CN102177070A - A pre-filled container insert for mixing two or more ingredients for use in a pharmaceutical container system - Google Patents
A pre-filled container insert for mixing two or more ingredients for use in a pharmaceutical container system Download PDFInfo
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- CN102177070A CN102177070A CN2009801400812A CN200980140081A CN102177070A CN 102177070 A CN102177070 A CN 102177070A CN 2009801400812 A CN2009801400812 A CN 2009801400812A CN 200980140081 A CN200980140081 A CN 200980140081A CN 102177070 A CN102177070 A CN 102177070A
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- Prior art keywords
- container
- embolus
- filled containers
- bottom plate
- shell
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- 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
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- 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
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- 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
Abstract
The present invention relates to pharmaceutical container systems (21), and to pre-filled container inserts (17) for use therein, for mixing two or more ingredients (8) of a pharmaceutical product. The pre-filled container insert (17) of one embodiment comprises a moulded container casing (1) having walls (2), a bottom (3) and an open top (4) for receiving a solid component (8), a resilient stopper (9) for sealing the open top (4) of the moulded container casing (1), and a bottom disc (3) formed by a weakening rim (5) in the bottom periphery of the moulded container casing (1). The bottom disc (3) is openable to allow mixing of the pre-filled solid component (8) with a diluents fluid of the pharmaceutical container system (21) by introducing a spike (20) through the resilient stopper (9) applying a pushing force on the bottom disc (3), by which force the weakening rim (5) is broken and the container (17) is opened. The pre-filled container insert (17) of a further embodiment comprises a moulded container casing (1) having walls (2), a bottom (3) and an open top (4) for receiving an inner open cylinder (30) and a solid component (8), a resilient stopper (9) for sealing the open top (4) of the moulded container casing (1), and a bottom disc (3) formed by a weakening rim (5) in the bottom periphery of the moulded container casing (1). The bottom disc (3) is openable to allow mixing of the pre- filled solid component (8) with a diluents fluid of the pharmaceutical container system (21) by applying a pushing force onto the top of the moulded container compressing the casing (1) and forcing the inner cylinder (30) to push on the bottom disc (3), by which force the weakening rim (5) is broken and the container insert (17) is opened.
Description
Technical field
The present invention relates to be used for two kinds or the medicine multichamber vessel system of more kinds of compositions of hybrid medicine product, and relate more particularly to the pre-filled containers embolus that uses with described system.
Background technology
The product of solid active drug ingedient (API) or preparation generally has the shelf life preferably, promptly degrades with slower speed than the solution (perhaps disperse system/emulsion) of same compound.Therefore, use usually for example cryodesiccated or spray-dired drug products of dry powder with shelf life of prolong drug product to practical length, typically at least 18-24 month.In use, described solid product must dissolve in appropriate solvent, afterwards can be to patient's administration, and oral administration or parenteral route or send administration usually by nose.Solid dissolves in solvent typically by using syringe that solvent is undertaken by bottle or sack transfer in-migration.Although described method is standard operation to the corpsman,hospital, it need training and skill and carry out and needle-less is stabbed (needle-stick injury) or destroy the danger that the product sterility damages patient safety thus with safety and effective and efficient manner.
Japanese patent abstract JP2000037441A relates to the infusion container system that has with liquid solution container bonded assembly solid drugs storage component.Set up and distribution member is opened and moved by packaged unit by the solid drugs storage component is depressed into by solution container one side between two containers for the fluid connection passage.For freedom by making after solid drugs storage vessel and solution container open, by the whole infusion container of jolting solid drugs is dissolved in liquid solution.Solution can be used for patient's administration and puncture needle is introduced in the infusion solution extraction connection (infusion solution take off connection) at solid drugs storage vessel top now.The shortcoming of this device is its complicated structure that needs the solid drugs storage component, and described storage component comprises several parts and will be referred to many production stages.Another shortcoming is solution can needed to carry out two steps before to patient's administration, promptly at first mix two kinds of compositions, syringe needle is introduced into for example to connect in the infusion device then.
The invention target
In embodiment preferred at least, target of the present invention is for providing containment system, wherein use the operation that has minimal risk at corpsman,hospital and patient simply, effectively and intuitively that two kinds of drug products or more kinds of composition are mixed, described composition is solid and solvent or two kinds of different liquids for example.
