JP2011530377A - Filled insert for containers for mixing two or more components used in drug container systems - Google Patents

Abstract

  The present invention relates to a drug container system (21) for mixing two or more components (8) of a pharmaceutical product, and to a filled insert (17) for a container used in such a system. The filled insert (17) for a container of one embodiment has a wall (2), a bottom (3), and an open top (4) for receiving a solid component (8). Container casing (1) by molding, elastic stopper (9) for sealing the open upper part (4) of the container casing (1) by molding, and weakened rim (5) at the outer periphery of the bottom of the container casing (1) by molding Comprises a bottom disc (3) formed by By introducing a spike (20) through the elastic stopper (9), a pushing force is applied to the bottom disk (3), and the weakened rim (5) is broken by this force to open the container (17). The bottom disk (3) can be opened so that the filled solid component (8) can be mixed with the diluent fluid of the drug container system (21). In a further embodiment, the filled insert (17) for the container comprises a wall (2), a bottom (3), an open inner cylinder (30) and an open top for receiving a solid component (8) ( 4), a molded container casing (1), a molded container casing (1), an elastic stopper (9) for sealing the open top (4), and a molded container casing (1) bottom. The bottom disc (3) formed by the weakening rim (5) on the outer periphery of the disc. By applying a pushing force to the upper part of the container by molding, the casing (1) is compressed and the inner cylinder (30) is pressed against the bottom disk (3), thereby breaking the weakened rim (5). By opening the container insert (17), the bottom disc (3) can be opened so that the filled solid component (8) can be mixed with the diluent fluid of the drug container system (21).

Description

  The present invention relates to a multi-chamber drug container system for mixing two or more components of a pharmaceutical product, and more particularly to a filled insert for a container used in such a system.

  Solid drug substances (APIs) or formulations generally have a better shelf life, i.e. they have a slower rate of degradation compared to solutions (or dispersions / emulsions) of the same compound. Therefore, it is common to use dry powder (eg, freeze-dry or spray-dry the drug) to extend the shelf life of the drug to a practical length (typically at least 18-24 months). Is. In use, such solid products must be dissolved in a suitable solvent in order to be able to be administered to the patient, usually via the oral or parenteral route, or by nasal delivery. Dissolution of a solid solvent is typically performed by transferring the solvent from a vial or bag using a syringe. Such a process is a standard practice for hospital personnel, but is performed in a safe and efficient manner without fear of needle puncture injury or product sterility, i.e., loss of patient safety. To do that, training and skill are required.

  Japanese Patent Abstract JP2000037441A relates to an infusion container system having a solid drug storage connected to a liquid solution container. A fluid communication path is established between the two containers by pushing the solid drug storage part toward the solution container side, opening the partition member and moving it from the seal part. After opening the solid drug storage container and solution container for free passage, the solid drug dissolves in the liquid solution by shaking the entire infusion container. Now that the solution can be administered to the patient, the puncture needle is introduced into the infusion take-out connection provided at the top of the solid drug storage container. The disadvantage of this device is that it requires a solid drug storage unit having a complicated configuration that is composed of a plurality of parts and involves a plurality of manufacturing steps. A further disadvantage is that two steps need to be carried out before the solution can be administered to the patient, i.e. first allowing mixing of the two components and then introducing a needle, for example to connect an infusion set There is a point to do.

  It is an object of the present invention to, in at least a preferred embodiment, use two or more components of a pharmaceutical product (e.g., using a simple, effective, and intuitive procedure with minimal risk to hospital personnel and patients) The object is to provide a container system in which mixing of solids and solvents or two different liquids) takes place.

  A further object of the present invention is to provide a robust concept used in connection with a blow-fill-seal (BFS) facility having a configuration requiring fewer parts and manufacturing processes, at least in a preferred embodiment. There is to do.

