EP0793954A1 - Ensemble de conditionnement pour préparations lyophilisées - Google Patents

Ensemble de conditionnement pour préparations lyophilisées Download PDF

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Publication number
EP0793954A1
EP0793954A1 EP19970480007 EP97480007A EP0793954A1 EP 0793954 A1 EP0793954 A1 EP 0793954A1 EP 19970480007 EP19970480007 EP 19970480007 EP 97480007 A EP97480007 A EP 97480007A EP 0793954 A1 EP0793954 A1 EP 0793954A1
Authority
EP
European Patent Office
Prior art keywords
bottle
communication
bottles
stopper
recesses
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Withdrawn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
EP19970480007
Other languages
German (de)
English (en)
French (fr)
Inventor
Charles Manni
Jean-Pierre Augier
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Individual filed Critical Individual
Publication of EP0793954A1 publication Critical patent/EP0793954A1/fr
Withdrawn legal-status Critical Current

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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
    • B65D51/00—Closures not otherwise provided for
    • B65D51/24—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes
    • B65D51/241—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes provided with freeze-drying means
    • 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

Definitions

  • the present invention relates to an improvement to assemblies intended for the extemporaneous preparation of solutions or suspensions of a solid active product, and in particular to an assembly of this type, the closure cap of the bottle containing the active product allows better product efficacy. active, both in quality and quantity.
  • Such an assembly consists on the one hand of two hermetic bottles, the first of these bottles being intended to contain said active product generally in the form of dry lyophilized powder , and the second being intended to contain the liquid in which the said product must be dissolved or in suspension at the time of its administration, and on the other hand a connecting piece allowing the communication of these two bottles, in view, firstly, of introducing said liquid into the first bottle then, secondly, of sucking into the second bottle the solution or suspension thus formed.
  • the first bottle A is rigid, for example made of glass, and closed by an elastomer stopper covered with a perforable cover, which is inserted into the neck of the bottle and has an axial channel.
  • the second bottle B made of flexible material, is closed by a dropper whose conical and rounded end has a diameter slightly smaller than that of the axial channel of the stopper.
  • the stilligout comes to penetrate the stopper of the rigid bottle, while maintaining the seal between the two bottles.
  • By compressing the second bottle it causes the passage of the liquid in the first bottle.
  • the suspension or solution is created, then by inverting the assembly and by successive pressures on the second bottle, the said solution or suspension is returned to the second bottle where it is easy to enclose it by placing a stopper on the stillicer.
  • the second bottle thanks to its dropper whose end is conical and rounded, can then be used for multiple pharmaceutical, cosmetic or other uses without the user running the risk of injury.
  • the rigid bottle has a stopper comprising an axial hole which is far preferable to a stopper comprising a slot preformed in a wall of deformable material as is the case of the device described in EP-A-0.138 .681. Indeed, it is on the one hand difficult if not impossible to correctly insert the stillicer through the wall of deformable material if its end is not pointed. And, on the other hand, the operation consisting in returning the solution (or suspension) from the rigid bottle into the bottle provided with the dropper becomes technically very difficult since the opening located at the pointed end of the dropper is very restricted in this case.
  • the object of the invention is to provide a packaging assembly of the type with two bottles placed in communication as described above, but having a stopper which does not have the abovementioned drawbacks.
  • Another object of the invention is to provide a packaging unit of the above type for which the bottles are closed during the lyophilization phase.
  • Yet another object of the invention is to provide a packaging unit of the above type for which there is no risk of contamination of the active product when the two bottles are placed in communication.
  • the main object of the invention is therefore a packaging assembly intended for the extemporaneous preparation of suspensions or solutions of a solid active product in a liquid product, the active product having undergone lyophilization and being contained in a bottle A, and the liquid product being contained in a bottle B closed by a dropper, a connecting piece allowing the communication of the two bottles in view, initially passing the liquid from the bottle B into the bottle A containing the solid, then, in a second step, invert the assembly and aspirate the suspension or solution thus formed in the bottle B, the bottle A containing the active product being closed by an elastomer stopper.
  • the assembly is characterized in that the stopper closing the bottle A comprises a central perforation making it possible to put the bottles A and B in communication, several lateral recesses (36, 38, 40 and 42) so that the lyophilization phase of the active product is applied to the bottle A in which the stopper is only partially depressed so that the gases resulting from the lyophilization are evacuated outside the bottle by passing through the lateral recesses, and a cover perforable by the stillised when the bottles are placed in communication by means of the connecting piece, the cover being made of aluminum sealed on the stopper by means of a sealable plastic film.
  • Another object of the invention is a packaging unit as defined above in which the upper part of the recesses of the plug is placed in communication with the central perforation of the latter so as to be able to suck all of the the suspension or solution formed after placing the two bottles in communication and inverting the assembly.
