WO2008079306A2 - Pharmaceutical packaging systems for improved patient compliance - Google Patents

Pharmaceutical packaging systems for improved patient compliance Download PDF

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Publication number
WO2008079306A2
WO2008079306A2 PCT/US2007/026098 US2007026098W WO2008079306A2 WO 2008079306 A2 WO2008079306 A2 WO 2008079306A2 US 2007026098 W US2007026098 W US 2007026098W WO 2008079306 A2 WO2008079306 A2 WO 2008079306A2
Authority
WO
WIPO (PCT)
Prior art keywords
blister package
packaging system
fastener
retaining device
storage device
Prior art date
Application number
PCT/US2007/026098
Other languages
English (en)
French (fr)
Other versions
WO2008079306A3 (en
Inventor
Yik Kit Kwok
Original Assignee
Schering Corporation
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Schering Corporation filed Critical Schering Corporation
Priority to CA002673236A priority Critical patent/CA2673236A1/en
Priority to EP07867903A priority patent/EP2097057A2/en
Priority to MX2009006872A priority patent/MX2009006872A/es
Priority to JP2009542926A priority patent/JP2010512952A/ja
Publication of WO2008079306A2 publication Critical patent/WO2008079306A2/en
Publication of WO2008079306A3 publication Critical patent/WO2008079306A3/en

Links

Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61JCONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035Blister-type containers
    • AHUMAN NECESSITIES
    • A47FURNITURE; DOMESTIC ARTICLES OR APPLIANCES; COFFEE MILLS; SPICE MILLS; SUCTION CLEANERS IN GENERAL
    • A47FSPECIAL FURNITURE, FITTINGS, OR ACCESSORIES FOR SHOPS, STOREHOUSES, BARS, RESTAURANTS OR THE LIKE; PAYING COUNTERS
    • A47F5/00Show stands, hangers, or shelves characterised by their constructional features
    • A47F5/0006Hangers for hanging articles on bars, tringles, bracket arms or the like

