JP6671281B2 - Laminate for blister pack and blister pack using the same - Google Patents

Description

  The present invention relates to a laminate for a blister pack and a blister pack using the laminate. In particular, the present invention relates to a laminate for a blister pack which does not cause molding failure even when a deep pocket is formed for packaging a large pharmaceutical preparation, and a blister pack using the laminate.

  Powdered pharmaceutical preparations are enclosed in thin paper bags or film bags, while pharmaceutical preparations such as tablets or capsules are enclosed in blister packs called PTPs (press-through packs). By pushing the pharmaceutical preparation enclosed in the blister pack with a finger, the lid containing aluminum or the like is broken, and the pharmaceutical preparation can be taken out.

  Pharmaceutical preparations may change their medicinal properties under high humidity conditions by absorbing water. Therefore, conventionally, a desiccant such as silica gel has been sealed in an outer bag in which the blister pack is sealed. However, the work of putting the desiccant into the outer bag is troublesome, and there is a risk that the desiccant may be ingested or eaten by mistake. Further, after the outer bag is opened, the inside of the blister pack cannot be kept at a low humidity, and there is a problem that the pharmaceutical preparation is deteriorated.

  On the other hand, Patent Literature 1 discloses a technique for improving the long-term stability of a pharmaceutical preparation by forming an adsorption layer having an adsorbent inside a blister pack. Here, first, a dome-shaped pocket portion is formed in the laminate of the base material and the adsorption layer, which is a barrier layer. Then, a pharmaceutical preparation is put in the pocket portion, and this is sealed with a lid material. According to this technique, it is considered that a dry state can be maintained without enclosing a desiccant or the like in the outer bag.

  In addition, some of the medicinal components contained in pharmaceutical preparations are deteriorated by ultraviolet rays or the like. If the packaging container is transparent, the medicinal components may be deteriorated. On the other hand, for example, Patent Literature 2 discloses a technique of forming an aluminum layer not only on the lid material on the back side of the blister pack but also on the laminate for the blister pack on the front side, that is, a so-called aluminum blister package. According to this technique, since the aluminum layer is formed inside the blister pack, the pharmaceutical preparation cannot be visually recognized, but the barrier property can be further enhanced.

  In an embodiment in which the above two techniques are simply combined, when forming a dome-shaped pocket in the blister pack laminate, the ceiling of the dome is torn, or a crack is generated in the hem or shoulder. In order to deal with this, a reinforcing layer using a specific polymer is inserted between the aluminum layer and the moisture absorbing layer. In this embodiment, although the moldability is considerably improved, the shoulder portion of the pocket may be torn or a pinhole may occur depending on the mold of the molding machine or the molding depth.

International Publication No. WO 2006/115264 JP-A-2004-58515 International Publication No. 2012/029899

  Therefore, the present invention provides a laminate for a blister pack that does not easily cause molding failure even if the pocket is formed to a certain depth, and that provides the blister pack with sufficient moldability, and a blister pack using the laminate. The purpose is to:

