EP0373016A1 - Dispensing device for liquids - Google Patents

Dispensing device for liquids Download PDF

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Publication number
EP0373016A1
EP0373016A1 EP19890403140 EP89403140A EP0373016A1 EP 0373016 A1 EP0373016 A1 EP 0373016A1 EP 19890403140 EP19890403140 EP 19890403140 EP 89403140 A EP89403140 A EP 89403140A EP 0373016 A1 EP0373016 A1 EP 0373016A1
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EP
European Patent Office
Prior art keywords
bellows
container
liquid
membranes
rigid
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.)
Withdrawn
Application number
EP19890403140
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German (de)
French (fr)
Inventor
Jérôme CORBIERE
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Individual
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Individual
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Publication date
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Publication of EP0373016A1 publication Critical patent/EP0373016A1/en
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Classifications

    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2089—Containers or vials which are to be joined to each other in order to mix their contents
    • 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
    • B65D81/32—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 for packaging two or more different materials which must be maintained separate prior to use in admixture
    • B65D81/3205—Separate rigid or semi-rigid containers joined to each other at their external surfaces
    • B65D81/3211—Separate rigid or semi-rigid containers joined to each other at their external surfaces coaxially and provided with means facilitating admixture
    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/201—Piercing means having one piercing end
    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/2006—Piercing means
    • A61J1/2013—Piercing means having two piercing ends
    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2003—Accessories used in combination with means for transfer or mixing of fluids, e.g. for activating fluid flow, separating fluids, filtering fluid or venting
    • A61J1/202—Separating means
    • A61J1/2027—Separating means having frangible parts
    • 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
    • A61J1/14—Details; Accessories therefor
    • A61J1/20—Arrangements for transferring or mixing fluids, e.g. from vial to syringe
    • A61J1/2093—Containers having several compartments for products to be mixed