Definitions

  • the present invention relates generally to a packaging system for pharmaceutical products. More particularly, the present invention relates to a packaging system designed to be prominently positioned in a location of the patient's choice, thus improving patient compliance with a recommended dosing regimen.
  • compositions in the form of tablets and capsules are generally dispensed to users in packages of two types.
  • the first type of packaging which has historically dominated the market is bulk packaging which generally takes the form of a small vial or bottle having a cap that either twists or pops away from the body of the containment article so as to provide access to the articles disposed therein.
  • Such caps may include locking structures when engaged with the package body so as to prohibit access to the contents by children.
  • blister packaging In order to address the inherent deficiencies of traditional bulk storage containers, a second category of storage systems, referred to as blister packaging, has been developed.
  • Such blister packaging typically consists of a set of individualized packets, one for each dose or fractional dose of the pharmaceutical agent, located together on a card. This card is printed with a designation of dosages and warnings.
  • the tablets themselves are encased between two materials such as aluminum foil and polyvinyl chloride film such that the tablet can be pressed through the aluminum foil backing thereby leaving a broken blister indicating that that dose has been utilized.
  • a traditional blister packaging system with a necessarily easily opened foil barrier may be susceptible to damage due to tearing or child intrusion.
  • the backing may comprise a sheet of material designed to be pealed away from the the packaging.
  • U.S. Pat. No. 5,927,500 provides a packaging material which includes a paperboard or polymer sheet stock reinforced with a fabric substrate layer, thereby providing a composite which is resistant to tearing.
  • U.S. Pat. No. 6,273,260 is directed to a packaging system that incorporates external reminders for effectively dispensing medication on an irregular basis or lengthy periodic basis. This reference also suggests that packaging systems that can be oriented vertically may, through their prominence, assist in reminding patients of the need to comply with a dosing regimen regarding the pharmaceutical product contained within.
  • the invention is directed to a packaging system for a pharmaceutical product comprising a blister package containing a plurality of medication dosages and a retaining device for attaching said blister package to a mounting surface, wherein said retaining device supports said blister package in a substantially vertical orientation.
  • the retaining device comprises a magnet disposed on the rear surface of said blister, wherein said magnet is suitable for suspending said blister package from a ferrous vertical mounting surface.
  • the retaining device comprises an adhesive disposed on the rear surface of said blister package, wherein said adhesive is suitable for suspending said blister package from a vertical mounting surface.
  • the adhesive is a repositionable adhesive.
  • the retaining device comprises a fastener suitable for supporting said blister package from a mounting surface, wherein said fastener is selected from the group consisting of hooks, pegs, clamps, clip springs, hook-and-loop strips, and suction cups.
  • the retaining device further comprises a magnetic base portion suitable for supporting said blister package from a ferrous mounting surface.
  • the retaining device further comprises a tether attached at one end to said blister package and at the other end to said fastener.
  • the blister package further comprises a ferrous surface disposed on the rear surface of said blister package, and said fastener comprises a magnet disposed to engage said ferrous surface.
  • the retaining device comprises a grooved retaining fastener adapted to supportingly engage an edge of said blister package.
  • the blister package is attached to said retaining device by a hinge joint allowing said blister package to pivot about said hinge joint.
  • the retaining device comprises a grooved retaining fastener for attaching said blister package to said mounting surface.
  • the invention is directed to a packaging system for a pharmaceutical product comprising a blister package containing a plurality of medication dosages and a stand suitable for supporting said medication storage device from a horizontal surface.
  • the stand is integral to said medication storage device.
  • the stand comprises at least one fold-out cross-member.
  • the stand comprises a horizontal fold-out base.
  • the invention is directed to a method of enhancing patient compliance comprising the use of the packaging system of claim 1 to store and display a pharmaceutical product.
  • FIGS. 1A and 1 B illustrate a packaging system comprising a blister package on the rear surface of which are located, alternatively, either magnetic or adhesive pads, as edge-mounted strips;
  • FIGS. 1C and 1 D illustrate a packaging system comprising a blister package on the rear surface of which are located, alternatively, either magnetic or adhesive pads, as buttons;
  • FIGS. 2A and 2B illustrate a packaging system comprising a blister package that is supported via a hinge joint to a mounting structure, the rear surface of which comprises, alternatively, either magnetic or adhesive buttons;
  • FIGS. 2C and 2D illustrate side views of a packaging system comprising a blister package that is supported via a hinge joint integral to a mounting structure;
  • FIGS. 3A and 3B illustrate a packaging system comprising a blister package that is mountable by a hook or pin;
  • FIG. 3C illustrates a packaging system comprising a blister package that is mounted by a hook
  • FIGS. 4A, 4B and 4C illustrate alternate embodiments of a packaging system comprising a blister package suspended from a grooved retaining fastener
  • FIGS. 4D and 4E illustrate side views of alternative embodiments of a grooved retaining fastener
  • FIGS. 5A, 5B and 5C illustrate embodiments of a packaging system comprising a blister package supported from its top edge by a retention component that comprises, alternatively, a clamp or spring clip;
  • FIGS. 6A, 6B and 6C illustrate embodiments of a packaging system comprising a blister package supported from a side edge by a retention component that comprises a base and, alternatively, a clamp or spring clip, and a tether;
