Abstract:
The invention relates to, among other things, a wallet package for presenting blister sheets comprising: (1) a first wallet panel with a width and height (without limitation as to shape); (2) a blister sheet comprising dosage forms enclosed between a first side material and a second side material, the second side material having one or more blister barriers, wherein the blister sheet is secured to the first wallet panel such that (i) the dosage forms and the corresponding area of the blister barrier(s) can nonetheless be pulled away from the first wallet panel, or (ii) an edge of the blister sheet can be pulled sufficiently away from the first wallet panel so that blister access devices for said blister barrier(s) can be accessed; and (3) additional wallet panels with a width and height hingably connected, among themselves and the first wallet panel, such that when folded to a fold position a resulting width and height of the folded wallet package is about the width and height of a largest said wallet panel, wherein the wallet package can be reversibly folded to the fold position to cover the blister sheet, and reversibly unfolded to uncover the blister sheet.

Description:
[0001]     The present invention relates to wallet packaging for dosage forms, such as dosage forms for medicaments, herbal extracts, vitamins, or the like.  
         [0002]     Wallet packages for dosage forms have gained popularity as vehicles for delivering medicaments and the like to consumers. In these packages, blister packs in which dosage units can be pushed through a retaining barrier are adhered between layers of cardboard or the like. The dosage units can be viewed through holes in one of the sandwiching layers, with this layer typically having language that helps the user comply with dosage requirements, dosage schedule or the like. To access a dosage unit, it may be pushed through the back barrier and a corresponding hole in the other sandwiching layer. Other panels of cardboard allow the sandwiching layers to be folded into the wallet, and provide surfaces on which to provide promotional material, compliance information, safety information, or the like.  
         [0003]     What has not been available is a cost-effective means to have the advantages of a wallet package along with child resistance. Efforts to provide such child resistance have typically involved making mechanical puzzles or other barriers involving the packaging around the blister sheet. For example, one device must be opened, a cardboard button engaged, and the working part of the wallet device slid out, as illustrated in  FIG. 13 . In other devices wallet packaging material must be removed, as may be facilitated with pull tabs, or pushed through. It has not been recognized that child-resistance as embodied in the blister sheet itself can be effectively incorporated into wallet designs.  
       SUMMARY OF THE INVENTION  
       [0004]     In one embodiment, the invention relates to a wallet package for presenting blister sheets comprising: (1) a first wallet panel with a width and height (without limitation as to shape); (2) a blister sheet comprising dosage forms enclosed between a first side material and a second side material, the second side material having one or more blister barriers, wherein the blister sheet is secured to the first wallet panel such that (i) the dosage forms and the corresponding area of the blister barrier(s) can nonetheless be pulled away from the first wallet panel, or (ii) an edge of the blister sheet can be pulled sufficiently away from the first wallet panel so that blister access devices for said blister barrier(s) can be accessed; and (3) additional wallet panels with a width and height hingably connected, among themselves and the first wallet panel, such that when folded to a fold position a resulting width and height of the folded wallet package is about the width and height of a largest said wallet panel, wherein the wallet package can be reversibly folded to the fold position to cover the blister sheet, and reversibly unfolded to uncover the blister sheet. 
     
    
     BRIEF DESCRIPTION OF THE DRAWINGS  
       [0005]      FIGS. 1A-1F  illustrate various views of a wallet package of the invention.  
         [0006]      FIG. 2  shows another embodiment of a wallet package of the invention.  
         [0007]      FIGS. 3A-3C  illustrate various views of a wallet package of the invention.  
         [0008]      FIG. 4  shows another embodiment of a wallet package of the invention.  
         [0009]      FIG. 5  shows another embodiment of a wallet package of the invention.  
         [0010]      FIG. 6  shows another embodiment of a wallet package of the invention.  
         [0011]      FIG. 7  shows another embodiment of a wallet package of the invention.  
         [0012]      FIGS. 8A and 8B  show another embodiment of a wallet package of the invention.  
         [0013]      FIGS. 9-11  shows further embodiments of wallet package of the invention.  
