WO2007047313A2 - Child resistant medicament storage and distribution back card and sealed blister card - Google Patents

Child resistant medicament storage and distribution back card and sealed blister card Download PDF

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Publication number
WO2007047313A2
WO2007047313A2 PCT/US2006/039746 US2006039746W WO2007047313A2 WO 2007047313 A2 WO2007047313 A2 WO 2007047313A2 US 2006039746 W US2006039746 W US 2006039746W WO 2007047313 A2 WO2007047313 A2 WO 2007047313A2
Authority
WO
WIPO (PCT)
Prior art keywords
card
blister
perimeter
inches
opening feature
Prior art date
Application number
PCT/US2006/039746
Other languages
French (fr)
Other versions
WO2007047313A3 (en
Inventor
Victor Gherdan
Dennis Chadwick
David Barndt
Timothy F. Craig
Original Assignee
R.P. Scherer Technologies, Inc.
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 R.P. Scherer Technologies, Inc. filed Critical R.P. Scherer Technologies, Inc.
Priority to JP2008535652A priority Critical patent/JP2009511375A/en
Priority to AU2006304122A priority patent/AU2006304122A1/en
Priority to BRPI0617251-2A priority patent/BRPI0617251A2/en
Priority to EP06816729A priority patent/EP1934115A4/en
Publication of WO2007047313A2 publication Critical patent/WO2007047313A2/en
Publication of WO2007047313A3 publication Critical patent/WO2007047313A3/en

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Classifications

    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D83/00Containers or packages with special means for dispensing contents
    • B65D83/04Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills
    • B65D83/0445Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills all the articles being stored in individual compartments
    • B65D83/0463Containers or packages with special means for dispensing contents for dispensing annular, disc-shaped, or spherical or like small articles, e.g. tablets or pills all the articles being stored in individual compartments formed in a band or a blisterweb, inserted in a dispensing device or container
    • BPERFORMING OPERATIONS; TRANSPORTING
    • B65CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65DCONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES
    • B65D2215/00Child-proof means

