HU222816B1 - Protective childproof packages - Google Patents

Abstract

The present invention relates to child-resistant packaging, and more particularly to blister packs having a safety backsheet for the packaging of medicaments. Child safety protective packaging devices according to the invention - made of one or more flexible blister foils forming compartments suitable for receiving medicaments; and - a backsheet that seals and seals the compartments formed by the blisters in said film and is secured to said film along each edge of each film and, except for surface portions at each blister, on substantially the entire surface of the backsheet, and - this backsheet is fixed to said film in such a way that it cannot be forcibly separated from said film by applying pressure to the blisters of said film; and - this backsheet has at least one layer which provides sufficient strength so that the backsheet cannot be torn from the blister side of the package by pressure on the drug or separated from said foil, and there is a line of intersection in this backsheet along one edge too. The advantage of the packaging devices according to the invention is that the drugs contained in them cannot be forcibly accessed by children, but at the same time, elderly adults can break them down without using any special physical force according to the instructions printed on them. ŕ

Description

BACKGROUND OF THE INVENTION The present invention relates to child-resistant packaging, more particularly to blister packs having a safety backsheet for packaging pharmaceuticals.

U.S. Patent No. 3,809,211 mentions that today's parents have trouble storing medications at home in such a way that their children cannot access them. Children are not able to recognize the dangers of taking medicines that are not for them. There is therefore an urgent need for packaging that can be easily taken out by adults, but not by children.

Nowadays, pressure-perforated or "blister pack" packaging is commonly used for the packaging of oral dosage forms. Pressure-perforated packaging means of a pre-formed sheet of flexible blisters formed of polyvinyl chloride or polystyrene, usually of a transparent material, and of another breakable sheet attached to the preceding sheet, e.g. consisting of aluminum foil or paper. The metal film is glued to the blister film by heat sealing, "solvent welding", gluing or otherwise. Pharmaceutical units, such as tablets or pills, are removed from the blister packs by, for example, pressing the tablet onto the foil by applying pressure to the flexible bladder, so that the tablet leaves the package by breaking the foil.

It is sometimes desirable to provide a pressure-perforated wrapper having an inelastic tray between the first and second foils having cavities arranged in accordance with the blisters of the first foil. The rigid tray protects the drug unit from contamination and mechanical damage and can also be used as a carrier for information such as the type of drug, the time of a given dose, and the number of doses already consumed.

The latest pharmaceutical trend is to develop packaging that provides safety even when children have access to medicines. Most of the improvements in child safety have so far focused on perfecting medicine bottles. As part of this development, for example, safety caps have been developed that need to be repeatedly pressed and rotated in a certain order in order to open the bottle. However, it should be noted that so far there has been little progress in the development of pressure-perforated blister foil wrappers for child safety of the present invention.

Up to now, the use of a non-puncture-resistant backing layer has not been used to make pressure-perforated blister packs comprising more than one backing layer. In the prior art, the backing layers used to cover the rupture layer have so far been made of paper or foil, and in some cases have been cut or weakened in such a way that each backing layer can be broken by pushing a pill through the packaging. Until now, such additional backing layers have been used to print enlightening text on the backside of pharmaceutical packages and to provide greater protection against environmental effects by better sealing of the package. Such solutions are disclosed, for example, in U.S. Patent Nos. 3,503,493 (Large), 3,621,992 (Osbom), 2,317,860 (Sorensen) and 3,387,699 (Heller). According to the patents listed, the backsheet of multiple layers of blister pack or pressure puncture-type packaging can be easily torn or peeled off, so that the packaging is not strong enough to protect the safety of children.

Helstrom has attempted to increase the resistance of the blister pack pills (U.S. Patent No. 3,472,368), but, contrary to the present invention, does not use a second backing layer which can be removed to release the puncture layer. The packaging developed by Helstrom is supposed to protect the safety of children simply by applying a peelable layer that is very difficult to tear. So this solution builds on the fact that the children are weak and their weakness necessarily prevents them from opening the package.

United States Patent No. 3,921,805 (Compere) is based on the idea that a pill packaging device should be developed which requires less effort than knowledge to resolve. Pills are probably taken by someone who is not usually in good physical shape. Very often, a child will exert more effort than the person likely to take the pills. With this in mind, the present invention has been developed to provide a device for packing pills that can be opened by any adult who is unable to exert more effort than an average physical child, subject to the instructions for use. Children who are not trained to open the packaging described in this patent will not have access to the contents of the packaging.