Definitions

  • the present invention relates to a dispensing device and in particular to a dispensing device for liquid preparations.
  • This device forms an assembly in one piece making it possible to pass a solvent liquid from the upper part of the device into the lower part by pressing on the intermediate part forming a bellows, then when the solvent liquid has come into contact with the solid product or liquid, to be able to distribute the resulting solution or suspension through the nozzle after turning the device over, without introducing air and without breaking the sterility if necessary.
  • the intermediate part of the device is an important element of it because it plays several functions. It first constitutes a barrier which prevents the liquid contained in the upper part from having access to the lower part thanks to two septa placed symmetrically inside said bellows then it allows the passage of said liquid through the two septum while ensuring their perforation using a rigid perforating means and having two acute ends arranged vertically, perpendicular to each of the two septa.
  • the pressure exerted on the bellows ensures the perforation of the upper septum, which allows the descent of the solvent liquid inside the bellows then the tearing of the lower septum, and thus causes the penetration by the solvent liquid of the contents of the container.
  • the bellows consists of a flexible sleeve formed by several concentric rings joined together inside which is the upper septum consisting of a washer of semi-rigid plastic material and a lower membrane of rigid material that can easily be torn off. Between these two discs, there is the perforation means consisting of a rigid rod having at each of its ends, a tapered portion. These tapered portions can be of the same material as the stick if the latter is of sufficient hardness or else be of another harder material and which will ensure the simultaneous perforation of the two films inside said bellows.
  • the lower membrane may be provided with inwardly arranged asperities which, when the two membranes are brought into contact, will produce a greater or more multiple perforation than that produced by the perforation means and thus ensure a perforation. more extensive and faster contacting of the solvent liquid with the powder or liquid product contained in the container.
  • This bellows is fixed to the neck of the container by fitting or screwing on a symmetrical screw pitch carried by the neck of the container or by crimping on a rim of the neck.
  • the neck of the container can also carry grooves, ribs or bosses allowing perfect attachment of the bellows to the neck of the bottle without the risk of the bottle falling out during pressure or of solvent liquid being able to slip between the bellows body and bottle neck.
  • the bellows is fitted into the neck of the bottle and this assembly has no discontinuity.
  • the oblong upper part is permanently fixed to the bellows by hot or cold forming, so that these two parts of the device according to the invention are assembled in a permanent and perfectly sealed manner.
  • the terminal nozzle is of the same material as the upper part. It is terminated by a slightly softened end so as to be able to ensure its cross-section when it is put into operation.
  • the accompanying drawing provides a preferred embodiment of the device according to the invention. It shows in a sectional view, the container (1) into which the solid or liquid phase (2) is introduced. the neck of the container (3) contains the bellows device (4).
  • the sectional view shows the lower membrane (5) possibly carrying spikes or asperities (6), the upper membrane (7) and the rod of the perforation device (8) disposed between the two membranes and terminated by two tapered portions ( 9) and (9 ′).
  • the perforation device (8) is secured to the two membranes (6) and (7) by simple fitting, ensuring at the start a simple contact.
  • the two membranes (5) and (7) are arranged inside the flexible rings (10) and (10 ′) of the bellows part (4), the space between the two membranes is determined by the length of the rod ensuring perforation.
  • the total height of the bellows part (4) is of the order of 15 to 20 mm. It is formed by four rings and the length of the perforating rod (8) is 5 to 10 mm terminated by two tapered portions (9) or (9 ′) of approximately 0.5 mm to 2 mm each.
  • the thickness of the membranes (5) and (7) is of the order of 6 to 9/10 mm.
  • the thickness of the upper membrane (7) may be slightly greater than that of the lower membrane (5) so as to ensure perfect sealing and hermeticity.
  • the membrane (5) must not be too thick to prevent its clear perforation from posing a technical problem. It will preferably have a thickness of 6/10 mm.
  • the solvent liquid contained in the upper oblong portion (11) rests on the membrane (7) without completely filling the volume determined by the cap portion (12).
  • the forming nozzle dropper (13) comes from the stretching or mounting of the cap (12) and is subject to the cap (12) in a fixed and permanent manner. This nozzle is closed by a thickening of the wall (13) which is torn or cut before being put into operation.
  • the upper portion of the device according to the invention is of spherocyclindric oblong shape terminated by a cylindrical capillary tip which forms a dropper.
  • This part of the device is formed from rigid material such as polyethylene or polypropylene or polystyrene.
  • the two membranes arranged in the bellows are different in nature.
  • the lower membrane, at the base of the bellows, is an aluminum film sufficiently thin to be able to be easily perforated by pressing the rod rod but rigid enough to guarantee the tightness of the device before perforation and sterility if there is location.
  • the upper membrane is made of ethylene or propylene polymer or copolymer
  • the solvent (14) contained in the part (11) is preferably an aqueous solvent or an alcoholic solvent or a glycolic solvent which is not aggressive for the material of which the oblong part (11) is made. It is essentially an aqueous solvent such as a solution of a buffering agent or physiological serum or else distilled water.
  • aqueous solutions of propylene glycol, glycerol or polyethylene glycol can be very fluid or very viscous without this being able to pose a problem of flow.
  • the solid or liquid product (2) placed in the container (1) is generally a medicinal active principle, soluble or dispersible or miscible with the solvent (14). Mention may be made, in this regard, of anti-inflammatory products of the aryl acetic or aryl propionic or aryl butanoic acid type. A preferred example will be that of indomethacin.
  • the device according to the invention is filled sterile or in a sterile atmosphere or even under laminar flow. After filling, the entire device is sterilized by ethylene oxide or by exposure to UV rays or even by ionizing radiation.
  • the contacting of the solvent and the product (2) is carried out by stirring or rotation of the container until a homogeneous phase is obtained depending on whether the product (2) is soluble or dispersible in the solvent.
  • the resulting solution or suspension is used to obtain ready-to-use, sterile liquid preparations such as, for example, eye drops or preparations for ophthalmic use or even nasal or otological preparations.

Abstract

The invention relates to the field of mechanics, and more precisely to the field of packaging. <??>The invention relates, in particular, to a stopper and distribution device formed from three pieces, characterised in that it comprises a container (1) containing a solid or liquid product (2), a flexible intermediate part permanently fixed onto the neck of the container and formed from concentric rings joined together, inside which rings are arranged two leaktight diaphragms (5, 7) interconnected by a perforation means (8) arranged vertically, perpendicular to the plane of the two diaphragms, and an upper part (12) of cylindrical-spherical shape terminating in an elongated nozzle closed at its end. <??>The upper part contains a solvent liquid (14) which is intended to come into contact with the liquid or solid product contained in the container after compression of the flexible intermediate part and perforation of the two diaphragms. <??>The solution or suspension formed is dispensed through the upper nozzle after the end has been cut off and the device turned upside down. <??>The device according to the invention can be used in the pharmaceutical industry for making and dispensing sterile preparations such as ophthalmic auricular and nasal preparations. <IMAGE>

Description

La présente invention se rapporte à un dispositif distributeur et notamment à un dispositif distributeur pour préparations liquides.The present invention relates to a dispensing device and in particular to a dispensing device for liquid preparations.

