WO2012029899A1 - 包装体 - Google Patents

包装体 Download PDF

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Publication number
WO2012029899A1
WO2012029899A1 PCT/JP2011/069881 JP2011069881W WO2012029899A1 WO 2012029899 A1 WO2012029899 A1 WO 2012029899A1 JP 2011069881 W JP2011069881 W JP 2011069881W WO 2012029899 A1 WO2012029899 A1 WO 2012029899A1
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WO
WIPO (PCT)
Prior art keywords
package
layer
solid preparation
container
aluminum foil
Prior art date
Application number
PCT/JP2011/069881
Other languages
English (en)
French (fr)
Japanese (ja)
Inventor
友宏 吉田
芙美 和泉
小川　達也
小泉　真一
山本　光
Original Assignee
アステラス製薬株式会社
共同印刷株式会社
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by アステラス製薬株式会社, 共同印刷株式会社 filed Critical アステラス製薬株式会社
Priority to EP11821914.6A priority Critical patent/EP2612827A4/de
Priority to US13/819,133 priority patent/US20130153459A1/en
Priority to JP2012531957A priority patent/JP5936542B2/ja
Publication of WO2012029899A1 publication Critical patent/WO2012029899A1/ja

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Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/325—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
    • B65D75/326—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming one compartment
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
    • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
    • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
    • B65D81/266—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants
    • B65D81/267—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants the absorber being in sheet form
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035—Blister-type containers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2585/00—Containers, packaging elements or packages specially adapted for particular articles or materials
    • B65D2585/56—Containers, packaging elements or packages specially adapted for particular articles or materials for medicinal tablets or pills

Definitions

  • the present invention relates to a package, and more particularly to a package having high hygroscopicity and gas adsorbability and high moldability.
  • a press-through pack (PTP) package has been widely used for packaging pharmaceutical products.
  • the PTP package is a package in a form that is sealed with a lid material that is easy to tear after the packaged material is accommodated in the container, and the lid material is torn by pressing from the container side toward the lid material side. Is taken out. Since such a PTP package is excellent in airtightness, handleability, portability, and productivity and can save resources, it is expected that the future demand will be further increased as a package for pharmaceutical products.
  • the material on the container side of the PTP package it is common to use a single layer of a polypropylene sheet or a polyvinyl chloride sheet, or a laminate composed of a plurality of materials in which a film or the like is laminated on an aluminum foil. Moreover, as the material on the lid member side, an aluminum foil coated with a resin is often used.
  • Patent Document 1 proposes a PTP package having a configuration in which a container using a highly moisture-proof aluminum foil and a lid material are bonded together.
  • the aluminum foil constituting the container is provided with a polyamide-based resin layer that is stretched on one side, and a thermal adhesive layer is provided on the other side.
  • it can be set as the moisture-proof PTP package by heat-sealing the aluminum foil of the structure similar to the aluminum foil which comprises the cover material containing an aluminum foil, or a container, and a container.
  • Patent Document 2 a technique is proposed in which a moisture absorbing layer is provided in a container of a PTP package and a drying function is imparted to the PTP package. Since the PTP package provided with a drying function can cause the drying function to act on the package, it can be stored well even if the package is hydrolyzable or highly hygroscopic. can do.
  • Patent Document 1 aluminum having high moisture resistance is used as a material constituting the container, and the lid member is also made of aluminum. And by heat-sealing the container and the lid material, it is possible to provide a PTP packaging body having moisture resistance.
  • the portion in which the package body is enclosed There was a problem that the water remaining inside the storage part) could not be removed, and the quality of the solid preparation was impaired. Therefore, a PTP package having a capability of absorbing moisture as well as moisture is desired. Further, depending on the package, there is a property that the decomposition is further promoted by the gas generated at the time of decomposition. Therefore, a PTP package capable of adsorbing not only moisture but also gas has been desired.
  • a PTP packaging in which a drying function is provided to the packaged body and the inside (container) in which the packaged body is sealed is provided. It can be a body.
  • the PTP package (blister package) disclosed in Patent Document 2 creates a film by bonding a moisture-absorbing layer to a moisture-proof barrier layer, and forms a PTP package by using this film. At this time, the film provided with the barrier layer and the moisture absorbing layer is formed with an accommodation portion for accommodating an object to be packaged in a heat-softened state.
  • An object of the present invention is to provide a package having a hygroscopic property and a gas adsorbing property and having good moldability.
  • another object of the present invention is to provide a package body having a hygroscopic property and a gas adsorbing property and having an appropriate rigidity.
  • the object is to provide a package containing a solid preparation containing solifenacin succinate or 1- ⁇ [( ⁇ -isobutanoyloxyethoxy) carbonyl] aminomethyl ⁇ -1-cyclohexaneacetic acid according to the package according to the present invention.
  • the package body is provided with a container sheet in which a concave container for containing the solid preparation is formed, and a lid sheet with airtightness for sealing the solid preparation,
  • the container sheet is composed of a packaging film in which an adsorption layer, at least one base layer composed of a resin, an aluminum foil, and a barrier layer are laminated, and the adsorption layer includes the base layer and the base layer. This is solved by being laminated and disposed on the side where the solid preparation is accommodated, and containing at least zeolite.
  • the container sheet constituting the package of the present invention includes the adsorption layer containing zeolite on the side where the solid preparation is accommodated, water in the accommodating portion and other molecules (gas molecules) Can be adsorbed. Furthermore, since the container sheet is provided with a highly moisture-proof aluminum foil, the moisture resistance of the package is dramatically improved by being combined with the adsorption layer. Moreover, since the packaging body film which comprises the container sheet
  • the solid preparation contained in the package is sufficiently protected, and when the PTP package is used, the solid preparation can be taken out with an appropriate external force.
