WO2025221983A1

WO2025221983A1 - Medicament container, set of medicament containers, kit comprising a medicament container and an adapter and methods of preparing an injectable liquid medicament

Info

Publication number: WO2025221983A1
Application number: PCT/US2025/025142
Authority: WO
Inventors: Alexander ALLERDINGS; Katrin NISSEN
Original assignee: Genzyme Corp
Current assignee: Genzyme Corp
Priority date: 2024-04-19
Filing date: 2025-04-17
Publication date: 2025-10-23
Anticipated expiration: 2026-10-19

Abstract

The present disclosure related to a medicament container (10) for a medicament (1), the medicament container (10) comprising: - a container wall (20) enclosing a cavity (30) for the medicament (1), the container wall (20) having a first wall portion (40) and a second wall portion (50), - an inlet (41) for a fluid at the fist wall portion (40) of the container wall (20), - an outlet (51) for the fluid at the second wall portion (50) of the container wall (20), - a first closure (42) closing the inlet (41), - a second closure (52) closing the outlet (51), - wherein the first closure (42) is at least one of breakable or pierceable by a first breaking or piercing feature and wherein the second closure (52) is at least one of breakable or pierceable by a second breaking or piercing feature to allow a fluid flow through the medicament container (10) from the inlet (41) through the cavity (30) to the outlet (51).

Description

Medicament container, set of medicament containers, kit comprising a medicament container and an adapter and methods of preparing an injectable liquid medicament

Description

Field

The present disclosure relates to the field of medicament containers, such as bottles, cartridges, carpules or vials. In particular, the disclosure relates to a primary packaging configured to accommodate a medicament. In a further aspect the present disclosure relates to a set of medicament containers. In a further aspect the present disclosure relates to a kit comprising a medicament container and an adapter. In further aspects the present disclosure relates to methods of preparing an injectable liquid medicament.

Background

A primary packaging for a medicament, such as a bottle, a cartridge, a vial, a carpule or is typically filled with medicament, e.g. a liquid medicament or a lyophilized medicament or a medicament powder. Before administration, e.g. by intravenous injection (IV) injection or subcutaneous injection, a lyophilized medicament or a medicament powder is reconstituted as a liquid. This might be done by combining a liquid diluent or solvent with the lyophilized medicament or the medicament powder.

Medicament containers such as bottles, cartridges, carpules or vials comprise an outlet that has to be closed in a liquid tight and/or gas tight manner. Since the interior of the medicament container has to be sterile the closure, e.g. a seal, is typically non-detachably fixed on or at the outlet of the medicament container. The closure may be penetrable by a piercing element, such as a cannula or an injection needle in order to enable withdrawal or expelling of a liquid diluent into the cavity of the medicament container and/or for withdrawing or expelling a liquid substance, e.g. a liquid medicament, from the cavity of the medicament container. The medicament container may be filled with a liquid, e.g. an injectable medicament. The medicament container may also accommodate a lyophilized medicament or a medicament powder. Here, the closure may be penetrated by some type of administering device in order to add a solvent or diluent into the cavity of the medicament container containing the medicament in order to prepare or to reconstitute the liquid medicament inside the medicament container. A medicament presentation for a patient might include a large number of vials, e.g. up to forty vials, each vial including a specific amount of a specific medicament, wherein the medicament contained in one vial might be different from the medicament of another vial, e.g. with respect to the amount, dose and/or kind of medicament. Thus, preparation of the medicament presentation includes reconstitution of the medicament contained in the respective vial and pooling of the reconstituted medicaments prior to administration. This is a complex and burdensome process leading to long preparation times and a high risk for errors, e.g. contamination of the medicament presentation. Further, multiple mixing and vial pooling steps may increase the chance of medicament loss.

Therefore, it would be beneficial to provide an improvement for preparation of medicament presentations including pooling of medicaments from multiple medicament containers.

