JP2010503588A - Pediatric safety blister package - Google Patents

Abstract

  An improved pediatric safety blister package is provided wherein the lid component includes a tear resistant nonwoven layer to which a heat resistant layer is adhered and a barrier layer.

Description

  The present invention relates to an improved pediatric safety blister package. More specifically, the present invention relates to blister packaging that includes a lid component that includes at least one nonwoven layer of melt spun continuous filament nonwoven sheet.

  Blister packages are known in the art as packaging for pharmaceuticals and other substances, for example. The blister package includes a blister component having formed therein at least one cavity into which a drug or other packaged material is placed before being sealed to the lid or top web component. Blister components known in the art include soft tempered aluminum foil, hard tempered aluminum foil, multilayer cold formable foil, and thermoformed film. Lid components known in the art include films, film combinations, paper, and / or foil. The lid component is generally applied on one side with a heat seal layer that is used to heat seal the lid component to the blister component during manufacture of the blister package. When used to package pharmaceuticals and other materials that are oxygen- and / or moisture-sensitive, the blister package should have sufficient barrier properties to ensure adequate shelf life for the packaged material. It is. When used to package pharmaceuticals or other substances that may be harmful to children, blister packages allow children to open packages in a way that exposes the packaged drugs or other packaged materials It should also be pediatric safe so that it can't be done, can't bite it, and can't otherwise damage the packaging. At the same time, it is generally desirable for adults to be able to open blister packages without undue effort.

  Examples of blister packages known in the art include peel-open, tier-open, push-through, and peel-push-through packages. In peel-open packaging, the lid component is peeled away from the blister component to expose the packaged material. In a tier-open package, the lid and blister components contain notches or perforations that extend from the edge of the package in the direction of the cavity. Indentations can be made on the outer edge of the package, or for packages containing multiple blisters separated by perforations, the indentation is preferably made by the individual blisters from the remaining blisters in the package. Contained on the inside of the package so that the notches in the separated blister are on its exposed edge when separated by the eye. The package is then torn and the tear is spread until the contents of the package can be removed. In push-through packages, the packaged material is pushed through the lid component by applying finger pressure to the outside of the blister cavity. In a peel-push-through package, the lid component is bonded to the foil layer with the film layer bonded to the foil layer by a peelable adhesive layer on the opposite side of the film to the paper layer. A multilayer laminate that generally includes an outer paper layer joined to a film layer (eg, a polyester film) by layers. The foil layer is generally applied to the opposite foil surface of the film that provides a non-peelable seal when the heat seal layer is coated or otherwise heat sealed to the blister component. To open the package, the lid is peeled between the film layer and the foil layer, leaving a foil layer attached to the blister component. After peeling the combined paper and film lid layer, the packaged material is forced through the lid layer that remains attached to the blister component. Generally, the peelable adhesive layer remains adhered to the film layer throughout peeling so that only the foil layer remains attached to the blister component after peeling. An example of a peel-push through blister package is described in Brunda, US Pat. No. 3,899,080. The blister package includes a peelable outer layer, such as a film, cardboard, or paper, that is adhered to the paper, selected plastic, or metal foil by a peelable adhesive.

  One challenge in the manufacture of blister packs is to produce a package that is pediatric safety and can be opened by an adult without undue difficulty. Certain pediatric safety blister packages known in the art include peel-open packages that include laminated paper-film lid components bonded to plastic blister components with peelable sealants. Further pediatric safety is obtained using a peel-push through package that includes the multilayer lid material described above. One drawback of current peel-push-through packages is that the paper-film-foil laminate used for the lid is generally intact and does not peel cleanly, and often tears at the perforations, making it difficult to initiate a new peel. It is to be. Some paper-film laminates and paper-film-foil laminates also have unsatisfactory penetration resistance and can be chewed by children. Another disadvantage of using a paper-film laminate or a paper-film-foil laminate for the lid component is that when the moisture retained in the paper forms water vapor at the high temperatures used in the heat sealing process. It is not uncommon to have the problem of moisture being sealed in the blister.

  Poore, UK Pat. No. 2,151,581 describes a push-through strip wrapping described as pediatric safety, comprising first and second flat sheet materials with the packaged elements enclosed between them. Yes. Neither of the flat sheet materials contain pre-formed blisters, but rather the necessary containment of the packaged elements is provided by stretching the material of each sheet when they are sealed together. The first sheet is a laminate of paper or foil with an adhesive layer, preferably a heat-sealable adhesive layer, and a tear resistant biaxially oriented plastic material. The second sheet preferably has a push-through force of at least about 70 N and is laminated with paper or metal foil and a plastic or other material capable of providing adhesion, preferably a layer of heat-sealable adhesive. Including. This package allows the removal of individual elements through the second sheet by application of finger pressure.

  Gerber, European Patent Application No. 0959020, is a release-pushthrough that includes a cover sheet that includes a push-through permeable plastic layer that does not include a metal foil, a peelable release adhesive, and a non-penetrating cover layer. A type blister package is described. The cover layer is peeled off from the release adhesive in the first step, and the packaging material is forced through the penetrating plastic layer that does not include the metal foil. Suitable cover layers include monofilms, film laminates containing thermoplastic resins, paper or thermoplastic paper layered materials. Suitable papers include cellulose paper, security paper, and paper made of synthetic fibers.

  Carter, US Pat. No. 4,947,620, includes steam sterilization that includes a Tyvek® nonwoven material lid material that is coated with an adhesive only on the area of the lid that is joined to the blister component. Describes a suitable blister pack. Tyvek® non-woven material is breathable and therefore such packaging is not suitable for packaging pharmaceuticals and other substances that are oxygen or moisture sensitive.

  There remains a need for improved pediatric safety blister packaging that protects the material packaged therein from moisture and / or oxygen, is economical to manufacture, and can be processed at high sealing temperatures. .