Elle a plus particulièrement pour objet un dispositif du type flaconnage qui permet de réaliser la mise en solution ou en suspension d'un produit solide ou liquide par introduction aseptique d'un liquide solvant et la distribution dudit liquide contenant ou mélangé au produit solide ou liquide.It more particularly relates to a device of the flacon type which makes it possible to dissolve or suspend a solid or liquid product by aseptic introduction of a solvent liquid and the distribution of said liquid containing or mixed with the solid or liquid product .

Elle a spécifiquement pour objet un nouveau dispositif constitué de trois parties ; un récipient dans lequel le produit à mettre en contact avec le liquide se trouve présent, une partie intermé­diaire emboitée sur le col du récipient de texture souple formant soufflet et une partie supérieure de forme oblongue formant réservoir, terminée par un ajutage ferme à son extrémité.It specifically relates to a new device made up of three parts; a container in which the product to be brought into contact with the liquid is present, an intermediate part fitted onto the neck of the container of flexible texture forming a bellows and an upper oblong-shaped part forming a reservoir, terminated by a firm nozzle at its end.

Ce dispositif forme un ensemble d'un seul tenant permettant de faire passer un liquide solvant de la partie supérieure du dispositif dans la partie inférieure par pression sur la partie intermediaire formant soufflet, puis lorsque le liquide solvant est venu en contact avec le produit solide ou liquide, de pouvoir distribuer la solution ou suspension résultante par l'intermé­diaire de l'ajutage après retournement du dispositif, sans introduction d'air et sans rupture de la stérilité s'il y a lieu.This device forms an assembly in one piece making it possible to pass a solvent liquid from the upper part of the device into the lower part by pressing on the intermediate part forming a bellows, then when the solvent liquid has come into contact with the solid product or liquid, to be able to distribute the resulting solution or suspension through the nozzle after turning the device over, without introducing air and without breaking the sterility if necessary.

La partie intermédiaire du dispositif est un élément important de celui-ci car elle joue plusieurs fonctions. Elle constitue d'abord une barrière qui empêche le liquide contenu dans la partie supérieure d'avoir accès à la partie inférieure grâce à deux septums placés symétriquement à l'intérieur dudit soufflet puis elle permet le passage dudit liquide à travers les deux septum en assurant leur perforation à l'aide d'un moyen de perforation rigide et présentant deux extrémités aiguës disposées verticalement, perpendiculairement à chacun des deux septums.The intermediate part of the device is an important element of it because it plays several functions. It first constitutes a barrier which prevents the liquid contained in the upper part from having access to the lower part thanks to two septa placed symmetrically inside said bellows then it allows the passage of said liquid through the two septum while ensuring their perforation using a rigid perforating means and having two acute ends arranged vertically, perpendicular to each of the two septa.

La pression exercée sur le soufflet assure la perforation du septum supérieur, ce qui autorise la descente du liquide solvant à l'intérieur du soufflet puis la déchirure du septum inférieur, et ainsi entraine la pénétration par le liquide solvant du contenu du récipient.The pressure exerted on the bellows ensures the perforation of the upper septum, which allows the descent of the solvent liquid inside the bellows then the tearing of the lower septum, and thus causes the penetration by the solvent liquid of the contents of the container.