In embodiment preferred at least, another target of the present invention for provide expansion-filling-sealing (Blow-Fill-Seal, BFS) device is united the strong notion of use, described device has the structure that relates to few parts and few production stage.
Summary of the invention
In at least one broad aspect, the invention provides two kinds or the pre-filled containers embolus that uses in the medicament reservoir system of more kinds of compositions being used for the hybrid medicine product.Described pre-filled containers embolus comprises:
-be used to receive the molded container shell with wall, bottom and unlimited top of solid constituent,
-be used for the elasticity obturator at the top of opening wide of closed die container made shell,
-the bottom plate that forms by the weakening limit (weakening rim) in the bottom margin of molded container shell, wherein said bottom plate is openable, thereby to allow passing through that the bottom plate applied thrust is introduced tip through the elasticity obturator prefill solid constituent is mixed with the diluent liquid of medicament reservoir system, described thrust disconnects the weakening limit and the container embolus is opened.
In another broad aspect at least, the invention provides two kinds or the pre-filled containers embolus that uses in the medicament reservoir system of more kinds of compositions being used for the hybrid medicine product.Described pre-filled containers embolus comprises:
-be used to receive the molded container shell with wall, bottom and unlimited top of inner cylinder that opens wide and solid constituent,
-be used for the elasticity obturator at the top of opening wide of closed die container made shell,
-the bottom plate that forms by the weakening limit in the bottom margin of molded container shell, wherein said bottom plate is openable, to allow by to molded container top applied thrust compression shell and make inner cylinder be pushed into bottom plate thus, thereby the prefill solid constituent is mixed with the diluent liquid of medicament reservoir system, and described thrust makes and weakens the limit disconnection and the container embolus is opened.
The advantage of the preferred embodiment of the invention is for providing the pre-filled containers embolus, and it is by minimum component set-up but have effective and strong structure simultaneously.Another advantage of the preferred embodiment of the invention is for providing the pre-filled containers embolus, and it can easily be opened with content in the embolus and the contents mixed in the liquid container.Another advantage is the pre-filled containers embolus as the separating device manufacturing and can be loaded to dissimilar expansion-filling-airtight containers to form medicine multichamber vessel system.Another advantage is that separating device can aseptic filling, sealing and processing under controlled condition (for example final sterilization), carries out device is mounted to the next unit operation of diluent container afterwards.
According to the preferred embodiment of the invention, form hinged disk (hinged disc) be placed in the bottom margin of shell of tank on the weakening limit of bottom plate around, thereby when weaken that the limit disconnects and container when opening the bottom plate maintenance be connected with shell of tank.
Therefore, after the pre-filled containers embolus is opened, prevent that bottom plate from dropping in the diluent container.
According to the preferred embodiment of the invention, the clamped ring of elasticity obturator (clamp ring) is fixing in position with the sealing open top.
Clamping ring pins and is fixed on the elasticity obturator in the top of opening wide of shell of tank, thereby molding outer casing is sealed.
According to the preferred embodiment of the invention, bottom plate is covered by the moisture barrier paper tinsel.
According to the preferred embodiment of the invention, the elasticity obturator is covered by the moisture barrier paper tinsel.
By one side or elastic top one side cover the container embolus in the bottom with the moisture barrier paper tinsel, the prefill content has the maximum protection of antagonism external environment (being light, moisture and/or oxygen).
According to the preferred embodiment of the invention, the pre-filled containers embolus is mounted to the top of BFS-container to form multicell medicament reservoir system under aseptic condition.
According to the preferred embodiment of the invention, the molded container shell has the pleated sidewall of formation bellows-shaped (bellow) container embolus.
By forming the shell of tank as the bellows-shaped container, the shell of easy deformation forms with single part.
According to the preferred embodiment of the invention, the pre-filled containers embolus can use such as the nose delivery system with one or more delivery systems.Preferably, the pre-filled containers embolus is connected with for example standard nose delivery apparatus such as nasal spray device or is positioned at described device inside, perhaps can incorporate in the described device.
According to the preferred embodiment of the invention, be provided for two kinds or the medicament reservoir system of more kinds of compositions of hybrid medicine product, it comprises:
-comprise first container of diluent liquid,
-under aseptic condition, being mounted to the second container embolus of first container top, described second container comprises:
-be used to receive the molded container shell of solid constituent,
-be used for the elasticity obturator at the top of opening wide of closed die container made shell,
-the bottom plate that forms by the weakening limit in the bottom margin of molded container shell, wherein said bottom plate is openable, thereby to allow passing through that the bottom plate applied thrust is introduced tip through the elasticity obturator prefill solid constituent is mixed with the diluent liquid of medicament reservoir system, described thrust disconnects the weakening limit and the container embolus is opened.