In accordance with the present invention, at least a first broad aspect provides a pre-filled insert for a container for use in a drug container system for mixing two or more components of a pharmaceutical product. The filled insert for this container
A molded container casing having a wall, a bottom and an open top for receiving solid components;
An elastic stopper for sealing the open upper part of the molded container casing, and a bottom disk formed by a weakening rim on the outer periphery of the bottom of the molded container casing,
Applying a pushing force to the bottom disk by introducing a spike through the elastic stopper, which breaks the weakened rim and opens the container insert to dilute the filled solid component The bottom disc can be opened for mixing with the working fluid.

According to the present invention, at least a further broad aspect provides a filled insert for a container for use in a drug container system for mixing two or more components of a pharmaceutical product. This filled insert for the container
A molded container casing having a wall, a bottom, and an open inner cylinder and an open top for receiving solid components;
An elastic stopper for sealing the open top of the container casing by molding, and a bottom disk formed by a weakened rim on the outer periphery of the bottom of the container casing by molding,
By applying a pushing force to the top of the container by molding, compress the casing and push the inner cylinder toward the bottom disk, which breaks the weakened rim and opens the container insert The bottom disk can be opened so that spent solid components can be mixed with the diluent fluid of the drug container system.

  An advantage of the preferred embodiment of the present invention is that it provides a filled insert for a container that is constructed from a minimum of parts while having an efficient and robust configuration. A further advantage of the preferred embodiment of the present invention is that it provides a filled insert for the container that can be easily opened to provide mixing of the insert and the contents of the liquid container. A still further advantage is that the container filled insert can be manufactured as a separate device and incorporated into various types of co-filled containers to form a multi-chamber drug container system. Yet another advantage is that this separate device is aseptically filled, sealed, and processed (eg, finalized) under controlled conditions prior to subsequent unit operations that are actually attached to the diluent container. Sterilization).

  According to a preferred embodiment of the present invention, a weakened rim of the bottom disk is arranged around the outer periphery of the bottom of the container casing so that the bottom disk is in the container casing when the weakened rim is broken and the container is opened. A hinged disk is formed so as to remain connected.

  In this way, the bottom disc after the container-filled insert is opened is prevented from falling into the diluent container.

  According to a preferred embodiment of the invention, the elastic stopper is fixed in place by a clamp ring so as to hermetically seal the upper opening.

  The clamp ring locks and fixes the elastic stopper to the open top of the container casing, and the molded casing is hermetically sealed.

  According to a preferred embodiment of the invention, the bottom disc is covered by a moisture barrier foil.

  According to a preferred embodiment of the invention, the elastic stopper is covered by a moisture barrier foil.

  By covering the container insert with a moisture barrier foil on both the lower side and the elastic upper side, the filled contents provide maximum protection from the outside environment (ie light, moisture and / or oxygen). Have.

  According to a preferred embodiment of the present invention, the filled insert for the container is aseptically attached to the top of the BFS container to form a multi-chamber drug container system.

  According to a preferred embodiment of the present invention, the molded container casing has pleated side walls forming a bellows-like container insert.

  By forming the container casing as a bellows-like container, a casing that can be easily deformed is formed with only one part.

  In accordance with a preferred embodiment of the present invention, the container filled insert can be used with one or more delivery systems, such as a nasal delivery system. Preferably, the filled insert for the container can be connected to, for example, a standard nasal delivery mechanism (such as nasal spray), connected to the interior of such a delivery mechanism, or otherwise Can be incorporated into any transport mechanism.

According to a preferred embodiment of the present invention, a drug container system for mixing two or more components of a pharmaceutical product, comprising:
A first container containing a dilution liquid;
A second container insert that is aseptically attached to the top of the first container;
The second container
-Molded container casing to accept solid components,
An elastic stopper for sealing the open top of the container casing by molding, and a bottom disk formed by a weakened rim on the outer periphery of the bottom of the container casing by molding,
Applying a pushing force to the bottom disk by introducing a spike through the elastic stopper, which breaks the weakened rim and opens the container insert to dilute the filled solid component for the drug container system A drug container system is provided that can open the bottom disk for mixing with a fluid.

