Nothing Special   »   [go: up one dir, main page]

US20110186451A1 - Prefilled container insert for mixing two or more ingredients for use in a pharmaceutical container system - Google Patents

Prefilled container insert for mixing two or more ingredients for use in a pharmaceutical container system Download PDF

Info

Publication number
US20110186451A1
US20110186451A1 US13/058,348 US200913058348A US2011186451A1 US 20110186451 A1 US20110186451 A1 US 20110186451A1 US 200913058348 A US200913058348 A US 200913058348A US 2011186451 A1 US2011186451 A1 US 2011186451A1
Authority
US
United States
Prior art keywords
container
casing
prefilled
insert
pharmaceutical
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.)
Abandoned
Application number
US13/058,348
Other languages
English (en)
Inventor
Pontus Dersjö
Anders Löfgren
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.)
AstraZeneca AB
Original Assignee
AstraZeneca AB
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 AstraZeneca AB filed Critical AstraZeneca AB
Priority to US13/058,348 priority Critical patent/US20110186451A1/en
Assigned to ASTRAZENECA AB reassignment ASTRAZENECA AB ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: DERSJO, PONTUS, LOFGREN, ANDERS
Publication of US20110186451A1 publication Critical patent/US20110186451A1/en
Abandoned legal-status Critical Current

Links

Images

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B65—CONVEYING; PACKING; STORING; HANDLING THIN OR FILAMENTARY MATERIAL
    • B65B—MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING
    • B65B29/00—Packaging of materials presenting special problems
    • B65B29/10—Packaging two or more different substances isolated from one another in the package but capable of being mixed without opening the package, e.g. forming packages containing a resin and hardener isolated by a frangible partition
    • 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
    • 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
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • 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
    • B65D25/00—Details of other kinds or types of rigid or semi-rigid containers
    • B65D25/02—Internal fittings
    • B65D25/04—Partitions
    • B65D25/08—Partitions with provisions for removing or destroying, e.g. to facilitate mixing of 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
    • B65D51/002—Closures to be pierced by an extracting-device for the contents and fixed on the container by separate retaining 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
    • 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
    • B65D51/28—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials
    • B65D51/2807—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container
    • B65D51/2814—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it
    • B65D51/2842—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it said element being provided with a preformed weakened line
    • B65D51/285—Closures not otherwise provided for combined or co-operating with auxiliary devices for non-closing purposes with auxiliary containers for additional articles or materials the closure presenting means for placing the additional articles or materials in contact with the main contents by acting on a part of the closure without removing the closure, e.g. by pushing down, pulling up, rotating or turning a part of the closure, or upon initial opening of the container the additional article or materials being released by piercing, cutting or tearing an element enclosing it said element being provided with a preformed weakened line ruptured by a sharp element, e.g. a cutter or a piercer
    • 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
    • A61J1/1406—Septums, pierceable membranes
    • 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