The present inventors have found that the above problem can be solved by the following means.
[1] including a base layer, an aluminum layer, a moisture absorbing layer, and a forming auxiliary layer in this order;
The surface of the molding auxiliary layer opposite to the moisture absorbing layer has a coefficient of static friction with ultra-high molecular weight polyethylene of less than 0.36 as measured according to ISO 8295, and the molding auxiliary layer is formed of JIS K7127. A film or sheet that requires less than 160.7 MPa in both the MD and TD directions for a 50% stretch when subjected to a tensile test in accordance with
Laminate for blister pack.
[2] The surface of the molding auxiliary layer opposite to the moisture-absorbing layer according to [1], wherein a coefficient of kinetic friction with ultrahigh molecular weight polyethylene is less than 0.36 as measured according to ISO8295. Laminate for blister pack.
[3] The method according to [1] or [2], wherein the tensile modulus of the molding auxiliary layer is more than 168 MPa and less than 1778 MPa in both the MD direction and the TD direction when measured in accordance with ISO 527-1. For blister packs.
[4] The laminate for a blister pack according to any one of [1] to [3], wherein the molding auxiliary layer contains a non-stretched polypropylene resin or a polyvinyl chloride resin.
[5] The static friction coefficient is 0.30 or less, and when a tensile test is performed in accordance with JIS K7127, the force required to stretch the film by 50% is 120 MPa or less. [1] The laminate for a blister pack according to any one of the above items [4] to [4].
[6] The static friction coefficient is 0.24 or less, and when a tensile test is performed in accordance with JIS K7127, the force required for the 50% stretching is 70 MPa or less. [5] 3. The laminate for a blister pack according to item 1.
[7] Any one of [1] to [6], wherein the moisture absorbing layer includes, in this order, an outer skin layer on the side of the base material layer, an intermediate layer having a moisture absorbent and a binder resin, and an inner skin layer. 3. The laminate for a blister pack according to item 1.
[8] The outer skin layer and the inner skin layer of the moisture absorbing layer are selected from the group consisting of polyethylene-based resins, polypropylene-based resins, saturated or unsaturated polyesters, polyvinyl chloride, polystyrene, and derivatives thereof, and mixtures thereof. The blister pack laminate according to [7], comprising a resin selected from each of the following.
[9] The group in which the base material layer is composed of a polyethylene resin, a polypropylene resin, polyvinyl chloride, polyvinylidene chloride, polychlorotrifluoroethylene, polytetrafluoroethylene, a saturated or unsaturated polyester, a polyamide, and a mixture thereof. The laminate for a blister pack according to any one of [1] to [8], comprising a resin selected from the group consisting of:
[10] The laminate for a blister pack according to any one of [1] to [9], further including a reinforcing layer between the aluminum layer and the moisture absorbing layer.
[11] The laminate for a blister pack according to [10], wherein the reinforcing layer contains a resin selected from the group consisting of polyvinyl chloride, saturated or unsaturated polyester, polyamide, and a mixture thereof.
[12] The laminate according to any one of [1] to [11], and a lid material having an aluminum layer and a resin layer different from the aluminum layer, wherein the laminate and the lid material are different from each other. A blister pack that is at least partially adhered and has a pocket formed in the laminate so that a pharmaceutical preparation can be stored between the laminate and the lid.
[13] A blister pack package comprising the blister pack according to [12] and a pharmaceutical preparation stored in the pocket.
[14] The laminated body for the blister pack and the lid material, wherein the laminate and the lid material are at least partially adhered to each other, and a pocket portion is formed in the laminated body to form the laminate and the lid material. A blister pack in which a pharmaceutical preparation can be stored between
The laminate comprises the following layers in this order:
A base material layer made of polyamide;
Aluminum layer;
Outer skin layer made of polyethylene resin;
An intermediate layer containing a binder resin composed of zeolite and a polyethylene resin;
An inner skin layer made of a polyethylene resin; and a molding auxiliary layer containing a polyvinyl chloride resin,
The lid material includes a polyvinyl chloride resin layer on the molding auxiliary layer side, and an aluminum layer different from the aluminum layer,
When measured according to ISO 8295, the coefficient of static friction between the surface of the molding auxiliary layer opposite to the moisture absorbing layer and the ultra-high molecular weight polyethylene is 0.24 or less, and a tensile test is performed according to JIS K7127. When performed, the load required to stretch the molding auxiliary layer by 50% is 70.0 MPa or less in both the MD direction and the TD direction.
Blister pack.

  ADVANTAGE OF THE INVENTION According to this invention, the blister pack with a moisture absorption layer which has a pocket with a depth can be produced by minimizing generation | occurrence | production of molding failure. By using such a blister pack, a relatively large pharmaceutical preparation can be stored in a stable state (suppression of deterioration) for a long period of time.

It is the schematic of the blister pack with a moisture absorption layer. It is a schematic diagram of a layer structure of a blister pack of the present invention.

<Laminate for blister pack>
The laminate for a blister pack of the present invention includes a base layer, an aluminum layer, a moisture absorbing layer, and a forming auxiliary layer in this order. A reinforcing layer may be provided between the aluminum layer and the moisture absorbing layer. Further, an adhesive layer may be provided between any two layers of the base material layer, the aluminum layer, the reinforcing layer, and the moisture absorbing layer, and between the moisture absorbing layer and the forming auxiliary layer. For example, as shown in FIG. 1, the laminate 10 for a blister pack of the present invention has a base layer 2, an aluminum layer 3, a moisture absorbing layer 4, and a forming auxiliary layer 5.

  Examples of a method for bonding at least two layers of the base material layer, the aluminum layer, the reinforcing layer, the moisture absorbing layer, and the forming auxiliary layer include a dry lamination method, a sand laminating method, and an extrusion laminating method. The dry lamination method is a method in which an adhesive is applied and dried, and then pressurized to cure and bond the adhesive. The extrusion laminating method is a method of extruding and bonding an adhesive resin melted by an extruder. The sand lamination method is a method in which a molten adhesive resin is extruded and bonded between a substrate and a film to be bonded.