Summary

In order to solve the above-mentioned problems, there is suggested a medicament container, a set of such medicament containers and a kit comprising such a medicament container and an adapter as defined by the independent claims, respectively. Further aspects and examples of the present disclosure are subject matter of dependent claims.

According to one aspect there is provided a medicament container for a medicament. The medicament container comprises a container wall enclosing a cavity for the medicament. The container wall has a first wall portion and a second wall portion. The medicament container comprises an inlet for a fluid at the first wall portion of the container wall and an outlet for the fluid at the second wall portion of the container wall. The medicament container further comprises a first closure closing the inlet and a second closure closing the outlet. The first closure is at least one of breakable or pierceable by a first breaking or piercing feature and the second closure is at least one of breakable or pierceable by a second breaking or piercing feature to allow a fluid flow through the medicament container from the inlet through the cavity to the outlet.

Breaking or piercing the first closure allows inflow of the fluid, e.g., a solvent or diluent, into the cavity through the inlet. This way, the medicament contained in the cavity may be dissolved, reconstituted or diluted. Breaking or piercing the second closure allows outflow of the fluid from the cavity through the outlet. This way, a fluid contained in the cavity, e.g., the reconstituted or diluted medicament, may be withdraw from the cavity through the outlet. Thus, the medicament container may allow inflow and outflow of a fluid at different, e.g., opposite portions of the container wall.

After inflow of the fluid into the cavity, the medicament container may be gently rotated or shaken to ensure proper distribution or resolving of the medicament. By breaking or piercing both, the first closure and the second closure, flushing the medicament container from the inlet through the cavity to the outlet with a reconstitution liquid may be performed thereby transferring the medicament from the cavity through the outlet by way of the reconstitution liquid flowing from the inlet to the outlet. This way, the medicament container allows inflow of the fluid, flushing the cavity and outflow of the fluid without changing flow direction, thus by an unidirectional flow. So, in contrast to a medicament container comprising only a single opening serving for both, inlet and outlet, the medicament container as describe above may allow using an unidirectional flow in order to dissolve or reconstitute the medicament and transfer of the dissolved or reconstituted medicament to another device, e.g. another medicament container as described above or an infusion bag.

The first closure might be non-detachably fixed on or at the first wall portion. The second closure might be non-detachably fixed on or at the first wall portion.

The first closure might form an integral part of the first wall portion. For example, the first closure might be a portion with a reduced wall thickness, e.g. the first closure may have a wall thickness that is smaller compared to a wall thickness of a portion of the container wall abutting the first closure. The second closure might form an integral part of the second wall portion. For example, the second closure might be a portion with a reduced wall thickness, e.g. the second closure may have a wall thickness that is smaller compared to a wall thickness of a portion of the container wall abutting the second closure.

The first closure might be one of a seal or a closure cap non-detachably fixed on or at the first wall portion. The second closure might be one of a seal or a closure cap non-detachably fixed on or at the second wall portion.

The first breaking or piercing feature might be a needle tip. The first breaking or piercing feature might be a needle tip or a spike.

In some examples the first wall portion and the second wall portion are opposing wall portions of the container wall. The medicament container may comprise an elongated shape, elongated in a longitudinal direction, wherein the medicament container has a distal end and a proximal end, wherein the distal end and the proximal end are opposing in the longitudinal direction of the medicament container, wherein the distal end comprises the second wall portion and the proximal end comprises the first wall portion.

The medicament container may comprise a tubular barrel, a bottle, a cartridge, a carpule or a vial. The tubular barrel may be open ended at both opposite ends.

A material of the container may be a glass material, a vitreous material or a dimensionally stable plastic material, which are pharmaceutically inert. The container may comprise a barrel made of Cyclic Olefin Polymer (COP) or Cyclic Olefin Copolymer (COCP).

