JP2016222274A - Lid material of press-through pack - Google Patents

Lid material of press-through pack Download PDF

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JP2016222274A
JP2016222274A JP2015109438A JP2015109438A JP2016222274A JP 2016222274 A JP2016222274 A JP 2016222274A JP 2015109438 A JP2015109438 A JP 2015109438A JP 2015109438 A JP2015109438 A JP 2015109438A JP 2016222274 A JP2016222274 A JP 2016222274A
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thickness
press
punch
aluminum foil
pack
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JP6559467B2 (en
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洋平 芳賀
Yohei Haga
洋平 芳賀
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UACJ Foil Corp
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Abstract

PROBLEM TO BE SOLVED: To provide a lid material of a press-through pack having the child resistance function capable of eliminating the problem of erroneous drinking of a baby, while holding easiness of an opening characteristic when taking out the content such as a medicine.SOLUTION: In a lid material 1 of a press-through pack having a heat adhesive layer to be adhered to a resin film, aluminum foil and a container, the resin film is a polyethylene terephthalate film, and when a film surface is thrust at a speed of 10 mm/min by a flat circular punch 4 having the tip of a diameter of 1.8 mm, a moving distance of the punch until the lid material ruptures, is 0.4 mm or more and less than 0.8 mm.SELECTED DRAWING: Figure 1

Description

本発明は、プレススルーパックの蓋材に関する。   The present invention relates to a lid material for a press-through pack.

医薬品などの錠剤やカプセルなどの包装には、プレススルーパック(以下、PTPという)と呼ばれる包装形態が採用されている。PTPは、例えば、樹脂シートを包装容器に成形し、包装容器内に錠剤やカプセルなどの内容物を収納したのち、通常、アルミニウム箔と熱接着層とで構成される蓋材を、包装容器のフランジ部に熱接着層を介して熱接着し、内容物を封緘することにより得られる。   A packaging form called a press-through pack (hereinafter referred to as PTP) is employed for packaging tablets such as pharmaceuticals and capsules. For example, after forming a resin sheet into a packaging container and storing the contents such as tablets and capsules in the packaging container, the PTP is usually made up of a lid made of an aluminum foil and a thermal adhesive layer. It is obtained by heat-bonding the flange part via a heat-bonding layer and sealing the contents.

PTPからの錠剤などの取り出しは、包装容器の部分に指で圧力をかけると、内容物である薬剤が蓋材を突き破り、容易に取り出せるようになっている。このように、PTPは開封の容易さから、老人や子供でも簡単に薬剤を取り出すことができるため、病院、薬局などに広く普及してきたが、幼児でも簡単に開封できるため幼児が誤って薬剤を飲み込んでしまう事故が生じ、大きな問題となっている。   When taking out a tablet or the like from the PTP, when a pressure is applied to the portion of the packaging container with a finger, the medicine as the contents breaks through the lid and can be easily taken out. In this way, PTP has been widely used in hospitals and pharmacies because it can be easily opened by elderly people and children because of its ease of opening. A swallowing accident has occurred and has become a major problem.

この問題を解消するためには、蓋材の構成が重要であり、高齢者などには開封できるが、幼児には開け難い、いわゆるチャイルドレジスタンス機能付きのPTP用蓋材や包装形態が提案されている。   In order to solve this problem, the structure of the lid material is important, and so-called child resistance function PTP lid materials and packaging forms that can be opened by elderly people but difficult for infants have been proposed. Yes.

特許第4196189号公報Japanese Patent No. 4196189 特許第4978295号公報Japanese Patent No. 4978295 特許第5053864号公報Japanese Patent No. 5053864 特開2012−176802号公報JP 2012-176802 A

本発明は、より簡単な構成でチャイルドレジスタンス機能を有するPTP用蓋材を得るために、アルミニウム箔に積層する樹脂フィルム、積層方法について試験、検討を行った結果としてなされたものであり、その目的は、薬剤などの内容物を取り出す際の開封性の容易さを保持するとともに、幼児の誤飲の問題を解消することができるチャイルドレジスタンス機能を有するプレススルーパックの蓋材を提供することにある。   The present invention was made as a result of testing and studying a resin film laminated on an aluminum foil and a lamination method in order to obtain a PTP lid material having a child resistance function with a simpler configuration. An object of the present invention is to provide a cover material for a press-through pack having a child resistance function that can maintain the ease of opening when taking out contents such as medicines and solve the problem of infant accidental ingestion. .

