JPH09201395A - Blister packaging for drugs with safety backing - Google Patents

Abstract

(57) [Abstract] [Problem] To obtain child protection. A non-through cut is made from one edge of an individual blister unit to the opposite or adjacent edge. If the blister unit is folded or bent in this non-penetrating cut, the blister forming sheet will be cut. The smaller portion of the segmented forming sheet still bonded to the backing material acts as a tab for peeling the backing sheet from the forming sheet to expose the contents of the blister.

Description

Detailed Description of the Invention

[0001]

FIELD OF THE INVENTION This invention relates to safety blister packaging for enclosing medications or pills.

[0002]

BACKGROUND OF THE INVENTION As explained in U.S. Pat. No. 3,809,211, one of the problems facing parents today is to keep drugs or pills out of the reach of their children. is there. Children are not capable of recognizing the risks associated with taking unspecified medications. For this reason, there is an urgent need for packages in which adults can easily remove pills from their packaging, but children cannot.

Today, PTP packages or "blister" packs are commonly used to package units of drugs or pills for oral administration. PTP packaging is a first sheet, typically made of transparent polyvinyl chloride or polystyrene, with a flexible foam chamber forming one or more separate compartments for pills, and an aluminum foil or paper sheet. A rupturable sheet, such as, made from a second sheet attached to the first sheet. Metal foil
It is attached to the blister sheet by heat sealing, solvent gluing, gluing, or other method of gluing the foil sheet. The tablet is removed from the blister compartment by pressing a flexible blister, which causes the tablet to press the foil, rupture the foil, and extruding the tablet.

In making such a PTP package, the blister has a sturdy tray between the first and second sheets, and the first sheet may have holes that match the blister. Sometimes desirable. The sturdy tray is used to protect the pills from contamination and mechanical damage, and may include printed instructions and indications of dose taken regarding the type of pill or the particular time to take it.

A recent trend in drug packaging is to provide a device that is safe even if found by a child. Most developments in "anti-child protection" measures have been directed towards improving pill bottles. In this regard, a safety cap was devised which required a series of pushes and turns to open the bottle. However, little progress has been made in the area of "anti-child protection" extrusion blister packaging to which the present invention pertains.

Packaging that uses one or more backing layers on an extruded blister package does not use a layer of backing material that cannot be ruptured. Conventional backing layers that have been used to cover rupturable layers are made of paper or foil and are scored or weakened so that all backing layers can be ruptured to push the pills through the package. It has been. Additional prior art backing layers have been used to provide printed information on the backside of the pill packaging and for additional hermetic bonding to protect the pill from the ambient environment. See, for example, the following US patents. Naji No. 3503493, Osborne No. 3621992
No. 2,317,860 by Sorensen, and No. 3,387,699 by Heller. In each of these patents, the multi-layer backing used in blister or extrusion pill packaging is easily rupturable or peelable and is not strong enough to provide "child protection".

One attempt to provide "anti-child protection" blister style pill packaging is in Healthstrom's US Pat.
See 472368. In this patent, there is no second backing member that is peeled off to expose the rupturable layer as described in this invention. This package is only virtual "child protection" by providing a rupturable sheet that is very difficult to rupture. Therefore,
This Helststrom patent only concerns the inability of the child as a necessary element to prevent the child from opening the packaging.

[0008] The idea of Compair US Pat. No. 3,921,805 is to provide a pill package that requires knowledge of the procedure for opening the package rather than the minimum amount of strength for opening the package. People who are likely to take pills are generally not in a very strong physical condition. Children are often stronger than those who are sick and trying to take pills. Thus, the present invention was developed to provide a pill package that could be opened by a trained adult who may be less powerful than the average child. Children who are not taught how to open as revealed here will not be able to reach the contents of the package. Therefore, the present invention
In order to create a package that is easily opened by an adult but not opened by a child, it is not the strength of an adult that is related to its good knowledge.

The main object of the present invention is to provide a "child-protective" pill package which can be opened easily by a person who is instructed to open it, but unopened by unsupervised children.

Another object of the invention is that when opened,
It is to provide a pill package that is accessible to the user for single dose pills, which is of course sublethal.

Another object of the present invention is to provide a pill package which, when opened, is accessible to any desired number of pills.

Another object of the present invention is to provide a pill package that allows one pill or a single dose of pills to be removed from the package while maintaining the remaining pills in an airtight enclosure.