  The present invention is a blister package comprising a blister component having an inner surface and an outer surface and a multi-layer lid component having an inner surface and an outer surface, wherein selected portions of the inner surface of the blister component and the lid component are bonded together And forming at least one cavity therebetween, wherein the blister component comprises a first barrier layer selected from the group consisting of a polymer film, a coated polymer film, a metal foil, and a film-foil laminate, and a lid The invention relates to a blister package wherein the components include a second barrier layer, a nonwoven layer comprising at least one melt spun continuous filament nonwoven sheet, and a heat resistant layer.

FIG. 6 is a schematic elevation view of a blister package. 1 is a schematic cross-sectional view of a lid material useful in the blister package of the present invention. FIG. 6 is a schematic cross-sectional view of a second embodiment of a lid material useful in the blister package of the present invention. 1 is a schematic diagram of a process suitable for manufacturing the blister package of the present invention. FIG. 4 is a portion of a product manufactured by the process of FIG. 3 showing multiple blister packages.

  The present invention relates to an improved pediatric safety blister package comprising a multi-layer lid component and a blister component. The multilayer lid component includes at least one barrier layer and at least one nonwoven layer melt spun continuous filament nonwoven sheet. Examples of these types of blister packages are disclosed in US Patent Application Publication No. 2005/0139505. The present invention further relates to a nonwoven sheet that is particularly suitable for typical blister package sealing temperatures. The blister packages of the present invention include peel-open, tear-open, and peel-push through packages. The use of melt-spun continuous filament nonwoven sheets in the lid results in a blister package that is difficult or impossible to open by pushing the packaged item through the lid or by chewing through the lid. Improves the level of pediatric safety compared to packages known in the art.

  As used herein, the term “copolymer” includes random, block, alternating, and graft copolymers made by polymerizing two or more comonomers, and thus, dipolymers, terpolymers. Etc. are included.

As used herein, the term “polyethylene” (PE) is intended to encompass not only ethylene homopolymers, but also copolymers in which at least 85% of the repeat units are ethylene units, and about 0.955 g / cm is a linear ethylene / alpha-olefin copolymer having a density of less than ³ "linear low density polyethylene" (LLDPE), and a polyethylene homopolymer having at least about a density of 0.94 g / cm ³ " High density polyethylene "(HDPE).

  As used herein, the term “polyester” is intended to include polymers in which the linkage is created by the formation of ester units and at least 85% of the repeating units are condensation products of a dicarboxylic acid and a dihydroxy alcohol. Is done. Examples of polyesters include poly (ethylene terephthalate) (PET), which is a condensation product of ethylene glycol and terephthalic acid, and poly (1,3, which is a condensation product of 1,3-propanediol and terephthalic acid. -Propylene terephthalate) and poly (ethylene naphthalate) which is a condensation product of ethylene glycol and 2,6-naphthalic acid.

  As used herein, the term “polyamide” is intended to encompass polymers containing recurring amide (—CONH—) groups. One class of polyamides is made by copolymerizing one or more dicarboxylic acids with one or more diamines. Examples of polyamides suitable for use in the present invention include poly (hexamethylene adipamide) (nylon 6,6) and polycaprolactam (nylon 6).

As used herein, the term “barrier layer” means a sheet layer, including films and coatings that limit the permeation of oxygen and / or water vapor into a blister package that includes the sheet layer. Preferably suitable barrier layer for use in the present invention, 38 ° C. and water vapor transmission rate of less than at 6 g / m ^2/24 measured under the conditions of 90% relative humidity in accordance with ASTM F1249 (MVTR) and / or 23 ° C., with 100% oxygen, and the oxygen permeation rate of less than at 28cm ³ / m ^2/24 measured under the conditions of 100% relative humidity in accordance with ASTM D3985.

  As used herein, the terms “nonwoven”, “nonwoven sheet”, “nonwoven layer”, and “nonwoven web” are in random terms without distinguishable patterns, as opposed to knitted or woven fabrics. By an individual fiber, filament, or yarn structure that is placed to form a planar material. Examples of nonwovens include meltblown webs, spunbond webs, flash spun webs, card webs, spunlace webs, and composite sheets that include two or more nonwoven webs.

  As used herein, the term “machine direction” (MD) means the direction in which the nonwoven web is produced (eg, the direction of movement of the support surface where the fibers are laid down during the formation of the nonwoven web). The term “lateral direction” (XD) means a direction generally perpendicular to the machine direction in the plane of the web.

  As used herein, the term “spunbond fiber” refers to extruding molten thermoplastic polymer material as fibers from a plurality of fine, usually circular capillaries of a spinneret, where the diameter of the extruded fibers is then drawn. By fibers that are rapidly lowered and then melt spun by rapidly cooling the fibers.

  As used herein, the term “meltblown fiber” refers to a fiber that is melt spun by meltblowing, including extruding melt processable polymer through a plurality of capillaries as a melt stream into a high velocity gas (eg, air) stream. means.

  As used herein, the term “spunbond-meltblown-spunbond nonwoven” (SMS) is a multilayer composite sheet comprising a web of meltblown fibers sandwiched between and bonded to two spunbond layers. Means. Additional spunbond and / or meltblown layers can be incorporated into the composite sheet, such as, for example, spunbond-meltblown-meltblown-spunbond web ("SMMS").

  As used herein, the term “multicomponent fiber” means a fiber composed of at least two different polymer components spun together to form a single fiber. The at least two polymer components are disposed in distinct, substantially constant zones over the cross-section of the multicomponent fiber that extend substantially continuously along the length of the fiber.

  As used herein, the term “composite fiber” refers to a sheath-core fiber comprising a first polymer component that forms a sheath and a second polymer component that forms a core; and the first polymer component is derived from the second polymer component. Forming at least one segment adjacent to the formed at least one segment, each segment being substantially continuous along the length of the fiber with both polymer components exposed on the fiber surface; By multi-component fiber made from two different polymer components, such as by-side fibers. Multicomponent fibers are distinguished from fibers that are extruded from a single uniform or heterogeneous blend of polymeric materials.

  As used herein, the term “multicomponent nonwoven web” means a nonwoven web comprising multicomponent fibers. As used herein, the term “composite web” means a nonwoven web comprising composite fibers. Multicomponent webs can include single component and / or polymer blend fibers in addition to multicomponent fibers.