上記の目的を達成するための請求項1によるプレススルーパックの蓋材は、樹脂フィルム、アルミニウム箔、容器に接着するための熱接着層を備えてなるプレススルーパックの蓋材であって、前記樹脂フィルムがポリエチレンテレフタレートフィルムであり、該フィルム面を先端が直径1.8mmの平坦円形状のポンチにより10mm/分の速度で突き刺した場合、蓋材が破断するまでのポンチの移動距離が0.4mm以上0.8mm未満であることを特徴とする。   The lid of a press-through pack according to claim 1 for achieving the above object is a lid of a press-through pack comprising a resin film, an aluminum foil, and a thermal adhesive layer for bonding to a container, When the resin film is a polyethylene terephthalate film and the film surface is pierced by a flat circular punch having a diameter of 1.8 mm at a speed of 10 mm / min, the movement distance of the punch until the lid material breaks is 0.00. It is 4 mm or more and less than 0.8 mm.

請求項2によるプレススルーパックの蓋材は、請求項1において、前記ポリエチレンテレフタレートフィルム面を先端が直径1.8mmの平坦円形状のポンチにより10mm/分の速度で突き刺した場合、ポンチの貫通に要する最大荷重が5〜6Nであることを特徴とする。   The press-through pack cover material according to claim 2 is used to penetrate the punch according to claim 1 when the polyethylene terephthalate film surface is pierced at a speed of 10 mm / min with a flat circular punch having a diameter of 1.8 mm. The maximum load required is 5-6N.

請求項3によるプレススルーパックの蓋材は、請求項2において、前記アルミニウム箔の厚さが15〜25μm、前記ポリエチレンテレフタレートフィルムの厚さが2.5〜4μmであり、アルミニウム箔の厚さに対するポリエチレンテレフタレートフィルムの厚さの比、(ポリエチレンテレフタレートフィルムの厚さ(μm)/アルミニウム箔の厚さ(μm))が0.15〜0.20であることを特徴とする。   The lid material of the press-through pack according to claim 3 is the invention according to claim 2, wherein the aluminum foil has a thickness of 15 to 25 μm, the polyethylene terephthalate film has a thickness of 2.5 to 4 μm, and the thickness of the aluminum foil is The ratio of the thickness of the polyethylene terephthalate film, (the thickness of the polyethylene terephthalate film (μm) / the thickness of the aluminum foil (μm)) is 0.15 to 0.20.

本発明によれば、薬剤などの内容物を取り出す際の開封性の容易さを保持するとともに、幼児の誤飲の問題を解消することができるチャイルドレジスタンス機能を有するプレススルーパックの蓋材が提供される。また、本発明による蓋材をそなえたPTPをポケットや袋などに入れて持ち歩いたり、他のPTPと一緒にしても、蓋材が破れたりすることもない。   ADVANTAGE OF THE INVENTION According to this invention, the cover material of the press-through pack which has the child resistance function which can eliminate the problem of the accidental ingestion of an infant while holding the ease of opening at the time of taking out contents, such as a chemical | medical agent, is provided. Is done. Moreover, even if the PTP provided with the lid according to the present invention is carried around in a pocket or a bag, or when it is combined with other PTP, the lid is not torn.

実施例における突き刺し試験の装置構成を示す図である。It is a figure which shows the apparatus structure of the piercing test in an Example.

以下、本発明によるプレススルーパックの蓋材について説明すると、本発明によるプレススルーパックの蓋材は、樹脂フィルム、アルミニウム箔、容器に接着するための熱接着層を備えてなる。
(アルミニウム箔):
アルミニウム箔としては、公知のPTPで使用されているアルミニウム箔、例えば、JIS等で規定される1N30、1070、1100、8021、8079材などの硬質材(厚さ:10〜30μm程度)を適用するのが望ましい。
Hereinafter, the lid of the press-through pack according to the present invention will be described. The lid of the press-through pack according to the present invention includes a resin film, an aluminum foil, and a thermal adhesive layer for bonding to a container.
(Aluminum foil):
As the aluminum foil, a hard material (thickness: about 10 to 30 μm) such as 1N30, 1070, 1100, 8021, and 8079 materials defined by JIS or the like is used as a known PTP. Is desirable.