Definitions

  • the present invention generally relates to medication packages and, more particularly, relates to a child-resistant medicament storage and distribution back card and a child-resistant sealed blister card incorporating same.
  • top and backing layers may be formed of flexible packaging materials, rigid thermoformable plastic materials, foil, paper, laminates, or combinations thereof.
  • Medicament cavities formed between such layers have been accessed by tearing into them from an edge of the package, which tearing may or may not be facilitated through the provision of a starting notch or slit, or by simply pushing on the blister until the medicament breaks through the backing layer.
  • these cavities may be accessed by stripping a backing layer from the package to expose the cavity, or to expose a push-through underlayer.
  • the backing layer is made of foil that can be ruptured when the medication in the blister is pushed against the backing layer.
  • these packages are tamper evident, but typically not child resistant.
  • Other medication packages require some form of peeling of the bottom surface from the top surface to get access to the medication.
  • Child resistant medication packages that use a peeling feature have been in use for some time, however, many people who do not have sufficient motor skills or whose hands shake are not able to easily gain access to the medicament in such packages. This can be a problem especially when the medicament and the medication packages are small. Additionally, there have been a number of medication packages that are designed to be torn open to access the medication. Many medication packages that are designed to be torn suffer from the same problems as those designed for peeling, namely they are difficult to open for those with reduced motor skills or do not exhibit a high degree of child-resistance.
  • Prior blister package systems have also incorporated covers that shield the foil portions of the blister package.
  • Such covers generally include a breakaway area in-line with the medicament cavity, often referred to as a "nicked back" opening feature, so that the medicament must first be forced through the foil layer and then break through the breakaway area. While such areas do indeed protect the foil layer, they often invite the attention of children who like to use their fingers to pick at the area. Little attention has been given to the design of the nicks of the nicked back, aside from ensuring that they weaken the cover enough to permit the user to force the medicament through the opening feature. Traditionally, the cut, or "nicked" area has been maximized, subject only to retaining sufficient strength in the backing to reliably retain the medication.
  • the present invention has accomplished these needs by creating a back card that reduces the likelihood of a child using their fingernails to pick away the portion of the cover that shields the blister unit.
  • the present invention advances the state of the art with a variety of new capabilities and overcomes many of the shortcomings of prior devices in new and novel ways.
  • the present invention overcomes the shortcomings and limitations of the prior ait in any of a number of generally effective configurations.
  • the instant invention demonstrates such capabilities and overcomes many of the shortcomings of prior methods in new and novel ways.
  • the present invention is a child-resistant medicament storage and distribution back card for senior-friendly and child-resistant distribution of a medicament.
  • the back card is incorporated into a medication package where it blocks, or protects, the area of the package that is most susceptible to attacks on the integrity of the package.
  • the package is often in the form of a child-resistant sealed blister card, where the back card shields a foil that seals, and retains, a medicament in a blister compartment.
  • the back card has a front surface, a rear surface, and a card opening feature.
  • the card opening feature has a perimeter that includes at least two cuts and at least two lands. The cuts extend from the front surface to the rear surface, and the lands connect the back card to the card opening feature across the perimeter.
  • Each cut has a cut length and each land has a land length.
  • the ratio of the land length to the cut length is between approximately 0.25 and approximately 0.80. This range of ratios had been found to substantially prevent removal of the card opening feature from the back card by picking at any of the cuts with a fingernail, as children often do to gain access to a medicament.
  • the card opening feature remains intact until the application of a predetermined force to the card opening feature results in it tearing away from at least one land.
  • each cut length is between approximately 0.020 (0.0508 cm) inches and approximately 0.125 inches (0.03175 cm).
  • land lengths of between approximately 0.015 inches (0.0381 cm) and approximately 0.100 inches (0.254 cm), have been found to further advance the child-resistance and senior-friendliness of the back card.
  • the back card may be incorporated into a medication package.
  • the back card is incorporated into a child-resistant sealed blister card that includes a front card, and a blister unit sandwiched between the back card and the front card.
  • the back card protects the relatively susceptible base layer of the blister unit.
  • a medication pacakge (200) for distribution of a medicament comprising a back card (100) having a front surface (110), a rear surface (120), and a card opening feature (130), wherein the card opening feature (130) has a perimeter (140) that includes at least two cuts (150), extending from the front surface (110) to the rear surface (120), and at least two lands (160), connecting the back card (100) to the card opening feature (130) across the perimeter (140), wherein each cut (150) has a cut length (150) and each land (160) has a land length (162) and the ratio of any land length (162) to any cut length (152) is between 0.25 and 0.80, thereby inhibiting the removal of the card opening feature (130) from the back card (100).
  • a child-resistant sealed blister card (30) for housing a medicament (M), comprising: (a) a blister unit (400) having:
  • a front card (300) having a front card interior surface (320) and a front card exterior surface (310), wherein the front card (300) is formed to have a blister receiver (330) configured to cooperate with the blister unit (400) such that a portion of the article receiving blister (428) extends through the front card (300) from the front card interior surface (320) to the front card exterior surface (310); and
  • a back card (100) having a front surface (110), a rear surface (120), and a card opening feature (130), wherein the card opening feature (130) has a perimeter (140) that includes at least two cuts (150), extending from the front surface (110) to the rear surface