According to the preferred embodiment of the invention, be provided for two kinds or the medicament reservoir system of more kinds of compositions of hybrid medicine product, it comprises:
-comprise first container of diluent liquid,
-the second container embolus of first container top is installed under aseptic condition, described second container comprises:
-be used to receive the molded container shell with wall, bottom and unlimited top of inner cylinder that opens wide and solid constituent,
-be used for the elasticity obturator at the top of opening wide of closed die container made shell,
-the bottom plate that forms by the weakening limit in the bottom margin of molded container shell, wherein said bottom plate is openable, to allow by to molded container top applied thrust compression shell and make inner cylinder be pushed into bottom plate thus, thereby the prefill solid constituent is mixed with the diluent liquid of medicament reservoir system, and described thrust makes and weakens the limit disconnection and the container embolus is opened.
The standard operation of preparation intravenous (IV)-container is for visually checking at IV-container (in certain operations at needle point) before the beginning infusion with regard to the nurse.Therefore, use medicament reservoir system according to embodiments of the present invention, standard operation can not change.In preferred embodiments, guarantee to finish married operation to allow to mix then through sight control, obtain simply and operation intuitively by pushing away container top simply.In addition, it is unnecessary making separately blend step by hypodermic needle, has eliminated needlestick injuries danger.Because solid and liquid chamber are the parts of identical airtight container, are blended under the condition of no microbial contamination danger and carry out.In other embodiments, except that preparing the nose delivery apparatus such as carrying out similar step the nasal spray device, described device comprises that typically container and atomizing cone or other are connected in this nose delivery apparatus.
Be suitable for that medicine multichamber vessel through being used for two kinds of the hybrid medicine product or more kinds of compositions is administered systemically and more specifically for example comprise with the medicine of container embolus prefill of the present invention, proton pump inhibitor is for example peptide hormone and growth factor, polypeptide vaccine, enzyme endorphin, lipoprotein and the polypeptide that relates in blood coagulation cascade of Omeprazole, cancer therapy drug, microbiotic, immunotherapy, vaccine, antiviral drugs, polypeptide and peptide for example.
Description of drawings
Shuo Ming order is more specifically described the present invention by embodiment and with reference to accompanying drawing presented for purpose of illustration, wherein:
Fig. 1 a-1g illustrates the manufacturing step according to the pre-filled containers embolus of the preferred embodiment of the invention, and
Fig. 2 a and 2b illustrate the opening operation of pre-filled containers embolus, and
Fig. 3 a-3d shows two kinds or the medicament reservoir system of more kinds of compositions that is used for the hybrid medicine product, and described system comprises BFS-container that is filled with diluent liquid and the prefill embolus that is sealed to container, and
Fig. 4 a-4h illustrates the manufacturing step according to another pre-filled containers embolus of the preferred embodiment of the invention, and
Fig. 5 a-5c illustrates the opening operation of the pre-filled containers embolus of Fig. 4 a-4h, and
Fig. 6 a-6d shows two kinds or the medicament reservoir system of more kinds of compositions that is used for the hybrid medicine product, and described system comprises the BFS-container that is filled with diluent liquid and is sealed to the prefill embolus of container.
The specific embodiment
Fig. 1 a and 1g and 4a and 4h illustrate the pre-filled containers embolus and can how to make.For example the container embolus of separately making by injection molding (iniection moulding) can use the thermoplastic material of any type, and for example high barrier engineering plastics are given high barrier with for example light, moisture or oxygen sensitive cmpd in case of necessity.
Fig. 1 a shows the molded container shell 1 at the top 4 that has wall 2, bottom 3 and open wide be used to receive drug component.Use the shell of tank 1 of the preparation of injection molding for example preferably to have cylindric geom and bottom 3 has suitable weakening limit 5 at bottom margin.Weakening limit 5 can push to allow material to shift bottom plate 3 open between prefill embolus and liquid container.Preferably, it is thicker that the weakening limit of fraction keeps, and come off fully by described solids container when solids container is opened to prevent bottom plate 3 as articulated section 6.