  As used herein, the term “film” includes not only films that are formed in a separate film-forming stage and then laminated to one or more other layers, as well as others in the lid or blister component. Also included are layers that are extruded directly onto one of the layers.

  As used herein, the term “full bonded nonwoven” refers to a nonwoven bonded by applying heat or pressure to the nonwoven between two substantially smooth bonded surfaces. A fully bonded nonwoven fabric is bonded by fiber-wire bonding over substantially 100% of its outer surface. The use of a smooth bonding surface results in each surface of the fully bonded nonwoven fabric being bonded substantially uniformly. Fully bonded nonwoven fabrics are described in US Patent Application Publication No. 2005/0130545.

  FIG. 1 illustrates a schematic elevation view of a blister package according to the present invention. The lid component 1 is heat sealed to a blister component that includes a plurality of cavities 2. The lid and blister components are heat sealed at the shoulder area 3 separating the individual cavities. The shoulder area generally includes perforations (not shown) between individual blisters or groups of individual blisters.

  The blister component is formed from a molded web comprising at least one barrier layer, such as a polymer film, a coated polymer film, or a metal foil. Suitable molded webs for forming blister components are known in the art. For example, a blister component can be manufactured by thermoforming cavities into a barrier film. Alternatively, the blister component can be formed from a soft or hard tempered foil such as an aluminum foil layer. Films and foils suitable for forming blister components generally have a thickness of about 5.0 mils (0.125 mm) to 15 mils (0.38 mm) for pediatric safety packaging. For example, a typical film thickness is about 10 mils (0.25 mm). The blister component can be formed from a multilayer sheet structure, such as a multilayer film or film-foil laminate.

  FIG. 2a is a cross-sectional view of an embodiment of a lid component suitable for use in peel-open, tear-open, and peel push-through blister packages of the present invention. A nonwoven layer 5 comprising at least one melt spun continuous filament sheet is joined to the heat-resistant layer 4 on one side of the nonwoven layer 5 and joined to the barrier layer 7 on the other side by an intervening adhesive tie layer 6. . The heat seal layer 8 is adhered to the barrier layer on the side of the barrier layer opposite the tie layer. The blister package is formed by heat sealing the lid component to the blister component with the heat seal layer 8 facing the blister component such that the heat resistant layer 4 forms one of the outer surfaces of the blister package.

  During heat sealing of the lid component to the blister component, the platen transfers heat through the lid component to activate the heat seal layer. Depending on the melting point of the nonwoven layer, the temperature of the platen and the pressure between the platen and the nonwoven layer and the time of contact, some softening or melting of the nonwoven layer can occur. The presence of a heat resistant layer between the nonwoven layer and the platen helps to suppress softening or melting of the nonwoven layer while transferring heat to the heat seal layer.

  Suitable heat resistant layers for use in the lid component shown in FIG. 2a include cellulosic resins such as ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, methyl cellulose, cellulose acetate, cellulose acetate butyrate, and nitrocellulose; polyvinyl alcohol, poly Vinyl resins such as vinyl acetate, polyvinyl butyral, polyvinyl acetal, and polyvinyl pyrrolidone; acrylic resins such as polyacrylamide, polyacrylonitrile-co-styrene, and polymethyl methacrylate; and silicone resins such as polyester resin and polydimethylsiloxane, silicone modification Or a fluorine-modified urethane resin etc. are contained. The heat-resistant layer may further contain a crosslinking agent.

  The tie layer 6 shown in FIG. 2a is peelable (eg with a peel push-through package) or non-separable between the nonwoven layer and the barrier layer, depending on the desired method for opening the blister package Can be formed (eg in peel-open or tier-open packages). A seal or joint is considered non-peelable if the layers joined by the non-peelable seal are not easily opened by an adult by manual peeling. In general, a seal having a peel strength of about 3-4 pounds per inch (5.1-7.2 N / cm) is preferred for a peelable seal. Peel strengths of less than about 3 pounds / inch generally peel too easily and are not useful in pediatric safety packages. Seals having a peel strength greater than about 4 pounds / inch are generally considered non-peelable or permanent seals. Peel strength can be measured according to ASTM F88-0 using the unsupported fixation method for samples described therein. Similarly, the heat seal layer 8 provides a peelable seal (eg, in a peel-open package) or a non-peelable seal (eg, in a peel push-through or tear-open package) between the barrier layer and the blister component. Can be formed. Examples of lid configurations according to FIG. 2a include (a) heat resistant layer / melt-spun continuous filament nonwoven sheet / adhesive tie layer / metal foil / heat seal layer and (b) heat-resistant layer / melt-spun continuous filament nonwoven sheet. / Adhesive tie layer / barrier film (metallized or non-metallized, coated or uncoated) / heat seal layer. The barrier film can be a film that is laminated to the nonwoven sheet or can be a layer that is coextruded onto the nonwoven sheet with an adhesive tie layer.

  Suitable barrier layers for use in the lid component shown in FIG. 2a include aluminum foil and monolayers, multilayers, and coated polymer films, and metallized polymer films, as well as foil layers such as film-foil laminates. And foil sheets such as laminated structures.

  Examples of other materials useful either as a barrier layer suitable for use in a lid component or as a blister component include polyvinyl chloride (PVC), polychlorinated used as monolayer films PVC films coated with vinylidene (PVdC), PVC films laminated with poly (chlorotrifluoroethylene) (PCTFE) films such as Aclar® PCTFE films available from Honeywell, Inc. (Morris Township, NJ), Used as cold-formable foils such as cycloolefin copolymer (COC), PVC / aluminum / nylon laminate structures, monolayer aluminum foils, monolayer films used as part of laminated or coextruded structures Polypropylene (PP), used as a monolayer film Poly (ethylene terephthalate) (PET), and poly modified with 1,4-cyclohexanedimethanol, available from Eastman Chemicals (Kingsport, TN) as a PETG copolymer used as a monolayer film (Ethylene terephthalate) copolymer is mentioned.