         [0014]      FIGS. 12 and 13  show a wallet packages. 
     
    
     DETAILED DESCRIPTION OF THE INVENTION  
       [0015]     The wallet package can be arranged with blister sheets secured face down on a panel, or face up. The face down embodiments are illustrated first.  
       Downward-Facing Embodiments  
       [0016]      FIG. 1  illustrates an embodiment of the invention utilizing wallet package  10  with four panels and three folds. A wide variety of fold sequences, layouts of panels, and numbers of panels can be used. Each illustrated exemplary panel has a first and second side (sides a and b, respectively). The first sides,  1   a ,  2   a ,  3   a  and  4   a  can be seen in  FIG. 1A . Panel side  4   a  has cutouts  11  (as exemplified, 2 rows of 4) The dotted box illustrates where blister sheet  20 , exemplified in  FIG. 1B , is fitted. Blister sheet  20 , turned over from the orientation illustrated, is fitted corner a to corner a, corner b to corner b, and so on, such that protrusions  22  (see  FIG. 1C ) fit into cutouts  11 .  
         [0017]     The blister sheet has one or more backing layers of sufficient strength that a dosage unit (i) cannot be conveniently pushed through the backing layer(s) without peeling off some or all of at least one of the backing layers or (ii) can only be pushed through with a force sufficient to provide child-resistance. For example, as exemplified in the cutaway of  FIG. 1C , the backing layers are made up of a vapor barrier  21 B (e.g., foil), and a reinforcing layer  21 C. Reinforcing layer  21 C can be layered against (such as adhered to) vapor barrier  21 B, and can be peeled away from outer layer  21 A with or without all or part of the underlying vapor barrier  21 B. As will be understood in the art, in many cases only a portion of the area of reinforcing layer  21 C under a given protrusion  22  may need to be peeled to make it convenient to push dosage unit  23  through the remaining backing layer structure. Outer layer  21  may or may not be transparent.  
         [0018]     The layers (of the backing layers) adapted to be peeled away are typically strong enough to not tear (except along perforations, cuts or other deliberate weakened structures) during the peeling process. These layers can be, for example, polymer-reinforced paper, polymer sheets, and the like.  
         [0019]     The dual-arrowed arcs shown in  FIG. 1A , show illustrative fold directions. Illustrated fold  1 D shows the fold of first side  1   a , onto first side  2   a , to yield the folded view of  FIG. 1D , where, as a result of the fold, second side  1   b  is face up. In  FIG. 1D , blister sheet  20  is shown adhered in place on first side  4   a , with its back side showing. The dark arrows illustrate positions for barrier access devices (defined below). Lines  24  can be perforations, cuts, or other weakenings in the reinforcing layer  21 C, such that any given blister barrier (defined below) is isolated to one dosage unit (or designated set of dosage units if appropriate). Or, lines  24  can simply be boundaries between areas (again blister barriers) corresponding to dosage units (or sets of dosage units), and may have no physical presence on the blister sheet. Perforations can be through all layers of the blister sheet. Blister access devices, if present, can be located in any number of locations on the blister sheet. Perforations or cuts of lines  24 , for example, can be deeper at the barrier access devices to facilitate manual access.  
         [0020]     First and second reusable closures  17 A and  17 B allow the wallet device to be stably but releasably closed to enclose the back side of blister sheet  20 .  
         [0021]     Fold  1 E yields the view of  FIG. 1E , where second side  4   b  can include compliance assistance printing. First and second reusable closures  12 A and  12 B allow the wallet package  10  to be releasably held in a closed position. Fold  1 F yields the view of  FIG. 1F , where second side  2   b  includes printing of illustrative marketing information. The reusable closures (e.g.,  12 A,  12 B,  17 A,  17 B) can be of a wide variety known in the art, including reclosable glue seals (in which case one of closures of a pair { 12 A or  12 B, or  17 A or  17 B} is simply wallet material suitable for accepting the glue seal provided by the other closure), hook and loop closures such as Velcro™, snaps, buttons, tuck and fit, and the like. Closures can be tapes or straps that partially or fully wrap around the folded wallet package. For example, closures can be label closures (as known in the art) which can be reclosable and/or tamper evident.  
