KR100503560B1 - Pill blister packaging with child safety backing - Google Patents

Abstract

Cut lines are formed on the exposed surface of the blister molded sheet. The cut line is formed from one edge of the individual blister unit to the opposite or adjacent edge. When the blister unit is bent or bent at the cut line, the blister molding sheet is broken. A small portion of the broken molded sheet still attached to the backing material acts as a tab to peel off the backing sheet from the molded sheet to expose the blister contents.

Description

Blister Packaging For Pills With Child Safety Backing

The present invention relates to a safety blister package that encloses a medicament or a pill.

As disclosed in US Pat. No. 3,809,211, one of the problems currently faced by parents is to keep medications or pills out of the reach of children. Children do not have the ability to recognize the risks of taking unprescribed medications. This fact makes it easy for adults to have access to the packaged pills, but the need for the packaging of the tablets to make them inaccessible to children is required.

Recently, press-through packaging (PTP) or "blister" packaging is widely used as a packaging unit for oral pharmaceuticals or pills. A press-release package is a first sheet, typically formed of transparent polyvinyl chloride or polystyrene, having flexible round bubbles that form an independent compartment for one or more pills, and attached to the first sheet and being made of aluminum It is formed from a tearable second sheet such as a foil or paper sheet. The metal foil is attached by heat sealing, solvent adhesion, glue bonding or other method of attaching the foil sheet to the blister sheet. The pill is removed from the blister compartment by pressing the flexible blister, forcing the pill against the foil, rupturing the foil, and ejecting the pill.

Often, when making such a press release package, a rigid tray is included between the first and second sheets, the rigid trays being provided with holes matching the blisters of the first sheet. Rigid trays are used to protect tablets from contamination and mechanical damage, and may include printed dosage instructions such as the type of tablet or the specific time taken and the amount already taken.

A recent trend towards the packaging of medications is to provide safe packaging, even if found by children. Most of the development of "child-resistance" relates to the improvement of pill bottles. In this regard, safety caps have been developed which require a certain series of compression and rotation to open the bottle. However, little development has been made in the field of "child safety" pressurized blister packaging contemplated by the present invention. .

Packaging using one or more backing layers in a pressurized blister package did not use a layer of backing material that would not rupture. Conventional backing layers used to coat the rupturable layer are made of paper or foil, have cut lines or are fragile, so that all the backing layers can be ruptured by pressing the packaged pills. This conventional backing layer provides information printed on the underside of the pill package and has been used for additional sealing bonds to protect the pill from the surrounding environment. See, for example, US Pat. Nos. 3,503,473 (betting), 3,621,992 (Osborn), 2,317,860 (Sorrensen) and 3,387,699 (Heller). In each of the above patents, the multiple backing layers used for blister or press release pill packaging are easily ruptured or peeled off and do not have sufficient strength to provide "child safety".

One attempt to provide a "child safety" blister pill package is disclosed in US Pat. No. 3,472,368 to Healthstrom. In this patent, as disclosed in the detailed description of the present invention, no second backing member is provided which is peeled off to expose the rupturable layer. The packaging suggests “child safety” by simply providing a burstable sheet that is very difficult to rupture, so the Hellstrom patent relies on the fragility of the child as an essential element to prevent the child from opening the package. Doing.

In US Patent No. 3,921,805 (Compir), it is essential to provide a pill package that requires knowledge of the package opening sequence rather than the minimum strength for opening the package. People who want to take pills generally do not have a very strong physical condition. Often, the strength of a child is greater than that of a sick person and a person trying to take a pill. Because of this fact, the present invention has been developed to provide a pill package that can be opened by educating adults who may be less powerful than average children. Children who are not educated about opening a package disclosed herein do not have access to the contents of the package. Thus, the present invention relies on the adult's superior knowledge rather than the adult's superior strength to produce a package that is easily opened by an adult but not opened by a child.

It is a primary object of the present invention to provide a "child safety" pill package that can be easily opened by a person who has been educated on how to open it but cannot be opened by an uneducated child.

