Patent Publication Number: US-6708825-B2

Title: Child-proof package for pharmaceutical products

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application is a continuation-in-part of our prior patent application Ser. No. 09/986,525 filed Nov. 9, 2001 (pending). 
    
    
     BACKGROUND OF THE INVENTION 
     1. Field of the Invention 
     The present invention relates to child-proof packages for pharmaceutical products in the form of solid, pulverized or liquid to pasty doses as e.g. tablets, capsules, ampoules or dragées, featuring a blister pack with at least one blister which is closed off by a push-through type foil lid, the blister serving the purpose of accommodating the pharmaceutical product(s). The packaging is such that, for the purpose of removing the pharmaceutical product, the push-through type foil lid of the blister pack lies against a wall part which protects the foil lid and with respect to which the blister can optionally be displaced by sliding from a closed position to an open position so that, when in the open position, the blister with the pharmaceutical product lie in line with openings in the wall part and the pharmaceutical product can be pushed through the openings. 
     2. Background Art 
     The danger of uncontrolled consumption of medicaments is undisputed; in particular, small children are especially exposed to this potential danger in the form of medicaments that have been left lying around. 
     The most common form of packaging for tablets and similar pharmaceutical products is that of blister packs. Widely known in particular is the so called push-through pack which is such that the tablet is pressed out of a cup in the base part of the pack (the so-called “blister”) and through a foil lid. Another known form of blister pack is such that a foil lid is removed by peeling. Other blister packs feature a notch as an aid to tearing. 
     The present day possibilities for increasing child safety in connection with blister packs mainly involve increasing the difficulty of opening by means of measures that require greater strength, e.g. thicker push-through films, greater force of adhesion of peeling films, or higher force of friction in the case of tearing notches. 
     Forms of packaging which can be opened only by applying greater force are indeed more child proof, but can present problems for senior citizens. 
     Known from International patent application WO-A-96/03329 is a child-proof form of packaging in which the lid film of the blister pack is covered by a rear wall part. Integrated into this rear wall part are tearing strips that can be removed along a line of weakness. In order to be able to push the tablet out of the blister through the lid film, the tearing strips have to be removed first. 
     A child-proof packaging of the kind mentioned at the start of this specification has been disclosed in the U.S. Pat. No. 5,150,793 which issued on Sep. 29, 1992 to PCI/Delvco Inc. 
     SUMMARY OF THE INVENTION 
     An object of the present invention is to provide a form of packaging of the kind mentioned at the start of this specification such that a combination capability is necessary to open it or a simultaneous or complex sequence of movements must be carried out. 
     According to one aspect of the present invention, there is provided a child-proof package for pharmaceutical product(s), comprising a blister pack with at least one blister which is closed off by a push-through type foil lid, the blister serving the purpose of accommodating the pharmaceutical product(s), the packaging being such that, for the purpose of removing the pharmaceutical product(s), the push-through type foil lid of the blister pack lies against a covering wall part with respect to which the blister pack can be displaced by sliding from a closed position to an open position so that, when in the open position, the blister with the pharmaceutical product(s) lies in line with openings in the covering wall part and the pharmaceutical product, can be pushed through the openings, wherein the blister pack is arranged between a rear wall part and a front part and the covering wall part with the openings is an inner wall part lying between the rear wall part and the foil lid, whereby the blisters can be displaced by sliding from the closed position to the open position into opening slits and the openings in the inner wall part are covered over by a tear-off strip which is arranged in the rear wall part and can be separated from it along a line of weakness thus forming a longitudinal slit. 
     According to another aspect of the invention, there is provided a child-proof package for tablets and similar pharmaceutical products, comprising a blister pack with at least one blister which is closed off by a push-through type foil lid, the blister serving the purpose of accommodating the pharmaceutical product(s), the packaging being such that, for the purpose of removing the pharmaceutical product(s), the push-through type foil lid of the blister pack lies against a covering wall part with respect to which the blister pack can be displaced by sliding from a closed position, where the foil lid lies adjacent to a solid region of the covering wall part, to an open position in which the blister with the pharmaceutical product(s) lies in line with a tear-off strip in the covering wall part, such that when the tear-off strip is removed to create an opening in the covering wall part, the pharmaceutical product(s) can be pushed through the foil lid and the opening in the covering wall part. 