Le soufflet est constitué d'un manchon souple formé de plusieurs anneaux concentriques réunis entre eux à l'intérieur duquel, se trouve le septum supérieur constitué par une rondelle en matière plastique semi-rigide et une membrane inférieure en matériau rigide aisément déchirable. Entre ces deux disques, se trouve le moyen de perforation constitué par un bâtonnet rigide présentant à chacune de ses extrémités, une portion effilée. Ces portions effilées peuvent être du même matériau que le bâtonnet si celui-ci est d'une dureté suffisante ou bien être d'un autre matériau plus dur et qui assurera la perforation simultanée des deux pellicules à l'intérieur dudit soufflet. Le cas échéant, la membrane inférieure peut être pourvue d'aspérités disposées vers l'inté­rieur qui lors de la mise en contact des deux membranes viendront réaliser une perforation plus importante ou plus multiple que celle réalisée par le moyen de perforation et assureront ainsi une perforation plus étendue et une mise en contact plus rapide du liquide solvant avec le produit en poudre ou liquide contenu dans le récipient.The bellows consists of a flexible sleeve formed by several concentric rings joined together inside which is the upper septum consisting of a washer of semi-rigid plastic material and a lower membrane of rigid material that can easily be torn off. Between these two discs, there is the perforation means consisting of a rigid rod having at each of its ends, a tapered portion. These tapered portions can be of the same material as the stick if the latter is of sufficient hardness or else be of another harder material and which will ensure the simultaneous perforation of the two films inside said bellows. If necessary, the lower membrane may be provided with inwardly arranged asperities which, when the two membranes are brought into contact, will produce a greater or more multiple perforation than that produced by the perforation means and thus ensure a perforation. more extensive and faster contacting of the solvent liquid with the powder or liquid product contained in the container.

Ce soufflet est assujetti au goulot du récipient par emboitage ou par vissage sur un pas de vis symétrique porté par le col du récipient ou par sertissage sur un rebord du goulot. Le col du récipient peut également porter des cannelures, des nervures ou des bossages permettant un parfait assujettissement du soufflet au col du flacon sans risque que celui-ci ne se désemboite au cours de la pression ou que du liquide solvant ne puisse se glisser entre le corps du soufflet et le goulot du flacon. De préférence, le soufflet est emboité dans le col du flacon et cet assemblage ne présente aucune discontinuité.This bellows is fixed to the neck of the container by fitting or screwing on a symmetrical screw pitch carried by the neck of the container or by crimping on a rim of the neck. The neck of the container can also carry grooves, ribs or bosses allowing perfect attachment of the bellows to the neck of the bottle without the risk of the bottle falling out during pressure or of solvent liquid being able to slip between the bellows body and bottle neck. Preferably, the bellows is fitted into the neck of the bottle and this assembly has no discontinuity.

La partie supérieure oblongue est fixée d'une manière permanente au soufflet par formage à chaud ou à froid, de manière à ce que ces deux parties du dispositif selon l'invention soient assemblées d'une manière permanente et parfaitement étanche.The oblong upper part is permanently fixed to the bellows by hot or cold forming, so that these two parts of the device according to the invention are assembled in a permanent and perfectly sealed manner.

L'ajutage terminal est du même matériau que la partie supérieure. Il est terminé par une extrémité légèrement adoucie de façon à pouvoir en assurer la section au moment de la mise en fonctionnent.The terminal nozzle is of the same material as the upper part. It is terminated by a slightly softened end so as to be able to ensure its cross-section when it is put into operation.

Dans un mode d'exécution préféré de l'invention, le dispositif se définit plus précisement par les caractéristiques suivantes :

