The present invention relates to apparatus and methods of packaging and dispensing items, and more specifically, the present invention is directed to a child-resistant package including a blister pack for dispensing items.
It is well known to use blister packaging to store and deliver items. Such items may include pharmaceutical tablets, pills, and capsules. Conventional blister packages include a blister tray that is typically a thermo-formed plastic sheet having a plurality of blister cells or depressions formed therein. Typically, after the items are placed in the cells, the items are retained and protected in the respective cells by securing a backing sheet comprising foil, plastic, or paperboard to the back of the tray to seal the cells. In other types of conventional blister packages the contents are placed in substantially puncture proof foil containers that are then covered with foil or paperboard backing.
In conventional blister packages, the foil backing is thin enough to be either punctured mechanically or ruptured by pressing the blister so that the enclosed item penetrates the foil. Typically with paperboard backing, gates are provided in the backing panel that covers the opening of the blister cells. In practice, each gate is deformed or manipulated so that it ruptures or partially separates from the surrounding paperboard, allowing the item within the blister cell to be pushed through the gate.
While the conventional blister packages are suitable for some applications, there are several design deficiencies. The conventional blister packages provide removal of the items from the blister cells, but offer very little child resistance. Child resistance is a feature that is particularly desired for unit dose pharmaceutical packaging, and is mandated by the Poison Prevention Packaging Act of 1970. Guidelines are prescribed for packaging to satisfy the criteria for child resistance. For example, a child-resistance (CR) rating of F=1 requires that a random sampling of the subject packages not be compromised by an age-specific test pool of children at no greater than a predetermined failure rate. This general guideline is designed to ensure that the package has sufficient integrity against tampering by children.
In addition to a blister package being child-resistant, it is also desirable that the package be senior friendly, that is, the package permits easy withdrawal of items from the package by an intended user requiring minimum manipulation even where a user's manual dexterity and strength is reduced. Accordingly, there remains in the art a need for apparatus and methods of blister packaging and dispensing items where child resistance is significant and can be easily increased, while the package remains senior friendly.
The present invention overcomes the deficiencies of the known art and the problems that remain unsolved by providing a child-resistant package that is inexpensive, easy to fabricate, and can be used with conventional blister packs. Generally speaking, one embodiment of the child-resistant package includes a blister pack that is disposed and sealed between three panels. The package includes at least one tab strip and pull tab formed from a first panel, where the tab strip covers a gate formed on a second panel. The gate correspondingly aligns with a blister of a blister pack to additionally secure at least one item within the blister. In some embodiments, adhesive, placed between the tab strip and gate during assembly of the package substantially prevents the tab strip from attaching to the gate.
In operation, pressure is applied to the pull tab to bend the pull tab out of the plane of the surrounding panel. The pull tab is pulled to break the tab strip from the surrounding panel and expose the gate. Finally, pressure is applied to the corresponding blister to force the enclosed item to rupture the backing sheet of the blister pack and to dislodge the gate, thereby gaining access to the item. The child-resistant value of the present invention includes security features that require a sequence of coordinated motions including pressing, pulling, and pressing again to gain access to an item.
More specifically, in one embodiment a blank for forming a package for use with a blister pack comprises a first panel, which includes a blister aperture and means for identifying an underlying finger tab, a second panel which includes at least one gate defined at least in part by a severance line and at least one finger tab defined at least in part by a severance line, and a third panel which includes at least one tab strip having a pull tab and a tear strip. Here, the panels are arranged such that the blister aperture, gate, and tear strip are operationally aligned, and the means for identifying an underlying finger tab, the finger tab, and the pull tab are operationally aligned. In another embodiment, a blank for forming a package for use with a blister pack comprises a first panel including at least one gate defined at least in part by a severance line and means for identifying an underlying pull tab, and a second panel including at least one tab strip having a pull tab and a tear strip. Here, the pull tab is removable and the tear strip is at least partially removable from the second panel, and the means for adhesion is positioned such that the gate and tear strip are not substantially connected. Further, the panels are secured to each other such that the gate and tear strip are operationally aligned, and the means for identifying an underlying pull tab and the pull tab are operationally aligned. In a different embodiment, a package comprises a first panel including blister apertures and means for identifying an underlying finger tab, a second panel includes gates and finger tabs defined at least in part by severance lines; and a third panel including tab strips having pull tabs and a tear strips. Here, a blister pack having blisters holding items are positioned such that the blisters extend through the blister apertures, the panels are arranged such that the blisters and gates and tear strips are operationally aligned, and the means for identifying an underlying finger tab and the finger tabs and the pull tabs are operationally aligned. In yet another embodiment, a blank for forming a package for use with a blister pack comprises a first panel including gates and means for identifying an underlying pull tab, a blister pack having blisters holding items attached to the first panel and positioned such that the blisters are operationally aligned with the gates, and a second panel including tab strips having pull tabs and tear strips. Here the panels are secured such that the gates and tear strips are operationally aligned, and the means for identifying an underlying pull tab and the pull tabs are operationally aligned. The pull tabs are removable and the tear strips are at least partially removable from said second panel. Means for adhesion is provided such that the gates are not connected to the respective tear strips.
