JP2024117840A - Lid material for PTP packaging - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a lid material for PTP packaging with child-resistant function without using resin film.

SOLUTION: A lid material 1 for PTP packaging is characterized in that it has an aluminum foil layer 2 but has no resin film layer, the aluminum foil layer 2 being made of soft aluminum foil with a thickness of 25 μm to 33 μm, and the Mullen burst strength of the lid material 1 being 225 kPa to 300 kPa. The extrusion strength of the lid material 1 is preferably 35 N to 80 N. For example, the aluminum foil layer 2 can be provided with a heat seal layer 3 on the back side thereof, a printing layer 4 on the front side of the aluminum foil layer 2, and an overprint layer 5 on top of it.

SELECTED DRAWING: Figure 1

COPYRIGHT: (C)2024,JPO&INPIT

Description

The present invention relates to a lid material used for PTP packages that mainly package medicines such as tablets, and more specifically, to a lid material for PTP packages that has a child-resistant function.

Press-through packs (PTPs) are often used to package medicines such as tablets and capsules. In PTPs, medicines such as tablets are individually stored in pockets (storage recesses) in a base material such as polyvinyl chloride, and are covered with a lid material such as aluminum foil or resin film. By pressing the pockets (storage recesses) with a finger or the like, the medicines such as tablets break through the lid material, allowing them to be easily removed.

For example, Patent Document 1 listed below discloses a top film for PTP packaging which is formed by laminating a sealant layer having a thickness of 10 to 40 μm onto a polyethylene terephthalate film or polypropylene film having a thickness of 10 to 30 μm and having a large number of fine holes formed all over the surface, the holes being formed in an inverted cone or pyramid shape, or an inverted truncated cone or truncated pyramid shape facing the sealant layer, having a diameter of 15 μmφ or less at the laminated surface with the sealant layer, and characterized in that 400 to 3000 such holes are provided per 1 ^cm2 .

The following Patent Document 2 shows a press-through pack package that includes a lid material having a resin film layer, a base material layer, and a thermal adhesive layer in that order, and a container having a flange portion and multiple pocket portions, and that has both press-through and easy-peel functions. One side of the resin film layer has multiple continuous linear half-cuts that are approximately parallel to each other and form stripes, the distance between adjacent half-cuts is smaller than the average diameter of the pocket portions, at least parts of the half-cuts are located in areas corresponding to all of the pocket portions, the thermal adhesive layer is made of an easy-peel thermal adhesive layer, the base material layer and the flange portion are bonded by the easy-peel thermal adhesive layer, and a grip portion is provided along one entire side of the periphery of the press-through pack package so that the direction in which the lid material is peeled off coincides with the direction of the stripes. This makes it easy for the elderly and young children to push out the medicine, and also makes it easy for hospitals to take out a large number of medicines at once.

However, in recent years, there has been a problem with PTP packaging, as there is a risk that infants and children may accidentally ingest the medicine if it is too easy to remove it from the PTP packaging. As a result, PTP packaging lids have been developed that are easy for adults to remove (senior-friendly) but have a child-resistant function (also known as the CR function for short) that makes it difficult for infants and children to remove the medicine.

For example, the following Patent Document 3 discloses a lid material for a press-through pack that includes a resin film, aluminum foil, and a thermal adhesive layer, and has tapered through holes formed in the resin film.

Utility Model Registration No. 3035462 Patent No. 5376646 JP 2014-181069 A

The lid materials disclosed in the above Patent Documents 1 and 2 require processing such as perforation and half-cutting, which necessitates the preparation of new equipment for production, resulting in a manufacturing problem of high costs.
In addition, the PTP package containing the medicine needs to be sealed to prevent deterioration of the medicine. Therefore, it is necessary to heat seal the package at a high temperature, for example, about 260±10° C. When the package is heat sealed at such a high temperature, the resin film of the lid material disclosed in the above Patent Document 3 melts, and the through-hole is blocked, so that the medicine cannot be pushed out at all.