Thus, in the process of developing the invention, we have been relying on the knowledge rather than the power of adults to develop a packaging that is easily opened by adults but cannot be opened by children.

In the development of the present invention, our primary objective was to develop a drug packaging device for the safety of children which can be opened by anyone who is guided in this regard.

EN 222 816 Blood has been received but cannot be picked up by an untrained child.

It was another object of the present invention to provide a pharmaceutical packaging device which, when opened, allows the user to access only one dose of the drug, which of course is less than the lethal dose.

It was a further object of the present invention to provide a pharmaceutical packaging device which, when opened, provides access to the desired number of drugs.

Another object of the present invention was to provide a pharmaceutical packaging device from which, after the removal of a single drug or a multiple-dose drug, the remaining drug would remain sealed.

It was a further object of the present invention to provide a pharmaceutical packaging device which, when used, avoids the inconvenience of using pharmaceutical bottles.

It was another object of the present invention to provide a pharmaceutical packaging device in which each drug unit is stored separately so that the person taking the drug can take the desired dose without having to carry the remainder of the drug.

It is a further object of the present invention to provide a pharmaceutical packaging device from which each additional dose of drug can only be removed after further opening of the packaging.

Another object of the present invention was to develop a pharmaceutical packaging device that protects the safety of children because an average child cannot decompose without using a tool.

It is also an object of the present invention to provide a pharmaceutical packaging device which, when opened, provides less than a hazardous dose of the drug. The amount (quantity) of drug available when the package is opened once can be varied depending on the toxic nature of the packaged drug.

Thus, the present invention relates to blister packs which are similar to conventional blister packs but differ in that they have a high strength, resilient backing layer which seals each blister. The high strength resilient backsheet is secured to the back of the blister film so that the backsheet does not move away from the blister when pressure is exerted on the blister side of the drug packaging device to push the drug through the packaging device. For example, in order for a user to be able to remove a pill from the packaging, he must first peel off the high strength backing layer. To provide the desired adhesion, the high strength backsheet can be secured to one another by heat sealing, solvent welding, adhesive bonding, or otherwise bonding the two layers. Among these, the heat seal method is preferred.

There are hundreds of coating compositions that can be used between the layers of the laminate wrapper of the present invention to provide heat sealability. These heat seal compositions are generally used in the manufacture of foil / paper and resin / resin layer laminates which can be used as packaging materials for the formulation of soap, flour, cakes and other products, and for making cardboard boxed packaging. Typically, the heat seal composition is an aqueous dispersion of a vinyl resin or, at lower heat seal temperatures, a wax containing vinyl resin. Vinyl resins can be ion-bonded and acid-modified ethylene interpolymers, so-called ionomeric resins. Wax and other modifiers can be used to widen the range of quality characteristics.

Aqueous dispersions of ethylene interpolymers, such as ethylene / vinyl acetate interpolymers, are preferably used as sealing compositions. Compositions containing vinyl resin have good adhesion properties and are moderately sticky when hot. Modifying additives such as pigments, waxes and other resins may also be used.

The heat seal coatings should be applied in an amount of about 7 g / m ² . The coatings may be applied by conventional techniques known in the art, such as by the use of fabric or rollers.

The blister film can be prepared in a known manner from materials commonly used to make blister films, such as polyvinyl chloride, and copolymers and terpolymers of vinyl chloride, such as the vinyl chloride / ethylene / propylene terpolymer.

The backsheet must have a layer or sheet of strong elastic polymeric material of sufficient strength to prevent a pill being manually forced through it.

The layers of polyester have been found to be strong enough to prevent the pills from being removed by pressing through the packaging. The polyester is preferably polyethylene terephthalate.

The foil can also be used as a backing sheet if a barrier layer is required to prevent moisture from penetrating into the bladder. For this purpose, it is sufficient to use a 0.02 mm metal foil, for example aluminum foil.

The back cover may also include a layer of paper on which text can be printed. It is preferable to use bleached kraft paper having a basis weight of about 13.5 kg.

Dates, numbers and text on the contents of the packaging can be printed on the paper to inform the user.

It is possible to form a multi-layer sheet from the layers forming the backing sheet before the backing sheet is applied to the blister film.

However, it is also possible to glue the backsheet layers to each other as if the backsheet itself was attached to the blister film. It is preferable to use the lamination method using the heat-sealing coatings previously described.