  • 1- ⁇ [( ⁇ -isobutanoyloxyethoxy) carbonyl] aminomethyl ⁇ -1-cyclohexaneacetic acid is a hydrolyzable substance, and generates acetaldehyde that causes odor by the hydrolysis reaction.
  • the solid preparation containing the compound is easily colored by moisture absorption. Accordingly, the package is required to have high moisture absorption and gas adsorption.
  • the package of the present invention can prevent generation of unpleasant odors and coloring of solid preparations by adsorbing water, acetaldehyde and the like by the adsorption layer. As a result, the preservation state of the solid preparation containing the compound can be favorably maintained.
  • the base material layer is preferably made of a polyamide resin or a polyvinyl chloride resin.
  • a polyamide resin or a polyvinyl chloride resin By using the above material as the base material layer, an appropriate rigidity can be imparted to the packaging film. As a result, when the container sheet constituting the package is formed, it can be easily formed by press working.
  • the ratio of the height of the housing portion to the diameter of the housing portion is formed with 0.335 as an upper limit.
  • the pinhole occurrence rate increases as the film is stretched. Therefore, when designing a storage part to be molded by press processing according to the shape or size of a pharmaceutical preparation such as a tablet or capsule to be stored, an appropriate frontage of the storage part is used to ensure the required height.
  • the ratio of the height of the accommodating portion to the diameter of the accommodating portion (the height of the accommodating portion / the diameter of the accommodating portion) is regulated to be equal to or less than a target value unique to each film.
  • the ratio of the height of the storage portion and the diameter of the storage portion equal to or less than the above numerical value, the occurrence of pinholes can be prevented when the container sheet of the package is formed.
  • the larger the ratio of the height of the housing portion to the diameter of the housing portion the larger the boundary portion between the top surface of the housing portion and the side surface of the housing portion (shoulder R Part) vicinity, a pinhole arises in the aluminum foil in a packaging body film.
  • the container sheet is formed by press working that does not heat the packaging film
  • the ratio of the height of the container to the diameter of the container is larger than the above value
  • the probability of occurrence of pinholes in the container increases.
  • the value is less than or equal to the above value, the probability of occurrence of pinholes can be made substantially zero. Therefore, when the packaging body film is pressed, a pinhole is unlikely to be generated in the housing portion, so that the packaging body having excellent moisture resistance can be obtained.
  • the lid sheet is provided with an aluminum foil.
  • the moisture resistance between the solid formulation container formed on the container sheet and the lid sheet can be improved.
  • water and gas molecules in the storage portion are adsorbed by the adsorption layer provided in the storage portion formed in the container sheet, so that moisture resistance is improved.
  • the lid sheet is made of aluminum foil, it is preferable that the PTP package is easily broken by an external force applied from the container sheet side, and as a result, the solid preparation in the container can be easily taken out.
  • the effective pore diameter of the zeolite is preferably 3 mm or more. Since zeolite has a high adsorption rate, it can adsorb moisture quickly.
  • Molecular sieve which is an example of zeolite, is a porous granular material used to separate materials according to the difference in molecular size, and has a structure with uniform pores. It acts as a kind of sieve by adsorbing molecules. In the present invention, when a molecular sieve is used, the adsorption port diameter is preferably 0.3 nm to 1 nm.
  • molecular sieves having pore sizes 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.
  • molecular sieve 3A or molecular sieve 4A is used as a suitable desiccant.
  • the average particle diameter of the molecular sieve is, for example, about 10 ⁇ m.
  • the substance adsorbed by the zeolite depends on the effective pore size of the zeolite.
  • the effective pore size of the zeolite is less than 4 mm, water can be adsorbed but relatively large molecules such as carbon dioxide and acetaldehyde cannot be adsorbed sufficiently.
  • the effective pore diameter of the zeolite is 4 mm or more, relatively large molecules such as water, carbon dioxide, acetaldehyde, hydrogen sulfide, ethane, and ethanol can be adsorbed. Therefore, when only water affects the storage state of the solid preparation, the solid preparation can be stored in a good state when the effective pore diameter of the zeolite is 3 mm or more.
  • the effective pore size of the zeolite is 4 mm or more, substances that emit odors such as hydrogen sulfide and substances that may affect the storage state of solid preparations such as ethanol are also adsorbed by the adsorption layer, which is good.
  • the solid preparation can be stored in a safe storage state.
  • the adsorption layer is provided in the packaging body film constituting the container sheet, and the base layer and the aluminum foil are further provided thereon. Therefore, the package is not only highly moisture-proof due to the aluminum foil, but also the moisture absorption is improved by adsorbing water and gas molecules in the container of the solid preparation by the adsorption layer, and appropriate rigidity is imparted by the base material layer. Is done. As a result of imparting appropriate rigidity, the package of the present invention can be easily processed by pressing without heating, and the moldability is dramatically improved. And the yield improves with the improvement of a moldability. Furthermore, as a result of imparting appropriate rigidity, the package of the present invention can improve the storage state of the solid preparation.
  • the ratio of the height of the storage portion to the diameter of the storage portion that stores the solid preparation is a predetermined height or less, it is possible to prevent the occurrence of pinholes particularly in the vicinity of the storage portion. Furthermore, moisture resistance is further improved by providing the lid sheet with an aluminum foil. Furthermore, by setting the effective pore diameter of the zeolite contained in the adsorption layer to a predetermined value or more, not only water but also other gas molecules can be adsorbed. And the solid preparation can be stored in a good storage state.