In one embodiment, the barrier layer comprises a polymer film that includes a polymer coating. For example, the barrier layer can comprise a PVdC-coated polyester film, such as a PVdC-coated Mylar® polyester film (eg, M30 and M34 films available from DuPont Teijin Films). In another embodiment, the barrier layer comprises a polymer film coated with a ceramic material. Suitable ceramic materials for coating the polymer film include oxides, nitrides or carbides of silicon, aluminum, magnesium, chromium, lanthanum, titanium, boron, zirconium, or mixtures thereof. Methods for depositing ceramic coatings on substrates are known in the art, such as by vapor deposition under vacuum or gas phase on a film layer at a thickness of about 5 to 500 nanometers (nm). It is. Suitable ceramic coated films include at least one layer of 5 to 500 nm thick SiO _x where x is a number in the range of 1.1 to 2 or Al _y O _z where Polyolefin film having a thickness of 23-100 micrometers (μm) or polyester film having a thickness of 12-80 μm, coated with a ratio y / z is a number in the range of 0.2-1.5) And films made of thermoplastic materials. Alternatively, the barrier layer can comprise a metallized film produced using methods known in the art such as vacuum evaporation or sputter coating. In one embodiment, the barrier layer is a metallized polyester film, such as a poly (ethylene terephthalate) film on which an aluminum metal layer is coated, preferably the metal layer is between about 10 angstroms and 1000 angstroms thick. Yes, the film is preferably at least 12 μm thick. Metallized polyester films are known in the art and include aluminum coated polyester films such as Mylar® MC2 aluminum coated polyester film (available from DuPont Teijin Films). When the barrier layer of the lid component comprises a ceramic coating or a metallized polymer film, the film can be ceramic coated or metallized on one or both sides. The polymer film is preferably ceramic coated or metallized on one side thereof, and the lid is preferably to avoid metallization on the packaged material or flaking of the ceramic layer when the package is opened. The metallized or ceramic coated surface of the film is configured to contact the adhesive tie layer 6. Metallized and ceramic coated films generally have better barrier properties than unmetallized and uncoated films, and therefore can be achieved with unmetallized or uncoated films. Preferred when a high barrier is required.

FIG. 2b is a cross-sectional view of a second embodiment of a lid component suitable for use in the peel-open and tier-open blister packages of the present invention. The lid component includes a heat resistant layer 4 'adhered to one surface of the nonwoven layer 5' and a heat seal layer 8 'adhered to the other surface of the nonwoven layer 5'. In this embodiment, the heat seal layer is selected so that it is not only heat sealable but also a barrier layer, thus eliminating the need for separate barrier and heat seal layers. The nonwoven layer comprises at least one melt spun continuous filament nonwoven sheet. When a heat-sealable barrier layer is applied as a coating on the nonwoven layer, it completely coats the nonwoven layer to provide the desired barrier properties in the blister package. For example, PVdC at a basis weight in the range of coated 5g / m ² ~120g / m ² non-woven layer can also provide sufficient barrier properties functions not only as a heat seal layer. Depending on the choice of heat sealable barrier layer and blister component, the heat seal can be peelable or non-peelable. When it is desired to form a peel-open package, the heat-sealable barrier layer and the blister component are selected such that the heat seal is peelable. When it is desired to form a tier-open package, the heat seal is preferably non-peelable. In one embodiment of the invention according to FIG. 2b, a tier-open package is formed using a PVdC blister component and a PVdC heat-sealable barrier layer (the heat seal is non-peelable). In another embodiment of the invention according to FIG. 2b, a peel-open package is formed using a PVC blister component and a PVdC heat-sealable barrier layer, where the PVdC formulation is peeled from the PVC blister. Selected to form a possible seal. The lid shown in FIG. 2b optionally includes a non-peelable tie layer (not shown) between the nonwoven layer and the heat seal / barrier layer. For example, the tie layer can be a polyester-based polyurethane composition such as Adcote® polyurethane adhesive available from Rohm & Haas (Philadelphia, PA).

  Melt spun continuous filament nonwoven sheets suitable for use in the nonwoven layer in the lid component include a spunbond web and a composite nonwoven comprising at least one spunbond web. A spunbond web suitable for use in the lid component of the blister package of the present invention can be manufactured using spunbonding methods known in the art. Alternatively, the melt-spun continuous filament nonwoven sheet is pre-collected that is laid down on a collection surface, such as in the method described in Davies et al., US Pat. No. 3,595,731. Can be formed from continuous filaments. Suitable polymers for forming melt spun continuous filament nonwoven sheets include polyesters such as poly (ethylene terephthalate) and poly (1,3-propylene terephthalate), polyamides such as nylon 6,6 and nylon 6, and the like These copolymers are included.

  Melt-spun continuous filaments of continuous filament nonwoven sheets can be spun from a single polymer or from a homogeneous or heterogeneous blend of two or more polymers. A homogeneous blend is defined as a mixture of two or more polymers where the final composition does not have discrete polymer regions throughout the filament. A heterogeneous blend is defined as a mixture of two or more polymers with distinct polymer regions throughout the filament. Alternatively, the melt spun continuous filament nonwoven sheet can comprise a multi-component spunbond web. The multi-component spunbond web preferably includes a polymer component having a melting point that is lower than the melting points of the other polymer components to facilitate thermal bonding of the web. Examples of suitable multicomponent fiber cross sections include composite fibers such as those having side-by-side or sheath-core cross sections. In one embodiment of the present invention, the melt-spun continuous filament nonwoven sheet is a multicomponent sheath-core spunbond fiber having a substantially concentric cross section, wherein the melting point of the sheath component is at least 10 ° C. above the melting point of the core component. Preferably containing at least 20 ° C. lower spunbond fibers. In one embodiment, the melt spun continuous filament includes a polyester copolymer sheath and a polyester core. For example, the sheath can include a poly (ethylene terephthalate) copolymer and the core can include poly (ethylene terephthalate). Poly (ethylene terephthalate) copolymers suitable for use as the sheath component include amorphous and semi-crystalline poly (ethylene terephthalate) copolymers. For example, not only the poly (ethylene terephthalate) copolymer formed from 1,4-cyclohexanedimethanol, about 5-60 mole percent based on the glycol component, but about 5-30 mole percent based on the diacid component Poly (ethylene terephthalate) copolymers formed from dimethylisophthalic acid are also suitable for use as the lowest melt component in multicomponent fibers. Poly (ethylene terephthalate) copolymers modified with 1,4-cyclohexanedimethanol are available from Eastman Chemicals (Kingsport, TN) as PETG copolymers. Poly (ethylene terephthalate) copolymer modified with dimethylisophthalic acid is E. coli as Crystar® polyester copolymer. I. available from du Pont de Nemours and Company (Wilmington, DE) (DuPont).