  • each cut (150) has a cut length (150) and each land (160) has a land length (162) and the ratio of any land length (162) to any cut length (152) is between 0.25 and 0.80, thereby substantially preventing removal of the card opening feature (130) from the back card (100) by picking at any of the cuts (150) with a finger;
  • the blister unit blister layer (420) is adjacent to the front card interior surface (320), the blister unit base layer (410) is adjacent to the back card rear surface (120), and a portion of the front card (300) is joined to the back card (100) thereby fixing the blister unit (400) there between, and the front card (300), the blister unit (400), and the back card (100) are located so that the article receiving blister perimeter (429), the blister receiver perimeter (332), and the back card opening feature perimeter (140) substantially align such that dispensing of the medicament (M) requires application of a predetermined force to the article receiving blister (428) to force the medicament (M) to break through the base layer (410) and act upon the card opening feature (130) resulting in the card opening feature (130) tearing away from at least one land (160) thereby permitting passage of the medicament (M) through the back card (100).
  • a base layer (410) having a base layer perimeter (416), a base layer exterior surface (412), and a base layer interior surface (414);
  • a blister layer (420) having a blister layer perimeter (426), a blister layer exterior surface (422), a blister layer interior surface (424), and including an article receiving blister (428), having a blister perimeter (429), formed therein, wherein the article receiving blister (428) is designed for holding the medicament (M); wherein (iii) a portion of the base layer interior surface (414) is joined to the blister layer interior surface (424) thereby sealing the medicament (M) in the article receiving blister (428);
  • a front card (300) having a front card interior surface (320) and a front card exterior surface (310), wherein the front card (300) is formed to have a blister receiver (330) configured to cooperate with the blister unit (400) such that a portion of the article receiving blister (428) extends through the front card (300) from the front card interior surface (320) to the front card exterior
  • the blister unit blister layer (420) is adjacent to the front card interior surface (320), the blister unit base layer (410) is adjacent to the back card rear surface (120), and a portion of the front card (300) is joined to the back card (100) thereby fixing the blister unit (400) there between, and the front card (300), the blister unit (400), and the back card (100) are located so that the article receiving blister perimeter (429), the blister receiver perimeter (332), and the back card opening feature perimeter (140) substantially align such that dispensing of the medicament (M) requires application of a predetermined force to the article receiving blister (428) to force the medicament (M) to break through the base layer (410) and act upon the card opening feature (130) resulting in the card opening feature (130) tearing away from at least one land (160) thereby permitting passage of the medicament (M) through the back card (100).
  • FIG. 1 is a perspective view of an embodiment of the child-resistant medicament storage and distribution back card and the components of a child-resistant sealed blister card, not to scale;
  • FIG. 2 is a top plan view of the back card, not to scale;
  • FIG. 3 is a table illustrating the preferred ranges of land length and cut length, and the associated ratios of land length to cut length;
  • FIG. 4 is a perspective view of a child-resistant sealed blister card, not to scale
  • FIG. 5 is a cross-sectional view of the child-resistant sealed blister card of FIG. 4 taken along section line 5-5, not to scale
  • FIG. 6 is a cross-sectional view of the child-resistant sealed blister card of FIG. 5 illustrating a force applied to the article receiving blister resulting in the release of a portion of the card opening feature, not to scale.
  • the child-resistant medicament storage and distribution back card, and sealed blister card incorporating same, of the instant invention enables a significant advance in the state of the art.
  • the preferred embodiments of the apparatus accomplish this by new and novel arrangements of elements that are configured in unique and novel ways and which demonstrate previously unavailable but preferred and desirable capabilities.
  • the detailed description set forth below in connection with the drawings is intended merely as a description of the presently preferred embodiments of the invention, and is not intended to represent the only form in which the present invention may be constructed or utilized.
  • the description sets forth the designs, functions, means, and methods of implementing the invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and features may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention.
  • the present invention is a child-resistant medicament storage and distribution back card (10) for senior-friendly and child-resistant distribution of a medicament.
  • the back card (100) is incorporated into a medication package (200) that is often in the form of a child- resistant sealed blister card (30), but is not limited to this particular blister card (30).
  • the back card (100) will first be disclosed in detail, followed by the blister card (30) disclosure.
  • the back card (100) has a front surface (110), a rear surface (120), and a card opening feature (130).
  • the card opening feature (130) has a perimeter (140), labeled in FIG. 1, that includes at least two cuts (150) and at least two lands (160), seen best in FIG. 2.
  • the cuts (150) extend from the front surface (110) to the rear surface (120), as seen in FIG. 5, and the lands (160) connect the back card (100) to the card opening feature (130) across the perimeter (140), as seen in FIG. 2.
  • Each cut (150) has a cut length (150) and each land (160) has a land length (162).
  • the ratio of any land length (162) to any cut length (152), meaning the land length (162) divided by the cut length (152), is between approximately 0.25 and approximately 0.80. This range of ratios had been found to substantially prevent removal of the card opening feature (130) from the back card (100) by picking at any of the cuts (150) with a fingernail; thus preventing distribution of the medicament until the application of a predetermined force to the card opening feature (130) results in the card opening feature (130) tearing away from at least one land (160).
  • the table of FIG. 3 illustrates the preferred range of ratios of land length (162) to cut length (152).
