JP4372857B2 - Press-through pack package - Google Patents

Description

[0001]
BACKGROUND OF THE INVENTION
The present invention relates to a press-through pack package that enables detection of the position of the press-through pack package by X-rays when a medicine packaged in the press-through pack package is accidentally swallowed together with the package. It can be used for packaging pharmaceutical tablets and capsules.
[0002]
[Prior art]
Press-through pack packaging (hereinafter referred to as PTP packaging) is generally a pocket of a depth of 20 mm or smaller by hot vacuum forming, hot air pressure forming, hot vacuum air forming, etc. of a transparent plastic sheet (or film). A deep-drawn container is made, filled with solid medicine, food, glass ampules, etc., and the opening is hermetically sealed with aluminum foil, thin rigid plastic sheet or flexible film, etc. In medicine, it is often used for packaging tablets and capsules.
[0003]
Drugs are required to guarantee efficacy and safety, and to ensure this, special attention must be paid to quality degradation.
For this reason, not only the quality of the pharmaceutical preparation itself but also the protective function of the packaging material is important for preventing quality deterioration.
Conventionally, as a material for molding PTP, a hard polyvinyl chloride sheet (hereinafter referred to as a PVC sheet) has been mainly used, but in recent years, an unstretched polypropylene sheet (hereinafter referred to as a CPP sheet) or an amorphous material has been used. A polyethylene terephthalate sheet (hereinafter referred to as an APET sheet) and a sheet provided with a cyclic polyolefin layer are used.
[0004]
As a material for molding PTP, PVC sheets have many excellent aspects in terms of good moldability in a PTP molding machine, transparency, good cutability, etc., but there is a drawback that moisture resistance is inferior depending on the purpose. is there.
In general, pharmaceutical preparations wrapped in tablets, capsules and the like have high hygroscopicity, and PVC alone as a molding material may have insufficient water vapor barrier properties.
In order to improve moisture resistance, a PVC sheet coated with polyvinylidene chloride (hereinafter referred to as PVDC) having a high water vapor barrier property is used, but there is a problem that the packaging material is expensive. In addition, packaging materials using PVC and PVDC also have pollution problems after disposal.
[0005]
Therefore, as a packaging material for molding PTP, polypropylene having a high moisture resistance, low cost, and low pollution (hereinafter referred to as PP) is used.
However, the PP sheet has disadvantages such as moldability, curling property, transparency, and cutability (separability) that are inferior to PVC, and is used by being laminated with PVC or polyethylene (hereinafter referred to as PE) having good moldability. In some cases.
In addition, although an APET sheet has attracted attention as a low-pollution packaging material, the moisture-proof property of the APET sheet alone is insufficient, and in this case, a packaging material laminated with PE or PP is used.
[0006]
[Problems to be solved by the invention]
In PTP packaging, the pockets formed in the bottom material (recesses formed in the packaging material by vacuum / compression molding) are pressed from the outside with fingers, and the aluminum foil as the lid material is broken to take out tablets and capsules. It is a general method.
The PTP package is formed by connecting a large number of pockets containing tablets and capsules, and can be separated one by one by perforation or half cut.
Usually, patients often have to take many kinds of tablets and capsules, so separate them one by one from a PTP package with a large number of pockets, and prepare the number to be used at one time. Take.
[0007]
As described above, PTP-packed tablets and capsules are often taken in small portions one by one, so the entire package may be swallowed by mistake.
In the case of PTP packaging, the bottom material for molding is hard, and what is cut off one by one has a sharp corner.
Therefore, if the entire package is accidentally swallowed, not only the esophagus but also the stomach and intestines are hurt and often become severe.
In this case, it is necessary to take the package out of the body by surgery, but it has been difficult to specify where the package exists in the digestive tract.
That is, there is a method for detecting a package by real-time imaging using a transmission type X-ray (hereinafter referred to as X-ray) apparatus, but a packaging material used for PTP packaging, such as PVC, PP, APET of a bottom material, The aluminum foil of the lid material is difficult to be reflected in X-rays, and it is difficult to specify the position of the package.