  Composite nonwoven fabrics comprising spunbond webs suitable for use in lid components include spunbond and / or meltblown non-woven fabrics such as spunbond-meltblown (SM) composite nonwovens, SMS composite nonwovens, and SMMS composite webs. Composite nonwoven fabrics including other combinations of woven webs are included. The meltblown web used to produce the composite nonwoven can be a single component or multicomponent meltblown web and can be produced using methods known in the art.

  A particularly suitable lid component can be obtained by smooth surface thermal bonding of nonwoven webs, where fiber-fiber hot melt bonding is non-woven as disclosed in US 2005/0130545. Heat the web between two smooth joint surfaces to a temperature sufficient to melt or soften the surface of the fiber on one or both sides of the nonwoven web to be formed at the fiber intersection on one or both sides of the web Can be achieved.

  Thermal calendering methods using various roll shapes are known in the art. The nonwoven layer can be calendered such that one side of the nonwoven layer is thermally bonded with the thermally bonded surface forming one of the outer surfaces of the final blister package. Alternatively, the nonwoven layer can be calendered so that both sides of the nonwoven layer are thermally bonded. Examples of other calendering methods suitable for joining nonwoven layers include David, US Pat. No. 3,532,589, Janis, US Pat. No. 5,972,147, and Lim. Et al., Those disclosed in US Pat. No. 5,308,691.

  In one embodiment, the nonwoven layer comprises a fully bonded melt spun multicomponent continuous filament nonwoven fabric that is heat bonded on both sides in a smooth calendering process. Fully bonded melt spun multicomponent continuous filament nonwovens have an improved combination of tensile strength and tear strength for a given fabric thickness compared to comparable smooth calendered single component melt spun nonwovens. Suitable full surface bonded melt spun multicomponent continuous filament nonwoven fabrics include a spunbond web comprising sheath / core fibers, which are smooth calendered and bonded on both sides, the melting point of the sheath being at least 10 ° C. below the melting point of the core, etc. A fully bonded two-component spunbond web. Suitable sheath components include polyester copolymers, poly (1,4-butylene terephthalate (4GT), and poly (1,3-propylene terephthalate) (3GT), and polyamides such as polycaprolactam (nylon 6). Suitable core components include poly (ethylene terephthalate) and poly (hexamethylene adipamide) (nylon 6,6) For example, a fully bonded two-component spunbond web includes a polyester copolymer sheath and Composite fibers having a poly (ethylene terephthalate) core can be included.

  A lid component comprising a non-woven layer and a barrier layer is at least 0.5 Joule, preferably at least 0.6 Joule Spencer Puncture (ASTM modified for a 9/16 inch diameter probe). As well as at least 2.0 N, preferably at least 2.5 N Elmendorf Tear (measured according to ASTM D1424) in both the longitudinal and transverse directions.

  In one embodiment of the present invention, the heat seal layer includes a peelable sealant, thus providing a peel-open blister package. Whether a particular heat seal layer forms a peelable seal is determined by the layer to which it is sealed (eg, the blister component and barrier layer for the embodiment shown in FIG. 2a or the embodiment shown in FIG. 2b). May depend on the nature of the blister component and the non-woven layer). In the peel-open configuration, the package is opened by peeling the multi-layer lid component from the blister component, with peeling occurring between the heat seal layer and the blister component. Exfoliable sealants suitable for use in the heat seal layer of the packages of the present invention include extrudable sealants such as E.I. I. Polychlorinated as well as blends of polyolefin resins containing primarily ethylene vinyl acetate or ethylene methyl acrylate copolymers, such as Appel® resin, available from du Pont de Nemours and Company (Wilmington, DE). Also included are vinylidene or solvent-based sealants such as modified vinyl / acrylic sealants available from Watson Rhenania (Pittsburgh, PA) such as JVHS-157-LT1 sealant. The heat seal layer can be applied to the barrier layer of the lid component using methods known in the art including, but not limited to, roll coating, gravure coating, spray coating, and extrusion coating. In peel-open packaging, the nonwoven and barrier layers are strongly bonded together, allowing the multi-layer lid to be cleanly separated from the blister component without delamination between the nonwoven and barrier layers. Thus, a non-peelable adhesive tie layer is preferably used to join the nonwoven layer to the barrier layer. Non-peelable adhesive tie layers suitable for use in the lids used in peel-open packages of the present invention include polyester-based polyurethane adhesives such as Adcote available from Rohm & Haas (Philadelphia, PA). Included are solvent-based two-component dry bond adhesive compositions such as a polyurethane-based adhesive. In the dry-bond method, the adhesive is applied to either the barrier layer or the nonwoven layer or both, while the two layers are either “dry” or substantially free of solvent. Joined together. If the starting adhesive composition contains a solvent, it is dried before laminating the nonwoven layer to the barrier layer. Other adhesive compositions that provide a non-peelable tie layer include modified ethylene vinyl acetate, ethylene vinyl acetate, and ethylene methyl acrylate based resins such as E.I. I. Included are extrudable resins such as Bynel® and Nucre® modified ethylene vinyl acetate and modified ethylene methyl acrylate resin, available from du Pont de Nemours and Company (Wilmington, DE).

