WO2019111940A1 - 包装体 - Google Patents
包装体 Download PDFInfo
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- WO2019111940A1 WO2019111940A1 PCT/JP2018/044701 JP2018044701W WO2019111940A1 WO 2019111940 A1 WO2019111940 A1 WO 2019111940A1 JP 2018044701 W JP2018044701 W JP 2018044701W WO 2019111940 A1 WO2019111940 A1 WO 2019111940A1
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- B—PERFORMING OPERATIONS; TRANSPORTING
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- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2250/00—Layers arrangement
- B32B2250/24—All layers being polymeric
- B32B2250/242—All polymers belonging to those covered by group B32B27/32
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2307/00—Properties of the layers or laminate
- B32B2307/70—Other properties
- B32B2307/724—Permeability to gases, adsorption
- B32B2307/7242—Non-permeable
- B32B2307/7246—Water vapor barrier
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2439/00—Containers; Receptacles
- B32B2439/40—Closed containers
- B32B2439/46—Bags
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B32—LAYERED PRODUCTS
- B32B—LAYERED PRODUCTS, i.e. PRODUCTS BUILT-UP OF STRATA OF FLAT OR NON-FLAT, e.g. CELLULAR OR HONEYCOMB, FORM
- B32B2439/00—Containers; Receptacles
- B32B2439/80—Medical packaging
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1334—Nonself-supporting tubular film or bag [e.g., pouch, envelope, packet, etc.]
- Y10T428/1341—Contains vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
- Y10T428/1379—Contains vapor or gas barrier, polymer derived from vinyl chloride or vinylidene chloride, or polymer containing a vinyl alcohol unit
Definitions
- the present invention is, for example, a package containing liquid contents such as pharmaceuticals to be administered to epidural, arteriovenous blood vessels, subcutaneous blood, muscles, various organs, etc., which is small, lightweight, portable, and medical Changes in quality of the drug, and the amount of residual drug after administration is minimal.
- liquid contents such as pharmaceuticals to be administered to epidural, arteriovenous blood vessels, subcutaneous blood, muscles, various organs, etc., which is small, lightweight, portable, and medical Changes in quality of the drug, and the amount of residual drug after administration is minimal.
- pump mechanism that enables the above-described drug solution injection system to be portable.
- a pump mechanism for example, a system in which a syringe filled with a drug solution is pressurized and driven by a battery, or a peristaltic pump using an electric motor as a power source is known.
- micropump-type portable medical pump devices that is, portable drug continuous administration devices, hereinafter referred to as “pump devices”
- medical agent is essential.
- the chemical solution to be injected needs to be injected into the human body so that there is no air mixing. Therefore, the pump apparatus as described above is used by evacuating the air after putting the drug solution into the container for injection.
- the pump apparatus as described above is used by evacuating the air after putting the drug solution into the container for injection.
- an insulin preparation stored in a glass vial container is injected into a previously sterilized syringe-like empty reservoir, It is necessary to perform preparation operations such as expulsion of air bubbles by work.
- the drug solution injection and preparation operations to the reservoir are extremely complicated and difficult to handle. Although detailed procedures are disclosed on the Internet by illustration or video, etc., the preparation operation of drug solution injection is performed under the general living environment, so there is a problem that there is a risk of contamination due to contamination of bacteria, dust, etc. Is not desirable because it In addition, when high pharmacologically active substances such as anti-cancer agents are included as pharmaceutical ingredients, it is desirable that such manipulations be avoided also in terms of the high exposure risk of workers.
- the use of the above chemical solution container pressure such as balloon pressure or gas pressure, makes the solution smaller, lighter, and less expensive than when using the above-described electric pump such as a syringe pump or a peristaltic pump.
- the injection device can be configured.
- the orifice at the outlet of the container a fluid resistor having fine holes
- the ejection pressure of the balloon pressure or the gas pressure can not be arbitrarily adjusted, and since the flow rate is adjusted with a single orifice, only one flow rate can be set for one drug solution injector.
- the flow path can not be turned on and off automatically and automatically, only the continuous injection operation with the initially set flow rate can be performed, and the flow rate can be increased or decreased according to the living action, or an interval can be set. It is difficult to control appropriately.
- the prefilled cartridge in this system requires a stroke corresponding to the plunger (plunger) of the syringe for administration of the whole amount of the drug solution, and there is a limit to the miniaturization of the pump device.
- the plunger plunger
- the pump device when trying to miniaturize the pump device, there is a problem that the filling amount of the chemical solution decreases. It is pointed out that the enlargement of the pump device leads to a decrease in portability and is a problem in terms of the need for continuous administration.
- FIG. 8 of presents a form in which a drug solution is contained in a space consisting of a cartridge base and a flexible reservoir film, and the reservoir film is deformed when the drug solution is discharged by the micro pump. Can be minimized. It is considered desirable that the reservoir film be processed to be in close contact with the cartridge base in accordance with the reduction of the chemical solution.
- the volume of the container used for continuous infusion of insulin is as small as 1.5 mL to 3 mL, and even such a small amount of residual liquid can not be ignored in such a container, and at the same time Since the concentration of the chemical solution is greatly changed even by slight evaporation, it is required that the barrier property and the flexibility for achieving the concentration maintenance of the chemical solution be compatible.
- the present inventors completed the following present invention in order to solve the problems as described above.
