Abstract:
A pharmaceutical child-resistant fold-over card package with secure, sealed edges having: front, middle and rear panels of non-tear-resistant conventional card stock; at least one hole in such front panel, and at least one formed blister with a closed portion and an open portion, and a thin sheet of material covering such open portion of such blister to retain the position of such preparation inside such blister. A first set of perforation lines in such card along and approximately one quarter inch inside of each outside exposed perimeter edge of each such panel; a set of perforated holes in middle panel aligned with such hole in such top panel; a second set of perforation lines in the interior of such middle and rear panels and surrounding the area under the at least one blister, to form a perforated window under such blister and to form a tear tab.

Description:
This utility patent application claims priority to provisional patent application Ser. No. 60/955,451 titled “Pharmaceutical Blister Card Package” having a filing date of Aug. 13, 2007. The subject matter of provisional patent application Ser. No. 60/955,451 is hereby incorporated by reference. 
    
    
     The present invention relates to the art of pharmaceutical packaging. More particularly, the invention relates to the art of pharmaceutical blister card packaging, which is packaging that includes a paperboard fold-over card containing thermoformed or cold formed blisters which hold tablets, capsules and gel capsules. Still more particularly, the invention relates to a cost-effective and convenient pharmaceutical blister card package that is child resistant, yet easy to use for senior adults. 
     THE PRIOR ART 
     As mentioned above, a pharmaceutical blister card package typically includes a paperboard fold-over card which contains a thermoformed or cold formed blister, which is referred to herein as a formed blister or a blister. The card provides robustness for structural stability of the package, while each formed blister protects and contains a pharmaceutical preparation such as a tablet, capsule or gel capsule (hereinafter collectively referred to as tablets for the purpose of convenience). When a user needs to take a tablet, he or she presses a selected blister, and the tablet contained in that blister breaks through a foil or paper backing or insert in the card 
     In the pharmaceutical packaging art, it is desirable for such blister card packaging to be both child resistant and easy to use by senior adults. That is, it is desirable to provide a package that prevents young children from being able to easily open it and thus access a tablet. At the same time, it is also desirable to provide a package that enables senior adults, who may suffer from arthritis or other conditions, to relatively easily open the package and access a tablet. Criteria for child resistance and ease of use by senior adults of pharmaceutical packaging are established by the Consumer Product Safety Commission (“CPSC”), and are set forth in the U S Code of Federal Regulations (“CFR”) at 16 CFR §1700. These Regulations specify tests that are performed on pharmaceutical packaging, and the results of these tests correspond to an assigned level of child resistance and senior friendliness. These levels are known in the art as an F-1, F-2, or F-3 status. A pharmaceutical package that achieves F-1 status adheres to the most stringent requirements for child resistance and senior friendliness, while a pharmaceutical package that achieves an F-3 status adheres to the least stringent requirements for child resistance and senior friendliness. Of course, it is desirable for a pharmaceutical package to achieve an F-1 status of child resistance and senior friendliness. 
     In the pharmaceutical blister card packaging art, there are package designs that have achieved an F-1 status, but these designs possess certain disadvantages, such as an undesirably high cost and an undesirable lack of consistency. More particularly, the F-1 status blister card packages of the prior art include fold-over cards that use a specialty paperboard, such as tear-resistant paperboard, and/or separately applied adhesive labels to trap and protect the blister containing the tablet. Such construction of prior-art blister card packages has led to disadvantages associated with material availability, label management, and cost. 
     Turning first to material availability, tear-resistant paper board is considered a non-standard, specialty paperboard that is manufactured by only a few paperboard mills in the United States. Since paperboard mills experience a significant cost to transition their mills from one type of board to another, the mills have established a minimum production volume of a particular paperboard grade or type in order to offset such costs. Thus, before a mill can manufacture tear-resistant paperboard, the mill must let orders from customers “build up” to the minimum production volume. The time required for such a build up creates an unpredictable lead time to obtain tear-resistant paperboard, which may be as short as 6 weeks, or as long as 12 weeks. Such variability in lead time makes it difficult for pharmaceutical companies and/or pharmaceutical packaging companies to efficiently plan their production schedules, and particularly to meet increased production forecasts. 
     In an attempt to reduce the problems created by such unpredictable material availability, pharmaceutical companies and/or pharmaceutical packaging companies have held tear-resistant paperboard in inventory. Since tear-resistant paperboard is expensive, and a large amount of the paperboard must be purchased for inventory, this solution creates a significant cash drain which is economically undesirable. In addition, the potential for the paperboard to be damaged while it is held in inventory, and the unpredictability of the correct size of the paperboard to buy for future production, add to the undesirability of storing the paperboard in inventory. 