  In another embodiment of the blister package of the present invention, the blister package is such that the outer nonwoven layer is bonded to the frangible barrier layer by a peelable tie layer and the packaging material is pushed through. It is a peel-push through package that is peeled from the package to expose it. A layer is considered fragile if the packaged material can be removed by tearing the layer by applying pressure outside the blister cavity. Delamination may occur between the nonwoven layer and the adhesive tie layer, or between the adhesive tie layer and the barrier layer. The adhesive tie layer is preferably selected such that when the package is opened without tearing or otherwise tearing the barrier layer, it remains adhered to the nonwoven layer and peels cleanly from the barrier layer. . That is, the adhesive tie layer preferably has a high adhesion to the nonwoven layer and a relatively low adhesion to the frangible barrier layer. If peeling occurs between the nonwoven layer and the adhesive tie layer, the adhesive tie layer should be a frangible layer as well. For example, in a peel-push-through package comprising a lid component according to FIG. 2a, the adhesive tie layer is a peelable layer so that the nonwoven layer can be peeled from the barrier layer of the lid component, and here Combined barrier layer / heat seal layer (for peeling between adhesive tie layer and barrier layer) or combined adhesive tie layer / barrier layer / heat seal layer (between nonwoven layer and tie layer) Is easy to break. Examples of fragile barrier layers include metal foil (eg, aluminum foil), fragile polymer film (eg, biaxially oriented poly (chlorotrifluoroethylene) film), fragile metallized polymer film, and fragile ceramic coated polymer film. Is mentioned. The fragile layer is selected such that once the nonwoven layer (or combined nonwoven / adhesive tie layer) has been peeled from the package, the pharmaceutical or other packaged material can be forced through the fragile layer. The adhesive tie layer is on a nonwoven layer (eg, melt spun continuous filament polyester-based spunbond web) or a breakable barrier layer joined together by an intermediate tie layer and one or both of the nonwoven and barrier layers. Can be extruded or coated. Examples of suitable peelable tie layers include modified vinyl / acrylic compositions such as JVHS-157-LT1 modified vinyl / acrylic adhesive available from Watson Rhenania (Pittsburgh, PA), or E.I. I. A blend of polyolefin resins primarily comprising ethylene vinyl acetate or ethylene methyl acrylate copolymer, such as Appel® polyolefin resin, available from du Pont de Nemours and Company (Wilmington, DE), and Rohm & Haas Examples include solvent-based modified acrylic pressure sensitive adhesives such as Adcote L74X105 (Philadelphia, PA). The heat-seal layer in the peel-push-through package is selected such that it forms a non-peelable seal between the blister component and the barrier layer in the lid. Examples of suitable permanent (non-peelable) sealants include modified vinyl / acrylic compositions such as JVHS-157-2, both available from Watson Rhenania (Pittsburgh, PA), or modified such as GNS01-014 Examples include polyester sealants.

  When a tier-open package is desired, the adhesive tie layer and heat seal layer of FIGS. 2a and 2b provide a non-peelable bond / seal between the barrier layer and the blister component and between the nonwoven layer and the barrier layer. Selected to form between. This allows the package to be cleanly torn at the pre-formed notches in the package without delamination occurring between the various layers in the multi-layer lid component.

  The blister package of the present invention can be manufactured using methods known in the art. FIG. 3 illustrates a process that is suitable for forming the blister package of the present invention. The blister cavity 10 is generally thermoformed into the formed web inline just prior to filling the cavity with the material 12 to be packaged. The lid component 14 is unwound from the roll 15 and brought into contact with the molded and filled blister component such that the heat seal layer of the lid component is in contact with the blister component. The lid and blister components are typically heat sealed using a heated platen 16 with or without a pattern. In general, some areas are not sealed to provide a starting point for peeling the lid or selected layers of the lid before removing the product. If the lid component has not been previously printed, printing is generally performed immediately prior to heat sealing (not shown). After heat sealing, the individual blisters are generally perforated (not shown) using methods known in the art so that they can be removed at the point of use. If the blister package is a tier-open package, notches are formed in the individual blisters during the perforation process. The nicks are preferably contained inside the package so that the individual blisters are not exposed until they are removed at the point of use. The indent can also be formed on one of the outer edges of the blister package, but forming an indent on the inside of the package reduces the chance that the child can tear open the package. Individual blister packages 18, which can include multiple blisters (as shown in FIG. 4) or a single blister, are then cut from a continuous sheet of sealed blisters. It is important that all materials maintain dimensional stability during the blister packaging process thanks to the platen registry, printing registry, and perforation registry.

  The improved tear resistance provided by the continuous filament nonwoven layer in the lid component of the package of the present invention provides a peel-push through and peel-open package where the lid or nonwoven layer cleanly peels away from the package without tearing. In contrast, packages known in the art that utilize paper-film-foil laminates often do not provide a clean release, thus making it difficult for even adults to open the package. Although the tear resistance of the lid components of the package of the present invention is improved compared to prior art lid materials, they are also used for tear-open packages where tearing is initiated by a pre-formed score. be able to.

Test Methods In the above description, the following test methods are used to measure various reported properties and properties. ASTM refers to the American Society for Testing and Materials.

Basis weight is a measure of the mass per unit area of a fabric or sheet, measured by ASTM D-3776 and reported in g / m ² units.

  Tensile strength is a measure of the force required to break apart a material by tension. For nonwovens and nonwoven / foil laminates, tensile strength is measured according to ASTM D5035 and reported in units of pounds per inch or N / cm. For nonwoven / film laminates, tensile strength is measured according to ASTM D882 and reported in units of N / cm.

  Elongation is a measure of the extent of a substrate that stretches before it breaks and is measured by ASTM D5035 and reported in percent.

  Elmendorf tear is a measure of the force required to propagate an initial tear from a break or nick. Elmendorf tear is measured according to ASTM D1424 for nonwovens and nonwoven / foil laminates and is reported in units of pounds or N. Elmendorf tear is measured according to ASTM 1922 for nonwoven / film laminates and is reported in units of Newtons.

  Spencer penetration is a measure of the ability of a substrate to resist penetration by impact. Spencer penetration was measured using a bullet shaped probe for nonwoven and nonwoven / foil laminates with ASTM D3420 (modified for 9/16 inch diameter probe) with a pendulum capacity of 5.4 Joules. Measured and reported in joules.

