage compartments 40 for containing the drug 50. The material of the container material 20 is not particularly limited and any known material can be used. Specifically, it can be appropriately selected from resin sheets, metal sheets, or a metal sheet laminated with a resin sheet. Preferably, the resin sheet is made of polypropylene, polyvinyl chloride, or the like. For the container material, the above-mentioned material is used, and a container for holding contents such as tablets is formed by hot vacuum forming, hot pressure forming, plug-assisted forming, or the like. The thickness of the container is not particularly limited, but is preferably 50 μm to 400 μm.

[0013] The housing section 40 typically has a circular or elliptical shape, and the maximum diameter of the opening of this housing section 40 is defined as diameter D70.

[0014] The lid material 30 is a sheet-like member having a laminated structure that protects the drug 50 contained in the storage section 40 of the container material 20 and shields it from the external environment.

[0015] As shown in Figure 3, the lid material 30 is constructed by laminating a base material layer 31, an adhesive layer 32, a metal layer 33, and a heat seal layer 34 in that order from the outside.

[0016] The base layer 31 is the outermost layer of the lid material 30, that is, the layer located on the outer surface side of the PTP packaging material 10. Normally, the lid material of PTP packaging material is made of a laminated metal foil layer and a heat seal layer, but by adding a base layer, it is possible to provide strength when peeling it off. On the other hand, the presence of the base layer increases the force required when pushing it out, making it more difficult to remove. Therefore, it is necessary to make the pushing force appropriate by forming a notch.

[0017] As long as the material constituting the base material layer 31 is a resin film, a known resin film that is not particularly limited can be used. Among these, it is preferable to use a resin film containing any one of a polyolefin resin, a polyamide resin, and a polyester resin. More specifically, it is preferable to use a resin film such as a polyethylene-based resin, a polypropylene-based resin, a nylon-based resin, or a polyethylene terephthalate resin. Also, either an unstretched film or a stretched film can be used. Generally, while a stretched film has high strength, it has a tendency to have low elongation and be easily torn. Therefore, it is preferable to use a stretched film in order to achieve both the strength when peeling and taking out and the ease of opening when extruding and taking out.

[0018] From the viewpoints of breaking characteristics and ease of handling, the thickness of the base material layer 31 is preferably in the range of 6 μm or more and 50 μm or less. If it is thinner than 6 μm, the strength is weak and there is a risk of breaking from an unintended location, so it is not preferable. If it is thicker than 50 μm, the strength becomes too large more than necessary, which may inhibit the extrudability. More preferably, it is 9 μm or more and 25 μm or less.

[0019] The adhesive layer 32 is a layer that joins the base material layer 31 and the metal layer 33. The adhesive for forming the adhesive layer 32 is not particularly limited, and known adhesives and resins having adhesiveness can be used, and can be appropriately selected according to the material of the metal layer 33 and the material of the base material layer 31.

[0020] As the adhesive, known adhesives, particularly adhesives that can be used for pharmaceutical packaging applications, can be used. For example, laminate adhesives and the like can be preferably used. Examples of the components of the laminate adhesive include polyurethane-based adhesives, polyester-based adhesives, etc., and at least one of these can be used. Also, the type of the adhesive is not particularly limited, and for example, solvent-based, solvent-free, water-based adhesives, etc. can be used.

[0021] The metal layer 33 is located between the adhesive layer 32 and the heat seal layer 34 and has a function of ensuring gas barrier properties such as water vapor and oxygen against the drug 50.

[0022] The metal layer 33 is made of aluminum foil to achieve both high barrier properties and processability. Known aluminum foils can be used, specifically pure aluminum (JIS (AA) 1000 series, e.g., 1N30, 1070, 1100), Al-Mn series (JIS (AA) 3000 series, e.g., 3003, 3004), Al-Mg series (JIS (AA) 5000 series), Al-Fe series (JIS (AA) 8000 series, e.g., 8021, 8079). Among these, aluminum foils of materials (compositions) such as 1N30, 1070, 1100, 3003, 8021, and 8079 as specified in JIS are preferably used. Furthermore, hard aluminum foil is preferable for ease of opening.

[0023] The thickness of the metal layer 33 is limited to a range of 7 μm to 30 μm in order to ensure both barrier properties and ease of drug extrusion.