     Label management is a second disadvantage of prior-art blister card packages. In the prior art, the labels that are applied to a tear-resistant fold-over card are adhesive labels. Adhesive labels include an undesirably high cost, which may be from about 25% to about 60% of the total package cost, depending on the number of labels used, the specific type of labels, and how the labels are applied. The factors that lead to such a high cost for labels include the cost of label stock, which is significantly higher than paperboard because it is of a higher mill quality. In addition, the production of adhesive labels must be performed on separate and unique equipment to facilitate the application of the adhesive onto the label, and the adhesive requires distinctive methods in order to handle and store it, all of which add to the cost of producing an adhesive label. 
     Prior art adhesive labels may also include a lack of consistency, adding to the disadvantages associated with label management. For example, since the labels typically are produced in a printing and die cutting process that is separate from production of the tear-resistant paperboard, it is possible that the colors printed on the label may undesirably not match the colors printed on the tear-resistant paperboard. Pharmaceutical companies and/or pharmaceutical packaging companies have attempted to address this lack of consistency by either not printing information on the label, or printing the labels in a color that is not used on the carton. Moreover, the application of the labels to the blister card packaging requires a separate production process, which adds more cost to the packaging and requires verification of the labels in order to ensure that they have been applied in the correct position on the packaging. This verification is an additional quality check that increases the cost of the packaging. In addition, other costly and therefore undesirable quality checks are associated with label management for adhesive labels, such as quality checks on the adhesive, which must be performed to ensure that the adhesive being used on the label is being applied in conformance with predetermined specifications. 
     For prior art blister card packaging, undesirably high cost is a third disadvantage. More particularly, prior art blister card packaging that has achieved F-1 status typically employs a tear-resistant fold-over card, and the cost of the tear-resistant paperboard used for the card significantly increases the cost of the packaging. For example, the cost of tear-resistant paperboard is approximately 40% higher than standard virgin fiber paperboard. In addition, the paperboard mills typically impose minimum volumes for a purchase of tear-resistant paperboard, such as at least 40,000 pounds, while such minimum volumes are not required for other forms of paperboard. Thus, the use of tear-resistant paperboard creates significant undesirable costs for pharmaceutical companies and/or pharmaceutical packaging companies. Moreover, as described above, if adhesive labels are used, the costs associated with such labels drives the cost of prior art blister card packaging even higher. Such undesirable costs may leave a small-to-medium sized pharmaceutical company without a cost-effective package that has F-1 status. 
     As a result, a need has existed in the art to develop a pharmaceutical blister card package that overcomes the disadvantages of the prior art by providing a package with a paperboard fold-over card and a formed blister, while having F-1 status and the ability to be manufactured more economically and with more consistency than prior art packages. The pharmaceutical blister card package of the present invention satisfies this need. 
     SUMMARY OF THE INVENTION 
     An embodiment is directed to a pharmaceutical child-resistant fold-over card package with secure, sealed edges having: front, middle and rear panels of non-tear-resistant conventional card stock, each panel having a top and a bottom side, aligned in a stack with each top side facing in the same direction; at least one hole in such front panel, and at least one formed blister with a closed portion and an open portion, protruding through such top panel and away from the middle and bottom panels, a pharmaceutical preparation inside of such blister, and a thin sheet of material covering such open portion of such blister to retain the position of such preparation inside such blister; a first set of perforation lines in such card along and approximately one quarter inch inside of each outside exposed perimeter edge of each such panel; a set of perforated holes in middle panel aligned with such hole in such top panel such holes having the geometric shape of such preparation, the size of such hole in the top panel being such that such preparation narrowly passes through such hole, and such hole in the middle panel being smaller in size than such hole in such top panel; a second set of perforation lines in the interior of such middle and rear panels and surrounding the area under the at least one blister, to form a perforated window under such blister and to form a tear tab adjacent to and outside of such perforated window; adhesive tear strips affixed to the bottom of the middle panel aligned with such tear tabs and crossing such perforated window area; and adhesive material that straddles such first set of perforation lines, and other adhesive material outside of such perforated window area, on the bottom side of the front panel and the top side of the rear panel, so such top, middle, and rear panels are affixedly aligned, so that the package is securely assembled and so that any tear of any exposed edge of such card is interrupted at any of such first set of perforation lines, and so that access to such capsule can be achieved by peeling a desired tab, tearing away the adjacent perforated window, and pressing a desired capsule or group of capsules through the foil and out such window by exerting pressure on the blister from the top side of the front panel. 
