EP0233418B1 - Impervious package in the form of a cellular block permitting exchanges of gas between the cells - Google Patents

Impervious package in the form of a cellular block permitting exchanges of gas between the cells Download PDF

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Publication number
EP0233418B1
EP0233418B1 EP86401152A EP86401152A EP0233418B1 EP 0233418 B1 EP0233418 B1 EP 0233418B1 EP 86401152 A EP86401152 A EP 86401152A EP 86401152 A EP86401152 A EP 86401152A EP 0233418 B1 EP0233418 B1 EP 0233418B1
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EP
European Patent Office
Prior art keywords
compartments
tablets
card
packaging according
packaging
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EP86401152A
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German (de)
French (fr)
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EP0233418A1 (en
Inventor
Jacques Dauphin
Alain Cuine
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ADIR SARL
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ADIR SARL
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Priority to AT86401152T priority Critical patent/ATE39905T1/en
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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
    • 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
    • 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
    • B65D75/28—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
    • B65D75/328—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 the compartments being interconnected, e.g. by small channels
    • 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 sealed package in the form of a blister card allowing gas exchanges between the cells.
  • This packaging which can be used for any product requiring waterproof packaging for its conservation, is particularly suitable for the pharmaceutical industry.
  • the packaging which is the subject of the present invention differs from the already existing packaging for the pharmaceutical forms and offers particularly advantageous advantages over the latter.
  • the packaging which allows gas exchanges are either closed bottles with an absorber or a gas generator, or blister packs overwrapped in a second sealed packaging containing an absorber or a gas generator, or packaging as described in the preamble of claim 1.
  • the bottle does not constitute a security packaging, in the sense that access to all of the content is facilitated.
  • the overwrapped blister pack requires the overlapping of two packaging operations.
  • the new packaging offered is a unique packaging which individualizes each pharmaceutical form while allowing gas exchanges. It combines both the stability of medication storage, guaranteed until then by the use of absorbent bottles, with the safety of use, presented by conventional blisters, and is therefore particularly interesting.
  • Patent GB-A 1 073 786 describes a unique sealed packaging which is in the form of a blister card allowing gas exchanges between the blisters and used for divided solid pharmaceutical forms.
  • the proximity of the pharmaceutical form to be stored and the dehydrating product entails the risk of expulsion of the latter at the same time as the pharmaceutical product when it is desired to release the latter; risk which does not exist with the blister packs of the present invention where the pharmaceutical product to be stored and the dehydrating product are each in very distinct blisters, separated by canaliculi.
  • Patent DE-A 2 224 965 describes a device in the form of a plate constituted in its lower part by a waterproof film in which cells are connected together by canaliculi. Such a device is used for the sterilization of packages external to this device which, at the end of use is intended to be immersed in an aqueous medium; the canaliculi then serving to establish a liquid contact between the different alveoli; which is never the case in the invention of the present application where the wafer as a whole is used to ensure the safety of the storage of the only pharmaceutical products which it contains, without any exchange with a fluid or an external packaging, nor via the canaliculi, nor at the level of the alveoli.
  • the present invention particularly relates to a gas-impermeable packaging in the form of a wafer consisting in its upper part of a waterproof fusible film and in its lower part of a waterproof film in which cells connected together by canaliculi are formed by stamping or thermoforming, or both.
  • the cells of the same wafer can be of different size.
  • One or more cells contain a gas absorber or generator, the other cells contain divided solid pharmaceutical forms (tablets, capsules, lyocs ).
  • the gas exchanges inside the wafer are made by canaliculi connecting the alveoli together. They can be of variable size according to the desired gas exchanges.
  • carrier materials, such as for example polypropylene or co-extrudates based on polyvinyl alcohol resin, can also be used.
  • Blister for packaging tablets based on a product sensitive to humidity Blister for packaging tablets based on a product sensitive to humidity.
  • the face in is formed by a polyethylene-aluminum-polyethylene complex; the upper side with a fusible aluminum film.
  • Such a plate comprises in its upper part a cell (A), receptacle for the absorbent product, to which is connected a double row of cells (C) intended to receive the tablets.
  • the cells (C) are grouped in pairs on either side of a canaliculus connecting them to each other and to the cell (A) containing the absorbent product.
  • Such a pack contains the medication valid for a 10-day treatment at the rate of 2 tablets / day.
  • the packaging method described above ensures the stability of the tablets during long-term storage, at the manufacturer or the wholesaler for example.
  • the title of the tablets in percentage relative to the initial title, after three months at 37 ° C. and 75% relative humidity, is as follows:
  • the blister pack shown schematically in Annex 1/2 therefore provides the packaged tablets with greater stability than that provided by conventional blisters, even overpackaged. It offers the same guarantee of stability of the tablets as the pillbox with absorber, but presents compared to the latter the advantages of a presentation for a sequential treatment particularly appreciated in the treatment of patients at high risk.
  • the title of the tablets in percentage compared to the initial title, after three months at 37 ° C and 75% relative humidity, is as follows:
  • the underside is formed by the polyvinyl chloride + polyethylene + polyvinylidene chloride assembly; the upper side with a fusible aluminum film.
  • Such a wafer comprises five alveolar groups each formed by a central alveolus (A) intended to contain the absorbent product connected, on either side, by a canaliculus to two alveoli receiving the tablets.
  • A central alveolus
  • Such a pack contains the medication valid for a treatment of 5 days at a dose of 2 tablets / day.