[0008]
In order to solve these problems, the present invention uses a bottom material in which a resin layer containing an X-ray contrast agent is laminated as a sheet for forming a PTP package (hereinafter referred to as a bottom material). Thus, the PTP package can be easily detected using a transmission type X-ray apparatus.
[0009]
[Means for Solving the Problems]
In order to solve the above problem, the structure of the PTP package was as follows. A press in which a transparent base sheet made of a thermoplastic resin is molded by a plug-assisted vacuum / pressure forming method to form a recess capable of storing the contents, and the opening of the recess is sealed with a lid having a heat seal layer a through pack packaging, the transparent substrate sheet is a thermoformable laminate by laminating a resin layer containing an X-ray contrast agents, and, in X-ray contrast medium content is 20 to 90 wt% There, and Ri thickness 20~100μm der X-ray contrast agent-containing resin layer, and the transparent substrate sheet, an intermediate layer by coating a resin layer containing an X-ray contrast agents by reverse coating and a press-through pack packaging, characterized in thermoformable laminate der Rukoto. Further, the resin layer containing the X-ray contrast agent is a resin layer in which an iodine organic compound or tungsten or a tungsten compound is contained in a thermoplastic resin, a thermosetting resin, or an ionizing radiation curable resin. A press-through pack package was obtained.
[0010]
That is, a resin layer containing an X-ray contrast agent is laminated on a PP sheet, PVC sheet or APET sheet as a bottom material of a PTP package, and tablets and capsules are stored by vacuum / compression molding using this laminated sheet. After forming a pocket for this purpose and filling the pocket with tablets and capsules, an aluminum foil coated with a heat sealant on the back surface is heat sealed and sealed to form a PTP package.
Since the PTP package of the present invention has a resin layer containing an X-ray contrast agent, the position of the PTP package can be easily determined by X-ray photography using a transmission X-ray apparatus even if swallowed by mistake. Can be detected.
In addition, if a resin layer containing an X-ray contrast agent is provided in an intermediate layer such as a PP sheet or a PVC sheet, a pocket can be formed by vacuum / compression molding or the like, similarly to a conventional laminated sheet made of PP or PVC. The PTP package can be manufactured without reducing the production efficiency.
[0011]
DETAILED DESCRIPTION OF THE INVENTION
Hereinafter, the present invention will be described in detail with reference to the drawings.
FIG. 1 is a schematic cross-sectional view showing an outline of a PTP package of the present invention.
FIG. 2 is a schematic cross-sectional view showing an example of a bottom material used for the PTP package of the present invention, and FIG. 3 is a schematic cross-sectional view showing an example of a lid used for the PTP package of the present invention.
FIG. 4 is an explanatory view when the PTP package of the present invention is produced.
[0012]
As shown in FIG. 1B, the PTP package of the present invention has a resin layer 12 containing an X-ray contrast agent (hereinafter referred to as an X-ray contrast agent-containing material) on a base sheet 11 made of a thermoplastic resin that can be thermoformed. Resin layer) and an inner surface sheet 13 made of a thermoplastic resin as an inner surface, and this laminated sheet is used as a bottom material 2 as shown in FIG. 1 (a), vacuum forming, pressure forming, vacuum / pressure forming. A concave pocket 5 for storing the tablet 4 (or capsule) is formed by, for example, filling the tablet 5 in the pocket 5, and then heat-sealing the lid 3 having a heat seal layer on the back surface at the opening. And sealed.
And since the PTP package 1 of the present invention has the X-ray contrast agent-containing resin layer 12 on the bottom material 2, even if it is swallowed by mistake, it can be digested by X-ray imaging using a transmission X-ray apparatus. The position of the PTP package in the vessel can be easily detected.
[0013]
That is, the PTP package of the present invention is characterized by using a laminated material in which the X-ray contrast agent-containing resin layer 12 is laminated on the bottom material 2.