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

Another object of the present invention is to provide a pill package in which each individual pill can be separately packaged so that the user can carry the desired dose without having to carry extra pills.

Another object of the present invention is to provide a pill package that requires an additional wrap open to remove each additional pill.

Another object of the present invention is to provide a safe pill package that the average child cannot open without the aid of tools.

Yet another object of the present invention is to provide a pill package which allows access to less than the number of dangerous drug units by opening the package. The number of units exposed each time the package is opened can vary depending on the toxicity of the packaged drug.

[0018]

SUMMARY OF THE INVENTION The present invention is directed to a blister package similar to conventional blister packages, but having a strong, flexible backing sheet surrounding each blister. This strong and flexible backing sheet, if adhered, is blistered in such a way that the backing sheet is not pushed away from the blister sheet when pressure is applied to the blister side of the pill package in an attempt to push the pill through the package. It is fixed to the back of the sheet. For the user to remove the pill from the package, the strong backing sheet must first be peeled and released. The strong backing sheet can be affixed to the blister sheet by heat sealing, solvent gluing, gluing, or any other method of gluing the two sheets together, so long as the desired degree of adhesion is obtained.
The preferred method is the heat sealing method.

There are many formulations for heat seal coatings that can be used to provide heat seal capability between the layers of the packaging laminate of the present invention. These heat-sealing formulations typically make foil / paper and resin sheet / resin sheet laminates for packaging of soap wrappers, carton wrappers, cereal food liners, cookie wrappers, and other uses. Used for. The heat-sealing formulation is typically an aqueous dispersion of vinyl resin or wax-containing vinyl resin to provide a lower heat-sealing temperature.
Vinyl resins can be ionically crosslinked and acid modified with ethylene interpolymers known as ionomer resins. Other modifiers further extend the range of performance characteristics.

The preferred heat sealing formulation is a water dispersant of an ethylene interpolymer, such as an ethylene / vinyl acetate interpolymer. Vinyl resin formulations combine wide adhesion with mild hot tack. Modifiers such as pigments, waxes or other resins are used.

It is preferred to apply the heat seal coating in an amount of about 7 grams / square meter. The coating may be applied by conventional methods, such as curtain coating or roller coating as is known in the art.

The blister sheet is made by a known method,
And made from conventional blister sheet materials such as polyvinyl chloride and copolymers and terpolymers of vinyl chloride, and copolymers and terpolymers of vinyl chloride, for example polyvinyl chloride / polyethylene / polypropylene terpolymers.

The backing sheet should be a layer or sheet of strong, flexible polymeric material of sufficient strength so that the pills are not manually pushed through the polymeric material. Sheets of polymeric material have been found to be strong enough to prevent pills from being forced through them. The preferred polyester material is polyethylene terephthalate.

A foil sheet can also be used as part of the backing sheet if a barrier resistant coating is required to prevent the entry of moisture into the blister. A thin aluminum foil, such as aluminum, with a thickness of 0.020 mm (0.0008 inches) is sufficient.

It is also possible to form part of the backing sheet with a paper sheet for printing purposes. Bleached kraft paper having a basis weight of approximately 30 pounds is preferred. The date, number, or description of the package contents can be printed on this paper as consumer information.

The various layers that make up the backing sheet are:
The backing sheet can be laminated to form a laminated sheet prior to application to the blister sheet, or multiple backing layers can be adhered to each other at the same time that they are adhered to the blister layer. it can. The preferred method of lamination is by heat seal coating as described above. It is usually desirable to provide the paper sheet as the sheet furthest from the blister sheet so that the print can be easily read from the underside of the package or from the non-blister side. However, if it is not necessary to prevent moisture from penetrating into the blister, the printed paper can be placed next to the transparent blister sheet and read through the blister sheet from the top of the package.

The strong polymer sheet, foil sheet, and paper sheet are attached to the blister sheet in an appropriate order unless it is necessary to prevent water from entering the blister and the paper sheet cannot be placed next to the blister sheet. You can Thus, the strong polymer sheet can be placed next to the blister sheet, or between the foil and the paper sheet, or as the sheet furthest from the blister sheet. If the paper sheet is between the foil and the strong polymer sheet, the polymer sheet must be transparent so that the consumer can read the print on the paper.