  The laminate for the blister pack has a pocket portion for containing a pharmaceutical preparation or the like. Examples of the forming method for forming the pocket portion include a flat plate type pneumatic forming method, a plug assist pneumatic forming method, a drum type vacuum forming method, a plug forming method, and the like. Among these, a plug molding method using a cylindrical rod (plug material) having a round tip with an ultra-high molecular weight polyethylene resin having a viscosity average molecular weight of 1,000,000 or more is preferable for forming a pocket. However, when a deep pocket is to be formed by this method, cracks are formed in the shoulder portion or the tail portion of the dome-shaped pocket portion, a dent is formed in the ceiling portion of the dome, or wrinkles are formed. Failure may occur.

  The present inventors have found that when a plug material and a plug material come into contact with each other and the surface layer of the laminate has a large friction, a crack is generated with a high probability in the blister pack laminate when the pocket portion is formed. I found it. That is, when the friction between the plug material and the surface layer is large, it is considered that only the contact portion between the plug material and the surface layer is greatly elongated, and a large tensile stress is generated in the laminated body at that portion, thereby causing a crack.

  Therefore, the present inventors pushed the plug material into the laminate by newly providing a forming auxiliary layer that reduces friction with the plug material as a surface layer on the side of the blister pack laminate that contacts the plug material. At this time, strain was applied as uniformly as possible to the entire pressed surface. In addition, the present inventors have found that when the auxiliary molding layer has a suitable elasticity, the above-mentioned molding defects are more unlikely to occur, and have reached the above-mentioned invention.

(Molding auxiliary layer)
(Molding auxiliary layer-static friction coefficient)
The molding auxiliary layer has a static friction coefficient (μS) with ultra-high molecular weight polyethylene of less than 0.36 when measured in accordance with ISO 8295 at least on the surface opposite to the surface in contact with the moisture absorbing layer. Here, the ultrahigh molecular weight polyethylene is a polyethylene having a viscosity average molecular weight of 1,000,000 or more measured according to JIS K7367-3: 1999, and particularly an ultrahigh molecular weight polyethylene resin having a viscosity average molecular weight of 5.5 million (product name: New Light (trademark) NL-W, manufactured by Sakushin Kogyo Co., Ltd.). This is to make the same as the ultra-high molecular weight polyethylene usually used for the plug material used when molding the pocket portion of the blister pack. When the coefficient of static friction is small, the slip between the plug material and the forming auxiliary layer is improved at the time of forming the pocket portion, and local distortion of the contact portion between the plug material and the forming auxiliary layer is less likely to occur. The above-mentioned coefficient of static friction is preferably 0.30 or less, more preferably 0.27 or less, further preferably 0.24 or less, and most preferably 0.23 or less.

(Molding auxiliary layer-force required for 50% stretching)
When a tensile test is performed in accordance with JIS K7127, the forming auxiliary layer has a force required for elongating it by 50% less than 160.7 MPa in both the MD (Machine Direction) direction and the TD (Traverse Direction) direction. Film or sheet. The MD direction is a mechanical transport direction of the film when manufacturing the film, and the TD direction is a direction perpendicular to the MD direction. This force is preferably 120.0 MPa or less, 100.0 MPa or less, more preferably 70.0 MPa or less, and even more preferably 65.0 MPa or less. Also, preferably, this force is greater than 9.2 MPa, 10.0 MPa or more, or 14.0 MPa or more. In this case, the "force required for 50% stretching" is a value obtained by dividing the load required for 50% stretching by the width of the film applied with the load and the thickness of the film. While not being bound by theory, it is considered that if the force required for stretching by 50% is within such a range, the stress applied to the laminate at the time of forming the pocket portion is in an appropriate range, and molding defects have not occurred. .

  When a pocket portion having a depth of 5.75 mm is formed in the laminate for a blister pack having a forming auxiliary layer, the forming auxiliary layer is stretched and a place where the thickness of the layer becomes about 2/3 is generated. On the other hand, when a tensile test is performed on only the molding auxiliary layer in accordance with JIS K7127, when the film is stretched by 50%, its thickness becomes about 2/3. Therefore, when forming a pocket portion having a depth of 5.75 mm, it can be evaluated that the forming auxiliary layer is stretched to the same extent as at the time of 50% stretching, that is, the above-mentioned 50% stretching is performed. Can be evaluated as the force applied when forming a pocket portion having a depth of 5.75 mm.