         [0022]      FIG. 2  shows an illustrative wallet package  30  with cutouts  31 , that uses an alternative fold pattern (from among the many available).  
         [0023]     The various panels of a wallet package can be used to provide printing with marketing, dosage, warnings, and the like. Booklets can be securely or releasably affixed to a panel. For example, a product insert, such as one required by a regulatory agency, can be so secured or affixed. Or, secured or affixed can be a booklet that provides compliance assistance, such as a generic calendar with checkoffs, or the like.  
         [0024]     It will be recognized that a wide variety of layouts of dosage units can be used in a blister sheet in a wallet package of the invention.  
         [0025]     For simplicity, a number of additional embodiments shall be illustrated in a 4-panel layout similar to that of wallet package  10 , with at least the first fold previously illustrated (fold  1 D) already made.  
         [0026]      FIG. 3  shows an exemplary embodiment of a wallet package  50  in which blister sheet  60  can, in part, be folded away from panel  4 , for example along optional hinges  65 , thereby allowing greater manual access to the barrier access devices.  FIG. 3B  shows the two illustrated hinges  65  being used, and  FIG. 3C  shows just one such hinge engaged. In the absence of hinge structure, the dosage units can still be drawn away from panel  4 . Protrusions  62  are illustrated as protruding through panel  4 , though this can vary with embodiments. The blister sheet can be secured to panel  4  at, for example, contact surface  66 . Securing can be by a number of methods, such as adhesive methods, stitching, stapling, riveting, or the like. Optional closure-facilitating area  5  illustrates extra spine material used to facilitate one illustrative pattern for folding the panels. If panel  4   b  provides compliance assistance printing, then the presence or absence of dosage units aligned with the compliance information can be apparent by looking through the cutouts.  
         [0027]     By pulling the dosage units away from panel  4 , the child-resistant opening mechanism can be more readily accessed. For example, blister access devices (defined below) located along an outer edge (pulled away from panel  4 ) can be accessed and engaged more easily. If a scissors or the like are needed to initiate a tear, pulling away allows access for a cut, and for any subsequent tear. Or, perforations can allow individual dosage units (or sets of dosage units) to be torn off, as facilitated by pulling away form panel  4 , and then the child-resistant opening mechanism can be operated.  
         [0028]      FIG. 4  shows one of many other folding sequences or patterns for wallet package  70 , which is otherwise analogous to wallet package  50  (with folds  85  and protrusions  82 ). Fold A, in this exemplification, is conducted before fold B.  
         [0029]     Hinges, such as hinges  65  or  85 , can be, for example, fold lines, where folding can be facilitated by methods known in the art, such as perforation along the fold line, compression along the fold line, heat with compression, pre-folding, or the like. The hinges can be designed to bias, to some extent, the blister pack tending to return to a flat aspect (ignoring the protrusions), so as to facilitate closing the wallet package.  
         [0030]      FIG. 5  shows a wallet package  90  in which the contact surface  106  is to one side of the blister sheet, and optional hinge  105  is on the same side. The contact surface can be on any side, such that the can pulled up from the right (as here), left, top or bottom (or still other orientations depending upon the blister sheet geometry, and the like). The hinge can be formed for example by wallet panel material, such as folds in the wallet panel. For example, supposing that contact surface  106  is on the left, top or bottom, a portion of wallet panel can extend to the corresponding left, top or bottom, connected by a hinge (such as a crease). The extended portion can fold over, and be adhered to, the contact surface, in which case the blister sheet  100  need not be hinged—while preserving all the function of wallet package  90  (or similar designs such as wallet package  230 ).  
         [0031]     Lines  104 A and  104 B are typically to the other side from the contact surface (here, on the right side). Italicized numbers 1 through 8 illustrate an optional order of usage for the dosage units. After dosage units 1-4 have been used, in some embodiments line  104 B allows the used portion of the blister sheet to be torn away, to provide greater access to the barrier access devices for dosage units 5-8. It will be recognized that the same multiple rows, and tearing away used rows, can be used with butterfly designs such as found in  FIG. 3 .  
