AU2009256145A1 - Package with enclosure for dispensing doses of a medicament - Google Patents

Description

WO 2009/149267 PCT/US2009/046274 PACKAGE WITH ENCLOSURE FOR DISPENSING DOSES OF A MEDICAMENT FIELD OF THE INVENTION The present invention relates generally to packages for holding and dispensing medicinal unit doses, and more particularly, is directed to a package for dispensing a single medicinal unit dose. BACKGROUND OF THE INVENTION Generally, medicinal units, such as tablets, capsules, caplets, films, gels or the like, are housed in a package, such as a plastic bottle that has an opening which is sufficiently large to accommodate and allow the flow of multiple medicinal units through the opening at one time in order to facilitate filling these containers during packaging line operations. Plastic bottles are inherently cheap and simple to process on packaging lines, making them a commonly used package for oral drug products. Such packages, however, may render it difficult for consumers to limit dispensing the desired number of medicinal units, particularly when the consumer has limited fine motor abilities. Consumers with limited fine motor abilities include patients, such as the elderly or those with neurological disorders (e.g., Parkinson's disease). Consequently, such patients may undesirably dispense too many medicinal units from a package such as a bottle. Also of concern is spillage from the undesirable dispensing of too many medicinal units which may result whereby one or more medicinal units drops to the floor and becomes lost, irretrievable, or contaminated. This may result in the loss of possibly very expensive medicinal units. Although there are single unit dose dispensing packages available, for example, blister packs, these packs still present problems. Blister packs or cards containing pharmaceutical unit doses are sold with the blister pack as the primary package which holds the unit doses. During dispensing by patients with neurological disorders such as Parkinson's disease, there is still the problem that a unit dose will drop to the floor or otherwise become lost, irretrievable or contaminated.

WO 2009/149267 PCT/US2009/046274 -2 Thus, it would therefore be desirable to provide a package containing unit doses, which limits dispensing of medicinal unit doses one at a time while minimizing the risk of spillage. SUMMARY OF THE INVENTION Various embodiments of the present invention provide a package for dispensing a single medicinal unit dose. The package may have a wall structure defining an enclosure; an access opening in the enclosure for retrieving a unit dose from the enclosure; and at least one medicament holder for holding the unit dose, the at least one medicament holder being mounted to the wall structure such that the unit dose removed from the medicament holder falls into and is captured by the enclosure, for later retrieval through the access opening. Each medicament holder may include a blister for holding the unit dose. A rupturable backing may be provided on an inner surface of the blister for retaining the unit dose in each the blister and there may be a plurality of blisters mounted to the wall structure. The medicament holder may be integrally formed with the wall structure or removable and replaced with a replacement medicament holder that has new set up doses of medicament. The medicament holder may include a blister for holding the unit dose, the blister being formed by a deformable portion of the wall structure, and further comprising a rupturable backing provided on an inner surface of the wall structure in association with each the blister for retaining the unit dose in the blister. The wall structure may include a removable closure cap or a cap that is attached to the package. The cap may be a senior friendly or child resistant cap. The wall structure may include at least one entry opening, and the at least one medicament holder is permanently secured to the wall structure in association with the at least one entry opening. The at least one medicament holder may include a blister for holding the unit dose and a rupturable backing provided on an inner surface of the blister for retaining the unit dose in the blister, the blister and rupturable backing being permanently secured to the wall structure for passing the unit dose from the blister through one the entry opening into the enclosure. An insert can have a plurality of the blisters therein, with the rupturable backing provided on an inner surface of the insert, the insert being permanently secured WO 2009/149267 PCT/US2009/046274 -3 to the wall structure for passing the unit dose from the blister through one the entry opening into the enclosure. The blister may extend through one the entry opening. The wall structure may include at least one entry opening, and the at least one medicament holder is removably secured to the wall structure. The wall structure may further include at least one guide for guiding and mounting the at least one medicament holder such that each medicament holder is positioned in covering relation to one the entry opening. The medicament holder may include an insert having a plurality of the blisters therein, with the rupturable backing provided on an inner surface of the insert, the insert being removably mounted to the wall structure by the at least one guide for passing the unit dose from each the blister through one the entry opening into the enclosure. The insert may include a card insert, and the at least one guide includes parallel, spaced apart, L-shaped walls on an outer surface of the wall structure for slidably receiving the card insert to mount the card insert to the wall enclosure. A label and/or instructions on the use or dosing information may be included loosely within the package or contained on a wall structure. Another embodiment provides for a package with a wall structure has a clam shell package having a center section and first and second hinged side sections hingedly secured to opposite sides of the center section, the first side section including at least one medicament holder therein, and a container having entry openings and mounted in the second side section, such that when the clam shell package is closed, each the medicament holder is positioned in covering relation to one the entry opening, the container including the access opening. The wall structure can be formed by a blank. The medicament holder can have a deformable front wall which can be depressed by a person's finger and a deformable rear wall for retaining the unit dose in the medicament holder, the deformable rear wall including an inwardly turned section which locks the unit dose in the medicament holder and which is turned outwardly upon deformation of the deformable front wall in order to release the unit dose through the deformable rear wall. Additional embodiments of the present invention provide methods of reducing the risk of a neurological patient dropping a single medicinal unit dose by providing the various packages of the present invention to a patient with a neurological disease.