Definitions

  • the present invention relates to a pharmaceutical multi-chamber container system for mixing two or more ingredients of a pharmaceutical product, and more particularly to a pre-filled container insert to be used with such a system.
  • Solid active pharmaceutical ingredients (API) or formulated products generally have better shelf-life, i.e. degrade at a slower rate than solutions (or dispersions/emulsions) of the same compound. Therefore, it is commonplace to use dry powder, for example to freeze-dry or spray-dry pharmaceutical products to extend shelf-life of a pharmaceutical product to practical length, typically at least 18-24 months.
  • a solid product must be dissolved in a suitable solvent before it can be administered to the patient, usually via is oral or parenteral routes or by nasal delivery.
  • the dissolution of the solid in a solvent is typically made via transfer of the solvent from a vial or bag using a syringe.
  • JP2000037441A relates to an infusion container system having a solid drug storing part connected to a liquid solution container.
  • a fluid communication channel is established between the two containers by pressing the solid medicine storing part to the solution container side and a partitioning member is opened and moved from a seal part.
  • the solid drug dissolves in the liquid solution by shaking the whole transfusion container.
  • the solution is now ready to be administered to a patient and a puncture needle is introduced into an infusion solution take off connection provided in the top of the solid drug storage container.
  • a drawback with this device is that it requires a complicated construction of the solid drug storing part comprising several parts and which will involve a number of production steps.
  • a further drawback is that two steps need to be carried out before the solution can be administered to a patient, namely first allow for mixing of the two ingredients and then introducing a needle to connect for example an infusion set.
  • a pharmaceutical product e.g. a solid and solvent or two different liquids
  • BFS blow-fill-seal
  • a pre-filled container insert for use in a pharmaceutical container system for mixing two or more ingredients of a pharmaceutical product.
  • the pre-filled container insert comprises;
  • moulded container casing having walls, bottom and an open top for receiving a solid component
  • a bottom disc formed by a weakening rim in the bottom periphery of the moulded container casing, wherein the bottom disc is openable to allow mixing of the pre-filled solid component with a diluents fluid of the pharmaceutical container system by introducing a spike through the resilient stopper applying a pushing force on the bottom disc, by which force the weakening rim is broken and the container insert is opened.
  • a pre-filled container insert for use in a pharmaceutical container system for mixing two or more ingredients of a pharmaceutical product.
  • the pre-filled container insert comprises;
  • moulded container casing having walls, bottom and an open top for receiving an inner open cylinder and a solid component
  • a bottom disc formed by a weakening rim in the bottom periphery of the moulded container casing, wherein the bottom disc is openable to allow mixing of the pre-filled solid component with a diluents fluid of the pharmaceutical container system by applying a pushing force onto the top of the moulded container, thereby compressing the casing and forcing the inner cylinder towards the bottom disc, by which force the weakening rim is broken and the container insert is opened.
  • An advantage of preferred embodiments of the present invention is that there is provided a pre-filled container insert that is constructed from a minimum of parts and at the same time has efficient and robust construction.
  • a further advantage of preferred embodiments of the present invention is that there is provided a pre-filled container insert that easily can be opened to provide mixing of contents in the insert and the liquids container.
  • the pre-filled container insert is manufactured as a separate device and can be incorporated into different types of blow-fill-seal containers forming a pharmaceutical multi-chamber container system.
  • the separate device can be aseptically filled, sealed and processed (e.g. terminally sterilised) under controlled conditions before the next unit operation of actually mounting the device into the diluents container.
  • the weakening rim in the bottom disc is arranged around the periphery of the bottom of the container casing forming a hinged disc such that the bottom disc remains connected to the container casing when the weakening rim is broken and the container is opened.
  • the resilient stopper is secured in place by a clamp ring to hermetically seal the top opening.
  • the clamp ring locks and fixes the resilient stopper in the open top of the container casing and the moulded casing is hermetically sealed.
  • the bottom disc is covered by a moisture barrier foil.
  • the resilient stopper is covered by a moisture barrier foil.
  • the pre-filled content has a maximum of protection from the outside environment, i.e. light, moisture and/or oxygen.