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  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Chemical & Material Sciences (AREA)
  • Composite Materials (AREA)
  • Food Science & Technology (AREA)
  • Packages (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Laminated Bodies (AREA)
  • Medicinal Preparation (AREA)
  • Processing Of Solid Wastes (AREA)
  • Rigid Containers With Two Or More Constituent Elements (AREA)
  • Structure Of Emergency Protection For Nuclear Reactors (AREA)
  • Heat Sensitive Colour Forming Recording (AREA)

Abstract

New impervious single packaging in the form of a card having compartments and permitting gaseous exchange between the compartments, of which one or more are designed to contain a gas absorber or generator and the others act as receptacles for the solid bodies to be stored; the said compartments being interconnected by small channels. This safety packaging is particularly suited to use in the storage of solid pharmaceutical bodies (tablets, capsules or others).

Description

Le présente invention a pour objet un conditionnement étanche sous forme de plaquette alvéolaire permettant des échanges gazeux entre les alvéoles. Ce conditionnement utilisable pour tout produit nécessitant pour sa conservation un emballage étanche, est particulièrement adapté à l'industrie pharmaceutique.The present invention relates to a sealed package in the form of a blister card allowing gas exchanges between the cells. This packaging, which can be used for any product requiring waterproof packaging for its conservation, is particularly suitable for the pharmaceutical industry.

Le conditionnement, objet de la présente invention, se distingue des conditionnements déjà existants pour les formes pharmaceutiques et offre par rapport à ces derniers des avantages particulièrement intéressants.The packaging which is the subject of the present invention differs from the already existing packaging for the pharmaceutical forms and offers particularly advantageous advantages over the latter.