  • 1. le récipient est un flacon en verre ou en matière plastique rigide ou semi-rigide dans lequel le produit solide ou liquide à mettre en contact avec le liquide solvant, est disposé au préalable. Le goulot dudit récipient reçoit la portion intermédiaire formant soufflet par emboitage ou par sertissage selon la nature du matériau dont l'une et l'autre pièces sont formées. La partie intermédiaire et le goulot du flacon pourront être soudés ensemble s'ils sont réalisés dans un matériau thermosoudable.
  • 2. la partie intermédiaire formant soufflet, assujettie au col du récipient est constituée de quatre ou cinq anneaux souples concentriques présentant cependant une rigidité suffisante pour soutenir la portion oblongue supérieure et pour assurer commodément une pression sur ces anneaux. La pression sera de nature à mettre le moyen de perforation en contact avec les deux membranes de façon à en assurer la perforation. Cette partie intermédiaire sera, en outre, d'une hauteur appropriée pour assurer la préhension par appui sur les rebords inférieurs et supérieurs sans que la pression à exercer requiert un effort physique d'importance. Une simple pression des doigts doit convenir pour assurer cette double perforation et permettre le passage du liquide solvant.
  • 3. la partie supérieure du dispositif selon l'invention forme un ensemble permanent avec le soufflet. Elle présente une partie cylindrique terminée par une portion en forme de calotte plus ou fins sphérique ou ovoïde. L'ajutage au sommet se présente sous la forme d'un petit tube de quelques millimètres assurant la dispensation de la solution ou de la suspension réalisée.
In a preferred embodiment of the invention, the device is more precisely defined by the following characteristics:
  • 1. the container is a glass or rigid or semi-rigid plastic bottle in which the solid or liquid product to be brought into contact with the solvent liquid is placed beforehand. The neck of said container receives the intermediate portion forming a bellows by fitting or crimping according to the nature of the material of which one and the other parts are formed. The intermediate part and the neck of the bottle can be welded together if they are made of a heat-sealable material.
  • 2. the intermediate portion forming a bellows, subject to the neck of the container, consists of four or five concentric flexible rings, however having sufficient rigidity to support the upper oblong portion and to conveniently ensure pressure on these rings. The pressure will be such as to bring the perforation means into contact with the two membranes so as to ensure their perforation. This intermediate part will also be of an appropriate height to ensure gripping by pressing on the lower and upper edges without the pressure to be exerted requiring significant physical effort. A simple pressure of the fingers must be suitable to ensure this double perforation and allow the passage of the solvent liquid.
  • 3. the upper part of the device according to the invention forms a permanent assembly with the bellows. It presents a part cylindrical ending in a portion in the shape of a more or fine spherical or ovoid cap. The nozzle at the top is in the form of a small tube of a few millimeters ensuring the dispensing of the solution or suspension produced.

Le dessin ci-annexé fournit un mode de réalisation préféré du dispositif selon l'invention. Il montre selon une vue en coupe, le récipient (1) dans lequel la phase solide ou liquide (2) est introduite. le goulot du récipient (3) contient le dispositif faisant soufflet (4). La vue en coupe montre la membrane inférieure (5) portant éventuellement des picots ou des aspérités (6), la membrane supérieure (7) et la tige du dispositif de perforation (8) disposée entre les deux membranes et terminée par deux portions effilées (9) et (9′). Le dispositif de perforation (8) est assujetti aux deux membranes (6) et (7) par simple emboitage en assurant au départ un contact simple.The accompanying drawing provides a preferred embodiment of the device according to the invention. It shows in a sectional view, the container (1) into which the solid or liquid phase (2) is introduced. the neck of the container (3) contains the bellows device (4). The sectional view shows the lower membrane (5) possibly carrying spikes or asperities (6), the upper membrane (7) and the rod of the perforation device (8) disposed between the two membranes and terminated by two tapered portions ( 9) and (9 ′). The perforation device (8) is secured to the two membranes (6) and (7) by simple fitting, ensuring at the start a simple contact.

Les deux membranes (5) et (7) sont disposées à l'intérieur des anneaux souples (10) et (10′) de la partie en soufflet (4), l'espace entre les deux membranes est déterminé par la longueur de la tige assurant la perforation. Dans le cas considéré, la hauteur totale de la partie faisant soufflet (4) est de l'ordre de 15 à 20 mm. Elle est formée de quatre anneaux et la longueur de la tige perforatrice (8) est de 5 à 10 mm terminée par deux portions effilées (9) ou (9′) d'environ 0,5 mm à 2 mm chacune.The two membranes (5) and (7) are arranged inside the flexible rings (10) and (10 ′) of the bellows part (4), the space between the two membranes is determined by the length of the rod ensuring perforation. In the case under consideration, the total height of the bellows part (4) is of the order of 15 to 20 mm. It is formed by four rings and the length of the perforating rod (8) is 5 to 10 mm terminated by two tapered portions (9) or (9 ′) of approximately 0.5 mm to 2 mm each.

L'épaisseur des membranes (5) et (7) est de l'ordre de 6 à 9/10è de mm. L'épaisseur de la membrane supérieure (7) pourra être un peu plus importante que celle de la membrane inférieur (5) de façon à assurer une étanchéité et une herméticité parfaite.The thickness of the membranes (5) and (7) is of the order of 6 to 9/10 mm. The thickness of the upper membrane (7) may be slightly greater than that of the lower membrane (5) so as to ensure perfect sealing and hermeticity.

