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
  • B65D81/00—Containers, packaging elements, or packages, for contents presenting particular transport or storage problems, or adapted to be used for non-packaging purposes after removal of contents
  • B65D81/24—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants
  • B65D81/26—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators
  • B65D81/266—Adaptations for preventing deterioration or decay of contents; Applications to the container or packaging material of food preservatives, fungicides, pesticides or animal repellants with provision for draining away, or absorbing, or removing by ventilation, fluids, e.g. exuded by contents; Applications of corrosion inhibitors or desiccators for absorbing gases, e.g. oxygen absorbers or desiccants
• • 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
  • B65D75/28—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
  • 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
  • B65D2575/3227—Cuts or weakening lines
• • 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 regards a blister pack ⁇ age., particularly a blister package providing preparation cavities and drying agent cavities for packaging moisture sensitive solid or semi-solid pharmaceutical prepara ⁇ tions.
• the expression blister package is used herein in its usual meaning, i.e. for any type of sheet package, preferably made of plastics and aluminum, which have cavities for the uptake of the solid to be packaged in the pan sheet (usually in the plastic sheet) and which are closed by sealing with a second sheet, a so called cover sheet, preferably a coated aluminum foil, whereby the product at its offtake can be pushed through the cover sheet by pressure on the pan sheet.
• blister packages are a preferred pack ⁇ aging form for solid or semi-solid pharmaceutical prepa ⁇ rations, respectively. They have the advantage that the preparations remain cleanly packed until they are used and furthermore - because of the usual labeling on the back side and/or on the top side - the risk of a mix-up is much reduced. Further advantages of the blister pack ⁇ age are a reduced abrasion of the product, the possibil ⁇ ity to get single units under retention of. the primary package, water vapor resistance etc.
• a known procedure exclusively uses aluminum composite films as pan sheet and cover sheet.
• An addi- tional drying effect can be achieved by providing two cavities connected with each other for air exchange, from which one comprises a drying agent and the other one the pharmaceutical preparation.
• Such a package has the disad ⁇ vantage that it is relatively expensive and that, par- ticularly because of the lack of transparency, the risk for the erroneous intake of the drying agent instead of the effective substance comprising preparation exists.
• the non-consummation of the effective sub- stance comprising preparation can very badly influence the state of health of the patient.
• EP-A-0 466 068 describes a blister package in which each cavity for a pharmeceutical preparation is connected with a cavity for a drying agent. Additionally a perforation can be provided enabling the separation of each combination of a pharmaceutical preparation and a drying agent.
• the disadvantage of this blister package is that by accident the drying agent can easily be consumed, particularly with a separated unit.
• FR-A-2 593 152 also describes a blister pack- age with drying agent whereby several cavities for a pharmaceutical preparation are connected with one cavity for drying agents.
• FR-A-2 660 634 discloses a package comprising a drying agent whereby between the drying agent and the cover sheet a membrane is located to keep the drying agent at the desires place.
• the offtake of the charge is not performed by pushing the charge through the cover sheet but by peeling the cover sheet off. A peeling of the cover sheet from the drying agent is made more diffi ⁇ cult by additional sealings.
• DE-OS-24 04 232 discloses a children- resistant package, however without any means to keep the pharmaceutical preparation dry. Besides of a removable tear resistant sheet on the cover sheet preventing push ⁇ ing of the charge through the cover sheet, the cavities are thus formed, that a child cannot open them by biting on the blister.
• US-5 172 812 discloses a children-resistant package with a rupturable cover sheet and with a paper- board material peelably laminated to the sheet of rup ⁇ turable material. Furthermore a die cut is provided "misregistered" with the opening so that only a part of the paperboard material is peeled off from the opening so that the tablet can only be removed if pressure is ap- plied in a specific manner. This document does not dis ⁇ close a drying agent comprising package.
• US-3 780 856 and US 3 835 995 both disclose blister packages with a cover sheet that is to be peeled off. In both packages a tear-off strip is provided where the cover sheet is not sealed to the carrier layer.
• the problem of the present invention thus was to provide a blister package for the dry storage of phar ⁇ maceutical preparations, for which the accidental intake of the drying agent is prevented.
• a blister package with a pan sheet with preparation cavities and drying agent cavities as well as a cover sheet characterized in that the blister package in the region of the drying agent cavities is enforced thus, that the withdrawing of the charge with usual finger pressure is prevented, and that the reinforcement over the drying agent cavities cannot be removed by applying usual means.
