JP2020203482A - Bottom material of pharmaceutical ptp package - Google Patents

Abstract

To provide a bottom material of pharmaceutical PTP package having excellent moisture proofness and also excellent heat sealability.SOLUTION: A bottom material of pharmaceutical PTP package 1 has a laminate film 5 having a substrate layer 2, a fluororesin layer 3, and a heat seal layer 4 laminated in this order from outside, and the heat seal layer 4 has a thickness of 1-30% relative to the total thickness of the laminate film 5. The heat seal layer 4 preferably has a thickness of 5 μm-60 μm.SELECTED DRAWING: Figure 3

Description

The present invention relates to a bottom material of a pharmaceutical PTP package for accommodating a drug such as a tablet or a capsule, and a pharmaceutical PTP package using the bottom material.

Pharmaceuticals such as tablets and capsules are often packaged in PTP packages and sold. The PTP package has advantages such as being able to individually package pharmaceutical products and easily maintaining quality. Therefore, for example, it is formed from a material that does not easily permeate oxygen, water vapor, etc. to prevent quality deterioration due to moisture absorption and oxidation of pharmaceutical products.

For example, Patent Document 1 below states that a rigid vinyl chloride film and a polychlorotrifluoroethylene film having a specific gravity of 2.15 or less have a thickness ratio of 50:50 to 95: 5, which is highly moisture-proof for blister packaging. Laminated film is shown.

Further, Patent Document 2 below shows a vinyl chloride sheet having a moisture-proof layer (B) made of polychlorotrifluoroethylene or the like on at least one side of the vinyl chloride resin layer (A), and this sheet is used for pharmaceutical packaging. It is shown that

In Patent Document 3 below, a fluorine-based resin layer composed of a base material layer, an intermediate layer, polychlorotrifluoroethylene, etc. is provided in this order, and the total thickness is 400 μm or less. the thickness of, and at 20μm or 150μm or less, the water vapor permeability of the laminate 0.5g / m ^2/24 hr or less is stack is shown, molding the laminated body in press-through package is shown ing.

Japanese Unexamined Patent Publication No. 2-116546 Japanese Unexamined Patent Publication No. 9-309186 Japanese Unexamined Patent Publication No. 2018-154056

Polychlorotrifluoroethylene (PCTFE) film has excellent moisture resistance, is suitable for quality protection of pharmaceutical products, and is found to be used for PTP packaging.
However, the polychlorotrifluoroethylene film has poor sealing properties, and has problems such as difficulty in heat-sealing with an aluminum foil used as a lid material.
Therefore, as shown in FIG. 4, the bottom material 11 of the PTP package 10 is molded from a laminated film in which a vinyl chloride resin layer 13 having excellent heat sealability is laminated inside the polychlorotrifluoroethylene film 12. , The lid material 14 such as aluminum foil can be heat-sealed.

Although such a bottom material 11 is superior in moisture-proof property as compared with the conventional product, there is still water vapor that permeates from the end face A of the vinyl chloride resin layer 13, and the quality of the enclosed tablet 15 and the like is ensured. Could not be maintained.

Therefore, an object of the present invention is to provide a bottom material for a PTP package for pharmaceuticals, which has excellent moisture resistance and heat sealability.

The bottom material of the pharmaceutical PTP package according to the present invention is a bottom material of the pharmaceutical PTP package composed of a laminated film in which a base material layer, a fluororesin layer, and a heat seal layer are laminated in this order from the outside. The heat-sealing layer is characterized in that the thickness is in the range of 1% to 30% with respect to the total thickness of the laminated film.

In this way, by making the thickness of the heat seal layer within the range of 1% to 30% with respect to the total thickness of the laminated film, it becomes difficult for water vapor to permeate from the end face of the bottom material. , A PTP package having excellent moisture resistance can be obtained.

In the above-mentioned one form of the bottom material, the thickness of the heat seal layer is preferably thinner than the thickness of the base material layer, and specifically, the thickness of the heat seal layer is set in the range of 5 μm to 60 μm. preferable.

In the above-mentioned one form of bottom material, a fluorine-based resin layer can be formed from polychlorotrifluoroethylene. Polychlorotrifluoroethylene has excellent moisture resistance and can prevent the permeation of water vapor from the outer surface.