- the present invention is A package comprising a bag body, at least one mouth member joined to the bag body, and a content which is a liquid contained in the bag body
- the bag main body of the package uses a laminate having at least a water vapor barrier layer made of a fluorine-based resin and a sealant layer as a forming material, and the sealant layers facing each other with the sealant layer inside are used to make a bag Form a state,
- the mouth member is sandwiched and joined between the opposing sealant layers,
- the volume ⁇ of the contents contained in the bag body is 0.1 to 20 (cm 3 ),
- the relationship between the area S (cm 2 ) of the bag body in contact with the contents contained in the bag body and the volume ⁇ (cm 3 ) satisfies the following (formula I) And packaging.
- (Formula I) 0.05 ⁇ / S ⁇ 0.25 I will provide a.
- the contents contained in the package may be discharged through the mouth part of the package, and the volume of the bag main body may be reduced according to the discharge of the contents.
- the water vapor transmission rate of the package may be 0.02% or more and 0.19% or less.
- the thickness of the water vapor barrier layer may be in the range of 5 ⁇ m to 50 ⁇ m.
- the total thickness of the laminate may be in the range of 15 ⁇ m to 200 ⁇ m.
- the fluorine-based resin may be polychlorotrifluorinated ethylene.
- the sealant layer may be composed of one layer or two or more layers, and may include a layer formed mainly of a cyclic olefin resin.
- the above-mentioned mouth part member may contain cyclic olefin system resin as a formation material.
- the content may be a pharmaceutical.
- the medicine may be an injection.
- the injection may contain, as a component, one or more selected from hormones, medical narcotics, local anesthetics, analgesics, anticancer agents, and antibiotics.
- the package of the present invention when the mouth member is connected to the pump device and the micro pump is operated, the bag body is deformed according to the negative pressure inside the reservoir, and the micro pump is oversized.
- the contents are discharged stably without applying any load.
- due to the high water vapor barrier property of the package evaporation of water is difficult to occur, and the concentration of the drug solution is kept constant even during long-term storage before the start of administration.
- the content of the contents after completion of administration is extremely low, for example, waste loss is reduced even when expensive drugs are enclosed as contents, and it is simple and easy to handle in terms of manufacturing of containers and filling of contents It also has the effect of
- FIG. 1 is a front view of a package illustrating an exemplary embodiment of the present invention. It is a fragmentary sectional view of the package of the present invention. It is a fragmentary sectional view of the present invention explaining modification of a package. It is sectional drawing of the laminated body which comprises the package which represents this invention.
- FIG. 1 is a front view showing a package according to an embodiment of the present invention.
- This package 1 has a bag main body 11 serving as a storage portion of contents 16 and a mouth member 21.
- FIG. 2 shows a cross section taken along line II of FIG. 1 of the package 1 in a state in which the contents 16 are accommodated.
- the mouth member 21 directed to the left for easy understanding, the package of the present invention may be used in any posture without being fixed in this direction.
- the package 1 has a rectangular bag main body 11 having a storage portion 30 capable of containing the contents 16 therein, and a cylindrical shape inserted and joined to an opening 12 formed at the center of one end of the bag main body 11 And the mouth member 21 of the The bag body 11 adheres or heat-seals the outer peripheries of the two resin rectangular laminates 4 and bonds them together, and forms a seal portion 15 over the entire periphery except the opening 12;
- the housing portion 30 is formed inside.
- the bag body 11 is not limited to the illustrated shape, and may have any shape as long as it has a bag shape.
- one laminated body 4 may be folded in two, and the center folding line may be used as the bottom of the bag body 11 to join other parts, or the laminated body 4 may be rolled into a cylindrical shape and both ends and the bonding surface It may be joined.
- the seal shape does not have to be a combination of straight lines, and may be, for example, a combination of arc-shaped sides. It may be formed in a three-dimensional box shape by the laminate 4. Even if it is formed in a box shape or a cylindrical shape, the bag body 11 can maintain flexibility.
- the dimensions of the bag body 11 are not limited in the present invention, but the length in the major axis direction is 20 to 100 mm, the width in the minor axis direction is 10 to 100 mm, and the filling amount of the contents 16 is about 1 to 100 cm 3 It is suitable as a package for such as.
- the tensile modulus of elasticity of the laminate 4 constituting the bag body 11 is not limited, but is preferably 1500 MPa or less, more preferably 200 to 1200 MPa.
- the thickness of the laminate 4 is not limited, but is preferably 30 to 200 ⁇ m, and more preferably 40 to 100 ⁇ m. If the tensile modulus of elasticity is too small or the thickness of the laminate 4 is too small, the laminate 4 tends to stretch during the manufacture of the package, making it difficult to manufacture.
- the bag body 11 When the tensile elastic modulus is too large or the thickness of the laminate 4 is too large, the bag body 11 is not flexible and the volume in the pump device is occupied by the laminate 4 so that it can be accommodated in the accommodating portion 30 Capacity will decrease.
- the tensile modulus of elasticity of the laminate can be measured by the measurement method defined in ISO 527-1.
- the laminate 4 of the present embodiment is flexible, deformation of the bag body 11 is easy with the discharge of the contents 16, and the load on the micro pump that operates to extract the contents 16 is reduced.
- the follow-up ability is good when the administration rate is fixed or the administration rate is changed by program control.
- FIG. 3 schematically shows the shape change of the bag main body 11 when the contents 16 are discharged by connecting the pump device.