     Thus, the blister pack is preferably arranged between a rear wall part, and a front part, and the covering wall part with the openings is an inner wall part lying between the rear wall part and the foil lid, whereby the blisters can be displaced by sliding from the closed position to the open position into opening slits and the openings in the inner wall part are covered over by a tear-off strip which is arranged in the rear wall part and can be separated from it along a line of weakness thus forming a longitudinal slit. 
     The packaging according to the above-mentioned aspects of the invention thus combines tear-off strips and a blister pack that can be displaced by sliding in the packaging as preferred elements that serve the purposes of child safety, and results in a packaging arrangement providing greater child safety than conventional forms of packaging. 
     Opening the packaging according to the above-mentioned aspects of the invention requires combination skill that recognizes that, in order to push the pharmaceutical product(s) out, the blister pack has to be moved to a particular position and also that it is necessary to remove a tear-off strip from a wall part of the packaging. 
     The wall parts of the packaging may consist of cardboard or a plastic material, e.g. PVC (polyvinyl chloride). The wall parts may be single-layer or multi-layer parts, where the latter parts may contain a combination of cardboard and plastic materials. 
     The opening slits may be arranged perpendicular to the tear-off strips. In this case the displacement of the blister pack is perpendicular to the direction of the tear-off strip. In an embodiment where the package contains an inner wall part, the opening slits may also run parallel to and over the tear-off strips. In this case the displacement of the blister pack is in the longitudinal direction of the tear-off strips. 
     The front part and the inner wall part are preferably joined by means of e.g. gluing or hot sealing at their peripheries at least in part and such that the blister pack lying in between can be displaced by sliding in the longitudinal direction of the opening slit. The rear wall part and the inner wall part are preferably at least in part or all-over joined by means of e.g. gluing or hot sealing in the region surrounding the tear-off strip, so that children are not able to tear off the rear wall from the inner wall when the tear-off strip is torn off. 
     An additional layer can be attached to the front part on its side facing the blister pack. The additional layer can be provided at least in part, i.e. in the region of the opening slits, or all-over. Further an additional layer can be attached to the rear wall part on its side facing the blister pack. The additional layer can be provided at least in part, i.e. in the region surrounding the tear-off strips, or all-over. The additional layers are e.g. made of a plastic material, preferably of PVC, and they can e.g. be glued, heat sealed or laminated. The additional layers serves to prevent tearing the front part with respect to the rear wall part. 
     In order to increase child safety further the resistance to sliding displacement of the blister can be increased in that the opening slits exhibit narrow regions, breakable barriers or other suitable means between the closed position and the open position. The greater frictional resistance to the blister at the narrow regions in the opening slits has to be overcome by stronger pressure applied by the fingers. Further the opening slit may be closed with a tear-off strip, whereby the tear-off strip is joined to the front part e.g. by a line of weakness, preferably a line of perforations. By tearing off the strip, the opening slit is freed an the blister is movable. 
     The arrangement of the inner wall part offers the advantage that, after removing the tear-off strip the foil lid of the blister pack is still not visible. In order that the openings in the inner wall part are also not readily visible, these can be covered by an opening closure that can be pushed through. The opening closure can be a defined area of the inner wall part which is delimited by a closed line of weakness, e.g. a notched or stamped line. 
     Further, it has also been found advantageous to cover the inner wall part on its side facing the rear wall part and/or on its side facing the foil lid with a protective layer of plastic material. The plastic material is preferably a PVC-layer. The protective layer can be laminated, heat sealed or glued onto the inner wall part. As a result this removes the possibility of small children in particular exposing the prepared openings after removal of the tear-off strips and possibly other rear wall parts. 