  • FIGS. 7A and 7B illustrate a packaging system comprising a blister package supported by a freestanding base
  • FIGS. 7C and 7D illustrate a packaging system comprising a blister package supported by an interlocking cross-member
  • FIGS. 7E and 7F illustrate a packaging system comprising a blister package supported by integral fold-out cross-members
  • FIGS. 7G and 7H illustrate a packaging system comprising a blister package supported by an integral horizontal fold-out base.
  • the present invention may be embodied as a packaging system or method.
  • the present invention is directed to a pharmaceutical packaging system comprising a substantially planar medication storage device from which one or more doses of a drug may be dispensed.
  • this invention is directed to such packaging systems that maintain the storage device in a substantially vertical orientation, and thus provide a visually prominent display to a patient.
  • a vertically-oriented, visually prominent display of the storage device is intended to provide the patient with a visual cue that will serve to remind him or her of the need to comply with the prescribed dosing regimen associated with the medication, and thus reduce the incidence of noncompliance.
  • This invention encompasses a variety of embodiments in which a medication storage device is supported in its vertical orientation from any direction, i.e., from the rear surface or front surface, from the top edge, or from either side edge, a bottom edge, or a corner.
  • All embodiments provide for attachment of the storage device to a mounting location that is intended to remain constant during the course of administration of the doses contained therein. This is intended to encourage the patient to return the storage device to the same mounting location after each administration, and thus avoid potential mislocation of the storage device.
  • the storage device is physically anchored or tethered to the mounting location, thus providing a tangible reminder to the patient of the association between the storage device and the mounting location and further reducing the possibility of misplacement.
  • the storage device is attached to the mounting surface by a retaining device.
  • the retaining device comprises a mounting surface attachment feature and a storage device attachment feature, either or both of which attachment features may include the use of adhesive, magnet, or a fastener such as a hook, peg, clamp, clip spring, a hook-and-loop system, base, suction cup and the like.
  • the fastener(s) must be fixed to a suitable location on the surface (herein referred to as the "mounting location").
  • the fastener(s) may be so fixed to the mounting location on the surface of choice by use of fastening hardware including one or more screws, nails, brads, staples, etc.
  • the fastener(s) may include a magnet in its base of suitable size to support the fastener and the storage device supported therefrom.
  • the spring load of the fastener must be sufficient to retain the storage device at rest, but not so great as to hinder removal and replacement of the storage device by the patient.
  • the fastener is a hook or peg
  • the hook may be sized and disposed to engage a wire or loop appropriately disposed from the rear surface or edge of the storage device, similar to a conventional picture-hanging arrangement.
  • the storage device may alternatively be fastened to the mounting location by use of a hook-and-loop fabric system, such as that which goes by the tradename of Velcro®.
  • the fabric backing of the two opposed hook-and- loop strips can be attached to the mounting surface and the rear surface of the storage device or mounting structure by means of adhesive.
  • the adhesive selected When adhesive is used to bond the storage device directly to the mounting surface, the adhesive selected must be capable of retaining the storage device on the mounting surface after repeated cycles of application to and removal from the mounting surface. Assuming the storage device is removed from the mounting surface once each time a dosage is administered, and only one dosage is administered at a time, the minimum number of such cycles to be expected will be the number of medication dosages contained in the blister pack when new. Thus, for a fourteen-dose blister pack, the adhesive must be able to retain the blister pack to the mounting surface after at least fourteen cycles of application and removal.
  • Adhesives suitable for this sort of service include those categorized as "repositionable adhesives.” Such repositionable adhesives are described and exemplified in the literature, e.g., U.S. Pat. no. 5, 795,636. Ultrastik® is an example of a repositionable adhesive.
  • the adhesive used to bond the storage device to the mounting surface may be disposed on a pad that is raised from the remainder of the adjacent surface of the storage device.
  • the pad may be integral to the storage device, or may be a distinct component, which is itself permanently bonded to the storage device. Such a pad may have a relatively soft surface that will conform to any irregularities in the mounting surface, and thus maximize the effective bonding area.
  • FIGS. 1A, 1 B, 1 C, and 1 D illustrate a number of preferred embodiments of this invention in which magnets or adhesive pads are fixed to the rear surface of a blister package.
  • magnets will only retain the storage to ferrous surfaces, while the adhesive pads can be used for most flat surfaces, whether ferrous or non-ferrous.
  • the magnets or adhesive may be disposed on raised pads on the rear surface of the blister package locally at corners and/or at mid-points or other locations near the edges.
  • the surface area of the magnets or surfaces to which adhesive is applied should be designed to sufficiently retain the storage device when loaded with the maximum number of medication doses.
  • the magnets or adhesive may be disposed on raised strips that extend for a portion of, or substantially the entirety of the length, of an edge of the blister package on the rear surface. In alternate embodiments, greater portions of the rear surface of the blister package, up to the entirety of the surface, are used to dispose a magnet or adhesive.
  • the rear surface of the blister package may have one or more ferrous surfaces attached or incorporated therein.