  • the preferred degree of child-resistance and senior-friendliness is found when each cut length (150) is between approximately 0.020 inches (0.508 cm) and approximately 0.125 inches (0.3175 cm).
  • land lengths (160) of between approximately 0.015 (0.0381 cm) inches and approximately 0.100 inches (0.254 cm), have been found to further advance the child-resistance and senior-friendliness of the back card (10).
  • each cut length (150) is substantially equal.
  • each land length (160) is substantially equal, also illustrated in FIG. 2. It is important to note that in certain embodiments the cut lengths (150) may be equal or unequal, and the land lengths (160) may be equal or unequal, as long as the ratio of land length (162) to cut length (152) falls within the range previously disclosed.
  • the card opening feature perimeter (140) is not limited to any particular shape. Most commonly the card opening feature perimeters (140) compliment the shape of the medicament. Therefore, the card opening feature perimeter (140) is substantially circular in shape when used with circular pills and substantially oval, oblong, or rectangular in shape when used with capsules of those shapes.
  • the back card (100) is intended to be incorporated into a medication package (200) that is often in the form of a child-resistant sealed blister card (30), seen in FIGS. 1 and 4, but is not limited to this particular blister card (30) and may be used in any packaging for the storage and distribution of a medicament.
  • a child-resistant sealed blister card (30) seen in FIGS. 1 and 4, but is not limited to this particular blister card (30) and may be used in any packaging for the storage and distribution of a medicament.
  • the blister card (30) of the present invention will now be disclosed in detail.
  • the child-resistant sealed blister card (30) of the present invention is designed for child-resistant and senior-friendly housing and distribution of a medicament (M) and incorporates the previously disclosed back card (100).
  • the blister card (30) also includes a front card (300), and a blister unit (400) sandwiched between the back card (100) and the front card (300), as seen in FIGS. 1, 5, and 6.
  • the blister unit (400) has a base layer (410) and a blister layer (420), labeled in FIG. 5.
  • the base layer (410) has a base layer exterior surface (412) and a base layer interior surface (414).
  • the blister layer (420) has a blister layer exterior surface (422), a blister layer interior surface (424), and includes an article receiving blister (428), having a blister perimeter (429), formed therein.
  • the article receiving blister (428) is designed for holding the medicament (M) regardless of form, including, but not limited to, round pills, oval pills, oblong capsules, caplets, and the like.
  • the front card (300) has a front card interior surface (320) and a front card exterior surface (310).
  • the front card (300) is formed to have a blister receiver (330), seen in FIG. 1, configured to cooperate with the blister unit (400) such that a portion of the article receiving blister (428) extends through the front card (300) from the front card interior surface (320) to the front card exterior surface (310), as seen in FIG. 5.
  • the back card (100), the front card (300), and the blister unit (400) are configured such that the blister unit blister layer (420) is adjacent to the front card interior surface (320), the blister unit base layer (410) is adjacent to the back card rear surface (120), and a portion of the front card (300) is joined to the back card (100) thereby fixing the blister unit (400) there between.
  • the front card (300) and the back card (100) are spaced apart in FIGS. 5 and 6 for clarity, as one with skill in the art will appreciate that the card (100, 300) are joined together in part to retain the blister unit (400).
  • the front card (300), the blister unit (400), and the back card (100) are located so that the article receiving blister perimeter (429), seen in FIG. 4, the blister receiver perimeter (332), seen in FIG. 1, and the back card opening feature perimeter (140), seen in FIGS. 1 and 2, substantially align such that dispensing of the medicament (M) requires application of a predetermined force to the article receiving blister (428) to force the medicament (M) to break through the base layer (410) and act upon the card opening feature (130) resulting in the card opening feature (130) tearing away from at least one land (160) thereby permitting passage of the medicament (M) through the back card (100), as illustrated in FIG. 6.
  • the back card (100) and the front card (300) are preferably made of coated paperboard.
  • the back card (100) and the front card (300) are comprised of a material and thickness that cannot be readily torn, ruptured, or otherwise compromised by action of a human hand of average strength.
  • the material may be paper, or other fiber product, plastic, foil, or composite.
  • the blister layer (420) is preferably made of pharmaceutical grade PVC or other thermoplastic material, such as plastic, polypropylene, polyethylene, styrene, cold-formed foil, or other suitable materials for packaging.
  • the article receiving blister (428) may be formed by a thermoforming process in which the blister layer (420) material is stretched into a cavity with a vacuum technique to form the blister portion.
  • a sheet of suitable material for the blister layer (420) is exposed to heating elements for a pre-determined time. This sheet is then trapped in a forming station where it is subjected to both vacuum and pressure. During this process, the material may also be mechanically assisted into the blister cavity via a matched metal plug to form the article receiving blister (428).
  • the article receiving blister (428) may be formed by using cold-formed foil and cold-form packaging processes.
  • the base layer (410) may be comprised of one or more separate layers of material, such as foil and polyester or other suitable child-resistant foils.
  • the base layer (410) is typically comprised of multiple layers, but it could be made of any material deemed child-resistant.
  • the child-resistant medicament storage and distribution back card, and associated sealed blister card answer a long felt need for a novel package that is both child-resistant and senior-friendly.
  • the back card introduces a card opening feature bounded by a series of cuts and lands having a predetermined relationship that improves the child-resistance over the prior art.
  • the back card is incorporated into a medication package where it blocks, or protects, the area of the package that is most susceptible to attacks.
  • the package is often in the form of a child-resistant sealed blister card, thus the back card shields the foil that seals, and retains, a medicament in a blister compartment.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