  • P packaging body F1, F2 packaging body film 1 adsorption layer 2 base material layer 2a main base material layer 2b sub base material layer 3 aluminum foil 4 barrier layer 5 container 6 container sheet 7 lid material sheet 8 solid preparation
  • FIG. 1 is a schematic cross-sectional view of a packaging body film
  • FIG. 2 is a schematic cross-sectional view of the packaging body
  • FIGS. 3 to 6 are Embodiment 1 of the present invention.
  • FIG. 7 is a graph of color difference measurement results in Comparative Examples 1 and 2
  • FIG. 7 is a graph of elution degree in Example 1 of the present invention
  • Comparative Examples 1 and 2 and
  • FIG. 8 is related to another embodiment of the present invention. It is a schematic sectional drawing of a package body film.
  • the packaging body film F1 As shown in FIG. 1, the packaging body film F1 according to one embodiment of the present invention is constituted by laminating an adsorption layer 1, at least one base material layer 2, an aluminum foil 3 and a barrier layer 4 in this order. Has been. A packaged body is disposed on the lower side of FIG.
  • the adsorbing layer 1 is preferably made of a resin and zeolite formed into a film or sheet by an inflation method, a T-die method, co-extrusion or the like.
  • the thickness of the adsorption layer 1 is preferably 30 to 100 ⁇ m in order to adsorb a sufficient amount of moisture and gas.
  • Examples of the resin material constituting the adsorption layer 1 include LDPE (low density polyethylene), LLDPE (linear low density polyethylene), PP (polypropylene), chlorinated polypropylene, saturated polyester, EAA (ethylene-acrylic acid copolymer). ), EMAA (ethylene-methacrylic acid copolymer), EEA (ethylene-ethyl acrylate copolymer), EMA (ethylene-methyl acrylate copolymer), ionomer, carboxylic acid modified polyethylene, carboxylic acid modified polypropylene, carboxylic acid modified At least one selected from EVA, PVC (polyvinyl chloride), polystyrene and the like, or a combination thereof can be used.
  • EVA low density polyethylene
  • LLDPE linear low density polyethylene
  • PP polypropylene
  • chlorinated polypropylene saturated polyester
  • EAA ethylene-acrylic acid copolymer
  • EMAA ethylene-methacrylic acid copolymer
  • the material for the skin layer is not particularly limited as long as it (1) prevents the zeolite-containing layer from being exposed on the surface and directly contacts the preparation, or (2) improves the laminating property.
  • Examples of the material for the skin layer include LDPE (low density polyethylene), LLDPE (linear low density polyethylene), PP (polypropylene), chlorinated polypropylene, saturated polyester, EAA (ethylene-acrylic acid copolymer), and EMAA.
  • Ethylene-methacrylic acid copolymer EEA (ethylene-ethyl acrylate copolymer), EMA (ethylene-methyl acrylate copolymer), ionomer, carboxylic acid-modified polyethylene, carboxylic acid-modified polypropylene, carboxylic acid-modified EVA, PVC (Polyvinyl chloride), at least one selected from polystyrene and the like, or a combination thereof can be used.
  • the zeolite constituting the adsorption layer 1 contains a molecular sieve, and the molecular sieve preferably has an effective pore diameter of about 3 to 10 mm.
  • the molecular sieve selects the effective pore diameter according to the size of the object to be adsorbed. In particular, when the effective pore size is 4 mm or more, not only water but also gas molecules such as carbon dioxide, acetaldehyde, hydrogen sulfide, ethane, and ethanol can be adsorbed.
  • a substance that causes odors such as acetaldehyde and hydrogen sulfide is also preferred because it is adsorbed by the adsorption layer 1.
  • artificial zeolite is obtained by forming a substance similar in nature to natural zeolite from various substances by an industrial method. Therefore, the adsorptivity and ion exchange properties are improved. Therefore, the zeolite material constituting the adsorption layer 1 may be appropriately selected according to the substance to be adsorbed.
  • the base material layer 2 is a layer made of a resin bonded to the adsorption layer 1 and mainly imparts appropriate rigidity and moldability to the packaging body film F1.
  • a material of the base material layer 2 at least one selected from polyvinyl chloride, polypropylene, polyvinylidene chloride, polyamide such as nylon (registered trademark), and the like, or a combination thereof can be used.
  • polyamides such as nylon (registered trademark) and PVC (polyvinyl chloride) are preferable, and PVC (polyvinyl chloride) having an appropriate elongation property is particularly preferable.
  • the thickness of the base material layer 2 is preferably 15 to 25 ⁇ m in order to ensure the rigidity of the packaging body film F1 and to maintain good moldability.
  • the aluminum foil 3 may be a pure aluminum foil or an aluminum alloy foil. Further, a pure aluminum foil coated with a resin such as PP (polypropylene) may be used. In addition, the thickness of the aluminum foil 3 is preferably 30 to 60 ⁇ m in order to maintain good moldability, maintain moisture resistance and light-shielding properties of the container, and provide appropriate rigidity and moldability.
  • the barrier layer 4 is formed from a film-like material that can be sealed.
  • the material constituting the barrier layer 4 include HDPE (high density polyethylene), MDPE (medium density polyethylene), LDPE (low density polyethylene), polyvinylidene chloride, polychlorotrifluoroethylene, PP (polypropylene), polyethylene terephthalate, And at least one selected from polyamide such as nylon (registered trademark), etc., or a combination thereof. Among these, it is preferable to select polyamide such as nylon (registered trademark) because the moldability is improved.