(Molding auxiliary layer-tensile modulus)
The molding auxiliary layer preferably has a tensile modulus of elasticity as measured in accordance with ISO 527-1 of more than 168 MPa and less than 1778 MPa in both the MD and TD directions. The forming auxiliary layer having such an elastic modulus can impart appropriate elasticity to the laminate and improve the moldability of the laminate.

(Forming auxiliary layer-dynamic friction coefficient)
The molding auxiliary layer has a dynamic friction coefficient (μD) with ultra-high molecular weight polyethylene of less than 0.36 when measured in accordance with ISO 8295 at least on the surface opposite to the surface in contact with the moisture absorbing layer. Here, the ultrahigh molecular weight polyethylene is a polyethylene having a molecular weight of 1,000,000 or more. This is to make the same as the ultra-high molecular weight polyethylene usually used for the plug material used when molding the pocket portion of the blister pack. When the coefficient of kinetic friction is small, the slip between the plug material and the forming auxiliary layer is improved during the formation of the pocket portion, and local distortion at the contact portion between the plug material and the forming auxiliary layer is less likely to occur. The above coefficient of dynamic friction is preferably 0.30 or less, more preferably 0.26 or less, further preferably 0.22 or less, and most preferably 0.21 or less.

(Molding auxiliary layer-other)
The forming auxiliary layer is not particularly limited to the type of the material as long as it is a film or sheet having the above physical properties. Examples of the film or sheet satisfying such physical properties include an unstretched polypropylene film and a polyvinyl chloride sheet. Can be

  The thickness of the molding auxiliary layer is preferably 5 μm or more, 10 μm or more, or 20 μm or more, and more preferably 200 μm or less, 100 μm or less, or 70 μm or less from the viewpoint of obtaining appropriate moldability and elasticity.

(Base material layer)
The resin used for the base material layer is not particularly limited as long as the resin gives a suitable moldability to the laminate for a blister pack. For example, polyethylene resin, polypropylene resin, polyvinyl chloride, polyvinylidene chloride, polychlorotrifluoroethylene, polytetrafluoroethylene, saturated or unsaturated polyester (for example, polyethylene terephthalate (PET), polybutylene terephthalate), and polyamide (For example, nylon (registered trademark), nylon 6, nylon 6,6, nylon MXD6), and mixtures thereof. Preferably, a material that prevents intrusion of moisture from the outside and has excellent moisture-proof properties is preferable, and examples thereof include polypropylene-based resin, polyamide, and polyethylene terephthalate.

  In this specification, a polyethylene resin is a resin containing a repeating unit of an ethylene group in a main chain of a polymer in an amount of 30 mol% or more, 40 mol% or more, 50 mol% or more, 60 mol% or more, 70 mol% or more, or 80 mol% or more. For example, low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), medium-density polyethylene (MDPE), high-density polyethylene (HDPE), ethylene-acrylic acid copolymer (EAA), ethylene-methacryl Acid copolymer (EMAA), ethylene-ethyl acrylate copolymer (EEA), ethylene-methyl acrylate copolymer (EMA), ethylene vinyl acetate copolymer (EVA), carboxylic acid-modified polyethylene, carboxylic acid-modified ethylene vinyl Acetate copolymer and this Derivatives, as well as selected from the group consisting of mixtures.

  In the present specification, a polypropylene resin is a resin containing a repeating unit of a propylene group in the main chain of the polymer in an amount of 30 mol% or more, 40 mol% or more, 50 mol% or more, 60 mol% or more, 70 mol% or more, or 80 mol% or more. For example, polypropylene (PP) homopolymer, random polypropylene (random PP), block polypropylene (block PP), chlorinated polypropylene, carboxylic acid-modified polypropylene, derivatives thereof, and mixtures thereof.

  The thickness of the substrate layer is preferably 10 μm or more, 20 μm or more, or 30 μm or more, and more preferably 300 μm or less, 200 μm or less, or 100 μm or less.