The medicament container may be used with at least one another medicament container as described above. Thus, the another medicament comprises another container wall enclosing another cavity for the another medicament. The another container wall has another first wall portion and another second wall portion. The another medicament container comprises another inlet for a fluid at the another first wall portion of the another container wall and another outlet for the fluid at the another second wall portion of the another container wall. The another medicament container further comprises another first closure closing the another inlet and another second closure closing the another outlet. The another first closure is at least one of breakable or pierceable by another first breaking or piercing feature and wherein the another second closure is at least one of breakable or pierceable by another second breaking or piercing feature to allow a fluid flow through the another medicament container from the another inlet through the another cavity to the another outlet.

In some examples the medicament container and the at least one another medicament container can be substantially identical, e.g. with respect to a shape of at least one of the first wall portion and the second wall portion and/or with respect to corresponding features of the wall portions.

The medicament container may further comprise the another first breaking or piercing feature, wherein the another first breaking or piercing feature is located at the second wall portion of the container wall, wherein the another first breaking or piercing feature is configured to break or pierce the another first closure of the another medicament container during fastening of the second wall portion of the container wall of the medicament container relative to the another first wall portion of the another container wall of the another medicament container. This way, breaking or piercing of the another first closure of the another medicament container occurs during connecting of the medicament container to the another medicament container, thereby maintaining integrity of the another cavity until connecting the medicament containers.

The medicament container may further comprise another second breaking or piercing feature, wherein the another second breaking or piercing feature is located at the first wall portion of the container wall, wherein the another second breaking or piercing feature is configured to break or pierce the another second closure of the another medicament container for another medicament during fastening of the first wall portion of the container wall of the medicament container relative to the another first wall portion of the another container wall of the another medicament container. This way, breaking or piercing of the another second closure of the another medicament container occurs during connecting of the medicament container to the another medicament container, thereby maintaining integrity of the another cavity until connecting the medicament containers.

In some examples, the medicament container comprises the another first breaking or piercing feature and the another medicament container comprises the second breaking or piercing feature, wherein the second breaking or piercing feature is located at the another first wall portion of the another container wall, wherein the second breaking or piercing feature is configured to break or pierce the second closure of the medicament container during fastening of the second wall portion of the container wall of the medicament container relative to the another first wall portion of the another container wall of the another medicament container. Thus, breaking or piercing of both, the another first closure and the second closure, occurs during connecting the medicament containers to one another, thereby immediately providing a fluid connection between the cavity and the another cavity.

In some examples, the medicament container comprises the another second breaking or piercing feature and the another medicament container comprises the first breaking or piercing feature, wherein the first breaking or piercing feature is located at the another second wall portion of the another container wall, wherein the first breaking or piercing feature is configured to break or pierce the first closure of the medicament container during fastening of the first wall portion of the container wall of the medicament container relative to the another second wall portion of the another container wall of the another medicament container. Thus, breaking or piercing of both, the another second closure and the first closure, occurs during connecting the medicament containers to one another, thereby immediately providing a fluid connection between the cavity and the another cavity. In some examples, the medicament container comprises the another first breaking or piercing feature and the another second breaking or piercing feature and the another medicament container comprises the first breaking or piercing feature and the second breaking or piercing feature.

The fastening of the first wall portion of the container wall of the medicament container relative to the another second wall portion of the another container wall may be provided by an external fastener providing a positive-lock fit or frictional fit with both, the medicament container and the another medicament container. The fastening of the second wall portion of the container wall of the medicament container relative to the another first wall portion of the another container wall may be provided by an external fastener providing a positive-lock fit or frictional fit with both, the medicament container and the another medicament container.

In some examples, the medicament container and the another medicament container may be substantially identical, at least with regard to their mutually corresponding interfaces. They may contain different medicaments and/or amounts of medicaments.

The medicament container may further comprise a first fastener at the first wall portion and a second fastener at the second wall portion, the first wall portion being fastenable to the another second wall portion of the another container wall of the another medicament container via the first fastener at the first wall portion of the medicament container directly or indirectly engaging another second fastener at the another second wall portion of the another medicament container and/or the second wall portion being fastenable to the another first wall portion of the another container wall of the another medicament container via the second fastener at the second wall portion of the medicament container directly or indirectly engaging another first fastener at the another first wall portion of the another medicament container. This allows direct or indirect mechanical coupling, e.g. connecting, fastening and/or fixing, of multiple medicament containers in a row, thereby providing a final assembly of multiple medicament containers.