  • the barrier layer 4 is preferably 5 to 30 ⁇ m in order to maintain sufficient hermeticity and appropriate moldability.
  • an adhesive layer may be provided between the adsorption layer 1, the base material layer 2, the aluminum foil 3, and the barrier layer 4, respectively.
  • the adhesive layer include urethane-based adhesive, HDPE (high density polyethylene), MDPE (medium density polyethylene), LDPE (low density polyethylene), polypropylene, chlorinated polypropylene, saturated polyester, EAA (ethylene- Acrylic acid copolymer), EMAA (ethylene-methacrylic acid copolymer), EEA (ethylene-ethyl acrylate copolymer), EMAC (ethylene-methyl acrylate copolymer), ionomer, carboxylic acid-modified polyethylene, carboxylic acid-modified At least one selected from polypropylene, carboxylic acid-modified EVA, PVC (polyvinyl chloride), polystyrene and the like, or a combination thereof can be used.
  • the thickness of the adhesive layer (not shown) is preferably about 10 ⁇ m.
  • each layer of the said adsorption layer 1, the base material layer 2, the aluminum foil 3, and the barrier layer 4 can be bonded together by a well-known method, and methods, such as extrusion lamination, dry lamination, wet lamination, thermal lamination, sand lamination, etc. Can be pasted together.
  • the packaging body film F1 composed of the adsorption layer 1, the base material layer 2, the aluminum foil 3, and the barrier layer 4 only needs to have appropriate rigidity to form the packaging body P described later. Accordingly, the total thickness of each layer, that is, the thickness of the packaging body film F1 is preferably about 120 to 200 ⁇ m.
  • the packaging body P As shown in FIG. 2, the packaging body P according to an embodiment of the present invention is formed by a container sheet 6 formed by the packaging film F1 and a lid sheet 7 having airtightness.
  • the solid preparation 8 is packaged inside the container 5. 2 exaggerates the thickness of the container sheet 6 for the sake of explanation.
  • the container sheet 6 is formed of a package film F1 in which an adsorption layer 1, at least one base layer 2, an aluminum foil 3, and a barrier layer 4 are laminated. And the container sheet
  • seat 6 is formed with the one or more concave accommodating parts 5 which accommodate the solid formulation 8 using the packaging body film F1.
  • the container sheet 6 has a configuration in which the adsorption layer 1 is disposed on the surface on the side where the solid preparation 8 is accommodated, as shown in FIG.
  • the adsorption layer 1 is disposed on the surface on the side where the solid preparation 8 is accommodated, as shown in FIG.
  • the container sheet 6 having the above-described configuration has one or more accommodating portions 5 formed on the packaging film F1 by a technique such as press molding.
  • the shape of the accommodating part 5 is suitably designed depending on the shape of the solid preparation 8 accommodated inside.
  • the method of press molding is not particularly limited, a known method such as stretch forming or deep drawing is used.
  • the lid material sheet 7 is in close contact with the surface of the container sheet 6 on which the adsorption layer 1 is provided, and seals the inside of the storage unit 5 in which the solid preparation 8 is stored. If the adhesion between the container sheet 6 and the lid sheet 7 is low, a heat-sealable resin layer (not shown) may be provided on the surface of the adsorption layer 1 facing the lid sheet 7. good. As a material for the heat-sealable resin layer, a material equivalent to the adhesive layer (not shown) can be used.
  • the lid material sheet 7 is formed from a film-like material that can be sealed and has a property of preventing the inflow and outflow of gas such as water vapor.
  • the material constituting the lid sheet 7 include aluminum, high density polyethylene, medium density polyethylene, low density polyethylene, polyvinylidene chloride, polychlorotrifluoroethylene, and polyamide such as polypropylene and nylon (registered trademark). At least one selected, or a combination thereof can be used. Among these, aluminum is preferable because moisture resistance and light shielding properties of the container are improved. When aluminum is used, it is preferable that an adhesive be applied to the surface facing the container sheet 6.
  • ethylene-vinyl acetate copolymer polyvinylidene chloride, vinyl chloride-vinyl acetate copolymer, chlorinated polypropylene, and the like can be used.
  • Aluminum may be either pure aluminum or an aluminum alloy.
  • Adsorption layer 1 LLDPE (both LLDPE (made by Tosoh Corporation, trade name: Petrocene 202, thickness: 50 ⁇ m)) containing LDPE (made by Union Showa Co., Ltd., trade name: molecular sieve 4A, effective pore size: 4 mm) Made of Prime Polymer Co., Ltd., trade name: Evolue (registered trademark) SP2520) skin layer 2 type 3 layer base material layer 2: PA (polyamide resin) (made by Kojin Co., Ltd., trade name: Bonil W) , Thickness: 15 ⁇ m)
  • Aluminum foil 3 Alloy aluminum foil (manufactured by Toyo Aluminum Co., Ltd., trade name: super foil, thickness: 40 ⁇ m)
  • Barrier layer 4 PA (polyamide resin) (manufactured by Kojin Co., Ltd., trade name: Bonile W, thickness: 15 ⁇ m)
  • Adsorption layer 1 LLDPE (on both sides of the LDPE (product name: Petrocene 202, thickness: 50 ⁇ m) layer containing zeolite (manufactured by Union Showa Co., Ltd., trade name: Molecular sieve 4A, effective pore size: 4 mm)) Made of Prime Polymer Co., Ltd., trade name: Evolue (registered trademark) SP2520) skin layer laminated, 2 types and 3 layers
  • Base material layer 2 PVC (polyvinyl chloride) (thickness: 60 ⁇ m)
  • Aluminum foil 3 Alloy aluminum foil (manufactured by Sumi Light Aluminum Foil Co., Ltd., trade name: BESP AII, thickness: 40 ⁇ m)
  • Barrier layer 4 PA (polyamide resin) (manufactured by Toyobo Co., Ltd., trade name: Harden N2102, thickness: 15 ⁇ m)
  • Table 2 shows a case in which a plurality of accommodating portions 5 are formed at different heights, and the light transmittance in each accommodating portion 5 is visually confirmed.
