EP0771737B1 - Blister pill package with safety backing - Google Patents

Blister pill package with safety backing Download PDF

Info

Publication number
EP0771737B1
EP0771737B1 EP96307834A EP96307834A EP0771737B1 EP 0771737 B1 EP0771737 B1 EP 0771737B1 EP 96307834 A EP96307834 A EP 96307834A EP 96307834 A EP96307834 A EP 96307834A EP 0771737 B1 EP0771737 B1 EP 0771737B1
Authority
EP
European Patent Office
Prior art keywords
sheet
blister
package
backing
pill
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.)
Expired - Lifetime
Application number
EP96307834A
Other languages
German (de)
English (en)
French (fr)
Other versions
EP0771737A1 (en
Inventor
Kenneth E. Fuller
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.)
Johnson and Johnson Consumer Inc
Original Assignee
McNeil PPC 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 McNeil PPC Inc filed Critical McNeil PPC Inc
Publication of EP0771737A1 publication Critical patent/EP0771737A1/en
Application granted granted Critical
Publication of EP0771737B1 publication Critical patent/EP0771737B1/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J1/00—Containers specially adapted for medical or pharmaceutical purposes
    • A61J1/03—Containers specially adapted for medical or pharmaceutical purposes for pills or tablets
    • A61J1/035—Blister-type containers
    • 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
    • B65D75/58—Opening or contents-removing devices added or incorporated during package manufacture
    • B65D75/5855—Peelable seals
    • 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
    • B65D2575/00—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
    • B65D2575/28—Articles or materials wholly enclosed in composite wrappers, i.e. wrappers formed by association or interconnecting two or more sheets or blanks
    • B65D2575/30—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
    • B65D2575/32—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
    • B65D2575/3209—Details
    • B65D2575/3218—Details with special means for gaining access to the contents
    • B65D2575/3245—Details with special means for gaining access to the contents by peeling off the non-rigid sheet
    • 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
    • B65D2585/00—Containers, packaging elements or packages specially adapted for particular articles or materials
    • B65D2585/56—Containers, packaging elements or packages specially adapted for particular articles or materials for medicinal tablets or pills