En effet, jusqu'à présent, les conditionnements qui permettent des échanges gazeux sont soit des flacons fermés avec un absorbeur ou un générateur de gaz, soit des plaquettes alvéolaires sur- emballées dans un second conditionnement étanche contenant un absorbeur ou un générateur de gaz, soit des conditionnements tels que décrits dans le préambule de la revendication 1. Le flacon ne constitue pas un conditionnement de sécurité, en ce sens où l'accès à l'ensemble du contenu est facilité. La plaquette alvéolaire suremballée nécessite la superposition de deux opérations de conditionnement. Le nouveau conditionnement proposé est un conditionnement unique réalisant une individualisation de chaque forme pharmaceutique tout en permettant des échanges gazeux. Il allie à la fois la stabilité de conservation des médicaments, garantie jusqu'alors par l'emploi de flacons à absorbeur, à la sécurité d'utilisation, présentée par les blisters classiques, et est de ce fait particulièrement intéressant.In fact, until now, the packaging which allows gas exchanges are either closed bottles with an absorber or a gas generator, or blister packs overwrapped in a second sealed packaging containing an absorber or a gas generator, or packaging as described in the preamble of claim 1. The bottle does not constitute a security packaging, in the sense that access to all of the content is facilitated. The overwrapped blister pack requires the overlapping of two packaging operations. The new packaging offered is a unique packaging which individualizes each pharmaceutical form while allowing gas exchanges. It combines both the stability of medication storage, guaranteed until then by the use of absorbent bottles, with the safety of use, presented by conventional blisters, and is therefore particularly interesting.

L'état antérieur de la technique peut être illustré par les brevets GB-A 1 073 786 et DE-A 2 224 965.The prior art can be illustrated by patents GB-A 1,073,786 and DE-A 2,224,965.

Le brevet GB-A 1 073 786 décrit un conditionnement étanche unique qui se présente sous forme de plaquette alvéolaire permettant des échanges gazeux entre les alvéoles et utilisé pour des formes pharmaceutiques solides divisées. Toutefois, la proximité de la forme pharmaceutique à stocker et du produit déshydratant entraîne le risque d'expulsion de ce dernier en même temps que le produit pharmaceutique lorsqu'on veut libérer celui-ci; risque qui n'existe pas avec les plaquettes alvéolaires de la présente invention où produit pharmaceutique à stocker et produit déshydratant sont chacun dans des alvéoles bien distincts, séparés par des canalicules.Patent GB-A 1 073 786 describes a unique sealed packaging which is in the form of a blister card allowing gas exchanges between the blisters and used for divided solid pharmaceutical forms. However, the proximity of the pharmaceutical form to be stored and the dehydrating product entails the risk of expulsion of the latter at the same time as the pharmaceutical product when it is desired to release the latter; risk which does not exist with the blister packs of the present invention where the pharmaceutical product to be stored and the dehydrating product are each in very distinct blisters, separated by canaliculi.

Le brevet DE-A 2 224 965 décrit un dispositif sous la forme d'une plaquette constituée en sa partie inférieure d'un film étanche dans lequel des alvéoles sont reliés entre eux par des canalicules. Un tel dispositif est utilisé pour la stérilisation de conditionnements extérieurs à ce dispositif qui, en fin d'utilisation est destiné a être plongé dans un milieu aqueux; les canalicules servant alors à établir un contact liquide entre les différents alvéoles; ce qui n'est jamais le cas dans l'invention de la présente demande où la plaquette dans son ensemble sert à assurer la sécurité du stockage des seuls produits pharmaceutiques qu'elle renferme, sans aucun échange avec un fluide ou un conditionnement extérieur, ni par l'intermédiaire des canalicules, ni au niveau des alvéoles.Patent DE-A 2 224 965 describes a device in the form of a plate constituted in its lower part by a waterproof film in which cells are connected together by canaliculi. Such a device is used for the sterilization of packages external to this device which, at the end of use is intended to be immersed in an aqueous medium; the canaliculi then serving to establish a liquid contact between the different alveoli; which is never the case in the invention of the present application where the wafer as a whole is used to ensure the safety of the storage of the only pharmaceutical products which it contains, without any exchange with a fluid or an external packaging, nor via the canaliculi, nor at the level of the alveoli.

La présente invention concerne particulièrement un conditionnement imperméable aux gaz se présentant sous la forme d'une plaquette constituée en sa partie supérieure d'un film étanche thermocollant et en sa partie inférieure d'un film étanche dans lequel des alvéoles reliés entre eux par des canalicules sont formés par emboutissage ou thermoformage, ou l'ensemble des deux techniques.The present invention particularly relates to a gas-impermeable packaging in the form of a wafer consisting in its upper part of a waterproof fusible film and in its lower part of a waterproof film in which cells connected together by canaliculi are formed by stamping or thermoforming, or both.