WO 2009/149267 PCT/US2009/046274 -4 Various embodiments provide a pharmaceutical product having at least one medicament holder and a package for dispensing a single medicinal unit dose. The package may have a wall structure defining an enclosure; an access opening in the enclosure for retrieving a unit dose from the enclosure; and at least one medicament holder for holding the unit dose, the at least one medicament holder being mounted to the wall structure such that the unit dose removed from the medicament holder falls into and is captured by the enclosure, for later retrieval through the access opening. A single medicinal unit dose may be one medicament or multiple medicaments and may be in any suitable pharmaceutical dosage form, such as but not limited to, a tablet, capsule, caplet and/or gelcaps. The single medicinal unit dose can have one or more medicaments such as one, two, three medicaments. For example, a single medicinal unit dose may be I tablet or 2 tablets or 3 tablets, etc. The single medicinal unit dose may have at least one tablet, capsule, caplet or geicap or combinations thereof. The medicament can be the same or different dosage forms. The medicament desirably contains an active pharmaceutical agent such as those useful in treating people with diseases that may make the patient's hand shake or otherwise impeded the performance of one's hands, such as but not limited to a those actives useful in treating a neurological disease, such as Parkinson's disease, epilepsy, arthritis, turret's disease and the like. Other embodiments provide for a pharmaceutical kit that includes a package for dispensing a single medicinal unit dose and a plurality of medicament holders which house a plurality of pharmaceutical dosage forms. The kit may be sold together so that the medicament holders may be swapped in and out of the package as the dosage forms in the medicaments are finished. Additional embodiments provide a blank for forming a package for dispensing a single medicinal unit dose where the blank has a plurality of wall panels connected together for forming an enclosure with at least a closed bottom, and at least one blister for holding a unit dose incorporated into at least one of the wall panels of the enclosure, such that when the wall panels are connected together to form the enclosure, a unit dose removed from one the. blister falls into and is captured by the enclosure, for later retrieval.

WO 2009/149267 PCT/US2009/046274 The blank may further have a rupturable backing provided on an inner surface of the wall panel to each the blister for retaining a unit dose in each the blister. There may be a plurality of the blisters incorporated into at least one of the wall panels. The wall panels and the at least one blister may be made from the same material, such as a plastic material. The plurality of wall panels may include a front wall panel, a rear wall panel and two side wall panels connected together in series along score lines. The plurality of wall panels may include a bottom flap connected to a lower end of one the wall panel along a score line, and a top flap connected to an upper end of one the wall panel. The plurality of wall panels may include at least one bottom side flap connected to a lower end of at least one the wall panel and at least one top side flap connected to an upper end of at least one the wall panel. Various embodiments of the present invention provide for a package for dispensing a single medicinal unit dose. The package may include an enclosure, an access opening in the enclosure for retrieving a unit dose from the enclosure, and at least one medicament holder for holding the unit dose, such that the unit dose removed from the medicament holder falls into and is captured by the enclosure, for later retrieval through the access opening. The medicament holder can be a blister that is integrally formed with the package. Alternatively, the medicament holder can be a removable insert. Multiple embodiments of the present invention provide a package in which an insert such as a blister pack is integrated into the walls of the package. Alternatively, the insert may be removably insertable into the package. A unit dose of a medicament is capable of falling into the interior or enclosure of the package, thereby preventing loss thereof. Various embodiments provide for safe, accurate, and/or low cost delivery of the single unit dose. Suitable delivery mechanisms include threaded closures on a neck finish, child resistant or senior friendly closures on a neck finish, a dispensing spout, a gable top, a sliding door, a tear strip, a locking flap, etc. The package and the inserts or blisters may be made from the same material, thereby assuring compliance with compatibility regulations. Desirably, a package is relatively inexpensive to manufacture and easy to use.

