JP2018008713A - PTP package and manufacturing method thereof - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a PTP package formed of a storage body storing a tablet or the like and a sealing member sealing an opening of the storage body which uses a plastic film as the sealing member, and has both high moisture proofness to the tablet or the like and seal break property at the time of taking out of the tablet or the like.SOLUTION: In a PTP package, a sealing member has an inorganic oxide layer, an overcoat layer and any one of an aluminum layer and an aluminum compound layer in this order on a base material, where the base material is formed of a plastic film, a large number of fine recesses having an average depth of 30-50% of the thickness of the base material are provided on a surface in an opposite side to the inorganic oxide layer of the base material, and a seal layer formed of a heat seal lacquer or a heat-sealable resin is provided on a surface side contacting the storage body.SELECTED DRAWING: Figure 2

Description

  The present invention relates to a package for tablets and pills, so-called PTP (press through pack) package.

  A conventional PTP package is composed of a molded body obtained by molding a transparent plastic, and includes a storage body having a storage portion for storing tablets and the like, and a sealing member for sealing the opening of the storage body, The sealing member is generally made of an aluminum foil having a thickness of 20 to 40 μm coated with a sealing agent such as a heat seal lacquer. The sealing member made of this aluminum foil has excellent gas barrier properties, moisture proof properties, and sealability (openability), and is widely used. However, when the aluminum foil is discarded after use, the aluminum becomes a lump when incinerated, and there is a need for improvement.

  Then, the PTP package which uses a plastic film instead of aluminum foil as a sealing member is known (patent document 1). However, in recent years, further improvement in moisture resistance has been demanded with the diversification of tablets. Conventionally, in a PTP package using a plastic film, it is difficult to extrude a tablet or the like when trying to enhance a protective function such as moisture resistance or oxygen barrier property against the tablet. Therefore, when a plastic film having a certain thin thickness is used, it is difficult to add a sufficient function for protecting tablets and the like.

Japanese Patent No. 3568557

  The present invention has been made in view of the above problems, and as a sealing member of a PTP package, without using an aluminum foil having a problem during incineration, even when using a plastic film without such a problem, It is an object of the present invention to provide a PTP package having both high moisture-proofing properties (water vapor barrier property) for tablets and the like and tearing properties when taking out tablets and the like.

In order to solve the above-mentioned problem, the invention according to claim 1 is a PTP package including a storage body for storing tablets and the like, and a sealing member for sealing an opening of the storage body,
The sealing member comprises an inorganic oxide layer, an overcoat layer, and either an aluminum layer or an aluminum compound layer in this order on a base material,
The substrate is made of a plastic film,
A PTP having a number of minute recesses having an average depth of 30 to 50% of the thickness of the substrate on the surface of the substrate opposite to the inorganic oxide layer side It is a package.

  The invention according to claim 2 is characterized in that the sealing member is provided with a seal layer made of a heat seal lacquer or a heat seal resin on the surface side in contact with the housing. The described PTP package.

  Invention of Claim 3 is equipped with the anchor-coat layer by which the surface of the said inorganic oxide layer is modified between the said base material and the said inorganic oxide layer, or Claim 1 characterized by the above-mentioned. 2. The PTP package described in 2.

Invention of Claim 4 is a manufacturing method of the PTP package of Claim 3, Comprising:
The surface of the base material on which the inorganic oxide layer is provided is subjected to plasma treatment to provide an anchor coat layer, and then the inorganic oxide layer is provided.

  In the present invention, a barrier film in which an inorganic oxide layer, an overcoat layer, and an aluminum layer or an aluminum compound layer are provided in this order as the sealing member is used, so that a high moisture-proof and oxygen barrier for protecting tablets and the like is used. It has sex. In addition, since a large number of minute recesses are provided on the surface opposite to the inorganic oxide layer side of the base material, substantially the entire surface is provided. By pressing, the sealing member can be broken like a conventional PTP package using an aluminum foil, and tablets and the like can be easily taken out. Moreover, since an aluminum foil is not used for a sealing member, it can be processed without problems during incineration after use.