This final assembly may allow flushing the cavities of the multiple medicament containers via the outlets and inlets of the medicament containers in a sequential manner. The multiple medicament containers each may comprise a proximal end comprising the first wall portion with the inlet and a distal end comprising the second wall portion with the outlet. The assembly of multiple medicament containers may comprise an inlet end and an outlet end.

The medicament containers may be arranged such that the distal end of the respective medicament container is facing the proximal end of the subsequent medicament container. Apart from that the outlet end of the assembly, which outlet is accessible, e.g. to couple another device, such as an infusion bag, a tube or for direct or indirect coupling of a pump for the fluid.

The inlet of the medicament container at the inlet end of the assembly is accessible, e.g. to couple another device, such as a bag containing the fluid or diluent, a tube or for direct or indirect coupling of a pump for the fluid. Flushing of the assembly may be performed by a pump coupled to the outlet of the medicament container at the outlet end, wherein the fluid is sucked through the assembly by the pump. Flushing of the assembly may be performed by a pump coupled to the inlet of the medicament container at the inlet end, wherein the fluid is pumped or expelled through the assembly by the pump.

In some examples, the first fastener may comprise a first engaging structure and the second fastener may comprise a second engaging structure, the first engaging structure being complementary to the second engaging structure, such that when another medicament container is provided at least one of a positive-locking fit or a frictional fit is provided between the first fastener of the medicament container and the another second fastener of the another medicament container. This way interconnection of medicament containers is facilitated by providing identical first fasteners and complementary second fasteners at each medicament container. This way, the medicament containers may be directly fastened to another to form a mechanically stable assembly that may be handled as a single unit, e.g. to rotate and/or shake the assembly to ensure proper distribution or resolving of the medicaments contained in the containers and/or transfer of the assembly, e.g. for administration.

In some examples the medicament container may further comprise a first seal located at the first wall portion, wherein the first seal is configured to provide a fluid-tight sealing between the first wall portion of the container wall and the second wall portion of the container wall of another medicament container as described above, when the medicament container and the another medicament container are connected directly or indirectly, wherein the fluid-tight seal prevents leakage of a fluid flowing from the outlet of the medicament container to the inlet of the another medicament container.

In some examples the medicament container may further comprise a second seal located at the second wall portion, wherein the second seal is configured to provide a fluid-tight sealing between the second wall portion of the container wall and the first wall portion of the container wall of another medicament container as described above, when the medicament container and the another medicament container are connected directly or indirectly, wherein the fluid-tight seal prevents leakage of a fluid flowing from the outlet of the another medicament container to the inlet of the medicament container.

In some examples, the medicament container may contain a medicament located within the cavity. An amount of the medicament located within the cavity may correspond to a predefined single dose or multiple doses of the medicament. The medicament may be a lyophilized medicament and/or a medicament powder. The lyophilization process may be performed with the medicament to be lyophilized being located in the cavity and at least one of the first closure or second closure not yet attached during the lyophilization process. The first closure or second closure of may be attached to the medicament container subsequent to the lyophilization process.

In another aspect the present disclosure relates to a method of preparing a liquid injectable medicament by using a medicament container as described above. Insofar all effects, features and benefits as described above in connection with medicament container equally apply to the method and vice versa.

The method comprises: using a medicament container as described above, wherein the medicament container contains a medicament, filling the cavity of the medicament container with a liquid diluent by introducing the liquid diluent into the inlet of the medicament container

Withdrawing of a liquid injectable medicament from the cavity of the medicament container may be conducted via the outlet of the medicament container.

In another aspect the present disclosure relates to a set of medicament containers, wherein the set comprises a first medicament container as described above and a second medicament container as described above. Insofar all effects, features and benefits as described above in connection with medicament container and/or the another medicament container equally apply to the set and vice versa.