As the bottom material 2, for example, as shown in FIG. 2, a CPP sheet 11a is used as a base material sheet, and a resin composition containing an X-ray contrast agent such as an iodine organic compound is formed on the CPP sheet 11a. An X-ray contrast medium-containing resin layer 12 is formed by coating, and a CPP film 13a is laminated on the X-ray contrast medium-containing resin layer 12 as an inner surface sheet to form a three-layer laminated sheet. .
As the base material sheet 11, a PVC sheet, an APET sheet, and the like are used in addition to the CPP sheet. In addition, various thermoplastic resin sheets that can be thermoformed can be used.
Moreover, the inner surface sheet 13 used as an inner surface layer can be used if it is a thermoplastic resin sheet which can be thermoformed and does not adversely affect the contents, like the base material sheet.
[0014]
Below, the manufacturing method of the PTP package of this invention is demonstrated.
First, an X-ray contrast agent such as iodine organic compound, sodium iodide, barium sulfate or the like is added to a coating liquid made of a thermoplastic resin, a thermosetting resin, or an ionizing radiation curable resin, and an X-ray contrast agent-containing coating is added. A working solution is prepared, and this coating solution is coated on a base sheet 11 such as a CPP sheet by a known coating method to form an X-ray contrast agent-containing resin layer 12 as shown in FIG. .
Next, a CPP film or the like is laminated as the inner surface sheet 13 on the X-ray contrast agent-containing resin layer 12 to produce the bottom material 2 having three layers as shown in FIG.
[0015]
The X-ray contrast agent-containing resin layer 12 can be formed by a known coating method such as a gravure roll, a direct roll, an air knife, or a screen using a coating liquid to which an X-ray contrast agent is added. In addition, the above X-ray contrast agent is blended with a thermoplastic resin, and the X-ray contrast agent blend thermoplastic resin is used to produce a sheet or film by a T-die method, an inflation method, or the like. Is laminated on the base sheet 11 using an adhesive.
Further, there is a method in which an X-ray contrast agent blend thermoplastic resin is directly extruded onto a base sheet by a T-die method or the like and laminated.
Furthermore, using a multi-layer co-extrusion machine, co-extrusion of the thermoplastic resin as the base sheet, the X-ray contrast agent blend thermoplastic resin, and the thermoplastic resin as the inner surface simultaneously to produce a three-layer laminated sheet You can also.
[0016]
The X-ray contrast medium resin layer 12 does not necessarily have to be three layers as described above, and the object of the present invention can be achieved by two layers or a single layer.
For example, a sheet can be made of PP or PVC blended with an X-ray contrast agent, and the sheet can be used as a bottom material. Moreover, these sheets or films can be laminated on a base sheet and used as a two-layer bottom material.
However, when the X-ray contrast agent resin layer 12 is on the surface, the X-ray contrast agent bleeds out to the surface or contaminates the molding die when heated during vacuum / compression molding. Since the X-ray contrast medium resin layer 12 may be an intermediate layer, it may be adversely affected, so that a conventional PTP molding machine can be used as it is.
[0017]
The X-ray contrast agent used in the present invention has a large X-ray absorption ability and a clear image can be obtained, and even if it is added to a coating solution and coated on a base sheet to form a resin layer, there is no change. The necessary conditions are that there is no change even if a sheet or film is prepared by blending with a resin, that there is no change even if the bottom material is thermoformed.
For example, iodine organic compounds such as amidotrizoic acid and iodine-pyridone sodium acetate, inorganic salts such as barium sulfate, bismuth oxycarbonate and sodium iodide, iodinated unsaturated fats and oils and iodine iodinated by suspending them in fats and oils Metal colloids such as oil, silver-protein colloid, silver iodide-gelatin colloid and the like can be used.
Further, tungsten, tungsten carbide, or the like can be used.
[0018]
The thickness of the X-ray contrast agent-containing resin layer varies depending on the X-ray contrast agent content. Usually, when the X-ray contrast agent content is 20 to 90% by weight, the thickness of the X-ray contrast agent-containing resin layer is 20 ~ 100μ is preferred.