It is a schematic cross section which shows one Example of the PTP package of this invention. It is a schematic cross section of the sealing member used with the PTP package of FIG.

  Next, the present invention will be described with reference to the drawings. FIG. 1 is a schematic cross-sectional view showing an embodiment of the PTP package of the present invention, and FIG. 2 is a schematic cross-sectional view of a sealing member used in the PTP package of FIG. FIG. 2A shows a form without the anchor coat layer 9 and FIG. 2B shows a form with the anchor coat layer 9.

[Overall configuration of PTP package 10]
As shown in FIG. 1, the PTP packaging body 10 of the present invention stores, for example, a tablet 13 or the like in a storage body 11 made of a molded body formed of a transparent plastic sheet, and then opens the opening 12 with a sealing member 1. It is sealed.

(Housing 11)
The transparent plastic sheet forming the storage body 11 is made of polyvinyl chloride, polycarbonate, polyester, polypropylene or the like, and preferably has a thickness of 100 to 300 μm after molding. You may give printing and coloring of the grade which does not inhibit transparency of.

  In addition, the transparent plastic sheet forming the storage body 11 is not limited to the resin single layer described above, but may be polyvinylidene chloride, an ethylene-vinyl alcohol copolymer, etc. in order to improve moisture resistance and oxygen barrier properties. A multilayer structure including a resin layer may be employed. As another method for improving the moisture resistance and oxygen barrier property of the storage body 11, a barrier layer made of an inorganic compound may be provided on the surface of the molded body instead of using the multilayer plastic sheet as described above.

(Entire configuration of the sealing member 1)
On the other hand, as shown in FIG. 2 (a), the sealing member 1 has an inorganic oxide layer 5, an overcoat layer 6, and an aluminum layer or an aluminum compound layer 7 on one side of a substrate 4 made of a plastic film. It consists of the laminated structure of the barrier film 2 which provides heel in order, and the sealing layer 3 provided in the single side | surface. A large number of minute recesses 8 are provided substantially on the entire surface of the substrate 4 on the side opposite to the inorganic oxide layer 7 side.

(Sealing layer 3)
The seal layer 3 is made of a heat seal lacquer or a heat seal resin, and the resin of the seal layer 3 may be polyester, urethane, polyolefin, vinyl chloride-vinyl acetate, depending on the resin constituting the container 11. A resin such as a polymer system is appropriately selected and used. The thickness of the seal layer 3 may be 3 to 15 g / m ² when the seal layer 3 is formed of a heat seal lacquer, and 3 to 15 μm when the seal layer 3 is formed of a heat sealable resin.

  The seal layer 3 may be provided on either the aluminum layer or the aluminum compound layer 7 side, or on the substrate 4 side of the barrier film 2, but the aluminum layer or aluminum compound layer 7 side, that is, “seal layer 3 / aluminum layer or In order to protect the barrier film 2, it is preferable to provide the aluminum compound layer 7 / overcoat layer 6 / inorganic oxide layer 5 / substrate 4 ”in this order.

  When the sealing layer is provided on the base material 4 side of the barrier film 2, the aluminum compound layer 7 becomes the outermost surface in the barrier film 2, so that the aluminum compound layer 7 is not damaged by an external force. It is preferable to provide a protective layer (for example, a coating layer of acrylic resin, polyester resin, etc., not shown) for protecting the compound layer 7 on the aluminum compound layer 7.

(Substrate 4)
As the base material 4, a stretched film such as polyester, polypropylene, and polyamide, or a plastic film having a thickness of 9 to 30 μm such as cellophane can be used.

(Inorganic oxide layer 5)
The inorganic oxide layer 5 is preferably made of a metal oxide layer such as aluminum oxide, silicon oxide, tin oxide, magnesium oxide, or a mixture thereof, but has transparency and barrier properties such as oxygen and water vapor. Any layer may be used. In consideration of various sterilization resistances, it is particularly preferable to use aluminum oxide and / or silicon oxide.