In some examples the first medicament container contains a first amount or first dose of a first medicament and the second medicament container contains a second amount or second dose of the first medicament, wherein the second amount or dose is an integral multiple of the first amount or dose. The set may comprise multiple medicament containers, wherein each medicament container comprises the medicament and the same amount of the same medicament. Thus, the length of an assembly of a number of medicament containers of the set assembled in a row would be a measure for the total amount or doses provided by this assembly.

Each of the medicament containers may contain a specific amount of a specific medicament each providing a component of a medicament preparation. The assembly of the medicament containers may facilitate the reconstitution of the medicaments or pooling of the medicaments contained in the medicament containers. The medicament containers each may comprise a proximal end comprising the first wall portion with the inlet and a distal end comprising the second wall portion with the outlet.

The medicament containers may be arranged or assembled such that that the distal end of the respective medicament container is facing the proximal end of the subsequent medicament container, apart from that medicament container at an outlet end of the assembly, which outlet is accessible, e.g. to couple another device, such as an infusion bag, a tube or for direct or indirect coupling of a pump for the fluid. Such kind of assembly or arrangement allows sequentially flushing of the multiple medicament containers, thereby reconstitute each medicament contained in the respective medicament container in a single reconstitution step by a fluid flow from the inlet of the medicament container at the first end of the assembly.

The fluid flowing into the cavity of the medicament container at the first end of the assembly may flow out through the outlet of this medicament container and then through the inlet of the subsequent medicament container and so on. This enables flushing the cavity of each medicament container by a single reconstitution step and thus preparing the final medicament presentation by a single reconstitution step. Thus, separate reconstitution steps and withdrawal steps for each medicament container may not be needed.

In some examples the first medicament container may contain a first medicament and the second medicament container may contain a second medicament, wherein the first medicament and the second medicament are different medicaments. The medicaments and respective amounts of the medicaments may correspond to a medicament presentation. As the medicament containers each correspond to the medicament container as described above, the preparation process of medicament presentation prior to administration is facilitated and less complex compared to a preparation process including reconstitution and/or withdrawing of the medicament for each medicament container separately. In some examples, the first wall portion may comprise a first shoulder portion, a first head portion and a first neck portion, wherein the first neck portion is located between the first head portion and the first shoulder portion, wherein a first recess is provided by the neck portion, wherein the first head portion comprises the inlet.

In some examples, the second wall portion may comprise a second shoulder portion, a second head portion and a second neck portion, wherein the second neck portion is located between the second head portion and the second shoulder portion, wherein a second recess is provided by the neck portion, wherein the second head portion comprises the outlet.

In another aspect the present disclosure relates to a method of preparing a liquid injectable medicament by using a set of medicament containers as described above. Insofar all effects, features and benefits as described above in connection with medicament container and/or the set equally apply to the method and vice versa.

The method comprises: using a set of medicament containers as described above, wherein the first medicament container contains a first medicament and wherein the second medicament container contains a second medicament, forming an assembly of interconnected medicament containers by connecting the first wall portion of the second medicament container to the second wall portion of the first medicament container such that the outlet of the first medicament container is in fluid connection with the inlet of the second medicament container, thereby allowing a fluid flow from first medicament container into the second medicament container, filling the cavity of the first medicament container and the cavity of the second medicament container with a liquid diluent by introducing the liquid diluent into the inlet of the first medicament container.

The assembly formed may allow flushing the cavities of the multiple medicament containers by introducing the liquid diluent in the inlet of the first medicament container, that may result in a filling of the cavity of the first medicament container and of the cavity of the second medicament container in a sequential manner.

For establishing the fluid connection between the outlet of the first medicament container and the inlet of the second medicament container, the first closure of the second medicament container may be pierced or broken by the first breaking or piercing feature and the second closure of the first medicament container may be pierced or broken by the second breaking or piercing feature.