The object of the present invention is to provide a lid material for PTP packages that has child resistance without using a resin film, and furthermore, this lid material for PTP packages has the advantage that no new equipment is required for its production.

The lid material for PTP packages of one embodiment of the present invention is a lid material for PTP packages that has an aluminum foil layer and does not have a resin film layer, characterized in that the aluminum foil layer is made of soft aluminum foil having a thickness of 25 μm to 33 μm, and the Mullen burst strength of the lid material is 225 kPa to 300 kPa.

Conventionally, when an aluminum foil layer is provided on the lid material of a PTP package, hard aluminum foil has mainly been used, but the lid material of this embodiment uses soft aluminum foil, which stretches more than hard aluminum foil, making it difficult to push out the contents with a small amount of pressure. In addition, since the Mullen burst strength of the lid material is 200 kPa or more, it can be made strong enough to be removed by adults but difficult for infants and children to remove, making it possible to create a lid material that is senior-friendly yet has child-resistant functions.

The lid material of the above embodiment preferably has a Mullen burst strength of 200 kPa to 300 kPa. If the Mullen burst strength exceeds this value, the lid material will be difficult to break, and even adults may have difficulty removing the contents.

In the above-mentioned embodiment of the lid material, the soft aluminum foil has a thickness of 17 μm to 45 μm, and preferably belongs to any of the alloy numbers 1N30, 8079, and 8021 specified in JIS H4160. Such soft aluminum foil is particularly suitable for use as a lid material with child resistance.

The lid material of the above embodiment preferably has an extrusion strength of 35 N or more. If it is less than this value, even infants and children may be able to easily remove the contents.

The above-mentioned lid material of one embodiment can have a laminated structure with a heat seal layer on the back side of the aluminum foil layer, a printed layer on the front side of the aluminum foil layer, and an overprint layer on top of the printed layer.

1 is a cross-sectional view showing a schematic diagram of a lid material for a PTP package according to one embodiment of the present invention. FIG. 2 is a cross-sectional view showing a schematic diagram of a lid material for PTP packaging according to another embodiment of the present invention. 2 is a side view showing a schematic diagram of a PTP package in which the lid material of FIG. 1 is attached to a base material. FIG. 2 is a side view showing a schematic diagram of a placebo tablet used in the Examples.

The following describes one embodiment of the lid material for PTP packages. However, the present invention is not limited to this embodiment.

A lid material 1 for PTP packaging according to one embodiment of the present invention (hereinafter referred to as lid material 1) is characterized in that it has at least an aluminum foil layer 2, as shown in FIG. 1, and does not have a resin film laminated thereon.
The resin film refers to, for example, a resin film such as a polyethylene film, a polypropylene film, a polyester film, a polyamide (nylon) film, a (meth)acrylic resin, a polyvinyl chloride resin, a polystyrene resin, a polyvinylidene chloride resin, a saponified ethylene-vinyl acetate copolymer, polyvinyl alcohol, a polycarbonate resin, a polyvinyl acetate resin, or an acetal resin.

In this embodiment, the lid material 1 has a heat seal layer 3 (hereinafter also referred to as HS layer 3) on the back side of the aluminum foil layer 2, a printed layer 4 on the front side, and an overprint layer 5 (hereinafter also referred to as OP layer 5) on top of that.

The aluminum foil layer 2 is made of soft aluminum foil, and although there is no particular limitation, it is preferable that the aluminum foil belongs to any one of alloy numbers 1N30, 8079, and 8021 specified in JIS H4160.
In addition, soft aluminum foil is a hard aluminum foil softened by heat treatment. For example, it can be produced by rolling aluminum to thinly stretch it into a hard aluminum foil and subjecting it to heat treatment at about 400 ° C.

The thickness of the aluminum foil layer 2 is not particularly limited, but is preferably 17 μm to 45 μm, particularly preferably 20 μm to 35 μm, and even more preferably 25 μm to 33 μm. If it is less than 17 μm, it will be easily torn, and if it exceeds 45 μm, it will be difficult to push out the contents.