A child-resistant medicament storage and distribution back card for senior-friendly and child-resistant distribution of a medicament. The back card is incorporated into a medication package where it protects the area of the package that is most susceptible to attacks on the integrity of the package. The back card has a card opening feature bounded by a perimeter that includes at least two cuts and at least two lands, often thought of as perforations. The cuts extend through the back card, and the lands connect the back card to the card opening feature. Each cut has a cut length and each land has a land length. The ratio of any land length to any cut length is between approximately 0.25 and approximately 0.80, which has been found to substantially prevent removal of the card opening feature from the back card by picking at any of the cuts with a fingernail.

Description

CHILD RESISTANT MEDICAMENT STORAGE AND DISTRIBUTION BACK CARD AND SEALED BLISTER CARD
TECHNICAL FIELD
The present invention generally relates to medication packages and, more particularly, relates to a child-resistant medicament storage and distribution back card and a child-resistant sealed blister card incorporating same.
BACKGROUND OF THE INVENTION
There is a continued need for medication packages that are child-resistant and tamper evident, yet allow the average adult to open the medication packages to get access to the medication therein, as well as the adult who, due to either age or medical infirmity, may have reduced motor skills. Such packaging has been called "child-resistant senior-friendly." There is also a need to make this type of package economical to manufacture.
Over the years, a wide variety of disposable medication packages have been suggested which are accessible through a variety of folding, stripping, rupturing, peeling and/or tearing procedures. These packages have typically been formed of transparent top layers which are sealed or otherwise bonded to backing layers in a manner which provides a cavity, pouch or "blister" in which the medicament is disposed. The top and backing layers may be formed of flexible packaging materials, rigid thermoformable plastic materials, foil, paper, laminates, or combinations thereof. Medicament cavities formed between such layers have been accessed by tearing into them from an edge of the package, which tearing may or may not be facilitated through the provision of a starting notch or slit, or by simply pushing on the blister until the medicament breaks through the backing layer. Alternatively, these cavities may be accessed by stripping a backing layer from the package to expose the cavity, or to expose a push-through underlayer. In other instances, the backing layer is made of foil that can be ruptured when the medication in the blister is pushed against the backing layer. Generally these packages are tamper evident, but typically not child resistant. Other medication packages require some form of peeling of the bottom surface from the top surface to get access to the medication. Some examples of these types of medication packages that use peeling include U.S. Pat. Nos. RE29,705 (Compere); 3,941,248 (Moser); 4,243,144 (Margulies); 4,988,004 (Intini); 5,046,618 (Wood); and 5,358,118 (Thompson). Child resistant medication packages that use a peeling feature have been in use for some time, however, many people who do not have sufficient motor skills or whose hands shake are not able to easily gain access to the medicament in such packages. This can be a problem especially when the medicament and the medication packages are small. Additionally, there have been a number of medication packages that are designed to be torn open to access the medication. Many medication packages that are designed to be torn suffer from the same problems as those designed for peeling, namely they are difficult to open for those with reduced motor skills or do not exhibit a high degree of child-resistance.
Prior blister package systems have also incorporated covers that shield the foil portions of the blister package. Such covers generally include a breakaway area in-line with the medicament cavity, often referred to as a "nicked back" opening feature, so that the medicament must first be forced through the foil layer and then break through the breakaway area. While such areas do indeed protect the foil layer, they often invite the attention of children who like to use their fingers to pick at the area. Little attention has been given to the design of the nicks of the nicked back, aside from ensuring that they weaken the cover enough to permit the user to force the medicament through the opening feature. Traditionally, the cut, or "nicked" area has been maximized, subject only to retaining sufficient strength in the backing to reliably retain the medication.
However, studies have shown that a common tactic used by small children to open traditional blister packages is to pick at the cuts on the backing until some or all of the nicked area is removed. Therefore, an optimal child-resistant design would have very small cut areas and very large land areas to deter picking. However, as the land area increases relative to the cut area, the package becomes increasingly difficult for adults, especially those with limited strength or dexterity, to open.
There is a need for a medication package that protects the common blister unit, while being relatively easy to open for an adult, but still child-resistant. Further, the solution should not encourage children to attempt to defeat the child-resistance characteristics of the package. The present invention has accomplished these needs by creating a back card that reduces the likelihood of a child using their fingernails to pick away the portion of the cover that shields the blister unit.
SUMMARY OF THE INVENTION In its most general configuration, the present invention advances the state of the art with a variety of new capabilities and overcomes many of the shortcomings of prior devices in new and novel ways. In its most general sense, the present invention overcomes the shortcomings and limitations of the prior ait in any of a number of generally effective configurations. The instant invention demonstrates such capabilities and overcomes many of the shortcomings of prior methods in new and novel ways.
The present invention is a child-resistant medicament storage and distribution back card for senior-friendly and child-resistant distribution of a medicament. The back card is incorporated into a medication package where it blocks, or protects, the area of the package that is most susceptible to attacks on the integrity of the package. The package is often in the form of a child-resistant sealed blister card, where the back card shields a foil that seals, and retains, a medicament in a blister compartment. The back card has a front surface, a rear surface, and a card opening feature. The card opening feature has a perimeter that includes at least two cuts and at least two lands. The cuts extend from the front surface to the rear surface, and the lands connect the back card to the card opening feature across the perimeter. Each cut has a cut length and each land has a land length. The ratio of the land length to the cut length is between approximately 0.25 and approximately 0.80. This range of ratios had been found to substantially prevent removal of the card opening feature from the back card by picking at any of the cuts with a fingernail, as children often do to gain access to a medicament. Thus, the card opening feature remains intact until the application of a predetermined force to the card opening feature results in it tearing away from at least one land.
The preferred degree of child-resistance and senior-friendliness is found when each cut length is between approximately 0.020 (0.0508 cm) inches and approximately 0.125 inches (0.03175 cm). Similarly, land lengths of between approximately 0.015 inches (0.0381 cm) and approximately 0.100 inches (0.254 cm), have been found to further advance the child-resistance and senior-friendliness of the back card.
As previously mentioned, the back card may be incorporated into a medication package. In one particular embodiment, the back card is incorporated into a child-resistant sealed blister card that includes a front card, and a blister unit sandwiched between the back card and the front card. In this embodiment the back card protects the relatively susceptible base layer of the blister unit.
There is disclosed a medication pacakge (200) for distribution of a medicament, comprising a back card (100) having a front surface (110), a rear surface (120), and a card opening feature (130), wherein the card opening feature (130) has a perimeter (140) that includes at least two cuts (150), extending from the front surface (110) to the rear surface (120), and at least two lands (160), connecting the back card (100) to the card opening feature (130) across the perimeter (140), wherein each cut (150) has a cut length (150) and each land (160) has a land length (162) and the ratio of any land length (162) to any cut length (152) is between 0.25 and 0.80, thereby inhibiting the removal of the card opening feature (130) from the back card (100).