La membrane (5) ne doit pas être trop épaisse pour éviter que sa perforation nette pose un problème technique. Elle aura de préférence, une épaisseur de 6/10 de mm.The membrane (5) must not be too thick to prevent its clear perforation from posing a technical problem. It will preferably have a thickness of 6/10 mm.

Le liquide solvant contenu dans la portion oblongue supérieure (11) repose sur la membrane (7) sans remplir complètement le volume déterminé par la portion en calotte (12). L'ajutage formant compte gouttes (13) provient de l'étirement ou du montage de la calotte (12) et se trouve assujetti à la calotte (12) d'une manière fixe et permanente. Cet ajutage est obturé par un épaississement de la paroi (13) que l'on déchire ou coupe avant mise en fonctionnent.The solvent liquid contained in the upper oblong portion (11) rests on the membrane (7) without completely filling the volume determined by the cap portion (12). The forming nozzle dropper (13) comes from the stretching or mounting of the cap (12) and is subject to the cap (12) in a fixed and permanent manner. This nozzle is closed by a thickening of the wall (13) which is torn or cut before being put into operation.

La portion supérieure du dispositif selon l'invention est de forme oblongue sphérocyclindrique terminée par un embout capillaire cylindrique qui forme compte-gouttes. Cette partie du dispositif est formée en matériau rigide comme un polyéthylène ou un polypropylène ou un polystyrène.The upper portion of the device according to the invention is of spherocyclindric oblong shape terminated by a cylindrical capillary tip which forms a dropper. This part of the device is formed from rigid material such as polyethylene or polypropylene or polystyrene.

Les deux membranes disposées dans le soufflet sont de nature différente. La membrane inférieure, à la base du soufflet, est une pellicule d'Aluminium suffisamment mince pour pouvoir être perforée aisément par pression de la tige du bâtonnet mais suffisamment rigide pour garantir l'étanchéité du dispositif avant perforation et la stérilité s'il y a lieu. La membrane supérieure est en polymère ou copolymère d'éthylène ou de propylèneThe two membranes arranged in the bellows are different in nature. The lower membrane, at the base of the bellows, is an aluminum film sufficiently thin to be able to be easily perforated by pressing the rod rod but rigid enough to guarantee the tightness of the device before perforation and sterility if there is location. The upper membrane is made of ethylene or propylene polymer or copolymer

Le solvant (14) contenu dans la partie (11) est de préférence un solvant aqueux ou un solvant alcoolique ou un solvant glycolique non agressif pour le matériau dont est constitué la partie oblongue (11). Il s'agit essentiellement d'un solvant aqueux comme une solution d'un agent tampon ou de sérum physiologique ou bien d'eau distillée.The solvent (14) contained in the part (11) is preferably an aqueous solvent or an alcoholic solvent or a glycolic solvent which is not aggressive for the material of which the oblong part (11) is made. It is essentially an aqueous solvent such as a solution of a buffering agent or physiological serum or else distilled water.

Cn peut également utiliser des solutions aqueuses de propylène glycol, de glycérol ou de polyéthylène glycol. Le solvant peut être très fluide ou très visqueux sans que cela puisse poser un problème d'écoulent.It is also possible to use aqueous solutions of propylene glycol, glycerol or polyethylene glycol. The solvent can be very fluid or very viscous without this being able to pose a problem of flow.

Le produit solide ou liquide (2) placé dans le récipient (1) est en général un principe actif médicamenteux, soluble ou dispersible ou miscible au solvant (14). On pourra citer, à cet égard, des produits anti-inflammatoires du type acide aryl acétique ou aryl propionique ou aryl butanoïque. Un exemple préféré sera celui de l'indométhacine.The solid or liquid product (2) placed in the container (1) is generally a medicinal active principle, soluble or dispersible or miscible with the solvent (14). Mention may be made, in this regard, of anti-inflammatory products of the aryl acetic or aryl propionic or aryl butanoic acid type. A preferred example will be that of indomethacin.