[0024] The heat seal layer 34 is a layer for heat-sealing the container material 20 and the lid material 30 to ensure airtight sealing of the storage section 40. It is preferable to use an adhesive thermoplastic resin for the heat seal layer 34. Specifically, examples include high-density polyethylene, medium-density polyethylene, low-density polyethylene, linear polyethylene, saturated polyester, linear saturated polyester, unstretched polypropylene, chlorinated polypropylene, ethylene-acrylic acid copolymer, ethylene-methacrylic acid copolymer, ethylene-ethyl acrylate copolymer, ethylene-methyl acrylate copolymer, ionomer, ethylene-ethyl acrylate-maleic anhydride terpolymer, vinyl chloride-vinyl acetate copolymer, polyolefin, carboxylic acid-modified polyethylene, carboxylic acid-modified polypropylene, carboxylic acid-modified ethylene-vinyl acetate copolymer, vinyl chloride, and polystyrene.

[0025] The laminated structure of this lid material 30 not only ensures barrier properties while providing sufficient strength to peel the lid material 30 from the container material 20 and remove the drug 50, but also, when combined with the notches 60, improves the ease of removal when pushing out the drug 50. The notches are formed in the base material layer and the adhesive layer, and preferably extend to just before the metal layer. The notches are formed, for example, by laser cutting.

[0026] When removing the drug 50 from the PTP packaging material 10, the user pushes the storage portion 40 of the container material 20 from the container material 20 towards the lid material 30. This pushing action applies stress to the lid material 30, and the notch 60 functions as a starting point for concentrating this stress.

[0027] The notch 60 is formed in the depth direction from the outer surface of the base material layer 31 of the lid material 30. When extrusion pressure of the drug 50 is applied, it breaks at the notch 60, allowing the drug to be removed.

[0028] The notch 60 has one of the following shapes, when the diameter of the housing portion 40 is D: (1) at least two straight lines with a length of 0.4 to 1.2 times the diameter of D; (2) a single curve with a length of 3.0 to 4.2 times the diameter of D, where the ends of the curves are not connected; or (3) a shape consisting of two or more lines, where at least one end of the lines is not connected to the other line. By having such a shape, the metal layer and the heat seal layer break along the notch, thereby ensuring barrier properties while allowing opening with an easy-to-open force.

[0029] The notch 60 is preferably X-shaped, Y-shaped, or S-shaped. With such a shape, the lid material in the portion corresponding to the containment section is separated, preventing it from mixing with the removed drug.

[0030] The PTP packaging material 10 may be provided with separation perforations 80 for individually separating multiple storage compartments 40. These perforations allow for separation into single doses or when dispensing the required amount of medication. [Examples]

[0031] The present invention will be specifically described below with reference to examples and comparative examples of the PTP packaging material of the present invention. However, the present invention is not limited to the following examples.

[0032] <Example 1> (1) Preparation of the lid As a lid material, a 12 μm thick biaxially oriented PET resin film was laminated to one side of a 17 μm thick rigid aluminum foil (1N30 material) using an adhesive. The adhesive used was a two-component dry laminating adhesive, consisting of 10 parts by weight of polyurethane adhesive main component and 1 part by weight of hardener. The adhesive was applied by gravure coating, with a dry weight of 3 g / m². 2 The application was carried out using the specified amount. After the applied coating (adhesive layer) dried, the PET resin film and aluminum foil were bonded together. Next, a vinyl chloride-vinyl acetate copolymer heat sealant was applied to the other side of the aluminum foil by gravure coating to form a heat seal layer. Then, a cut was formed from the substrate side by laser cutting. The shape of the cut was an X shape as shown in Figure 4, with half-cut lines provided where the length of each of the two straight lines was 1.1 times the diameter of the housing.

[0033] (2) Preparation of container materials A 250 μm thick polyvinyl chloride (PVC) film was used as the container material, and the storage compartments were formed by a known hot pressure forming method. The storage compartments were arranged in a regular pattern of 5 in the longitudinal direction and 2 in the short direction, with each storage compartment being a circle with a diameter of 10 mm and a height of 4 mm.