  • One or more magnetic pads can then be used to detachably engage the ferrous surface on the rear surface of the blister pack, while being more strongly attached to the mounting surface by adhesive or a mechanical fastener, such as a bolt.
  • FIGS. 2A and 2B illustrate embodiments of the storage device in which a blister package is supported from a mounting structure through a hinge arrangement arranged, alternatively, horizontally or vertically.
  • FIGS. 2C and 2D are side views of a horizontally mounted hinged packaging system.
  • the mounting structure may be a flat panel that mounts directly to the mounting surface by adhesive, fastener, or magnet.
  • the hinge joint allows the blister package to pivot away from the mounting structure, thus allowing access to the rear surface of the blister package and removal of a dosage form therefrom, without physically detaching the blister package from the mounting structure.
  • This is an example of an embodiment in which the storage device is physically anchored to the mounting location.
  • the blister package is suspended from a surface mounted fastener such as a hook or a peg.
  • the blister package has at least one hole sized to accommodate the hook or peg.
  • the fastener may be mounted to the mounting surface via a magnet or adhesive.
  • FIGS. 3A, 3B and 3C illustrate embodiments in which a blister package is suspended from one or two hooks.
  • the blister package is suspended from a grooved retaining fastener which features a lip or groove sized and located to accommodate a surface edge of the blister pack.
  • FIGS. 4A, 4B and 4C illustrate the use of a rectangular grooved retaining fastener that has a lip disposed on its top edge.
  • the lip is dimensioned to accommodate the upper edge of the cut out central area of the blister pack, and when so disposed, to support the blister pack against the vertical surface.
  • the groove may be dimensioned to allow the blister pack to be easily lifted out.
  • the blister pack is open at one end, allowing for its removal by laterally sliding it across the mounting surface.
  • the grooved retaining fastener may be fixed to the mounting surface by magnet, adhesive clamp, spring clip, hook-and-loop system or other fastening device, as described above.
  • a tether may be used to tie the blister package to the grooved retaining fastener.
  • the storage device may be suspended from a horizontal surface, to which a fastener is attached either permanently or detachably.
  • the horizontal surface may be, for example, a ceiling or a lower surface of a shelf or a cabinet and the fastener may be a magnet, adhesive clamp, spring clip, hook-and-loop system or other fastening device, as described above.
  • FIGS. 5A, 5B and 5C illustrate embodiments of the suspension of a blister package from a horizontal surface by use of, alternatively, a clamp or a spring clip.
  • the storage device is suspended by one of its vertical edges.
  • This arrangement allows the storage device to be very prominently suspended from the edge of a cabinet, refrigerator, or wall, for example.
  • This embodiment may include the use of adhesive, one or more magnets, spring clip, clamp or other fastener disposed on the vertical surface at the mounting surface and suitable for supportingly engaging an edge of the storage device.
  • FIGS. 6A, 6B and 6C illustrate embodiments in which the fastener comprises, alternatively, a clamp or a spring clip, and the blister package is attached to the fastener by means of a tether.
  • the tether is long enough to allow sufficient access to the blister package to allow removal of a dosage but prevents the patient from removing the blister package to a distance beyond its length.
  • This is another example of an embodiment in which the storage device is physically anchored to the mounting location.
  • the medication storage device is supported in its vertical orientation by a stand that reposes on a horizontal surface, such as a table top or a counter top.
  • the medication storage device may be vertically supported by a stand that is either integral to, or distinct from, the storage device.
  • FIGS. 7 A and 7B illustrate an embodiment of a blister package supported from a horizontal surface by a stand that is distinct to the blister package.
  • FIGS. 7C and 7D illustrate an embodiment in which the bottom edge of the blister package has a vertical notch dimensioned to accommodate a distinct cross- member that has a matching vertical notch.
  • supporting members may fold out from the base of the storage device to provide lateral stability, and maintain the vertical orientation of the storage device.
  • the supporting members may be flaps that are integrally bonded or otherwise attached to the lower part of the storage device.
  • the cross-members may be formed by perforated segments of the lower edge of the blister package that can be folded outward, as shown in FIGS. 7E and 7F.
  • the base can be formed by appropriately folding the lower edge of the blister package at horizontal locations, as shown in FIGS. 7G and 7H. The fold locations may be marked and of lesser cross-section or stiffness to facilitate folding.
  • the present invention is directed to pharmaceutical storage systems designed to maintain an essentially planar medication storage device in a vertical orientation.
  • the medication storage device is a conventional blister-pack card.
  • a typical blister pack card comprises a translucent sheet and a rupturable or pealable backing, and is mounted atop a sheet having a plurality of cutouts, each cutout defining an opening having an area large enough for one dose of medication to pass through. The cutouts can be perforated or non-perforated.
  • a translucent sheet is placed over a portion of the first sheet, essentially overlapping it.
  • the translucent sheet forms a plurality of blisters and is preferably manufactured from clear plastic, but can be manufactured from any other comparable material or combination of materials known to those skilled in the art.
  • Each blister has a hollow cavity upon which one dose of medication is stored.
  • a rupturable or pealable backing seals the hollow cavity so as to prevent contamination of dose of medication, each backing positioned to overlap each opening.
  • the backing is preferably manufactured using a flexible, rupturable material such as a thin metallic sheet, however it can be manufactured using plastic or any other comparable material or combination of materials known to those skilled in the art.
  • the rupturable backing is sandwiched in between the translucent sheet and the first sheet.