  • the pre-filled container insert is aseptically mounted into the top of a BFS-container forming a multi-chamber pharmaceutical container system.
  • the moulded container casing has pleated sidewalls forming a bellows container insert.
  • the container casing By forming the container casing as a bellows container an easily deformable casing is formed in one single piece.
  • the pre-filled container insert is capable of use with one or more delivery systems, such as a nasal delivery system.
  • a nasal delivery system such as a nasal delivery system.
  • the pre-filled container insert is connectable to or within, or otherwise can be incorporated with, for example, a standard nasal delivery mechanism such as a nasal spray.
  • a pharmaceutical container system for mixing two or more ingredients of a pharmaceutical product comprising
  • a first container comprising a diluents liquid
  • a second container insert aseptically mounted into the top of the first container, the second container comprising
  • a bottom disc formed by a weakening rim in the bottom periphery of the moulded container casing, wherein the bottom disc is openable to allow mixing of the pre-filled solid component with a diluents fluid of the pharmaceutical container system by introducing a spike through the resilient stopper applying a pushing force on the bottom disc, by which force the weakening rim is broken and the container insert is opened.
  • a pharmaceutical container system for mixing two or more ingredients of a pharmaceutical product comprising
  • a first container comprising a diluents liquid
  • a second container insert aseptically mounted into the top of the first container, the second container comprising
  • moulded container casing having walls, bottom and an open top for receiving an inner open cylinder and a solid component
  • a bottom disc formed by a weakening rim in the bottom periphery of the moulded container casing, wherein the bottom disc is openable to allow mixing of the pre-filled solid component with a diluents fluid of the pharmaceutical container system by applying a pushing force onto the top of the moulded container, thereby compressing the casing and forcing the inner cylinder towards the bottom disc, by which force the weakening rim is broken and the container insert is opened.
  • a standard procedure for a nurse preparing an intra-venous (IV)-container is to visually inspect, and in some procedures to spike, the IV-container before starting infusion. Therefore, using a pharmaceutical container system according to embodiments of the present invention, the standard working procedure is not changed. In preferred embodiments, by simply pushing the container top to allow mixing and then ensure the complete mixing operation by visual inspection, a simple an intuitive procedure is obtained. In addition, no separate mixing step using hypodermic needles are necessary, eliminating the risk of needle-stick injuries. Mixing is made without risk of microbial contamination since the solid and liquid chambers are both parts of the same hermetically sealed container. In other embodiments, similar steps are carried out but for preparing a nasal delivery device such as a nasal spray, which typically comprises a container, and a spray or other nasal delivery mechanism attached thereto.
  • a nasal delivery device such as a nasal spray, which typically comprises a container, and a spray or other nasal delivery mechanism attached thereto.
  • Medicaments suitable for administration via a pharmaceutical multi-chamber container system for mixing two or more ingredients of a pharmaceutical product, and more particularly to be pre-filled with the container insert of the present invention include for example proton pump inhibitors, for example omeprazol, anticancer medicaments, antibiotics, immunotherapies, vaccines, antiviral medicaments, polypeptides and peptides, for example, peptide hormones and growth factors, polypeptide vaccines, enzymes endorphines, lipoproteins and polypeptides involved in the blood coagulation cascade.
  • FIGS. 1 a - 1 g illustrate schematically the manufacturing steps of a pre-filled container insert in accordance with a preferred embodiment of the present invention
  • FIGS. 2 a and 2 b schematically illustrate the opening procedure of the pre-filled container insert
  • FIGS. 3 a - 3 d show a pharmaceutical container system for mixing two or more ingredients s of a pharmaceutical product, which system consists of a BFS-container filled with a diluents liquid and a pre-filled insert sealed to the container, and,
  • FIGS. 4 a - 4 h illustrate schematically the manufacturing steps of a further pre-filled container insert in accordance with a preferred embodiment of the present invention.
  • FIGS. 5 a - 5 c schematically illustrate the opening procedure of the pre-filled container insert of FIGS. 4 a - 4 h, and;
  • FIGS. 6 a - 6 d show a pharmaceutical container system for mixing two or more ingredients of a pharmaceutical product, which system consists of a BFS-container filled with a diluents liquid and a pre-filled insert sealed to the container.
  • FIGS. 1 a to 1 g and 4 a to 4 h schematically illustrate how pre-filled container inserts can be manufactured.