  The optimum condition of the thickness of the inorganic oxide layer 5 varies depending on the type and configuration of the inorganic compound used, but it is generally desirable to be within the range of 5 to 300 nm. If the film thickness is less than 5 nm, a uniform film may not be obtained or the function as a gas barrier material may not be sufficiently achieved. On the other hand, when the film thickness exceeds 300 nm, flexibility cannot be maintained in the thin film, and the thin film may be cracked due to external factors such as bending and pulling after the film formation. More preferably, it exists in the range of 10-150 nm.

  There are various methods for forming the inorganic oxide layer 5 on the substrate 4, and for example, it can be formed by a vacuum deposition method. Further, as other thin film forming methods, a sputtering method, an ion plating method, a plasma vapor deposition method (CVD), or the like can be used. However, considering productivity, the vacuum deposition method is the best at present. As a heating means of the vacuum evaporation method, it is preferable to use any one of an electron beam heating method, a resistance heating method, and an induction heating method. Is more preferable. Further, in order to improve the adhesion between the inorganic oxide layer 5 and the base material 4 and the denseness of the inorganic oxide layer 5, it is possible to perform vapor deposition by using a plasma assist method or an ion beam assist method in combination. Moreover, in order to raise the transparency of a vapor deposition film, you may use the reactive vapor deposition which adds various gas, such as oxygen, in the case of vapor deposition.

(Overcoat layer 6)
The overcoat layer 6 is a composite coating layer, and the composite coating layer is a coating layer having gas barrier properties, and is an aqueous solution or water / alcohol mixed solution containing a water-soluble polymer and one or more metal alkoxides or hydrolysates thereof. It is formed using the coating agent which uses as a main ingredient. For example, a solution in which a water-soluble polymer is dissolved in an aqueous (water or water / alcohol mixed) solvent and a metal alkoxide is directly or hydrolyzed in advance is mixed, and this solution is inorganic. After the oxide layer 5 is coated, it is formed by heating and drying.

  Each component contained in the coating agent will be described in more detail. Examples of the water-soluble polymer used in the coating agent in the present invention include polyvinyl alcohol, polyvinyl pyrrolidone, starch, methyl cellulose, carboxymethyl cellulose, sodium alginate and the like. In particular, when polyvinyl alcohol (hereinafter abbreviated as PVA) is used for the coating agent of the present invention, the gas barrier property is most excellent, which is preferable. PVA here is generally obtained by saponifying polyvinyl acetate. As PVA, for example, complete PVA in which only a few percent of acetic acid groups remain can be used from so-called partially saponified PVA in which several tens of percent of acetic acid groups remain, and other materials may be used. .

The metal alkoxide is a compound represented by a general formula M (OR) _n (M: metal such as Si, Ti, Al, Zr, R: alkyl group such as CH ₃ , C ₂ H ₅ ). Specific examples include tetraethoxysilane [Si (OC ₂ H ₅ ) ₄ ] and triisopropoxyaluminum [Al (O-2′-C ₃ H ₇ ) ₃ ], among which tetraethoxysilane and triisopropoxy. Aluminum is preferred because it is relatively stable in aqueous solvents after hydrolysis.

  Add known additives such as isocyanate compounds, silane coupling agents, or dispersants, stabilizers, viscosity modifiers, and colorants to the coating agent solution as long as the gas barrier properties are not impaired. Is also possible.

  As a coating method of the coating agent, a conventionally known method such as a dipping method, a roll coating method, a screen printing method, a spray method, or a gravure printing method can be used.

  The thickness of the overcoat layer varies depending on the type of coating agent, the processing machine and the processing conditions, and is not particularly limited. However, when the thickness after drying is 0.01 μm or less, the uniformity of the coating film may not be obtained and sufficient gas barrier properties may not be obtained. On the other hand, if the thickness exceeds 50 μm, cracks are likely to occur in the film, which may be a problem. It is preferable that it exists in the range of 0.01-50 micrometers, More preferably, it exists in the range of 0.1-10 micrometers.