Les alvéoles d'une même plaquette peuvent être de taille différente. Un ou plusieurs alvéoles contiennent un absorbeur ou un générateur de gaz, les autres alvéoles contiennent des formes pharmaceutiques solides divisées (comprimés, capsules, lyocs ...).The cells of the same wafer can be of different size. One or more cells contain a gas absorber or generator, the other cells contain divided solid pharmaceutical forms (tablets, capsules, lyocs ...).

Les échanges gazeux à l'intérieur de la plaquette se font par des canalicules reliant les alvéoles entre eux. Ils peuvent être de taille variable suivant les échanges gazeux souhaités.The gas exchanges inside the wafer are made by canaliculi connecting the alveoli together. They can be of variable size according to the desired gas exchanges.

Les matériaux constituant une barrière aux gaz utilisés pour la fabrication de la plaquette sont:

  • - Les complexes aluminium thermocollants: polyéthylène-aluminium-polyéthylène,
  • - les matières plastiques thermoformables: chlorure de polyvinyle (PVC) + chlorure de polyvinylidène; chlorure de polyvinyle + polyéthylène + chlorure de polyvinylidène.
The materials constituting a gas barrier used for the manufacture of the wafer are:
  • - Iron-on aluminum complexes: polyethylene-aluminum-polyethylene,
  • - thermoformable plastics: polyvinyl chloride (PVC) + polyvinylidene chloride; polyvinyl chloride + polyethylene + polyvinylidene chloride.

D'autres matériaux «barrière», tels que par exemple le polypropylène ou les co-extrudés à base de résine d'alcools polyvinyliques, peuvent également être utilisés.Other “barrier” materials, such as for example polypropylene or co-extrudates based on polyvinyl alcohol resin, can also be used.

Les produits absorbants ou générateurs de gaz sont:

  • - les tamis moléculaires seuls ou contenant de l'azote
  • - les gels de silice
  • - les carbonates de potassium
  • l'oxyde de magnesium
  • - les argiles réactivées.
The absorbent products or gas generators are:
  • - molecular sieves alone or containing nitrogen
  • - silica gels
  • - potassium carbonates
  • magnesium oxide
  • - reactivated clays.

Les exemples suivants, donnés à titre non limitatif, illustrent la présente invention.The following examples, given without limitation, illustrate the present invention.

EXEMPLE 1EXAMPLE 1 Plaquette alvéolaire pour conditionnement de comprimés à base d'un produit sensible à l'humidité.Blister for packaging tablets based on a product sensitive to humidity.

Exemple 1A

  • a) formule du comprimé: (N-dicyclopropylméthyl) amino-2 oxazoline phosphate 1 mg Lactose 70 mg Cellulose microcristalline 28 mg Stéarate de magnésium 1 mg
  • b) produit absorbant: gel de silice
  • c) type de plaquette alvéolaire:
Example 1A
  • a) tablet formula: (N-dicyclopropylmethyl) 2-amino-oxazoline phosphate 1 mg Lactose 70 mg Microcrystalline cellulose 28 mg Magnesium stearate 1 mg
  • b) absorbent product: silica gel
  • c) type of blister:

Il correspond à la figure annexée 1/2. La face inférieure est formée par un complexe polyéthylène-aluminium-polyéthylène; la face supérieure par une pellicule d'aluminium thermocollant.It corresponds to the attached figure 1/2. The face in is formed by a polyethylene-aluminum-polyethylene complex; the upper side with a fusible aluminum film.

Une telle plaquette comprend en sa partie supérieure un alvéole (A), réceptacle du produit absorbant, auquel est reliée une double rangée d'alvéoles (C) destinés à recevoir les comprimés.Such a plate comprises in its upper part a cell (A), receptacle for the absorbent product, to which is connected a double row of cells (C) intended to receive the tablets.