  • the container inserts being manufactured separately e.g. by injection moulding can use any type thermoplastic material, e.g. high-barrier engineering plastics if necessary to impart high-barrier properties, e.g. with light, moisture or oxygen sensitive compounds.
  • FIG. 1 a shows the moulded container casing 1 having walls 2 , bottom 3 and an open top 4 for receiving a medicament component.
  • the container casing 1 which is made using e.g. injection moulding preferably has a cylindrical geometry and the bottom 3 has a suitable weakening rim 5 in the bottom periphery.
  • the weakening rim 5 will make it possible to push open the bottom disc 3 to allow material transfer between the pre-filled insert and a liquid container.
  • a small portion of the weakening rim is kept thicker, functioning as a hinge 6 so as to prevent the bottom disc 3 to completely disengage from the solids container on opening.
  • a barrier foil 7 e.g. an aluminium foil can be used to cover the bottom disc 3 , which can be seen in FIG. 1 b.
  • the moulded container casing is pre-filled with a content 8 , a powder or other suitable solid (or semi-solid) in a well-defined, clean environment (e.g. aseptic filling in isolator or other suitable uni directional air flow hood (UDF)).
  • a powder or other suitable solid (or semi-solid) in a well-defined, clean environment e.g. aseptic filling in isolator or other suitable uni directional air flow hood (UDF)
  • UDF uni directional air flow hood
  • FIGS. 1 d, 1 e and 1 f show how the container insert is hermetically closed using a resilient stopper 9 , e.g. a standard rubber stopper or thermoplastic elastomer (TPE) part, which is mounted through the open top and secured by a clamp ring 10 to ensure a safe and tight fastening of the stopper 9 .
  • a barrier foil 15 i.e. an aluminium foil, can be used to cover the resilient stopper 9 and clamp ring 10 to further augment the moisture or gas barrier of the pre-filled container insert 17 .
  • the open centre of the clamp ring 10 reveals a circular area of the resilient stopper where the spike (or a puncture needle) can be entered through the stopper.
  • the pre-filled container insert 17 can be sterilised either in-line or in a separate step after filling/closing using standard methods such as e-beam or gamma irradiation. Such a sterile pre-filled container insert can then be transported to a suitable standard filling line for liquids to be mounted to a blow-fill-seal container or other suitable liquids plastic container.
  • the container may comprise a component of a nasal delivery device, which preferably contains the appropriate liquid.
  • FIG. 2 a schematically illustrate how a spike 20 is pushed through the resilient stopper 9 of the pre-filled container insert and in 2 b how the pushing force from the spike 20 breaks the weakened rim 5 in bottom periphery (as well as the barrier foil 7 ) and the content 8 of the pre-filled container insert is free to leave the container.
  • FIG. 3 a illustrates an embodiment of a pharmaceutical container system 21 wherein a pre-filled container insert 17 according to the present invention is mounted into the top of a blow-fill-seal container 22 .
  • the system 21 comprises means suitable for intravenous delivery of a medicament, but the system may comprise any other, suitable pharmaceutical system, such as a container (e.g. a bottle, vial or tube) for use with a nasal delivery mechanism, e.g. a spray or dropper that connects to the container.
  • a container e.g. a bottle, vial or tube
  • a nasal delivery mechanism e.g. a spray or dropper that connects to the container.
  • FIG. 3 a embodiment filled with a content 8 will be enclosed into the liquid blow-fill-seal container and the top portion of the pre-filled container is revealed to the user by opening a twist-off top 23 of the blow-fill-seal container 22 , which is shown in FIG. 3 b .
  • a moisture barrier seal 15 covers the top, i.e. a resilient stopper 9 of the pre-filled container under the twist-off top 23 .
  • FIG. 3 c shows how a spike 20 punctures the resilient stopper 9 and enters into the pre-filled container 17 .
  • the pushing force from the spike 20 acts on the bottom disc 3 and the weakened rim 5 in the periphery of the disc breaks up.
  • the disc 3 is prevented from falling out into the blow-fill-seal container 22 by a hinge 6 connecting the bottom disc to the wall 2 of the container insert.
  • the content of the pre-filled container can now be mixed with the diluents fluid of the blow-fill-seal container by gentle shaking the container.
  • a bottom flap 25 is pulled up to allow hanging of the container system near a patient while administering the substance to the patient.
  • the pre-filled container insert is welded into a flexible bag wall being filled with the diluents liquid.
  • FIG. 4 a shows another embodiment of the present invention.
  • the moulded container casing 1 has walls 2 , bottom 3 and an open top 4 for receiving a medicament component.
  • the container casing 1 which is made using e.g. injection moulding preferably has a cylindrical geometry and differs from the previous embodiment in that the walls 2 are pleated such that the container casing has the form of a bellows.