The soft aluminum foil forming the aluminum foil layer 2 preferably has an elongation of 5% or more, particularly preferably 7% to 20%. By having an elongation of 5% or more, it is possible to obtain a lid material 1 that is moderately elongated and makes it difficult for infants and children to remove contents. The elongation can be increased by increasing the thickness of the aluminum foil layer 2 or by selecting the material.
The elongation can be measured, for example, by the measurement method shown in the examples below.

The soft aluminum foil forming the aluminum foil layer 2 preferably has a yield stress of 100 N/mm2 ^or less, particularly preferably 20 N/ ^mm2 to 70 N/ ^mm2 . By having a yield stress of 100 N/mm2 or ^less , the lid material 1 can be broken by a moderate stress, making it easy for adults to remove the contents. The yield stress can be increased by increasing the thickness of the aluminum foil layer 2 or by selecting the material.
The yield stress can be measured, for example, by the measurement method shown in the following examples.

The soft aluminum foil forming the aluminum foil layer 2 preferably has a tensile strength of 100 N/mm2 ^or less, particularly preferably 50 N/ ^mm2 to 80 N/ ^mm2 . By having a tensile strength of 100 N/mm2 or ^less , the lid material 1 can be broken by a moderate stress, making it easy for adults to remove the contents.
The tensile strength can be measured, for example, by the measurement method shown in the following examples.

The HS layer 3 can be formed using a heat-sealing agent known in the art, such as a heat-sealing agent made of polyvinyl chloride (PVC), polypropylene (PP), polystyrene (PS), polyethylene terephthalate (PET), vinyl chloride-vinyl acetate copolymer, or the like.
The HS layer 3 can be formed, for example, by applying a heat seal agent by gravure coating or the like. The amount of coating is not particularly limited, but can be formed to be 2 g/m ² to 5 g/m ² per unit area, preferably 2.5 g/m ² to 4 g/m ² .

The printing layer 4 can be formed by printing, for example, characters, figures, symbols, and more specifically, immutable information such as the product name, price, dosage, efficacy, and other information, and variable information such as the date of manufacture, lot number, and expiration date. In particular, it is preferable to print a one-dimensional code (e.g., a barcode) or two-dimensional code (e.g., a QR code (registered trademark)) that contains variable information such as the date of manufacture and lot number, which is individual information about the product, and it is preferable to print a barcode for pharmaceuticals such as GS1 (old RSS code), GS1-RSS limited composite symbol CC-A, or GS1-RSS14 stack composite symbol CC-A.

The printing layer 4 may be printed in any color, for example, black, blue, green, red, yellow, etc. The ink used for printing the printing layer 4 may be any conventionally known ink, and for example, when printing in black, an ink containing carbon black is preferred.
The printed layer 4 can be formed by a conventionally known method, for example, inkjet printing, gravure printing, or the like.
The printing layer 4 may be provided on the back surface (HS layer 3 side) of the aluminum foil layer 2, or on both surfaces of the aluminum foil layer 2.

The OP layer 5 is a layer for protecting the printed layer 4 etc., and can be formed of a material that has been used in the OP layers of conventionally known PTP packages, for example, by applying an OP coating agent made of a transparent resin such as a nitrocellulose-based, acrylic-based, or epoxy-based resin by gravure coating or the like.
The coating amount of the OP layer 5 is not particularly limited, but may be 0.5 g/m ² to 2.5 g/m ² per unit area, and preferably 0.5 g/m ² to 1.5 g/m ^2. The OP layer 5 may contain 3 to 5 mass % of a matting agent such as silicon oxide.

The lid material 1 may be laminated with layers other than the aluminum foil layer 2, HS layer 3, print layer 4, and OP layer 5, such as an anchor coat layer, a primer coat layer, a colored layer, etc. The colored layer may be, for example, a white layer containing titanium oxide as a white pigment.