For the moisture that further increases the container embolus or gas shield and thus with the protection content, can use barrier foil 7 for example aluminium foil cover bottom plate 3, can be referring to Fig. 1 b.
In Fig. 1 c, the molded container shell is the meaningful thing 8 of prefill, powder or other suitable solid (perhaps semisolid) in the cleaning ambient (for example aseptic filling in windstream cover (UDF) at isolator or other suitable folk prescription) that fully limits.According to the another aspect of the present invention that does not show in the accompanying drawings, the prepackage of molded container shell is filled with semisolid content or liquid, and it was mixed with dilution before infusion.
Fig. 1 d, 1e and 1f show how to use elasticity obturator 9 for example standard soft rubber ball or thermoplastic elastomer (TPE) parts are airtight with the container embolus, the top of described obturator through opening wide are installed and fixing to guarantee obturator 9 safety and to connect closely through clamping ring 10.As showing in Fig. 1 g, barrier foil 15 is that aluminium foil can be used for covering elasticity obturator 9 and clamping ring 10 moisture or the gas shield with further increase pre-filled containers embolus 17.The center of opening of clamping ring 10 exposes the border circular areas of elasticity obturator, and its sharp head (perhaps puncture needle) can be passed obturator and be entered.Use standard method such as e-light beam or γ radiation that pre-filled containers embolus 17 is sterilized in coherent step that can be after filling/sealing or the division step.Described aseptic pre-filled containers embolus can be sent to then in the proper standard fill line of liquid to be mounted to expansion-filling-airtight container or other suitable liquid plastics container.Described container can comprise the assembly of nose delivery apparatus, and it preferably contains suitable liquid.
The elasticity obturator 9 how Fig. 2 a illustrates through the pre-filled containers embolus pushes tip 20, and weakening limit 5 (and barrier foil 7) at bottom margin is disconnected Fig. 2 b thrust of illustrating tip 20 and how the content 8 of pre-filled containers embolus freely breaks away from container.
Fig. 3 a example has illustrated the embodiment of medicament reservoir system 21, and pre-filled containers embolus 17 wherein according to the present invention is mounted to the top of expansion-filling-airtight container 22.In the embodiment of Fig. 3 a to 3d, system 21 comprises and is suitable for the device that the medicine intravenous is sent, but this system can comprise other suitable drug system arbitrarily, such as with the nose delivery apparatus container (for example bottle, bottle or pipe) that uses of atomizing cone or dropper for example, described nose delivery apparatus is connected with container.The pre-filled containers embolus 17 that is filled with content 8 of Fig. 3 a embodiment is mounted to expansion of liquids-filling-airtight container and by opening top 23 that expansion-filling-airtight container 22 reverses the top of pre-filled containers is exposed to the user, as in Fig. 3 b, showing.In preferred embodiments, show in Fig. 3 b also that it is the elasticity obturator 9 of pre-filled containers that moisture barrier seal ring 15 covers the top below the top of reversing 23.After removing moisture barrier seal ring 15, the content 8 of pre-filled containers embolus 17 can mix with the diluent liquid in expansion-filling-airtight container 22.Fig. 3 c shows how tip 20 passes elasticity obturator 9 and enter into pre-filled containers 17.The thrust of tip 20 to bottom plate 3, is disconnected on the weakening limit 5 at bottom plate edge.By articulated section 6 bottom plate is connected with the wall 2 of container embolus to prevent that bottom plate 3 from dropping in expansion-filling-airtight container 22.The content of pre-filled containers can be mixed with the diluent liquid of expansion-filling-airtight container by slight agitato vase.In Fig. 3 d, when giving material, pull up base lamina 25 and containment system is suspended near the patient allowing the patient.According to the another aspect of the present invention that does not show in the accompanying drawings, the pre-filled containers embolus is connected with flexible bag wall (bag wall), and described bag is filled with diluent liquid.
Fig. 4 a shows another embodiment of the invention.Use similar reference number with to the similar assembly of assembly of the embodiment of Fig. 1 to 3.Be used to receive the top 4 that the molded container shell 1 of drug component has wall 2, bottom 3 and opens wide.Use the shell of tank 1 of the preparation of injection molding for example preferably have cylindric geom and different with previous embodiments be that wall 2 is to such an extent as to that the shell of tank of pleated has the bellows form.Bottom 3 has suitable weakening limit 5 at bottom margin.Preferably, it is thicker that the weakening limit of fraction keeps, and is used as articulated section 6 and come off fully by described solids container when solids container is opened to prevent bottom plate 3.For the moisture that further increases the container embolus or gas shield and thus with the protection content, can use barrier foil 7 for example aluminium foil cover bottom plate 3, can be referring to Fig. 4 b.