Definitions

  • the present invention relates to a safety blister-type package for enclosing medication or pills.
  • Press-through packs or "blister" packs are commonly used today to package units of medication or pills for oral ingestion.
  • the press-through package is made up of a first sheet, typically a clear, performed polyvinyl chloride or polystyrene with flexible bubbles which form separate compartments for one or more pills; and a second rupturable sheet material, like an aluminum foil or paper sheet, which has been attached to the first sheet.
  • the metal foil is attached by heat-sealing, solvent welding, gluing, or otherwise adhering the foil sheet to the blister sheet.
  • the tablet is removed from the blister compartments by pressing on the flexible blister which in turn forces the tablet against the foil, rupturing the foil, and ejecting the tablet.
  • a press-through package it is sometimes desirable in making such a press-through package to include between the first and second sheets a rigid tray in which there are holes while coincide with the blisters in said first sheet.
  • the rigid tray is used to protect the pills from contamination and mechanical damage and may contain printed instructions as to the type of pill or the time a particular dosage is to be taken and with an indication of the dosage that has already been taken.
  • FR-A-2,227,190 discloses a "child-proof' pill package having a bend and peel opening mechanism with a cut line across the comer of blisters in the package all the way through the blister layers.
  • a primary object of the present invention is to provide a "child-resistant" pill package which can be easily opened by one who has been given instructions on how to do so, but cannot be opened by the uninstructed child.
  • Another object of the present invention is to provide a pill package which, when opened, makes only one dosage of pills accessible to the user, which dosage, of course, is less than a lethal dosage.
  • Another object of the present invention is to provide a pill package in which any desired number of pills can be made accessible upon opening.
  • Another object of the present invention is to provide a pill package in which one pill or one dosage of pills can be removed from the package while the remaining pills can be maintained in an air-tight enclosure.
  • Another object of the present invention is to provide a pill package in which the use of cumbersome bottles is not required.
  • Another object of the present invention is to provide a pill package in which each individually pill can be separately packaged so that the desired dosage can be carried by the user without the necessity of carrying excess pills.
  • Another object of the present invention is to provide a pill package which requires additional package opening to remove each additional pill.
  • Another object of the present invention is to provide a safety pill package which children, an average, cannot open without the aid of tools.
  • Yet another object of the present invention is to provide a pill package in which opening of the package makes accessible fewer than a dangerous number of units of medication.
  • the number of units exposed upon each opening of the package can be varied depending upon the toxicity of the packaged medication.
  • the strong flexible backing sheet is secured to the back of the blister sheet in such a manner that when secured, the backing sheet is not pushed away from the blister sheet when pressure is put on the blister-side of the pill package in an attempt to push the pill through the package.
  • the strong backing sheet For the user to be able to remove a pill form the package, the strong backing sheet must first be peeled away. So long as the required adherence is obtained, the strong backing sheet must first be peeled away. So long as the required adherence is obtained, the strong backing sheet can be secured to the blister sheet by heat sealing, solvent welding, gluing or otherwise adhering the two sheets together. A preferred method is by heat-sealing.
  • heat-sealed coating formulations which can be used to provide heat-sealability between the layers of the package laminate of the present invention. These heat-seal formulations are commonly used in making foil/paper and resin sheet/resin sheet laminates for soap wraps, carton overwraps, cereal liners, cookie wraps, and other uses.
  • the heat-seal formulations are typically a water dispersion of a vinyl resin or a vinyl resin containing wax for providing lower heat-sealing temperatures.
  • the vinyl resin can be ion-linked and acid-modified ethylene interpolymers known as ionomer resins. Was and other modifiers further extend the range of performance properties.
  • the preferred heat-seal formulations are water dispersions of ethylene interpolymers - for example ethylene/vinyl acetate interpolymers.
  • the vinyl resin formulations combine broad adhesion properties with moderate hot tack. Modifiers such as pigments, waxes or other resins can be used.
  • the heat-seal coatings in an amount of about 7 grams/meter 2 .
  • the coatings can be applied by common methods, for example, curtain coating or roller coatings as known in the art.
  • the blister sheet is made in a known manner and is made from common blister sheet material such as polyvinyl chloride, and copolymers and terpolymers of vinyl chloride, and copolymers and terpolymers of vinyl chloride, for example the terpolymer of polyvinyl chloride/polyethylene/polypropylene.
  • the backing sheet should have a layer or sheet of a strong flexible polymeric material of sufficient strength that a pill cannot be hand-forced through the polymeric material.
  • a sheet of polyester material has been found to have sufficient strength to prevent a pill from being forced therethrough.
  • a preferred polyester material is polyethylene terephthalate.
  • a foil sheet can also be used as part of the backing sheet if a barrier resistance coating is needed to prevent moisture from penetrating into the blister.
  • a metal foil such as aluminum, having a thickness as small as 0,02 mm (0.0008 inch) is sufficient.
  • a sheet of paper for the purpose of printing may also form part of the backing sheet.
  • Bleached kraft paper having a basis weight of roughly 13,6 kp (30 pounds) is preferred. Dates, numbers, or a description of the package contents can be printed on the paper for consumer information.