If the content of the X-ray contrast agent is less than 20% by weight, a clear image cannot be obtained unless the X-ray contrast agent-containing resin layer is 100 μm or more during X-ray imaging. In addition, when the content of the X-ray contrast agent exceeds 90% by weight, a clear image can be obtained by X-ray imaging at 90% by weight or less, so even if the content of the X-ray contrast agent exceeds 90% by weight. , The special merit is not obtained, it becomes economically disadvantageous.
[0019]
In the present invention, as shown in FIG. 4C, pockets 5 for storing tablets, capsules, and the like are formed using the bottom material on which the X-ray contrast agent-containing resin layer is laminated. As a pocket forming method, a known sheet forming method can be used.
For example, a vacuum forming method, a pressure forming method, a vacuum / pressure forming method, a vacuum forming method using a plug assist, a pressure forming method, a vacuum / pressure forming method and the like can be used.
As a method for forming the pocket, a molding method suitable for the type of bottom material (laminate), pocket size, pocket depth, pocket shape, etc. is selected.・ Pneumatic forming method is often used.
[0020]
Usually, in the case of PTP packaging, a long bottom material (laminated sheet) is used to form a pocket, and the contents (tablets or capsules) in the pocket using a vacuum / pneumatic molding machine equipped with many dies. Filling and heat sealing of the lid material are continuously performed to obtain a sheet-like material in which a large number of pockets are arranged. This is cut into a certain size, and a large number of pockets are connected as shown in FIG. The multi-array PTP package 1a is produced.
Further, this multi-array PTP package 1a is provided with perforations 6 (or half cuts) so that the multiple PTP packages can be separated one by one or two. .
[0021]
The lid material used in the present invention can be easily broken when the pocket is pushed with a finger, the contents can be easily taken out, and physical properties for protecting the contents such as moisture resistance and gas barrier properties. A material having heat sealability with the bottom material is further used.
As a cover material having physical properties satisfying the above physical properties, a material in which a heat seal layer 14 is formed on an aluminum foil 15 (hereinafter referred to as Al foil) is usually used as shown in FIG.
The thickness of the Al foil is in the range of 15 to 25 μm.
The lid material may be provided with a printing layer as necessary. Further, an overprint layer can be formed as a protective layer on the print layer.
[0022]
As the lid material, any material other than Al foil can be used as long as the material can be easily taken out by pushing the pocket with a finger and has physical properties for protecting the content.
For example, a uniaxially stretched polypropylene film, a uniaxially stretched polyethylene terephthalate film, a uniaxially stretched polyethylene naphthalate film, or the like can be used.
In addition, a polypropylene film blended with an inorganic powder such as talc has good breakability, and can be used as a cover material.
[0023]
The heat seal layer of the lid material is formed by coating the bottom material and a heat sealable substance on the back surface of the Al foil. As the coating agent, any material having a heat sealability with the bottom material can be used.
For example, a known heat sealable coating agent such as a varnish for heat seal can be used.
In addition, a base material and a heat-sealable film can be laminated on an aluminum foil to form a heat-seal layer, but in this case, if the heat-sealable film is too thick, the tablet or capsule can be fingered from the pocket. When extruding, the lid is difficult to tear, and tablets, capsules and the like cannot be easily taken out.
[0024]
【Example】
Hereinafter, the present invention will be described in more detail based on examples.
Example 1
Addition of 30% by weight to the binder resin made of melamine resin using a gastrographin made by Nippon Sealing Co., Ltd. containing iodine organic compound (amidotrizoic acid) as an X-ray contrast agent. Thus, a coating solution was prepared and used as an X-ray contrast agent-containing coating solution.
Using this X-ray contrast agent-containing coating solution, as shown in FIG. 6A, a 200 μm-thick unstretched polypropylene sheet 11a (hereinafter referred to as CPP sheet) is coated by a reverse coating method as shown in FIG. Then, the X-ray contrast agent-containing resin layer 12 was formed so that the film thickness after drying was 90 μm.
