JP7129080B2 - Lid material for PTP packaging for pharmaceuticals - Google Patents

Description

TECHNICAL FIELD The present invention relates to a lid material used for a PTP package for packaging pharmaceuticals such as tablets, and more particularly to a lid material for a pharmaceutical PTP package having a child resistance function.

PTP packages (press-through packs) are often used for packaging pharmaceuticals such as tablets and capsules. The PTP package, for example, individually stores medicines such as tablets in a pocket portion (accommodating concave portion) of a bottom material made of vinyl chloride or the like, is covered with a lid material made of aluminum foil or the like, and the pocket portion (accommodating concave portion) ), a drug such as a tablet can be taken out by breaking the cover material and penetrating it, so that the drug can be easily taken out.

However, since the medicine can be taken out easily, there is a risk that an infant or the like may take out the medicine and swallow it by mistake. Therefore, recently, a cover material for a PTP package having a child resistance function (also called a CR function for short), which makes it difficult for infants to take it out, has been developed.
For example, in order to increase the extrusion pressure, a cover material in which aluminum foil is laminated on a polyethylene terephthalate film, a cover material in which aluminum foil is laminated on paper, and the like have been developed.

Specifically, a press-through pack lid material has been developed that includes a resin film, an aluminum foil, and a thermal adhesive layer, and in which a tapered through-hole is formed in the resin film (Patent Document 1 below: reference).

Also, a lid material for a press-through pack comprising a resin film, an aluminum foil, and a thermal adhesive layer for adhering to a container, wherein the resin film is a polyethylene terephthalate film, and the film surface has a tip with a diameter of 1.8 mm. A lid material for a press-through pack, characterized in that, when a flat circular punch is pierced at a speed of 10 mm/min, the punch moves a distance of 0.4 mm or more and less than 0.8 mm until the lid material breaks. has been developed (see Patent Document 2 below).

JP 2014-181069 A JP 2016-222274 A

A lid made of a resin film made of polyethylene terephthalate (PET) or the like or paper laminated with aluminum foil is not easily torn, and the risk of children taking out medicines is reduced.
However, a PTP package containing a drug must be sealed in order to prevent deterioration of the drug. need to
In a lid material in which an aluminum foil is laminated on a resin film, heat sealing at such a high temperature and high pressure may cause the resin film to melt, resulting in a problem of heat resistance.

In addition, the lid material in which the aluminum foil is laminated on the paper has a problem that it is difficult to match the printing pitch on both sides because the aluminum foil is laminated after printing on the paper. Recently, various printings have been applied to the front and back sides of the lid material in order to manage the drugs contained inside the package. I could not manage it.

SUMMARY OF THE INVENTION Accordingly, an object of the present invention is to provide a lid material for a PTP package for pharmaceuticals, which has a child resistance function, can be heat-sealed at high temperature and high pressure, and can match the printing pitch on both sides.

A lid material for a pharmaceutical PTP package according to one embodiment of the present invention comprises a substrate layer having at least one polyethylene terephthalate-based film or polypropylene-based film, a first aluminum foil layer on the surface side of the substrate layer, and A second aluminum foil layer is provided on the back side of the base material layer.

By doing so, the presence of the base material layer can increase the pushing pressure of the medicine, and the lid material can have a child resistance function. In addition, since aluminum foil is laminated on both sides of the base material layer, the base material layer does not melt even when heat-sealed at high temperature and high pressure. Furthermore, since printing can be performed after laminating aluminum foil on both sides of the base material layer, it is possible to perform printing with matching pitches on both sides.

When the thickness of the base material layer is 1, the thickness of the first aluminum foil layer is 0.4 to 8, and the thickness of the second aluminum foil layer is 0.4 to 8. Specifically, the thickness of the base material layer is 2 μm to 14 μm, the thickness of the first aluminum foil layer is 6 μm to 30 μm, and the thickness of the second aluminum foil layer is 6 μm to 30 μm. is preferred.
By doing so, it is possible to set the pushing pressure so that it is difficult for an infant to take out.