Usually, the paper layer is used as the furthest layer away from the blister film so that the printed text can be easily read on the underside of the packaging, i.e. not on the blister side. However, it should be noted in this connection that, if it is not necessary to prevent moisture from entering the blisters, a sheet of printed paper can be placed directly next to the translucent blister and the text can be read from the top of the package through the blister.

The high strength polymer layer, the film, and the paper layer can be attached to the blister film in any order except that moisture must be prevented from entering the blisters. In this case, the paper layer should not be placed directly next to the blister. For example, a layer of high strength polymeric material may be located adjacent to the blister film, between the film layer and the paper layer, or as a layer furthest from the blister film. In the case where the paper layer is between the film layer and the high-strength polymeric material layer, the polymeric layer must be transparent so that the text printed on the paper can be read by the consumer.

In the case of making a single multi-layer sheet, the backsheet layers may be bonded to one another by heat sealing, solvent welding, gluing, applying adhesive layers between the layers or otherwise bonding the layers to one another. For example, the layer of extruded polyethylene may be between the layer of high-strength resilient polymer and the film layer, and between the film layer and the paper layer. When pressure is applied, the extruded polyethylene will hold the three layers together without heat transfer. For this purpose, a layer or film of extruded polyethylene may be used. The heat seal coatings can be applied in addition to the intermediate adhesive layers.

After attaching the blister film to the backsheet, the backsheet cannot be forced to separate from the blister film by applying pressure to the medicament from the blister side of the packaging. It should be noted, however, that the backsheet can be easily peeled off the back of the package to remove the blister drug. The adhesion between the blister film and the backsheet must be strong enough so that the resilient backsheet remains in contact with the blister film even when applying pressure to the blister. The backsheet must be strong enough not to force drug onto the blister when attached to the blister by applying pressure from the blister side of the packaging.

Poly (ethylene terephthalate) is a high-strength polyester which has been found to be particularly useful as at least one of the components of the backsheet. Preferably, the polyester has a thickness of about 0.3 mm. A polyester layer of this thickness also prevents biting into the packaging. However, it should be noted in this connection that all plastics of sufficient strength to prevent the drug from being pushed through the backsheet are suitable for the purpose.

An impermeable incision line is cut into the outer surface of the blister film. An impermeable incision line extends from one edge of the individual bladder unit to an opposite or adjacent edge. When the corner of the bladder unit is folded or bent along the impermeable cut line, the blister film is broken. The smaller portion of the broken bladder blister still attached to the backsheet can be used as an ear to peel back the backsheet from the blister foil, and as a result, the drug in the bladder becomes accessible.

The critical factor for good packaging production is the depth of the non-penetrating incision line in the blister film. With a minimum depth penetration incision line, the wrapper provides greater safety for children than a deeper incision incision line, while the maximum depth incision incision line makes it easier for older adults to handle the wrapper than a less deep incision incision line. The cut line should be cut deep enough to produce a packaging that is safe for children and handled by the elderly, taking into account the level of toxicity of the product.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The invention will be best understood by reference to the foregoing and other purposes, by studying an embodiment, which will be described in more detail by way of example below. Referring to the accompanying drawings, in which this embodiment is described, Figure 1 is a plan view of a security blister pack (card) according to the invention showing a plurality of individual blister units within a package;

Figure 2 is a perspective view of one of the individual blister units shown in Figure 1;

Figure 3 is a perspective view of one of the individual blister units shown in Figure 1 with the blister unit partially open; and Figure 4 is an enlarged cross-sectional view of a portion of the package of the present invention showing various layers, adhesives, and uncoated surfaces.

DETAILED DESCRIPTION OF THE INVENTION The invention is illustrated in the accompanying drawings, first in FIG

- with more details. In Figure 1, a security blister pack 10 is complete

EN 222 816 Bl is visible throughout. Packaging device 10 may comprise a plurality of individual blister units 13 having one or two cavities 11 of any particular shape, such as a tablet or pill, contained in said blister. The individual bladder units 13 can be separated from one another by tearing the wrapper along the perforated cut line 12. Throughout one corner of each individual bladder unit 13, a non-penetrating intersection line 14 is incised into the formed film 15, allowing the individual bladder unit 13 to be opened. When the corners of each individual bladder unit 13 are folded or bent along the non-penetrating line 14, the formed film 15 is broken along the line 14.