In Fig. 4 c, inner cylinder 30 places in the molded container shell, and as show at Fig. 4 d, be arranged in the inner cylinder of wall of container then at the cleaning ambient of fully qualification (for example at isolator or other suitable folk prescription to the aseptic filling of windstream cover (UDF)) the meaningful thing 8 of prefill, powder or other suitable solid (perhaps semisolid).According to the another aspect of the present invention that does not show in the accompanying drawings, the inner cylinder prepackage in the container is filled with semisolid content or liquid, and it was mixed with dilution before infusion.Use inner cylinder 30, weaken limit 5 bottom plate 3 can be pushed open to allow material to shift between prefill embolus and liquid container.Inner cylinder 30 is tapered and towards weakening the limit, tapered thus end at first promotes to weaken the direct relative position of the articulated section on limit on the edge.
Fig. 4 e and 4f show how to use elasticity obturator 9 for example standard soft rubber ball or thermoplastic elastomer (TPE) parts are airtight with the container embolus, the top of described obturator through opening wide are installed and fixing to guarantee obturator 9 safety and to connect closely through clamping ring 10.As showing in Fig. 4 h, barrier foil 15 is that aluminium foil can be used for covering elasticity obturator 9 and clamping ring 10 moisture or the gas shield with further increase pre-filled containers embolus 17.Replacedly, aluminium foil replaces with standard anti-revealed secrets seal (tamper-evident protective seal).The center of opening of clamping ring 10 exposes the border circular areas of elasticity obturator, and its sharp head (perhaps puncture needle) can be passed obturator and be entered.Use standard method such as e-light beam or γ radiation that pre-filled containers embolus 17 is sterilized in coherent step (during filling) that can be after filling/sealing or the division step.Described aseptic pre-filled containers embolus can be sent to then in the proper standard fill line of liquid to be mounted to expansion-filling-airtight container or other suitable liquid plastics container.
Fig. 5 a illustrates the how wall 2 of compression container embolus of the top that how to apply pressure to bellows-shaped container embolus 17 and thrust.In Fig. 5 b, inner cylinder 30 extruding bottom 3 also disconnects weakening limit 5 (and barrier foil 7) at bottom margin and the content 8 of pre-filled containers embolus freely breaks away from container and mixes (not shown) with diluent liquid.In Fig. 5 c, tip 20 is passed soft rubber ball 9 introduce with preparation and be used for container patient's administration.
Fig. 6 a example has illustrated the embodiment of medicament reservoir system 21, and pre-filled containers embolus 17 wherein according to the present invention is mounted to the top of expansion-filling-airtight container 22.As above discuss, this system can comprise other suitable drug system arbitrarily, such as the container that uses with the nose delivery apparatus.With pack into expansion of liquids-filling-airtight container and the top of pre-filled containers is exposed to the user of the pre-filled containers embolus 17 that is filled with content 8, show among the described Fig. 6 of the operating in b by opening top 23 that expansion-filling-airtight container 22 reverses.In preferred embodiments, show in Fig. 6 b also that it is the elasticity obturator 9 of pre-filled containers that moisture barrier seal ring 15 covers the top below the top of reversing 23.After removing moisture barrier seal ring 15, the content 8 of pre-filled containers embolus 17 can mix with the diluent liquid in expansion-filling-airtight container 22.Circle 6c shows the wall 2 that how to compress the bellows-shaped embolus.Thrust makes inner cylinder 30 and this limit to be disconnected in 5 fractures of the weakening limit at bottom plate 3 edges.By articulated section 6 bottom plate is connected with the wall 2 of container embolus to prevent that bottom plate 3 from dropping in expansion-filling-airtight container 22.The content of pre-filled containers can be mixed with the diluent liquid of expansion-filling-airtight container by slight agitato vase.After sight control mixes fully with the assurance content and confirms that no particulate exists, removable moisture barrier seal ring (the perhaps seal ring of obvious chock plug).Tip 20 (perhaps puncture needle) can pass soft rubber ball 9 and introduce so that container is suitable for the administration to the patient.According to the another aspect of the present invention that does not show in the accompanying drawings, pre-filled containers embolus and flexible bag wall welding (weld), described bag is filled with diluent liquid.