WO 2009/149267 PCT/US2009/046274 -6 In accordance with an aspect of the present invention, a package for dispensing a single medicinal unit dose, includes a plurality of wail panels forming an enclosure, an access opening in the enclosure for retrieving a unit dose from the enclosure, and at least one insert or blister for holding a unit dose incorporated into at least one of the wall panels of the package enclosure, such that a unit dose removed from one blister falls into and is captured by the enclosure thereby rendering the unit dose ready for retrieval through the access opening. There may also be a rupturable backing provided on an inner surface of the wall panel to each blister for retaining a unit dose in each blister. There may be a plurality of the blisters incorporated into at least one of the wall panels of the enclosure, and the package may be a rectangular parallelepiped configuration. In addition, the wall panels and the at least one insert or blister may be made from the same material. In various embodiments, the plurality of wall panels include a front wall panel, a rear wall panel and two side wall panels connected together in a rectangular parallelepiped configuration which defines a lower opening thereof and an upper end thereof forming the access opening, a bottom flap for closing the lower opening and a top flap removably closing the access opening. The above and other features of the invention will become readily apparent from the following detailed description thereof which is to be read in connection with the accompanying drawings.

WO 2009/149267 PCT/US2009/046274 -7 BRIEF DESCRIPTION OF THE DRAWINGS Fig. I is a perspective view of a package for dispensing unit doses with dosage and spillage control according to the present invention; Fig. 2 is a top plan view of a blank for forming the package of Fig. 1; Fig. 3 is a cross-sectional view of the blank of Fig. 2, taken along line 3-3 thereof; Fig. 4 is a side elevational view of the package of Fig. 2; Fig. 5 is a cross-sectional view of the package of Fig. 1, taken along line 5-5 thereof; Fig. 6 is a perspective view of a card insert containing blisters; Fig. 7 is a cross-sectional view similar to Fig. 5, showing a package according to another embodiment, for use with the card insert of Fig. 6; Fig. 8 is perspective view of a package according to another embodiment of the present invention; Fig. 9 is perspective view of a package according to another embodiment of the present invention; Fig. 10 is perspective view of a bottle according to another embodiment of the present invention; Fig. II is perspective view of a bottle according to another embodiment of the present invention; Fig. 12 is front elevational view of a bottle according to another embodiment of the present invention; Fig. 13 is top plan view of the bottle of Fig. 12; Fig. 14 is a perspective view of the assembled clam shell package according to another embodiment of the present invention; Fig. 15 is a side elevational view of the clam shell package of Fig. 14 in an opened configuration; Fig. 16 is a side elevational view of the clam shell package of Fig. 14 in an assembled condition; WO 2009/149267 PCT/US2009/046274 -8 Fig. 17 is a cross-sectional view of a modified blister arrangement in the non activated condition; and Fig. 18 is a cross-sectional view of the modified blister arrangement in the activated condition. DETAILED DESCRIPTION Referring to the drawings in detail, and initially to Figs. 1-3 thereof, a receptacle 10 for dispensing unit doses with dosage and spillage control is formed from a blank II which includes, in order, a first side wall panel 12, a front wall panel 14, a second side wall panel 16, a rear wall panel 18, and a securing tab panel 20, connected together respectively at longer sides thereof The receptacle can be any suitable shape such as a boxed shape, cylindrical shape, triangular shape, rounded shape, etc. The outlet may be conical to facilitate removal of the medicament. The front wall panel can be any suitable shape, including rectangular, square, triangular, trapezoidal, etc. The wall panels can also have rounded edges. Score lines 22, 24, 26 and 28 or the like are provided between adjacent connected panels, namely, between first side wall panel 12 and front wall panel 14, between front wall panel 14 and second side wall panel 16, between second side wall panel 16 and rear wall panel 18 and between rear wall panel 18 and securing tab panel 20, to enable blank II to be folded along score lines 22, 24, 26 and 28 such that each panel is bent perpendicular to its adjacent panel. The receptacle can made out of any suitable material, including paperboard, cardboard, plastic, metal and the like. The receptacle may be reusable. In such cases, the medicament containing insert may be removed and replaced with another insert. One of the walls of the receptacle may be movable to allow for removal and insertion of the insert. The bottom wall, side wall or opening top may be removably connected with an appropriate latch or hinge mechanism. Alternatively, rather than score lines, thinner diameter lines or V-shaped cut outs can be provided in place thereof, and reference to score lines in the claims is intended to encompass all such variations. In this manner, securing tab panel 20 is WO 2009/149267 PCT/US2009/046274 secured to first side wall panel 12 by an adhesive, as best shown in Fig. 5, to form an enclosure. A bottom flap 30 is connected to one shorter side of rear wall panel 18 along a score line 32, and includes a tab 34 connected at the opposite end thereof along a score line 36. In addition, bottom side flaps 38 and 40 are connected to one shorter side of first and second side wall panels 12 and 16 along score lines 42 and 44, respectively, on the same side of blank 11 as bottom flap 30. When blank I1 has been folded along score lines 22, 24, 26 and 28 such that each panel is bent perpendicular to its adjacent panel, and securing tab panel 20 is secured to first side wall panel 12 by an adhesive to form an enclosure, bottom side flaps 38 and 40 are bent inwardly along score lines 42 and 44, and bottom flap 30 is folded along score line 32 to a position overlapping bottom side flaps 38 and 40, and which closes the lower opening of the enclosure. Tab 34 is folded along score line 36 to be perpendicular to bottom flap 30 and thereby lie against the inner surface of front wall panel 14, thereby retaining bottom flap 30 in this position. A top flap 46 is connected to one shorter side of front wall panel 14 along a score line 48, on the opposite side of blank 11 from bottom flap 30, and includes a tab 50 connected at the opposite end thereof along a score line 52. In addition, top side flaps 54 and 56 are connected to the opposite shorter side of first and second side wall panels 12 and 16 along score lines 58 and 60, respectively, on the same side of blank 1I as top flap 46. When blank I1 has been folded along score lines 22, 24, 26 and 28 such that each panel is bent perpendicular to its adjacent panel, and securing tab 20 is secured to first side wall panel 12 by an adhesive to form an enclosure, top side flaps 54 and 56 are bent inwardly along score lines 58 and 60, and top flap 46 is folded along score line 48 to a position overlapping top side flaps 54 and 56, and which closes the upper opening of the enclosure. Tab 50 is folded along score line 52 to be perpendicular to top flap 46 and thereby lie against the inner surface of rear wall panel 18, thereby retaining top flap 46 in this position. With this arrangement, package 10 forms a rectangular parallelepiped configuration. Alternatively, the package may be any suitable shape, including triangular, circular, rectangular, conical and the like.