  • the pockets where light transmission was confirmed were counted as having pinholes, and the pinhole generation rate relative to the whole was shown.
  • the pocket diameter of the mold used for molding is 15 mm.
  • Measured pinhole occurrence rate of each accommodating part 5 was found to be 0% when the height of the accommodating part 5 was 5.032 mm or less. Therefore, from the above test results, when the diameter of the accommodating part 5 is 15 mm, it is preferable that the height of the accommodating part 5 is 5.032 mm or less because no pinhole is observed.
  • the “height” of the container 5 is the distance from the flat surface of the barrier layer 4 of the container sheet 6 (that is, the surface where the container 5 is not formed) to the uppermost surface (top surface) of the pocket ( It refers to H) in FIG. Further, the “diameter (pocket diameter) of the accommodating portion 5” refers to the inner diameter of the opening of the accommodating portion 5 (that is, L in FIG. 2).
  • the opening part of the accommodating part 5 does not necessarily need to be a perfect circle.
  • the “diameter of the housing part 5 (pocket diameter)” refers to the inner diameter in the longitudinal direction.
  • the packaging body film F1 including one or more kinds of the base material layers 2 is suitable without generating cracks and pinholes when the packaging body P is formed.
  • the diameter of the accommodating part 5 was 15 mm
  • the package P that does not include the base material layer 2 was molded, cracks occurred in the vicinity of the top surface of the housing 5.
  • the ratio of the height of the housing part 5 to the diameter of the housing part 5 is formed with an upper limit of 0.335 based on the test result.
  • the height of the accommodating part 5 will not be specifically limited if it selects suitably by the shape or magnitude
  • Adsorption layer 1 zeolite (made by Union Showa Co., Ltd., trade name: molecular sieve 4A, effective pore size: 4 mm) containing LDPE (made by Tosoh Corporation, trade name: Petrocene 202, thickness: 130 ⁇ m) on both sides of LLDPE ( Made of Prime Polymer Co., Ltd., trade name: Evolue (registered trademark) SP2520) skin layer 2 type 3 layer base material layer 2: PA (polyamide resin) (made by Kojin Co., Ltd., trade name: Bonil W) , Thickness: 15 ⁇ m)
  • Aluminum foil 3 Alloy aluminum foil (manufactured by Toyo Aluminum Co., Ltd., trade name: super foil, thickness: 40 ⁇ m)
  • Barrier layer 4 PA (polyamide resin) (manufactured by Kojin Co., Ltd., trade name: Bonile W, thickness: 15 ⁇ m)
  • the package P of the present invention contains 1- ⁇ [( ⁇ -isobutanoyloxyethoxy) carbonyl], a drug containing a component that is hydrolyzed by moisture in the storage environment or moisture contained in the solid preparation 8. Particularly useful for drugs containing aminomethyl ⁇ -1-cyclohexaneacetic acid.
  • the package P is applied to the solid preparation 8 containing 1- ⁇ [( ⁇ -isobutanoyloxyethoxy) carbonyl] aminomethyl ⁇ -1-cyclohexaneacetic acid will be described.
  • the solid preparation 8 is a sustained-release oral drug comprising tablets, and has 1- ⁇ [( ⁇ -isobutanoyloxyethoxy) carbonyl] aminomethyl ⁇ -1 represented by the chemical formula (1) as an active ingredient.
  • 1- ⁇ [( ⁇ -isobutanoyloxyethoxy) carbonyl] aminomethyl ⁇ -1-cyclohexaneacetic acid is a prodrug of gabapentin (chemical formula (2)) which is a ⁇ -aminobutyric acid (GABA) derivative.
  • Symptoms for which gabapentin is prescribed and for which drugs containing gabapentin are effective include epilepsy, depression, anxiety, psychosis, cognition, schizophrenia, fainting, motor function decline, cranial disorders, neurodegenerative disorders, panic, Pain ⁇ especially neuropathic pain (eg postherpetic neuralgia), muscle pain, and skeletal pain ⁇ , restless leg syndrome, hot flashes, urinary incontinence, inflammatory disorders (ie arthropathy), insomnia, gastrointestinal disorders, alcohol / Cocaine poisoning, ethanol withdrawal syndrome, vulvar lesions, premature ejaculation, glutamatergic activity, etc.
  • epilepsy depression, anxiety, psychosis, cognition, schizophrenia, fainting, motor function decline, cranial disorders, neurodegenerative disorders, panic, Pain ⁇ especially neuropathic pain (eg postherpetic neuralgia), muscle pain, and skeletal pain ⁇ , restless leg syndrome, hot flashes, urinary incontinence, inflammatory disorders (ie arthropathy
  • the drug can be administered to patients as a preventive measure against the above diseases or disorders. Therefore, the drug is used for epilepsy, depression, anxiety, psychosis, fainting, decreased motor function, cranial disorder, neurodegenerative disorder, panic, pain (especially neuropathic pain and muscle pain, and skeletal pain), It can be administered as a preventive measure to patients with a tendency for inflammatory disorders (ie arthropathy), insomnia, gastrointestinal disorders, ethanol withdrawal syndrome, premature ejaculation, and vulvar lesions.