• each cavity comprising a pharmaceu ⁇ tical preparation is connected to at least one cavity comprising a drying agent, and at least one sheet, par ⁇ ticularly the cover sheet is reinforced in the region of the drying agent thus that the reinforcement over the drying agent cavities cannot be removed by usual applica ⁇ tion of usual means as for example pressing, pushing or peeling off with the fingers or the finger nails.
• Figure 1 is a top view on a blister package in which each pharmaceutical preparation cavity is con ⁇ nected to a drying agent cavity by a connecting passage, and with an additional protection sheet being placed on the cover sheet in the region of the drying agent
• Figure 2 is a section along the line II-II of the blister package of Figure 1
• Figure 3 shows the structure of a specific protection sheet against withdrawing simultaneously serv ⁇ ing as child-resistant
• Figure 4 is a top view on a blister package with a specific withdrawing-protection sheet according to Figure 3
• Figure 5 is a section along line V-V of the blister package of Figure 4 during the peeling off of the protection sheet from the preparation side, and
• Figure 6 shows a blister package in which two preparation cavities are connected to one drying agent cavity.
• the inventive blister package has a pan sheet 4 with cavities 1 for the uptake of effective substance comprising preparations and cavities 2 for the uptake of drying agents as well as a cover sheet 5, characterized in that the blister package in the region of the drying agent cavities 2 is enforced thus, that the withdrawing of the charge with usual finger pressure is prevented, and that the reinforcement over the drying agent cavities 2 cannot be removed by applying usual means.
• each cavity 1 is connected with at least one cavity 2 by a connecting means 3, thus that an air exchange is of course possible, but not a direct contact of the effec- tive substance comprising preparation with the drying agent.
• said connecting means 3 is a connecting passage-like cavity in the formed pan sheet 4 of the blister package, which is particularly a plastic sheet.
• the lifetime of the package can be controlled by the amount of drying agent used, dependent on the en ⁇ vironmental conditions.
• the amount of drying agent results from its water absorbing capacity, the blister design, the used foil quality, the provided storage conditions and the de ⁇ sired shelf life of the product.
• drying agent e.g. as represented in Figure 6
• the drying agent ad ⁇ vantageously is also applied in the form of tablets whereby the dosage as well as the introduction into the cavities 2 is facilitated and additionally a clogging up of the passages by loose particles is diminished or avoided, respectively, for such an embodiment possibly larger drying agent tablets are used.
• Suitable as drying agent are all solid, pref ⁇ erably pharmaceutically harmless substances such as mo ⁇ lecular sieves and silica gel.
• the package comprises additional security elements preventing the accidental intake of the drying agent instead of the effective substance comprising preparation.
• a security measure can for example be the sealing of an additional plastic sheet in the drying agent region, particularly onto the cover sheet 5.
• This additional sheet prevents a pushing through of the drying agent through the cover sheet 5.
• one addi ⁇ tional sheet simultaneously covers several drying agent comprising cavities 2, resulting in an improved adhesion thereof.
• This foil can be clear or colored. Measures on the side of the pan sheet 4 such as local coloring, local reinforcement of the sheet or covering hood, respec- tively, etc. are possible but technically much more ex ⁇ pansive.
• drying agent cavi ⁇ ties 2 are situated adjacently, particularly in one or several adjacent rows.
• the preferred inventive blister packages with enhanced security against withdrawing of the drying agents provide on the cover sheet side at least in the region of the cavities 2 for the uptake of drying agent a protection sheet 6.
• the protection sheet 6 can be of any shape, provided that the withdrawing of the drying agent is ef- fectively prevented. Suitable are e.g. plastic foils which, due to their toughness prohibit a pushing through. Because of their toughness polyethylene (PE) sheets or polyethylene composite films, respectively, for example a laminate of polyethylene (PE) and polyethyleneterephtha- late (PET) sheet (PET/PE sheet) are preferred.
• PE polyethylene
• PET polyethyleneterephtha- late
• cover sheets 5 of a multi ⁇ layer laminate with the protection sheet 6 being already comprised (cf. Fig. 3) .
• such sheets which are commercially available, inside (contact to the pan sheet 4) have a hot-melt layer, e.g. a thermoplastic lac ⁇ quer.
• a hot-melt layer e.g. a thermoplastic lac ⁇ quer.
• an aluminum foil an adhesive
• a polyester sheet e.g. polyethyleneterephthalate (PET)
• PET polyethyleneterephthalate
• an adhesion enhancer e.g. another solid adhesive layer
• a paper layer e.g.
• a sheet with e.g. 20 ⁇ m thickness of the Al-layer and 12 ⁇ m thickness of the polyester sheet and an adhesive with restricted adhesion in the laminate is e.g.
• the adhesive can either be thus construed that it only provides restricted laminate adhesion so that a separation between the cover sheet 5 and the pro ⁇ tection sheet 6 is possible by hand, or it is thus that the adhesion of the laminate is so strong that the multi ⁇ layer laminate is peeled off as such, i.e. cover sheet 5 and protection sheet 6 together.
• the whole cover sheet region is covered, that is also the preparation region.
• Such a cover is considered as child-resistant.