A lid material provided with an aluminum foil layer can be heat-sealed on the bottom material of the above form to prepare a pharmaceutical PTP package.

By providing the lid material with an aluminum foil layer, it is possible to prevent the permeation of water vapor from the lid material side.

It is a side view which showed the pharmaceutical PTP package of one Embodiment of this invention. FIG. 5 is an enlarged cross-sectional view schematically showing a laminated structure of a film used for a bottom material and a lid material of the PTP package for pharmaceuticals shown in FIG. It is a partially enlarged sectional view showing the vicinity of the pocket portion of the bottom material of the PTP package for pharmaceuticals of FIG. It is a partially enlarged sectional view which showed the PTP package for pharmaceuticals of the conventional example.

Hereinafter, the bottom material of the pharmaceutical PTP package according to the embodiment of the present invention will be described. However, the present invention is not limited to this embodiment.

As shown in FIGS. 1 to 3, the bottom material 1 of the pharmaceutical PTP package according to the embodiment of the present invention is formed from the laminated film 5 provided with the base material layer 2, the fluororesin layer 3, and the heat seal layer 4. Can be formed.

The base material layer 2 is a layer for maintaining the moldability of the bottom material 1, and is formed of, for example, a film made of vinyl chloride resin (PVC), polypropylene resin (PP), or the like, vinyl chloride resin, polypropylene resin, or the like. It can be formed by coating a coating agent containing.
It is preferable that the base material layer 2 contains 80% by mass or more of the vinyl chloride resin, particularly 90% by mass or more, and further 95% by mass or more.
The vinyl chloride resin may include a copolymer such as a vinyl chloride-vinyl acetate copolymer, a vinyl chloride-polyethylene copolymer, and the like, in addition to a vinyl chloride homopolymer.

The thickness of the base material layer 2 is preferably in the range of 25% to 80%, particularly preferably in the range of 30% to 70%, and further preferably in the range of 40% to 60% with respect to the total thickness of the laminated film 5. Specifically, the thickness of the base material layer 2 is preferably in the range of 50 μm to 320 μm, particularly preferably in the range of 70 μm to 300 μm, and further preferably in the range of 80 μm to 250 μm.

From the viewpoint of moisture resistance, the fluorine-based resin layer 3 is preferably formed from a film made of a fluorine-based resin.
It is preferable that the fluorine-based resin layer 3 contains 80% by mass or more, particularly 90% by mass or more, and further 95% by mass or more of the fluorine-based resin.
Fluoro-based resins include polychlorotrifluoroethylene (PCTFE), polytetrafluoroethylene (PTFE), tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer (PFA), and tetrafluoroethylene / hexafluoropropylene copolymer. (FEP), tetrafluoroethylene / hexafluoropropylene / perfluoroalkyl vinyl ether (EPA), tetrafluoroethylene / ethylene copolymer (ETFE), polyvinylidene fluoride (PVDF), chlorotrifluoroethylene / ethylene copolymer (ECTFE). ) Etc. can be included.
Specifically, ACLAR (registered trademark) of polychlorotrifluoroethylene (PCTFE) film can be used.

The thickness of the fluororesin layer 3 is preferably in the range of 3% to 70%, particularly in the range of 10% to 60%, and further in the range of 20% to 50% with respect to the total thickness of the laminated film 5. .. Specifically, the thickness of the fluororesin layer 3 is preferably in the range of 10 μm to 200 μm, particularly preferably in the range of 50 μm to 180 μm, and further preferably in the range of 75 μm to 150 μm.

The heat-sealing layer 4 is a layer for heat-sealing the lid material 7, and is formed of a film made of vinyl chloride resin (PVC), polypropylene resin (PP), polyvinylidene chloride (PVDC), or vinyl chloride. It can be formed by coating a coating agent containing a resin, a polypropylene resin, and polyvinylidene chloride.
It is preferable that the heat seal layer 4 contains 80% by mass or more, particularly 90% by mass or more, and 95% by mass or more of vinyl chloride resin or the like.
In addition to the vinyl chloride homopolymer, the vinyl chloride resin can also include copolymers such as vinyl chloride-vinyl acetate copolymer and vinyl chloride-polyethylene copolymer.
The heat seal layer 4 may use the same type of resin as the base material layer 2 or a different type of resin, but it is preferable to use the same resin.