According to a preferred embodiment of the present invention, a drug container system for mixing two or more components of a pharmaceutical product, comprising:
A first container containing a dilution liquid;
A second container insert that is aseptically attached to the top of the first container;
The second container
A molded container casing having a wall, a bottom, and an open inner cylinder and an open top for receiving solid components;
An elastic stopper for sealing the open top of the container casing by molding, and a bottom disk formed by a weakened rim on the outer periphery of the bottom of the container casing by molding,
By applying a pushing force to the top of the container by molding, compress the casing and push the inner cylinder toward the bottom disk, which breaks the weakened rim and opens the container insert A drug container system is provided that can open the bottom disk so that spent solid components can be mixed with the diluent fluid of the drug container system.

  The standard procedure for a nurse preparing an intravenous (IV) container is to visually inspect the IV container prior to the start of the infusion, and in some procedures to penetrate with a spike. Therefore, even if the drug container system according to the embodiment of the present invention is used, the standard work procedure is not changed. In a preferred embodiment, a simple and intuitive procedure is obtained by simply allowing the mixing by pushing the top of the container and then confirming the complete mixing operation by visual inspection. In addition, a separate mixing step using a hypodermic needle is unnecessary, and the risk of injury due to needle sticking is eliminated. Mixing takes place without the risk of microbial contamination because both the solid and liquid chambers are part of the same hermetically sealed container. In other embodiments, a similar process provides for a nasal delivery device such as a nasal spray that typically includes a container and a spray attached to the container or other nasal delivery mechanism. To be executed.

  Suitable for administration by a multi-chamber drug container system for mixing two or more components of a pharmaceutical, and more particularly as a drug suitable for filling the container insert of the present invention, for example, a proton pump inhibitor, For example omeprazole, anticancer drugs, antibiotics, immune drugs, vaccines, antiviral drugs, polypeptides and peptides such as peptide hormones and growth factors, polypeptide vaccines, enzymes endorphins, lipoproteins, and polypeptides involved in the blood coagulation cascade Is mentioned.

The invention will now be described in more detail, by way of example, with reference to the accompanying drawings, by way of example.

Figure 3 schematically shows the steps of the production of a filled insert for a container according to a preferred embodiment of the invention. Figure 3 schematically shows the steps of the production of a filled insert for a container according to a preferred embodiment of the invention. Figure 3 schematically shows the steps of the production of a filled insert for a container according to a preferred embodiment of the invention. Figure 3 schematically shows the steps of the production of a filled insert for a container according to a preferred embodiment of the invention. Figure 3 schematically shows the steps of the production of a filled insert for a container according to a preferred embodiment of the invention. Figure 3 schematically shows the steps of the production of a filled insert for a container according to a preferred embodiment of the invention. Figure 3 schematically shows the steps of the production of a filled insert for a container according to a preferred embodiment of the invention. Fig. 4 schematically shows a procedure for opening a filled insert for a container. Fig. 4 schematically shows a procedure for opening a filled insert for a container. A drug container system for mixing two or more components of a pharmaceutical product comprising a BFS container filled with a diluting liquid and a filled insert sealed in the container. Show. A drug container system for mixing two or more components of a pharmaceutical product comprising a BFS container filled with a diluting liquid and a filled insert sealed in the container. Show. A drug container system for mixing two or more components of a pharmaceutical product comprising a BFS container filled with a diluting liquid and a filled insert sealed in the container. Show. A drug container system for mixing two or more components of a pharmaceutical product comprising a BFS container filled with a diluting liquid and a filled insert sealed in the container. Show. Figure 3 schematically shows the steps of the production of a further filled container insert according to a preferred embodiment of the invention. Figure 3 schematically shows the steps of the production of a further filled container insert according to a preferred embodiment of the invention. Figure 3 schematically shows the steps of the production of a further filled container insert according to a preferred embodiment of the invention. Figure 3 schematically shows the steps of the production of a further filled container insert according to a preferred embodiment of the invention. Figure 3 schematically shows the steps of the production of a further filled container insert according to a preferred embodiment of the invention. Figure 3 schematically shows the steps of the production of a further filled container insert according to a preferred embodiment of the invention. Figure 3 schematically shows the steps of the production of a further filled container insert according to a preferred embodiment of the invention. Figure 3 schematically shows the steps of the production of a further filled container insert according to a preferred embodiment of the invention. Fig. 4 schematically shows the procedure for opening the filled insert for the container of Figs. Fig. 4 schematically shows the procedure for opening the filled insert for the container of Figs. Fig. 4 schematically shows the procedure for opening the filled insert for the container of Figs. A drug container system for mixing two or more components of a pharmaceutical product, comprising a BFS container filled with a liquid for dilution and a filled insert sealed in the container ing. A drug container system for mixing two or more components of a pharmaceutical product, comprising a BFS container filled with a liquid for dilution and a filled insert sealed in the container ing. A drug container system for mixing two or more components of a pharmaceutical product, comprising a BFS container filled with a liquid for dilution and a filled insert sealed in the container ing. A drug container system for mixing two or more components of a pharmaceutical product, comprising a BFS container filled with a liquid for dilution and a filled insert sealed in the container ing.