Landscapes

  • Health & Medical Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Packages (AREA)
PCT/US2007/026098 2006-12-22 2007-12-20 Pharmaceutical packaging systems for improved patient compliance WO2008079306A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
CA002673236A CA2673236A1 (en) 2006-12-22 2007-12-20 Pharmaceutical packaging systems for improved patient compliance
EP07867903A EP2097057A2 (en) 2006-12-22 2007-12-20 Pharmaceutical packaging systems for improved patient compliance
MX2009006872A MX2009006872A (es) 2006-12-22 2007-12-20 Sistemas de empaquetado farmaceutico para el cumplimiento mejorado del paciente.
JP2009542926A JP2010512952A (ja) 2006-12-22 2007-12-20 患者の遵守を改善するための医薬品パッケージングシステム

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US87160106P 2006-12-22 2006-12-22
US60/871,601 2006-12-22

Publications (2)

Publication Number Publication Date
WO2008079306A2 true WO2008079306A2 (en) 2008-07-03
WO2008079306A3 WO2008079306A3 (en) 2008-10-09

Family

ID=39367501

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/026098 WO2008079306A2 (en) 2006-12-22 2007-12-20 Pharmaceutical packaging systems for improved patient compliance

Country Status (6)

Country Link
US (1) US20080190801A1 (ja)
EP (1) EP2097057A2 (ja)
JP (1) JP2010512952A (ja)
CA (1) CA2673236A1 (ja)
MX (1) MX2009006872A (ja)
WO (1) WO2008079306A2 (ja)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
BR112013010024A2 (pt) 2010-10-27 2016-08-02 Kraft Foods Global Brands Llc embalagem para acomodar produto a qual pode ser fechada de forma magnética
US8662304B2 (en) * 2010-11-24 2014-03-04 Mckesson Corporation Pharmaceutical package having a twistable actuator and associated method of accessing medication
EP2654658A4 (en) 2010-12-23 2016-04-06 Tailorpill Technologies Llc SYSTEM AND METHOD FOR PERSONALIZED PILLAR CONNECTIONS
JP2014529457A (ja) 2011-08-26 2014-11-13 ウォックハート リミテッド 患者コンプライアンス用ブリスターパッケージ
US9150119B2 (en) 2013-03-15 2015-10-06 Aesynt Incorporated Apparatuses, systems, and methods for anticipating and delivering medications from a central pharmacy to a patient using a track based transport system
US9511945B2 (en) 2012-10-12 2016-12-06 Aesynt Incorporated Apparatuses, systems, and methods for transporting medications from a central pharmacy to a patient in a healthcare facility
JP6890384B2 (ja) * 2016-06-24 2021-06-18 朝日印刷株式会社 包装体
JP6650544B1 (ja) * 2019-04-02 2020-02-19 啓一 猿橋 Ptp包装シート

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EP0642988A1 (en) * 1993-09-14 1995-03-15 Peter John Adams Dot matrix application of adhesive for blister and skin packaging
US5927500A (en) * 1998-06-09 1999-07-27 Milliken & Company Pharmaceutical containment package
WO2001046040A1 (en) * 1999-12-20 2001-06-28 Merck & Co., Inc. Blister package for pharmaceutical treatment card
US20040004018A1 (en) * 2002-03-29 2004-01-08 Shinji Nittono Blister pack display holder
US20040148054A1 (en) * 2003-01-24 2004-07-29 Monty Schwartz Method and system for packaging and dispensing medication
CA2516324A1 (en) * 2005-09-09 2005-12-03 Manrex Limited Dispensing container for a blister pack of medications

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Publication number Priority date Publication date Assignee Title
EP0642988A1 (en) * 1993-09-14 1995-03-15 Peter John Adams Dot matrix application of adhesive for blister and skin packaging
US5927500A (en) * 1998-06-09 1999-07-27 Milliken & Company Pharmaceutical containment package
WO2001046040A1 (en) * 1999-12-20 2001-06-28 Merck & Co., Inc. Blister package for pharmaceutical treatment card
US20040004018A1 (en) * 2002-03-29 2004-01-08 Shinji Nittono Blister pack display holder
US20040148054A1 (en) * 2003-01-24 2004-07-29 Monty Schwartz Method and system for packaging and dispensing medication
CA2516324A1 (en) * 2005-09-09 2005-12-03 Manrex Limited Dispensing container for a blister pack of medications

Also Published As

Publication number Publication date
EP2097057A2 (en) 2009-09-09
WO2008079306A3 (en) 2008-10-09
US20080190801A1 (en) 2008-08-14
MX2009006872A (es) 2009-08-31
CA2673236A1 (en) 2008-07-03
JP2010512952A (ja) 2010-04-30

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