  • the various layers comprising the backing sheet can be laminated to form a single laminated sheet prior to applying the backing sheet to the blister sheet, or the backing layers can be secured together at the same time they are adhered to the blister sheet.
  • the preferred method of laminating is by using heat-seal coatings, as previously described. It is usually desirable to provide a paper sheet as the sheet farthest from the blister sheet so that printing is easily read from the bottom or non-blister side of the package. However, if it is not necessary to prevent moisture penetration into the blister, the printed paper can be positioned next to the transparent blister sheet and read through the blister sheet from the top of the package.
  • the strong polymeric sheet, foil sheet, and paper can be applied to the blister sheet in any order except that the paper sheet cannot be positioned next to the blister sheet if it is necessary to prevent moisture from entering the blister.
  • the strong polymeric sheet can be positioned next to the blister sheet or intermediate between the foil and paper sheet, or as the sheet farthest from the blister. If the paper sheet is between the foil and strong polymeric sheet, the polymeric sheet would have to be transparent so that printing on the paper can be read by the consumer.
  • the layers of the backing sheet can be secured together by heat-sealing, solvent welding, gluing, applying sheets of adhesive materials between the layers, or otherwise adhering the layers together.
  • a sheet of extruded polyethylene can be included between the sheet of strong flexible material and the foil sheet and likewise between the foil and paper sheet. The extruded polyethylene will adhere the three sheets together upon the application of pressure without the necessity of heat-sealing. It is preferred to use an extruded polyethylene sheet or film. Heat-seal coatings can be used in addition to intermediate adhesive layers.
  • the backing sheet After securing the blister sheet to the backing sheet, the backing sheet cannot be forced to disengage the blister sheet by applying pressure on the pill from the blister-side of the packet.
  • the backing sheet can readily be peeled from the back of the package so that the blister contents can be removed.
  • the seal between the blister sheet and backing sheet must be strong enough so that when pressure is applied to the blister, the flexible backing sheet remains in contact with the blister sheet.
  • the backing must be strong enough so that with the backing sheet engaged, a pill cannot be forced through the backing sheet by applying pressure to the pill from the blister-side of said package.
  • a strong polyester which has been found particularly effective as at least one component of the backing sheet is polyethylene terephthalate.
  • the thickness of the polyester is preferably about 48 gauge. This gauge also helps prevent biting of the package. However, any plastic with strength sufficient to prevent a pill from being hand-forced therethrough can be used for this purpose.
  • a "non-through" score cut is made in the exposed surface of the blister forming sheet.
  • the non-through score cut is made from one edge of an individual blister unit to an opposite or adjacent edge.
  • the blister forming sheet will fracture.
  • the depth of the non-through score cut into the blister forming sheet is critical for producing an effective package.
  • a non-through score cut of minimal depth will produce a more effective child resistant package than that with a deeper cut and a non-through score cut of maximum depth will produce a more effective senior adult use package than that with a lesser cut.
  • An effective score cut depth is required to produce a package that is both child resistant and senior effective for a given product toxicity level.
  • a safety blister package is indicated as a whole by the reference character 10 .
  • the package 10 may contain multiple individual blister units 1 3 having only one single or double cavity 11 of any desired shape which conform to the shape of the particular medicament or pill contained within said blister.
  • the individual blister units 13 can be separated from each other by tearing the package at the perforated cut lines 12 .
  • a non-through score line 14 is cut into the forming sheet 15 providing an opening feature for each individual blister unit 13 .
  • the corner of each individual blister unit 13 is angulated or flexed along the non-through score cut line 14 , the forming sheet 15 is broken along that score cut line 14 .
  • Backing sheet 25 as shown in Figure 4 contain a heat seal coating 16 , a foil barrier sheet 17 , a sheet of a strong flexible polymeric material for example a polyester such as polyethylene terephthalate 18 , and a paper sheet 19 which can have printing thereon to convey information to the consumer such as the package contents and package opening instructions.
  • Figure 2 and Figure 3 shows tab 20 which is formed by angulating or flexing the corner of the individual blister unit along the non-through score cut 14 as explained above.
  • the backing sheet 25 need not contain all three layers of foil, strong flexible polymeric material and paper.
  • the strong polymeric material is necessary for the purpose of providing a safety backing to the blister sheet 15 so that the pills cannot be forced out of the package without first peeling the backing sheet 25 from the blister sheet 15.
  • the heat seal coating 16 is typically extruded onto the foil layer 17.
  • Figure 4 shows one embodiment of adhering the foil, strong flexible polymeric material, and paper layer (i.e. backing material 25) to the blister forming material 15.
  • This heat seal coating layer 16 is heated and with pressure applied, bonds to the blister forming material 15.
  • the layers 17, 18, and 19 of the backing sheet 25 can be secured together by heat sealing, solvent welding, gluing, applying sheets of adhesive materials between the layers, or otherwise adhering the layers together.
  • Figure 4 shows one embodiment of adhering the foil, strong flexible polymeric material, and paper layers together by means of adhesive layers 32 and 34.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Composite Materials (AREA)
  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
EP96307834A 1995-10-31 1996-10-30 Blister pill package with safety backing Expired - Lifetime EP0771737B1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US55090195A 1995-10-31 1995-10-31
US550901 1995-10-31