In the one form of the lid material, the base material layer is provided with a resin film on either side or one side of either a polyethylene terephthalate film or a polypropylene film, or a single layer of polyethylene terephthalate film or a polypropylene film. It preferably consists of a single layer.
By providing the polyethylene terephthalate-based film or the polypropylene-based film in this way, the lid material is less likely to burst, and infants cannot easily take out the medicine.

It is preferable that the lid material of the one form described above has an extrusion strength of 35 N or more.

1 is a cross-sectional view schematically showing a lid material of a pharmaceutical PTP package according to an embodiment of the present invention; FIG. FIG. 4 is a cross-sectional view schematically showing a lid member of a pharmaceutical PTP package according to another embodiment of the present invention.

The lid material of the pharmaceutical PTP package according to one embodiment of the present invention will be described below. However, the present invention is not limited to this embodiment.

As shown in FIG. 1, a lid material 1 of a pharmaceutical PTP package according to one embodiment of the present invention comprises a base material layer 2, a first aluminum foil layer 3, and a second aluminum foil layer 4. Prepare.

The base material layer 2 includes a layer consisting of a single layer of polyethylene terephthalate (PET) film, a layer consisting of a single layer of polypropylene (PP) film, a layer obtained by laminating a resin film on both sides or one side of polyethylene terephthalate (PET) film, It is either a layer in which a resin film is laminated on both sides or one side of a polypropylene (PP) film. FIG. 2 shows an example in which resin films 2B are laminated on both sides of a PET film (or PP film) 2A.
Examples of the resin film 2B to be laminated include polyolefin films such as polyethylene films and polypropylene films, polyester films such as polyethylene terephthalate films, polyamide (nylon) films, (meth)acrylic films, and polyvinyl chloride. film, polystyrene film, polyvinylidene chloride film, saponified ethylene-vinyl acetate copolymer film, polyvinyl alcohol film, polycarbonate film, polyvinyl acetate film, acetal film and the like can be used. More specifically, it can be a layer in which a polyethylene film is laminated on both sides of a polyethylene terephthalate (PET) film. Lamination may be performed by a conventionally known method, for example, dry lamination using a dry lamination adhesive, coextrusion, or the like.

The polyethylene terephthalate (PET)-based film includes a film obtained by modifying polyethylene terephthalate, and also includes a film containing polyethylene terephthalate as a main component and other components. Polypropylene (PP)-based films also include films obtained by modifying polypropylene, and films containing polypropylene as a main component and containing other components.
In the present invention, the main component means that the component is contained in an amount of 70% by mass or more, preferably 80% by mass or more, particularly preferably 90% by mass or more (including 100% by mass). In addition, other components are allowed to be contained within a range that does not interfere with the function of the main component.

The base material layer 2 preferably has a thickness of 2 μm to 14 μm, particularly preferably 4 μm to 9 μm, further preferably 5 μm to 7 μm.

The base material layer 2 preferably has a puncture strength of 0.5N or more, particularly preferably 2N or more, and more preferably 2.5N or more. By doing so, the lid member 1 is not easily broken, and a child resistance function can be provided. Puncture strength generally increases as the thickness of the film increases. Moreover, it can be reduced by processing such as forming micropores in the film.
The puncture strength can be measured, for example, by the method shown in the examples below.

Specifically, as the base layer 2, a biaxially stretched polyester film manufactured by Mitsubishi Chemical Corporation, product name "Diafoil", a biaxially stretched polyester film manufactured by Teijin Film Solution Co., Ltd., product name "Teijin Tetoron Film ”, a polyester film manufactured by Futamura Chemical Co., Ltd. under the product name “PET-KE”, and a polyester film manufactured by Toyobo Co., Ltd. under the product name “Tiafine TF110”.

The first aluminum foil layer 3 is provided on the front side of the substrate layer 2 and the second aluminum foil layer 4 is provided on the back side of the substrate layer 2 . For the first aluminum foil layer 3 and the second aluminum foil layer 4, aluminum foil conventionally used as a cover material for PTP packages can be used, and any of soft material, semi-hard material and hard material can be used. may be used. For example, 1N30, 1070, 1100, 8021, 8079 materials specified by JIS can be used.