Le dispositif selon l'invention est rempli stérilement ou en atmosphère stérile ou bien encore, sous flux laminaire. Après remplissage, l'ensemble du dispositif est stérilisé par l'oxyde d'éthylène ou par exposition aux rayons UV ou bien encore par un rayonnement ionisant.The device according to the invention is filled sterile or in a sterile atmosphere or even under laminar flow. After filling, the entire device is sterilized by ethylene oxide or by exposure to UV rays or even by ionizing radiation.

La mise en contact du solvant et du produit (2) s'effectue par agitation ou rotation du récipient jusqu'à obtention d'une phase homogène selon que le produit (2) est soluble ou dispersible dans le solvant.The contacting of the solvent and the product (2) is carried out by stirring or rotation of the container until a homogeneous phase is obtained depending on whether the product (2) is soluble or dispersible in the solvent.

La solution ou suspension résultante sert à l'obtention de préparations liquides prêtes à l'emploi, stériles comme par exemple des collyres ou des préparations à l'usage ophtalmique ou bien encore des préparations nasales ou otologiques.The resulting solution or suspension is used to obtain ready-to-use, sterile liquid preparations such as, for example, eye drops or preparations for ophthalmic use or even nasal or otological preparations.

Claims (11)

1°- Un dispositif distributeur pour préparations liquides constitué de trois parties formant un ensemble d'un seul tenant caractérisé en ce qu'il est formé d'un récipient, d'une partie intermédiaire de texture souple formant soufflet emboité sur le col du récipient et d'une partie supérieure surmontant le soufflet, de forme arrondie, formant réservoir terminée par un ajutage ferme à son extrémité.1 ° - A dispensing device for liquid preparations consisting of three parts forming a whole in one piece characterized in that it is formed of a container, of an intermediate part of flexible texture forming bellows fitted on the neck of the container and of an upper part surmounting the bellows, of rounded shape, forming a reservoir terminated by a firm nozzle at its end. 2°- Un dispositif distributeur selon la revendication 1° dans lequel le récipient est rempli d'un produit liquide ou solide.2 ° - A dispensing device according to claim 1 ° wherein the container is filled with a liquid or solid product. 3°- Un dispositif distributeur selon la revendication 1° dans lequel la partie intermédiaire est constituée d'un manchon souple formé de plusieurs anneaux concentriques réunis entre eux à l'intérieur duquel se trouvent disposés deux membranes étanches séparées par un moyen de perforation rigide présentant deux extrémités effilées, disposé verticalement, perpendiculairement à chacune des deux membranes.3 ° - A dispensing device according to claim 1 ° wherein the intermediate part consists of a flexible sleeve formed by several concentric rings joined together inside which are arranged two waterproof membranes separated by a rigid perforation means having two tapered ends, arranged vertically, perpendicular to each of the two membranes. 4°- Un dispositif selon la revendication 1° dans lequel la partie supérieure oblongue se présente sous la forme d'une portion cylindrique assujettie d'une manière permanente au soufflet et surmontée par une portion en forme de calotte, sphérique ou ovoïde, qui est terminée par un ajutage cylindrique obturé à son extrémité.4 ° - A device according to claim 1 ° in which the oblong upper part is in the form of a cylindrical portion permanently fixed to the bellows and surmounted by a cap-shaped portion, spherical or ovoid, which is terminated by a cylindrical nozzle closed at its end. 5°- Un dispositif selon l'une des revendications 1 à 4° dans lequel le récipient est un flacon rigide ou semi-rigide dans lequel le produit liquide ou pulvérulent est disposé au préalable.5 ° - A device according to one of claims 1 to 4 ° wherein the container is a rigid or semi-rigid bottle in which the liquid or pulverulent product is disposed beforehand. 6°- Un dispositif selon l'une des revendications 1 à 5° dans lequel la portion intermédiaire faisant soufflet est emboitée ou sertie sur le goulot du flacon d'une manière permanente.6 ° - A device according to one of claims 1 to 5 ° wherein the intermediate portion forming a bellows is fitted or crimped on the neck of the bottle in a permanent manner. 7°- Un dispositif selon l'une des revendications 1 à 6° dans lequel la partie intermédiaire formant soufflet est constituée d'une pluralité d'anneaux souples concentriques, à l'intérieur desquels, les deux membranes sont disposées l'une au-dessus de l'autre séparées par une tige perforatrice comportant deux extrémités effilées.7 ° - A device according to one of claims 1 to 6 ° wherein the intermediate portion forming bellows consists of a plurality of concentric flexible rings, inside which, the two membranes are arranged one au- above the other separated by a perforating rod having two tapered ends. 8°- Un dispositif selon l'une des revendications 1 à 7° dans lequel la membrane supérieure possède une épaisseur de l'ordre de 6 à 9/10 de mm.8 ° - A device according to one of claims 1 to 7 ° wherein the upper membrane has a thickness of the order of 6 to 9/10 of mm. 9°- Un dispositif selon l'une des revendications 1 à 7° dans lequel la membrane inférieure possède une épaisseur de 6 à 9/10 de mm et présente sur sa face supérieure un ou plusieurs picots ou aspérités.9 ° - A device according to one of claims 1 to 7 ° wherein the lower membrane has a thickness of 6 to 9/10 mm and has on its upper face one or more pins or roughness. 10°- Un dispositif selon l'une des revendications 1 à 7° dans lequel le moyen de perforation est une tige rigide ayant de 5 à 10 mm terminée à chaque extrémité par une partie pointue d'environ 0,5 mm à 2 mm chacune.10 ° - A device according to one of claims 1 to 7 ° wherein the perforation means is a rigid rod having 5 to 10 mm terminated at each end by a pointed part of about 0.5 mm to 2 mm each . 11°- En tant que moyen pour la réalisation de l'invention, la partie du dispositif formant soufflet constituée d'une pluralité d'anneaux concentriques reliés entre eux et portant à l'intérieur deux membranes disposées l'une au-dessus de l'autre en matériau déchirable et séparées par une tige perforatrice comportant deux extrémités effilées.11 ° - As a means for carrying out the invention, the part of the bellows device consisting of a plurality of concentric rings connected together and carrying inside two membranes arranged one above the other in tearable material and separated by a perforating rod having two tapered ends.
EP19890403140 1988-12-05 1989-11-15 Dispensing device for liquids Withdrawn EP0373016A1 (en)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
FR8815886 1988-12-05
FR8815886A FR2639914B1 (en) 1988-12-05 1988-12-05 NEW DISPENSING DEVICE FOR LIQUID PREPARATIONS