Dans chacune de ces rangées, les alvéoles (C) sont groupés par couple de part et d'autre d'un canalicule les reliant entre eux et à l'alvéole (A) contenant le produit absorbant.In each of these rows, the cells (C) are grouped in pairs on either side of a canaliculus connecting them to each other and to the cell (A) containing the absorbent product.

Une telle plaquette contient la médication valable pour un traitement de 10 jours à raison de 2 comprimés /jour.Such a pack contains the medication valid for a 10-day treatment at the rate of 2 tablets / day.

d) avantages :d) advantages:

Le mode de conditionnement ci-dessus décrit assure la stabilité des comprimés lors d'un stockage de longue durée, chez le fabricant ou le grossiste par exemple.The packaging method described above ensures the stability of the tablets during long-term storage, at the manufacturer or the wholesaler for example.

En effet, selon le mode de conditionnement, le titre des comprimés, en pourcentage par rapport au titre initial, après trois mois à 37°C et 75% d'humidité relative, est le suivant:

Figure imgb0001
In fact, according to the packaging method, the title of the tablets, in percentage relative to the initial title, after three months at 37 ° C. and 75% relative humidity, is as follows:
Figure imgb0001

La plaquette alvéolaire schématisée dans l'annexe 1/2 assure donc aux comprimés conditionnés une stabilité supérieure à celle assurée par les blisters classiques même suremballés. Elle offre la même garantie de stabilité des comprimés que le pilulier avec absorbeur, mais présente par rapport à ce dernier les avantages d'une présentation pour un traitement séquenciel particulièrement apprécié dans le traitement de patients à haut risque.The blister pack shown schematically in Annex 1/2 therefore provides the packaged tablets with greater stability than that provided by conventional blisters, even overpackaged. It offers the same guarantee of stability of the tablets as the pillbox with absorber, but presents compared to the latter the advantages of a presentation for a sequential treatment particularly appreciated in the treatment of patients at high risk.

Exemple 1 BExample 1 B

Des résultats analogues ont été obtenus en utilisant le même type de plaquette alvéolaire et le même produit absorbant que dans l'exemple 1A, pour des comprimés dont la formule unitaire est: (N-dicyclopropylméthyl) amino-2 oxazoline phosphate (correspondant à 0,001 g de base) 0,001544 g

  • Carboxyméthylamidon sodique 0,0045 g
  • Cellulose microcristalline 0,03367 g
  • Cire blanche q.s.
  • Lactose 0,047 g
  • Paraffine 0,00015 g
  • Silice colloïdale 0,00023 g
  • Stéarate de magnésium 0,0009 g
  • Talc 0,002 g
  • pour un comprimé terminé à 0,090 g
Analogous results were obtained using the same type of blister and the same absorbent product as in Example 1A, for tablets whose unit formula is: (N-dicyclopropylmethyl) 2-amino-oxazoline phosphate (corresponding to 0.001 g 0.001544 g
  • Carboxymethyl sodium starch 0.0045 g
  • Microcrystalline cellulose 0.03367 g
  • White wax qs
  • Lactose 0.047 g
  • Paraffin 0.00015 g
  • Colloidal silica 0.00023 g
  • Magnesium stearate 0.0009 g
  • Talc 0.002 g
  • for a tablet finished at 0.090 g

Selon le mode de conditionnement, le titre des comprimés, en pourcentage par rapport au titre initial, après trois mois à 37°C et 75 % d'humidité relative, est le suivant:

Figure imgb0002
According to the packaging method, the title of the tablets, in percentage compared to the initial title, after three months at 37 ° C and 75% relative humidity, is as follows:
Figure imgb0002

Les résultats comparatifs ci-dessus permettent d'établir la même conclusion que dans l'exemple 1A.The above comparative results make it possible to establish the same conclusion as in Example 1A.