WO 2009/149267 PCT/US2009/046274 DE06S19 -10 In accordance with other aspects of the present invention, blank I I is formed with a plurality of inserts, blisters or compartments 62 in front wall panel 14 and each extending forwardly thereof, each for holding a single unit dose such as a tablet, capsule, caplet or the like, and each in alignment with an opening 64 (Figs. 3 and 5) in front wall panel 14. Blisters 62 extend forwardly out of the plane of front wall panel 14. A backing 66 can be made of foil, plastic, soft polymeric material or the like, which can be punctured, and is secured in covering relation to the rear or inner surface of front wall panel 14 to hold the unit doses in the individual blisters 62. It will be appreciated that the formation of blisters 62 is not limited to front wall panel 14, but may be provided in other wall panels, or in a plurality of the wall panels of package 10. Blank I1, including blister inserts 62, may be made from one sheet of material, which may be a clear, fully colored or partially colored thermoformed plastic material. In use, a person merely presses on one of the blisters 62 to push the unit dose through backing 66, whereby the unit dose falls into the enclosure of package 10. The unit dose can then be removed from package 10 by merely opening top flap 46 and top side flaps 54 and 56. Alternatively, or in addition thereto, after a unit dose has been removed from its respective blister 62, dispensing of the unit dose from package 10 can be accomplished by means of a child-resistant closure, flap, funnel or spout connected with one or more wall panels or flaps, so that the patient receives the single dose with lowered chance of spillage. It will be appreciated that a single unit dose can be dispensed into box shaped package 10. This means that the risk that the unit dose will drop, become lost and contaminated will be minimized. Advantageously, this bottle will help a person with a neurological disorder who attempts to remove a single unit dose from a bottle or from a conventional blister pack. Additionally, an outer package or box for holding the blister pack may not be needed, since blisters 62 are built directly into package 10, thereby reducing the costs and time of manufacture. This means of manufacture provides the advantages of fewer process steps, fewer errors and improved quality control. Because blisters 62 and package 10 are made from the same material, manufacture thereof is less costly and easier, and a further benefit is derived because this assures compliance with WO 2009/149267 PCT/US2009/046274 - 11 compatibility regulations. It will be appreciated that lower cost can be achieved because package 10 including blisters 62 can be manufactured from one continuous roll of plastic. in addition, the material can be made transparent so that the patient is able to observe the dose they are about to dispense. It will also be appreciated that once the single dose is dispensed into the chamber, access to or further dispensation of the dose into the patient's hand or mouth can be further controlled. Thus, the present invention replaces the current blister pack to hand to mouth dispensing method with a blister pack to receptacle to hand to mouth (or directly from receptacle to mouth), without adding any packaging compatibility issue. It will be appreciated that reference to unit doses in the claims is intended to encompass all types of unit doses including but not limited to capsules, tablets, colloids, caplets, powders, liquids, etc. Other embodiments of the present invention provide for a labeling either on the package or the blisters or the wails. Such labeling could identify the type of drug contained therein. Suitable labels include weeks, days of the week or indications within a day such as nighttime/PM or morning/AM that would be in accordance with the desirable dosing regimens of the particular medicament(s) contained therein. Other embodiments include packages that include at least two active pharmaceutical agents either in separate dosage forms or in a combined dosage form. The package can contain labeling of the separate dosage forms with instructions of the appropriate use and dosing of such active pharmaceutical agents. It will be appreciated that various modifications can be made to the present invention. For example, as shown in Fig. 6 and 7, rather than blisters 62 being formed as part of the package, they can be formed as an insert that is assembled with the package. Specifically, referring first to Fig. 7, there is a shown a box shaped package 10a in which elements corresponding to box shaped package 10 are identified by the same numerals but with the letter "a" appended thereto, and a detailed description of the common elements is not provided. Basically, box shaped package 10a is identical to box shaped package 10, except that blisters 62 are not formed thereon. instead, WO 2009/149267 PCT/US2009/046274 - 12.