     According to a further aspect of the invention there is provided a child-proof package for tablets and similar pharmaceutical products, comprising a blister pack with at least one blister which is closed off by a push-through type foil lid, the blister serving the purpose of accommodating the pharmaceutical product(s), the packaging being such that the push-through type foil lid of the blister pack lies against a covering wall part, whereby the covering wall part is a multi-layer part and contains an inner layer facing the foil lid of the blister and an outer layer. The outer layer may be bonded to the inner layer in part or all-over. The inner layer contains an opening covered by a push-through opening closure which is delimited by line of weakness. The opening closure lies for the purpose of removing the pharmaceutical product over the blister. The outer layer contains an opening which lies on the opening closure. The said opening is preferably a hatch-like opening. The opening and the opening closures are preferably circular and the opening is preferably concentrically arranged on the opening closure. The opening of the outer layer is preferably equal or smaller than the opening closure. That is to say, the diameter of the opening of the outer layer is preferably equal or smaller than the diameter of the opening closure. The outer layer features an annular region surrounding the opening. The annular region of the outer layer is not bonded to the inner layer. The annular region is delimited towards the plane outer layer by means of a line of weakness, e.g. a circular line of perforations. The annular region preferably contains radial lines of weakness, e.g. cuts or lines of perforations, which subdivide the annular region into sectors. If the opening is smaller than the opening closure then the line of weakness of the opening closure is protected under the annular region and on pressing out the pharmaceutical product, the individual sectors stick out in the shape of a crown or a bloom. The inner layer is preferably made of cardboard and the outer layer is preferably made of a plastic material, e.g. PVC. 
     The described annular region represents a mean for diversion of attention of the children, which first try to open the packaging by detaching the loosened annular region, particularly the loosened sectors, from the laminate. This way children hardly pay attention to the underlying opening closure. 
     A rear wall part may be arranged adjacent to the outer layer facing of the covering wall part, whereby the opening of the covering wall part is covered over by a tear-off strip which is arranged in the rear wall part and can be separated from it along a line of weakness thereby forming a longitudinal slit. 
     A further contribution to increasing child safety in the packaging according to the invention can be made by special shaping of the tear-off strip. This exhibits preferably a gripping flange that terminates in an edge part of the rear wall part, that is freed from it only after bending the edge part, and can then be gripped between two fingers. The gripping flange can be delimited from the edge part by means of a cut or line of weakness, e.g. a punched line or a line of perforations, so that after bending the edge part the gripping flange is freed along the line of weakness and sticks out of the edge part. 
     As a further contribution to increasing child safety in the packaging, means, e.g. spring-loaded elements, can be provided which automatically set back the unhanded blister pack from the opened to the closed position by displacing in the opening slit. 
     The package according the invention can contain one or more cups which are movable individual or together in groups. The cups of a blister pack containing a number of cups may e.g. be arranged and movable in rows or in columns. In this case the cups may be movable horizontal or vertical with regard to the rows and columns of cups. In the embodiment where the movement of the cups is perpendicular to a row or a column of cups the displacement of the row or column is preferably only successful by pushing at least two cups at once. The sliding displacement by pushing e.g. only one single cup of a row or column affects that the blister pack tilts in a diagonal position in such a manner that at maximum one cup of the row or column does move into line with the openings in the adjacent wall. 
     The packaging according the invention can be developed in the form of a single card containing at least one blister pack with at least one cup, where the cups are arranged in rows and columns. Further the packaging may be developed in the form of a foldable strip shaped card with several segments that can be folded, where the segments may contain blister packs as forgoing described. 
     A useful design of the packaging according to the invention comprises of a strip-shaped card which can be folded together, whereby in the folded state one end part is folded over a first folding axis onto a middle part and is covered by a lid part folded over a second folding axis. A blister pack is preferably provided in both the middle part and in the end part, whereby the blister pack in the middle contains a daily dose e.g. of a first kind of table or similar pharmaceutical product intended to be taken in the morning and the blister pack in the end part contains the daily dose of a second kind of tablet or similar pharmaceutical product to be taken in the evening. 