  • the bottle designated by the reference A to be distinguished from the other bottle having the reference B, is closed by an elastomeric stopper 10 having a vertical perforation 12 and surmounted by a perforable aluminum cover 14 fixed on the stopper 10.
  • the bottle A is supplied to the customer by being equipped with a connecting piece 16 covering the neck of the bottle A and which will be used to put the bottle A in communication with the bottle B containing the liquid product making it possible to put the active principle P in solution or in suspension.
  • the connecting piece 16 comprises an upper portion 18 in the form of a socket having an internal thread for screwing the bottle B into it, and a lower portion 20 which is fixed to the bottle by snap-fastening on a shoulder of the neck of the bottle A When supplied to the customer, the connecting piece 16 is capped with a cap 21.
  • the top of the upper portion 18 of the connecting piece 16 can be closed by a self-breaking seal 22 forming a single molding piece with the connecting piece as illustrated in FIG. 2.
  • This self-breaking cover 22 can easily be separated from the connecting piece 16 by pushing on an eccentric vertical bar 24 comprising a strut 26 and connected to the connecting piece 16 by a thin wall.
  • a second bottle B is placed in communication with the bottle A as illustrated in FIG. 3.
  • the bottle B made of compressible plastic material and containing the solvent, is turned over and screwed into the upper portion 18 of the connecting piece 16 by means of an external thread adapted to the internal thread of the portion 18.
  • the threaded cylindrical part 28 is extended by a dropper 30, which, when the bottle B is screwed into the connecting piece, punctures the lid 14 of the stopper 10 of the bottle A and opens into the perforation 12, putting in communication the two bottles A and B. Then, by compressing the bottle B, one causes the passage of the liquid solvent in the bottle A. Then by shaking the whole, one creates the solution of active principle. Finally, by inverting the assembly and applying successive pressures on the bottle B, the solution is returned to the bottle B which is thus ready for use.
  • bottle A is packaged by freeze-drying. During this lyophilization process, it is necessary for the liquid contained in the active ingredient A to have evaporated in order to avoid any trace of humidity, which was the case when the capped antibiotic type caps were installed at the outlet of the lyophilizer in the prior art. It is to avoid such a risk that the plug 10 shown in FIGS. 4, 5 and 6 has a particular shape as explained below.
  • the elastomer stopper 10 comprises a plate 32 which covers the opening of the neck of the bottle A when the stopper is pressed.
  • the plate 32 is covered with a sealed aluminum cover as we will see later.
  • the part 34 intended to be inserted into the neck of the bottle is extended by a portion having a sectional shape illustrated in FIG. 6, that is to say that the elastomer cylinder comprises four identical vertical recesses 36, 38, 40 and 42 , the recess 36 being highlighted in FIG. 5.
  • the stopper On each of the four non-recessed portions separating the recesses, there is a stop 44, 46, 48 or 50. Finally, as mentioned previously, the stopper has a central perforation 12 intended to put the bottles A and B in communication when the stillised perforated the lid 14.
  • the glass vials containing the active ingredient are subjected to lyophilization, they are placed in the lyophilizer with the caps already placed in the vials.
  • the plugs are not fully inserted into the necks, but only partially, the stops 44, 46, 48 and 50 resting on the edge of the neck.
  • the gases are therefore evacuated from the bottles thanks to the four lateral recesses of each stopper.
  • the final insertion of the plugs is carried out by exerting a force at the top which allows the solid cylindrical portion 34 to be introduced into the neck.
  • the first problem which has been solved by this invention is due to the configuration of the plug.
  • the lateral recesses 36, 38, 40 and 42 are necessary in the lyophilization phase.
  • part of the product may remain in these recesses because the passage of the product from one bottle to the other takes place through the central hole 12, the inlet of which is higher than the recesses. This portion of the unused product is not negligible and represents a loss for the customer.
  • the plug 10 has two horizontal holes 52 (see FIG. 5) and 54 (see FIG. 4) putting the recesses in communication with the central hole 12.
  • the hole 52 puts the recess 36 and the recess 40 in communication with the central hole while the hole 54 communicates the recess 38 and the recess 42 with the central hole.
  • the cover is fixed by sealing on the stopper.
  • a layer of aluminum is superimposed on a thin polyethylene film.
  • an instant softening means of the polyethylene layer so as to strongly adhere it to the aluminum during the curing which follows this treatment.
  • Such sealing is preferably carried out by compressing the seal on the stopper and applying ultrasound to the aluminum-polyethylene assembly, but can be achieved by any other means.
  • the plugs thus closed are then sterilized with steam without danger of detachment of the polyethylene layer.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Closures For Containers (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Package Specialized In Special Use (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
  • Drying Of Solid Materials (AREA)
EP19970480007 1996-03-04 1997-02-28 Ensemble de conditionnement pour préparations lyophilisées Withdrawn EP0793954A1 (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
FR9602921 1996-03-04
FR9602921A FR2745492B1 (fr) 1996-03-04 1996-03-04 Ensemble de conditionnement pour preparations lyophilisees
US08/632,525 US5740654A (en) 1996-03-04 1996-04-12 Packaging assembly for freeze-dried preparations