There is further disclosed a child-resistant sealed blister card (30) for housing a medicament (M), comprising: (a) a blister unit (400) having:
(i) a base layer (410) having a base layer perimeter (416), a base layer exterior surface
(412), and a base layer interior surface (414); (ii) a blister layer (420) having a blister layer perimeter (426), a blister layer exterior surface (422), a blister layer interior surface (424), and including an article receiving blister (428), having a blister perimeter (429), formed therein, wherein the article receiving blister (428) is designed for holding the medicament (M); wherein (iii) a portion of the base layer interior surface (414) is joined to the blister layer interior surface (424) thereby sealing the medicament (M) in the article receiving blister (428);
(b) a front card (300) having a front card interior surface (320) and a front card exterior surface (310), wherein the front card (300) is formed to have a blister receiver (330) configured to cooperate with the blister unit (400) such that a portion of the article receiving blister (428) extends through the front card (300) from the front card interior surface (320) to the front card exterior surface (310); and
(c) a back card (100) having a front surface (110), a rear surface (120), and a card opening feature (130), wherein the card opening feature (130) has a perimeter (140) that includes at least two cuts (150), extending from the front surface (110) to the rear surface
(120), and at least two lands (160), connecting the back card (100) to the card opening feature (130) across the perimeter (140), wherein each cut (150) has a cut length (150) and each land (160) has a land length (162) and the ratio of any land length (162) to any cut length (152) is between 0.25 and 0.80, thereby substantially preventing removal of the card opening feature (130) from the back card (100) by picking at any of the cuts (150) with a finger;
(d) wherein the blister unit blister layer (420) is adjacent to the front card interior surface (320), the blister unit base layer (410) is adjacent to the back card rear surface (120), and a portion of the front card (300) is joined to the back card (100) thereby fixing the blister unit (400) there between, and the front card (300), the blister unit (400), and the back card (100) are located so that the article receiving blister perimeter (429), the blister receiver perimeter (332), and the back card opening feature perimeter (140) substantially align such that dispensing of the medicament (M) requires application of a predetermined force to the article receiving blister (428) to force the medicament (M) to break through the base layer (410) and act upon the card opening feature (130) resulting in the card opening feature (130) tearing away from at least one land (160) thereby permitting passage of the medicament (M) through the back card (100). There is still further disclosed a sealed blister card (30) for housing a medicament
(M), comprising:
(a) a blister unit (400) having:
(i) a base layer (410) having a base layer perimeter (416), a base layer exterior surface (412), and a base layer interior surface (414); (ii) a blister layer (420) having a blister layer perimeter (426), a blister layer exterior surface (422), a blister layer interior surface (424), and including an article receiving blister (428), having a blister perimeter (429), formed therein, wherein the article receiving blister (428) is designed for holding the medicament (M); wherein (iii) a portion of the base layer interior surface (414) is joined to the blister layer interior surface (424) thereby sealing the medicament (M) in the article receiving blister (428); (b) a front card (300) having a front card interior surface (320) and a front card exterior surface (310), wherein the front card (300) is formed to have a blister receiver (330) configured to cooperate with the blister unit (400) such that a portion of the article receiving blister (428) extends through the front card (300) from the front card interior surface (320) to the front card exterior surface (310); and
(c) a back card (100) having a front surface (110), a rear surface (120), and a card opening feature (130), wherein the card opening feature (130) has a perimeter (140) that includes at least two cuts (150), extending from the front surface (110) to the rear surface (120), and at least two lands (160), connecting the back card (100) to the card opening feature (130) across the perimeter (140), wherein each cut (150) has a cut length (150) between approximately 0.020 inches and approximately 0.125 inches and each land (160) has a land length (162) between 0.015 inches and 0.100 inches, and the ratio of any land length (162) to any cut length (152) is between 0.25 and 0.80, thereby substantially preventing removal of the card opening feature (130) from the back card (100) by picking at any of the cuts (150) with a finger;
(d) wherein the blister unit blister layer (420) is adjacent to the front card interior surface (320), the blister unit base layer (410) is adjacent to the back card rear surface (120), and a portion of the front card (300) is joined to the back card (100) thereby fixing the blister unit (400) there between, and the front card (300), the blister unit (400), and the back card (100) are located so that the article receiving blister perimeter (429), the blister receiver perimeter (332), and the back card opening feature perimeter (140) substantially align such that dispensing of the medicament (M) requires application of a predetermined force to the article receiving blister (428) to force the medicament (M) to break through the base layer (410) and act upon the card opening feature (130) resulting in the card opening feature (130) tearing away from at least one land (160) thereby permitting passage of the medicament (M) through the back card (100). Various objects and advantages of the present invention will become apparent from the following detailed description when viewed in conjunction with the accompanying drawings, which set forth certain embodiments of the invention.
BRIEF DESCRIPTION OF THE DRAWINGS Without limiting the scope of the present invention as claimed below and referring now to the drawings and figures:
FIG. 1 is a perspective view of an embodiment of the child-resistant medicament storage and distribution back card and the components of a child-resistant sealed blister card, not to scale; FIG. 2 is a top plan view of the back card, not to scale;
FIG. 3 is a table illustrating the preferred ranges of land length and cut length, and the associated ratios of land length to cut length;
FIG. 4 is a perspective view of a child-resistant sealed blister card, not to scale; FIG. 5 is a cross-sectional view of the child-resistant sealed blister card of FIG. 4 taken along section line 5-5, not to scale; and
FIG. 6 is a cross-sectional view of the child-resistant sealed blister card of FIG. 5 illustrating a force applied to the article receiving blister resulting in the release of a portion of the card opening feature, not to scale.
DETAILED DESCRIPTION OF THE INVENTION
The child-resistant medicament storage and distribution back card, and sealed blister card incorporating same, of the instant invention enables a significant advance in the state of the art. The preferred embodiments of the apparatus accomplish this by new and novel arrangements of elements that are configured in unique and novel ways and which demonstrate previously unavailable but preferred and desirable capabilities. The detailed description set forth below in connection with the drawings is intended merely as a description of the presently preferred embodiments of the invention, and is not intended to represent the only form in which the present invention may be constructed or utilized. The description sets forth the designs, functions, means, and methods of implementing the invention in connection with the illustrated embodiments. It is to be understood, however, that the same or equivalent functions and features may be accomplished by different embodiments that are also intended to be encompassed within the spirit and scope of the invention.
The present invention is a child-resistant medicament storage and distribution back card (10) for senior-friendly and child-resistant distribution of a medicament. The back card (100) is incorporated into a medication package (200) that is often in the form of a child- resistant sealed blister card (30), but is not limited to this particular blister card (30). The back card (100) will first be disclosed in detail, followed by the blister card (30) disclosure.
As seen in FIGS. 1, 4, and 5, the back card (100) has a front surface (110), a rear surface (120), and a card opening feature (130). The card opening feature (130) has a perimeter (140), labeled in FIG. 1, that includes at least two cuts (150) and at least two lands (160), seen best in FIG. 2. The cuts (150) extend from the front surface (110) to the rear surface (120), as seen in FIG. 5, and the lands (160) connect the back card (100) to the card opening feature (130) across the perimeter (140), as seen in FIG. 2.