  Figures 1a to 1g and 4a to 4h schematically show how a filled insert for a container can be produced. For example, container inserts that are manufactured separately by injection molding can be used with any barrier, such as engineering plastics with high barrier properties where it is necessary to provide high barrier properties in compounds that are sensitive to light, moisture, or oxygen. Various types of thermoplastic materials can be used.

  FIG. 1 a shows a molded container casing 1 having a wall 2, a bottom 3 and an open top 4 for receiving drug components. For example, the container casing 1 manufactured using injection molding preferably has a cylindrical shape, and the bottom 3 has a suitable weakening rim 5 on the outer periphery of the bottom. The weakened rim 5 allows the bottom disk 3 to be pushed open so that the substance can be transferred between the filled insert and the liquid container. Preferably, a small portion of the weakened rim is kept thicker and functions as a hinge 6 that prevents the bottom disk 3 from leaving the solid container completely when opened.

  In order to further supplement the moisture or gas blockage of the container insert and protect the contents, a barrier foil 7 (eg, aluminum foil) is used to cover the bottom disc 3 as can be seen in FIG. 1b. can do.

  In FIG. 1c, the molded container casing is filled with contents 8, powder, or other suitable solid (or semi-solid) in a well-defined clean environment (eg, an isolator or other suitable unidirectional airflow). Aseptic filling in the hood (UDF)). According to another aspect of the invention, not shown in the drawings, the molded container casing is filled with a semi-solid content or liquid that is mixed with diluent prior to injection.

  FIGS. 1d, 1e, and 1f show how the container insert is hermetically sealed using a resilient stopper 9 (eg, a standard rubber stopper or a thermoplastic elastomer (TPE) part). An elastic stopper 9 is attached through the open top and is secured by a clamp ring 10 to ensure a safe and tight fixation of the stopper 9. As shown in FIG. 1g, a barrier foil 15, i.e. an aluminum foil, may be used to cover the elastic stopper 9 and the clamp ring 10 to further supplement the moisture or gas blockage of the filled container insert 17. it can. The open center of the clamp ring 10 exposes a circular area of the elastic stopper, in which a spike (or puncture needle) can be advanced through the stopper. The filled container insert 17 can be sterilized in situ, or in a separate step after filling / closing, using standard methods such as electron beam or gamma irradiation. Such sterile filled container inserts can then be transported to a suitable standard liquid filling line for attachment to a co-molded container or other suitable liquid plastic container. The container can include the components of a nasal delivery device that preferably contains a suitable liquid.

  FIG. 2a schematically shows how the spike 20 is pushed through the elastic stopper 9 of the filled container insert, and FIG. 2b shows how the push 20 is pushed in. It is schematically shown that the force breaks the weakened rim 5 (and the barrier foil 7) on the outer periphery of the bottom, and the filled container insert contents 8 are released from the container.