As shown in Figure 4, the backsheet 25 includes a heat sealable coating 16, a moisture barrier metal foil 17, and a polymeric layer 18 made of a high-strength resilient polymer such as polyester such as polyethylene terephthalate. and a layer of paper 19 on which can be printed text informing the user, for example, of the contents and resolution of the packaging material. Figures 2 and 3 show the tab 20 (i.e., the folded corner portion) which, as already indicated, is formed when the corner of the individual bladder unit is folded or bent along a completely impermeable incision line 14.

As mentioned earlier, the backsheet 25 need not include all three layers, i.e., the film layer, the high-strength resilient plastic layer, and the paper layer, but it should be noted that the high-strength polymer layer is definitely required. so that the molded foil 15 has a security backsheet so that the medicament cannot be forcibly removed from the packaging, i.e., only after the backsheet 25 has been peeled off from the molded foil 15.

The heat sealable coating 16 is usually pressed onto the metal film layer 17. Fig. 4 shows a solution for attaching the film to the high-strength polymer layer 18 and the paper layer 19 (i.e. the backsheet 25) to the formed film 15. The heat sealable coating 16 may be glued to the formed film 15 by heating and applying pressure. The layers 17, 18 and 19 of the backsheet 25 can be secured to one another by heat sealing, solvent welding, gluing, applying adhesive layers between the layers, or otherwise bonding the layers to one another. Figure 4 illustrates a solution for bonding the metal film layer 17, the high strength polymer layer 18 and the paper layer 19 with the adhesive layers 32 and 34.

Although the invention has so far been generally described with reference to drugs or pills, child-safe packaging can also be provided in capsules, tablets, suppositories and other forms.

We believe that there are significant differences between the present invention and, for example, US Patent 3,921,805 (Compere), which make the packaging of the present invention more child-friendly, safer and easier to open for older adults. . These differences include:

1. On the safety of children

Children tend to focus on surface differences (protrusions and non-sealed surfaces) on the hollow or "blush" side of the bladder unit. In the absence of surface difference, children randomly grab and bend the bladder unit.

a) In the case of the invention, there are no visible surface differences:

1. no projections;

2. there are no accessible, non-sealed surface portions; and

3. the incision line is almost invisible to children, partly due to the fact that it is "camouflaged" by transverse shading when the package is closed.

b) The packaging according to the invention cannot be opened by random aggressive treatment because:

1. the depth of the intersection is minimal; and

2. the position of the incision line (at the corner of the package) is optimal.

2. For easy opening

Older adults are not forced to exert a significant physical force when opening the packaging according to the invention:

(a) folding and breaking the ear requires only a minimum of physical effort dependent on the accessibility of children; and

(b) minimum physical force is required to remove the backing; in cases where the peelability is not obvious to children, the bond strength between the backsheet and the formed film may be reduced.

3. Recognition

When opening the packaging according to the invention, older persons must rely on their recognition ability rather than their physical strength. Provided that the instructions for the multi-step resolution operation are clear, older people, unlike children, will be able to access the contents of the packaging.

Claims (6)

PATENT CLAIMS A child-resistant wrapper (10), comprising a molded film (15) having one or more elastic blister units (13) forming compartments, the molded film (15) running through an incision line (14) extending through its incomplete thickness, extending from the edge of each blister unit (13) to the edge of an adjacent bladder unit (13) or to an opposite bladder unit (13); A backsheet (25) hermetically sealing the compartments formed by the blister units (13) in the molded film (15), which is attached to the molded film (15) along the edges of the latter and substantially over the entire surface of the backsheet (25), except the surface corresponding to each bladder unit (13); said backsheet (25) being secured to said first film (15) such that it cannot be removed from its position on the formed film (15) by applying pressure to the bladder units (13); the bladder units (13) comprising at least one dose of a pill; and the incision line (14) disguised by a cross-sectional pattern. A child-resistant wrapper according to claim 1, characterized in that the backsheet (25) comprises a polymeric material. A child-resistant wrapper according to claim 2, characterized in that the polymeric material is polyester. A child-resistant packaging according to claim 3, characterized in that the polyester is polyethylene terephthalate. 10 Packaging device according to claim 1 or 2, characterized in that the backsheet (25) consists of at least two layers and one layer is a metal foil. A child-resistant wrapper according to claim 5, characterized in that the metal foil is aluminum.