     Another embodiment is directed to a pharmaceutical child-resistant fold-over card package with secure, sealed edges having: front, middle and rear panels of non-tear-resistant conventional card stock, each panel having a top and a bottom side, aligned in a stack with each top side facing in the same direction; at least one hole in such front panel, and at least one formed blister with a closed portion and an open portion, protruding through such top panel and away from the middle and bottom panels, a pharmaceutical preparation inside of such blister, and a thin sheet of material covering such open portion of such blister to retain the position of such preparation inside such blister; a first set of perforation lines in such card along and approximately one quarter inch inside of each outside exposed perimeter edge of each such panel; a second set of perforation lines in the interior of such middle and rear panels and surrounding the area under the at least one blister, to form a perforated window under such blister and to form a tear tab adjacent to and outside of such perforated window; adhesive tear strips affixed to the bottom of the middle panel aligned with such tear tabs and crossing such perforated window area; and adhesive material that straddles such first set of perforation lines, and other adhesive material outside of such perforated window area, on the bottom side of the front panel and the top side of the rear panel, so such top, middle, and rear panels are affixedly aligned, so that the package is securely assembled and so that any tear of any exposed edge of such card is interrupted at any of such first set of perforation lines, and so that access to such capsule can be achieved by peeling a desired tab, tearing away the adjacent perforated window, and pressing a desired capsule or group of capsules through the foil and out such window by exerting pressure on the blister from the top side of the front panel. 
     Another embodiment is directed to a method of making a pharmaceutical child-resistant fold-over card package, with secure, sealed edges, suitable for holding and allowing access to at least one pharmaceutical preparation such as a capsule, having the steps: die-cutting a rectangular card from non-tear-resistant conventional paperboard cardstock, having two parallel fold lines forming a first end, a second middle and a third end panel of approximately equal length or width, and such card having a first and second side, die-cutting at least one hole in such middle panel; pressing a sheet of plastic having at least one formed blister against the second side of such middle panel so that the at least one blister protrudes through such hole; placing a pharmaceutical preparation in such blister; pressing a thin film of material over such sheet of plastic; making a first set of perforation lines in such card along and approximately one quarter inch inside of the outside perimeter edge of the sides of such card perpendicular to such fold line, and of the outside perimeter edge of such first panel; die-cutting in such third panel at least one perforated hole having the geometric shape of such pharmaceutical preparation and being smaller in size than and positioned to align with such hole in such middle panel; making a second set of perforation lines in the interior of such first end panel positioned to surround the area under the at least one blister, and forming a perforated window and a tear tab adjacent to and outside of such perforated window; affixing adhesive tear strips to the first side of such third end panel and aligned with such tear tabs; applying adhesive material that straddles such first set of perforation lines on the second side of such first end and second middle panel, and other adhesive material outside of such perforated window area to second side of the first end and second middle panels and straddling the fold line between such panels; folding the third end panel along its adjacent fold line to align with the middle panel, and folding the first panel along its adjacent fold line to align with the third end and second middle panels, so that so that after such folding such middle, first, and third panels are affixedly aligned, so that the package is securely assembled and so that any tear of any exposed edge of such card is interrupted at any of such first set of perforation lines, and so that access to such capsule can be achieved by peeling a desired tab, tearing away the adjacent perforated window, and pressing a desired capsule or group of capsules through the foil and out such window by exerting pressure on the blister from the top side of the front layer. 
