JP2010512952A - Pharmaceutical packaging system to improve patient compliance - Google Patents

Abstract

Disclosed herein is a packaging system that supports a blister package in a substantially vertical orientation. Such a vertical orientation of the drug storage device serves as a reminder to the patient that the drug storage device is visually more prominent and consequently adheres to the prescribed dosage regimen for that drug Is intended to be. Examples of preferred embodiments are given and described. In one embodiment, the holding device supports the blister package in a substantially vertical orientation.

Description

(Citation of related application)
This application claims the benefit of US Provisional Patent Application No. 60 / 871,601, filed December 22, 2006, which is incorporated herein in its entirety.

(Field of Invention)
The present invention relates generally to pharmaceutical packaging systems. More specifically, the present invention relates to a packaging system that is designed to be prominently positioned at a location chosen by the patient, thereby improving patient compliance with the recommended dosing regimen.

(background)
Patient compliance with the recommended regimen is an important public health issue. The World Health Organization referred to non-compliance as a “significant global problem” in its 2003 report. In developed countries, it is estimated that half of patients did not take medications for chronic diseases in a prescribed manner. Research shows that non-compliance results in 125,000 deaths each year in the US (Non-Patent Document 1), leading to 10% to 25% of hospital admissions and nursing home admissions and is expanding internationally Has shown that. One study concluded that 23% of admissions to care facilities are due to non-compliance (Non-Patent Document 2). Another study concluded that 10% of hospital admissions were due to non-compliance (Schering Report IX, The Forgetful Participant: The High Cost of Improvant Patient Compliance, March 1981). It is also estimated that about 50% of prescription drugs dispensed each year are not taken correctly (Hayes, RB, NCPIE Prescription Month, October 1989). Thus, there is clearly a need to improve patient compliance.

  Drugs in the form of tablets and capsules are generally distributed to users in two types of packages. The first type of packaging that has historically dominated the market is generally either twisted or removed from the body of the containment to provide access to the objects placed therein. Bulk packaging in the form of small small bottles or bottles with a cap. Such a cap may include a locking structure when engaged with the package body to prohibit child access to the contents.

  One drawback of bulk packaging is that the user is responsible for maintaining an independent record of human memory or other means as to whether proper dosing has actually taken place. This drawback is particularly problematic for users who suffer from weak memory and a short memory period. Thus, too many or too few doses can be easily taken in a given period, thereby reducing the efficiency of the drug or, in more severe situations, actually damaging the organ system. Bring.

  In order to address the shortcomings inherent in conventional bulk storage containers, a second category of storage systems called blister packaging has been developed. Such blister packaging typically consists of a set of individualized packets placed together on a card, one packet for each dose or small dose of drug. This card is printed with dosing instructions and warnings. The tablet itself, such as aluminum foil or polyvinyl chloride film, can leave the tablet blistered to indicate that the dose has been utilized, thereby allowing the tablet to be pushed through the aluminum foil backing Between the two materials. While the use of blister packs solves the problem of those who cannot remember whether or not a dose has been made, the conventional blister packaging system with a foil barrier that is inevitably easily opened is torn or It can be susceptible to damage due to child invasion. Instead of a sheet that pushes through, the backing may comprise a sheet of material designed to be peeled from the packaging.

  Conventional bulk packaging systems and blister packaging systems may be visually inconspicuous to the patient and as a result may not provide a visual stimulus that encourages patient compliance with drug administration and promotes compliance. Furthermore, because of the fact that they are not related or fixed in any way in any way, they can in some cases be misplaced within the reach of children. obtain.

  The prior art reflects various attempts to remedy some of these disadvantages. U.S. Patent No. 6,057,836 provides a packaging material that includes a cardboard or polymer sheet platform reinforced with a fabric substrate layer, thereby providing a composite that is resistant to tearing. U.S. Patent No. 6,099,059 is directed to a packaging system that incorporates external reminders to effectively dispense drugs on an irregular basis or on a long term basis. This reference also suggests that a packaging system that can be oriented vertically can help to remind the patient of the need to comply with the medications contained therein.