Regarding the embodiments described herein, as well as those covered by the claims, the face panel, center panel, or back panel may or may not include a tear-resistant layer to provide structural integrity or increased child-resistance. In addition, the panels and package may be designed to include any shape or dimension that accommodates any blister pack. Further, the terms, “face”, “center”, and “back” are merely directional in order to distinguish one panel from another. Accordingly, those terms are not limitations but may be used interchangeably.
In addition, terms such as “cut line”, “severance line”, “cut”, and “frangible line”, whether in the singular or plural, are used expansively and interchangeably to include all manner of full and partial cuts, perforations, slits, nicks, combinations thereof, and all similar means for separating an element from a surrounding panel. In some embodiments the fold or score lines may likewise be severance lines.
Further, the terms “adhesive”, “adhesion”, “means for adhesion”, and all variations thereof as used herein will be understood by those skilled in the art to include the substantial opposite of adhesion, such that adhesion prevents the substantial or complete adhering, bonding, binding, attaching, or connecting of elements. Adhesive compositions and the chemical preparation thereof, as well as adhesive methods and the mechanical execution thereof, are known in the art.
As required, detailed embodiments of the present invention are disclosed herein. It must be understood that the disclosed embodiments are merely exemplary of the invention that may be embodied in various and alternative forms, and combinations thereof. As used herein, the word “exemplary” is used expansively to refer to embodiments that serve as an illustration, specimen, model or pattern. The figures are not necessarily to scale and some features may be exaggerated or minimized to show details of particular components. In other instances, well-known components, systems, materials or methods have not been described in order to avoid obscuring the present invention. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art to variously employ the present invention.
For the purposes of illustration and teaching only, the present invention is taught within the context of pharmaceutical products. It will be understood that the present invention is applicable to the packaging, storing, and dispensing of various items or products, including but not limited to, tablets, pills, capsules, lozenges, chewables, patches, drug delivery devices, medications, and/or non-medications, liquids and the like. The term “items” as used herein include a unit dose of a pharmaceutical product and all manner of portable items or products that a user may wish to keep secure and dispense in a regulated, safe manner.
Referring now to the drawings, wherein like elements are represented by like numerals,
The packaging blank 10 can be constructed from any suitable substrate material to include plastics, conventional paperboard grades, including solid bleached sulfate (SBS) paperboard of suitable weight, size, and shape, and combinations thereof. Examples of suitable substrate include Easy Seal® brand and Easy Seal Plus® self-sealing boards, presently available through the Applicant. A tear resistant layer may or may not be adhered to packaging blank 10. Tear resistant layers are often laminated to the blank before cutting. The blank 10 may also be an unbleached board, depending on the desired appearance of the final package.
The face panel 12 includes blister apertures 22 and finger apertures 24. The blister apertures 22 are shaped and dimensioned to receive the blisters 25a of a blister pack 25, each containing an item 25b. In this illustrated embodiment, the finger apertures 24 are shaped and dimensioned to receive a finger of a user, or some tool, in a method that will be described in more detail below. The face panel 12 further includes foldable score lines 26.
The back panel 14 includes tab strips 28. Each tab strip 28 includes a tear strip 30 hingedly connected to a pull tab 32 along a foldable score line 34. Each tear strip 30 is defined by a severance line 36 and the foldable score line 34. Each pull tab 32 is defined by a cut line 38 and the foldable score line 34. Each pull tab 32 aligns with a respective finger aperture 24 and each tear strip 30 aligns with a respective blister aperture 22, when the blank 10 is folded as described below. Further, the back panel includes foldable score lines 26.
The center panel 16 includes gates 42 and finger tabs 44. The gates 42 are defined by severance lines 46 and the finger tabs 44 are defined by severance lines 48. The gates 42 are aligned with respective blisters 25a and the finger tabs 44 are aligned with respective tabs 32 when the blank 10 is folded as described below.
While the illustrated embodiment shows a so-called “starter pack” with a single row of two blisters, it will be understood that alternative embodiments of the invention include any number of rows, columns, and number of blisters desired, the number, configuration, and orientation being merely design choices. Likewise, the shape and orientation of the various related elements, including the blister apertures 22, finger apertures 24, tab strips 28, gates 42, and finger tabs 44, are not limited to the illustrated embodiments, but may vary as desired to accommodate various blister configurations and still collectively function as described herein.