  • the bottom 3 has a suitable weakening rim 5 in the bottom periphery. Preferably, a small portion of the weakening rim is kept thicker, functioning as a hinge 6 so as to prevent the bottom disc 3 to completely disengage from the solids container on opening.
  • a barrier foil 7 e.g. an aluminium foil can be used to cover the bottom disc 3 , which can be seen in FIG. 4 b.
  • an inner cylinder 30 is placed inside the moulded container casing and, as shown in FIG. 4 d , the inner cylinder placed within the container walls is then pre-filled with a content 8 , a powder or other suitable solid (or semi-solid) in a well-defined, clean environment (e.g. aseptic filling in isolator or other suitable uni directional air flow hood (UDF)).
  • a content 8 e.g. aseptic filling in isolator or other suitable uni directional air flow hood (UDF)
  • UDF uni directional air flow hood
  • the weakening rim 5 will make it possible to push open the bottom disc 3 using the inner cylinder 30 to allow material transfer between the pre-filled insert and a liquid container.
  • the inner cylinder 30 is tapered and oriented in relation to the weakening rim so that the tapered end push first at the position directly opposite the hinge part of the weakening rim along the periphery.
  • FIGS. 4 e and 4 f show how the container insert is hermetically closed using a resilient stopper 9 , e.g. a standard rubber stopper or thermoplastic elastomer (TPE) part, which is mounted through the open top and secured by a clamp ring 10 to ensure a safe and tight fastening of the stopper 9 .
  • a barrier foil 15 i.e. an aluminium foil, can be used to cover the resilient stopper 9 and clamp ring 10 to further augment the moisture or gas barrier of the pre-filled container insert 17 .
  • the aluminium foil is replaced with a standard tamper-evident protective seal.
  • the open centre of the clamp ring 10 reveals a circular area of the resilient stopper where the spike (or a puncture needle) can be entered through the stopper.
  • the pre-filled container insert 17 can be sterilised either in-line (at filling) or in a separate step after filling/closing using standard methods such as e-beam or gamma irradiation. Such a sterile pre-filled container insert can then be transported to a suitable standard filling line for liquids to be mounted to a blow-fill-seal container or other suitable liquids plastic container.
  • FIG. 5 a schematically illustrates how a pressing force is applied to the top of the bellows container insert 17 and how the pushing force compresses the walls 2 of the container insert.
  • the inner cylinder 30 presses on the bottom 3 and breaks the weakened rim 5 in bottom periphery (as well as the barrier foil 7 ) and the content 8 of the pre-filled container insert is free to leave the container and be mixed with a diluent fluid (not shown).
  • a spike 20 is introduced through the rubber stopper 9 to make the container ready for administration to a patient.
  • FIG. 6 a illustrates an embodiment of a pharmaceutical container system 21 wherein a pre-filled container insert 17 according to the present invention is mounted into the top of a is blow-fill-seal container 22 .
  • the system may comprise any other, suitable pharmaceutical system, such as a container for use with a nasal delivery mechanism.
  • the pre-filled container insert 17 filled with a content 8 will be enclosed into the liquid blow-fill-seal container and the top portion of the pre-filled container is revealed to the user by opening a twist-off top 23 of the blow-fill-seal container 22 , which is shown in FIG. 6 b .
  • a moisture barrier seal 15 covers the top, i.e.
  • FIG. 6 c shows how the walls 2 of the bellows insert are compressed.
  • the pushing force makes the inner cylinder 30 to break the weakened rim 5 in the periphery of the bottom disc 3 and the rim breaks up.
  • the disc 3 is prevented from falling out into the blow-fill-seal container 22 by a hinge 6 connecting the bottom disc to the wall 2 of the container insert.
  • the content of the pre-filled container can now be mixed with the diluents fluid of the blow-fill-seal container by gentle shaking of the container. After visual inspection to ensure complete mixing of the contents and confirmation of the absence of particulates, the moisture barrier seal (or tamper-evident seal) can be removed. A spike 20 (or puncture needle) may be introduced through the stopper 9 to make the container ready to be administered to a patient.
  • the pre-filled container insert is welded into a flexible bag wall being filled with the diluents liquid.
  • the user typically a nurse
  • IV-infusions A preferred use of a system in accordance with an embodiment of the present invention as illustrated in FIGS. 1 to 3 is described below in chronological order.
  • a sterile IV-administration set bag is opened.
  • the IV-spike of the administration set is inserted into the rubber stopper top, thereby piercing the rubber stopper.
  • the pre-filled insert is for use with, e.g., a nasal is delivery device
  • some of the above steps may be carried out, but with the insert contained within, or otherwise associated with, a suitable container such as a nasal spray bottle or the like.