  However, there remains a need for a pharmaceutical packaging system that further improves patient compliance.

US Pat. No. 5,927,500 US Pat. No. 6,273,260

Smith, D.M. , Compliance Packaging: A Patent Education Tool, American Pharmacy, Vol. NS29, no. 2 February 1989 Standberg, L.M. R. , Drugs as a Reason for Nursing Home Admissions, American Health Care Association Journal, 10, 20, 1984.

(Summary of Invention)
In some embodiments, the present invention is directed to a pharmaceutical packaging system comprising a blister package that accommodates multiple drug doses and a holding device for mounting the blister package to an installation surface. The holding device supports the blister package in a substantially vertical orientation.

  In some embodiments, the holding device comprises a magnet disposed on the back of the blister, the magnet being suitable for suspending the blister package from the vertical mounting surface of the iron.

  In some embodiments, the holding device comprises an adhesive disposed on the back surface of the blister package, which is suitable for suspending the blister package from an iron vertical mounting surface. In some embodiments, the adhesive is a repositionable adhesive.

  In some embodiments, the retaining device comprises a fastener suitable for supporting the blister package from the mounting surface, the fastener comprising a hook, peg, clamp, clip spring, hook and loop strip, and suction cup Selected from the group consisting of In some embodiments, the holding device further comprises a magnet-based portion suitable for supporting the blister package from the iron mounting surface. In some embodiments, the holding device further comprises a tether attached to the blister package at one end and the fastener at the other end.

  In some embodiments, the blister package further comprises an iron surface disposed on the back surface of the blister package, and the fastener comprises a magnet disposed to engage the iron surface.

  In some embodiments, the retaining device comprises a grooved fastener adapted to engage while supporting the end of the blister package.

  In some embodiments, the blister package is attached to the device it holds by a hinge joint that allows the blister package to pivot about the hinge joint.

  In some embodiments, the retaining device comprises a grooved fastener for attaching the blister package to the mounting surface.

  In some embodiments, the present invention provides a pharmaceutical packaging system comprising a blister package that accommodates multiple drug doses and a stand suitable for supporting a drug storage device from a horizontal surface. Is directed to. In some embodiments, the stand is an integral part of the drug storage device. In some embodiments, the stand includes at least one folded cross member. In some embodiments, the stand comprises a horizontal folding base.

  In some embodiments, the present invention is directed to a method for increasing patient compliance, including the use of the packaging system of claim 1 for storing and displaying a pharmaceutical product.