Each cut (150) has a cut length (150) and each land (160) has a land length (162). The ratio of any land length (162) to any cut length (152), meaning the land length (162) divided by the cut length (152), is between approximately 0.25 and approximately 0.80. This range of ratios had been found to substantially prevent removal of the card opening feature (130) from the back card (100) by picking at any of the cuts (150) with a fingernail; thus preventing distribution of the medicament until the application of a predetermined force to the card opening feature (130) results in the card opening feature (130) tearing away from at least one land (160).
The table of FIG. 3 illustrates the preferred range of ratios of land length (162) to cut length (152). The preferred degree of child-resistance and senior-friendliness is found when each cut length (150) is between approximately 0.020 inches (0.508 cm) and approximately 0.125 inches (0.3175 cm). Similarly, land lengths (160) of between approximately 0.015 (0.0381 cm) inches and approximately 0.100 inches (0.254 cm), have been found to further advance the child-resistance and senior-friendliness of the back card (10). In one particular embodiment, seen in FIG. 2, each cut length (150) is substantially equal. In a further embodiment each land length (160) is substantially equal, also illustrated in FIG. 2. It is important to note that in certain embodiments the cut lengths (150) may be equal or unequal, and the land lengths (160) may be equal or unequal, as long as the ratio of land length (162) to cut length (152) falls within the range previously disclosed.
Further, the card opening feature perimeter (140) is not limited to any particular shape. Most commonly the card opening feature perimeters (140) compliment the shape of the medicament. Therefore, the card opening feature perimeter (140) is substantially circular in shape when used with circular pills and substantially oval, oblong, or rectangular in shape when used with capsules of those shapes.
The back card (100) is intended to be incorporated into a medication package (200) that is often in the form of a child-resistant sealed blister card (30), seen in FIGS. 1 and 4, but is not limited to this particular blister card (30) and may be used in any packaging for the storage and distribution of a medicament. The blister card (30) of the present invention will now be disclosed in detail.
The child-resistant sealed blister card (30) of the present invention is designed for child-resistant and senior-friendly housing and distribution of a medicament (M) and incorporates the previously disclosed back card (100). In addition to the back card (100), the blister card (30) also includes a front card (300), and a blister unit (400) sandwiched between the back card (100) and the front card (300), as seen in FIGS. 1, 5, and 6.
Now, with respect to the blister unit (400), it has a base layer (410) and a blister layer (420), labeled in FIG. 5. The base layer (410) has a base layer exterior surface (412) and a base layer interior surface (414). The blister layer (420) has a blister layer exterior surface (422), a blister layer interior surface (424), and includes an article receiving blister (428), having a blister perimeter (429), formed therein. The article receiving blister (428) is designed for holding the medicament (M) regardless of form, including, but not limited to, round pills, oval pills, oblong capsules, caplets, and the like.
A portion of the base layer interior surface (414) is joined to the blister layer interior surface (424) thereby sealing the medicament (M) in the article receiving blister (428). The blister layer (410) may be joined to the base layer (420) by heat sealing, adhesive such as heat-activated adhesive that has been pre-applied to the base layer (410) or solvent adhesive, radio frequency or sonic seal, or by other suitable means. The area of the blister layer (420) that is formed into the article receiving blister (428) is not joined to the base layer (410). With continued reference to FIG. 5, the front card (300) has a front card interior surface (320) and a front card exterior surface (310). The front card (300) is formed to have a blister receiver (330), seen in FIG. 1, configured to cooperate with the blister unit (400) such that a portion of the article receiving blister (428) extends through the front card (300) from the front card interior surface (320) to the front card exterior surface (310), as seen in FIG. 5.
As illustrated in FIGS. 1 and 5, the back card (100), the front card (300), and the blister unit (400) are configured such that the blister unit blister layer (420) is adjacent to the front card interior surface (320), the blister unit base layer (410) is adjacent to the back card rear surface (120), and a portion of the front card (300) is joined to the back card (100) thereby fixing the blister unit (400) there between. The front card (300) and the back card (100) are spaced apart in FIGS. 5 and 6 for clarity, as one with skill in the art will appreciate that the card (100, 300) are joined together in part to retain the blister unit (400). The front card (300), the blister unit (400), and the back card (100) are located so that the article receiving blister perimeter (429), seen in FIG. 4, the blister receiver perimeter (332), seen in FIG. 1, and the back card opening feature perimeter (140), seen in FIGS. 1 and 2, substantially align such that dispensing of the medicament (M) requires application of a predetermined force to the article receiving blister (428) to force the medicament (M) to break through the base layer (410) and act upon the card opening feature (130) resulting in the card opening feature (130) tearing away from at least one land (160) thereby permitting passage of the medicament (M) through the back card (100), as illustrated in FIG. 6. The back card (100) and the front card (300) are preferably made of coated paperboard. In one particular embodiment the back card (100) and the front card (300) are comprised of a material and thickness that cannot be readily torn, ruptured, or otherwise compromised by action of a human hand of average strength. The material may be paper, or other fiber product, plastic, foil, or composite. The blister layer (420) is preferably made of pharmaceutical grade PVC or other thermoplastic material, such as plastic, polypropylene, polyethylene, styrene, cold-formed foil, or other suitable materials for packaging. The article receiving blister (428) may be formed by a thermoforming process in which the blister layer (420) material is stretched into a cavity with a vacuum technique to form the blister portion. In a preferred embodiment, a sheet of suitable material for the blister layer (420) is exposed to heating elements for a pre-determined time. This sheet is then trapped in a forming station where it is subjected to both vacuum and pressure. During this process, the material may also be mechanically assisted into the blister cavity via a matched metal plug to form the article receiving blister (428). In another embodiment, the article receiving blister (428) may be formed by using cold-formed foil and cold-form packaging processes. The base layer (410) may be comprised of one or more separate layers of material, such as foil and polyester or other suitable child-resistant foils. The base layer (410) is typically comprised of multiple layers, but it could be made of any material deemed child-resistant.
Numerous alterations, modifications, and variations of the preferred embodiments disclosed herein will be apparent to those skilled in the art and they are all anticipated and contemplated to be within the spirit and scope of the instant invention. For example, although specific embodiments have been described in detail, those with skill in the art will understand that the preceding embodiments and variations can be modified to incorporate various types of substitute and or additional or alternative materials, relative arrangement of elements, and dimensional configurations. Accordingly, even though only few variations of the present invention are described herein, it is to be understood that the practice of such additional modifications and variations and the equivalents thereof, are within the spirit and scope of the invention as defined in the following claims.
INDUSTRIAL APPLICABILITY
The child-resistant medicament storage and distribution back card, and associated sealed blister card, answer a long felt need for a novel package that is both child-resistant and senior-friendly. The back card introduces a card opening feature bounded by a series of cuts and lands having a predetermined relationship that improves the child-resistance over the prior art. The back card is incorporated into a medication package where it blocks, or protects, the area of the package that is most susceptible to attacks. The package is often in the form of a child-resistant sealed blister card, thus the back card shields the foil that seals, and retains, a medicament in a blister compartment.