The lid material 1 has a laminated structure of, from the top, OP layer 5/printed layer 4/aluminum foil layer 2/HS layer 3, but is not limited to this. For example, as shown in Figure 2, the lid material 1 can have a laminated structure of OP layer 5/printed layer 4/aluminum foil layer 2/printed layer 4/HS layer 3.

The overall thickness of the lid material 1 is not particularly limited, but is preferably 25 μm to 55 μm, and more preferably 30 μm to 45 μm.

The lid material 1 preferably has a Mullen burst strength of 200 kPa or more, particularly preferably 200 kPa to 300 kPa, and even more preferably 220 kPa to 280 kPa. This makes it difficult for small children to take out medicines from the lid material 1. The Mullen burst strength can be increased by increasing the thickness of the aluminum foil layer 2, for example.
The Mullen burst strength can be measured, for example, in accordance with JIS P8131.

The lid material 1 preferably has an extrusion strength of 35 N or more, particularly preferably 40 N to 80 N, and further preferably 45 N to 65 N. In this way, it is possible to make the lid material 1 difficult for small children to take out medicines, etc. The extrusion strength can be increased by increasing the thickness of the aluminum foil layer 2, etc.
The extrusion strength can be measured, for example, by the measurement method shown in the following Examples.

3, the lid material 1 can be attached to a base material 6 made of polyvinyl chloride or the like by heat sealing to form a PTP package 7. The heat sealing can be performed under conditions of, for example, about 220° C. to 270° C. and about 0.2 MPa to 0.4 MPa.
The PTP packaging body 7 can store items such as medicines such as tablets and capsules, electronic components such as mercury batteries, etc. in its pocket (storage recess) 8, and can store items that may be accidentally swallowed by infants and children.

When the lid material 1 is used in a PTP package, it is difficult for infants and children to tear it, but can be easily torn by adults, making it a PTP package that is senior-friendly and also has a child-resistant function. As with conventional PTP packages, the medicines and other items inside can be removed by pressing the pocket 8, so the method of use is the same as before and there is no need to give detailed instructions to patients.
In addition, it is possible to create a PTP package with child resistance without using a resin film, and there is no need to perform processing such as perforating the resin film as with conventional lid materials, so it can be produced at conventional line speeds and quality variation can be reduced.
Furthermore, the cost can be reduced, and since existing packaging equipment (such as PTP packaging machines, bundling machines, and cartoners) can be used, the number of manufacturing steps does not increase compared to conventional methods.

The following describes one embodiment of the lid material for PTP packages according to the present invention. However, the present invention is not limited to this embodiment.

Example 1
The lid material for PTP packaging of Example 1 was produced as follows.

(Aluminum foil layer)
The aluminum foil layer was made of soft aluminum foil of 1N30 material based on JIS H4160. The thickness was 30 μm.
This soft aluminum foil has an elongation of 9.10%, a yield stress of 31.50 N/mm ² , and a tensile strength of 64.00 N/mm ² .

The elongation, yield stress, and tensile strength of the aluminum foil were measured using a tensile tester (Autograph (registered trademark) AGS-500NJ) manufactured by Shimadzu Corporation. The aluminum foil test pieces used were 15.1 mm wide x 150 mm long. The following Examples 2 to 4 and Comparative Example 1 were also measured in the same manner.
The test conditions were set as follows: H material (hard material) was pulled at 1 mm/min from the start to the displacement point, and 2.5 mm/min after the displacement point. Also, O material (soft material) was pulled at 1 mm/min from the start to the displacement point, and 5 mm/min after the displacement point.

(Printing layer)
As a printing layer, a white ink was applied to the entire surface of the aluminum foil layer (OP layer side), and GS1 Databar Limited was printed on it. In addition, the back side (HS layer side) was printed with black, indigo, and red inks with the name of the drug, etc.