The features and objects of the invention may be better understood from the following detailed description taken in conjunction with the following drawings.
1A and 1B illustrate a packaging system comprising a blister package placed on the back as a strip with either a magnet or adhesive pad mounted on the end. 1A and 1B illustrate a packaging system comprising a blister package placed on the back as a strip with either a magnet or adhesive pad mounted on the end. 1C and 1D illustrate a packaging system comprising a blister package with either a magnet or adhesive pad placed on the back as a button. 1C and 1D illustrate a packaging system comprising a blister package with either a magnet or adhesive pad placed on the back as a button. FIGS. 2A and 2B illustrate a packaging system comprising a blister package that is supported by a mounting structure via a hinge joint and the back of the mounting structure is provided with a pad of either magnet or adhesive. Yes. FIGS. 2A and 2B illustrate a packaging system comprising a blister package that is supported by a mounting structure via a hinge joint and the back of the mounting structure is provided with a pad of either magnet or adhesive. Yes. 2C and 2D illustrate a side view of a packaging system that includes a blister package that is supported via a hinged joint that is integral to the mounting structure. 2C and 2D illustrate a side view of a packaging system that includes a blister package that is supported via a hinged joint that is integral to the mounting structure. 3A and 3B illustrate a packaging system comprising a blister package that can be installed by hooks or pins. 3A and 3B illustrate a packaging system comprising a blister package that can be installed by hooks or pins. FIG. 3C illustrates a packaging system comprising a blister package installed by hooks. 4A, 4B and 4C illustrate an alternative embodiment of a packaging system comprising a blister package suspended from a grooved retaining fastener. 4A, 4B and 4C illustrate an alternative embodiment of a packaging system comprising a blister package suspended from a grooved retaining fastener. 4A, 4B and 4C illustrate an alternative embodiment of a packaging system comprising a blister package suspended from a grooved retaining fastener. 4D and 4E illustrate side views of an alternative embodiment of a sculpted retaining fastener. 4D and 4E illustrate side views of an alternative embodiment of a sculpted retaining fastener. 5A, 5B and 5C illustrate an embodiment of a packaging system comprising a blister package supported from the top by a holding component comprising either a clamp or a spring clip. 5A, 5B and 5C illustrate an embodiment of a packaging system comprising a blister package supported from the top by a holding component comprising either a clamp or a spring clip. 5A, 5B and 5C illustrate an embodiment of a packaging system comprising a blister package supported from the top by a holding component comprising either a clamp or a spring clip. FIGS. 6A, 6B and 6C illustrate an embodiment of a packaging system comprising a blister package supported from a side end by a holding component comprising a base, either a clamp or a spring clip, and a tether. ing. FIGS. 6A, 6B and 6C illustrate an embodiment of a packaging system comprising a blister package supported from a side end by a holding component comprising a base, either a clamp or a spring clip, and a tether. ing. FIGS. 6A, 6B and 6C illustrate an embodiment of a packaging system comprising a blister package supported from a side end by a holding component comprising a base, either a clamp or a spring clip, and a tether. ing. 7A and 7B illustrate a packaging system that includes a blister package supported by a free-standing foundation. 7A and 7B illustrate a packaging system that includes a blister package supported by a free-standing foundation. Figures 7C and 7D illustrate a packaging system comprising a blister package supported by interdigitated cross members. Figures 7C and 7D illustrate a packaging system comprising a blister package supported by interdigitated cross members. Figures 7E and 7F illustrate a packaging system comprising a blister package supported by an integral folded cross member. Figures 7E and 7F illustrate a packaging system comprising a blister package supported by an integral folded cross member. Figures 7G and 7H illustrate a packaging system comprising a blister package supported by an integrated horizontal fold base. Figures 7G and 7H illustrate a packaging system comprising a blister package supported by an integrated horizontal fold base.

(Detailed Description of the Invention)
The present invention will now be described more fully herein with reference to the accompanying drawings, in which preferred embodiments of the invention are shown. This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; Rather, these embodiments are provided so that this disclosure will be thorough and complete, and will fully convey the scope of the invention to those skilled in the art. As will be appreciated by those skilled in the art, 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 flat drug storage device in which one or more doses of a drug can be dispensed. In particular, the present invention is directed to a packaging system that maintains the storage device in a substantially vertical orientation, thereby providing a visually noticeable display to the patient. A visually prominent indication of such a vertical orientation of the storage device provides the patient with visual cues that help to remind him or her that they must comply with the prescribed dosage plan associated with the drug And is intended to reduce the occurrence of non-compliance. The present invention provides a variety of drug storage devices that are supported in their vertical orientation from any direction, i.e., from the back or front, from the top edge, or from either side edge, bottom edge, or corner. Embodiments are included.

  Many options that fall within the scope of the present invention make it difficult to reach any pediatric hand that may be present, so that visually conspicuous and patient avoiding the possibility of overdose to the child It is intended to provide a degree of flexibility in the selection of installation positions necessary to achieve both convenience for the user. All embodiments provide for the mounting of the storage device in a stationary position that is intended to be in a fixed position during administration of the dose contained therein. This is intended to help the patient return the storage device to the same installed position after each administration, thus avoiding the possibility of accidentally placing the storage device. In some embodiments, the storage device is physically fixed or coupled to the installation position to provide a tangible reminder of the relationship between the storage device and the installation position.