     In a first version of the packaging according to the invention the opening slits may be arranged perpendicular to the tear-off strips. In a second version, the opening slits are arranged parallel to and over the tear-off strips. 
     The line of weakness in the wall part to delimit the tear-off strip is preferably a line of perforations. 
    
    
     BRIEF DESCRIPTION OF THE DRAWINGS 
     Further advantages, features and details of the invention are revealed in the following description of preferred exemplified embodiments and with the aid of the drawing, in which: 
     FIG. 1 is a plan view of the rear side of a packaging for tablets, which has been folded open; 
     FIG. 2 is plan view of the inner side of the folded open packaging shown in FIG. 1; 
     FIG. 3 is a section through the packaging shown in FIGS. 1 and 2 along line I—I in FIGS. 1 and 2; 
     FIG. 4 is a perspective view of the packaging in FIG. 1 during the removal of the cover part; 
     FIG. 5 is a plan view of a part of the packaging in FIG. 4 after removal of the cover part; 
     FIG. 6 is a plan view of a part of the packaging in FIG. 5 during the pulling off of a tear-open strip; 
     FIG. 7 a  is a plan view of a part of the opening closure of the covering wall part of another embodiment of the invention; and 
     FIG. 7 b  is section through the covering wall part shown in FIG. 7 a  along line II—II in FIG. 7 a.   
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
     A package  10  for tablets  12  or similar pharmaceutical products (e.g. liquid-filled or solids-filled capsules, etc.) is shown in FIGS. 1 and 2. The package  10  has the form of a flat elongated rectangular (strip-shaped) card with parts that can be folded together, whereby, in the folded state, one part C is folded along a first folding axis f onto a middle part B and is covered by a lid part A folded along a second folding axis e. The size of the package  10  folded together in this manner is about one third of the unfolded strip-shaped card. The card contains rear wall parts  14 B,  14 C and front wall parts  16 B,  16 C. 
     Situated between the rear wall parts  14 B and  14 C of the middle part B or the end part C and the corresponding front parts  16 B and  16 C are, in each case, blister packs  18 B,  18 C. The blister packs  18 B,  18 C comprise a blister film  20 , made for example of PVC, in which blisters or cups  22  are provided, e.g. by thermoforming. The open side of the blister  22  is closed off by a foil lid  24  made, for example, of aluminum foil, through which the contents can be pressed. 
     In the illustrated embodiment, the middle part B has seven rows of blisters  22 , each for three tablets running in a first horizontal direction x, and the end part C has seven rows of blisters  22  each for two tablets running in a first horizontal direction x. Each blister pack  18 B,  18 C comprises a row of blisters  22 . The tablets in the middle part B are, for example, intended to be taken in the morning and those in the end part C to be taken in the evening. The seven rows of tablets correspond to the seven days in the week. The version of packaging  10  shown here corresponds therefore to a weekly pack for consumption of two or three tablets twice daily. 
     Integrated into each of the rear wall parts  14 B,  14 C of the middle part B and end part C are seven tear-off strips  26  running in the first, horizontal direction x. The front parts  16 B,  16 C of the middle part B and end part C exhibit—corresponding to the blister packs  18 B,  18 C—three or two opening slits  44  running in a second perpendicular direction y. The blisters  22  are introduced from the rear side of the front part  16 B into these opening slits  44  in the longitudinal direction of the opening slits  44 —the largest opening width b of which slits  44  corresponds basically to the diameter of an individual blister  22  in the blister packs  18 B,  18 C. The front parts  16 B,  16 C and the rear wall parts  14 D,  14 C are joined at their peripheries at least in part and such that the blister packs  18 B,  18 C lying in between and delimited by its periphery  19  are enclosed in the middle part B and end part C and can be displaced by sliding only in the longitudinal direction y of the opening slit  44 . As a result of this limited ability of displacing the blister packs  18 B,  18 C each row of tablets has two extreme positions—namely, a closed position S and an open position O. The displacement t between both extreme positions of the blister packs  18 B,  18 C is a result of the limited possibility to displace the blister packs inside the middle part B and end part C or as a result of the corresponding selected length of opening slit  44 . The opening slits  44  are selected such that there is preferably a narrowing  45  between the closed position S and the open position O. As a consequence of this narrowing  45 , a frictional force of resistance has to be overcome on displacing the blister  22  from the closed position S to the open position O. This feature, i.e. the narrowing  45  of the opening slit  44 , results in a significant increase in the child-proof property of the package  10 . It is clear that after removing a dosage of tablets  12  the blister packs  18 B,  18 C must be pushed back into the closed position S to keep the packaging  10  child-proof. 