  FIG. 3 a shows an embodiment of a drug container system 21 in which a filled container insert 17 according to the present invention is attached to the top of a co-molded container 22. In the embodiment of FIGS. 3a-3d, the system 21 comprises means suitable for the delivery of the drug into the vein, but the system comprises a nasal delivery mechanism (e.g. a spray connected to the container). Or any other suitable drug system, such as a container (eg, bottle, vial, or tube) used with a dropper. The filled container insert 17 of the embodiment of FIG. 3a filled with the contents 8 is placed in a co-filled liquid container and the top of the filled container is molded as shown in FIG. 3b. It is exposed to the user by opening the unscrewing upper part 23 of the simultaneous filling container 22. In a preferred embodiment, as also shown in FIG. 3b, a moisture barrier seal 15 covers the top, ie covers the elastic stopper 9 of the filled container below the top 23 to be unscrewed. . After removing the moisture barrier seal 15, the now filled container insert 17 contents 8 can be mixed with the diluting fluid in the co-molded container 22. FIG. 3 c shows how the spike 20 pierces the elastic stopper 9 and enters the filled container 17. The pushing force from the spike 20 acts on the bottom disk 3, and the weakened rim 5 on the outer periphery of the disk is torn. The fall of the disc 3 into the co-molding container 22 is prevented by the hinge 6 connecting the bottom disc to the wall 2 of the container insert. The contents of the now filled container can be mixed with the dilution fluid in the co-filled container by gently shaking the container. In FIG. 3d, the bottom flap 25 is raised so that the container system can be hung near the patient as the substance is administered to the patient. According to another aspect of the invention, not shown in the drawings, the filled container insert can be welded to the wall of a flexible bag filled with the liquid for dilution.

  FIG. 4a shows another embodiment of the present invention. Similar reference numbers are used to indicate similar components to those of the embodiment of FIGS. A molded container casing 1 has a wall 2, a bottom 3 and an open top 4 for receiving drug components. For example, the container casing 1 manufactured using injection molding preferably has a cylindrical shape, and the wall 2 is pleated so that the container casing has the form of a bellows. It is different from the form. The bottom 3 has a suitable weakening rim 5 on the outer periphery of the bottom. Preferably, a small portion of the weakened rim is kept thicker and functions as a hinge 6 that prevents the bottom disk 3 from leaving the solid container completely when opened. In order to further supplement the moisture or gas blockage of the container insert and protect the contents, a barrier foil 7 (eg, aluminum foil) is used to cover the bottom disc 3 as can be seen in FIG. 4b. can do.

  In FIG. 4c, the inner cylinder 30 is placed inside the molded container casing, and then, as shown in FIG. 4d, the inner cylinder placed inside the container wall is filled with the contents 8 in a well-defined clean environment. Filled with powder, or other suitable solid (or semi-solid) (eg, aseptic filling in an isolator or other suitable unidirectional airflow hood (UDF)). According to another aspect of the invention, not shown in the drawings, the inner cylinder is filled with the container with a semi-solid content or liquid that is mixed with the diluent prior to injection. The weakened rim 5 allows the bottom disc 3 to be pushed open using the inner cylinder 30 so that the substance can be transferred between the filled insert and the liquid container. The inner cylinder 30 is tapered and is directed against the weakened rim so that the position directly facing the hinged portion of the weakened rim along the outer periphery is initially pushed by the tapered end.

  FIGS. 4e and 4f show how the container insert is hermetically sealed using an elastic stopper 9 (eg, a standard rubber stopper or a thermoplastic elastomer (TPE) part). A stopper 9 is mounted through the open top and is secured by a clamp ring 10 to ensure a safe and tight fixation of the stopper 9. As shown in FIG. 4h, a barrier foil 15, i.e. an aluminum foil, may be used to cover the elastic stopper 9 and the clamp ring 10 to further supplement the moisture or gas blockage of the filled container insert 17. it can. Alternatively, the aluminum foil is replaced with a standard tamper-evident seal. The open center of the clamp ring 10 exposes a circular area of the elastic stopper, in which a spike (or puncture needle) can be advanced through the stopper. The filled container insert 17 can be sterilized in situ (at the time of filling) using standard methods such as electron beam or gamma irradiation, or in a separate step after filling / closing. be able to. Such sterile filled container inserts can then be transported to a suitable standard liquid filling line for attachment to a co-molded container or other suitable liquid plastic container.