The backing layer, when applied in a single laminate construction, is by heat sealing, solvent bonding, gluing, applying sheets of adhesive material between the layers, or other methods of bonding the layers together. Can be glued together. For example, a sheet of extruded polyethylene can be provided between the strong, flexible material and the foil sheet, or similarly between the foil and the paper sheet. Extruded polyethylene is
Three sheets will be glued together under pressure without the need for heat sealing operations. The use of extruded polyethylene sheets or films is preferred. A heat seal coating can be used in addition to the intermediate adhesive layer.

After the blister sheet has been secured to the backing sheet, the backing sheet will not be forced away from the blister sheet by applying force to the pills from the blister side of the package. However, the backing sheet is
The blister contents can be easily peeled off from the back of the package for removal. The seal between the blister sheet and the backing sheet must be strong enough so that the flexible backing sheet remains in contact with the blister sheet when pressure is applied to the blister. Also, the backing must be strong enough so that the pills are not forced through the backing sheet by applying pressure to the pills from the blister side of the package.

A strong polyester that has been found to be particularly useful as at least one component of the backing sheet is polyethylene terephthalate. The polyester is preferably about 48 thick. This thickness also helps prevent wrapping of the package. However, any plastic that is strong enough to prevent the pills from being pushed by hand can be used for this purpose.

A "non-penetrating" notch is made in the exposed surface of the blister forming sheet. This non-penetrating cut is made from one edge of the individual blister unit to the opposite or adjacent edge. If the blister unit is folded or bent in this non-penetrating cut, the blister forming sheet will be cut. The smaller portion of the segmented forming sheet still bonded to the backing material acts as a tab for peeling the backing sheet from the forming sheet to expose the contents of the blister.

The depth of cut into the blister forming sheet of the non-through cut is important for the production of useful packaging. A minimal depth non-penetrating cut will provide a more effective child-protective packaging than a deeper cut. Also, maximum depth non-penetrating cuts will make more useful adult packaging than shallower cuts. Effective cut depths are required to make both child-protective and adult packaging effective for a given product toxicity level.

[0033]

The present invention, together with the above and other objects,
It will be best understood from the following detailed description with reference to the accompanying drawings of the illustrated embodiments.

Referring first to FIG. 1, safety blister packaging is generally designated by the numeral 10. The packaging 10 comprises an individual blister unit 13 having one or two recesses 11.
, And these recesses are of any desired shape to match the shape of the particular drug or pill contained within the blister. The individual blister units 13 can be separated from each other by tearing the packaging at the perforated cutting line 12. A non-penetrating score line 14 is cut into the forming sheet 15 across one corner of each individual blister unit 13 so that each individual blister unit 13
To provide openness. When the corner of the individual blister unit 13 is bent along the non-penetrating score line, the forming sheet 15 is broken along the score line 14.

The backing sheet 25 shown in FIG. 4 comprises a heat seal coating 16, a foil barrier sheet 17, a sheet of strong and flexible polymeric material, for example polyester such as polyethylene terephthalate 18, and the contents of the package and the opening of the package. Includes a sheet of paper 19 that can be printed with information for consumers such as. 2 and 3 show a tab 20 formed by bending a corner of an individual blister unit along a non-through cut 14 as described above.

As explained above, the backing 25 is
It is not necessary to include all three layers of foil, strong flexible polymer material and paper. However, a strong polymeric material is needed for the purpose of providing a secure backing to the blister sheet 15 so that the pills are not pushed out of the package without peeling the backing sheet 25 from the blister sheet 15.

The heat seal coating 16 is typically extruded onto the foil layer 17. . FIG. 4 shows a foil, a strong flexible polymer material, and a paper layer (ie, backing material 2
An example of adhesion of 5) to the blister forming material 15 will be shown. This heat seal coating layer 16 is heated and pressured to adhere to the blister forming material 15. The layers 17, 18, and 19 of the backing sheet 25 may be adhered together by heat sealing, solvent gluing, gluing, applying sheets of adhesive material between the layers, or any other method of adhering the layers together. it can. FIG. 4 shows an embodiment in which the foil, the strong flexible polymeric material and the paper layer are glued together by means of adhesive layers 32 and 34.

Although the present invention has been described in relation to a drug or pill, the present invention can also be used to make capsules, tablets, suppositories and the like.