  The storage device is attached to the mounting surface by the device that holds it. The holding device comprises a mounting surface mounting mechanism and a storage device mounting mechanism, either or both of which can be an adhesive, a magnet, or a hook, peg, clamp, clip spring, hook and loop, for example. -And-loop) systems, bases, suction cups and the like may be used. The fasteners must be secured in place on the surface (referred to herein as the “installation position”). The fasteners can be secured in place on a selected surface by the use of securing hardware including one or more screws, nails, headless nails, staples, and the like. If the chosen mounting location comprises ferrous metal, the fastener may include a magnet in the base of the fastener that is appropriately sized to support the supported fastener and the storage device. In the case of a clamp or clip spring, the spring load of the fastener must be sufficient to hold the stationary storage device, but not so great as to prevent the patient from removing and replacing the storage device. If the fastener is a hook or peg, there must be a hole that is appropriately sized and placed in the storage device to allow the hook or peg to pass through, so that the storage device Must be able to hang vertically from there. In the case of a hook as an alternative, the hook is sized and arranged to engage a properly placed wire or loop from the back or end of the storage device, similar to the traditional picture hanging arrangement. Can be done.

  The storage device may alternatively be secured in the installed position by use of a hook and loop fabric system such as that passed under the Velcro® brand name. Two opposing hook and loop strip fabric backings can be attached to the mounting surface and the storage device and back or mounting structure by adhesive.

  If the adhesive is used to bond the storage device directly to the mounting surface, the selected adhesive will be used to attach the storage device to the mounting surface after repeated cycles of application to and removal from the mounting surface. It should be possible to hold on. Assuming that the storage device is removed from the mounting surface once each dose is administered and only one dose is administered at a time, the minimum number of such cycles that can be expected is a blister pack. When pack is new, it is the number of drug doses contained in it. Thus, for a 14 dose blister pack, the adhesive must be able to hold the blister pack to the mounting surface after at least 14 cycles of application and removal. Adhesives suitable for this type of function include those categorized as “repositionable adhesives”. Such repositionable adhesives are described and illustrated in documents such as US 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 can be placed on a pad raised from the rest of the adjacent surface of the storage device. The pad can be an integral part of the storage device or can be a separate component, the pad itself being permanently bonded to the storage device. Such pads can have a relatively soft surface that conforms to any bumps on the mounting surface to maximize the effective bonding area.

  The patient may choose to place the drug storage device in any number of locations at home, work, etc. In the home, it may be desirable to place the storage device on a convenient and visually accessible vertical surface, such as a pharmaceutical cabinet, washbasin cabinet, or refrigerator wall or side. 1A, 1B, 1C, and 1D illustrate several preferred embodiments of the present invention with a magnet or adhesive pad secured to the back of the blister package. Of course, the magnet only holds the storage device on the iron surface, while the adhesive pad can be used for most flat surfaces, whether iron or non-ferrous.

  As shown, the magnet or adhesive may be placed on the raised pad on the back of the blister package locally at the corners and / or at a midpoint or other location near the edge. . The surface area of the magnet or surface to which the adhesive is applied should be designed to hold the storage device well when loaded with the maximum number of drug doses. Alternatively, the magnet or adhesive may be placed on a raised strip that extends for a portion or substantially the entire length of the end of the blister package on the back. In an alternative embodiment, a larger portion of the back of the blister package (up to the entire maximum surface) is used to place the magnet or adhesive.

  Alternatively, the back of the blister package may have one or more iron surfaces mounted or incorporated therein. One or more magnets are then used to detachably engage the iron surface on the back of the blister pack while being more firmly attached to the mounting surface by adhesive or mechanical fasteners such as bolts. Can be.

  2A and 2B illustrate an embodiment of a storage device in which the blister package is supported from the mounting structure via a hinge configuration that is arranged horizontally or vertically as an alternative. 2C and 2D are side views of a horizontally mounted hinged packaging system. The mounting structure can be a flat panel that is mounted directly to the mounting surface by adhesives, fasteners, or magnets. The hinge joint allows the blister package to pivot away from the mounting structure so that access to the back of the blister package and removal of dose therefrom is physically removed from the mounting structure. Make it possible without. This is an example of an embodiment in which the storage device is physically fixed in the installed position.