Example 1
The nonwoven sheet of the present invention is produced by the high speed spinning method disclosed in US Pat. Nos. 3,802,817, 5,545,371, and 5,885,909. It may be produced using a high speed melt spinning method. Spunbond fabric is a linear low density polyethylene (obtained from Equistar, melting point 125 ° C.) and an intrinsic viscosity of 0.53 (US Pat. No. 4,743,504) available from DuPont as Crystar polyester (Merge 3949). (As measured in the specification) using a two-component spin pack that produces fibers from poly (ethylene terephthalate) polyester. The polyester resin was crystallized at a temperature of 180 ° C. before use and dried at a temperature of 120 ° C. to a moisture content of less than 50 ppm.

  In a separate extruder, the polyester was heated to 290 ° C and the polyethylene was heated to 280 ° C. The polymer was extruded, filtered and metered into a two component spin pack maintained at 295 ° C. and designed to give a sheath-core filament cross section. The polymer was spun through a spinneret to produce a polyethylene sheath and poly (ethylene terephthalate) core composite filament. The total polymer extrusion rate per spin pack capillary was 0.8 g / min. The polymer was metered to give filament fibers that were 30% polyethylene (sheath) and 70% polyester (core) based on fiber weight. The filament was cooled in a 38 cm long quench zone with quench air provided from two opposing quench boxes at a temperature of 12 ° C. and a speed of 1 m / sec.

The web was thermally bonded between two polished chrome rolls. The webs were bonded at a temperature of 125 ° C., a nip pressure of 500 psi, and a line speed of 22.9 m / min. The joining sheet was collected on a roll. The physical properties of the nonwoven sheet are shown in the table. The heat bonded nonwoven was then mixed with 0.5 part polydimethylsiloxane coating (NuRelease 17J Part A, NuRelease 17J Part B, NuTech, Newark, NJ) with 0.5 part polydimethylsiloxane. , NuTech, Newark, NJ) using a roll coater at a line speed of 50 m / min. The coating was then dried at 80 ° C. to form a surface layer with a dry coat weight of 0.5 g / m ² . The heat resistant coating that forms the nonwoven structure of the present invention may be applied by conventional coating methods. Thus, by way of example and not limitation, US Pat. No. 6,071,585 (spray coating, roller coating, gravure, or application with a doctor blade, such as a kiss roll, air knife, or Meyer bar) ), US Pat. No. 5,981,058 (Myer bar coating), US Pat. No. 5,997,227, US Pat. No. 5,965,244, US Pat. No. 5,891,294 Described in the specification, US Pat. No. 5,716,717, US Pat. No. 5,672,428, US Pat. No. 5,573,693 and US Pat. No. 4,304,700. One or more of the existing coating methods may be used.

The thermo-calendered and coated two-component spunbond web was then subjected to Adcote 503A / Cat F solvent-based poly (ethylene terephthalate) -based polyurethane permanent adhesive tie layer obtained from Rohm & Haas (Philadelphia, PA). Used to laminate (uncoated surface) to a 0.93 mil (23 micron) thick soft tempered aluminum foil obtained from Alcoa (Pittsburgh, PA). Lamination was performed using an Inta-Roto dry-bond coater / lamination machine (model “The Delaware”). Adcote 503A / Cat F was mixed in a ratio of 62 wt% 503A, 3.5 wt% Cat F, and 34.5 wt% methyl ethyl ketone and the adhesive was applied using a reverse gravure coating method. The bicomponent spunbond web was unwound from the primary unwind and the adhesive was applied to the bicomponent spunbond web using a counter-rotating gravure roll. Alternatively, an adhesive can be applied to the barrier layer. The gravure roll was engraved with a tri-helical pattern of 35 lines per inch (13.8 lines per cm) where the continuous triangular channel in the spiral pattern avoided the gravure roll. The machine speed was 65 feet / minute (19.8 m / minute). Typical line speeds used in the reverse gravure coating process are usually about 15 m / min to 305 m / min. The adhesive was applied at a dry coating weight of about 8 g / m ^2. About adhesive tie layer dry coating weight of 3g / m ² ~10g / m ² is generally used, a dry coating weight of about 4g / m ² ~8g / m ² is generally preferred. The coated spunbond web was dried to remove the solvent present in the tie layer adhesive using a hot air impingement dryer. Air heated to 74 ° C. was forced through the grooved nozzle assembly onto the adhesive-coated surface of the spunbond web to evaporate the solvent.

  After drying, the adhesive-coated spunbond web layer was laminated to a foil layer that was unwound from the roll and contacted with the adhesive-coated surface of the spunbond web at a nip formed by two cylindrical calender rolls. One of the rolls was a rubber covered roll and the second roll was a steel roll heated to 82 ° C. by internal water heating. The nonwoven web was in contact with the heated steel roll at the nip and the aluminum foil was in contact with the rubber face roll. The laminated substrate was then wound again on a rewinder.

A solvent-based peelable heat seal layer was then applied to the aluminum foil surface of the spunbond web / aluminum foil laminate using the reverse gravure coating method described above. The peelable heat seal composition used was a vinyl / acrylic solvent-based sealant (JVHS-157-LT1, supplied by Watson-Rhenania, Pittsburgh, PA). A heat seal coating was applied to the nonwoven / foil laminate at 5.2 g / m ² . In general, heat seal coatings applied at a dry coating weight of 4.8 to 5.6 g / m ² are preferred. After the sealant was applied, the coating material was dried to remove the ethyl acetate solvent using the same hot air impingement dryer described above and an air temperature of 275 ° F. (135 ° C.). After drying, the laminate was wound up again on a rewinder. The multi-layer laminate can be used directly as a lid component to produce a blister package, or further processed by printing on the nonwoven side of the laminate prior to forming the blister package. The penetration resistance and Elmendorf tear of the manufactured laminate lid components are shown in the table.