Next, a CPP film 13a having a thickness of 50 μm is laminated on the X-ray contrast medium-containing resin layer 12 formed on the CPP sheet 11a by a dry lamination method, and as shown in FIG. Produced.
[0025]
Moreover, as shown in FIG.6 (c), the PTP aluminum foil (thickness 20micrometer) for PP which has a heat seal layer by Nippon Foil Co., Ltd. was used as the cover material 3. As shown in FIG.
[0026]
Next, the bottom material 2 is formed by a plug assist vacuum / pressure forming method using a vacuum / pressure forming machine, and as shown in FIG. A pocket 5 having a depth of 5 mm was formed.
Next, as shown in FIG. 7 (b), the pocket 5 is filled with the tablet 4, and immediately, the lid 3 is heat-sealed around the bottom pocket 5 to seal the opening. A PTP package 1 as shown in (c) was obtained.
[0027]
The molding of the pocket, filling of the tablet, and heat sealing of the lid material were continuously performed as follows.
That is, using a vacuum / pneumatic molding machine equipped with a mold having 45 recesses, 15 in the sheet width direction and 3 in the sheet flow direction, a long bottom with a sheet width of 300 mm is used. After supplying the material and heating the bottom material in the molding step, 45 pockets were formed in one shot by plug-assist vacuum / pressure forming.
This is continuously performed, and a strip-like sheet (bottom material) in which a large number of pockets are formed is sent to the next filling process. In the filling process, tablets are supplied from 15 filling nozzles to the tablets in the pocket 5. 4 and the band-like sheet in which the tablet is filled in the pocket is sent to the heat sealing process.
In the heat sealing step, a long cover material having a width of 290 mm was continuously supplied, and the opening of the pocket 5 was sealed by heat sealing around the pocket of the bottom material using a heat roll.
Next, a long sheet with a large number of pockets connected thereto is perforated in the sheet flow direction with a cutting device, and then 5 × 3 pieces are cut as one packaging unit as shown in FIG. Individual arrangement PTP package 1a was obtained.
[0028]
(Example 2)
As in Example 1, a 200 μm-thick PVC sheet 11b as a base material sheet was coated with an X-ray contrast medium-containing coating solution, and the film thickness after drying was 90 μm as shown in FIG. The X-ray contrast agent-containing resin layer 12 was formed so as to be.
Next, a PVC film 13b having a thickness of 50 μm is laminated on the X-ray contrast agent-containing resin layer 12 formed on the PVC sheet 11b by a dry lamination method, and as shown in FIG. Produced.
Further, a heat sealing varnish was coated on a soft Al foil 15 having a thickness of 20 μm, and a heat sealing layer 14 having a thickness of 3 μm was formed as shown in FIG.
[0029]
Next, in the same manner as in Example 1, the bottom material 2 was molded by a plug-assist vacuum / compressed air molding method, and then the tablet filling and the lid material were heat-sealed, as shown in FIG. A package 1 was produced.
[0030]
(Example 3)
As in Example 1, an APET sheet 11c having a thickness of 200 μm was coated as a base material sheet with an X-ray contrast agent-containing coating solution, and as shown in FIG. 9A, the film thickness after drying was 90 μm. The X-ray contrast agent-containing resin layer 12 was formed so as to be.
Next, on the X-ray contrast medium-containing resin layer 12 formed on the APET sheet 11c, an APET film 13c having a thickness of 50 μm was laminated by a dry lamination method, and as shown in FIG. Produced.
Further, a heat sealing varnish was coated on a soft Al foil 15 having a thickness of 20 μm, and a heat sealing layer 14 having a thickness of 3 μm was formed as shown in FIG.
[0031]
Next, in the same manner as in Example 1, the bottom material 2 was molded by a plug-assist vacuum / compressed air molding method, and then the tablet filling and the lid material were heat-sealed, as shown in FIG. A package 1 was produced.
[0032]
When one PTP package produced in Examples 1, 2, and 3 was viewed with a transmission X-ray apparatus through a phantom, it was clearly visible.