EXEMPLE 2EXAMPLE 2

Plaquette alvéolaire pour conditionnement de comPrimés effervescents:

  • a) formule du comprimé:
    • Acide ascorbique 100 mg
    • Inositocalcium 20 mg
    • Acide tartrique 100 mg
    • Bicarbonate de sodium 100 mg
    • Chlorure de sodium 3 mg
    • Cyclamate de sodium 9 mg
    • Extrait sec d'orange 12,7 mg
    • Jaune orangé S 0,3 mg
    • Polyoxyéthylène glycol 6000 5 mg
    • Saccharose 100 mg
  • b) produit absorbant: Un tamis moléculaire
  • c) type de plaquette alvéolaire:
Blister for packaging of effervescent tablets:
  • a) tablet formula:
    • Ascorbic acid 100 mg
    • Inositocalcium 20 mg
    • Tartaric acid 100 mg
    • Sodium bicarbonate 100 mg
    • Sodium chloride 3 mg
    • Sodium cyclamate 9 mg
    • Dry orange extract 12.7 mg
    • Orange yellow S 0.3 mg
    • Polyoxyethylene glycol 6000 5 mg
    • Sucrose 100 mg
  • b) absorbent product: A molecular sieve
  • c) type of blister:

Il correspond au schéma, objet de la figure annexée 2/2. La face inférieure est formée par l'ensemble chlorure de polyvinyle + polyéthylène + chlorure de polyvinylidène; la face supérieure par une pellicule d'aluminium thermocollant.It corresponds to the diagram, object of the appended figure 2/2. The underside is formed by the polyvinyl chloride + polyethylene + polyvinylidene chloride assembly; the upper side with a fusible aluminum film.

Une telle plaquette comprend cinq groupes alvéolaires formés chacun d'un alvéole central (A) destiné à contenir le produit absorbant relié, de part et d'autre, par un canalicule à deux alvéoles récepta- des des comprimés.Such a wafer comprises five alveolar groups each formed by a central alveolus (A) intended to contain the absorbent product connected, on either side, by a canaliculus to two alveoli receiving the tablets.

Une telle plaquette contient la médication valable pour un traitement de 5 jours à la dose de 2 compri- més/jour.Such a pack contains the medication valid for a treatment of 5 days at a dose of 2 tablets / day.

d) avantages:d) advantages:

Une détermination de l'effervescence des comprimés, après un stockage de trois mois à 37°C et 75% d'humidité relative, a été effectuée pour différents conditionnements. Les résultats sont regroupés dans le tableau ci-après:

Figure imgb0003
La plaquette alvéolaire schématisée dans l'annexe 2/2 assure outre l'intérêt d'une individualisation de chaque comprimé, une parfaite conservation des dits comprimés lors du stockage puisque ceux- ci conservent leur effervescence originelle.A determination of the effervescence of the tablets, after storage for three months at 37 ° C. and 75% relative humidity, was carried out for various packages. The results are grouped in the table below:
Figure imgb0003
 The blister card shown schematically in Annex 2/2 ensures, in addition to the advantage of individualizing each tablet, perfect preservation of said tablets during storage since they retain their original effervescence.

Claims (7)