• a usual pressing through of the tablet through the laminate is not possible.
• the protection sheet part of the multilayer laminate can only be peeled off from the effective sub ⁇ stance comprising preparations but not from the drying agent. This is for example secured in that (as shown in Figures 4 and 5) in the effective substance comprising preparation part opening aids are provided, e.g. seal free zones 7, as well as a perforation or a cross section 8 to the drying agent region.
• the seal free zones 7 are preferably located directly at the perforation or the cross section 8, or at the inter ⁇ section of the perforation or the cross section 8 and the perforation or the cross section 9, so that the peel off direction necessarily leads away from the drying agent.
• the seal free zone 7 is e.g. made in that the sealing tool, e.g.
• a stamp provides respective "cold" parts, and/or by deep drawing of the package form in the respec ⁇ tive region, so that no contact can be made and at the same time the seizing of the loose sheet part is facili ⁇ tated, or by punching out the respective zone from the pan sheet prior to sealing it with the cover sheet.
• the perforation or the cross section 8, respectively, as well as the perforation or cross section 9 preferably concern at least the protection foil part of the multi- layer laminate. Particularly a perforation 9 through the whole blister package can be provided so that single units can be separated. Since the drying agent region be ⁇ cause of the protection foil is secured against withdraw ⁇ ing also for a 1:1 combination (one effective substance comprising preparation per drying agent tablet) no risk of withdrawing exists.
• the paper + PET complex can only be peeled off from the region of the preparation. This is achieved in that the opening aids 7 are exclusively present in the preparation field. If a sheet with an adhesive providing strong laminate adhesion between cover sheet 5 and protection sheet 6 is used, a perforation or cross section 8 as well as a perforation or cross section 9 must be provided to ensure that the multilayer laminate is only peeled off from one effective substance preparation, which then is laid open.
• the paper layer, particu ⁇ larly in the region over the drying agent can be colored or provided with a warning imprint.
• a label in the product region e.g. specification of the weekdays etc., on which the respective tablet shall be consumed.
• Such a label additionally diminishes the prob ⁇ ability that the sequence of the intake is thus that - e.g.
• a monitoring device can be provided indicating the complete consump- tion of the drying agent or the enhancement of the humid ⁇ ity, respectively.
• a monitoring device can be provided indicating the complete consump- tion of the drying agent or the enhancement of the humid ⁇ ity, respectively.
• a monitoring device can be provided indicating the complete consump- tion of the drying agent or the enhancement of the humid ⁇ ity, respectively.
• a monitoring device e.g. the sil ⁇ ica gel with indicator, a silica gel colored with C0CI 2 to show the water absorption.
• silica gel with indicator preferably should only be used in inventive blister packages providing the additional protection to prevent the intake of the drying agent.
• the pan sheet itself should - as already men ⁇ tioned above - be as little moisture permeable as possi- ble. Furthermore it should be sealable as well as also having a good compatibility with the product.
• a today usual sheet for such applications is a combination sheet of PVC (polyvinylchloride) ,PE (polyethylene) and PVDC (polyvinylidenechloride) . Such a sheet is e.g. sold under the name Alfoil®, Tristar®, Aclar®, etc. and extensively used for pharmaceuticals.
• cover sheet a usual sheet can be used, particularly one comprising an aluminium layer or an aluminium foil such as a usually used polymer coated aluminium foil or the above mentioned multilayer lami ⁇ nate, respectively.
• the pan sheet is formed according to the blister design with usual methods and after the introduc ⁇ tion of the drying agent and the product conneted with the cover foil in a manner usual for blister packages , particularly sealed.
• Example 1 Protection against withdrawing for blister packages
• a cover sheet Onto the cover sheet, a usual aluminum sheet, in the region of the part to be protected against with ⁇ drawing (drying agent region) a protection sheet of PET/PE (thickness about 60 urn) is sealed at about 120- 130°C. Due to the toughness of the PET/PE sheet a pushing through of the drying agent is not possible.
• the thus se ⁇ cured blister package then can be perforated as desired, preferably between each unit.
• Example 2 Protection against withdrawing by a multilayer laminate
• the filled pan sheet is sealed at about 200°C with a multilayer laminate (Peel-Push-Folie from Neher, Buchlingen, Switzerland) according to Figure 3 as cover sheet and protection sheet instead of an aluminum sheet thus, that, in the product region at the perforation line to the drying agent region and at the perforation line between the units, for each unit at least one seal free zone is formed. If the seal is made by a stamp, this is achieved by "cold" zones on the stamp itself.
• a multilayer laminate Peel-Push-Folie from Neher, Buchlingen, Switzerland
• the withdrawing of the product is made in several steps:
• the protection sheet part of the multilayer laminate can exclusively be peeled off in the product region.- This is not possible in the region of the drying agents since any opening aid such as a seal free zone is lacking.