(Hygroscopic layer)
The moisture absorbing layer is a layer having a function of absorbing moisture, and this layer can improve the long-term stability of the pharmaceutical preparation. The moisture absorbing layer preferably includes an outer skin layer, an intermediate layer containing a moisture absorbent and a binder resin, and an inner skin layer in this order. In this case, the moisture absorbing agent contained in the intermediate layer is prevented from being detached during use, and the moisture absorbing layer is easily sandwiched between the upper and lower skin layers because it is easy to manufacture. Here, the outer skin layer is a layer used on the side (outside) opposite to the side where the pharmaceutical preparation of the blister pack is placed, and the inner skin layer is a layer used on the side (inside) where the pharmaceutical preparation is placed. As shown in FIG. 1, the moisture-absorbing layer 4 can be used by being laminated on the base layer 2, the aluminum layer 3, and the forming auxiliary layer 5 in the blister pack laminate 10 of the present invention. For example, as shown in FIG. 2, the moisture absorbing layer 4 has an outer skin layer 41, an intermediate layer 42, and an inner skin layer 43.

  The moisture absorbing layer including the outer skin layer, the intermediate layer, and the inner skin layer can be manufactured by an inflation method. This is a method of manufacturing a multilayer film by simultaneously extruding a plurality of resins into a tube shape by a plurality of extruders and sending air into the tubes to expand them. Further, the intermediate layer of the moisture absorbing layer is formed into a film or sheet by extrusion or injection molding such as inflation, T-die, co-extrusion, etc., and the outer skin layer and the inner skin layer are formed by known methods. Then, by laminating with the intermediate layer interposed therebetween, a moisture absorbing layer can be produced.

  Examples of the resin constituting the inner skin layer and the outer skin layer include a polyethylene resin, a polypropylene resin, a saturated or unsaturated polyester, polyvinyl chloride (PVC), polystyrene, a derivative thereof, and a mixture thereof. Preferably, the inner skin layer and the outer skin layer comprise the same resin as the intermediate layer, in particular LDPE, LLDPE, HDPE, random PP, block PP and / or PVC, thereby increasing the adhesion with the intermediate layer.

  The thickness of the inner skin layer and the outer skin layer is preferably 5 μm or more, 10 μm or more, or 20 μm or more, from the viewpoint of obtaining appropriate moldability and elasticity, and is 100 μm or less, 70 μm or less, 50 μm or less, or 40 μm or less. Preferably, there is.

  In the intermediate layer, a moisture absorbent is dispersed in a binder resin. The intermediate layer functions as a layer that absorbs moisture in the blister pack.

  Zeolite can be used as the moisture absorbent of the intermediate layer. Zeolite can obtain high hygroscopicity even in a low humidity region, and can also absorb moisture slightly contained in the blister pack.

  As the zeolite, a natural zeolite, an artificial zeolite, a synthetic zeolite, or the like can be used. Zeolite is a porous granular material used to separate substances according to the difference in molecular size.It has a structure with uniform pores, and absorbs small molecules entering the pore cavities to form a kind. Water (steam, water vapor) can be absorbed. As an example of the synthetic zeolite, there is a molecular sieve, and among these, a molecular sieve having a pore (absorption opening) diameter of 0.3 nm to 1 nm can be used. Usually, molecular sieves having pore diameters of 0.3 nm, 0.4 nm, 0.5 nm, and 1 nm are referred to as molecular sieve 3A, molecular sieve 4A, molecular sieve 5A, and molecular sieve 13X, respectively. The pore diameter can be confirmed by a structural analysis using an X-ray diffraction method. The average particle size of the molecular sieve (the particle size at an integrated value of 50% in the particle size distribution obtained by the laser diffraction / scattering method) is, for example, about 10 μm. In the present invention, these zeolites can be appropriately used according to the properties of the contents and the like.

  From the viewpoint of the ability to absorb moisture, the moisture absorbent ranges from 5% by weight or more, 10% by weight or more, 20% by weight or more, 30% by weight or more, 40% by weight or more, or 50% by weight or more based on the weight of the intermediate layer. And in the range of 90% by weight or less, 80% by weight or less, 70% by weight or less, or 60% by weight or less from the viewpoint of dispersibility in a binder resin and moldability. Can be

  Binder resins that can be used in the intermediate layer include polyethylene resins, polypropylene resins, saturated or unsaturated polyesters, ionomers, polyvinyl chloride (PVC), polystyrene, and derivatives thereof, and mixtures thereof.

  The thickness of the intermediate layer is preferably 20 μm or more, 30 μm or more, or 40 μm or more from the viewpoints of moisture absorption capacity, moldability, and elasticity, and is 500 μm or less, 300 μm or less, 200 μm or less, 150 μm or less, or 100 μm or less. Is preferred.