Another object of the present invention is to provide a pill package that, when opened, allows a user to access only one dose of the pill lower than the lethal dose.

Another object of the present invention is to provide a pill package that can access the required number of pills when opened.

It is another object of the present invention to provide a pill package in which one pill or one dose of pill can be removed from the package and the remaining pill can be held in an air-tight enclosure.

Another object of the present invention is to provide a pill package which does not require the use of cumbersome bottles.

It is still another object of the present invention to provide a pill package in which each individual pill is separately packaged so that the user can carry the necessary dosage without having to carry an excessive pill.

It is a further object of the present invention to provide a pill package which requires an additional package opening to remove each additional pill.

Another object of the present invention is to provide a safety pill package that the average child cannot open without the use of a tool.

It is a further object of the present invention to provide a pill package which allows access to a smaller number of medicaments than the number of units of dangerous medicament by opening the package. The number of units exposed at the opening of each package may vary depending on the toxicity of the packaged medicament.

The present invention is similar to conventional blister packaging, but relates to a blister packaging having a strong flexible backing sheet that surrounds each blister. The strong flexible backing sheet, if stuck, adheres to the underside of the blister sheet in such a way that the backing sheet is not pushed out of the blister sheet when pressure is applied to the blister side of the pill package during attempts to press the tablet through the package. . In order for the rider to take the pills out of the package, they must first peel off the rigid backing sheet. As long as the required adhesion is obtained, the rigid backing sheet is fixed to the blister sheet by heat sealing, solvent adhesion, adhesive bonding, or another method of bonding the two sheets together. Suitable method is heat sealing.

There are a number of heat-sealed coating formulations that can be used to provide heat sealing between the layers of the packaging laminate of the present invention. The heat sealant is commonly used to make foil / paper and resin sheet / resin sheet laminates for soap packaging, carton packaging, liner of cereal foods, cookie packaging and other applications. Typically, the heat sealant is a water dispersion of a vinyl resin that includes a vinyl resin or wax to provide a low heat seal temperature. The vinyl resin can be an ion-linked and acid-modified ethylene interpolymer known as an ionomer resin. Waxes and other modifiers further extend the range of performance properties.

Suitable heat sealants are, for example, water dispersions of ethylene interpolymers such as ethylene / vinyl acetite interpolymers. Vinyl resins have a wide range of adhesive properties with suitable hot tack. Modifiers such as pigments, waxes or other resins can be used.

It is suitable to apply a heat seal coating of about 7 g / m ² . The coating can be applied by known methods such as, for example, curtain coating or roller coating known in the art.

Blister sheets are produced by known methods, for example known blisters such as polyvinyl chloride, copolymers and terpolymers of vinyl chloride and, for example, terpolymers of polyvinyl chloride / polyethylene / polypropylene. It is made of sheet material.

The backing sheet should have a layer or sheet of rigid flexible polymer material of sufficient strength that the tablet cannot be forced out of the hand through the polymer material. It has been found that the sheet of polyester material has sufficient strength to prevent the tablet from being forced out through it. Suitable polyester materials are polyethylene terephthalates.

If a barrier resistive coating is required to prevent moisture from penetrating into the blister, a foil sheet can be used as part of the backing sheet. Metallic foils such as aluminum with a thickness of about 0.02 mm (0.0008 in) are suitable.

In addition, the printing paper sheet may form part of the backing sheet. Bleached kraft paper having a basis weight of about 13.6 kg (301b) is suitable. The date, number or description of the package contents may be printed on paper for consumer information.

The various layers that make up the backing sheet may be laminated to form a single laminated sheet prior to attaching the backing sheet to the blister sheet, or the backing sheets may be stuck together at the same time when attached to the blister. A suitable lamination method is to use a heat seal coating as described above. Often, it is appropriate to provide a sheet of paper at the part farthest from the blister sheet so that the printed portion can be easily read from the underside or non-blister side of the package. However, if there is no need to prevent the penetration of moisture into the blister, the printed paper can be placed next to the transparent blister sheet and can be read through the blister sheet from the top of the package.