The package 50 (best shown in
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With reference now to
In practice, to access an item 25b from a package 25, a user's finger or some tool is used to locate a finger aperture 24 then press and sever the double pull tab 32a (tabs 44, 32) from the respective panels 16, 14. The double pull tab 32a forms a grip by which a user can begin to pull a tear strip 30. Pulling the double pull tab 32a, the user separates the tear strip 30 from the back panel 14. Because of the severance line 36 and adhesive B between the tear strip 30 and gate 42, the tear strip 30 is removed with little or no delamination of the tear strip 30, gate 42, or adjacent panel 14. In other words, the use of adhesive B and the tear strip severance line 36 permits a substantially clean removal of the tear strip 30.
Removing the tear strip 30 exposes the respective gate 42, attached to the surrounding panel 16. Each gate 42 impedes access to the item 25b stored in the respective blister 25a. To access the item 25b the blister 25a is pushed with sufficient pressure to force the gate 42 to sever from the adjacent panel 16 along the severance line 46 and permit the item 25b to be removed from the package 50. In some embodiments the tear strip 30 and gate 42 are fully removable, in alternative embodiments the elements are hingedly removable.
In alternative embodiments an adhesive is not applied to the tear strip 30 or gate 42, rather an “area seal” that does not contact these elements 30, 42 together is used. As understood by one skilled in the art, when self-sealing panels, such as the Easy Seal® and Easy Seal Plus® products referenced above, are used to construct a package typically heat is applied to the entire area of the panels in order to bond one panel to another. If attachment between a portion of the panels is not desired, heat is not applied to that section of panel area, forming an unbonded section termed an “area seal”. A similar result is achieved through alternative methods of attaching panels, such as ultrasonic welding, when those bonding methods leave a certain area unattached to an adjacent panel or panels. Alternatively, adhesive is not applied to areas where a connection is not desired. All these various means for adhesion B, and combinations thereof and the like, can be used to prevent the bonding of a tear strip 30 and respective gate 42. Likewise, bonding methods such as cold glue or tape may be used to attach various panels 12, 14, 16 and a blister pack without attaching the tear strip 30 to a respective gate 42.
For various reasons it may be desirable to increase the child resistance capabilities or rating of the exemplary embodiments illustrated and described above. For example, an adult with a history of heart attacks may be on a regime of nitroglycerin tablets and that adult may reside with children or grandchildren. Because of the danger of a child accessing and swallowing nitroglycerin tablets, the child resistance features of the exemplary embodiments can be enhanced as described below.
In one exemplary embodiment of a package with increased child resistance, the tactile indicator of a finger aperture 24 is replaced with a different means for identifying an underlying finger tab, namely a finger tab 24a (not shown), similar to the finger tab 44 shown in the center panel 16. In other words, rather than fully cutting and removing a portion of the front panel 12 to create the finger aperture 24, such an area is designated with a severance line and the same area remains intact until removed by the user. In other alternative embodiments, other means include treated surface areas by which the user is directed where to initiate the first push sequence of opening the package, namely the finger tab 24, 24a proximate the blister 25a. In alternative embodiments the user may be directed to the finger tab 24, 24a by a visual indicator such as printed words, symbols, or designs. With such an embodiment the respective finger tabs 24a, 44, 32 can be of the same size or different, and the cuts used to define the respective finger tabs 24a, 44, 32 can be designed to increase the amount of resistance needed to push through a triple pull tab 32b formed by the bonded finger tabs 24a, 44, 32.
Another exemplary embodiment of a package with increased child resistance is one wherein the tear strip 30 is joined to the respective gate 42 and/or the surrounding panel 16. In such an embodiment no means for preventing adhesion, as described above, is used. Rather, this tear strip 30 will be more difficult to remove than the illustrated embodiment because it is bonded to the surrounding elements, and thus will likely delaminate when being pulled by the user. Further, the cuts used to define the respective severance lines 36, 46 for a tear strip 30 and gate 42, can be designed to increase the amount of resistance needed to push the item through the gate 42 and whatever part of the tear strip 30 that remains adhered to the gate 42.
As understood by one skilled in the art, the exemplary package embodiments illustrated and/or taught herein may comprise a single card, a bi-fold card, or a tri-fold card. Further, these embodiments may be constructed of a single, double, or triple panel. In addition, the invention may be practiced with a single panel or multiple discrete panels.
It must be emphasized that the law does not require and it is economically prohibitive to illustrate and teach every possible embodiment of the present claims. Hence, the above-described embodiments are merely exemplary illustrations of implementations set forth for a clear understanding of the principles of the invention. Many combinations and variations of combinations may be made to the above-described embodiments without departing from the scope of the claims. All such combinations and variations of combinations are included herein by the scope of this disclosure and the following claims.
This application claims benefit of U.S. Provisional Application No. 60/717,129 filed Sep. 14, 2005, the entirety of which is herein incorporated by reference.
Number | Date | Country | |
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60717129 | Sep 2005 | US |