When the thickness of the base material layer 2 is 1, the thickness of the first aluminum foil layer 3 is preferably 0.4 to 8, particularly preferably 0.8 to 6, and 1 to 3. more preferably. Specifically, the thickness is preferably 6 μm to 30 μm, particularly preferably 7 μm to 20 μm, further preferably 9 μm to 17 μm.

When the thickness of the base layer 2 is 1, the thickness of the second aluminum foil layer 4 is preferably 0.4 to 8, particularly preferably 0.8 to 6, and 1 to 3. more preferably. Specifically, the thickness is preferably 6 μm to 30 μm, particularly preferably 7 μm to 20 μm, further preferably 9 μm to 17 μm.

The thicknesses of the first aluminum foil layer 3 and the second aluminum foil layer 4 may be the same or different.

Lamination of the substrate layer 2, the first aluminum foil layer 3, and the second aluminum foil layer 4 can be performed by a conventional lamination method, for example, a dry lamination method using a dry lamination adhesive. Can be laminated with Examples of dry laminate adhesives that can be used include urethane-based, olefin-based, butyl rubber-based, acrylic resin-based, polyester-based, epoxy-based, and silicone resin-based adhesives. The thickness of each adhesive layer is preferably 1 μm to 3 μm.

The lid material 1 may be laminated with layers other than the base material layer 2, the first aluminum foil layer 3, and the second aluminum foil layer 4, such as a heat seal layer, an anchor coat layer, and a primer coat layer. , a printed layer, a colored layer, an overcoat layer, and the like may be laminated. The heat seal layer can be formed using a conventionally known heat seal agent. It can be formed using an agent.

Preferred laminate structures include, from the top, aluminum foil/PET film/aluminum foil/heat seal layer, aluminum foil/PP film/aluminum foil/heat seal layer, and the like.

Although the overall thickness of the lid member 1 is not particularly limited, it is preferably 18 μm to 44 μm, particularly preferably 22 μm to 42 μm, further preferably 24 μm to 38 μm.

The lid member 1 preferably has an extrusion strength of 35N or more, particularly preferably 40N to 80N, and more preferably 45N to 65N. By doing so, it is possible to make the cover member 1 difficult for infants to take medicines out. The extrusion strength can be increased by, for example, increasing the thickness of the base material layer 2 .
The extrusion strength can be measured, for example, by the method shown in the Examples below.

The lid member 1 can be heat-sealed and attached to a bottom member made of vinyl chloride or the like to form a pharmaceutical PTP package. Since the base material layer 2 is sandwiched between the two aluminum foil layers 3 and 4 at the time of heat sealing, the base material layer 2 does not melt even when the heat sealing is performed at high temperature and high pressure. Therefore, for example, heat sealing can be performed under conditions of 220° C. to 270° C. and 0.2 MPa to 0.4 MPa.

The lid member 1 is made difficult to break and has a so-called child resistance function, and can be a PTP package from which it is difficult for infants and the like to take out medicines. In addition, both sides of the lid member 1 can be printed with matching printing pitches.

A cover material for a pharmaceutical PTP package according to one embodiment of the present invention will be described below. However, the present invention is not limited to this example.

<Example 1>
A lid material for the PTP package for pharmaceuticals of Example 1 was produced as follows.

(Base material layer)
A polyethylene terephthalate-based film (trade name “Diafoil” manufactured by Mitsubishi Chemical Corporation, biaxially oriented polyester film) was used as the substrate layer. Its thickness is 6 μm.
The puncture strength of this film was measured and found to be 3.1N.
The puncture strength was measured using a force tester (model: MCT-2150) manufactured by A&D Co., Ltd. More specifically, a punch having a hemispherical tip R of 0.5 mm and a diameter of 1 mm was pierced into the film at a speed of 50 mm/min, and the maximum load required for the punch to penetrate was measured. This value was measured 5 times and the average value was calculated.

(First aluminum foil layer and second aluminum foil layer)
A 1N30 material based on the JIS standard was used for the first aluminum foil layer and the second aluminum foil layer. Its thickness is 17 μm.