openings 68a are provided at positions of blisters 62 of box shaped package 10. An insert card 70a is provided, having blisters or compartments 62a formed thereon, each extending forwardly thereof, each for holding a single unit dose such as a tablet, capsule, caplet or the like, and each in alignment with an opening 64a in insert card 70a for removal of the unit dose. Blisters 62a extend forwardly out of the plane of insert card 70a. A backing 66a can be made of foil, plastic, soft polymeric material or the like, which can be punctured, and is secured in covering relation to the rear surface of insert card 70a to hold the unit doses in the individual blisters 62a. Insert card 70a, including blisters 62a, may be made from one sheet of material, which may be a clear, fully colored or partially colored thermoformed plastic material. With this arrangement, insert card 70a can be secured to the rear surface of front wall panel 14a such that blisters 62a extend out through openings 68a in front wall panel 14. Securement can be made by any suitable means, including adhesive, ultrasonic welding, etc. Insert card 70a can be assembled with front wall panel 14a of the flattened blank I1, when the package 10 is fully assembled, or during any step therebetween. It will also be appreciated that insert card 70a is not limited to assembly with front wall panel 14, but may be provided in other wall panels, or in a plurality of the wall panels of package 1Oa. Although the present invention has been discussed with a package 10 of a rectangular parallelepiped shape, the present invention is not limited thereby. For example, as shown in Fig. 8, a package lOb can have a cylindrical main body section 72b on which blisters 62b are formed, and a conical spout section 74b secured to the upper end of main body section 72b. A lid flap 76b is secured at the upper open end 78b of conical spout section 74b by any suitable means, such as a living hinge 80b. Lid flap 76b can be secured to close open end 7gb, for example, by a clasp (not shown), a friction fit, etc. To this end, the upper surface of lid flap 76b can have a gripping handle (not shown). Further, blisters 62b can be formed in the cylindrical wall of main body section 72b in a similar manner to blisters 62 of Figs. 1-5 or can be formed on an insert card in a similar manner to blisters 62a of Figs. 6 and 7. Another example of a different shape is shown in Fig. 9 in which a package I0c is formed in a conical shape by a conical wall 82c having an open lower end which can WO 2009/149267 PCT/US2009/046274 be closed by a bottom closure flap 84c and an open upper end 86c which can be closed by a lid flap 88c. Bottom closure flap 84c and lid flap 88c can be secured to conical wall 82c by any suitable means, such as a living hinge. Lid flap 88c and bottom closure flap 84c can be secured to close the upper and lower open ends, for example, by a clasp (not shown), a friction fit, etc. To this end, the upper surface of lid flap 88c and the lower surface of bottom closure flap 84c can each have a gripping handle (not shown). Conical wall 82c has a plurality of openings 68c therein, similar to the arrangement of Fig. 7, and a card insert 70c similar to card insert 70a of Fig. 6 and having a plurality of blisters 62c thereon with a backing sheet (not shown) can be assembled with conical wall 82c such that blisters 62c extend out through openings 68c. Securement can be made by any suitable means, including adhesive, ultrasonic welding, etc. Insert card 70c can be assembled with conical wall 82c of a flattened blank thereof, when the package 10c is fully assembled, or during any step therebetween. It will be appreciated that the above embodiments have discussed the package formed from a blank. However, package 10 can be a conventional plastic bottle on which the blisters are formed in the same manner as discussed in Figs. 1-5, or as an insert through openings in the bottle in the same manner as discussed in Figs. 6 and 7. Referring now to Fig. 10, a bottle 10 d as the package according to another modification of the present invention includes a cylindrical main body 90d having a reduced diameter neck 92d at the upper end thereof, with a closure cap 94d threadedly received on neck 92d in a conventional manner. A plurality of openings 68d are formed in main body 90d. Individual blisters 62d, each having a unit dose thereon and closed by a backing (not shown), are permanently secured to the outer surface of main body 90d in alignment with and in covering relation to openings 68d. When a person pushes on a blister 62d, the unit dose breaks through the backing and enters bottle I Od through the respective opening 68d. Although the embodiment of Fig. 10 has been discussed with respect to unit doses, such as capsules or tablets, this embodiment, as well as other embodiments can be used such that each blister 62d can hold a secondary ingredient, such as a colorant, sugar, etc., which when the blister 62d is burst, enters main body 90d which is already WO 2009/149267 PCT/US2009/046274 -14 filled with a primary product or which is filled by the consumerjust prior to or after bursting the blister 62d. Bottle I Od can then be shaken or stirred to mix the components. In this manner, a consumer can change the contents of bottle I Od to the consumer's preference. For example, one blister can include a red colorant, a second blister a blue colorant, a third blister sugar, etc. In this manner, the contents of the primary product in bottle 10d can be adjusted in strength, color, sweetness, etc. It will be appreciated that the openings need not be formed in the main body of the bottle, For example, as shown in bottle I0e of Fig. 11, having a main body 90e, a reduced diameter neck (not shown) and a closure cap 94e, blisters 62e can be formed on the upper surface of closure cap 94e in alignment with openings (not shown) in closure cap 94e. Alternatively, as shown in Figs. 12 and 13, a bottle 10Of has a main body 90f, a reduced diameter neck 92f and a closure cap 94f threaded on neck 92f. A plurality of openings 68f are provided in main body 90f. In addition, L-shaped guides 96f extend down in parallel, spaced apart facing relation to each other on opposite sides of openings 68f. A bottom ledge 98f secured to the outer surface of main body 90f connects the lower ends of L-shaped guides 96f and has two upstanding tabs I 00f thereon. A card insert 70f which is substantially identical to card insert 70a has a plurality of blisters 62f thereon, as well as two recesses 102f at the lower edge thereof. With this embodiment, it is only necessary to slide card insert 70f into L-shaped guides 96f until recesses 102f receive tabs 00f. The reason for tabs I00f and recesses 102f is to ensure accurate alignment of blisters 62f with openings 68f However, it will be appreciated that tabs 100f and recesses 102f can be eliminated if the tolerances of card insert 70f in guides 96f are small. The advantage of this embodiment is that a single bottle can be used for a plurality of different medicines since it is only necessary to slip in a different card insert 70f containing a different medicine. Referring now to Figs. 14-16, there is shown a package lOg according to another embodiment of the present invention. Package 10g is formed in a molded clam shell type configuration with three sections, namely, a center triangular section 104g and two side sections 106g and 108g secured to opposite sides of triangular section 104g by living hinges 80g or the like.