Publications (2)

Publication Number Publication Date
EP0771737A1 EP0771737A1 (en) 1997-05-07
EP0771737B1 true EP0771737B1 (en) 2003-03-19

Family

ID=24199043

Family Applications (1)

Application Number Title Priority Date Filing Date
EP96307834A Expired - Lifetime EP0771737B1 (en) 1995-10-31 1996-10-30 Blister pill package with safety backing

Country Status (20)

Country Link
EP (1) EP0771737B1 (es)
JP (1) JPH09201395A (es)
KR (1) KR100503560B1 (es)
CN (1) CN1072165C (es)
AR (1) AR004243A1 (es)
AT (1) ATE234773T1 (es)
AU (1) AU710058B2 (es)
BR (1) BR9605388A (es)
CZ (1) CZ317896A3 (es)
DE (1) DE69626737T2 (es)
DK (1) DK0771737T3 (es)
ES (1) ES2194082T3 (es)
HU (1) HU222816B1 (es)
IN (1) IN188708B (es)
MX (1) MX9605252A (es)
NZ (1) NZ299640A (es)
PL (1) PL184674B1 (es)
PT (1) PT771737E (es)
RU (1) RU2180209C2 (es)
ZA (1) ZA969138B (es)

Families Citing this family (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0959020A1 (de) * 1998-05-20 1999-11-24 Alusuisse Technology & Management AG Manipulationssichere Verpackung
DE19931364A1 (de) * 1999-07-07 2001-01-18 Lohmann Therapie Syst Lts Blisterkartonverpackung für empfindliches Packgut mit leichtflüchtigen und/oder feuchtigkeitsempfindlichen Komponenten
DE50107522D1 (de) * 2000-12-22 2006-02-02 Henkel Kgaa Verfahren zur herstellung einer mit tabletten gefüllten verpackung
WO2002083520A2 (en) * 2001-04-18 2002-10-24 Alcan International Limited Child-proof package for pharmaceutical products
CN100556762C (zh) * 2002-02-13 2009-11-04 迈克尔K·韦伯尔 药物剂型及其制造方法
US20030234203A1 (en) * 2002-06-21 2003-12-25 Urban Joseph J. Blister package
DE102004062864A1 (de) 2004-12-21 2006-06-22 Boehringer Ingelheim Pharma Gmbh & Co. Kg Folienbehälter
US20100168074A1 (en) * 2007-04-13 2010-07-01 Christopher Culligan Freezable Unit Dosage Delivery System and Method of Preparation
JP2011184067A (ja) * 2010-03-08 2011-09-22 Hitachi Maxell Energy Ltd ブリスターパック及びその製造方法
EP2639183B1 (en) * 2010-11-12 2018-06-13 Asahi Kasei Kabushiki Kaisha Push-through pack packaging
JP2015221686A (ja) * 2014-05-23 2015-12-10 株式会社カナエ 台紙付きブリスター包装体
EP3121132A1 (en) * 2015-07-21 2017-01-25 Renata AG Blister pack for button battery
CN105560054A (zh) * 2016-01-22 2016-05-11 仲恺农业工程学院 一种预防儿童误食的障碍式药片包装
JP6271614B2 (ja) * 2016-02-11 2018-01-31 Ｎｉｓｓｈａ株式会社 収納シート、マイクロニードルシートの梱包体
GB2558666A (en) * 2017-01-17 2018-07-18 Cedar Advanced Tech Group Ltd Blister packaging for dispensing pills, apparatus and method of manufacturing the same
KR200484588Y1 (ko) 2017-02-14 2017-09-27 (주)우진켐 의약품용 어린이 안전 블리스터 포장체
PT4219336T (pt) 2019-11-14 2024-07-18 Perfetti Van Melle Benelux B V Embalagem blíster inviolável

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US3387699A (en) 1966-03-10 1968-06-11 Packaging Components Inc Dispensing containers
US3503493A (en) 1968-01-08 1970-03-31 Hoffmann La Roche Medicament packaging device
US3472368A (en) 1968-10-04 1969-10-14 Harold R Hellstrom Quick-opening blister packets
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US3809211A (en) 1971-12-14 1974-05-07 B Padilla Conveyor system
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US3921805A (en) 1972-10-10 1975-11-25 Newton L Compere Rupturable blister pill package with safety backing
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Also Published As

Publication number Publication date
DE69626737D1 (de) 2003-04-24
AR004243A1 (es) 1998-11-04
RU2180209C2 (ru) 2002-03-10
EP0771737A1 (en) 1997-05-07
HUP9603013A3 (en) 1999-03-01
KR100503560B1 (ko) 2005-11-16
PL184674B1 (pl) 2002-11-29
PT771737E (pt) 2003-06-30
JPH09201395A (ja) 1997-08-05
CN1152529A (zh) 1997-06-25
DE69626737T2 (de) 2004-02-05
CN1072165C (zh) 2001-10-03
HU222816B1 (hu) 2003-11-28
MX9605252A (es) 1997-06-28
HU9603013D0 (en) 1996-12-30
NZ299640A (en) 1998-07-28
PL316747A1 (en) 1997-05-12
ATE234773T1 (de) 2003-04-15
HUP9603013A2 (en) 1997-08-28
ES2194082T3 (es) 2003-11-16
DK0771737T3 (da) 2003-06-30
KR970020078A (ko) 1997-05-28
AU710058B2 (en) 1999-09-09
CZ317896A3 (en) 1997-05-14
IN188708B (es) 2002-10-26
AU7044996A (en) 1997-05-08
ZA969138B (en) 1998-04-30
BR9605388A (pt) 1998-07-28

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