The rigid polymer sheet, foil sheet, and paper are blessed in any order, except that the paper sheet cannot be placed next to the blister sheet when it is necessary to prevent moisture from penetrating into the blister. Can be attached to the rotor sheet. Thus, the rigid polymer sheet may be placed next to the blister sheet, or at an intermediate position between the foil and the paper sheet, or at a position farthest away from the blister. If the paper sheet is between the foil and the rigid polymer sheet, the polymer sheet should be transparent so that the printed portion on the paper can be read by the consumer.

When applied as a single laminate structure, the layers of the backing sheet can be fixed by heat sealing, solvent adhesion, adhesive bonding, adhesion of sheets of interlayer adhesives or other methods of securing the layers together. For example, an extruded polyethylene sheet can be disposed between the foil and the paper sheet, as well as between the rigid flexible material and the foil sheet. Extruded polyethylene can stick the three sheets together by application of pressure without the need for heat sealing. It is suitable to use extruded polyethylene sheets or films. Heat seal coatings may be used in addition to the intermediate adhesive layer.

After the blister sheet is fixed to the backing sheet, the backing sheet cannot be forcibly removed from the blister sheet by applying pressure to the pills from the blister side of the package. However, the backing sheet can be easily peeled off the underside of the package so that the blister contents can be taken out. The seal between the blister sheet and the backing sheet should be strong enough to keep the flexible backing sheet in contact with the blister when pressure is applied to the blister. The backing must be strong enough so that the tablet is not ejected through the backing sheet by applying pressure to the tablet from the blister side of the package with the backing sheet engaged.

A rigid polyester that has been found to be particularly effective as at least one component of the backing sheet is polyethylene terephthalate. The thickness of the polyester is suitably about 48 gauge. However, for this use any plastic may be used that has sufficient strength to prevent ejection of the tablet by hand.

A "non-through" cut line may be formed on the exposed surface of the blister molded sheet. Non-penetrating cut lines are formed from one edge of the individual blister unit to opposite or adjacent edges. If the blister unit is bent or bent at the non-penetrating cut line, the blister forming sheet will break. A small portion of the broken molded sheet still attached to the backing material acts as a tab to peel off the backing sheet from the molded sheet to expose the blister contents.

The depth of the non-penetrating cut line into the blister molded sheet is important for producing an effective package. The minimum depth of non-penetrating cut lines can provide more effective child safety packaging than with deeper cut lines, and the maximum depth of non-penetrating cut lines provide more effective adult use packaging than with shallower cut lines. To do it. The effective depth of the cut line is necessary to produce a package that is child safe and efficient for adults for a given product toxicity level.

The above and other objects of the present invention will be better understood from the following detailed description of exemplary embodiments with reference to the accompanying drawings.

Referring first to FIG. 1, a safety blister package is shown at 10. The package 10 may include a plurality of individual blister units 13 having a single or double cavity 11 of a predetermined shape suitable for the shape of a particular medicament or pill contained within the blister. The individual blister units 13 can be separated from each other by tearing the package at the through-cut line 12. Across one corner of each individual blister unit 13, a non-penetrating cut line 14 is formed in the blister sheet 15 to provide an opening for each individual blister unit 13. When the corner portion of each individual blister unit 13 is bent or bent along the non-penetrating cutting line 14, the blister sheet 15 is broken along the cutting line 14.

As shown in FIG. 4, the backing sheet 25 comprises a heat seal coating 16, a foil barrier layer 17, for example a sheet of rigid polymer material such as polyethylene terephthalate and polyester layer 18, and And a paper layer 19 having a portion printed thereon to provide the user with information such as package contents and package unpacking instructions. 2 and 3 show tabs 20 formed by bending or bending corner portions of individual blister units along non-penetrating cutting lines 14 as described above.