WO 2009/149267 PCT/US2009/046274 - 15 One side section 106g is formed from two side wall panels I1 Og and I 12g connected in a V-shaped formation, with side edges thereof closed by triangular shaped end panels 114g. Side wall panel 1 lOg includes a plurality of openings 68g therein, and a plurality of blisters 62g are formed on one side of side wall panel I1 Og in alignment with openings 68g. Alternatively, as in the first embodiment of Figs, 1-5, blisters 62g can be integrally formed with side wall panel I 10g. A backing 66g of foil, plastic, soft polymeric material or the like, which can be punctured, is secured in covering relation to the opposite surface of side wall panel 1 Og to hold the unit doses in the individual blisters 62. Backing 66g can be supplied from a roll 67g during manufacture and then be cut. The other side section 108g is formed from two side wall panels 11 6g and 118g connected in a V-shaped formation, with side edges thereof closed by triangular shaped end panels 120g. Side wall panel I 16g includes a curved wall section 122g for receiving a bottle 124g having a main body 90g, a reduced diameter neck 92g with threads 93g thereon and a closure cap 94g threadedly received on neck 92g. Curved wall section 122g can have marketing information or different graphics thereon. Although not shown, the upper end of curved wall section 122g has an opening (not shown) for receiving neck 92g such that neck 92g and closure cap 94g extend out of curved wall section 122g. In this embodiment, it is preferred that one side 126g of main body 90g of bottle 124g is flat so that openings 68g formed therein can properly align with blisters 62g in the assembled condition of package 10g. It will be appreciated that bottle 124g will be rotated 90 degrees from the position shown in Fig. 15 to be in facing relation to blisters 62g in the assembled condition, and that bottle 124g is only shown in this rotated position to show openings 68g. Thus, in this embodiment, after blisters 62g and backing 66g have been formed on side wall panel IOg, bottle 124g is inserted into curved wall section 122g. Side sections 106g and 108g are then pivoted about living hinges 80g until side wall panels Ii Og and I 16g are in abutting relation where they are secured together, either releasably, for example, in snap fitting manner, or permanently, for example, by adhesive, ultrasonic welding, etc.