Publications (1)

Publication Number Publication Date
EP0793954A1 true EP0793954A1 (fr) 1997-09-10

Family

ID=26232573

Family Applications (1)

Application Number Title Priority Date Filing Date
EP19970480007 Withdrawn EP0793954A1 (fr) 1996-03-04 1997-02-28 Ensemble de conditionnement pour préparations lyophilisées

Country Status (4)

Country Link
US (1) US5740654A (ja)
EP (1) EP0793954A1 (ja)
JP (1) JPH09240752A (ja)
FR (1) FR2745492B1 (ja)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000002795A1 (en) * 1998-07-10 2000-01-20 Pentapharm Ag Dual vial connecting system

Families Citing this family (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5884678A (en) * 1996-12-27 1999-03-23 Chudy; Dennis J. Connector device for holding two necks in an abutting relationship
SE9902610D0 (sv) * 1999-07-07 1999-07-07 Astra Ab Förslutningsanordning vid medicinsk behållare
US6745802B2 (en) 2001-07-16 2004-06-08 Carole Varga Bottle drainage coupler
US6910720B2 (en) 2001-08-10 2005-06-28 Gen-Probe Incorporated Connector for use in combining the contents of a pair of containers
JP4278362B2 (ja) * 2001-11-05 2009-06-10 大成化工株式会社 用時混合容器、並びに、バイアル瓶
US6779566B2 (en) 2003-01-14 2004-08-24 Access Business Group International Llc Connector device for sealing and dispensing freeze-dried preparations
CA2585149A1 (en) * 2004-10-27 2006-05-04 Glaxosmithkline Biologicals S.A. Process for preparing a lyophilised material
FR2893926B1 (fr) * 2005-11-25 2010-05-21 Sanofi Aventis Douille pour la reception de goulot stilligoutte, conditionnement et kit correspondants
DE202011050413U1 (de) * 2011-06-10 2012-09-11 Helvoet Pharma Belgium N.V. Kolbenstopfen für eine Lyophilisations-Einheit
WO2014028745A2 (en) * 2012-08-17 2014-02-20 Archon Pharmaceutical Consulting Llc A system for compounding and packaging ready to reconstitute drug powders of solutions to a solution or to a suspension or to an injectable
JP6960266B2 (ja) * 2017-07-24 2021-11-05 東急建設株式会社 粘性流体の収容容器用架台
US11633329B2 (en) 2017-09-15 2023-04-25 Amsino Medical (Shangha) Co., Ltd. Feeding system for treating liquid medical waste
CN207174020U (zh) * 2017-09-15 2018-04-03 美昕医疗器械（上海）有限公司 外加料系统
WO2019113276A1 (en) * 2017-12-08 2019-06-13 Unipharma, Llc Container and method for reconstitution of substances
CN115158889B (zh) * 2022-09-05 2022-11-29 常州远望流体科技有限公司 包装瓶