(Aluminum layer or aluminum compound layer 7)
The aluminum layer or the aluminum compound layer 7 has a function of improving the barrier property of the barrier film 2 and may be a single aluminum layer, but a compound such as aluminum oxide is also effective, and for the sake of simplification, it is collectively referred to hereinafter. This is referred to as an aluminum compound layer.

  In general, the thickness of the aluminum compound layer 7 is preferably in the range of 1 to 1000 nm. If the film thickness is less than 1 nm, a uniform film may not be obtained or the function as a barrier film may not be sufficiently achieved. On the other hand, when the film thickness exceeds 1000 nm, the thin film cannot be kept flexible, and the thin film may be cracked due to external factors such as bending and pulling after the film formation. More preferably, it exists in the range of 400-1000 nm.

  There are various methods for forming the aluminum compound layer 7 on the overcoat layer 6. For example, the aluminum compound layer 7 can be formed by a vacuum deposition method. Further, as other thin film forming methods, a sputtering method, an ion plating method, a plasma vapor deposition method (CVD), or the like can be used. However, considering productivity, the vacuum deposition method is the best at present. As a heating means of the vacuum evaporation method, it is preferable to use any one of an electron beam heating method, a resistance heating method, and an induction heating method. Is more preferable. Further, in order to improve the adhesion between the aluminum compound layer 7 and the overcoat layer 6 and the denseness of the aluminum compound layer 7, it is also possible to perform deposition by using a plasma assist method or an ion beam assist method in combination.

(Micro recess 8)
The minute recesses 8 are formed, for example, by pressing a plastic film (base material 4) against a roll embedded with diamond powder or gold sand, and the average depth of the minute recesses 8 is the thickness of the base material 4. It is preferable that the depth is 30 to 50%. If the average depth of the minute recesses 8 is shallower than 30% of the base material 4, the tearability is low. On the other hand, if the average depth of the minute recesses 8 is deeper than 50% of the base material 4, through holes are generated. There is a fear.

(Anchor coat layer 9)
In order to reinforce the adhesion between the base material 4 and the inorganic oxide layer 5, it is preferable to form an anchor coat layer 9 between the base material 4 and the inorganic oxide layer 5 as shown in FIG. The anchor coat layer 9 is a layer in which the substantial surface of the substrate 4 is modified. As a result of the modification, for example, when X-ray photoelectron spectroscopy measurement of the surface of the substrate 4 is performed, The change of the half value width of a CC bond peak is mentioned.

  As a method for modifying the surface of the substrate 4, plasma treatment such as reactive ion etching (RIE) using plasma is preferable. By performing plasma treatment, a chemical effect such as giving a functional group to the surface of the base material 4 using the generated radicals or ions, and a physical effect that the surface is ion-etched to remove impurities and smooth the surface. Both effects can be obtained at the same time. By performing such a surface treatment, the adhesion between the base material 4 and the inorganic oxide layer 5 can be enhanced when the inorganic oxide layer 5 is formed later. In addition, a dense film of the inorganic oxide layer 5 can be formed. Moreover, since it leads to prevention of cracks during heat sterilization, it is effective for further improving the gas barrier property.

Plasma processing conditions indicated by processing speed, energy level, and the like can be set as appropriate according to the type of substrate, application, discharge device characteristics, and the like. However, the plasma self-bias value is set to 200V or 2000V or less, Ed = a (plasma density) × (processing time) Ed value defined 100W · ^m -2 · sec or more 10000W · ^m -2 · sec or less at It is preferable. Even at values slightly lower than the above values, a certain degree of adhesion is exhibited, but the superiority is lower than that of untreated products. On the other hand, if the value is higher than the above value, a strong treatment is excessively applied, the surface of the base material is deteriorated, and the adhesiveness is lowered. As the gas for plasma, there is an inert gas such as Ar, or a reactive gas such as oxygen or halogen gas, and a mixed gas thereof may be used. Their flow rate and mixing ratio should be set as appropriate according to the application, base material, and device characteristics depending on the pump performance and mounting position.