(Aluminum layer)
The aluminum layer is used for providing a barrier property. This may be a pure aluminum-based aluminum foil or an aluminum alloy-based aluminum foil. The thickness of the aluminum layer is preferably 7 μm or more, 10 μm or more, or 20 μm or more, and is 60 μm or less, 50 μm or less, or 40 μm or less, in order to impart appropriate moldability and elasticity to the blister pack laminate.

(Reinforcing layer)
The reinforcing layer is used to improve the moldability of the laminate for a blister pack. It may be composed of polyvinyl chloride, saturated or unsaturated polyester (eg, polyethylene terephthalate, polybutylene terephthalate), polyamide, and mixtures thereof. The thickness of the reinforcing layer is preferably 10 μm or more, 15 μm or more, or 25 μm or more, and is 60 μm or less, or 50 μm or less. In the present invention, a reinforcing layer as described in Patent Document 3 can be used as the reinforcing layer.

(Adhesive layer)
The laminate for a blister pack of the present invention may have an adhesive layer between any two of the base layer, the aluminum layer, the reinforcing layer, and the moisture absorbing layer. Adhesives that may be used for this adhesive layer include urethane adhesives, olefin resin adhesives, butyl rubber adhesives, acrylic resin adhesives, polyester resin adhesives, epoxy resin adhesives, and silicone resin adhesives. An adhesive and the like can be mentioned.

<Blister pack and blister pack package>
A blister pack of the present invention includes the above-described laminate for a blister pack and a lid material. The lid material is at least partially adhered to the laminate, especially to the auxiliary molding layer. A blister pack containing a pharmaceutical preparation in the blister pack pocket, after forming the pocket for storing the pharmaceutical preparation in the blister pack laminate, and then storing the pharmaceutical preparation in the pocket and attaching the lid. A package can be made.

(Lid material)
The lid member includes a resin layer, and further includes an aluminum layer different from the aluminum layer included in the above-described laminate for a blister pack. Here, “another aluminum layer” may be the same material and thickness, that is, the same aluminum layer may be present in the blister pack laminate and the lid material, respectively. doing. The resin of the resin layer is selected from the group consisting of polypropylene resin, polyvinyl chloride, ethylene vinyl acetate copolymer, and a mixture thereof. Preferably, the lid member has a form in which a resin layer is coated on an aluminum layer. Preferably, the resin layer of the lid member and the layer (forming auxiliary layer) to which the laminate for a blister pack adheres contain the same resin from the viewpoint of enhancing the adhesiveness.

  FIG. 1 is a schematic view of a blister pack package 1 with a moisture absorbing layer. Here, the lid material 6 is adhered to the blister pack laminate 10 in which the base layer 2, the aluminum layer 3, the moisture absorbing layer 4, and the forming auxiliary layer 5 are laminated in this order. The pharmaceutical preparation 100 is contained in the dome-shaped pocket. Although not shown, when laminated by a dry lamination method, an adhesive layer exists between the base material layer and the aluminum layer, between the aluminum layer and the moisture absorbing layer, and between the moisture absorbing layer and the forming auxiliary layer. I do.

  FIG. 2 is a schematic view of the layer structure of the blister pack of the present invention. In this figure, an end portion of the blister pack where no pocket portion is formed is shown, and a blister pack in which a base material layer 2, an aluminum layer 3, a moisture absorbing layer 4, and a forming auxiliary layer 5 are sequentially laminated. The lid member 6 is bonded to the laminate 10 for use. The moisture absorbing layer 4 includes an outer skin layer 41, an intermediate layer 42, and an inner skin layer 43. The lid 6 includes a resin layer 61 and an aluminum layer 62. A pocket portion for accommodating a pharmaceutical preparation is formed in the laminate 10.

<Sample creation>
The blister pack laminates of Examples 1 to 6 and Comparative Examples 1 to 8 were produced with the configuration shown in Table 1 below, except that only the forming auxiliary layer was changed. Further, as the laminate of Comparative Example 9, a laminate having the configuration shown in Table 1 was prepared, except that the molding auxiliary layer was not provided. Furthermore, as the laminate of Comparative Example 10, a laminate having no auxiliary forming layer but having a reinforcing layer between the moisture absorbing layer and the aluminum layer was produced. The laminate of Comparative Example 10 was the same as Comparative Example 9 except that the laminate had a 60-μm-thick polyvinyl chloride resin sheet (Vinifoil C-455, Mitsubishi Plastics, Inc.) as a reinforcing layer. In Example 6, a 12 μm-thick polyethylene terephthalate film was added to the laminate of Example 4 as a reinforcing layer.