For the content of hybrid solid and liquid container in above-mentioned intravenous embodiment, user's (typically being the nurse) takes the normal operating process of intravenous, i.e. intravenous infusion.According to as in Fig. 1 to 3 the preferred use of the system of the embodiment of the present invention of example explanation as described below with time sequence.
1) nurse turns on expansion-filling-airtight container top and takes off moisture barrier seal ring (if having (and if standard operation then carries out disinfection to the soft rubber ball top)).
2) open aseptic intravenous administration equipment bag.
3) the intravenous tip with doser is inserted into the soft rubber ball top, pierces through soft rubber ball thus.When tip inserted fully, the bottom plate of solids chamber was pushed open by tip, thereby and solid and liquid chamber be can mixing of communicating.
4) make the contents mixed of solid and liquid chamber by slightly shaking container.
5) nurse's sight control container contents exists to guarantee to dissolve fully and do not have particulate matter.
6) after cleaning, syringe needle is connected with the patient, and prepares the beginning intravenous infusion.
According to as in Fig. 4 to 6 the preferred use of the system of another embodiment of the invention of example explanation as described below with time sequence.
1) nurse reverses expansion-filling-airtight container top.
2) the prefill content drops in the diluent container and solid and liquid chamber are can mixing of communicating thereby the nurse compresses the bellows-shaped embolus.
3) make the contents mixed of solid and liquid chamber by slightly shaking container.
4) nurse takes off moisture barrier (perhaps protectiveness) seal ring and to soft rubber ball top carry out disinfection (if standard operation).
5) open aseptic intravenous administration equipment bag.The intravenous tip of doser is inserted into the soft rubber ball top, pierces through soft rubber ball thus.
6) nurse's sight control container contents exists to guarantee to dissolve fully and do not have particulate matter.
7) after cleaning, syringe needle is connected with the patient, and prepares the beginning intravenous infusion.
In other embodiments, for example described prefill embolus can carry out some above-mentioned steps when for example the nose delivery apparatus uses, and unites use but described embolus is included in appropriate containers such as the nose spray bottle etc. or with described container.
In addition, it should be understood that to the invention is not restricted to the foregoing description, but can many different modes make amendment and do not depart from the scope of claims.
Claims (12)
1. pre-filled containers embolus that in the medicament reservoir system, uses, described pre-filled containers embolus is used for two kinds or more kinds of composition of hybrid medicine product, and described pre-filled containers embolus comprises:
-be used to receive the molded container shell with wall, bottom and unlimited top of solid constituent,
-be used for the elasticity obturator at the top of opening wide of closed die container made shell,
-the bottom plate that forms by the weakening limit in the bottom margin of molded container shell, wherein said bottom plate is openable, thereby to allow passing through that the bottom plate applied thrust is introduced tip through the elasticity obturator prefill solid constituent is mixed with the diluent liquid of medicament reservoir system, described thrust disconnects the weakening limit and the container embolus is opened.
2. pre-filled containers embolus that in the medicament reservoir system, uses, described pre-filled containers embolus is used for two kinds or more kinds of composition of hybrid medicine product, and described pre-filled containers embolus comprises:
-be used to receive the molded container shell with wall, bottom and unlimited top of inner cylinder that opens wide and solid constituent,
-be used for the elasticity obturator at the top of opening wide of closed die container made shell,
-the bottom plate that forms by the weakening limit in the bottom margin of molded container shell, wherein said bottom plate is openable, to allow by to molded container top applied thrust compression shell and make inner cylinder be pushed into bottom plate thus, thereby the prefill solid constituent is mixed with the diluent liquid of medicament reservoir system, and described thrust makes and weakens the limit disconnection and the container embolus is opened.
3. according to the pre-filled containers embolus of claim 2, wherein said molded container shell has the pleated sidewall that forms bellows-shaped container embolus.
4. according to claim 1,2 or 3 pre-filled containers embolus, form hinged disk around wherein being placed in the bottom margin of shell of tank on the weakening limit of bottom plate, thereby when weaken that the limit disconnects and container when opening the bottom plate maintenance be connected with shell of tank.
5. according to the pre-filled containers embolus of any aforementioned claim, the clamped ring of wherein said elasticity obturator is fixing in position with the sealing open top.