(樹脂フィルム):
樹脂フィルムとして、ポリエチレンテレフタレートフィルムが望ましく、アルミニウム箔とポリエチレンテレフタレートフィルムとの積層は、ウレタン系、オレフィン系、ブチルゴム系、アクリル樹脂系、ポリエステル系、エポキシ系、シリコーン樹脂系のドライラミネート接着剤を用いたドライラミネート法によるのが好ましい。接着層の厚さは0.5〜5μmが好ましい。
(Resin film):
Polyethylene terephthalate film is desirable as the resin film, and lamination of aluminum foil and polyethylene terephthalate film uses urethane, olefin, butyl rubber, acrylic resin, polyester, epoxy, and silicone resin dry laminate adhesives. The dry lamination method is preferable. The thickness of the adhesive layer is preferably 0.5 to 5 μm.

(熱接着層):
熱接着層は、蓋材を包装容器のフランジ部に接着して包装容器に収納された薬剤などの内容物を封緘するためのもので、公知のPTPで用いられている熱接着剤で構成することができ、ポリプロピレン系接着剤、塩化ビニル系接着剤、塩化ビニル−酢酸ビニル系共重合体系接着剤などが適用される。
(Thermal bonding layer):
The thermal adhesive layer is used to seal the contents such as medicine stored in the packaging container by adhering the lid material to the flange portion of the packaging container, and is composed of a thermal adhesive used in a known PTP. Polypropylene adhesives, vinyl chloride adhesives, vinyl chloride-vinyl acetate copolymer adhesives, and the like are applied.

上記は本発明によるプレススルーパックの蓋材の主要構成であり、具体的には、必要に応じて、印刷層、着色層、バーコード層、接着層、オーバーコート層などを設けることができる。   The above is the main configuration of the cover material of the press-through pack according to the present invention. Specifically, a printing layer, a colored layer, a barcode layer, an adhesive layer, an overcoat layer, and the like can be provided as necessary.

樹脂フィルム、アルミニウム箔、熱接着層を備えてなる本発明によるプレススルーパックの蓋材の特徴は、ポリエチレンテレフタレートフィルム面を先端が直径1.8mmの平坦円形状のポンチにより10mm/分の速度でフィルム面と垂直方向に突き刺した場合、蓋材が破断するまでのポンチの移動距離(蓋材がポンチで押されて破断までに撓んだ距離)が0.4mm以上0.8mm未満であることを特徴とする。   The feature of the cover material of the press-through pack according to the present invention comprising the resin film, the aluminum foil, and the thermal adhesive layer is that the polyethylene terephthalate film surface is formed at a speed of 10 mm / min by a flat circular punch having a tip of 1.8 mm in diameter. When piercing in the direction perpendicular to the film surface, the distance that the punch moves until the lid breaks (the distance that the lid is bent by the punch when it is bent) is 0.4 mm or more and less than 0.8 mm It is characterized by.

市販の包装容器に錠剤を収納して包装容器のフランジにこの蓋材を熱接着してPTP包装体を作製し、包装容器の底を圧迫して、錠剤が蓋材を破って取り出せるかどうか評価した結果、蓋材が破断するまでのポンチの移動距離(蓋材がポンチで押されて破断までに撓んだ距離)が0.4mm未満では、蓋材が破れ易く、チャイルドレジスタンス機能を達成することができ難い。ポンチの移動距離が0.8mm以上では蓋材が破れ難く、錠剤の取り出しが困難であった。   Evaluate whether tablets can be taken out by storing the tablets in a commercially available packaging container, making the PTP package by thermally bonding this lid material to the flange of the packaging container, and pressing the bottom of the packaging container. As a result, when the movement distance of the punch until the lid material breaks (the distance that the lid material is pushed by the punch and bent until the fracture) is less than 0.4 mm, the lid material is easily broken and the child resistance function is achieved. It is difficult to do. When the movement distance of the punch was 0.8 mm or more, the lid material was difficult to tear and it was difficult to take out the tablet.