  FIG. 5a schematically shows how an indentation force is applied to the top of the bellows-like container insert 17 and how the indentation force compresses the wall 2 of the container insert. Yes. In FIG. 5b, the inner cylinder 30 has pushed the bottom 3, has broken the weakened rim 5 (and the barrier foil 7) on the outer periphery of the bottom, and the contents 8 of the filled container insert have been released from the container for dilution. Of fluid (not shown). In FIG. 5c, a spike 20 is introduced through the rubber stopper 9 and the container is ready for administration to the patient.

  FIG. 6 a shows an embodiment of a drug container system 21 in which a filled container insert 17 according to the present invention is attached to the top of a co-molded container 22. As noted above, the system can include any other suitable drug system, such as a container used with a nasal delivery mechanism. The filled container insert 17 filled with the contents 8 is placed into a co-molded liquid container and the top of the filled container is twisted into the co-molded container 22 as shown in FIG. 6b. It is exposed to the user by opening the upper part 23 to be removed. In a preferred embodiment, as also shown in FIG. 6b, a moisture barrier seal 15 covers the top, i.e. covers the elastic stopper 9 of the filled container below the top 23 to be unscrewed. . After removing the upper part to be unscrewed, the now filled contents 8 of the container insert 17 can be mixed with the diluting fluid of the co-filled container 22. FIG. 6c shows how the wall 2 of the bellows-like insert is compressed. Due to the pushing force, the inner cylinder 30 breaks the weakened rim 5 on the outer periphery of the bottom disk 3, and the rim is broken. The fall of the disc 3 into the co-molding container 22 is prevented by the hinge 6 connecting the bottom disc to the wall 2 of the container insert. The contents of the now filled container can be mixed with the dilution fluid in the co-filled container by gently shaking the container. After visual inspection to ensure complete mixing of the contents and confirmation of the absence of particles, the moisture barrier seal (or tamper-evident seal) can be removed. A spike 20 (or puncture needle) can be introduced through the stopper 9 to prepare the container for administration to the patient. According to another aspect of the invention, not shown in the drawings, the filled container insert can be welded to the wall of a flexible bag filled with the liquid for dilution.

  In order to mix the contents of the solid and liquid containers in the intravenous injection example described above, the user (typically a nurse) employs the normal operating procedure for intravenous injection (ie, IV infusion). A preferred use of a system according to an embodiment of the invention as shown in FIGS.

1) The nurse unscrews the top of the co-filled container and tears off the moisture barrier seal if present (and sterilizes the top of the rubber stopper, if it is a standard procedure) To do).
2) The sterilized IV dosing set bag is opened.
3) The IV spike of the dosing set is inserted into the top of the rubber stopper and penetrates the rubber stopper. When the spike is fully inserted, the bottom disk of the solid container is pushed open by the spike and the solid and liquid chambers are now in contact and allowed to mix.
4) The contents of the solid and liquid chambers are mixed by gently shaking the container.
5) The nurse visually inspects the contents of the container to ensure complete dissolution and absence of particulate matter.
6) The needle is attached to the patient after purging and is ready for IV infusion.

  A preferred use of a system according to another embodiment of the present invention as shown in FIGS. 4-6 will be described below in time series.

1) The nurse twists and removes the upper part of the simultaneous filling container.
2) The nurse compresses the bellows-like insert and drops the filled contents into the diluent container, where the solid and liquid chambers are now in contact and can be mixed.
3) The contents of the solid and liquid chambers are mixed by gently shaking the container.
4) The nurse removes the moisture barrier (or protective) seal and performs sterilization of the top of the rubber stopper if it is a standard procedure.
4) The sterilized IV dosing set bag is opened. The IV spike of the administration set is inserted into the top of the rubber stopper and the rubber stopper is penetrated.
5) The nurse visually inspects the contents of the container to ensure complete dissolution and absence of particulate matter.
6) The needle is attached to the patient after purging and is ready for IV infusion.

  In other embodiments where, for example, a filled insert is used with, for example, a nasal delivery device, some of the above steps may be performed by placing the insert in a suitable container such as a nasal spray bottle, or otherwise Can be combined and executed in the same way.