Landscapes

  • Engineering & Computer Science (AREA)
  • Mechanical Engineering (AREA)
  • Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Medical Preparation Storing Or Oral Administration Devices (AREA)
  • Details Of Rigid Or Semi-Rigid Containers (AREA)
US13/058,348 2008-08-11 2009-08-10 Prefilled container insert for mixing two or more ingredients for use in a pharmaceutical container system Abandoned US20110186451A1 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
US13/058,348 US20110186451A1 (en) 2008-08-11 2009-08-10 Prefilled container insert for mixing two or more ingredients for use in a pharmaceutical container system

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US8778408P 2008-08-11 2008-08-11
US8778908P 2008-08-11 2008-08-11
US13/058,348 US20110186451A1 (en) 2008-08-11 2009-08-10 Prefilled container insert for mixing two or more ingredients for use in a pharmaceutical container system
PCT/SE2009/050922 WO2010019096A1 (en) 2008-08-11 2009-08-10 A pre-filled container insert for mixing two or more ingredients for use in a pharmaceutical container system

Publications (1)

Publication Number Publication Date
US20110186451A1 true US20110186451A1 (en) 2011-08-04

Family

ID=41669083

Family Applications (1)

Application Number Title Priority Date Filing Date
US13/058,348 Abandoned US20110186451A1 (en) 2008-08-11 2009-08-10 Prefilled container insert for mixing two or more ingredients for use in a pharmaceutical container system

Country Status (12)

Country Link
US (1) US20110186451A1 (ko)
EP (1) EP2323907A1 (ko)
JP (1) JP2011530377A (ko)
KR (1) KR20110040987A (ko)
CN (1) CN102177070A (ko)
AU (1) AU2009280391B2 (ko)
BR (1) BRPI0917490A2 (ko)
CA (1) CA2733173A1 (ko)
MX (1) MX2011001578A (ko)
NZ (1) NZ591074A (ko)
RU (1) RU2011105467A (ko)
WO (1) WO2010019096A1 (ko)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013026995A1 (en) * 2011-08-22 2013-02-28 Eulysis Uk Limited Container and method of manufacture of container
US20130240476A1 (en) * 2010-11-24 2013-09-19 West Pharmaceutical Services Deautschland GmbH & Co. KG Device for stopping a container, container provided with such a device, and method for closing a batch of such containers
US20130255827A1 (en) * 2012-03-29 2013-10-03 R.P. Scherer Technologies, Llc Three circuit fill system for blow fill seal containers
US20140182141A1 (en) * 2013-01-02 2014-07-03 Stuart D. Farnworth Scissors and Manufacturing Method Therefor
US11607369B2 (en) 2017-11-17 2023-03-21 Koska Family Limited Systems and methods for fluid delivery manifolds
USD992110S1 (en) 2021-08-10 2023-07-11 Koska Family Limited Sealed fluid container
US12059389B2 (en) 2016-04-25 2024-08-13 Koska Family Limited Systems and methods for fluid delivery
USD1052082S1 (en) 2020-06-01 2024-11-19 Koska Family Limited Sealed fluid container