6. according to the pre-filled containers embolus of any aforementioned claim, wherein said bottom plate is covered by the moisture barrier paper tinsel.
7. according to the pre-filled containers embolus of any aforementioned claim, wherein said elasticity obturator is covered by the moisture barrier paper tinsel.
8. according to the pre-filled containers embolus of any aforementioned claim, wherein the pre-filled containers embolus is mounted to the top of expansion-filling-sealing (BFS) container under aseptic condition, forms multicell medicament reservoir system.
9. according to the pre-filled containers embolus of any aforementioned claim, thus wherein the pre-filled containers embolus under aseptic condition, be mounted to provide multicell drug delivery system, described container to have in the container can connected delivery apparatus.
10. according to the pre-filled containers embolus of claim 9, wherein delivery apparatus comprises the nose delivery components, is preferably atomizing cone, dropper etc.
11. two kinds or the medicament reservoir system of more kinds of compositions that is used for the hybrid medicine product, it comprises:
-comprise first container of diluent liquid,
-under aseptic condition, being mounted to the second container embolus of first container top, described second container comprises:
-be used to receive the molded container shell of solid constituent,
-be used for the elasticity obturator at the top of opening wide of closed die container made shell,
-the bottom plate that forms by the weakening limit in the bottom margin of molded container shell, wherein said bottom plate is openable, thereby to allow passing through that the bottom plate applied thrust is introduced tip through the elasticity obturator prefill solid constituent is mixed with the diluent liquid of medicament reservoir system, described thrust disconnects the weakening limit and container is opened.
12. two kinds or the medicament reservoir system of more kinds of compositions that is used for the hybrid medicine product, it comprises:
-comprise first container of diluent liquid,
-under aseptic condition, being mounted to the second container embolus of first container top, described second container comprises:
-be used to receive the molded container shell with wall, bottom and unlimited top of inner cylinder that opens wide and solid constituent,
-be used for the elasticity obturator at the top of opening wide of closed die container made shell,
-the bottom plate that forms by the weakening limit in the bottom margin of molded container shell, wherein said bottom plate is openable, to allow by to molded container top applied thrust compression shell and make inner cylinder be pushed into bottom plate thus, thereby the prefill solid constituent is mixed with the diluent liquid of medicament reservoir system, and described thrust makes and weakens the limit disconnection and the container embolus is opened.
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US8778908P | 2008-08-11 | 2008-08-11 | |
| US8778408P | 2008-08-11 | 2008-08-11 | |
| US61/087,789 | 2008-08-11 | ||
| US61/087,784 | 2008-08-11 | ||
| 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 |
|---|---|
| CN102177070A true CN102177070A (en) | 2011-09-07 |
Family
ID=41669083
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CN2009801400812A Pending CN102177070A (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 |
Country Status (12)
| Country | Link |
|---|---|
| US (1) | US20110186451A1 (en) |
| EP (1) | EP2323907A1 (en) |
| JP (1) | JP2011530377A (en) |
| KR (1) | KR20110040987A (en) |
| CN (1) | CN102177070A (en) |
| AU (1) | AU2009280391B2 (en) |
| BR (1) | BRPI0917490A2 (en) |
| CA (1) | CA2733173A1 (en) |
| MX (1) | MX2011001578A (en) |
| NZ (1) | NZ591074A (en) |
| RU (1) | RU2011105467A (en) |
| WO (1) | WO2010019096A1 (en) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105125340A (en) * | 2015-09-10 | 2015-12-09 | 成都华神生物技术有限责任公司 | Medicine solution preparing device, using method thereof, medicine using device and using method thereof |