Therefore, even if this PTP package is swallowed by mistake, it is expected that the position of the PTP package in the digestive tract can be confirmed by X-ray imaging using a transmission X-ray apparatus.
[0033]
【The invention's effect】
According to the present invention, as a bottom material of a PTP package, a resin layer containing an X-ray contrast agent such as an iodine-based organic compound is laminated on a PP, PVC, or APET sheet. A pocket for storing tablets and capsules is formed by pressure forming or the like, and after filling the pockets with tablets and capsules, an aluminum foil with a heat sealant applied to the back surface is heat sealed and sealed, and a PTP package. Is manufacturing.
Therefore, since the PTP package of the present invention has a resin layer containing an X-ray contrast agent, even if the PTP package is accidentally swallowed and the PTP package is taken out of the body by surgery, the transmission X-ray If X-ray imaging is performed using the apparatus, the position of the PTP package in the digestive organ can be easily detected, so that the surgical operation can be completed in a short time.
In addition, if a resin layer containing an X-ray contrast agent is provided in the intermediate layer of PP, PVC, or APET sheet, as with a conventional laminated sheet made of PP, PVC, or APET sheet, by vacuum / pressure forming, etc. Since the pocket can be molded, the PTP package can be manufactured without reducing the production efficiency.
Further, by providing a resin layer containing an X-ray contrast agent in the intermediate layer of the bottom material sheet, even if the bottom material sheet is heated during molding, the X-ray contrast agent bleeds out to the surface of the sheet, and the molding die The conventional PTP molding machine can be used as it is.
[Brief description of the drawings]
FIG. 1 is a schematic cross-sectional view showing an outline of a PTP package of the present invention.
FIG. 2 is a schematic cross-sectional view showing an example of a bottom material used in the PTP package of the present invention.
FIG. 3 is a schematic cross-sectional view showing an example of a lid material used in the PTP package of the present invention.
FIG. 4 is an explanatory view when producing the PTP package of the present invention.
FIG. 5 is a plan view of a PTP package in which a large number are arranged.
6 is a schematic cross-sectional view of a bottom material and a lid material produced according to Example 1. FIG.
7 is an explanatory view when a PTP package is produced according to Example 1. FIG.
8 is an explanatory view when a PTP package is produced according to Example 2. FIG.
9 is an explanatory view when a PTP package is produced according to Example 3. FIG.
[Explanation of symbols]
DESCRIPTION OF SYMBOLS 1 PTP package 1a Multiple arrangement PTP package 2 Bottom material 3 Lid 4 Tablet 5 Pocket 6 Perforation 11 Base material sheet 11a CPP sheet 11b PVC sheet 11c APET sheet 12 X-ray contrast agent containing resin layer 13 Inner surface sheet 13a CPP Film 13b PVC film 13c APET film 14 Heat seal layer 15 Al foil

Claims (3)

A press in which a transparent base sheet made of a thermoplastic resin is molded by a plug-assist vacuum / pneumatic molding method to form a recess that can contain the contents, and the opening of the recess is sealed with a lid having a heat seal layer a through pack packaging, the transparent substrate sheet is a thermoformable laminate by laminating a resin layer containing an X-ray contrast agents, and, in X-ray contrast medium content is 20 to 90 wt% There, and Ri thickness 20~100μm der X-ray contrast agent-containing resin layer, and the transparent substrate sheet, an intermediate layer by coating a resin layer containing an X-ray contrast agents by reverse coating Press-through pack packaging, characterized in thermoformable laminate der Rukoto.   The press according to claim 1, wherein the resin layer containing the X-ray contrast medium is a resin layer in which an iodine organic compound is contained in a thermoplastic resin, a thermosetting resin, or an ionizing radiation curable resin. Through pack package.   The resin layer containing the X-ray contrast agent is a resin layer in which tungsten or a compound of tungsten is contained in a thermoplastic resin, a thermosetting resin, or an ionizing radiation curable resin. Press-through pack packaging.

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