As mentioned above, the backing sheet 25 need not include all three layers of foil, strong flexible polymer material, and paper. However, a layer of rigid polymer material is necessary to provide a safety backing to the blister sheet 15 so that pills cannot be ejected from the package without first peeling off the backing sheet 25 from the blister sheet 15.

The heat seal coating 16 is usually extruded onto the foil layer 17. 4 illustrates one embodiment of attaching a foil, a rigid flexible polymer material and a paper layer (ie, backing sheet 25) to the blister sheet 15. The heat seal coating 16 is heated and adhered to the blister sheet 15 under pressure. The layers 17, 18, 19 of the backing sheet 25 may be adhered together by a method of heat sealing, solvent adhesion, adhesive bonding, adhesion of sheets of interlayer adhesive material or bonding other layers together. FIG. 4 illustrates one embodiment of bonding the foil, the strong flexible polymer material, and the paper layer together by adhesive layers 32, 34.

Although the present invention has been described with respect to a medicament or a pill, it can also be used to make child safe packaging for capsules, tablets, suppositories and the like.

There is a significant difference in forming the concept that the present invention is more recognizable, more child-safe, and easier for adults to open, compared to Compier's' 805 patent, for example.

1. Child safety-Children tend to pay attention to different areas on the cavity or "pill" side of the blister unit (ie, protrusions, non-sealed areas). If there are no different areas, the children will randomly pick and bend the blister unit.

a. There are obviously no different areas.

1. No protrusions,

2. There is no accessible unsealed area;

3. The cut lines are hardly visible to the child, especially by being “camouflaged” indistinctly by the crosshatch pattern of the seal.

b. The opening pattern is resistant to the aggressive handling of the random.

1.The cut line depth is minimized,

2. The cutting line is optimally arranged (corner cutting)

2. Ease of opening-Adults do not rely on physical force to open the package.

a. Bending and breaking the tab requires minimal force (depending on the child's approach),

b. Peel strength of the backing material is minimal If the bending operation is not apparent to children, the sealing strength of the backing material to the molding material can be reduced.

3. Cognition-Adults rely on cognitive skills rather than physical forces to open the package. With multiple levels of opening education, adults can effectively access the contents of the package, but children cannot.

1 is a plan view of a safety blister package (card) of the present invention showing multiple individual blister units in one package;

FIG. 2 is a perspective view of one of the individual blister units shown in FIG. 1. FIG.

3 is a perspective view of one of the individual blister units of FIG. 1 with the blister unit partially open;

4 is a partially enlarged cross-sectional view illustrating the various layers, adhesive and non-sealed regions.

Explanation of symbols on main parts of drawing

10 packing 11: hollow

12: cutting line 13: blister unit

15: blister sheet 16: coating film

17: foil layer 18: polyester layer

20: tab 25: backing sheet

Claims (6)

A first sheet having one or more blister units each comprising a flexible blister forming a compartment suitable for containing a medicament; Closing and sealing the compartment formed by the blister in the first sheet, the backing sheet being secured to the first sheet along each edge of the first sheet over the entire backing sheet except the respective blister Include, The first sheet has a cut line contained therein, the cut line extends along the sheet but does not penetrate through the thickness of the sheet, the cut line being adjacent from one edge of each respective blister unit. To the edge, The backing sheet is fixed to the first sheet such that the backing sheet is not forcibly separated from the first sheet when a force is applied to the flexible blister, The blister maintains one or more doses of pills, The blister package for a pill having child safety backing, wherein the cut line is camouflaged by a crosshatch pattern. The blister package of claim 1, wherein the backing sheet comprises a polymeric material. 3. A blister package for a tablet having a child safety backing according to claim 2, wherein said polymer material is polyester. 4. The blister package for a pill of claim 3, wherein the polyester is polyethylene terephthalate. 5. A blister package for a tablet having a child safety backing according to claim 1 or 4 wherein the backing sheet comprises a metal foil. 6. The blister package for a pill of claim 5, wherein said metal foil is aluminum.