     Another embodiment is directed to a method of making a pharmaceutical child-resistant fold-over card package, with secure, sealed edges, suitable for holding and allowing access to at least one pharmaceutical preparation such as a capsule, comprising: die-cutting a rectangular card from non-tear-resistant conventional paperboard cardstock, having two parallel fold lines forming a first end, a second middle and a third end panel of approximately equal length or width, and such card having a first and second side, die-cutting at least one hole in such middle panel; pressing a sheet of plastic having at least one formed blister against the second side of such middle panel so that the at least one blister protrudes through such hole; placing a pharmaceutical preparation in such blister; pressing a thin film of material over such sheet of plastic; making a first set of perforation lines in such card along and approximately one quarter inch inside of the outside perimeter edge of the sides of such card perpendicular to such fold line, and of the outside perimeter edge of such first panel; making a second set of perforation lines in the interior of such first and third end panels positioned to surround the area under the at least one blister, and forming a perforated window and a tear tab adjacent to and outside of such perforated window; affixing adhesive tear ships to the first side of such third end panel and aligned with such tear tabs; applying adhesive material that straddles such first set of perforation lines on the second side of such first end and second middle panel, and other adhesive material outside of such perforated window area to second side of the first end and second middle panels and straddling the fold line between such panels; folding the third end panel along its adjacent fold line to align with the middle panel, and folding the first panel along its adjacent fold line to align with the third end and second middle panels, so that so that after such folding such middle, first, and third panels are affixedly aligned, so that the package is securely assembled and so that any tear of any exposed edge of such card is interrupted at any of such first set of perforation lines, and so that access to such capsule can be achieved by peeling a desired tab, tearing away the adjacent perforated window, and pressing a desired capsule or group of capsules through the foil and out such window by exerting pressure on the blister from the top side of the front layer. 
    
    
     
       DETAILED DESCRIPTION 
       The preferred embodiment of the invention, illustrative of the best mode in which applicants have contemplated applying the principles of the invention, is set forth in the following description and is shown in the drawings. 
         FIG. 1  is a plan view of the front side of an exemplary embodiment of a pharmaceutical blister card package of the present invention, after cutting of the paperboard and before the application of adhesive and formed blister. 
         FIG. 2  is a plan view of the back or rear side of the embodiment of the invention shown in  FIG. 1 , after the application of adhesive. 
         FIG. 3  is a photograph of the front panel of the embodiment of the invention shown in  FIG. 2 , after assembly and folding 
         FIG. 4  is a photograph of the rear panel of the embodiment of the invention shown in  FIG. 3 . 
     
    
    
     Similar numerals refer to similar parts throughout the drawings.  
     Turning now to the drawings of the present invention, wherein the illustrations are for showing preferred embodiments of the invention, and not for limiting the same,  FIGS. 1-4  show an exemplary embodiment of a pharmaceutical blister card package of the present invention, indicated generally at  10 . With particular reference to  FIG. 1 , blister card package  10  includes a paperboard fold-over card  12  that preferably is made of standard paperboard, such as virgin fiber paperboard. Card  12  includes a front panel F, a middle panel M, and a rear panel R. Holes  14  are formed in front panel F and correspond to tablets  16  ( FIG. 3 ) that are contained by package  10 , as will be described below. Thus, in the illustrated embodiment, six holes  14  are formed to correspond to six tablets  16 . Holes  14 , as with all of the features formed in card  12 , preferably are formed by die cutting. 
     Holes  18  are formed in middle panel M of card  12 , and correspond to holes  14  formed in front panel F, but are of a slightly smaller size than the holes formed in the front panel, in order to retain the position of tablets  16 , as will be described in greater detail below. Rear panel R is formed with tabs  20  adjacent respective perforated lines  22  and respective perforated windows  24 . Middle panel M is formed with tabs  34  that correspond to rear panel tabs  20 . The operation of tabs  20 ,  34 , perforated lines  22  and perforated windows  24  will also be described in greater detail below. It is to be understood that holes  14  and holes  18 , while shown as round openings, may be other geometric shapes, such as oval or square openings. 
     During manufacturing, a sheet of plastic, preferably made of clear polyvinyl chloride (“PVC”) and having thermoformed or cold formed blisters  26  ( FIG. 3 ), is pressed against the bottom surface of front panel F, so that the blisters extend through front panel holes  14 . Blisters  26  can be applied to card  12  either manually or by a machine, depending on specific processing considerations. Tablets  16  are then placed in blisters  26  from the bottom surface of front panel F and a foil or paper backing  28  ( FIG. 3 ), preferably a heat-sealable aluminum foil, is pressed against the PVC sheet and sealed to the sheet, as known in the art, to seal the tablets in the blisters. A strip of pressure sensitive tape  30 , such as tensilized polypropylene teartape with a rubber adhesive, is applied to middle panel M from each tab  34  across the middle panel, which corresponds to an area  32  on rear panel R that is located between each respective perforated line  22  and perforated window  24 . 