         [0032]     Shaded areas  108 A,  108 B,  108 C,  108 D, are optional areas under the blister sheet that are secured to panel  4  with reclosable glue seals.  
         [0033]      FIG. 6  illustrates that nonlinear design elements can be incorporated into the presentation of dosage forms (wallet package  110 , hinges  125 , lines  124 , protrusions  122 ).  
         [0034]      FIG. 7  illustrates wallet package  130 , with lines  144 . The blister sheet  140  can be secured over various areas, such as contact surface  146 A, contact surface  146 B, or contact surface  146 C. Even if the secured area is relatively close to the barrier access devices, some separation allows more room for a users&#39; fingers to manipulate the barrier access devices, with less interference from panel  4 .  
       Upward-Facing Embodiments  
       [0035]     Similar embodiments to those described above, but with the dosage units oriented upwards, are shown in  FIGS. 8A, 8B ,  9 ,  10  and  11 . In  FIG. 8A and 8B , wallet package  210  has blister sheet  220 , optional hinge  225 , contact surface  226 , protrusions  222  and lines  224 . In  FIG. 9 , wallet package  230  has blister sheet  240 , optional hinge  245 , contact surface  246 , and optional reclosable glue seals  248 A,  248 B.  FIG. 10  illustrates wallet package  250 . The blister sheet  260  can be secured over various areas, such as contact surface  266 A, contact surface  266 B, or contact surface  266 C. In  FIG. 11 , wallet package  270  is folded in one of the many alternative fold patterns.  
         [0036]      FIG. 12  illustrates a prior art design in which a blister sheet is adhered between panel  3  and panel  4 , such that there is no access to the back side of the blister sheet.  
         [0000]     Definitions  
         [0037]     The following terms shall have, for the purposes of this application, the respective meanings set forth below.  
         [0000]     Dosage Form  
         [0038]     The term “dosage form” includes any solid form that is sufficiently self-cohesive to be presented in a blister sheet, and includes an amount of a material for delivery to a subject (such as by ingestion, as a suppository, as a lozenge, as a mucosal adherent, or the like).  
         [0000]     Blister Barrier  
         [0039]     A “blister barrier” is a covering for one or more dosage units of which at least a portion must be peeled, torn, cut, or pushed through to allow a user of a dosage unit to conveniently, but in a child-resistant manner, access the dosage unit. Any blister barrier usable to provide child resistance in a blister sheet can be used in the invention. Child resistance is as recognized in the pharmaceutical industry (e.g., F1, F2, F3 levels of child resistance).  
         [0000]     Blister Access Device  
         [0040]     A “blister access device” is any device used in a child-resistant blister sheet. Blister access devices can include, for example, a pull tab, a pull tab access by tearing perforations to allow peeling to reveal the pull tab, notches to facilitate tearing, and the like.  
         [0000]     Wallet Panels  
         [0041]     A “wallet panel” is any panel made of a moderately stiff material allowing a wallet package to be reusably opened and closed over a useful lifetime. It will be recognized that, depending on dimension, the support provided by adhered components, and the like, that the stiffness required for making a useful wallet package can vary.  
         [0000]     Subject  
         [0042]     A “subject” is any animal, including a human, for which it may be appropriate to delivery a dosage form.  
         [0043]     Publications and references, including but not limited to patents and patent applications, cited in this specification are herein incorporated by reference in their entirety in the entire portion cited as if each individual publication or reference were specifically and individually indicated to be incorporated by reference herein as being fully set forth. Any patent application to which this application claims priority is also incorporated by reference herein in the manner described above for publications and references.  
         [0044]     While this invention has been described with an emphasis upon preferred embodiments, it will be obvious to those of ordinary skill in the art that variations in the preferred devices and methods may be used and that it is intended that the invention may be practiced otherwise than as specifically described herein. Accordingly, this invention includes all modifications encompassed within the spirit and scope of the invention as defined by the claims that follow.