The thickness of the heat seal layer 4 is preferably made thin in order to secure moisture resistance from the end face, for example, in the range of 1% to 30% with respect to the total thickness of the laminated film 5, especially 1.5. It is preferably in the range of% to 25%, more preferably in the range of 2% to 10%. Specifically, the thickness of the heat seal layer 4 is preferably in the range of 5 μm to 60 μm, particularly preferably in the range of 6 μm to 30 μm, and further preferably in the range of 7 μm to 20 μm.
Further, the thickness of the heat seal layer 4 is preferably thinner than the thickness of the base material layer 2, and is in the range of 1% to 50% with respect to the thickness of the base material layer 2, particularly 3% to 40%. It is preferably within the range of 5% to 30%.

The laminated film 5 can be formed by laminating a base material layer 2, a fluorine-based resin layer 3, and a heat seal layer 4. Lamination can be performed by, for example, extrusion lamination, dry lamination, wet lamination, thermal lamination, sand lamination or the like.

The thickness of the laminated film 5 is preferably in the range of 150 μm to 350 μm, particularly in the range of 180 μm to 300 μm, and further preferably in the range of 200 μm to 250 μm.

The bottom material 1 can be formed by producing a concave pocket portion 6 by, for example, deep drawing the laminated film 5. At this time, the base material layer 2 is on the outside and the heat seal layer 4 is on the inside.

As shown in FIG. 3, a PTP package can be produced by accommodating a drug such as a tablet or a capsule in the pocket portion 6 of the bottom material 1 and heat-sealing the lid material 7.

The lid material 7 is preferably provided with an aluminum foil layer 8 from the viewpoint of moisture resistance, and is preferably provided with a heat seal layer 9 for heat sealing on one surface side of the aluminum foil layer 8.

The aluminum foil layer 8 includes an aluminum foil laminated product in addition to the aluminum foil.
As the aluminum foil 8, a hard or soft aluminum foil can be used, and a type in which one surface is a glossy surface (mirror surface) and the other surface is a matte surface (matte surface), both sides are glossy. Either a type with a surface (mirror surface) or a type with both sides having a matte surface (matte surface) can be used.
As the aluminum foil laminated product, for example, one in which a synthetic resin sheet such as polystyrene resin or polyethylene terephthalate resin is laminated on one side or both sides of the aluminum foil can be used.

The heat seal layer 9 can be formed by applying a coating agent containing a vinyl chloride resin or the like to one surface of an aluminum foil.

Since the heat seal layer 4 of the PTP package formed from the bottom material 1 is thinned, water vapor is less likely to penetrate into the pocket portion 6 from the end face, and the quality of tablets and the like in the pocket portion 6 is less likely to deteriorate.

Hereinafter, the bottom material of one embodiment of the present invention will be described. However, the present invention is not limited to this embodiment.

(Moisture proof test)
The bottom materials of Examples 1 to 3, Comparative Example 1 and Reference Example 1 shown below were prepared and subjected to a moisture resistance test.

<Example 1>
The bottom material of Example 1 was prepared as follows.

(Base layer)
As the base material layer, a polyvinyl chloride resin film (manufactured by Mitsubishi Chemical Corporation) having a thickness of 200 μm was used.

(Fluorine resin layer)
As the fluorine-based resin layer, ACLAR (manufactured by Honeywell) of a polychlorotrifluoroethylene (PCTFE) film having a thickness of 15 μm was used.

(Heat seal layer)
As the heat seal layer, a polyvinyl chloride resin film having a thickness of 7 μm was used.

(Lid material)
As the lid material, a coating agent made of vinyl chloride resin was applied to one surface of an aluminum foil (manufactured by Mitsubishi Aluminum Co., Ltd.) having a thickness of 20 μm so as to be 3.5 g / m ² after drying.