1. Single impervious packaging used for separate solid pharmaceutical bodies in the form of a card having compartments and permitting gaseous exchange between the compartments, characterised in that:
- the card comprises in its upper part a heat-sealable impervious film and in its lower part an impervious film in which compartments, interconnected by small channels, have been formed by embossing, thermoforming, or a combination of the two techniques, and
- one or more compartments are designed to contain an absorber whilst each of the others acts as a receptacle for a pharmaceutical body to be stored.
2. Packaging according to claim 1, characterised in that the materials constituting a gas barrier used for the manufacture of the card are selected from heat-sealable aluminium composite materials, thermoformable plastics materials, polypropylene and co-extruded materials based on polyvinyl alcohol resins.
3. A packaging according to claims 1 and 2, for tablets based on a product that is sensitive to moisture, characterised in that it is in the form of a card comprising in its upper part a compartment (A), for receiving an absorbent product, to which there is connected a double row of compartments (C) designed to receive the tablets; in each of these rows, the compartments (C) being arranged in pairs, on one side and on the other of a small channel connecting them to one another and to the compartment (A) containing the absorbent product.
4. A packaging according to claim 3, characterised in that the lower face of the card having compartments is formed by a polyethylene-aluminium- polyethylene composite material and the upper face by a heat-sealable aluminium foil.
5. A packaging according to claim 4, characterised in that the prepared tablets contain as active ingredient 2-(N-dicyclopropylmethyl)aminooxazoline phosphate.
6. A packaging according to claim 5, characterised in that the prepared tablets each contain 0.001544 g of 2-(N-dicyclopropylmethyl)aminooxa- zoline phosphate corresponding to 0.001 g of base.
7. A packaging according to claims 1 to 4 for effervescent tablets, characterised in that it is in the form of a card comprising five groups of compartments each formed by a central compartment (A), designed to contain the absorbent product, which is connected on one side and on the other by a small channel to two compartments for receiving tablets, the lower face of the card with compartments being formed by the composite polyvinyl chloride + polyethylene + polyvinylidene chloride and the upper face by a heatsealable aluminium foil.
EP86401152A 1986-01-22 1986-05-30 Impervious package in the form of a cellular block permitting exchanges of gas between the cells Expired EP0233418B1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AT86401152T ATE39905T1 (en) 1986-01-22 1986-05-30 TIGHT CELLULAR SHELL PACKAGING THAT ALLOWS GAS EXCHANGE BETWEEN CELLS.

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR8600837A FR2593152B1 (en) 1986-01-22 1986-01-22 WATERPROOF PACKAGING IN THE FORM OF ALVEOLAR PLATES ALLOWING FOR GAS EXCHANGES BETWEEN THE ALVEOLES.
FR8600837 1986-01-22

Publications (2)

Publication Number Publication Date
EP0233418A1 EP0233418A1 (en) 1987-08-26
EP0233418B1 true EP0233418B1 (en) 1989-01-11

Family

ID=9331356

Family Applications (1)

Application Number Title Priority Date Filing Date
EP86401152A Expired EP0233418B1 (en) 1986-01-22 1986-05-30 Impervious package in the form of a cellular block permitting exchanges of gas between the cells

Country Status (15)

Country Link
US (1) US4753352A (en)
EP (1) EP0233418B1 (en)
JP (1) JPS62182073A (en)
AT (1) ATE39905T1 (en)
AU (1) AU597254B2 (en)
DE (1) DE3661717D1 (en)
DK (1) DK163050C (en)
ES (1) ES2000557A6 (en)
FR (1) FR2593152B1 (en)
GR (1) GR861400B (en)
IE (1) IE57511B1 (en)
NZ (1) NZ216349A (en)
OA (1) OA08333A (en)
PT (1) PT82687B (en)
ZA (1) ZA864013B (en)

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Also Published As

Publication number Publication date
AU597254B2 (en) 1990-05-31
ES2000557A6 (en) 1988-03-01
PT82687A (en) 1986-11-28
DK252686D0 (en) 1986-05-29
GR861400B (en) 1986-10-02
DE3661717D1 (en) 1989-02-16
DK163050C (en) 1992-06-09
DK252686A (en) 1987-07-23
ZA864013B (en) 1987-01-28
AU5809686A (en) 1987-07-23
EP0233418A1 (en) 1987-08-26
JPS62182073A (en) 1987-08-10
FR2593152A1 (en) 1987-07-24
US4753352A (en) 1988-06-28
OA08333A (en) 1988-02-29
IE57511B1 (en) 1992-10-07
DK163050B (en) 1992-01-13
IE861433L (en) 1987-07-22
ATE39905T1 (en) 1989-01-15
NZ216349A (en) 1988-04-29
PT82687B (en) 1992-11-30
FR2593152B1 (en) 1988-12-23

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