[0034] (3) Preparation of PTP packaging material Using a PTP packaging machine 600E3 (manufactured by CKD), the previously described container material was filled with circular tablets (Φ7.0 mm, without a score line), the lid material and the container material were heat-sealed via a heat-seal layer, and then perforations were made in the container material along the short side to divide the storage sections, resulting in a 37 mm x 94 mm PTP package. (4) Evaluation of PTP packaging materials Twenty adult subjects were given PTP packaging and asked to rate on a scale of 1 to 5 (1 point: (A) difficult to remove tablets by pushing the container's contents outwards, (B) difficult to separate the container by folding it parallel to the perforations, and using one of the separated pieces as a gripping surface to detach the lid from the container without tearing) each of them.

[0035] <Example 2> Example 2 was prepared in the same manner as Example 1, except that the shape of the notch in the base layer was changed to a Y-shape as shown in Figure 5, with the length of each of the three straight lines being 0.6 times the diameter of the storage section.

[0036] <Example 3> Example 3 was prepared in the same manner as Example 1, except that the shape of the notch provided in the base layer was changed to an S-shape as shown in Figure 6, with the length of one curve being 3.2 times the diameter of the storage section.

[0037] <Comparative Example 1> Comparative Example 1 was prepared in the same manner as Example 1, except that no notches were made in the base layer.

[0038] <Comparative Example 2> Comparative Example 2 was created to simulate the structure of a conventional PTP packaging material that lacks the function of peeling off. As the base material, a 17 μm thick, rigid aluminum foil (1N30 material) was laminated with an OP coat layer (overprint layer) on one side. An epoxy-based OP coat agent was used to form the OP coat layer, and it was applied by gravure coating. Next, a vinyl chloride-vinyl acetate copolymer heat sealant was applied to the other side of the aluminum foil by gravure coating to form a heat seal layer. Using the same container material as in Example 1 as the lid material, a PTP packaging material was created in the same manner as in Example 1.

[0039] The examples and comparative examples were evaluated after opening. The results are shown in Table 1.

[0040] [Table 1]

[0041] (A) Extrusion test 3.0 points or higher: Tablets are easy to push out. Below 3.0 points: Difficult to push out the tablets. (B) Peel test 3.0 points or higher: The lid material is easy to peel off. Below 3.0 points: Difficult to remove the lid material.

[0042] Comparative Example 1 showed that the lid material was easy to peel off, but it was difficult to push the tablets out. It was determined that while the lid material was suitable for peeling off and removing multiple tablets at once, it was not suitable for removing tablets one at a time.

[0043] Conventional PTP packaging (Comparative Example 2) made it easy to push out and remove tablets, but the lid was difficult to peel off. It is suitable for removing tablets one at a time, but not suitable for removing multiple tablets at once.

[0044] On the other hand, the packaging of the present invention (Examples 1-3) is suitable for dispensing tablets one at a time by pushing them out, and also for dispensing multiple tablets at once by easily peeling the lid material from the container material. [Explanation of Symbols]

[0045] 10 PTP packaging material 20 Container material 30 Lid material 31 Base material layer 32 Adhesive layer 33 Metal layer 34 Heat seal layer 40 Storage Units 50 medications 60 Notches 61 X-shape 62 Y shape 63 S-shape 70 Diameter D 80 perforations

Claims

1. A PTP packaging material comprising a container material and a lid material, The container material has a compartment for containing the drug, The aforementioned lid material is constructed by laminating a base material layer, an adhesive layer, a metal layer, and a heat seal layer in this order. The aforementioned substrate layer is made of a resin film, The base material layer of the lid material has a notch formed in the depth direction from the outer surface of the lid material within the region corresponding to the housing portion. The cut portion of the PTP packaging material has one of the following shapes, where D is the diameter of the housing portion: (1) at least two straight lines with a length of 0.4 to 1.2 times the diameter of D; (2) a single curve with a length of 2.1 to 3.8 times the diameter of D, and whose ends are not connected; or (3) a shape consisting of two or more lines, where at least one end of the lines is not connected to the other line.

2. The PTP packaging material according to claim 1, wherein the notched portion has an X-shape, a Y-shape, or an S-shape.

3. The PTP packaging material according to claim 1, further comprising perforations for division that penetrate the container material and the lid material.

4. The PTP packaging material according to claim 1, wherein the base layer is a stretched resin film comprising at least one selected from the group consisting of polyolefin resin, polyamide resin, and polyester resin, and has a thickness of 9 μm or more and 100 μm or less.

5. The PTP packaging material according to claim 1, wherein the metal layer is a hard aluminum foil having a thickness of 10 μm or more and 30 μm or less.

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