These layers were laminated by dry lamination using a polyester-based dry lamination adhesive. Each adhesive layer has a thickness of 2 μm.

(Heat seal layer)
The heat seal layer was formed by applying a heat seal agent made by Dainichiseika Co., Ltd. to one side of the first aluminum foil layer. Its thickness is 4 μm.

<Comparative Example 1>
An aluminum foil (thickness: 20 μm) made of 1N30 material based on JIS standard and having the heat seal layer used in Example 1 above formed thereon was used as a lid member.

<Comparative Example 2>
Comparative Example 2 was a PTP package lid material having a CR function of European specifications. This PTP package was purchased in Germany around May 2014.
The specification of this cover material was that aluminum foil (7 μm thick) was laminated on paper.

(leak test)
The lid material of Example 1 was heat-sealed to a bottom material made of vinyl chloride under the conditions shown in Table 1 below to prepare a pharmaceutical PTP package.
Under the sealing conditions shown in Table 1 below, 30 PTP packages for pharmaceuticals were produced, submerged in water at 0.06 MPa for 120 seconds, and the presence or absence of water intrusion into the pocket (accommodating portion) was confirmed. did. Those in which the intrusion of water was confirmed were regarded as disqualified (NG). The results are shown in Table 1 below.

(Extrusion strength test)
A placebo tablet was accommodated in a pocket (accommodating portion) of a bottom material made of vinyl chloride, and the lid materials of Example 1 and Comparative Example 1 were heat-sealed to produce a pharmaceutical PTP package. In Comparative Example 2, the purchased product was used as it was.
The extrusion strength was measured using a force tester (model: MCT-2150) manufactured by A&D Co., Ltd. More specifically, a cylindrical extrusion jig with a diameter of 5 mm was applied to the bottom material, and the tablet was pressed from the bottom material side at a speed of 10 mm/min to measure the maximum load at which the lid material was broken by the tablet. This value was measured 5 times and the average value was calculated.
The results are shown in Table 2 below.

(Test results)
From the results of the leak test, it was confirmed that Example 1 can be tightly adhered to the bottom material even when heat-sealed at high temperature and high pressure, and can be made difficult to peel off. In addition, it was confirmed that the push-out strength was 35 N or more, and it was difficult for infants to take out the package, and it was confirmed that a PTP package having a child resistance function could be obtained.

In Comparative Example 1, the extrusion strength was less than 35 N, the lid material was easily broken, and the medicine such as tablets was easily taken out.
Comparative Example 2 has an extrusion strength of 40.2 N and can be said to have a child resistance function, but since it is formed by attaching paper to aluminum, it is difficult to match the pitch during double-sided printing.

Reference Signs List 1 Lid material 2 Base material layer 3 First aluminum foil layer 4 Second aluminum foil layer

Claims (5)

A substrate layer having at least one polyethylene terephthalate film or polypropylene film, a first aluminum foil layer on the surface side of the substrate layer, and a second aluminum foil layer on the back surface side of the substrate layer. A lid material for a PTP package for pharmaceuticals , wherein the thickness of the base material layer is 2 μm to 14 μm, and the extrusion strength of the lid material is 35 N to 80 N. When the thickness of the base material layer is 1, the thickness of the first aluminum foil layer is 0.4 to 8, and the thickness of the second aluminum foil layer is 0.4 to 8. Lid material for PTP packaging for pharmaceuticals described. 3. The lid material for the pharmaceutical PTP package according to claim 1 , wherein the first aluminum foil layer has a thickness of 6 μm to 30 μm, and the second aluminum foil layer has a thickness of 6 μm to 30 μm. The lid material for the PTP package for pharmaceuticals according to any one of claims 1 to 3, wherein the base material layer comprises a resin film on either one or both sides of a polyethylene terephthalate film or a polypropylene film. The cover material for the PTP package for pharmaceuticals according to any one of claims 1 to 3, wherein the base material layer comprises a single layer of polyethylene terephthalate film or a single layer of polypropylene film.

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