- the volume of the bag body 11 gradually decreases, and the space 30a after discharge generated inside the bag body 11 when discharging the whole amount can be minimized.
- the laminate 4 used for the bag body 11 is not flexible, deformation of the bag body 11 accompanied by discharge becomes difficult, and when discharge of the contents 16 is completed, remaining around the mouth increases.
- the packaging body 1 of the present invention since the space 30a after discharge is small, waste loss is reduced particularly when expensive contents are accommodated, which is advantageous in cost.
- the laminated body 4 which comprises the bag main body 11 can be set as the structure which has the water vapor
- the bag main body 11 shown in FIG. 1 is configured by using the two laminates 4 with the sealant layers 43 of the respective laminates 4 facing each other and bonding the sealant layers 43 together as a sealing portion.
- the materials described below are appropriately selected according to the properties and purposes of the package 1 and the contents 16, and an extrusion laminating method, a dry laminating method, a multilayer coplanar method It can obtain by superimposing by the extrusion film-forming method etc.
- the water vapor barrier layer 41 is a layer disposed to prevent deterioration of the contents 16 contained in the bag body 11.
- the water vapor barrier layer 41 of the present embodiment includes a layer having a fluorine-based resin as a forming material.
- the water vapor barrier layer 41 includes a layer having a fluorine-based resin as a forming material, it is possible to provide a laminate excellent in mechanical strength and optical properties and low in water vapor permeability, and a package formed therefrom.
- polytetrafluoroethylene PTFE
- tetrafluoroethylene / perfluoroalkyl vinyl ether copolymer PFA
- FEP tetrafluoroethylene / hexafluoropropylene copolymer
- EPA tetrafluoroethylene-ethylene copolymer
- PVDF polyvinylidene fluoride
- PCTFE polychlorotrifluorinated ethylene
- ECTFE chlorotrifluoroethylene-ethylene copolymer
- PCTFE polychlorotrifluoride ethylene
- the fluorine-based resin has a glass transition temperature higher than that of a resin such as polyethylene terephthalate (PET) used as a base layer of a vapor-deposited polyester film, which has been applied to the water vapor barrier layer 41 so far. It is done. Therefore, as a material for forming the sealant layer 43, a material which has conventionally been inapplicable because the glass transition temperature is too high can be applied, and the choice of the material for forming the sealant layer 43 can be broadened.
- PET polyethylene terephthalate
- the water vapor barrier layer 41 may have a single layer structure consisting of a single layer, or may have a laminated structure of two or more layers.
- a layer having a function other than the gas barrier property and the gas barrier property (hereinafter, referred to as “other layer”) may be further included.
- As another layer a reinforcement layer, a gas barrier layer, a light shielding layer, a printing layer, metal foil, a synthetic paper etc. are mentioned, for example.
- the other layers can be configured not to contain a fluorine-based resin.
- the laminate 4 may have a print layer or a coat layer on the side opposite to the sealant layer. By printing the ink on the surface of the water vapor barrier layer 41, the printed layer can impart the distinctiveness and the design of the package 1.
- the coating layer may be a layer for protecting the water vapor barrier layer 41 or the printing layer provided on the water vapor barrier layer 41 or for improving the gas barrier property, and a coating layer using a thin resin layer or an ultraviolet curable resin. It can be done.
- the resin layer etc. which consist of a different material may be provided in the outer side of the water vapor barrier layer 41. As shown in FIG.
- the thickness of the layer made of a fluorine-based resin is preferably 5 ⁇ m or more and 50 ⁇ m or less, and more preferably 15 ⁇ m or more and 25 ⁇ m or less.
- the water vapor transmission rate of the package 1 can be made sufficiently low that the thickness of the layer made of the fluorine-based resin is 15 ⁇ m or more.
- the thickness of the layer made of the fluorine-based resin is 25 ⁇ m or less, the production cost can be reduced, and flexibility for smoothly discharging the contents 16 can be imparted.
- the intermediate layer 42 improves the adhesion between the water vapor barrier layer 41 and the sealant layer 43.
- the intermediate layer 42 is not an essential layer, but in order to obtain sufficient adhesion between layers based on the combination of the water vapor barrier layer 41 and the sealant layer 43 and the method of manufacturing the laminate. It is a layer to distribute.
- the material constituting the intermediate layer 42 is not particularly limited as long as it can improve the adhesiveness of these layers, but, for example, a polyurethane-based adhesive or a material which the present inventors have found and has already filed a patent application
- the resin composition is preferably formed from a resin composition containing a polyethylene-based resin and a modified polyethylene-based resin as described in Japanese Patent Application No. 2017-091287.
- the intermediate layer 42 By forming the intermediate layer 42 using the above-described materials, it is possible to provide the package 1 in which delamination between the water vapor barrier layer 41 and the intermediate layer 42 or between the intermediate layer 42 and the sealant layer 43 is less likely to occur. In addition, by obtaining good adhesion by the intermediate layer 42, it is possible to suppress the occurrence of delamination of the laminate and cracking of the package 1.
- the sealant layer 43 is used when the laminate 4 is bonded by heat sealing or the like to form a bag.
- the sealant layer 43 is a layer in contact with the contents 16 in the package 1 of the present invention.
- polyolefin resin such as polyethylene (PE), polypropylene (PP), ethylene-vinyl acetate copolymer (EVA), cyclic olefin resin, polyester resin, etc. can be used. It is not limited to the material of.