The first breaking or piercing feature may be provided by the first medicament container. For example the first breaking or piercing feature may be located at the second wall portion of the container wall of the first medicament container, wherein the first breaking or piercing feature may be configured to break or pierce the first closure of the second medicament container during fastening of the second wall portion of the container wall of the first medicament container relative to the first wall portion of the container wall of the second medicament container.

The second breaking or piercing feature may be provided by the second medicament container. For example the second breaking or piercing feature may be located at the first wall portion of the container wall of the second medicament container, wherein the second breaking or piercing feature may be configured to break or pierce the second closure of the first medicament container during fastening of the second wall portion of the container wall of the first medicament container relative to the first wall portion of the container wall of the second medicament container.

The set may comprise at least one additional medicament container as described above. The forming of the assembly may comprise forming a sequential assembly of consecutive medicament containers, by connecting the first wall portion of each medicament container, apart from the first medicament container, to the second wall portion of a preceding medicament container such that the outlet of the preceding medicament container is in fluid connection with the inlet of the subsequent medicament container, thereby allowing a fluid flow from the preceding medicament container into the subsequent medicament container. Such kind of an assembly allows sequentially flushing of the multiple medicament containers, thereby filling the cavity of each medicament container by introducing the liquid diluent into the inlet of the first medicament container.

Withdrawing of a liquid injectable medicament from the cavities of the medicament containers of the assembly may be conducted via the outlet of a medicament container of the assembly that forms an end adapter of the assembly being opposite to the first medicament container.

In another aspect the present disclosure relates to a kit comprising a first medicament container as described above and at least one adapter for connecting the medicament container to a second medicament container as described above. Insofar all effects, features and benefits as described above in connection with medicament container and/or the another medicament container equally apply to the set and vice versa. The adapter comprises a first side and a second side, a first container connecting portion at the first side of the adapter, wherein the first container connecting portion is configured for fastening the second wall portion of the container wall of the first medicament container to the adapter. The adapter comprises a second container connecting portion at the second side of the adapter, wherein the second container connecting portion is configured for fastening the first wall portion of the container wall of the second medicament container to the adapter. This way, the first medicament container and the second medicament container may be connected to one another via the adapter and thus indirectly. By this, the first container connecting portion and the second container connecting portion may have a rather simple structure, e.g. a flange, and the closure might be a usual closure, e.g. a septum fastened by crimped cap. Thus, the medicament container may be void of fasteners and/or breaking or piercing features.

The kit may further comprise the second medicament container.

In some examples the adapter is configured to connect two medicament containers as described above. It may be limited to connect only two medicament containers.

In some examples the first side and the second side are opposing sides of the adapter. Thereby and by use of one or more adapters a linear row of interconnected medicament containers can be assembled.

Further, at least one of the first breaking or piercing feature and the second breaking or piercing feature may be provided by the adapter.

According to a further example the first breaking or piercing feature may be located at the second side of the adapter and the second breaking or piercing feature may be located at the first side of the adapter. This way, when connecting the first medicament container and the second medicament container via the adapter a fluid flow from the cavity of the first medicament container through the outlet of the first medicament container through the inlet of the second medicament container into the cavity of the second medicament container is enabled. Such kind of assembly or arrangement allows sequentially flushing of the medicament containers, thereby reconstituting each medicament contained in the respective medicament container in a single reconstitution step by a fluid flow from the inlet of the first medicament container. Outflow of the reconstituted medicament / fluid from the assembly or arrangement may be performed via the outlet of the second medicament container. Inflow and outflow may be performed at the same time.

An assembly comprising more than two medicament containers may be prepared by use of additional adapters.

In some examples the first container connecting portion may comprise a first container engaging structure and the second wall portion of the container wall of the first medicament container may comprise a first adapter engaging structure complementary shaped to the first container engaging structure for providing at least one of a positive-locking fit or a frictional fit.

In some examples the second container connecting portion may comprise a second container engaging structure and the first wall portion of the container wall of the second medicament container may comprise a second adapter engaging structure complementary shaped to the second container engaging structure for providing at least one of a positive-locking fit or a frictional fit.