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9237985B2 (en) * 2013-07-18 2016-01-19 Tokitae Llc Multi-compartment pharmaceutical vials
CN105125340A (zh) * 2015-09-10 2015-12-09 成都华神生物技术有限责任公司 制备药物溶液的装置及其用法以及用药装置及其用法
TWI589278B (zh) * 2015-11-19 2017-07-01 財團法人金屬工業研究發展中心 植入物載具、混合罐以及植入物載具組件
US11305064B2 (en) * 2017-01-01 2022-04-19 Balanced Pharma Incorporated Mixing vial
GB2563867B (en) * 2017-06-28 2019-06-26 Ndm Technologies Ltd Drug delivery apparatus
JP7379158B2 (ja) * 2017-10-10 2023-11-14 大日本印刷株式会社 薬剤収容容器、閉鎖部材、薬剤収容容器の製造方法、および微生物夾雑物検査方法、ならびに緩衝液調製用固形剤
CN111977168A (zh) * 2020-08-27 2020-11-24 茶立享科技有限公司 一种多料腔即配式瓶盖及采用该瓶盖的瓶

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3220588A (en) * 1964-09-17 1965-11-30 Lipari Michael Compartmental dispensing receptacle with accessories
US3603484A (en) * 1969-02-28 1971-09-07 Mix O Matic Corp A two-compartment mixing and dispensing device
US5322165A (en) * 1993-02-16 1994-06-21 University Of Florida Sharp instrument encasement system
US5860569A (en) * 1996-06-13 1999-01-19 Carnaudmetalbox Sante-Beaute Product-dispensing container
US20020066750A1 (en) * 2000-07-17 2002-06-06 Nicolas Albisetti Device for packaging and dispensing a substance, in particular for hair care

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE7717165U1 (de) * 1976-09-01 1979-02-22 Henkel Kgaa Zweikomponentenverpackung
CH621985A5 (en) * 1977-12-29 1981-03-13 Ernst & Co Inh Geiger & Neuens Portion package for drainage pipe cleaning agents
IT1185850B (it) * 1985-08-02 1987-11-18 Zambon Spa Tappo serbatoio contagocce per flaconi
IT1259924B (it) * 1992-03-19 1996-03-28 Lameplast Srl Flacone contagocce particolarmente per prodotti farmaceutici attivabili all'uso per miscelazione
EP1781357A4 (en) * 2004-08-19 2009-11-18 Jong Suk Oh MEDICAL BOTTLE FOR INJECTION
EP1842795A1 (en) * 2006-04-03 2007-10-10 Soria Natural, S.A. An additive carrying cartridge for mixing the additive with the content of a container

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3220588A (en) * 1964-09-17 1965-11-30 Lipari Michael Compartmental dispensing receptacle with accessories
US3603484A (en) * 1969-02-28 1971-09-07 Mix O Matic Corp A two-compartment mixing and dispensing device
US5322165A (en) * 1993-02-16 1994-06-21 University Of Florida Sharp instrument encasement system
US5860569A (en) * 1996-06-13 1999-01-19 Carnaudmetalbox Sante-Beaute Product-dispensing container
US20020066750A1 (en) * 2000-07-17 2002-06-06 Nicolas Albisetti Device for packaging and dispensing a substance, in particular for hair care