(Making bottom material)
The base material layer, the fluorine-based resin layer, and the heat seal layer were roll-bonded with an adhesive to prepare a laminated film. This laminated film was molded to prepare a bottom material. The total thickness of the laminated film was 222 μm. The bottom material is provided with a total of 10 pockets in which tablets can be stored, in 2 horizontal rows and 5 vertical rows. The shape of each pocket has a diameter of 10 mm and a depth of 4.5 mm.

A PTP package was prepared by filling the pocket portion with silica gel and heat-sealing the lid material with a sealer under the conditions of 260 ° C. and 0.35 MPa.

<Example 2>
A PTP package was prepared in the same manner as in Example 1 except that the bottom material was prepared using a polyvinyl chloride resin film having a thickness of 30 μm as the heat seal layer. The total thickness of the laminated film of this bottom material was 245 μm.

<Example 3>
A PTP package was prepared in the same manner as in Example 1 except that the bottom material was prepared using a polyvinyl chloride resin film having a thickness of 60 μm as the heat seal layer. The total thickness of the laminated film of this bottom material was 275 μm.

<Comparative example 1>
A PTP package was produced in the same manner as in Example 1 except that the base material was not provided and the bottom material was produced using a polyvinyl chloride resin film having a thickness of 200 μm as the heat seal layer. The total thickness of the laminated film of this bottom material was 215 μm.
In this comparative example, since the rigidity equivalent to that in the case where the base material layer is provided only by the heat seal layer can be maintained, only the heat seal layer and the fluorine-based resin layer are configured.

<Reference example 1>
A PTP package was prepared in the same manner as in Example 1 except that the bottom material was prepared without providing the heat seal layer and the bottom material was adhered to the lid material using an adhesive. The total thickness of the laminated film on which this bottom material was produced was 215 μm.
In Reference Example 1, the peeling strength equivalent to that in the case where the heat seal layer is provided cannot be maintained. The peeling strength between the lid material and the bottom material of the actual product was about 10 N / 15 mm, but the peel strength of Reference Example 1 was about 5 N / 15 mm.

(test)
Moisture resistance was measured using the PTP packages of Examples 1 to 3, Comparative Example 1 and Reference Example 1. The moisture resistance was measured by leaving the PTP package in a 40 ° C. × 90% RH environment for 30 days and calculating the mass increase due to moisture absorption before and after the test. The number of measurements was 5, and the average is shown in Table 1 below.

(result)
It was confirmed that the PTP packages of Examples 1 to 3 had the same mass increase as when the lid was directly adhered to the fluororesin layer and had excellent moisture resistance, and the heat with respect to the total thickness of the laminated film was confirmed. It is considered that the seal layer has excellent moisture resistance up to a thickness of 30%. On the other hand, in Comparative Example 1, it was confirmed that the amount of increase was large, the moisture permeated the heat seal layer, and easily reached the inside.
Further, although Reference Example 1 is excellent in moisture resistance, as described above, the peeling strength is weak and it cannot be put into practical use.

1 ... Bottom material 2 ... Base material layer 3 ... Fluorine-based resin layer 4 ... Heat seal layer 5 ... Laminated film 6 ... Pocket 7 ... Lid material 8 ... Aluminum foil layer 9 ... Heat seal layer

Claims (6)

It is a bottom material of a pharmaceutical PTP package composed of a laminated film in which a base material layer, a fluorine-based resin layer, and a heat seal layer are laminated in this order from the outside.
A bottom material of a pharmaceutical PTP package in which the thickness of the heat seal layer is in the range of 1% to 30% with respect to the total thickness of the laminated film. The bottom material of a pharmaceutical PTP package according to claim 1, wherein the thickness of the heat seal layer is made thinner than the thickness of the base material layer. The bottom material of a pharmaceutical PTP package according to claim 1 or 2, wherein the base material layer and the heat seal layer are made of the same resin. The bottom material of a pharmaceutical PTP package according to any one of claims 1 to 3, wherein the thickness of the heat seal layer is in the range of 5 μm to 60 μm. The bottom material of a pharmaceutical PTP package according to any one of claims 1 to 4, wherein the fluorine-based resin layer is formed of polychlorotrifluoroethylene (PCTFE). A pharmaceutical PTP package obtained by heat-sealing a lid material provided with an aluminum foil layer on the bottom material of the pharmaceutical PTP package according to any one of claims 1 to 5.

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