WO 2009/149267 PCT/US2009/046274 -16 In use, a person presses against a blister 62g, whereupon the unit dose therein breaks through backing 66g and falls through the respective opening 68g into bottle 124g. Cap 94g is then removed and the unit dose can be easily retrieved. It will further be appreciated that, while blisters 62-62g have been shown as being closed by a backing 66-66g, each blister can be formed in any other suitable manner. For example, as shown in Figs. 17 and 18, a blister 62h is shown to be backed by a deformable non-foil, deformable backing 66h which extends away from blister 62h so as to increase the size of the cavity 63h between blister 62h and backing 66h. However, backing 66h has an inwardly turned section 128h which extends into the cavity 63h and serves as a lock which holds the unit dose 130h in cavity 63h, preferably with pressure. The inwardmost wall 132h of inwardly turned section 128h has an opening 134h therein. Initially, inwardly turned section 128h holds unit dose 130h in cavity 63h with pressure. However, when a person's finger 136h presses against blister 62h, unit dose 130h forces inwardly turned section 128 to turn outwardly, along with the remainder of backing 66h, and continued pressure forces unit dose 130h out through opening 134h. Having described various embodiments of the invention with reference to the accompanying drawings, it will be appreciated that the present invention is not limited to those precise embodiments and that various changes and modifications can be effected therein by one of ordinary skill in the art without departing from the scope or spirit of the invention as defined by the appended claims.

Claims (39)

1. A package for dispensing a single medicinal unit dose, the package comprising: a wall structure defining an enclosure; an access opening in the enclosure for retrieving a unit dose from the enclosure; and at least one medicament holder for holding the unit dose, the at least one medicament holder being mounted to the wall structure such that the unit dose removed from the medicament holder falls into and is captured by the enclosure, for later retrieval through the access opening.

2. A package according to claim 1, wherein each the medicament holder comprises a blister for holding the unit dose.

3. A package according to claim 2, further comprising a rupturable backing provided on an inner surface of the blister for retaining the unit dose in each the blister.

4. A package according to claim 1, wherein there are a plurality of blisters mounted to the wall structure.

5. A package according to claim 1, wherein the at least one medicament holder is integrally formed with the wall structure.

6. A package according to claim 5, wherein each the medicament holder includes a blister for holding the unit dose, the blister being formed by a deformable portion of the wall structure, and further comprising a rupturable backing provided on an inner surface of the wall structure in association with each the blister for retaining the unit dose in the blister.

7. A package according to claim 1, wherein the wall structure includes a removable closure cap.

8. A package according to claim 1, wherein the wall structure includes at least one entry opening, and the at least one medicament holder is permanently secured to the wall structure in association with the at least one entry opening.

9. A package according to claim 8, w herein the at least one medicament holder includes a blister for holding the unit dose and a rupturable backing provided on an inner surface of the blister for retaining the unit dose in the blister, the blister and rupturable backing being permanently secured to the wall structure for passing the unit WO 2009/149267 PCT/US2009/046274 - 18 dose from the blister through one the entry opening into the enclosure.

10. A package according to claim 9, further comprising an insert comprising a plurality of the blisters therein, with the rupturable backing provided on an inner surface of the insert, the insert being permanently secured to the wall structure for passing the unit dose from the blister through one the entry opening into the enclosure.

11. A package according to claim 9, wherein each the blister extends through one the entry opening.

12. A package according to claim 1, wherein the wall structure includes at least one entry opening, and the at least one medicament holder is removably secured to the wall structure.

13. A package according to claim 12, wherein the wall structure further includes at least one guide for guiding and mounting the at least one medicament holder such that each medicament holder is positioned in covering relation to one the entry opening.