     In the example shown here, the pairs of blisters  22  in the end part C of the blister packs  18 C are in each case displaced a horizontal distance from each other. In this case, of course, the opening slits in the front part  16 C are corresponding in shape and feature regions  44   a ,  44   b  which are displaced with respect to each other. 
     In the open position O, the tablets  12  are situated in a row—as viewed in their projection onto the plane of the drawing—over the tear-off strip  26  or over a longitudinal slit  27  in the rear wall parts  14 B,  14 C defined by it. 
     As shown in FIG. 3, an inner wall  36  is provided on the inner side of the rear wall part  14 B, which is made e.g. of cardboard. This inner wall part  36 , which is likewise made of cardboard, is preferably provided with a protective layer or film  42  e.g. of PVC (polyvinylchloride) on its side facing rear wall part  14 B. 
     Provided in the inner wall part  36 , by means of notches or partially stamping through the inner wall part  36 , are openings  38  which in the unopened package are closed off e.g. by the stamped parts  40 . The number and arrangement of the openings  38  corresponds to the number and arrangement of the individual blisters  22  in the blister pack  18 B. As viewed in their vertical projection to the plane of the middle part B the openings  38  lie within the corresponding opening slits  44  in the front parts  16 B,  16 C. The diameter m of the openings  38  is chosen to correspond to the diameter of the tablets  12  in such a manner that the tablets can be pushed through the openings without any great effort. 
     The opening of the packaging  10  and the removal of the required daily dose of tablets  12  is described in the following with the aid of FIGS. 4 to  6 . 
     In order to make the tear-off strips  26  in the middle part B accessible, first the cover part A has to be opened from the middle part B. Starting from the edge at the side of the middle part B are cuts  30  which run in the first horizontal direction x parallel to the tear-off strips  26  and form between them edge parts  32  which extend up to a folding line p. Via a line of weakness or perforations  28  along the whole length up to the folding line p, the tear-off strips  26  are releasably attached to the rear wall part  14 B. A part of the tear-off strip  26  extending into the edge part  32  is designed as a flange  34  for gripping the tear-off strip  26 : whereby in order to form the edge region delimiting the gripping flange  34 , the line of weakness  28  of the tear-off strip  26  is punched through in the edge part  32 . As a result, on bending back the gripping flange  34  is freed from the edge part  32 , i.e. the flange for gripping  34  remains and can be readily gripped between two fingers and the tear-off strip  26  removed from the rest of the back wall panel  14 B. 
     The procedure described for middle part B, i.e. for removing a tear-off strip  26 , also applies analogously to end part C, whereby in that case the cuts  30  and therefore the prepared edge parts  32  in rear wall part  14 C are already lying free. 
     After the tear-off strip  26  has been removed from the appropriate rear wall part  14 B,  14 C for the desired time of day and desired day, the blisters  22  are pushed out of their closed position S by the displacement distance t into the open position O. This displacement takes place at the front side  16 B,  16 C in such a manner that two fingers engage the blisters lying farthest apart and the blister pack  18 B,  18 C is pushed parallel to the opening slits  44  by applying pressure simultaneously by both fingers. 