Claims

WE CLAIM:
1. A medication package (200) for distribution of a medicament, comprising: a back card (100) having a front surface (110), a rear surface (120), and a card opening feature (130), wherein the card opening feature (130) has a perimeter (140) that includes at least two cuts (150), extending from the front surface (110) to the rear surface (120), and at least two lands (160), connecting the back card (100) to the card opening feature (130) across the perimeter (140), wherein each cut (150) has a cut length (150) and each land (160) has a land length (162) and the ratio of any land length (162) to any cut length (152) is between 0.25 and 0.80, thereby inhibiting the removal of the card opening feature (130) from the back card (100).
2. The medication package (200) of claim 1, wherein the each cut length (150) is between approximately 0.020 inches (0.0508 cm) and 0.125 inches (0.3175 cm).
3. The medication package (200) of claim 1, wherein the each land length (160) is between 0.015 (0.0381 cm) inches and 0.100 inches (0.254 cm).
4. The medication package (200) of claim 1, wherein the each cut length (150) is between 0.020 inches (0.0508 cm) and approximately 0.125 inches (0.3175 cm) and each land length (160) is between 0.015 inches (0.0381 cm) and 0.100 inches (0.254 cm).
5. The medication package (200) of claim 2, wherein the each cut length (150) is substantially equal.
6. The medication package (200) of claim 3, wherein the each land length (160) is substantially equal.
7. The medication package (200) of claim 4, wherein the each cut length (150) is substantially equal and each land length (160) is substantially equal.
8. The medication package (200) of claim 1, wherein the perimeter (140) is substantially circular in shape.
9. The medication package (200) of claim 1, wherein the perimeter (140) is substantially oval in shape.
10. The medication package (200) of claim 1, wherein the perimeter (140) is substantially rectangular in shape.
11. A child-resistant sealed blister card (30) for housing a medicament (M), comprising: (a) a blister unit (400) having:
(i) a base layer (410) having a base layer perimeter (416), a base layer exterior surface (412), and a base layer interior surface (414); (ii) a blister layer (420) having a blister layer perimeter (426), a blister layer exterior surface (422), a blister layer interior surface (424), and including an article receiving blister (428), having a blister perimeter (429), formed therein, wherein the article receiving blister (428) is designed for holding the medicament (M); wherein
(iii) a portion of the base layer interior surface (414) is joined to the blister layer interior surface (424) thereby sealing the medicament (M) in the article receiving blister (428);
(b) a front card (300) having a front card interior surface (320) and a front card exterior surface (310), wherein the front card (300) is formed to have a blister receiver (330) configured to cooperate with the blister unit (400) such that a portion of the article receiving blister (428) extends through the front card (300) from the front card interior surface (320) to the front card exterior surface (310); and
(c) a back card (100) having a front surface (110), a rear surface (120), and a card opening feature (130), wherein the card opening feature (130) has a perimeter (140) that includes at least two cuts (150), extending from the front surface (110) to the rear surface (120), and at least two lands (160), connecting the back card (100) to the card opening feature (130) across the perimeter (140), wherein each cut (150) has a cut length (150) and each land (160) has a land length (162) and the ratio of any land length (162) to any cut length (152) is between 0.25 and 0,80, thereby substantially preventing removal of the card opening feature (130) from the back card (100) by picking at any of the cuts (150) with a finger; (d) wherein the blister unit blister layer (420) is adjacent to the front card interior surface (320), the blister unit base layer (410) is adjacent to the back card rear surface (120), and a portion of the front card (300) is joined to the back card (100) thereby fixing the blister unit (400) there between, and the front card (300), the blister unit (400), and the back card (100) are located so that the article receiving blister perimeter (429), the blister receiver perimeter (332), and the back card opening feature perimeter (140) substantially align such that dispensing of the medicament (M) requires application of a predetermined force to the article receiving blister (428) to force the medicament (M) to break through the base layer (410) and act upon the card opening feature (130) resulting in the card opening feature (130) tearing away from at least one land (160) thereby permitting passage of the medicament (M) through the back card (100).
12. The child-resistant sealed blister card (30) of claim 11, wherein the each cut length (150) is between 0.020 inches (0.0508 cm) and 0.125 inches (0.3175 cm).
13. The child-resistant sealed blister card (30) of claim 11, wherein the each land length (160) is between 0.015 inches (0.0381 cm) and 0.100 inches (0.254 cm).
14. The child-resistant sealed blister card (30) of claim 11, wherein the each cut length (150) is between 0.020 inches (0.0508 cm) and approximately 0.125 inches (0.3175 cm) and each land length (160) is between 0.015 inches (0.0381 cm) and 0.100 inches (0.254 cm).
15. The child-resistant sealed blister card (30) of claim 12, wherein the each cut length (150) is substantially equal.
16. The child-resistant sealed blister card (30) of claim 13, wherein the each land length (160) is substantially equal.
17. The child-resistant sealed blister card (30) of claim 14, wherein the each cut length (150) is substantially equal and each land length (160) is substantially equal.
18. The child-resistant sealed blister card (30) of claim 11, wherein the perimeter (140) is substantially circular in shape.
19. The child-resistant sealed blister card (30) of claim 11, wherein the perimeter (140) is substantially oval in shape.
20. The child-resistant sealed blister card (30) of claim 11, wherein the perimeter (140) is substantially rectangular in shape.
21. A blister card (30) for housing a medicament (M), comprising: (a) a blister unit (400) having:
(i) a base layer (410) having a base layer perimeter (416), a base layer exterior surface (412), and a base layer interior surface (414); (ii) a blister layer (420) having a blister layer perimeter (426), a blister layer exterior surface (422), a blister layer interior surface (424), and including an article receiving blister (428), having a blister perimeter (429), formed therein, wherein the article receiving blister (428) is designed for holding the medicament (M); wherein
(iii) a portion of the base layer interior surface (414) is joined to the blister layer interior surface (424) thereby sealing the medicament (M) in the article receiving blister (428);
(b) a front card (300) having a front card interior surface (320) and a front card exterior surface (310), wherein the front card (300) is formed to have a blister receiver (330) configured to cooperate with the blister unit (400) such that a portion of the article receiving blister (428) extends through the front card (300) from the front card interior surface (320) to the front card exterior surface (310); and
(c) a back card (100) having a front surface (110), a rear surface (120), and a card opening feature (130), wherein the card opening feature (130) has a perimeter (140) that includes at least two cuts (150), extending from the front surface (110) to the rear surface (120), and at least two lands (160), connecting the back card (100) to the card opening feature (130) across the perimeter (140), wherein each cut (150) has a cut length (150) between approximately 0.020 inches and approximately 0.125 inches and each land (160) has a land length (162) between 0.015 inches and 0.100 inches, and the ratio of any land length (162) to any cut length (152) is between 0.25 and 0.80, thereby substantially preventing removal of the card opening feature (130) from the back card (100) by picking at any of the cuts (150) with a finger;
(d) wherein the blister unit blister layer (420) is adjacent to the front card interior surface (320), the blister unit base layer (410) is adjacent to the back card rear surface (120), and a portion of the front card (300) is joined to the back card (100) thereby fixing the blister unit (400) there between, and the front card (300), the blister unit (400), and the back card (100) are located so that the article receiving blister perimeter (429), the blister receiver perimeter (332), and the back card opening feature perimeter (140) substantially align such that dispensing of the medicament (M) requires application of a predetermined force to the article receiving blister (428) to force the medicament (M) to break through the base layer (410) and act upon the card opening feature (130) resulting in the card opening feature (130) tearing away from at least one land (160) thereby permitting passage of the medicament (M) through the back card (100).
PCT/US2006/039746 2005-10-12 2006-10-11 Child resistant medicament storage and distribution back card and sealed blister card WO2007047313A2 (en)

Priority Applications (4)

Application Number Priority Date Filing Date Title
JP2008535652A JP2009511375A (en) 2005-10-12 2006-10-11 Back card and sealed blister card for safe drug storage and dispensing for children
AU2006304122A AU2006304122A1 (en) 2005-10-12 2006-10-11 Child resistant medicament storage and distribution back card and sealed blister card
BRPI0617251-2A BRPI0617251A2 (en) 2005-10-12 2006-10-11 child-resistant medicine storage and back pack and sealed blister pack
EP06816729A EP1934115A4 (en) 2005-10-12 2006-10-11 Child resistant medicament storage and distribution back card and sealed blister card

Applications Claiming Priority (2)

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US11/248,937 2005-10-12
US11/248,937 US20070080090A1 (en) 2005-10-12 2005-10-12 Child-resistant medicament storage and distribution back card and sealed blister card

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WO2007047313A2 true WO2007047313A2 (en) 2007-04-26
WO2007047313A3 WO2007047313A3 (en) 2007-10-25

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EP (1) EP1934115A4 (en)
JP (1) JP2009511375A (en)
CN (1) CN101326110A (en)
AU (1) AU2006304122A1 (en)
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EP1934115A2 (en) 2008-06-25
BRPI0617251A2 (en) 2011-07-19
JP2009511375A (en) 2009-03-19
AU2006304122A1 (en) 2007-04-26
WO2007047313A3 (en) 2007-10-25
US20070080090A1 (en) 2007-04-12
EP1934115A4 (en) 2009-11-25
CN101326110A (en) 2008-12-17

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