上記の特性を備えるためには、前記ポリエチレンテレフタレートフィルム面を先端が直径1.8mmの平坦円形状のポンチにより10mm/分の速度で突き刺した場合、ポンチの貫通に要する最大荷重が5〜6Nであることが望ましい。下限未満では蓋材が破れ易く、チャイルドレジスタンス機能を達成することができ難い。上限を超えると蓋材が破れ難く、薬剤の取り出しが困難となる。   In order to provide the above characteristics, when the polyethylene terephthalate film surface is pierced at a speed of 10 mm / min by a flat circular punch having a diameter of 1.8 mm, the maximum load required to penetrate the punch is 5 to 6 N. It is desirable to be. If it is less than the lower limit, the lid material is easily broken, and it is difficult to achieve the child resistance function. When the upper limit is exceeded, the lid material is difficult to tear and it becomes difficult to take out the medicine.

また、前記アルミニウム箔の厚さが15〜25μm、前記ポリエチレンテレフタレートフィルムの厚さが2.5〜4μmで、アルミニウム箔の厚さに対するポリエチレンテレフタレートフィルムの厚さの比、(ポリエチレンテレフタレートフィルムの厚さ(μm)/アルミニウム箔の厚さ(μm))が0.15〜0.20であることが望ましい。この比が下限未満では蓋材が破れ易く、チャイルドレジスタンス機能を達成することができ難い。上限を超えると蓋材が容易に破れ難く、薬剤の取り出しが困難となる。   The thickness of the aluminum foil is 15 to 25 μm, the thickness of the polyethylene terephthalate film is 2.5 to 4 μm, the ratio of the thickness of the polyethylene terephthalate film to the thickness of the aluminum foil, (the thickness of the polyethylene terephthalate film (Μm) / aluminum foil thickness (μm)) is preferably 0.15 to 0.20. If this ratio is less than the lower limit, the lid member is easily broken, and it is difficult to achieve the child resistance function. When the upper limit is exceeded, the lid material is not easily broken, and it is difficult to take out the medicine.

以下、本発明の実施例を比較例と対比して説明し、その効果を実証する。なお、これらの実施例は、本発明の一実施態様を示すものであり、本発明はこれらに限定されない。   Examples of the present invention will be described below in comparison with comparative examples to demonstrate the effects. In addition, these Examples show one embodiment of this invention, and this invention is not limited to these.

実施例1、比較例1
片面に印刷層を有するアルミニウム箔(1N30、硬質箔、厚さ20μm)の印刷層面に、表1に示す厚さを有する市販のポリエチレンテレフタレートフィルムを、ウレタン系のドライラミネート接着剤(乾燥後重量4g/m)を用いてドライラミネートし、アルミニウム箔の他の片面(非印刷面)にポリプロピレン系の熱接着剤(乾燥後重量4g/m)を塗布し、乾燥させて表1に示す蓋材No.1〜4を作製した。
Example 1 and Comparative Example 1
A commercially available polyethylene terephthalate film having a thickness shown in Table 1 is applied to a printed layer surface of an aluminum foil (1N30, hard foil, thickness 20 μm) having a printed layer on one side, and a urethane-based dry laminate adhesive (weight 4 g after drying) / M 2 ), a polypropylene thermal adhesive (weight after drying 4 g / m 2 ) is applied to the other surface (non-printing surface) of the aluminum foil, and the lid shown in Table 1 is dried. Material No. 1-4 were produced.

Figure 2016222274
Figure 2016222274

突き刺し試験:得られた蓋材1を、図1に示すように、内径30mmの穴2Hを有する治具2上に置き、その上に内径25mmの穴3Hを有する治具3を、治具2の穴2Hおよび治具3の穴3Hの中心を一致させるよう載置して蓋材1を押さえ、先端が平坦円形状でその直径が1.8mmのポンチ4により、穴3Hの中心部から蓋材1のPET面を垂直方向に10mm/分の速度で突き刺し、蓋材1が破断するまでのポンチ4の移動距離(蓋材がポンチで押されて破断までに撓んだ距離)、およびポンチ4の貫通に要する最大荷重を測定した。   Piercing test: As shown in FIG. 1, the obtained lid member 1 is placed on a jig 2 having a hole 2H having an inner diameter of 30 mm, and a jig 3 having a hole 3H having an inner diameter of 25 mm is placed thereon. The hole 2H of the jig 3 and the hole 3H of the jig 3 are placed so as to coincide with each other and the lid material 1 is pressed, and the punch 4 having a flat circular tip and a diameter of 1.8 mm is used to cover the center of the hole 3H. The PET surface of the material 1 is stabbed in the vertical direction at a speed of 10 mm / min, and the movement distance of the punch 4 until the lid material 1 breaks (the distance by which the lid material is pushed by the punch and bent until breakage), and the punch The maximum load required to penetrate 4 was measured.