| CN106725927A (en) * | 2015-11-19 | 2017-05-31 | 财团法人金属工业研究发展中心 | Implant carrier, mixing tank and implant carrier assembly |
Families Citing this family (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2967655B1 (en) * | 2010-11-24 | 2014-03-14 | Biocorp Rech Et Dev | DEVICE FOR CLOSING A CONTAINER, CONTAINER EQUIPPED WITH SUCH A DEVICE AND METHOD FOR CLOSING A BATCH OF SUCH CONTAINERS |
| GB2485254C (en) * | 2011-08-22 | 2013-12-25 | Eulysis Uk Ltd | A container having a recessed closure for drying and storing one or more active agents |
| US9440754B2 (en) * | 2012-03-29 | 2016-09-13 | 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 |
| US9237985B2 (en) * | 2013-07-18 | 2016-01-19 | Tokitae Llc | Multi-compartment pharmaceutical vials |
| 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 |
| WO2019073846A1 (en) * | 2017-10-10 | 2019-04-18 | 大日本印刷株式会社 | Drug storage container, closing member, method for manufacture of drug storage container, method for inspection of microorganisms and contaminants, and solid preparation for buffer solution preparation |
| CN111615409A (en) | 2017-11-17 | 2020-09-01 | 科斯卡家族有限公司 | System and method for fluid delivery manifold |
| USD992110S1 (en) | 2021-08-10 | 2023-07-11 | Koska Family Limited | Sealed fluid container |
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| 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 |
| DE7717165U1 (en) * | 1976-09-01 | 1979-02-22 | Henkel Kgaa | Two-component packaging |
| CH621985A5 (en) * | 1977-12-29 | 1981-03-13 | Ernst & Co Inh Geiger & Neuens | Portion package for drainage pipe cleaning agents |
| IT1185850B (en) * | 1985-08-02 | 1987-11-18 | Zambon Spa | DROP TANK CAP FOR BOTTLES |
| IT1259924B (en) * | 1992-03-19 | 1996-03-28 | Lameplast Srl | DROPPER BOTTLE PARTICULARLY FOR PHARMACEUTICAL PRODUCTS ACTIVATED FOR MIXING USE |
| US5322165A (en) * | 1993-02-16 | 1994-06-21 | University Of Florida | Sharp instrument encasement system |
| FR2749833B1 (en) * | 1996-06-13 | 1998-07-31 | Kerplas Snc | PRODUCT DISTRIBUTION CONTAINER |
| FR2811639B1 (en) * | 2000-07-17 | 2002-10-04 | Oreal | DEVICE FOR PACKAGING AND DISPENSING A PRODUCT, ESPECIALLY A HAIR PRODUCT |
| WO2006019211A1 (en) * | 2004-08-19 | 2006-02-23 | Jong Suk Oh | Medecine 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 |
-
2009
- 2009-08-10 US US13/058,348 patent/US20110186451A1/en not_active Abandoned
- 2009-08-10 EP EP09806918A patent/EP2323907A1/en not_active Withdrawn
- 2009-08-10 CN CN2009801400812A patent/CN102177070A/en active Pending
- 2009-08-10 BR BRPI0917490A patent/BRPI0917490A2/en not_active IP Right Cessation
- 2009-08-10 JP JP2011522933A patent/JP2011530377A/en active Pending
- 2009-08-10 KR KR20117005628A patent/KR20110040987A/en not_active Application Discontinuation
- 2009-08-10 CA CA2733173A patent/CA2733173A1/en not_active Abandoned
- 2009-08-10 MX MX2011001578A patent/MX2011001578A/en unknown
- 2009-08-10 RU RU2011105467/12A patent/RU2011105467A/en not_active Application Discontinuation
- 2009-08-10 AU AU2009280391A patent/AU2009280391B2/en not_active Expired - Fee Related
- 2009-08-10 NZ NZ591074A patent/NZ591074A/en not_active IP Right Cessation
- 2009-08-10 WO PCT/SE2009/050922 patent/WO2010019096A1/en active Application Filing
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN105125340A (en) * | 2015-09-10 | 2015-12-09 | 成都华神生物技术有限责任公司 | Medicine solution preparing device, using method thereof, medicine using device and using method thereof |
| CN106725927A (en) * | 2015-11-19 | 2017-05-31 | 财团法人金属工业研究发展中心 | Implant carrier, mixing tank and implant carrier assembly |
Also Published As
| Publication number | Publication date |
|---|---|
| EP2323907A1 (en) | 2011-05-25 |
| BRPI0917490A2 (en) | 2015-12-01 |
| CA2733173A1 (en) | 2010-02-18 |
| KR20110040987A (en) | 2011-04-20 |
| JP2011530377A (en) | 2011-12-22 |
| WO2010019096A1 (en) | 2010-02-18 |
| MX2011001578A (en) | 2011-05-02 |
| US20110186451A1 (en) | 2011-08-04 |
| NZ591074A (en) | 2012-09-28 |
| RU2011105467A (en) | 2012-09-20 |
| AU2009280391B2 (en) | 2012-05-31 |
| AU2009280391A1 (en) | 2010-02-18 |
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Application publication date: 20110907 |