  In yet another set of embodiments, the blister package is suspended from a more securely mounted surface, such as a hook or peg. The blister package has at least one hole sized to receive a hook or peg. The fastener can be mounted to the mounting surface via a magnet or adhesive. 3A, 3B and 3C illustrate an embodiment in which the blister package is suspended from one or two hooks.

  In yet another set of embodiments, the blister package retains a grooved feature, characterized by a lip or groove sized and arranged to receive the edge of the surface of the blister pack. Can be hung from a fastener. 4A, 4B and 4C illustrate the use of a rectangular grooved retaining fastener having a lip located at the upper end. The lip is dimensioned to receive the top edge of the blister pack's cut out central region and, when so positioned, support the blister pack against a vertical surface. The groove may be sized to allow the blister pack to be easily pulled up. In the embodiment illustrated in FIG. 4B, the blister pack is open at one end and allows its removal by sliding it sideways across the mounting surface. The grooved retaining fasteners can be secured to the mounting surface by magnets, adhesives, clamps, spring clips, hook and loop systems or other securing devices as described above. A tether can be used to tie the blister package to the sculpted holding fastener. These embodiments provide grooves to display information that is valuable to the patient, such as dosing instructions, warnings, or simply reminding to return the blister package to its original position after each dose administration. It has the further advantage of providing a prominent surface on the carved retaining fastener.

  In some embodiments, the storage device can be suspended from a horizontal surface and the fasteners are either fixedly or removably attached. The horizontal surface can be, for example, the top or bottom surface of a shelf or cabinet, and the fastener can be an adhesive, clamp, spring clip, hook and loop system or other securing device, as described above. . 5A, 5B, and 5C illustrate an embodiment of hanging a blister package from a horizontal surface by using clamps or spring clips as an alternative.

  In other embodiments, the storage device is suspended by one of the vertical ends of the storage device. This configuration allows the storage device to be suspended very prominently from, for example, a cabinet, refrigerator, or wall edge. This embodiment is located on a vertical surface located on the mounting surface and is suitable for engagement to support the end of the storage device, one or more magnets, spring clips, clamps or other fasteners. May include the use of tools. 6A, 6B and 6C illustrate an embodiment in which the fastener includes a clamp or spring clip as an alternative, and the blister package is attached to the fastener by a tether. The tether is long enough that sufficient access to the blister package allows removal of the dose, but prevents the patient from removing the blister package to a distance that exceeds the length of the tether. This is another example of an embodiment where the storage device is physically fixed in the installed position.

  In yet another embodiment, the drug storage device is supported in a vertical orientation by a stand that rests on a horizontal surface such as the upper surface of the table or the upper surface of the counter. The drug storage device can be vertically supported by a stand, which is an integral part of the storage device or is separate.

  In embodiments where the stand is separate from the product to be dispensed, the stand clips or pins the foundation of the product to be dispensed. The stand may be free to rest on a horizontal surface without being fixed thereto, or alternatively may be fixed to the mounting surface by any of the fasteners described above. 7A and 7B illustrate an embodiment of a blister package that is supported from a horizontal surface by a stand that is separate from the blister package. FIGS. 7C and 7D illustrate an embodiment having a vertical cut that is sized to receive a separate cross-member with the bottom edge of the blister package having a vertical cut. When assembled as shown in the figure, the blister package and the cross member are combined together to form the foundation.

  In embodiments where the stand is an integral part of the storage device, the support member can fold away from the base of the storage device to provide lateral stability and maintain the vertical orientation of the storage device. The support member may be a flap that is integrally joined or otherwise attached to the lower portion of the storage device. Alternatively, the cross member may be formed by a perforated portion of the lower end of the blister package that can be folded outward and spread, as shown in FIGS. 7E and 7F. In yet another embodiment, the foundation may be formed by appropriately folding the lower end of the blister package in a horizontal position, as shown in FIGS. 7G and 7H. The folding position can be marked to facilitate folding and can be of less cross-section or stiffness.