14. A package according to claim 13, wherein the at least one medicament holder includes an insert comprising a plurality of the blisters therein, with the rupturable backing provided on an inner surface of the insert, the insert being removably mounted to the wall structure by the at least one guide for passing the unit dose from each the blister through one the entry opening into the enclosure.

15. A package according to claim 14, wherein the insert includes a card insert, and the at least one guide includes parallel, spaced apart, L-shaped walls on an outer surface of the wall structure for slidably receiving the card insert to mount the card insert to the wall enclosure.

16. A package according to claim 1, wherein the wall structure and the at least one medicament holder are made from the same material.

17. A package according to claim 1, wherein the at least one wall structure includes at least one of the following: at least one label, and instructions related to using/dosing information of the unit dose.

18. A package according to claim 1, wherein the wall structure includes: a clam shell package comprising a center section and first and second hinged side sections hingedly secured to opposite sides of the center section, the first side WO 2009/149267 PCT/US2009/046274 -19 section comprising at least one medicament holder therein, and a container comprising entry openings and mounted in the second side section, such that when the clam shell package is closed, each the medicament holder is positioned in covering relation to one the entry opening, the container comprising the access opening.

19. A package according to claim 1, wherein the wall structure is formed from a blank.

20. A package according to claim 1, wherein at least one the medicament holder includes a deformable front wall which can be depressed by a person's finger and a deformable rear wall for retaining the unit dose in the medicament holder, the deformable rear wall comprising an inwardly tumed section which locks the unit dose in the medicament holder and which is turned outwardly upon deformation of the deformable front wall in order to release the unit dose through the deformable rear wall.

21. A method of reducing the risk of a neurological patient dropping a single medicinal unit dose comprising providing the package of claim I to a patient with a neurological disease.

22. A pharmaceutical product comprising at least one medicament holder and a package for dispensing a single medicinal unit dose, the package comprising: a wall structure defining an enclosure; an access opening in the enclosure for retrieving a unit dose from the enclosure; and at least one medicament holder for holding the unit dose, the at least one medicament holder being mounted to the wall structure such that the unit dose removed from the medicament holder falls into and is captured by the enclosure, for later retrieval through the access opening.

23. A pharmaceutical product according to claim 22, wherein the at least one medicament holder comprising at least one pharmaceutical dosage form.

24. A pharmaceutical product according to claim 23, wherein the pharmaceutical dosage form is selected from the group consisting of a tablet, capsule, caplet, gelcaps.

25. A pharmaceutical product according to claim 23, wherein the pharmaceutical dosage form for treating a neuroigical disease. WO 2009/149267 PCT/US2009/046274 -20

26. A pharmaceutical kit, comprising the package of claim I and a plurality of medicament holders which comprises a plurality of pharmaceutical dosage forms.

27. A blank for forming a package for dispensing a single medicinal unit dose, the blank comprising: a plurality of wall panels connected together for forming an enclosure with at least a closed bottom, and at least one blister for holding a unit dose incorporated into at least one of the wall panels of the enclosure, such that when the wall panels are connected together to form the enclosure, a unit dose removed from one the blister falls into and is captured by the enclosure, for later retrieval.

28. A blank according to claim 27, further comprising a rupturable backing provided on an inner surface of the wall panel to each the blister for retaining a unit dose in each the blister.

29. A blank according to claim 27, wherein there are a plurality of the blisters incorporated into at least one of the wall panels.

30. A blank according to claim 27, wherein the wall panels and the at least one blister are made from the same material.

31. A blank according to claim 27, wherein the wall panels and the at least one blister are made from a plastic material.

32. A blank according to claim 27, wherein the plurality of wall panels include a front wall panel, a rear wall panel and two side wall panels connected together in series along score lines.

33. A blank according to claim 32, wherein the plurality of wall panels further include a bottom flap connected to a lower end of one the wall panel along a score line, and a top flap connected to an upper end of one the wall panel.

34. A blank according to claim 33, wherein the plurality of wall panels further include at least one bottom side flap connected to a lower end of at least one the wall panel and at least one top side flap connected to an upper end of at least one the wall panel.

35. A package according to claim 1, wherein the single medicinal unit dose comprises one medicament. WO 2009/149267 PCT/US2009/046274 -21

36. A package according to claim 1, wherein the single medicinal unit dose comprises more than one medicament.

37. A package according to claim 1, wherein the single medicinal unit dose comprises two medicaments.

38. A package according to claim 1, wherein the single medicinal unit dose comprises three medicaments.

39. A package according to claim 1, wherein the single medicinal unit dose comprises at least one tablet, capsule, caplet or gelcap.