- the sealant layer 43 in the present embodiment does not need to use the above-described resin material alone, and may be obtained by arranging two or more kinds of materials in a multilayer or blending different materials. By combining a plurality of materials, it is possible to enhance various physical properties necessary for maintaining the quality of the content 16 such as heat resistance, flexibility, transparency, impact resistance, heat seal strength and the like.
- the water vapor barrier layer 41 includes a layer having a high glass transition temperature and using a fluorine-based resin as a forming material.
- the sealant layers 43 can be bonded to each other using heat sealing or the like at a high temperature. Therefore, it is also possible to select and use a material having a high glass transition temperature as a material for forming the sealant layer 43.
- the sealant layer 43 of the present embodiment preferably contains a cyclic olefin resin.
- the sealant layer 43 contains a cyclic olefin resin, a package excellent in non-adsorbability to the contents 16 can be provided.
- cyclic olefin resin cyclic olefin polymer (COP), cyclic olefin copolymer (COC), etc. are mentioned.
- the resin component constituting the sealant layer may be one or more of cyclic olefin resins, and may be a mixture of cyclic olefin resins and other resins or elastomers.
- the homopolymer of cyclic olefin or the copolymer of 2 or more types of cyclic olefins, or its hydrogenated substance is mentioned, for example.
- the cyclic olefin polymer is preferably a non-crystalline polymer, and more preferably a ring-opened polymer of cyclic olefin by metathesis or the like, or a hydrogenated product thereof.
- the cyclic olefin polymer has a high proportion of containing an alicyclic structure as compared to a cyclic olefin copolymer and the like, and is excellent in non-adsorbability to the content 16.
- the COC includes, for example, a copolymer of one or more cyclic olefins and one or more acyclic olefins, or a hydrogenated product thereof.
- the cyclic olefin copolymer is preferably a non-crystalline polymer, more preferably a copolymer of a cyclic olefin and ethylene, or a hydrogenated product thereof.
- the cyclic olefin used as a constituent monomer of the cyclic olefin resin is an unsaturated hydrocarbon (olefin) having at least one ring structure.
- unsaturated hydrocarbon olefin
- vinyl cycloalkanes having cycloalkanes having 3 to 20 carbon atoms and derivatives thereof, monocycloalkenes having 3 to 20 carbon atoms and derivatives thereof, cyclic olefins having a norbornene skeleton (norbornene-based monomers), and the like are listed.
- Examples of the norbornene-based monomer include bicyclo [2.2.1] -2-heptene (norbornene) and derivatives thereof.
- Examples of the derivative include a compound having a substituent such as an alkyl group, a compound having two or more unsaturated bonds such as norbornadiene, and three or more ring structures, of which two ring structures constitute a norbornene skeleton Compounds are mentioned.
- norbornene-based monomers having three or more ring structures tricyclo [5.2.1.0 2,6 ] decene (dihydrodicyclopentadiene), norbornene or dihydrodicyclopentadiene in one or more molecules of cyclopentadiene
- Compounds added by Diels-Alder reaction for example, tetracyclododecene, pentacyclopentadecene, hexacycloheptadecene etc.
- hydrogenated products thereof isomers with different double bond positions, alkylated products etc.
- non-cyclic olefins used as constituent monomers of COC include ethylene, propylene, 1-butene, 1-pentene, 1-hexene, ⁇ -olefins such as 1-heptene and 1-octene, 3-decene, 3 And alkenes such as dodecene.
- the sealant layer 43 may be a single film consisting of one layer or may be a multilayer film consisting of two or more layers. Further, the sealant layer 43 includes one or more layers formed mainly of the cyclic olefin resin, but the cyclic olefin resin layer may be disposed so as to be the innermost side of the laminate 1. It may be arranged at a position near the middle layer. When the layer containing the cyclic olefin-based resin as the main component is disposed on the seal surface, the package 1 having the best non-adsorption performance can be obtained.
- the heat sealing time can be shortened. It can be appropriately selected according to the nature of the contents 16.
- the glass transition temperature of the material forming the sealant layer 43 is preferably 50 ° C. or more and 170 ° C. or less, and more preferably 70 ° C. or more and 140 ° C. or less.
- the sealant layer 43 tends to be excellent in non-adsorbability with respect to the contents 16.
- laminating the laminated body 4 as the glass transition temperature of the material which forms the sealant layer 43 is 140 degrees C or less, since high temperature is not required, it is excellent in moldability.
- the thickness of the sealant layer 43 is preferably 20 ⁇ m or more, and more preferably 30 ⁇ m or more.
- the thickness of the sealant layer 43 is 20 ⁇ m or more, the laminating process of the laminate 4 is easy, and the sealant layer 43 is bonded by heat sealing or the like to form a bag-like seal. Sufficient strength can be obtained.
- 80 micrometers or less are preferable and, as for the thickness of the sealant layer 43, 60 micrometers or less are more preferable.
- the thickness of the sealant layer 43 is 80 ⁇ m or less, the production cost can be reduced and appropriate flexibility can be imparted.
- the upper limit value and the lower limit value of the thickness of the sealant layer 43 can be arbitrarily combined.
- the sealant layer 43 contains a cyclic olefin resin
- the water vapor transmission rate of the package 1 decreases as the sealant layer 43 becomes thicker.
- the flexibility of the package 1 is reduced as the sealant layer 43 is thicker. Therefore, from the viewpoint of lowering the water vapor transmission rate of the package 1, the sealant layer 43 is preferably thick, but from the viewpoint of securing the flexibility of the bag body 11, the sealant layer 43 is preferably thin.