(Heat seal layer)
The heat seal layer was formed by gravure coating the back side of the aluminum foil layer with a heat sealant (A type) made of vinyl chloride/vinyl acetate copolymer manufactured by Dainichi Seikagaku Kogyo Co., Ltd. The coating amount was 3.3 g/ ^m2 .

(Overprint Layer)
The overprint layer was formed by gravure coating on the printed layer using an OP agent (acrylic transparent resin) manufactured by Toyo Ink Co., Ltd. The coating amount was 1.7 g/ ^m2 .

Example 2
The lid material for PTP packaging of Example 2 was produced in the same manner as in Example 1, except that the following aluminum foil was used as the aluminum foil layer.

(Aluminum foil layer)
The aluminum foil layer was made of soft aluminum foil made of 8079 material based on JIS H4160. The thickness of the aluminum foil layer was 25 μm.
This soft aluminum foil has an elongation of 12.50%, a yield stress of 40.00 N/mm ² and a tensile strength of 79.50 N/mm ² .

Example 3
The lid material for PTP packaging of Example 3 was produced in the same manner as in Example 1, except that the aluminum foil layer was made of the following aluminum foil and the heat seal layer had the following configuration.

(Aluminum foil layer)
The aluminum foil layer was made of soft aluminum foil made of 8079 material based on JIS H4160. The thickness of the aluminum foil layer was 30 μm.
This soft aluminum foil has an elongation of 12.70%, a yield stress of 40.00 N/mm ² , and a tensile strength of 77.00 N/mm ² .

(Heat seal layer)
The heat seal layer was formed by gravure coating the back side of the aluminum foil layer with a heat sealant (A type) made of vinyl chloride/vinyl acetate copolymer manufactured by Dainichi Seikagaku Kogyo Co., Ltd. The coating amount was 3.3 g/ ^m2 .

Example 4
The lid material for PTP packaging of Example 4 was produced in the same manner as in Example 1, except that the aluminum foil layer was made of the following aluminum foil and the heat seal layer had the following configuration.

(Aluminum foil layer)
The aluminum foil layer was made of soft aluminum foil made of 8079 material based on JIS H4160. The thickness of the aluminum foil layer was 30 μm.
This soft aluminum foil has an elongation of 12.70%, a yield stress of 40.00 N/mm ² , and a tensile strength of 77.00 N/mm ² .

(Heat seal layer)
The heat seal layer was formed by gravure coating the back side of the aluminum foil layer with a heat sealant (B type) made of vinyl chloride/vinyl acetate copolymer manufactured by Dainichi Seikagaku Kogyo Co., Ltd. The coating amount was 3.5 g/ ^m2 .

<Comparative Example 1>
The lid material for PTP packaging of Comparative Example 1 was produced in the same manner as in Example 1, except that the following aluminum foil was used as the aluminum foil layer.

(Aluminum foil layer)
As the aluminum foil layer, a hard aluminum foil of 1N30 material based on JIS H4160 was used. The thickness was 20 μm.
This hard aluminum foil has an elongation of 2.25%, a yield stress of 160.00 N/mm ² , and a tensile strength of 185.00 N/mm ² .

<Mullen burst strength test>
Using the lid materials of Examples 1 to 4 and Comparative Example 1, a Mullen burst strength test was carried out in accordance with JIS P8131.
Measurement was performed from the HS layer side in Examples 1 to 3 and Comparative Example 1, and measurement was performed from both the HS layer side and the OP layer side in Example 4. The measurement was performed three times, and the average value was calculated.
The results are shown in Table 1 below.

(Preparation of PTP packaging)
The lid materials of Examples 1 to 4 and Comparative Example 1 were heat-sealed at 240° C. and 0.4 Pa to a base material made of vinyl chloride (thickness 250 μm) and having 10 pockets (storage recesses) (2 columns x 5 rows) to prepare PTP packages. The size of each pocket was a maximum diameter of about 10 mm and a maximum depth of about 4.8 mm. At this time, a total of 10 placebo tablets ("Reduced Maltose Processed Food" manufactured by Placebo Pharmaceutical Co., Ltd.) were stored in each pocket of the base material. As shown in FIG. 4, the placebo tablets had a diameter (dimension X) of about 8 mm, a maximum thickness (dimension Y) of about 3.5 mm, and a minimum thickness (dimension Z) of about 2.1 mm.