For example, Compair US Pat. No. 39218.
It is believed that, compared to No. 05, there are considerable differences in more cognitive ability, more protection against children, and ease of opening by adults. These differences include:

1. Child protection : Children are more likely to focus their attention on the recessed or "pill" side of the blister unit, which is the difference (ie, protrusion, unsealed portion). If there are no differences, the child will grab the blister unit and bend it.

A. There are some areas where the difference is not clear.

1. There is no protrusion.

2. There is no unblocked part accessible.

3. In particular, the score lines are "camouflage" due to the cross-parallel pattern of the seals, so that the score line is difficult for children to understand.

B. The opening is tough against undesired aggressive handling.

1. The depth of cut is minimized.

2. The cuts are placed optimally (cutting the corner).

2. Ease of opening: An adult will not necessarily rely on physical force to open the package.

A. Minimal force (depending on the child's approach) will be required to bend and fold the tablet.

B. The peel strength of the backing material will be minimal. The strength of the closure of the backing material to the forming material can be reduced if there is no risk of bending by the child.

3. Cognitive : Adults must have cognitive rather than physical power to open this package. If the multi-step opening instructions were well communicated, the adult could effectively gain access to the package contents that a child could not.

The embodiments of the present invention are as follows.

1. A first sheet having one or more flexible blisters forming compartments, each blister being adapted to receive a medicament, closing and sealing the compartment formed by the blister in the first sheet And a backing sheet secured to the first sheet along each edge of the first sheet over substantially the entire backing sheet except for each blister. The backing sheet is affixed to the first sheet so that the backing sheet is not forcibly disengaged from the first sheet when force is applied to the blister,
Further, the backing sheet does not rupture when a force is applied to the medicine from the blister side of the package, and thus the first backing sheet does not burst.
A child-proof package having at least one sheet of material of sufficient strength so as not to force the separation of the sheet from the sheet and having a weakening line along one of its edges.

2. A child-protective package as defined in embodiment 1 wherein the first sheet is secured to the backing sheet by a heat seal coating.

3. A first sheet having one or more flexible blisters forming compartments, each blister being adapted to receive a medicament, closing and sealing the compartment formed by the blister in the first sheet And a backing sheet secured to the first sheet along each edge of the first sheet over substantially the entire surface of the backing sheet except for each blister. The backing sheet is affixed to the first sheet so that the backing sheet is not forcibly removed from the bond with the first sheet when the backing sheet is applied to Comprises at least one sheet material having sufficient strength so that the backing sheet does not rupture or force separation of the bond with the first sheet when a force is applied to the drug from the blister side Its has a weakening line along the one edge, and packaging pair child protection formula wherein the blister is also holding the pill once dose amount less to.

[Brief description of drawings]

FIG. 1 is a plan view of a safety blister pack (card) of the present invention showing a number of individual blister units in one pack.

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

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

FIG. 4 is an enlarged exploded cross-sectional view illustrating various layers, adhesives, and unsealed portions.

[Explanation of symbols]

 10 Packaging 11 Recess 12 Cutting Line 13 Blitter Unit 14 Notching Line 15 Sheet for Forming 16 Heat Seal Coating 17 Foil Barrier Sheet 25 Backing Sheet

Claims (2)

[Claims] 1. A first sheet having one or more flexible blister forming compartments, each blister adapted to receive a medicament, the compartment formed by the blister in the first sheet. A backing sheet that is fixed to the first sheet along the respective edges of the first sheet and substantially the entire backing sheet except for each blister, The backing sheet is affixed to the first sheet so that the backing sheet is not forced out of association with the first sheet when a force is applied to the first flexible blister, and The backing sheet has sufficient strength to prevent the backing sheet from bursting and forcing the bond with the first sheet when a force is applied to the drug from the blister side of the package. Versus child protection type packaging with a weakening line along one further edge thereof has a number of sheet material. 2. A first sheet having one or more flexible blister forming compartments, each blister adapted to receive a medicament, the compartment formed by the blister in the first sheet. A backing sheet that is fixed to the first sheet along the respective edges of the first sheet and substantially the entire backing sheet except for each blister, The backing sheet is secured to the first sheet so that the backing sheet is not forced out of engagement with the first sheet when a force is applied to the flexible blister, and the backing sheet further comprises The sheet has sufficient strength so that the backing sheet does not rupture or force separation of the bond with the first sheet when force is applied to the drug from the blister side of the package. Over further comprising a preparative material has a weakened line along one of its edges, and packaging pair child protection formula wherein the blister is also holding the pill once dose amount less.