  As for the moisture absorbing layer, LLDPE was used as the inner and outer skin layers. As the intermediate layer, LDPE and zeolite as a hygroscopic agent were put into a kneading extruder and kneaded while heating and melting the resin, and then extruded into pellets and cooled to obtain mixed pellets. Then, a film to be a moisture absorbing layer was formed by coextrusion molding using an inflation molding method. The inflation molding was performed by a three-layer inflation molding machine (3SOIB, Placo Co., Ltd.) at a resin temperature of 170 ° C. and a take-up speed of 13 m / min.

  The base material layer, the aluminum layer, the moisture absorbing layer, and the forming auxiliary layer were laminated by applying an adhesive to a surface to be bonded using a wire bar, drying the solvent, and applying pressure with a pressure roller. At that time, urethane-based adhesives (Takelac (trademark) and Takenate (trademark) each containing a main agent (A1143), a curing agent (A12), and ethyl acetate at a weight ratio of 9: 1: 10 as the adhesives are used. , Mitsui Chemicals, Inc.). The thickness of the adhesive layer was 3 μm.

<Evaluation 1: Slip test>
The slipperiness (dynamic friction coefficient and static friction coefficient) of the forming auxiliary layer of each example was measured in accordance with ISO8295. It measured using the friction measuring machine (TR-2, Toyo Seiki Seisaku-sho, Ltd.). The measuring speed was 100 mm / min, the sliding piece used 200 g (40 cm ² ), and the paired sample was an ultra-high molecular weight polyethylene film of the same material as the molded plug (viscosity average molecular weight 5.5 million, product name: Newlite Film NL-W) Industrial Co., Ltd.) was used. Table 2 shows the results of the dynamic friction coefficient and the static friction coefficient of the forming auxiliary layer of each example.

<Evaluation 2: Tensile test>
A tensile test was performed on the film or sheet of the forming auxiliary layer in each example in accordance with JIS K7127, and the force required to stretch by 50% was evaluated. Further, the tensile modulus was evaluated in accordance with ISO527-1. Table 2 shows the results.

<Evaluation 3: Molding test>
A pocket portion of a pharmaceutical preparation having a depth of 4.75 to 5.75 mm was formed at room temperature on the laminate for blister packs of Examples 1 to 6 and Comparative Examples 1 to 10. As a molding machine, a high-speed hydraulic press (HYP505H) manufactured by Nippon Automatic Machine Co., Ltd. was used. The plug material is an ultra-high molecular weight polyethylene resin having a viscosity average molecular weight of 5.5 million (product name: Newlite (trademark) NL-W, Sakushin Kogyo Co., Ltd.), the plug diameter is 13 mm, and the molding speed is 200 mm / s. . Here, after the periphery of the portion to be formed is fixed while applying pressure, the plug (convex portion) is extruded by a set length to form a dome shape on the film.

  Here, the case where the appearance defect such as cracks, scratches, dents, etc. was not visually observed in the molded pocket portion was indicated by ○, the case where the appearance defect such as dents occurred in the dome ceiling portion was indicated by △, and the tearing was also performed. When a defect such as a pinhole or the like occurred, it was evaluated as x. Table 2 shows the results.

  As can be seen from Examples 1 to 6, when the static friction coefficient of the forming auxiliary layer is low and the force at the time of 50% stretching is low, the pocket portion can be formed deeply. Referring to Comparative Examples 1 to 7, it can be seen that, even if the friction is relatively small, molding failure is likely to occur when the force at the time of 50% stretching is large. Insufficiency in molding is a phenomenon in which a dent is formed in the dome ceiling portion due to local thinning of the laminate, and can be considered as a state immediately before cracks and pinholes occur. Further, from Comparative Example 8, it can be seen that when the friction at the time of stretching at 50% is small even if the force is small, molding failure occurs even at a depth of 5.00 mm.

  In the laminate for a blister pack of the present invention, a deep pocket can be formed, and a blister pack using the same can store a relatively large pharmaceutical preparation in a stable state (suppressing deterioration) for a long period of time. it can.