開封試験:得られた蓋材を市販のPTP用容器のフランジに熱接着し、容器内に予め錠剤を収納したPTP包装体を作製して、作製されたPTP包装体の包装容器の底を指で圧迫して、錠剤が蓋材を破って取り出せるかどうかを評価した。   Opening test: The obtained lid material is thermally bonded to a flange of a commercially available PTP container, a PTP package body in which tablets are stored in advance in the container is prepared, and the bottom of the prepared PTP package body is pointed to the bottom. The tablet was squeezed to evaluate whether the tablet can be removed by breaking the lid.

表1に示すように、アルミニウム箔に厚さ2μmのPETフィルムを積層した蓋材No.1は、アルミニウム箔の厚さに対するPETフィルムの厚さの比が0.1、蓋材が破断するまでのポンチの移動距離が0.36mm、ポンチの貫通に要する最大荷重が4.7Nで、開封試験では蓋材が簡単に破れ、本発明の効果を達成することができなかった。また、PETフィルムを積層しないアルミニウム箔のみの蓋材No.4も、蓋材が破断するまでのポンチの移動距離が0.29mm、ポンチの貫通に要する最大荷重が3.7Nで、開封試験では蓋材が簡単に破れ、本発明の効果を達成することができなかった。   As shown in Table 1, a cover material No. 1 in which a PET film having a thickness of 2 μm was laminated on an aluminum foil. 1 is that the ratio of the thickness of the PET film to the thickness of the aluminum foil is 0.1, the movement distance of the punch until the lid breaks is 0.36 mm, and the maximum load required to penetrate the punch is 4.7 N, In the opening test, the lid material was easily broken, and the effects of the present invention could not be achieved. In addition, a cover material No. 1 made only of aluminum foil without laminating a PET film. No. 4, the punch travel distance until the lid breaks is 0.29 mm, the maximum load required to penetrate the punch is 3.7 N, and the lid material can be easily broken in the opening test to achieve the effect of the present invention I could not.

アルミニウム箔に厚さ3.5μmのPETフィルムを積層した蓋材No.2は、アルミニウム箔の厚さに対するPETフィルムの厚さの比が0.175、蓋材が破断するまでのポンチの移動距離が0.42mm、ポンチの貫通に要する最大荷重が5.3Nで、開封試験において指で圧したとき、少し硬いが開封は可能であり、チャイルドレジスタンス機能が確認でき、本発明の効果が達成できるものと認められた。   Cover material No. 1 having a 3.5 μm thick PET film laminated on an aluminum foil. 2, the ratio of the thickness of the PET film to the thickness of the aluminum foil is 0.175, the movement distance of the punch until the lid breaks is 0.42 mm, and the maximum load required to penetrate the punch is 5.3 N. When pressed with a finger in the opening test, it was slightly hard but could be opened, and the child resistance function could be confirmed, and it was recognized that the effects of the present invention could be achieved.

アルミニウム箔に厚さ4.5μmのPETフィルムを積層した蓋材No.3は、アルミニウム箔の厚さに対するPETフィルムの厚さの比が0.225、蓋材が破断するまでのポンチの移動距離が0.88mm、ポンチの貫通に要する最大荷重が6.3Nで、開封試験において指で圧したとき、開封が困難であり、本発明の効果を達成することができなかった。   Cover material No. 1 in which a PET film having a thickness of 4.5 μm was laminated on an aluminum foil. 3, the ratio of the thickness of the PET film to the thickness of the aluminum foil is 0.225, the movement distance of the punch until the lid breaks is 0.88 mm, and the maximum load required to penetrate the punch is 6.3 N. When pressing with a finger in the opening test, opening was difficult, and the effects of the present invention could not be achieved.