  • the medicament can be used for the prevention of certain diseases or disorders and at the same time to treat other diseases or disorders (e.g. prevention of psychosis, treatment of gastrointestinal disorders, prevention of neuropathic pain, Treatment of ethanol withdrawal syndrome, etc.).
  • diseases or disorders e.g. prevention of psychosis, treatment of gastrointestinal disorders, prevention of neuropathic pain, Treatment of ethanol withdrawal syndrome, etc.
  • agents can be used in combination with other drugs, such as antiviral drugs, during early viral infections to inhibit or reduce events resulting from neurological disorders.
  • Suitable dosage ranges for oral administration of gabapentin are usually about 100 mg / day to about 3600 mg / day and 1- ⁇ [( ⁇ -isobutanoyloxyethoxy) carbonyl] aminomethyl ⁇ -1-cyclohexane Acetic acid or a pharmaceutically acceptable salt or pharmaceutically acceptable solvate thereof can be adjusted to provide equimolar amounts of gabapentin.
  • the dose range can be readily determined by methods known to those skilled in the art.
  • the amount of 1- ⁇ [( ⁇ -isobutanoyloxyethoxy) carbonyl] aminomethyl ⁇ -1-cyclohexaneacetic acid in the solid formulation is about 50 mg to about 800 mg, in some embodiments about 100 mg to about 800 mg, and In some embodiments, it will be in the range of about 300 mg to about 700 mg.
  • the dosage is orally administered 1 to 3 times per day. The dose is expected to be appropriately determined according to individual cases in consideration of symptoms, age, sex, and the like.
  • 1- ⁇ [( ⁇ -isobutanoyloxyethoxy) carbonyl] aminomethyl ⁇ -1-cyclohexaneacetic acid is hydrolyzed in the presence of water to give 1 mol of water and 1- ⁇ [( ⁇ -isobutanoyloxy, respectively).
  • 1 mol of acetaldehyde, carbon dioxide, gabapentin and isobutyl alcohol are generated from ethoxy) carbonyl] aminomethyl ⁇ -1-cyclohexaneacetic acid, respectively.
  • the solid preparation 8 includes 1- ⁇ [( ⁇ -isobutanoyloxyethoxy) carbonyl] aminomethyl ⁇ -1-cyclohexaneacetic acid as an active ingredient, and a release rate controlling polymer, excipient, and diluent as additives.
  • Fluidizers, lubricants, thickening inhibitors, surfactants, buffers, dyes, wetting agents, emulsifiers, pH buffers, stabilizers, thickeners, disintegrants, and colorants One or two or more additives can be added in an appropriate amount.
  • the release rate controlling polymer is a glyceryl ester such as glyceryl monostearate, glyceryl behenate, glyceryl palmitostearate, lauroyl macrogol glyceride, stearoyl macrogol glyceride, or any combination of the above.
  • the release rate improving polymer is glyceryl behenate.
  • Other fat and / or wax release rate improving polymers include lauryl alcohol, myristyl alcohol, stearyl alcohol, cetyl alcohol, cetostearyl alcohol, palmitoyl alcohol, ouricury wax, hydrogenated vegetable oil, candelilla wax, esparto wax, stearic acid, Includes paraffin wax, beeswax, glycowax, castor wax, and carnauba wax.
  • Excipients include starch, sugar, gelatin, malt, rice, flour, chalk, silica gel, sodium stearate, glycerol monostearate, talc, sodium chloride, glycerol, propylene glycol, water, ethanol and the like.
  • Diluents can be added to increase the volume of the drug to make it practical for compression. Examples of useful diluents are dicalcium phosphate, dicalcium phosphate dihydride, calcium sulfate, tricalcium phosphate, lactose, cellulose containing microcrystalline cellulose, kaolin, mannitol, sodium chloride, dried starch, alpha starch, Compressible sugar, mannitol, and combinations of any of the above.
  • the single diluent is selected from dicalcium phosphate and microcrystalline cellulose.
  • the agent may include an amount of diluent that ranges from about 30 wt% to about 50 wt%, and in some embodiments from about 35 wt% to about 45 wt%.
  • the agent comprises an amount of diluent that ranges from about 5 wt% to about 20 wt%, and in some embodiments from about 10 wt% to about 16 wt%. I can do it.
  • a fluidizing agent is included in the drug of the present invention to reduce the adhesion effect during manufacture, film formation, and / or drying.
  • useful fluidizing agents are talc, magnesium stearate, glyceryl monostearate, colloidal silicon dioxide, precipitated silicon dioxide, any combination of the above.
  • the fluidizing agent is colloidal silicon dioxide.
  • the medicament may comprise less than about 2% by weight fluidizing agent, and in certain embodiments, less than about 1% by weight fluidizing agent.
  • Lubricants and thickening inhibitors can be included in the agents of the present invention to aid in processing.
  • useful lubricants and / or thickening inhibitors are calcium stearate, glyceryl behenate, glyceryl monostearate, magnesium stearate, mineral oil, polyethylene glycol, sodium stearyl fumarate, sodium lauryl sulfate, dodecyl Sodium sulfate, stearic acid, talc, hydrogenated vegetable oil, zinc stearate, and any combination of the above.