  The blister package was manufactured according to the process shown in FIG. 3 using a Uhlmann 1070 form-fill-seal blister packaging machine. The molded web used to form the blister component was a 10 mil (0.254 mm) Pengapharm M570 / 01 polyvinyl chloride film supplied by Klockner Pentaplast of America (Gordonsville, Va.). The platen used to heat seal the lid to the blister component was heated to a temperature of 200 ° C. to obtain a peel-open package. A number of blister packages of the present invention were made on this machine without any sticking of the nonwoven to the platen.

Example 2
In Example 2, the heat resistant coating added to the nonwoven fabric was a silicone / urethane copolymer (SP-2105, Advanced Polymer, Carlstadt, NJ) containing an isocyanate crosslinking agent (D-70 Advanced Polymer, Carlstadt, NJ). The same production as in Example 1 was carried out except for. The crosslinker was added at 8 parts to the silicone / urethane copolymer. The physical properties of the laminate lid component are shown in the table. A number of blister packages were produced without the nonwoven sticking to the platen of the blister packaging machine.

Comparative Example A
Comparative Example A was prepared in the same manner as Example 1 except that no heat resistant coating was added to the nonwoven fabric. The physical properties of the laminate lid component are shown in the table. A number of blister packages were produced with the non-woven sticking to the platen of the blister packaging machine. The adhesion problem is a result of the low melting point of the polymer in the nonwoven and the absence of a heat resistant coating.

Comparative Example B
Comparative Example B was prepared in the same manner as Example 2 except that the crosslinker (D-70 Advanced Polymer, Carlstadt, NJ) was added in 4 parts to the silicone / urethane copolymer. The physical properties of the laminate lid component are shown in the table. A number of blister packages were produced with the non-woven sticking to the platen of the blister packaging machine. The sticking problem is the result of incomplete crosslinking of the coating resulting in a soft and sticky surface.

Table Properties of non-woven / foil lid components

Claims (20)

  A blister package comprising a blister component having an inner surface and an outer surface and a multi-layer lid component having an inner surface and an outer surface, wherein a selected portion of the inner surface of the blister component and a selected inner surface of the lid component First parts selected from the group consisting of a polymer film, a coated polymer film, a metal foil, and a film-foil laminate, wherein the parts are bonded together to form at least one cavity therebetween. A blister package comprising a barrier layer, wherein the lid component comprises a second barrier layer, a nonwoven layer comprising at least one melt spun continuous filament nonwoven sheet, and a heat resistant layer.   The blister package of claim 1, wherein the second barrier layer comprises a sheet layer selected from the group consisting of a polymer film, a coated polymer film, a metallized polymer film, and a metal foil.   The lid component includes an adhesive tie layer intermediate, the second barrier layer, and an inner surface of the lid component including a heat seal layer, and an outer surface of the lid component includes the heat-resistant layer. The non-woven layer having a heat-resistant layer bonded to the side opposite to the adhesive tie layer; and a heat seal layer bonded to the side of the second barrier layer opposite to the adhesive tie layer; The blister package of claim 2, wherein the lid component and the blister component are heat sealed to each other to form a seal therebetween.   The heat seal layer is a polyvinylidene chloride, vinyl / acrylic composition, a blend of polyolefin resins comprising an ethylene vinyl acetate copolymer, a blend of polyolefin resins comprising an ethylene / methyl acrylate copolymer, and a polyester-based composition The blister package of claim 3, comprising a heat sealable sealant selected from the group consisting of:   The tie layer is a vinyl / acrylic composition, a polyolefin resin blend containing an ethylene vinyl acetate copolymer, a polyolefin resin blend containing an ethylene / methyl acrylate copolymer, an ethylene vinyl acetate resin, an ethylene / methyl acrylate resin, The blister package of claim 3, comprising an adhesive composition selected from the group consisting of: and a polyester-based polyurethane.   The blister package of claim 3, wherein the second barrier layer comprises a breakable sheet layer selected from the group consisting of a breakable polymer film and a breakable metal foil.   The blister according to claim 1 or 3, wherein the heat-resistant layer includes a binder composition selected from the group consisting of a cellulose resin, a vinyl resin, an acrylic resin, a polyester resin, a silicone resin, and a silicone-modified or fluorine-modified urethane resin. package.   The blister package of claim 7, wherein the binder composition comprises a cellulosic resin selected from the group consisting of ethyl cellulose, hydroxyethyl cellulose, hydroxypropyl cellulose, methyl cellulose, cellulose acetate, cellulose acetate butyrate, and nitrocellulose.   The blister package of claim 7, wherein the binder composition comprises a vinyl resin selected from the group consisting of polyvinyl alcohol, polyvinyl acetate, polyvinyl butyral, polyvinyl acetal, and polyvinyl pyrrolidone.   The blister package of claim 7, wherein the binder composition comprises an acrylic resin selected from the group consisting of polyacrylamide, polyacrylonitrile-co-styrene, and polymethyl methacrylate.   The blister package of claim 7, wherein the binder composition comprises a polydimethylsiloxane silicone resin.   The blister package of claim 7, wherein the binder composition further comprises a cross-linking agent.   4. A blister package according to claim 1 or 3, wherein the nonwoven layer comprises a single component spunbond web.   The blister package of claim 1 or 3, wherein the nonwoven layer comprises a fully bonded multi-component spunpond web.   The blister package of claim 1 or 3, wherein the nonwoven layer comprises at least one meltblown web sandwiched between first and second melt spun continuous filament nonwoven sheets.   The blister package of claim 15, wherein the first and second melt spun continuous filament nonwoven sheets are multicomponent spunbond webs.   The blister package of claim 16, wherein the at least one meltblown web is a multi-component meltblown web comprising composite side-by-side meltblown fibers.   The blister package of claim 16, wherein the first and second multi-component spunbond webs comprise sheath-core spunbond fibers wherein the core component comprises polyester and the sheath component comprises a polyolefin.   The second barrier layer is a heat-sealable barrier layer adhered to the nonwoven layer, the inner surface of the lid component includes the heat-sealable barrier layer, and the lid component and the blister The blister package of claim 1, wherein the components are heat sealed together to form a seal therebetween.   The blister package of claim 19, wherein the heat sealable barrier layer comprises polyvinylidene chloride.

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