<Extrusion strength test>
The extrusion strength test was carried out using a force tester (model: MCT-2150) manufactured by A&D Co., Ltd. More specifically, a cylindrical extrusion tool with a diameter of 5 mm was placed on the base material, and the tablet was pressed from the base material side at a speed of 10 mm/min, and the maximum load at which the lid material was broken by the tablet was measured. This value was measured five times and the average value was calculated.
The results are shown in Table 2 below.

<Child Resistance Test>
Using the above PTP packages produced from the lid materials of Example 4 and Comparative Example 1, a child resistance test was carried out under the following conditions.
1. Children (panelers) aged 42 to 60 months were given the PTP packages.
2. They may open it by any means (including biting it).
3. The child is given five minutes to measure how many pieces he or she can remove. However, if the panelist declares that the pieces are too hard to remove (give up), the test ends at that point.
4. The panelists were free to choose whether to test the PTP package of Example 4 or Comparative Example 1.

The results of the child resistance test are shown in Table 3 below. Note that "give up" in Table 3 indicates the time when the give up was reported.

(Child resistant test results)
The average number of tablets that could be taken out of the PTP package of Example 4 was about 1.4 tablets. Some children were able to take out all 10 tablets, but 13 out of 18 children were unable to take out any tablets. In addition, 15 children gave up midway and gave up on opening the package.
Therefore, it was confirmed that the PTP package of Example 4 is a PTP package in which the tablets are difficult to remove and has a child-resistant function.

In contrast, all 18 participants were able to remove all 10 tablets from the PTP package of Comparative Example 1. The lid was easily torn, allowing the tablets and other medicines to be easily removed.

<Senior Friendly Test>
Using the PTP packaging body prepared from the lid material of Example 4, a senior-friendliness test was carried out under the following conditions.
1. Give the PTP package to panelists aged 50 to 80 years.
2. They may open it by any means.
3. Record how many tablets the panelists were able to remove within 5 minutes.
4. After that, we conducted an interview and asked the participants to answer which of the following categories A to D they considered the ease of tablet removal to be.
A: Too hard. It is considered inappropriate as a product. B: Quite hard. It is problematic when considering a wide range of users. C: Somewhat hard. It is not particularly difficult to remove. D: Not hard. It is the same as a normal product.

The results of the Senior Friendly Test are shown in Table 4 below.

(Senior Friendly Test Results)
Adults (seniors) were able to take out all 10 tablets within the time limit even from the PTP package of Example 4. It was confirmed that, like the conventional PTP package, it was a senior-friendly package that adults could easily take out tablets from.

1... Lid material 2... Aluminum foil layer 3... Heat seal (HS) layer 4... Printed layer 5... Overprint (OP) layer 6... Base material 7... PTP packaging body 8... Pocket (storage recess)

Claims (4)

A lid material for PTP packaging having an aluminum foil layer and no resin film layer,
The aluminum foil layer is made of a soft aluminum foil having a thickness of 25 μm to 33 μm, and the Mullen burst strength of the lid material is 225 kPa to 300 kPa. The lid material for PTP packaging according to claim 1, wherein the extrusion strength of the lid material is 35N to 80N. The lid material for PTP packaging according to claim 2, wherein the soft aluminum foil has an elongation of 5% or more, a yield stress of 100 N/mm2 ^or less, and a tensile strength of 100 N/mm2 ^or less. The lid material for PTP packaging according to any one of claims 1 to 3, which comprises a heat seal layer on the back side of the aluminum foil layer, a printed layer on the front side of the aluminum foil layer, and an overprint layer on the printed layer.

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