     With reference now to  FIG. 2 , adhesive means, such as pressure sensitive tape or a hot melt adhesive, is applied to the bottom surface of front panel F and rear panel R in areas designated as “Glue”. Middle panel M is then folded along line A, which causes middle panel holes  18  to align with front panel holes  14 , and the adhesive on front panel F causes the front and middle panels to adhere to one another in alignment. Rear panel R is then folded along line B, and the adhesive on the rear panel causes the rear panel to adhere to middle panel M in an aligned manner. Once adhered to middle panel M, each perforated window  24  formed in rear panel R aligns with holes  18  formed in the middle panel and with holes  14  formed in front panel F Also, once rear panel R is adhered to middle panel M, rear panel tabs  20  align with middle panel tabs  34 , and area  32  on the rear panel aligns with tape  30  on the middle panel. 
     Turning now to  FIGS. 3 and 4 , the folded package  10  is shown. Blisters  26  protrude through holes  14  formed in front panel F, and instructions are printed directly on card  12 . To access tablets  16 , a user grasps a selected one of tabs  20  and pulls. Tape  30  ( FIG. 1 ), which is aligned with selected tab  20 , causes area  32  to pull away from card  12  when the tab is pulled, thereby reducing the strength of rear panel R and enabling tablets  16  to be pressed from blisters  26  through perforated windows  24 . That is, while tape  30  is still in place on card  12 , rear panel R maintains enough strength to generally prevent tablets  16  from being pressed though perforated windows  24 . However, when tab  20  is pulled, tape  30  causes area  32  to be removed so that tablets  16  can be pressed through window  24 . 
     Package  10  also includes a secure seal edge  36 . In the prior art, blister card packages using fold-over cards had to employ expensive adhesive security labels to eliminate the possibility of a child gaining entry into the package and to the tablets by splitting the edge of the fold-over card. Secure seal edge  36  prevents such entry without expensive adhesive labels. More particularly, with reference to  FIGS. 1 and 2 , card  12  is formed with perforated lines  38  approximately one quarter of an inch inside the outer edge of the card. Two of the “Glue” areas, as shown in  FIG. 2 , are along lines  38  of front panel F and rear panel R. In use, if a child attempts to tear into package  10  along the edge of card  12 , perforated line  38  will tear, leaving the adhesive on the very edge of the card. This significantly reduces the child&#39;s ability to gain access through the edge of card  12 . 
     The use of secure seal edge  36  is important to note because it is not possible to apply adhesives known in the art to the extreme edge of card  12 , thus leaving an opportunity for a child to gain access by leveraging the strengths of the paperboard to pull apart the card. By using secure seal edge  36 , package  10  effectively has adhesive to the outer edge of card  12 , and thus eliminates the need to use expensive adhesive security labels. 
     Package  10  of the present invention has undergone testing, and has achieved F-1 status in conformance with 16 CFR §1700. Thus, the unique design and construction of package  10  provides a child-resistant and senior-friendly blister card package using fold-over card  12 , which is economical to manufacture. 
     By using card  12  made of virgin fiber paperboard and formed blisters  26 , which are readily available in the marketplace, the cost of the base materials has been reduced by at least 40% when compared to prior art blister card packages with tear-resistant paperboard fold-over cards. Moreover, with the elimination of special or custom made materials, such as tear-resistant paperboard, lead times are reduced and the ready availability of standard virgin fiber paperboard eliminates the material availability problems and minimum purchase quota problems of the prior art. In addition, virgin paperboard is a recyclable material, thus reducing solid waste problems associated with the non-recyclable material of the prior art. 
     The elimination of a separately applied adhesive label or labels in package  10  with F-1 status reduces the cost of the package and improves the consistency and quality of the package. In addition, the design and construction of package  10  enables most of the manufacturing of the package to occur in-line through one production process, rather than many separate processes. The cost effectiveness of package  10  of the present invention enables small to mid-sized pharmaceutical companies or low volume users to have an F-1 status blister card package, and thus provide high-quality packaging for their products at competitive costs. 
     While package  10  is shown and described above as a six-cavity package, the package of the present invention may employ any number of cavities, such as from 1 cavity to 60, without affecting the overall concept or operation of the invention. Of course, alternative configurations for holes  14 ,  18 , windows  24  and tabs  20  may also be used without affecting the overall concept or operation of the invention. Package  10  of the present invention may also be designed to accommodate auto-fill equipment, in which case the package will continue to utilize the same basic design and production processes, with minor variations to adhere to machine and processing specifications. Moreover, although originally designed for application in the pharmaceutical industry, the features of package  10  of the present invention may find application in other industries as well. 
     The present invention has been described with reference to a specific embodiment. It is understood that this description and illustration is by way of example and not by way of limitation. Potential modifications and alterations will occur to others upon a reading and understanding of this disclosure, and it is understood that the invention includes all such modifications and alterations and equivalents thereof.