- the water vapor barrier layer 41 includes a layer having a fluorine-based resin as a forming material.
- the water vapor barrier layer 41 is more flexible than in the case of a biaxially stretched polyester film subjected to alumina or silica vapor deposition treatment, packages having the same laminate area are compared with each other.
- the amount of content 16 that can be accommodated can be increased, and space can be saved.
- the follow-up ability in the case where the administration rate is fixed or the administration rate is changed by program control is good.
- the water vapor transmission rate is sufficiently lowered while maintaining the flexibility required to deform the bag body 11 as compared to the case where a material other than the fluorine-based resin is used as a barrier material. be able to. That is, the package 1 which is excellent in the barrier property to water vapor can be provided.
- the sealant layer 43 can be thinned because the water vapor barrier layer 41 has sufficient water vapor blocking performance.
- the content 16 is stored by thinning the laminate 4 that configures the storage unit 30. Since it is possible to expand the space, it has the advantage of facilitating the miniaturization of the device.
- the mouth member 21 has, for example, a cylindrical shape such as a cylindrical shape, and the base end is joined to the laminate 4 on both sides by adhesion or heat sealing in a state of being inserted into the opening 12 of the bag main body 11 It is done.
- the dimensions of the mouth member 21 are not limited in the present invention, for example, the outer diameter excluding the convex portion is about 4 to 10 mm, the thickness is about 0.5 to 3 mm, and the length is about 5 to 30 mm. , Suitable as a connection with the pump device.
- the shape of the mouth member 21 may be in a form suitable for assembly so that the package 1 constitutes a part of the replaceable cartridge, and the joint portion with the laminate 4 may not be a curved surface.
- Sealing body (not shown) for maintaining the quality of the content 16 by preventing the leakage to the outside and the intrusion of dust and bacteria from the outside of the system after filling the content 16 in the mouth member 21 Install and seal).
- a sealing body an elastic body etc. which were shape
- a treatment for attaching the cap or arranging a sealing material or the like as needed and fixing the sealing body is also generally performed.
- the specific state, the shape, and the like of the contents 16 accommodated in the package 1 of the present embodiment are not particularly limited.
- the content 16 may be, for example, a solid, a liquid, a gas, a powder, particles, a mixture, a composition, a dispersion, and the like.
- the content 16 may be a liquid or an aqueous solution containing a drug.
- the contents 16 When the contents 16 are contained in the package 1, the contents 16 may be filled with an inert gas or liquid such as nitrogen, or the contents 16 may be filled to a full capacity without creating a void as much as possible.
- the container 30 of the bag body 11 can contain any substance as long as it passes through the mouth member 21 such as liquid, powder, gas, a mixture of these, etc. Suitable for liquid pharmaceuticals where a small amount needs to be administered continuously.
- this type of drug include hormones, narcotic drugs for pain relief, anti-cancer drugs, antibiotics and the like, and these drugs are used with a micro pump to deliver subcutaneous, blood vessels, muscles, epidural, various The method of injecting into organs etc. is common. At this time, administration can be controlled by an electric circuit or a computer, and minute administration or finely controlled administration can be performed according to the condition of the patient.
- the medical product which is the contents 16 can be sterilized by steam heating after sealing, or can be filled aseptically to keep the contents 16 in a sterile state.
- a cylindrical mouth member having an outer diameter of 5 mm, an inner diameter of 3 mm, and a length of 10 mm, which is made of COP, was obtained by injection molding.
- Test Examples 4 and 5 the resins used as the raw materials of the respective layers shown in Table 1 were separately heated and melted and mixed, and simultaneous multilayer film formation was carried out by using an extruder capable of simultaneous multilayer extrusion molding. To obtain a three-layered laminate having a water vapor barrier layer, an intermediate layer and a sealant layer in this order. The materials used for the intermediate layer were those mixed together at a mass ratio shown in () in Table 2.
- Test Examples 10 to 13 In Test Examples 10 to 13, a laminate of coextruded two layers in which the thickness of the sealant layer was variously changed from 50 ⁇ m to 250 ⁇ m without using the water vapor barrier layer and the intermediate layer was used as it was. The thickness and material of each layer are described in accordance with Table 1.
- PCTFE 1 Polychlorotrifluorinated ethylene film (manufactured by Honeywell, Aclar (registered trademark))
- PCTFE 2 Polychlorotrifluorinated ethylene pellet (manufactured by Daikin Industries, Neoflon PCTFE (trademark), DF0050-C1)
- Al 2 O 3 -PET Alumina-deposited biaxially oriented polyester (GL film (trademark) manufactured by Letterpress Printing Co., Ltd.)
- COP cycloolefin polymer ((manufactured by Nippon Zeon Co., Ltd., ZEONOR (registered trademark) 1020R)
- PE Linear low density polyethylene (specific gravity 0.930 g / cm 3 , manufactured by Tosoh Corporation, Nipolon-L (registered trademark))
- Adhesive Urethane-based two-component curing type laminating adhesive
- LLDPE Linear low density polyethylene (manufactured by Japan Polyethylene Corporation, Harmorex (registered trademark) NH745N)
- ADMER Maleic anhydride modified polyethylene (Mitsui Chemical Co., Ltd., ADMER (registered trademark))
- Epoxy component Epoxidized 1,2-polybutadiene (made by Adeka, specific gravity 0.99 g / cm 3 , average molecular weight 1,000)
- the distilled water in the syringe is filled into the package until the pressure gauge shows 25 kPa ( ⁇ 2 kPa is within the allowable range) by pushing the plunger. did.