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1547380A (fr) * 1965-12-02 1968-11-29 Pharma Gummi Hans Wimmer Fa Obturateur pour flacons subissant un séchage par réfrigération
FR2188565A5 (ja) * 1972-06-13 1974-01-18 Semco Emballage Conditio
FR2427960A1 (fr) * 1978-06-06 1980-01-04 Dehais Claude Manchon pour etablir une communication temporaire entre deux recipients
EP0138681A2 (en) * 1983-09-26 1985-04-24 LABORATOIRES MERCK, SHARP & DOHME-CHIBRET Assembly for preparing and dispensing a solution
DE3626923A1 (de) * 1986-08-08 1988-02-18 Rass Richard Spritzgusswerk Kg Deckel aus kunststoff fuer einen insbesondere lebensmittel enthaltenden behaelter aus flexiblem material, insbesondere aus klarsichtigem kunststoff
US4795043A (en) * 1986-11-06 1989-01-03 Astra Plastique Cap for container initially closed by a frangible lid
FR2682088A1 (fr) * 1991-10-04 1993-04-09 Emballages Conditionnement Conditionnement pour la preparation extemporanee de produits medicamenteux.

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE1629035B1 (de) * 1965-12-02 1972-03-09 Wimmer Pharma Gummi Gmbh Stopfen fuer Flaschen fuer gefrierzutrocknendes Gut
US3773205A (en) * 1971-03-04 1973-11-20 Klm Co Stratford Thermoformed closures which are sealed to containers by the use of sonic energy and the method of sealing the same
US4747502A (en) * 1986-10-07 1988-05-31 Ethyl Molded Products Company Vented beverage closure
US4986322A (en) * 1987-03-24 1991-01-22 Societe Semco System of packaging for ready to use preparations
FR2616656A1 (fr) * 1987-06-22 1988-12-23 Lille Transfusion Sanguine Pulverisateur de produits steriles, notamment de solutions aseptiques pour traitements medicaux et chirurgicaux
US4982769A (en) * 1990-02-21 1991-01-08 Survival Technology, Inc. Package
US5197620A (en) * 1992-04-27 1993-03-30 Owens-Illinois Closure Inc. Venting closure

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1547380A (fr) * 1965-12-02 1968-11-29 Pharma Gummi Hans Wimmer Fa Obturateur pour flacons subissant un séchage par réfrigération
FR2188565A5 (ja) * 1972-06-13 1974-01-18 Semco Emballage Conditio
FR2427960A1 (fr) * 1978-06-06 1980-01-04 Dehais Claude Manchon pour etablir une communication temporaire entre deux recipients
EP0138681A2 (en) * 1983-09-26 1985-04-24 LABORATOIRES MERCK, SHARP & DOHME-CHIBRET Assembly for preparing and dispensing a solution
DE3626923A1 (de) * 1986-08-08 1988-02-18 Rass Richard Spritzgusswerk Kg Deckel aus kunststoff fuer einen insbesondere lebensmittel enthaltenden behaelter aus flexiblem material, insbesondere aus klarsichtigem kunststoff
US4795043A (en) * 1986-11-06 1989-01-03 Astra Plastique Cap for container initially closed by a frangible lid
FR2682088A1 (fr) * 1991-10-04 1993-04-09 Emballages Conditionnement Conditionnement pour la preparation extemporanee de produits medicamenteux.

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2000002795A1 (en) * 1998-07-10 2000-01-20 Pentapharm Ag Dual vial connecting system

Also Published As

Publication number Publication date
FR2745492B1 (fr) 1998-06-12
US5740654A (en) 1998-04-21
FR2745492A1 (fr) 1997-09-05
JPH09240752A (ja) 1997-09-16

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