  As noted above, the present invention is directed to a pharmaceutical storage system designed to maintain a drug storage device that is essentially flat in a vertical orientation. In many preferred embodiments, the drug storage device is a conventional blister pack card. A typical blister pack card is equipped with a translucent sheet and a backing that can be torn or peeled and mounted on a sheet with multiple cutouts, each cutout passing through a single dose of drug. An opening having a sufficiently large area is defined. The cutout may or may not be perforated. The translucent sheet is disposed on a portion of the first sheet and essentially overlies it. The translucent sheet forms a plurality of blisters and is preferably made from light plastic, but can be made from any other similar material or combination of materials known to those skilled in the art. Each blister has a cavity in which one dose of drug is stored. A backing that can be torn or peeled seals the cavity to prevent contamination of the drug dose, and each backing is positioned to overlie each opening. In the case of a tearable backing, the backing is preferably manufactured using a flexible, tearable material such as a thin metal sheet, but it may be made of plastic or any other similar material or It can be manufactured using combinations of materials known to those skilled in the art. The tearable backing is sandwiched between the translucent sheet and the first sheet. When a user wants to take a drug dose from the packaging system, all the user has to do is press the blister, break the backing that can break the drug dose, and open the packaging system from the opening It is only to issue.

  In the above specification, the invention has been described with reference to specific preferred embodiments thereof, and numerous details have been set forth for purposes of illustration, but those skilled in the art will recognize that the invention is It will be apparent that some of the details described herein may vary considerably without departing from the basic principles of the invention.

Claims (16)

  A pharmaceutical packaging system comprising a blister package containing a plurality of drug doses and a holding device for mounting the blister package on a mounting surface, the holding device comprising the blister package A packaging system that supports a substantially vertical orientation.   The package of claim 1, wherein the holding device comprises a magnet disposed on a back surface of the blister package, the magnet being suitable for suspending the blister package from a vertical mounting surface of iron. System.   The package of claim 1, wherein the holding device comprises an adhesive disposed on a back surface of the blister package, the adhesive being suitable for hanging the blister package from a vertical mounting surface. System.   The packaging system of claim 3, wherein the adhesive is a repositionable adhesive.   The holding device comprises a fastener suitable for supporting the blister package from an installation surface, the fastener comprising a group consisting of a hook, a peg, a clamp, a clip spring, a hook and loop strip, and a suction cup. The packaging system of claim 1, wherein the packaging system is selected.   6. The packaging system of claim 5, wherein the holding device further comprises a magnet base portion suitable for supporting the blister package from an iron mounting surface.   6. The packaging system of claim 5, further comprising a tether attached to the blister package at one end and the fastener at the other end.   The blister package further comprises an iron surface disposed on a back surface of the blister package, and the fastener comprises a magnet disposed to engage the iron surface. The packaging system described.   The packaging system of claim 1, wherein the retaining device comprises a grooved supporting fastener adapted to engage and support an end of the blister package.   The packaging system of claim 1, wherein the blister package is attached to the holding device by a hinge joint that allows the blister package to pivot about the hinge joint.   The packaging system of claim 1, wherein the holding device comprises a grooved holding fastener for mounting the blister package to the mounting surface.   A pharmaceutical packaging system comprising a blister package containing a plurality of drug doses and a stand suitable for supporting a drug storage device from a horizontal surface.   The packaging system of claim 12, wherein the stand is integral with the drug storage device.   14. The packaging system of claim 13, wherein the stand comprises at least one folded cross member.   14. The packaging system of claim 13, wherein the stand comprises a horizontal folding base. A method for increasing patient compliance comprising the use of a packaging system according to claim 1 for storing and displaying pharmaceutical products.

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