- the metal needle was withdrawn from the rubber plug, and the total weight was measured to calculate the amount of filling liquid from the difference with the empty bag weight.
- the water vapor transmission rate of the package was determined according to the water vapor permeability test in the 17th Amended Japanese Pharmacopoeia, ⁇ 7.02> Plastic Drug Container Test Method. Specifically, each sample of the test example was filled with (fill liquid volume) -0.1 (cm 3 ) of distilled water and stored for 14 days at a temperature of 25 ⁇ 2 ° C. and a relative humidity of 60 ⁇ 5%. The weight change of was calculated in percent and this value was taken as the water vapor transmission rate. As a standard of the plastic aqueous injection container, it is specified that the weight loss from the initial internal volume is 0.20% or less, and "suitable” or “not fit” against the standard was judged.
- Table 3 The results of each test are shown in Table 3.
- Table 3 the ⁇ / S value represented by the ratio of the filling liquid amount ⁇ to the area S of the bag body is shown together.
- the packages of Test Examples 1 to 5 to which the present invention is applied can increase the amount of discharged liquid while preventing the loss of water. From this, it was shown that the packages of Test Examples 1 to 5 can accommodate a large amount of liquid in a small space while having high water vapor barrier properties.
- the package formed by the laminate obtained by the coextrusion film forming method can be filled with a larger amount of liquid as compared with the package formed by the dry laminate laminate, and the discharge is further discharged. There was a tendency for the amount of residual liquid to be smaller.
- the smaller the amount of content to be filled the smaller the value represented by S / S.
- the value represented by S / S increases.
- the ratio S / S is excessively reduced, the water vapor transmission rate will deviate from the standard. This is because the area of the laminate at which water vapor permeation occurs does not change even if the amount of filling liquid decreases. Moreover, it is unpreferable also from the point of occupying the space in a pump apparatus largely.
- the amount of liquid to be filled is small, the water permeation amount can be suppressed by reducing the area of the bag body, and the storage suitability of the contents can be secured.
- ⁇ / S value may fall in a fixed range.
- it is in the range of 0.01 or more and 0.5 or less, more preferably 0.05 or more and 0.25 or less.
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Abstract
Description
本願は、2017年12月8日に、日本に出願された特願2017-236530号に基づき優先権を主張し、その内容をここに援用する。
例えば、Medtronic社製「ミニメド620G」システムを使用した、インスリンの持続投与においては、あらかじめ滅菌処理されたシリンジ様の空リザーバに対し、ガラスバイアル容器内に保存されたインスリン製剤を注入した後、手作業により気泡を追い出すなどの準備操作が必要である。
本発明は、上記事情に鑑みてなされたものであり、ポンプ機器のリザーバが複雑な構造や材質を有することなく、小型・軽量で携帯可能であり、かつ内容物の品質変化が生じにくく、投与後の内容物の残留が僅少な包装体を提供することを課題としている。
袋本体と、前記袋本体に接合された少なくとも一つの口部部材と、前記袋本体に収容された液体である内容物とを有する包装体であって、