Landscapes

• Engineering & Computer Science (AREA)
• Health & Medical Sciences (AREA)
• Mechanical Engineering (AREA)
• Pharmacology & Pharmacy (AREA)
• Composite Materials (AREA)
• Chemical & Material Sciences (AREA)
• Food Science & Technology (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Packages (AREA)
• Medical Preparation Storing Or Oral Administration Devices (AREA)
• Die Bonding (AREA)

Priority Applications (8)

Applications Claiming Priority (2)

Publications (1)

Family

ID=4240569

Family Applications (1)

Country Status (14)

Cited By (20)

Families Citing this family (1)

Citations (7)

• 1994
  • 1994-09-07 CH CH02741/94A patent/CH687615A5/de not_active IP Right Cessation
• 1995
  • 1995-09-05 AU AU32307/95A patent/AU700873B2/en not_active Expired
  • 1995-09-05 AT AT95928599T patent/ATE173710T1/de active
  • 1995-09-05 MX MX9701821A patent/MX9701821A/es unknown
  • 1995-09-05 EP EP95928599A patent/EP0779872B1/en not_active Expired - Lifetime
  • 1995-09-05 JP JP8509353A patent/JPH10505047A/ja active Pending
  • 1995-09-05 WO PCT/IB1995/000728 patent/WO1996007601A1/en active IP Right Grant
  • 1995-09-05 CA CA002199263A patent/CA2199263C/en not_active Expired - Lifetime
  • 1995-09-05 DK DK95928599T patent/DK0779872T3/da active
  • 1995-09-05 DE DE69506267T patent/DE69506267T2/de not_active Expired - Lifetime
  • 1995-09-05 ES ES95928599T patent/ES2125643T3/es not_active Expired - Lifetime
  • 1995-09-07 IL IL11520295A patent/IL115202A/xx not_active IP Right Cessation
  • 1995-09-07 ZA ZA9575300A patent/ZA957530B/xx unknown
  • 1995-09-23 TW TW084109929A patent/TW308577B/zh not_active IP Right Cessation

Patent Citations (7)

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