  The plasma treatment and the film formation of the inorganic oxide vapor deposition 5 can be performed by switching the operation mode with the same film forming machine (in-line film forming machine).

  The PTP package 10 of the present invention is opened by filling the storage body 11 with, for example, tablets 13 and the like, and then stacking the sealing member 1 so that the seal layer 3 is in contact with the storage body 11 and heat-sealing. It is obtained by sealing the portion 12.

  When taking out the tablet 13 etc. from the PTP package 10 of the said invention, like the conventional PTP package, press the tablet 13 etc. from the storage body 11 side, and tear off the sealing member 1 with the tablet 13 etc. From which the tablets 13 and the like can be taken out.

Next, examples of the present invention will be described.

<Example 1>
What was obtained as follows was used for the sealing member. A high-frequency power source with a frequency of 13.56 MHz is used on a non-treated surface of a polyethylene terephthalate (PET) film having a thickness of 12 μm as a substrate, an applied power of 120 W, a treatment time of 0.1 sec, a treatment gas Ar, and a treatment unit pressure of 2.0 Pa. Plasma treatment using a reactive ion etching (RIE) apparatus was performed under the following conditions. At this time, the self-bias was 450 V, and the Ed value was 200 W · m ⁻² · sec. On top of this, aluminum oxide having a thickness of 15 nm was deposited by reactive deposition using an electron beam heating method to form an inorganic oxide layer.

Next, a solution obtained by mixing the following I solution and II solution at a mixing ratio (wt%) of 60/40 is applied and dried on the inorganic oxide layer by a gravure coating method, and an overcoat layer having a thickness of 0.3 μm Formed.
<Liquid I>
Was stirred for 30 minutes addition of hydrochloric acid (0.1 N) 89.6 g of tetraethoxysilane 10.4 g, it is hydrolyzed, solids in terms of SiO ₂ to prepare a 3 wt% of hydrolyzed solution.
<Liquid II>
97% by weight of a water-isopropyl alcohol solution in which water and isopropyl alcohol were mixed at a weight ratio of 90:10 and 3% by weight of polyvinyl alcohol were mixed.

Next, aluminum was vapor-deposited to form an aluminum compound layer to obtain a barrier film. Next, a roll embedded with diamond powder was pressed against the surface of the base material opposite to the inorganic oxide layer of the barrier film to provide a large number of minute recesses. The density of the minute recesses was 40,000 pieces / m ² , the depth was 4 to 5 μm, and the average was 4.5 μm (depth of 38% of the thickness of the base material).

On the aluminum compound layer side of the barrier film, a heat seal lacquer mainly composed of an ethylene-vinyl acetate copolymer is applied at an application amount of 5 g / m ² to form a seal layer, and FIG. The sealing member of Example 1 having the form shown was obtained.

  Next, a 250 μm-thick polypropylene sheet was vacuum-formed to form a storage body composed of a molded body having a substantially cylindrical storage portion. The storage portion of the storage body was filled with a substantially columnar tablet and sealed with the sealing member to obtain a PTP package of Example 1.

<Example 2>
The sealing member of Example 2 is the same as Example 1 except that a large number of minute concave portions are provided, the depth is 5 to 6 μm, and the average is 5.5 μm (the depth is 46% of the thickness of the base material). Got. Further, a PTP package of Example 2 was obtained in the same manner as Example 1.

<Comparative Example 1>
A sealing member and a PTP package of Comparative Example 1 were obtained in the same manner as in Example 1 except that the aluminum compound layer was omitted.