前記包装体の前記袋本体は、少なくともフッ素系樹脂からなる水蒸気バリア層と、シーラント層とを有する積層体を形成材料とし、前記シーラント層を内側とし対向する前記シーラント層同士を貼り合わせることで袋状をなすものであり、
前記口部部材は、対向する前記シーラント層同士に挟持されて接合されてなり、
前記袋本体内に収容された前記内容物の体積∨は0.1から20(cm3)であり、
前記袋本体が前記袋本体内に収容された前記内容物と接液する面積S(cm2)と、前記体積∨(cm3)からなる関係性が、下記(式I)を満たすことを特徴とする包装体。
(式I) 0.05 ≦ ∨/S ≦ 0.25
を提供する。
図2は、内容物16が収容された状態における包装体1の図1のI-I線に沿った断面を表したものである。以下の説明では解りやすいように口部部材21を左に向けた状態で説明を行うが、本発明の包装体は、この向きに固定されることなく、如何なる姿勢で使用されてもよい。
袋本体11を構成する積層体4は、図4に例示した、水蒸気バリア層41と、中間層42と、シーラント層43とをこの順で有する構成とすることができる。図1に示す袋本体11は、2枚の積層体4を用い、各積層体4のシーラント層43同士を対向させ、シーラント層43同士を貼り合わせシール部とし、構成したものである。本発明の包装体1を構成する積層体4は、以下に記述される材料を、包装体1および内容物16の特性や目的に応じて適宜選択し、押出ラミネート工法、ドライラミネート工法、多層共押出製膜法等により、重ね合わせることで得ることができる。
水蒸気バリア層41は、袋本体11に収容された内容物16の変質を防ぐために配置される層である。本実施形態の水蒸気バリア層41は、フッ素系樹脂を形成材料とする層を含む。水蒸気バリア層41がフッ素系樹脂を形成材料とする層を含むと、機械的強度や光学的性質に優れ、水蒸気透過性が低い積層体、及びそれから構成される包装体を提供できる。
中間層42は、水蒸気バリア層41とシーラント層43との接着性を向上するものである。本発明の包装体において、中間層42は、必須の層ではないが、水蒸気バリア層41とシーラント層43との組合せ及び積層体の製造方法に基づいて、充分な層間の接着性を得るために配する層である。中間層42を構成する材料としては、これらの層の接着性を向上し得るものであれば、特に限定されないが、例えば、ポリウレタン系接着剤や、本願発明者らが見出し、既に特許出願した特願2017-091287に記述されるような、ポリエチレン系樹脂と、変性ポリエチレン系樹脂とを含む樹脂組成物から形成されることが好ましい。
シーラント層43は、積層体4をヒートシール等により貼り合わせて袋状に形成する際に用いられる。シーラント層43は、本発明の包装体1において、内容物16と接触する層である。
シーラント層43の材質としては、例えばポリエチレン(PE)、ポリプロピレン(PP)、エチレン―酢酸ビニル共重合体(EVA)、環状オレフィン系樹脂などのポリオレフィン樹脂、ポリエステル系樹脂などが利用できるが、上記記載の材質に限定されない。
口部部材21は、例えば、円筒形状のような筒形状をなし、基端部は袋本体11の開口部12に挿通された状態で、接着またはヒートシールにより両側の積層体4と隙間無く接合されている。口部部材21の寸法は、本発明では限定されないが、一例を挙げれば、凸部を除く外径が4~10mm、肉厚が0.5~3mm、長さが5~30mm程度であると、ポンプ機器との接続部として好適である。また、口部部材21の形状は、包装体1が交換式カートリッジの一部を構成するよう、組み付けに適した形態をとっても良く、積層体4との接合部は曲面でなくとも差し支えない。
[試験例1~3/試験例6~9]
水蒸気バリア層の貼合面に中間層となる接着剤を、固形分が3.5g/m2の付着量となるよう塗工し、ドライラミネート工法を用いてシーラント層との貼り合せを行い、水蒸気バリア層、中間層、シーラント層をこの順で有する3層構成の積層体を製造した。シーラント層は同時多層押出製膜法により、ポリエチレン(PE)と環状オレフィン(COP)が隣接して配置された共押出2層の積層体を、COP面が内容物に接触する側に配置されるようにした。
表1に示す各層の材質および厚みをもつ積層体を用いて、試験例1~3および試験例6~9の積層体を得た。なお、表1において[ ]内の数値は各層の厚みである。
試験例4および5は、表1に示す各層の原料となる樹脂をそれぞれ別々に加熱、溶融混合したものを、同時多層押出成形が可能な押出機を用いて同時多層製膜を行って製膜し、水蒸気バリア層、中間層、シーラント層をこの順で有する3層構成の積層体を得た。中間層に用いた材料は、表2の( )内に示す質量比で混配したものを使用した。
試験例10~13は水蒸気バリア層および中間層を配置せず、シーラント層の厚みを50μmから250μmに種々変化させた共押出2層の積層体をそのまま用いた。各層の厚みおよび材質は、表1に合わせて記載した。
上記により得られた積層体2枚を、1枚あたり50mm×30mmの長方形となるよう切り出し、シーラント層が内側に対向するよう重ね合わせ、周縁部のうち2つの長辺と1つの短辺をそれぞれ幅5mmとなるよう熱シールし、袋本体を得た。続いて、袋本体の未シール辺の積層体間に口部部材を挟み込み、積層体と口部部材とを接合して、包装体を製造した。
PCTFE1: ポリクロロ三フッ化エチレンフィルム(ハネウェル社製、アクラー(登録商標))
PCTFE2:ポリクロロ三フッ化エチレンペレット(ダイキン工業社製、ネオフロンPCTFE(商標)、DF0050-C1)
Al2O3-PET:アルミナ蒸着二軸延伸ポリエステル(凸版印刷社製、GLフィルム(商標))
COP:シクロオレフィンポリマー((日本ゼオン社製、ZEONOR(登録商標)1020R)
PE:直鎖状低密度ポリエチレン(比重0.930g/cm3、東ソー社製、ニポロン-L(登録商標))
接着剤:ウレタン系2液硬化型ラミネート接着剤(三井化学社製、タケラック(登録商標))
LLDPE:直鎖状低密度ポリエチレン(日本ポリエチレン社製、ハーモレックス(登録商標)NH745N)
アドマー:無水マレイン酸変性ポリエチレン(三井化学社製、アドマー(登録商標))
エラストマー:スチレン-エチレン-ブチレン-スチレンブロック共重合体(クレイトンポリマー社製、クレイトンG(スチレン含有率13質量%、比重0.90g/cm3、MFR=22g/10min(230℃、5kgf))
エポキシ成分:エポキシ化1,2-ポリブタジエン(アデカ社製、比重0.99g/cm3、平均分子量1,000)
試験例1~13の各包装体について、以下の各試験を行った。