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EP0373016A1 true EP0373016A1 (en) 1990-06-13

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US (1) US5071034A (en)
EP (1) EP0373016A1 (en)
FR (1) FR2639914B1 (en)

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ES2032359A1 (en) * 1990-10-08 1993-02-01 Rhone Poulenc Quimica S A System for soil application of mineral nutrient supplements and organic soil conditioners, notably in gardens and household recipients.
WO2007038773A1 (en) * 2005-09-28 2007-04-05 Biodel, Inc. Self-filling two chamber injectable device
US7882859B2 (en) 2006-03-02 2011-02-08 Bernd Hansen System for preparing and making available a flowable medium formed by mixing a dry substance with a fluid
WO2007098801A1 (en) * 2006-03-02 2007-09-07 Bernd Hansen System for preparing and making available a flowable medium formed by mixing a dry substance with a fluid
EP2186748A1 (en) * 2008-05-05 2010-05-19 Stanislaw Veniaminovih Sawinskiy Cover container for self-contained mixing
EP2186748A4 (en) * 2008-05-05 2010-09-15 Stanislaw Veniaminovih Sawinskiy Cover container for self-contained mixing
FR2937957A1 (en) * 2008-10-30 2010-05-07 Baby Milk Vessel for use in infant's feeding bottle, has rupture structure arranged inside compartment for successively causing rupture of portions of central walls of vessel during deformation of vessel
EP2371343B1 (en) * 2010-04-01 2015-12-02 Siemens Healthcare Diagnostics Products GmbH Device for storing and metering a solution
WO2011124946A1 (en) * 2010-04-06 2011-10-13 Leonardo Palmeri Compartmentalized container
WO2012137091A1 (en) * 2011-04-05 2012-10-11 Wyeth Llc Cap with additive chamber and associated packaging unit
JP2014513015A (en) * 2011-04-05 2014-05-29 ワイス・エルエルシー Cap with additional chamber and associated packaging unit
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FR2639914A1 (en) 1990-06-08
FR2639914B1 (en) 1991-03-22
US5071034A (en) 1991-12-10

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