<Comparative example 2>
A comparative example 2 was prepared in the same manner as in Example 1 except that a large number of minute recesses were provided, the depth was 1.5 to 2.5 μm, and the average was 2 μm (17% of the thickness of the base material). A sealing member was obtained. Further, in the same manner as in Example 1, a PTP package of Comparative Example 2 was obtained.

<Comparative Example 3>
The sealing member of Comparative Example 3 is provided in the same manner as in Example 1 except that a large number of minute recesses are provided, the depth is 7 to 8 μm, and the average is 7.5 μm (63% of the thickness of the base material). Got. Further, in the same manner as in Example 1, a PTP package of Comparative Example 3 was obtained.

Table 1 shows the layer structure of the sealing members of Examples 1 and 2 and Comparative Examples 1, 2, and 3 described above.

[Evaluation method]
<Sealability evaluation>
(Measurement of puncture strength)
The puncture strength was measured according to the Food Sanitation Law. The sealing members of Examples 1 and 2 and Comparative Examples 1, 2, and 3 were fixed, and a semicircular needle having a diameter of 1.0 mm and a tip shape radius of 0.5 mm was applied to the sealing member surface at a speed of 50 ± 5.0 mm per minute The maximum load until the needle penetrates the sealing member was measured.

(Sensory test)
For the sensory test of the breakability, the tablets were pressed from the container side using the PTP packaging bodies of Examples 1, 2 and Comparative Examples 1, 2 and 3 in which the containers were filled with tablets and sealed with a sealing member. Then, it was confirmed whether the sealing member could be broken with the tablet and the tablet could be taken out. ○ if you can take it out. If it could not be removed, it was marked as x.

<Dampproof evaluation>
The water vapor transmission rate was measured by MOCON method according to JIS K 7129. That is, the water vapor permeability of the sealing members of Examples 1 and 2 and Comparative Examples 1, 2, and 3 was measured at 40 ° C. and 90% RH. Since the water vapor permeability of the polypropylene sheet as the container was 1 g / m ² / day or less, 1 g / m ² / day or less was judged to have moisture resistance.

Table 2 shows the evaluation results of the sealing members and PTP packaging bodies of Examples 1 and 2 and Comparative Examples 1, 2 and 3, and the PTP package.

  From Table 2, in the case of Examples 1 and 2, which meet the conditions of the present invention, both the sealability and moisture resistance were good. On the other hand, since Comparative Example 1 does not have an aluminum compound layer, Comparative Example 3 was insufficient in moisture resistance because the depth of the minute recesses was too deep. Moreover, since the depth of the micro recessed part was too shallow, the comparative example 2 was unsealable.

DESCRIPTION OF SYMBOLS 10 ... PTP package 1 ... Sealing member 2 ... Barrier film 3 ... Seal layer 4 ... Base material 5 ... Inorganic oxide layer 6 ... Over Coat layer 7... Aluminum layer or aluminum compound layer 8... Micro-recess 9... Anchor coat layer 11.

Claims (4)

A PTP package comprising a storage body for storing tablets and the like, and a sealing member for sealing an opening of the storage body,
The sealing member comprises an inorganic oxide layer, an overcoat layer, and either an aluminum layer or an aluminum compound layer in this order on a base material,
The substrate is made of a plastic film,
A PTP having a number of minute recesses having an average depth of 30 to 50% of the thickness of the substrate on the surface of the substrate opposite to the inorganic oxide layer side Packaging body.   2. The PTP package according to claim 1, wherein the sealing member is provided with a seal layer made of a heat seal lacquer or a heat seal resin on a surface side in contact with the storage body.   The PTP package according to claim 1 or 2, further comprising an anchor coat layer in which a surface of the inorganic oxide layer is modified between the base material and the inorganic oxide layer. It is a manufacturing method of the PTP package of Claim 3,
A method for producing a PTP package, wherein the inorganic oxide layer is provided after plasma treatment is performed on a surface of the substrate on which the inorganic oxide layer is provided to provide an anchor coat layer.

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