DESCRIPTION OF SYMBOLS 1 Blister pack package with a moisture absorbing layer 10 Blister pack laminated body 2 Base layer 3 Aluminum layer 4 Moisture absorbing layer 41 Outer skin layer 42 Intermediate layer 43 Inner skin layer 5 Forming auxiliary layer 6 Lid material 61 Resin layer 62 Aluminum layer 100 Pharmaceutical formulations

Claims (14)

Including a base layer, an aluminum layer, a moisture absorbing layer, and a forming auxiliary layer in this order,
The surface of the auxiliary molding layer opposite to the moisture-absorbing layer has a static friction coefficient of less than 0.36 with ultra-high molecular weight polyethylene used as a plug material for molding a pocket portion , as measured according to ISO 8295. And the molding auxiliary layer is a film in which, when a tensile test is performed in accordance with JIS K7127, the force required to stretch by 50% is less than 160.7 MPa in both the MD direction and the TD direction. Or a sheet,
Laminate for blister pack. The blister pack according to claim 1, wherein the surface of the auxiliary molding layer opposite to the moisture absorbing layer has a dynamic friction coefficient with the ultrahigh molecular weight polyethylene of less than 0.36 as measured according to ISO8295. For laminate.   The laminate for a blister pack according to claim 1 or 2, wherein a tensile modulus of the molding auxiliary layer is more than 168 MPa and less than 1778 MPa in both the MD direction and the TD direction when measured in accordance with ISO527-1. body.   The blister pack laminate according to any one of claims 1 to 3, wherein the molding auxiliary layer includes a non-stretched polypropylene resin or a polyvinyl chloride resin.   The force according to claim 1, wherein the static friction coefficient is 0.30 or less, and when a tensile test is performed in accordance with JIS K7127, the force required for the 50% stretching is 120 MPa or less. The laminate for a blister pack according to any one of the preceding claims.   The force according to claim 5, wherein the static friction coefficient is 0.24 or less, and when a tensile test is performed in accordance with JIS K7127, the force required for the 50% elongation is 70 MPa or less. Laminate for blister pack.   The blister pack according to any one of claims 1 to 6, wherein the moisture absorbing layer includes, in this order, an outer skin layer on the base material layer side, an intermediate layer having a moisture absorbent and a binder resin, and an inner skin layer. For laminate.   The outer skin layer and the inner skin layer of the moisture absorbing layer are each selected from the group consisting of polyethylene resin, polypropylene resin, saturated or unsaturated polyester, polyvinyl chloride, polystyrene, and derivatives thereof, and mixtures thereof. The laminate for a blister pack according to claim 7, comprising a resin.   The base layer is selected from the group consisting of polyethylene resins, polypropylene resins, polyvinyl chloride, polyvinylidene chloride, polychlorotrifluoroethylene, polytetrafluoroethylene, saturated or unsaturated polyesters, polyamides, and mixtures thereof. The blister pack laminate according to any one of claims 1 to 8, comprising a resin.   The blister pack laminate according to any one of claims 1 to 9, further comprising a reinforcing layer between the aluminum layer and the moisture absorbing layer.   The blister pack laminate according to claim 10, wherein the reinforcing layer includes a resin selected from the group consisting of polyvinyl chloride, saturated or unsaturated polyester, polyamide, and a mixture thereof.   A laminate comprising the laminate according to any one of claims 1 to 11, and a lid having an aluminum layer and a resin layer different from the aluminum layer, wherein the laminate and the lid are at least partially bonded to each other. A blister pack, wherein a pocket portion is formed in the laminate so that a pharmaceutical preparation can be stored between the laminate and the lid member.   A blister pack package comprising the blister pack according to claim 12 and a pharmaceutical preparation stored in the pocket. A laminate for the blister pack and a lid material, wherein the laminate and the lid material are at least partially adhered to each other, and a pocket portion is formed in the laminate to form a gap between the laminate and the lid material. A blister pack in which a pharmaceutical preparation can be stored,
The laminate comprises the following layers in this order:
A base material layer made of polyamide;
Aluminum layer;
Outer skin layer made of polyethylene resin;
An intermediate layer containing a binder resin composed of zeolite and a polyethylene resin;
An inner skin layer made of a polyethylene resin; and a molding auxiliary layer containing a polyvinyl chloride resin,
The lid material includes a polyvinyl chloride resin layer on the molding auxiliary layer side, and an aluminum layer different from the aluminum layer,
When measured according to ISO 8295, the coefficient of static friction between the surface of the molding auxiliary layer opposite to the moisture absorbing layer and the ultra-high molecular weight polyethylene used for the plug material for molding the pocket portion is 0.24 or less. And when a tensile test is performed in accordance with JIS K7127, the load required to stretch the forming auxiliary layer by 50% is 70.0 MPa or less in both the MD direction and the TD direction.
Blister pack.

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