  • the lubricant is glyceryl monostearate.
  • the lubricant is magnesium stearate.
  • the medicament may comprise from about 1% to about 13% by weight, in some embodiments, from about 4% to about 10% by weight lubricants and / or thickening inhibitors.
  • surfactants useful in the agents of the present invention include pharmaceutically acceptable anionic surfactants, cationic surfactants, amphoteric ⁇ amphiphilic / amphiphilic ⁇ surfactants. Agents, nonionic surfactants, polyethylene glycol esters or ethers, and combinations of any of the above. Suitable pharmaceutically acceptable anionic surfactants are monovalent alkyl carboxylates, acyl lactylates, alkyl ether carboxylates, N-acyl sarcosinates, polyvalent alkyl carbonates, N-acyl glutamates, fatty acid-polys.
  • the solid preparation 8 of the present embodiment is formed of a shaped tablet, but may be a capsule.
  • composition per tablet was as follows: 1- ⁇ [( ⁇ -isobutanoyloxyethoxy) carbonyl] aminomethyl ⁇ -1-cyclohexaneacetic acid 300 mg, calcium hydrogen phosphate 259.1 mg, glycerin fatty acid ester 30.05 mg, talc 40 0.0 mg, light anhydrous silicic acid 2.7 mg, sodium lauryl sulfate 12.0 mg, and magnesium stearate 11.15 mg.
  • Example 1 The solid body 8 obtained in the above formulation example is sealed by adhering and sealing the container sheet 6 formed by the packaging film F1 having the following configuration and the lid sheet 7 made of aluminum. Obtained.
  • seat 6 for containers of Example 1 is the same as that of Example 1 mentioned above, the description is abbreviate
  • Adsorption layer 1 low density polyethylene containing calcium oxide (calcium oxide amount relative to polyethylene: 30 wt%) (thickness: 40 ⁇ m)
  • Base material layer 2 EAA (ethylene-acrylic acid copolymer) (thickness: 10 ⁇ m)
  • Aluminum foil 3 Pure aluminum foil (thickness: 45 ⁇ m)
  • Barrier layer 4 Stretched polyamide resin (thickness: 25 ⁇ m)
  • coloring means that a color other than white is exhibited in appearance.
  • the following tests were performed using the package P of the solid preparation 8 obtained in Example 1 and Comparative Examples 1 and 2 as a sample.
  • the solid preparation 8 stored in a cold place after production at a predetermined temperature was used as a control sample, and the samples of Example 1 and Comparative Examples 1 and 2 were 50 ° C., 40 ° C., 30 ° C., and 25 ° C., respectively (relative humidity). 75%) was used as a sample after storage.
  • the solid preparation 8 packaged in each package P was taken out, and the appearance was evaluated by measuring the color difference ⁇ E between the control sample and the sample after storage with a color difference meter (CM-3500d, manufactured by Konica Minolta).
  • FIG. 3 shows that when stored at 50 ° C., Example 1 has a lower degree of coloring of solid preparation 8 than Comparative Examples 1 and 2. Compared to Comparative Example 1 that does not include the adsorption layer 1, the color difference ⁇ E of Example 1 is about one third after 3 days, and the packaging P of Example 1 colored the solid preparation 8. Is greatly suppressed. Furthermore, it was shown that Example 1 can suppress coloring of the solid preparation 8 rather than the package P of Comparative Example 2 containing calcium oxide in the adsorption layer 1.
  • Example 1 showed that the degree of coloring of the solid preparation 8 was smaller than that of Comparative Examples 1 and 2 even when stored at 40 ° C.
  • ⁇ E showed a high value of about 32 after one month, but Comparative Example 2 containing calcium oxide in the adsorption layer 1 and Example 1 was about 1.
  • ⁇ E of Example 1 was about 12, but ⁇ E of Comparative Example 2 was about 22, and the difference in ⁇ E was remarkable after long-term storage. It was. Therefore, it was shown by this color difference measurement that the package P of the present invention effectively suppresses coloring.
  • FIG. 5 shows that Example 1 and Comparative Example 1 are slightly different when stored at 30 ° C., but ⁇ E is smaller in Example 1.
  • ⁇ E is smaller in Example 1.
  • the degree of coloring is extremely small, and it is confirmed that it is suitable for storage of the solid preparation 8 It was done.
  • Example 1 when stored at 25 ° C., after 6 months, Example 1 shows that ⁇ E is held at a small value as compared with Comparative Example 2 in which calcium oxide is contained in the adsorption layer 1. ing. Even in the case of 25 ° C., it was confirmed that the degree of coloring remained small when 6 months passed.
  • the packaging body P of Example 1 (the thickness of the adsorption layer 1 is 50 ⁇ m) was evaluated, but the packaging body P of Example 2 described above (however, the thickness of the adsorption layer 1 was set to 130 ⁇ m).
  • the color difference measurement of the layer structure other than the adsorption layer 1 is the same as that of the above-described Example 2, the both showed substantially the same color difference ⁇ E.
  • Test Example 4 Dissolution rate of orally disintegrating tablets
  • the package P of Example 1 and Comparative Examples 1 and 2 the effect of the package P of the present invention on the orally disintegrating tablet containing a water-soluble drug component was evaluated.
  • the description is abbreviate
  • solid preparation 8 which is a 150 mg orally disintegrating tablet containing solifenacin succinate was produced.
  • Orally disintegrating tablets are packaged by the package P of Example 1 and Comparative Examples 1 and 2 for 3 months (Example 1-1, Comparative Example 1-1, Comparative Example 2-1) and 6 months, respectively.