     If an attempt is made to effect the sliding displacement e.g. by pushing only one single blister  22 , the blister pack  18 B,  18 C tilts in a diagonal position in such a manner that the whole row of tablets does not move into line with the tear-off strip  26 . As a result, at most only one tablet can be pressed out of the pack, thus providing increased child safety as small children are hardly able to achieve the required parallel displacement of the blister pack  18 B,  18 C. In addition to the required parallel displacement of the blister pack  18 B,  18 C there is the further hindrance in that the narrowing of the opening slits  44  creates resistance to displacement so that the displacement movement which is absolutely necessary to be able to remove the tablets  12  can not be achieved by a small child. 
     After the desired tear-off strip  26  has been removed and the blister has been brought into the open position O, the tablets can be pressed out of the selected row of individual blisters  22 , through the prepared openings  38  and out of the package  10 . In the example shown in FIG. 3 the inner wall part  36  is of cardboard optionally laminated, glued or heat sealed with a PVC film acting as a protective layer  42 . This results in increased child safety in that after removing one or more tear-off strips  26  or the whole rear wall part  14 B,  14 C, the pre-stamped or notched openings  38  in the inner wall part  36  are not readily accessible for a small child. The PVC layer prevents small children from being able to free or scratch out the prepared openings  38 . Furthermore, the PVC coating makes it necessary to apply additional force to press out the tablets. Of course, other shapes of prepared openings  38  are possible. It is possible for example to prepare the opening by means of a star-shaped cut forming essentially triangular segments, whereby on pressing out the tablet, the individual segments open in the shape of a spiky crown. Likewise, the PVC film, which is used as a protective layer  42 , may exhibit a line of weakness that corresponds to the opening formed later. 
     The rear wall part  14 B,  14 C may be joined to the underlying inner wall  36  or the protective layer  42  on it, in such a manner that the tear-off strip  26  separates from the underlying wall part  36  or protective layer  42  by peeling. 
     In the example shown the front parts  16 B,  16 C are of cardboard as are the rear wall parts  14 B,  14 C. In order to increase the resistance of the rear wall parts  14 A,  14 B,  14 C and front parts  16 B,  16 C to tearing, a laminate containing plastic e.g. a cardboard/PVC laminate may be employed. 
     In the example shown, the opening slits  44  are arranged perpendicular to the tear-off strips  26 . It is self-evident that the opening slits  44  may also run parallel to the tear-off slits  26 . In this case the displacement of the blister packs  18 B,  18 C is in the longitudinal direction of the tear-off strips  26 . This does not, however, change anything with respect to the basic principle of the orientation of the individual blisters  22  or tablets  12  with corresponding openings  38 . 
     In an embodiment that is slightly different from that of FIG. 1, the blisters of the blister packs are arranged in columns (not shown in the drawings). The opening slits may be vertically arranged, i.e. the blister packs are vertically displaced, according FIG. 2, whereby no tilting of the columns of the blister packs will occur by pushing only one single blister. The opening slits may also be horizontally arranged, i.e. the moving of the blister packs is horizontally, whereby a tilting of the columns of the blister packs will occur by pushing only one single blister as above described. 
     FIG. 7 a , FIG. 7 b  show an embodiment of the covering wall part according to a further aspect of the invention. The covering wall part is a multi-layer part  50  which contains an inner layer  56  facing the foil lid of the blister and an outer layer  55 , which may facing a rear wall part. The inner layer  56  contains a circular push-through opening closure  53  which is delimited by a line of perforations  54 . The outer layer contains a circular opening  57  which is concentrically arranged on the opening closure  53 , whereby the opening  57  is smaller than the opening closure  53 . The outer layer  55  features an annular region  61  which surrounds the opening  57  and which is not bonded to the inner layer  56 . The annular region  61  is delimited towards the plane outer layer  55  by means of a line of perforations  51 . The annular region  61  preferably contains radial cuts  60 , which subdivide the annular region  61  into sectors  52 . On pressing out the pharmaceutical product, the opening closure  53  is pushed out and the individual sectors  52  open in the shape of a crown.