1 蓋材
2 治具
3 治具
2H 穴
3H 穴
4 ポンチ
1 Lid 2 Jig 3 Jig 2H Hole 3H Hole 4 Punch

Claims (3)

樹脂フィルム、アルミニウム箔、容器に接着するための熱接着層を備えてなるプレススルーパックの蓋材であって、前記樹脂フィルムがポリエチレンテレフタレートフィルムであり、該フィルム面を先端が直径1.8mmの平坦円形状のポンチにより10mm/分の速度で突き刺した場合、蓋材が破断するまでのポンチの移動距離が0.4mm以上0.8mm未満であることを特徴とするプレススルーパックの蓋材。 A cover material of a press-through pack comprising a resin film, an aluminum foil, and a thermal adhesive layer for bonding to a container, wherein the resin film is a polyethylene terephthalate film, and the tip of the film surface has a diameter of 1.8 mm A cover material for a press-through pack, wherein when the flat circular punch is pierced at a speed of 10 mm / min, the movement distance of the punch until the cover material breaks is 0.4 mm or more and less than 0.8 mm. 前記ポリエチレンテレフタレートフィルム面を先端が直径1.8mmの平坦円形状のポンチにより10mm/分の速度で突き刺した場合、ポンチの貫通に要する最大荷重が5〜6Nであることを特徴とする請求項1に記載のプレススルーパックの蓋材。 The maximum load required for penetrating the punch is 5 to 6 N when the polyethylene terephthalate film surface is pierced at a speed of 10 mm / min by a flat circular punch having a diameter of 1.8 mm at the tip. The cover material of the press-through pack as described in 2. 前記アルミニウム箔の厚さが15〜25μm、前記ポリエチレンテレフタレートフィルムの厚さが2.5〜4μmであり、アルミニウム箔の厚さに対するポリエチレンテレフタレートフィルムの厚さの比、(ポリエチレンテレフタレートフィルムの厚さ(μm)/アルミニウム箔の厚さ(μm))が0.15〜0.20であることを特徴とする請求項2に記載のプレススルーパックの蓋材。 The aluminum foil has a thickness of 15 to 25 μm, the polyethylene terephthalate film has a thickness of 2.5 to 4 μm, and the ratio of the thickness of the polyethylene terephthalate film to the thickness of the aluminum foil (the thickness of the polyethylene terephthalate film ( The cover material for a press-through pack according to claim 2, wherein the thickness of the aluminum foil is 0.15 to 0.20.
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Cited By (1)

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JP2019137410A (en) * 2018-02-06 2019-08-22 株式会社タケトモ Lid material for the ptp package of pharmaceutical products

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JP2005255173A (en) * 2004-03-09 2005-09-22 Toyo Seikan Kaisha Ltd Film-like lid having excellent piercing openability
JP2006035646A (en) * 2004-07-27 2006-02-09 Toyo Seikan Kaisha Ltd Multilayer film and its manufacturing method
JP2008308213A (en) * 2007-06-18 2008-12-25 Ask:Kk Press-through package
JP2015093727A (en) * 2013-11-14 2015-05-18 旭化成ケミカルズ株式会社 Lid material for press-through pack package and package

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JPS60177897A (en) * 1984-02-24 1985-09-11 日本電信電話株式会社 Piezoelectric type drill
JP2002178450A (en) * 2000-12-11 2002-06-26 Mitsubishi Polyester Film Copp Lid material for ptp packaging
JP2005255173A (en) * 2004-03-09 2005-09-22 Toyo Seikan Kaisha Ltd Film-like lid having excellent piercing openability
JP2006035646A (en) * 2004-07-27 2006-02-09 Toyo Seikan Kaisha Ltd Multilayer film and its manufacturing method
JP2008308213A (en) * 2007-06-18 2008-12-25 Ask:Kk Press-through package
JP2015093727A (en) * 2013-11-14 2015-05-18 旭化成ケミカルズ株式会社 Lid material for press-through pack package and package

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019137410A (en) * 2018-02-06 2019-08-22 株式会社タケトモ Lid material for the ptp package of pharmaceutical products
JP7129080B2 (en) 2018-02-06 2022-09-01 株式会社タケトモ Lid material for PTP packaging for pharmaceuticals

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