製造した包装体の口部に、直径3.2mm×高さ8mmのブチルゴム材質の円柱形状ゴム栓を嵌合した後に、空袋重量を測定して記録した。包装体を6mmの間隔で並行に配置した2枚の板材からなるスペーサー内に収納した。口部のゴム栓に太さ21ゲージの金属針を刺通し、さらに金属針とプラスチック製シリンジを、流体圧力がモニタリングできるよう圧力計が分岐した金属製チューブを介して接続した。シリンジのプランジャーを引き、包装体内のエアーを吸引した後、シリンジ内の蒸留水をプランジャーの押し込み操作により、圧力計が25kPa(±2kPaは許容範囲とする)を示すまで、包装体内へ充填した。充填操作が完了した後に、ゴム栓から金属針を抜取り、全体重量を測定することで、空袋重量との差から充填液量を計算によって求めた。
排出液量が3cm3以上のものを「適」、3cm3未満であったものを「不適」と判定した。
包装体の水蒸気透過率は、第十七改正日本薬局方、<7.02>プラスチック製医薬品容器試験法における水蒸気透過性試験に準じて求めた。具体的には、試験例の各検体に、(充填液量)-0.1(cm3)の蒸留水を充填し、温度25±2℃、相対湿度60±5%で14日間保存した前後の重量変化をパーセント単位で計算して、この値を水蒸気透過率とした。
プラスチック製水性注射剤容器の規格として、初期内容量からの減量が0.20%以下であることが定められており、同規格に対する「適」「不適」を判定した。
試験例1の包装体に対して、蒸留水の量を0.5から3.5(cm3)まで、1(cm3)刻みに制限して充填した。実験1と同様の手法により、水蒸気透過率と∨/S値を求め、その結果を集約し、表4に示した。
試験例1の積層体に対して、袋本体の長辺寸法を5(cm)から3.5(cm)まで、0.5(cm)刻みで短縮し、それ以外は実験1と同様の手順で包装体を形成した。内容物として蒸留水を0.5(cm3)充填し、実験1および実験2と同様の手法により、水蒸気透過率と∨/S値を求め、その結果を集約し、表5に示した。
Claims (11)
- 袋本体と、前記袋本体に接合された少なくとも一つの口部部材と、前記袋本体に収容された液体である内容物とを有する包装体であって、
前記包装体の前記袋本体は、少なくともフッ素系樹脂からなる水蒸気バリア層と、シーラント層とを有する積層体を形成材料とし、前記シーラント層を内側とし対向する前記シーラント層同士を貼り合わせることで袋状をなすものであり、
前記口部部材は、対向する前記シーラント層同士に挟持されて接合されてなり、
前記袋本体内に収容された前記内容物の体積∨は0.1から20(cm3)であり、
前記袋本体が前記袋本体内に収容された前記内容物と接液する面積S(cm2)と、前記体積∨(cm3)からなる関係性が、下記(式I)を満たすことを特徴とする包装体。
(式I) 0.05 ≦ ∨/S ≦ 0.25 - 前記包装体に収容された前記内容物は、前記包装体の前記口部部材を通じて排出され、
前記内容物の排出に応じて前記袋本体の容積が減少することを特徴とする、請求項1に記載の包装体。 - 前記包装体の水蒸気透過率は0.02%以上、0.19%以下である、請求項1又は2に記載の包装体。
- 前記水蒸気バリア層の厚みが、5μm以上50μm以下の範囲であることを特徴とする、請求項1から3のいずれか1項に記載の包装体。
- 前記積層体の総厚みが、15μm以上200μm以下の範囲であることを特徴とする、請求項1から4のいずれか1項に記載の包装体
- 前記フッ素系樹脂がポリクロロ三フッ化エチレンであることを特徴とする、請求項1から5のいずれか1項に記載の包装体。
- 前記シーラント層は、1層または2層以上から構成されてなり、環状オレフィン系樹脂を主成分として形成される層を含むことを特徴とする、請求項1から6のいずれか1項に記載の包装体。
- 前記口部部材が、形成材料として環状オレフィン系樹脂を含むことを特徴とする、請求項1から7のいずれか1項に記載の包装体。
- 前記内容物が医薬品であることを特徴とする、請求項1から8のいずれか1項に記載の包装体。
- 前記医薬品が、注射剤であることを特徴とする、請求項9に記載の包装体。
- 前記注射剤が、ホルモン剤、医療用麻薬、局所麻酔薬、鎮痛薬、抗がん剤、抗生物質から選択される1種以上を成分として含んでなることを特徴とする、請求項10に記載の包装体。
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- 2018-12-05 EP EP18885808.8A patent/EP3721852B1/en active Active
- 2018-12-05 CA CA3084961A patent/CA3084961A1/en active Pending
- 2018-12-05 US US16/770,348 patent/US11833109B2/en active Active
- 2018-12-05 CN CN201880078413.8A patent/CN111432775A/zh active Pending
- 2018-12-05 KR KR1020207017463A patent/KR102618324B1/ko active IP Right Grant
- 2018-12-05 WO PCT/JP2018/044701 patent/WO2019111940A1/ja unknown
- 2018-12-05 JP JP2019558246A patent/JP7186181B2/ja active Active
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- 2023-10-25 US US18/494,229 patent/US20240050313A1/en active Pending
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Also Published As
Publication number | Publication date |
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US20240050313A1 (en) | 2024-02-15 |
US20200383869A1 (en) | 2020-12-10 |
EP3721852A1 (en) | 2020-10-14 |
EP3721852B1 (en) | 2024-02-07 |
JP7186181B2 (ja) | 2022-12-08 |
EP3721852A4 (en) | 2021-09-01 |
KR20200092345A (ko) | 2020-08-03 |
CA3084961A1 (en) | 2019-06-13 |
KR20240005154A (ko) | 2024-01-11 |
KR102618324B1 (ko) | 2023-12-27 |
JPWO2019111940A1 (ja) | 2020-11-26 |
CN111432775A (zh) | 2020-07-17 |
US11833109B2 (en) | 2023-12-05 |
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