  • Example 1-2, Comparative Example 1-2 Stored (storage conditions: 40 ° C., relative humidity 75%, dark place).
  • FIG. 7 shows the degree of dissolution of the orally disintegrating tablet after a predetermined storage period (measured after 0, 30, 45 minutes). The dissolution test was carried out at 900 rpm with a paddle method using 900 mL of pH 6.8 phosphate buffer.
  • Example 1-2 the dissolution rate was 92%, and in Comparative Example 1-2, 82%. It was shown that the orally disintegrating tablet packaged in the package P of Example 1 retains high dissolution properties. It was.
  • Orally disintegrating tablets are tablets that disintegrate in the oral cavity with saliva or a small amount of water, and are required to dissolve (disintegrate) rapidly in the oral cavity.
  • the orally disintegrating tablet is not preferably stored, the dissolution is delayed and it is difficult to dissolve (disintegrate) in a short time.
  • the dissolution delay of an orally disintegrating tablet was suppressed by the package P of this invention, and it has high dissolution property in a short time. This result is presumed that the adsorption layer 1 provided in the package P of the present invention effectively adsorbs water and the like, and thus contributes to the stabilization of the orally disintegrating tablet of the adsorption layer 1.
  • the packaging body film used for the packaging body P of this invention is not limited to the structure of said packaging body film F1.
  • the packaging film F1 only the base material layer 2 is provided as the base material layer, but a plurality of base material layers (main base materials) are used as the base material layer as in the packaging film F2 shown in FIG.
  • the structure provided with the layer 2a and the sub-base material layer 2b) may be sufficient.
  • FIG. 8 is a schematic cross-sectional view of a packaging body film F2 according to another embodiment of the present invention. Since the structure and action of the adsorption layer 1, the aluminum foil 3, and the barrier layer 4 are the same as those of the packaging film F1, description thereof is omitted.
  • the main base material layer 2a and the sub base material layer 2b are provided in order to impart appropriate rigidity and moldability to the packaging body film F2, similarly to the base material layer 2. And the main base material layer 2a and the sub base material layer 2b are comprised with the material similar to the said base material layer 2.
  • FIG. 1 is a schematic cross-sectional view of a packaging body film F2 according to another embodiment of the present invention. Since the structure and action of the adsorption layer 1, the aluminum foil 3, and the barrier layer 4 are the same as those of the packaging film F1, description thereof is omitted.
  • the main base material layer 2a and the sub base material layer 2b are provided in order to impart appropriate rigidity and moldability to the packaging body film F2, similarly to the base material
  • the compounding amount of the drug is not particularly limited as long as it is a pharmaceutically preventive or therapeutically effective amount, but is usually 10 ng or more and 5000 mg or less per day, and as another embodiment, 500 ⁇ g or more and 1000 mg or less, Administered to patients at an adult dosage level of 1 mg to about 100 mg.
  • the compounding ratio is usually appropriately selected according to the type, use (indication), and age (or body weight) of the drug, but is particularly limited if it is a therapeutically effective amount or a prophylactically effective amount. Not.

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JPWO2015194644A1 (ja) * 2014-06-18 2017-04-20 アステラス製薬株式会社 ブリスターパック用積層体、及びそれを用いたブリスターパック
CN107074419A (zh) * 2014-10-23 2017-08-18 共同印刷株式会社 泡罩包装用层叠体、使用其的泡罩包装、和泡罩包装包装体、以及该层叠体的制造方法
WO2016063987A1 (ja) * 2014-10-23 2016-04-28 共同印刷株式会社 ブリスターパック用積層体、それを用いたブリスターパック、及びブリスターパック包装体、並びにその積層体の製造方法
JPWO2016063987A1 (ja) * 2014-10-23 2017-08-03 共同印刷株式会社 ブリスターパック用積層体、それを用いたブリスターパック、及びブリスターパック包装体、並びにその積層体の製造方法
WO2016204292A1 (ja) * 2015-06-18 2016-12-22 共同印刷株式会社 ブリスターパック用積層体、及びそれを用いたブリスターパック
JPWO2016204293A1 (ja) * 2015-06-18 2018-01-25 共同印刷株式会社 ブリスターパック用積層体、及びそれを用いたブリスターパック
JPWO2016204292A1 (ja) * 2015-06-18 2018-01-25 共同印刷株式会社 ブリスターパック用積層体、及びそれを用いたブリスターパック
JPWO2016204291A1 (ja) * 2015-06-18 2018-01-25 共同印刷株式会社 ブリスターパック用積層体、及びそれを用いたブリスターパック
CN107735251A (zh) * 2015-06-18 2018-02-23 共同印刷株式会社 泡罩包装用层叠体及使用该层叠体的泡罩包装
WO2016204291A1 (ja) * 2015-06-18 2016-12-22 共同印刷株式会社 ブリスターパック用積層体、及びそれを用いたブリスターパック
WO2016204293A1 (ja) * 2015-06-18 2016-12-22 共同印刷株式会社 ブリスターパック用積層体、及びそれを用いたブリスターパック
WO2019111960A1 (ja) * 2017-12-06 2019-06-13 大原薬品工業株式会社 非晶質体ソリフェナシン製剤包装体
JP2020157559A (ja) * 2019-03-26 2020-10-01 大日本印刷株式会社 消臭積層体
JP7255278B2 (ja) 2019-03-26 2023-04-11 大日本印刷株式会社 消臭積層体

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US20130153459A1 (en) 2013-06-20

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