  Furthermore, it will be appreciated that the invention is not limited to the embodiments described above but may be varied in a number of different ways without departing from the scope of the appended claims.

Claims (12)

A filled insert for a container for use in a drug container system to mix two or more components of a pharmaceutical product,
A molded container casing having a wall, a bottom, and an open top for receiving solid components;
An elastic stopper for sealing the open upper part of the container casing by the molding, and a bottom disk formed by a weakening rim on the outer periphery of the bottom of the container casing by the molding,
A force is applied to the bottom disk by introducing a spike through the elastic stopper and the weakened rim is broken by the force to open the container insert so that the filled solid component is A filled insert for a container that can open the bottom disk so that it can be mixed with the diluent fluid of a drug container system. A filled insert for a container for use in a drug container system to mix two or more components of a pharmaceutical product,
A molded container casing having a wall, a bottom, and an open inner cylinder and an open top for receiving solid components;
An elastic stopper for sealing the open upper part of the container casing by the molding, and a bottom disk formed by a weakening rim on the outer periphery of the bottom of the container casing by the molding,
By applying a pushing force to the upper part of the container by the molding, the casing is compressed and the inner cylinder is pushed toward the bottom disk, whereby the weakened rim is broken by the force and the container insert is inserted. A filled insert for a container that can open the bottom disc so that the filled solid components can be mixed with the diluent fluid of the drug container system by opening the.   The filled insert for containers according to claim 2, wherein the molded container casing has pleated side walls forming a bellows-like container insert.   A weakened rim of the bottom disk is placed around the outer periphery of the bottom of the container casing so that the bottom disk remains connected to the container casing when the weakened rim is broken and the container is opened. The filled insert for a container according to any one of claims 1 to 3, wherein a hinge-type disk is formed on the container.   The filled insert for containers according to any one of claims 1 to 4, wherein the elastic stopper is fixed at a predetermined position by a clamp ring so as to hermetically seal the opening of the upper part.   The filled insert for a container according to any one of claims 1 to 5, wherein the bottom disk is covered with a moisture barrier foil.   The filled insert for a container according to any one of claims 1 to 6, wherein the elastic stopper is covered with a moisture barrier foil.   8. The filled insert for a container according to any one of claims 1 to 7, which is aseptically attached to the top of a BFS container to form a multi-chamber drug container system.   9. A filled insert for a container according to any one of claims 1 to 8, which is aseptically attached to a container to which a delivery mechanism can be attached so as to provide a multi-chamber drug delivery system.   10. A filled insert for a container according to claim 9, wherein the delivery mechanism comprises a nasal delivery component, preferably a spray or dropper. A drug container system for mixing two or more components of a pharmaceutical product, comprising:
A first container containing a dilution liquid;
A second container insert that is aseptically attached to the top of the first container;
The second container comprises:
-Molded container casing to accept solid components,
An elastic stopper for sealing the open upper part of the container casing by the molding, and a bottom disk formed by a weakening rim on the outer periphery of the bottom of the container casing by the molding,
A force is applied to the bottom disc by introducing a spike through the elastic stopper, and the force is applied to the weakened rim to break the weakened rim and open the container so that the filled solid component can be removed from the drug container. A drug container system capable of opening the bottom disc for mixing with the dilution fluid of the system. A drug container system for mixing two or more components of a pharmaceutical product, comprising:
A first container containing a dilution liquid;
A second container insert that is aseptically attached to the top of the first container;
The second container comprises:
A molded container casing having a wall, a bottom, and an open inner cylinder and an open top for receiving solid components;
An elastic stopper for sealing the open upper part of the container casing by the molding, and a bottom disk formed by a weakening rim on the outer periphery of the bottom of the container casing by the molding,
By applying a pushing force to the upper part of the container by the molding, the casing is compressed, and the inner cylinder is pushed toward the bottom disk, whereby the weakened rim is broken by the force and the container insert is inserted. Opening the bottom disk so that the filled solid components can be mixed with the diluent fluid of the drug container system.

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