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130240476A1 (en) * 2010-11-24 2013-09-19 West Pharmaceutical Services Deautschland GmbH & Co. KG Device for stopping a container, container provided with such a device, and method for closing a batch of such containers
US8950609B2 (en) * 2010-11-24 2015-02-10 West Pharmaceutical Services Deutschland Gmbh & Co. Kg Device for stopping a container, container provided with such a device, and method for closing a batch of such containers
WO2013026995A1 (en) * 2011-08-22 2013-02-28 Eulysis Uk Limited Container and method of manufacture of container
US20170224586A1 (en) * 2011-08-22 2017-08-10 Eulysis Uk Limited Container and method of manufacture of container
US20130255827A1 (en) * 2012-03-29 2013-10-03 R.P. Scherer Technologies, Llc Three circuit fill system for blow fill seal containers
US9440754B2 (en) * 2012-03-29 2016-09-13 R.P. Scherer Technologies, Llc Three circuit fill system for blow fill seal containers
US10351272B2 (en) 2012-03-29 2019-07-16 R.P. Scherer Technologies, Llc Three circuit fill system for blow fill seal containers
US20140182141A1 (en) * 2013-01-02 2014-07-03 Stuart D. Farnworth Scissors and Manufacturing Method Therefor
US12059389B2 (en) 2016-04-25 2024-08-13 Koska Family Limited Systems and methods for fluid delivery
US11607369B2 (en) 2017-11-17 2023-03-21 Koska Family Limited Systems and methods for fluid delivery manifolds
USD1052082S1 (en) 2020-06-01 2024-11-19 Koska Family Limited Sealed fluid container
USD992110S1 (en) 2021-08-10 2023-07-11 Koska Family Limited Sealed fluid container

Also Published As

Publication number Publication date
AU2009280391B2 (en) 2012-05-31
AU2009280391A1 (en) 2010-02-18
EP2323907A1 (en) 2011-05-25
KR20110040987A (ko) 2011-04-20
RU2011105467A (ru) 2012-09-20
JP2011530377A (ja) 2011-12-22
WO2010019096A1 (en) 2010-02-18
MX2011001578A (es) 2011-05-02
CA2733173A1 (en) 2010-02-18
NZ591074A (en) 2012-09-28
CN102177070A (zh) 2011-09-07
BRPI0917490A2 (pt) 2015-12-01

Similar Documents

Publication Publication Date Title
AU2009280391B2 (en) A pre-filled container insert for mixing two or more ingredients for use in a pharmaceutical container system
US10898659B1 (en) System for handling and dispensing a plurality of products
JP6371369B2 (ja) 流体の閉鎖移送のためのシステム
JP4549680B2 (ja) 流体移送アセンブリ
US5368586A (en) Closure for a drug-vial
AU2002240070B2 (en) Reconstitution device and method of use
AU2002240070A1 (en) Reconstitution device and method of use
JP7570392B2 (ja) 点滴又は注射によって患者に投与される液状の薬剤又は栄養物質の投与量を再構成するための圧力補償器を含む滅菌フレキシブルパッケージ
US11697527B1 (en) Tamper evident closure assembly
US11952155B2 (en) Manufacturing a flexible container
EP0327519B1 (en) An appliance for the mixing and/or transfer of a substance
SK285419B6 (sk) Usporiadanie na uchovávanie a podávanie medicínskej kvapaliny
WO1999006089A1 (fr) Contenant medical
JP3404177B2 (ja) 輸液容器
KR20210021029A (ko) 고진공 병을 통해서 약물을 투약하기 위한 재구성 시스템
JP3319777B2 (ja) 静脈内投与薬液の無菌調製法及び装置
JPH05123376A (ja) 輸液用容器
US20230373707A1 (en) Packaging System with a Molded Component
CA3226420A1 (en) Closure cap and closure system for a syringe that is prefilled with a medicament or medical active substance
NZ752137A (en) Sterile flexible package with pressure compensator for the dosed reconstitution of fluid medicinal or nutritional substances to be administered to patients by infusion or injection.

Legal Events

Date Code Title Description
AS Assignment

Owner name: ASTRAZENECA AB, SWEDEN

Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:DERSJO, PONTUS;LOFGREN, ANDERS;SIGNING DATES FROM 20110309 TO 20110315;REEL/FRAME:026156/0363

STCB Information on status: application discontinuation

Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION