EP1343701A2 - Moyen d'emballage a plaquette alveolee incorporee - Google Patents

Moyen d'emballage a plaquette alveolee incorporee

Info

Publication number
EP1343701A2
EP1343701A2 EP01271316A EP01271316A EP1343701A2 EP 1343701 A2 EP1343701 A2 EP 1343701A2 EP 01271316 A EP01271316 A EP 01271316A EP 01271316 A EP01271316 A EP 01271316A EP 1343701 A2 EP1343701 A2 EP 1343701A2
Authority
EP
European Patent Office
Prior art keywords
packaging means
panel
means according
packaging
folding
Prior art date
Legal status (The legal status 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 status listed.)
Granted
Application number
EP01271316A
Other languages
German (de)
English (en)
Other versions
EP1343701B1 (fr
Inventor
Philippe Ragot
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Glaxo Group Ltd
Original Assignee
Glaxo Group Ltd
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 Glaxo Group Ltd filed Critical Glaxo Group Ltd
Publication of EP1343701A2 publication Critical patent/EP1343701A2/fr
Application granted granted Critical
Publication of EP1343701B1 publication Critical patent/EP1343701B1/fr
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS 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
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/325—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil
    • B65D75/327—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents one sheet being recessed, and the other being a flat not- rigid sheet, e.g. puncturable or peelable foil and forming several compartments
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS 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
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/52—Details
    • B65D75/54—Cards, coupons, or other inserts or accessories
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS 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
    • B65D2583/00—Containers or packages with special means for dispensing contents
    • B65D2583/04—For dispensing annular, disc-shaped or spherical or like small articles or tablets
    • B65D2583/0404—Indications, e.g. directions for use
    • B65D2583/0413—Tactile indication, e.g. Braille
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65D—CONTAINERS 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
    • B65D75/00—Packages comprising articles or materials partially or wholly enclosed in strips, sheets, blanks, tubes, or webs of flexible sheet material, e.g. in folded wrappers
    • B65D75/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by associating or interconnecting two or more sheets or blanks
    • B65D75/30—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding
    • B65D75/32—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents
    • B65D75/34—Articles or materials enclosed between two opposed sheets or blanks having their margins united, e.g. by pressure-sensitive adhesive, crimping, heat-sealing, or welding one or both sheets or blanks being recessed to accommodate contents and having several recesses to accommodate a series of articles or quantities of material

Definitions

  • the invention provides a packaging means for use in packaging solid dose pharmaceutical formulations, methods and processes for the preparation of said packaging means and uses thereof.
  • packaging means are widely used in the form of boxes in various sizes. This is also true of pharmaceuticals, which may be manufactured in one country and sold in a different country.
  • boxes containing solid dose formulations of medicament contain several internal units in which the medicament is sealed, for example, in blister packs.
  • a separate instruction/information leaflet will also be included to provide the end-user with instructions/information on the correct use of the medicament.
  • the boxes are often bulky and the blister packs may be removed by the end-user to facilitate transit of medicament, for example, in a handbag or wallet.
  • the medicament is no longer located in its original packaging, which would provide greater protection than the blister pack alone, and also is no longer in the proximity of the instruction leaflet. Alternatively the instructions may simply be lost.
  • GMP GMP
  • this practice extends to the packaging of the end product. This is because a pharmaceutical product may be prepared to the required standards but if an error occurred where the product went into packaging for a different pharmaceutical, a patient may take a dose of their prescribed medication, for example, where the patient has an attack of asthma or angina, and if the medicament is wrong as a result of incorrect packaging, the dose will not relieve the symptoms. This could have serious repercussions and even be life threatening. So it is extremely important that medicaments are packaged correctly in every aspect.
  • the present invention ameliorates or eliminates the above mentioned disadvantages whilst simultaneously providing good protection for a blister pack contained within the packaging means.
  • EP 0940 353 describes a form of self-contained reclosable packaging especially suitable for containing different medicament types.
  • WO98/00351 describes a foldable blister pack wherein the blister parts are offset relative to each other and are contained in a supporting unit.
  • US4974729 discloses a calender type dispenser
  • WO01/66438 discloses a packaging system for storing and dispensing individual doses of medication
  • GB2228922 discloses a packaging with certain doses of medicaments grouped together. The aim of such packaging is to aid patient compliance with particular dosing regimes.
  • GB2266880 describes a blister package comprising two card portions which are sealable on the other by contact adhesive.
  • EP0430013 provides a container with an external flap capable of detachable bonding to walls of the container.
  • US3756384 describes a resealable paperboard carton wherein the batch number printed on the blister pack is visible when said blister pack is contained within the carton.
  • WO94/21530 describes blister packaging provided from thermoplastic material.
  • the present invention provides a foldable, unitary, packaging means for use in conjunction with one or more blister pack(s) containing medicament comprising:
  • the ratio of the first surface area to the second surface area is greater than 1 :2.
  • the ratio will be 1 :5 or greater, in particular 1 :7 or greater.
  • the present invention provides a packaging means wherein said means is unitary and substantially complete.
  • the packaging means does not require any additional component other than the blister pack to be added to it to form the final product.
  • the packaging means may be prepared from paper card, or similar flexible material, the starting material may be "one sheet" which is scored strategically so that when folded the packaging means is formed.
  • the individually component surfaces may have previously been fixed relative to each other to provide a unitary packaging means.
  • packaging means is unitary is important because only one product code is necessary to identify the said packaging means. This means the potential for errors is much smaller as it is not necessary to ensure that the correct combination of components, including the instruction leaflet, is used. Thus there is a safety aspect and possibly a cost benefit associated with the unitary nature of the packaging means.
  • the said folding mechanism allows the packaging means to be essentially unitary whilst still performing all the necessary functions.
  • the first and second surface areas of the packaging means are defined in panel(s) which are hingedly located to facilitate a folding type mechanism. This allows the packaging means to fold into a compact unit that is convenient for transit and also has a large total surface area that is made available when the packaging means is open.
  • This large total surface area can accommodate the instructions/information relating to the medicament.
  • a panel comprises two substantially parallel surface areas which are defined by, for example, edges and/or fold lines.
  • Fully assembled refers to the packaging means after the blister pack has been inserted i.e. as the packaging would be used by a patient to obtain a dose of medicament.
  • FIG. 1 illustrates: 4 panels wherein (a) is the first surface and (b), (c) and (d) represent the second surface; an edge (1) and a fold line (2).
  • One folding mechanism as shown in figs 1 , 1a, 1b and 1 c comprises: (i) keeping panel (b) stationary and moving panel (a), which contains the blister pack, such that it comes to rest above and substantially parallel to panel (b); (ii) moving panel (c) such that it comes to rest above and substantially parallel to panel (a) and (b) wherein panel (a), is effectively sandwiched between panel (b) and panel (c) as shown in fig 1 b; and (iii) moving panel (d) until it comes to rest such that the packaging means is closed as shown in fig 1c.
  • one or more panels will move through more than one plane during the folding mechanism, for example in fig.1 bb panel (c), which has previously moved through one plane to come to a resting position as shown in fig 1b, moves through a second perpendicular plane until it comes to rest as shown in fig 1c.
  • the invention includes a packaging means as described above wherein at least one panel travels through at least two planes which are perpendicular to each other during the folding to close the said means.
  • FIG. 2a An alternative folding mechanism is shown in figs 2, 2a, 2b and 2c comprising: steps (i) to (ii) above and the further step of folding panel (e) until it comes to rest above and substantially parallel to panel (d). The final step is then folding the combined panels (d) and (e) as in step (iii) above to close the said means as shown in fig 2c.
  • Fig 4 shows a packaging means comprising 8 panels and a method of folding comprising:
  • step (d) folding panel Y/Z, as formed in step (a) above, until it comes to rest substantially parallel to panel X such that panel Z is sandwiched between panel X and panel Y as shown in fig. 4d;
  • step (e) folding panel V/W, as formed in step (b) above, until it comes to rest substantially parallel to panels X/Z/Y, as formed in step (d) above, as shown in fig 4e;
  • step (g) folding panelS/U/T, a formed in step (f) above, such that it comes to rest such that the packaging means is substantially closed as shown in fig 4g;
  • a flap R can be folded such that the packaging means is retained in the closed position as shown in fig 4h.
  • step (a) folding panel Z containing the blister pack until it comes to rest substantially parallel to panel Y as shown in fig.4a; and (b)folding panel Y/Z, as formed in step (a) above, until it comes to rest substantially parallel to panel X such that panel Z is sandwiched between panel X and panel Y as shown in fig. 4bb; and
  • step (b) folding panel V/W, as formed in step (b) above, until it comes to rest substantially parallel to panels X Z/Y, as formed in step (b) above, as shown in fig 4dd; and
  • step (g) folding panel S/U/T, a formed in step (f) above, wherein it comes to rest such that the packaging means is substantially closed as shown in fig 4g;
  • a flap R can be folded such that the packaging means is retained in the closed position as shown in fig 4h.
  • the number of possible methods of folding the packaging means increases with the number panels which said means is composed of. Thus the methods described above are simply examples.
  • folding mechanisms are within the scope of this invention, for example, where the number of panels is varied and/or wherein the medicament is located in a panel other than a or Z and/or where the order of folding the panels is different.
  • the folding mechanism of the packaging means protects the blister pack efficiently due to at least one layer of material covering each side of the said blister pack and usually a multiplicity of layers covering the foil side of the blister pack, which is the side most susceptible to damage.
  • the said folding mechanism used also has the advantage that a deliberate act of unfolding is required to open the packaging means.
  • the content is less likely to spill out due to the natural bias in the system to remain closed, unlike a box wherein the fastening flap may be forced open when dropped.
  • another aspect of the invention is a packaging means which once closed has an inherent bias to remain closed.
  • the packaging means can be used with existing blister packs, which means the expense and delay of redesigning the blister packs, to be inserted, may be avoided.
  • the packaging means is extremely flexible in that it can easily be varied and designed to facilitate use with various shaped blister packs. This means development times for the packaging means are rapid.
  • the design of the said packaging means allows the blister pack(s) to be inserted without the need for processing which may induce changes in the blister pack(s), for example by printing on the blister pack.
  • the surface area presenting the medicament/blister pack is the surface(s) wherein the blister pack is visible and/or wherein the medicament will exit the packaging prior to ingestion.
  • perforations in the material may preferably be used to facilitate access to the pharmaceutical formulation which is located behind it.
  • the blister pack will be inserted into the packaging means as part of the manufacturing process.
  • the product will be provided complete for patients and end users.
  • the component materials from which the packaging means is made will preferably be recyclable it is not envisaged that, for example, a new blister pack will be inserted into the said packaging means after the patient has used all the medicament held in the original blister pack.
  • the packaging means is disposable.
  • the packaging means will contain one type of medicament or one type of therapy.
  • One therapy type may require one or more medicaments to be present in the same packaging.
  • An aspect of the invention is a packaging means with a surface area presenting substantially complete instructions.
  • the packaging means must provide a surface area capable of accommodating all the necessary patient instructions and/or information, optionally for a variety of classes of patients, which obviates the requirement for a supplementary instruction/information leaflet to be supplied with the said packaging means.
  • the packaging means usually has a total surface area (the sum of the first and second surface areas) which, when fully open (ie unfolded), is significantly larger than the external surface visible when the packaging means is closed (i.e. folded up). This is achieved by the folding mechanism employed therein.
  • the total surface area will be more than 2 times larger than the external visible surface area when the said packaging means is closed. More preferably the total surface area will be 4 to 10 times larger, in particular 5 to 8 times larger.
  • a further aspect of this invention is a packaging means made of material which is conducive to the presentation of information, for example, by printing directly or indirectly onto the surface of the packaging means (an example of the latter would be sticking pre-printed labels onto the surface of the material) or inscribing braille onto the surface of the packaging means.
  • the presentation of information on the surface of the packaging means will be by direct and/or indirect printed means and/or braille. More preferably by direct printed means and/or braille, especially printed means or braille.
  • a further feature of the invention is that it allows the packaging to be printed on the production line which may provide further cost and safety advantages.
  • the said fastening means can be incorporated into the design of the said packaging means.
  • the said fastening means is reusable, for example, a resealable adhesive strip or a slot and corresponding tab mechanism.
  • the packaging means Once the packaging means is closed it has the advantage of being slimline due to the efficient use of space and all the elements being in close proximity possibly leading to a certain amount of resistance to moderate crushing.
  • This in conjunction with the lightweight of the complete unit makes the packaging means very suitable for transit by the end-user, for example, in a purse or wallet, and also to the end-user as the slimline design and preferably regular shape, when closed, allows efficient packing of the said packaging means for bulk transportation. The latter may result in cost savings if more units can be transported with less weight per unit in less space, which may be advantageous.
  • These features mean the end-user will also be encouraged to keep the medicament in its original packaging.
  • a further aspect of this invention is the use of said means in the packaging of pharmaceutical formulations, preferably solid dose pharmaceutical formulations.
  • the said packaging means may be made from a variety of materials, for example, paper card or plastic, having the necessary features of flexibility and resilience.
  • paper card is the preferred material for use in preparing the packaging means as it is lightweight, extremely suitable for the presentation of information and may also be environmentally friendly if recycled materials are used.
  • a suitable process for preparing a packaging means comprises: (i) cutting the raw material into the required shape; (ii) scoring lines to define panels; and
  • a process for preparing a packaging means comprises: (i) cutting the raw material into the required shape; (ii) printing the instructions/information onto the surface of the raw material
  • the order the steps of the process are performed in may vary and/or two or more steps may be performed concomitantly depending the specific manufacturing used.
  • the outline shape will be designed to satisfy the specific needs of the individual product to be packaged. Examples of outlines shapes are given in figs 1 , 2 and 3.
  • Scoring is a procedure wherein a cut which only extends part way through the material in question is made. This facilitates folding which occurs along the lines defined by the scoring.
  • the packaging means may be treated, for example, with a coating after processing to provide wear resistance.
  • Additional safety and anti-counterfeiting measures may optionally be in incorporated into the packaging means. This may, for example, be by overwrapping the packaging means when the processing is complete. Overwrapping may be foil or plastic. Preferably the overwrap will be transparent, more preferably a sealed plastic film. Such an overwrap may provide extra protection to the packaging means during transit and an anti-counterfeiting/anti-tamper deterrent, i.e. if the overwrap is damaged it may be an indication the product has been tampered with.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Composite Materials (AREA)
  • Packages (AREA)
  • Supplying Of Containers To The Packaging Station (AREA)
  • Containers And Plastic Fillers For Packaging (AREA)
  • Basic Packing Technique (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)

Abstract

L'invention concerne un moyen d'emballage unitaire repliable à utiliser conjointement avec une ou plusieurs plaquette(s) alvéolée(s) renfermant un médicament. Ce moyen d'emballage comporte : (i) une première zone de surface présentant la ou les plaquette(s) alvéolée(s) et une (ii) seconde zone de surface présentant des informations/instructions textuelles relatives au médicament. Selon ladite invention, le rapport entre la première surface et la seconde surface est supérieur à 1:2. Cette invention concerne également des procédés de préparation et d'utilisation dudit moyen d'emballage.
EP01271316A 2000-12-21 2001-12-21 Moyen d'emballage a plaquette alveolee incorporee Expired - Lifetime EP1343701B1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GBGB0031294.2A GB0031294D0 (en) 2000-12-21 2000-12-21 Packaging means
GB0031294 2000-12-21
PCT/GB2001/005746 WO2002049936A2 (fr) 2000-12-21 2001-12-21 Moyen d'emballage a plaquette alveolee incorporee

Publications (2)

Publication Number Publication Date
EP1343701A2 true EP1343701A2 (fr) 2003-09-17
EP1343701B1 EP1343701B1 (fr) 2006-09-13

Family

ID=9905624

Family Applications (1)

Application Number Title Priority Date Filing Date
EP01271316A Expired - Lifetime EP1343701B1 (fr) 2000-12-21 2001-12-21 Moyen d'emballage a plaquette alveolee incorporee

Country Status (8)

Country Link
US (1) US20040108240A1 (fr)
EP (1) EP1343701B1 (fr)
JP (1) JP2004524071A (fr)
AT (1) ATE339371T1 (fr)
AU (1) AU2002216259A1 (fr)
DE (1) DE60123114T2 (fr)
GB (1) GB0031294D0 (fr)
WO (1) WO2002049936A2 (fr)

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Also Published As

Publication number Publication date
US20040108240A1 (en) 2004-06-10
DE60123114T2 (de) 2007-02-08
JP2004524071A (ja) 2004-08-12
EP1343701B1 (fr) 2006-09-13
DE60123114D1 (de) 2006-10-26
WO2002049936A3 (fr) 2002-10-17
ATE339371T1 (de) 2006-10-15
GB0031294D0 (en) 2001-01-31
AU2002216259A1 (en) 2002-07-01
WO2002049936A2 (fr) 2002-06-27

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