In some examples the second container connecting portion may be identical to the first container connecting portion, thereby facilitating the handling of the adapter.

In some examples the adapter may comprise a needle hub and an elongated needle, wherein the needle hub comprises the first container connecting portion at the first side and the second container connecting portion at the second side. The needle may have a first end with a first needle tip and a second end with a second needle tip, wherein the first end of the needle comprises the first breaking or piercing feature and the second end of the of the needle comprises the second breaking or piercing feature. The needle of the adapter enables the fluid flow from the first medicament container to the second medicament container in a simple way.

The first container connecting portion may comprise a receptacle. This receptacle is configured for receiving the second wall portion. The second container connecting portion may comprise a receptacle. This receptacle is configured for receiving the second wall portion.

The needle may comprise a hollow cannula, thereby allowing a fluid flow through the needle.

In some examples the needle is configured such that the first end protrudes beyond the second connecting portion or into the second connecting portion, e.g. into the receptacle of the second connecting portion. In some examples the needle is configured such that the second end protrudes beyond the first connecting portion or into the first connecting portion, e.g. into the receptacle of the second connecting portion. This way, breaking or piercing of the first closure and/or the second closure may occur together with the fastening of the container to the adapter. Generally, the scope of the present disclosure is defined by the content of the claims. The disclosure is not limited to specific embodiments or examples but comprises any combination of elements of different embodiments or examples. Insofar, the present disclosure covers any combination of claims and any technically feasible combination of the features disclosed in connection with different examples or embodiments.

In another aspect the present disclosure relates to a method of preparing a liquid injectable medicament by using a kit as described above. Insofar all effects, features and benefits as described above in connection with medicament container and/or the kit equally apply to the method and vice versa.

The method comprises: using a kit as described above, wherein the first medicament container contains a first medicament, fastening the second wall portion of the medicament container to the first container connecting portion of the adapter, filling the cavity of the medicament container with a liquid diluent by introducing the liquid diluent into the inlet of the medicament container.

In another aspect the present disclosure relates to a method of preparing a liquid injectable medicament by using a kit as described above, wherein the kit comprises a first medicament container and a second medicament container. Insofar all effects, features and benefits as described above in connection with medicament container and/or the kit equally apply to the method and vice versa.

The method comprises: using a kit as described above, wherein the kit comprises a first medicament container and a second medicament container, wherein the first medicament container contains a first medicament and wherein the second medicament container contains a second medicament, forming an assembly of interconnected medicament containers by fastening the second wall portion of the first medicament container to the first container connecting portion of the adapter and by fastening the first wall portion of the second medicament container to the second container connecting portion of the adapter, such that the outlet of the first medicament container is in fluid connection with the inlet of the second medicament container, thereby allowing a fluid flow from first medicament container into the second medicament container, filling the cavity of the first medicament container and the cavity of the second medicament container with a liquid diluent by introducing the liquid diluent into the inlet of the first medicament container.

The kit may comprise at least one additional medicament container as described above and at least one additional adapter as described above. The forming of the assembly may comprise forming a sequential assembly of consecutive medicament containers interconnected via adapters such that the outlet of a preceding medicament container of the assembly is in fluid connection with the inlet of a subsequent medicament container of the assembly, thereby allowing a fluid flow from the preceding medicament container into the subsequent medicament container. Such kind of assembly allows sequentially flushing of the multiple medicament containers, thereby filling the cavity of each medicament container by introducing the liquid diluent into the inlet of the first medicament container.

In the present context the term ‘distal’ or ‘distal end’ relates to an end of the injection device that faces towards an injection site of a person or of an animal. The term ‘proximal’ or ‘proximal end’ relates to an opposite end of the injection device, which is furthest away from an injection site of a person or of an animal.

The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., shorter long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dualchamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and/or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and/or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

Examples of APIs for the treatment and/or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and/or exchanging at least one amino acid residue occurring in the naturally occurring peptide and/or by adding at least one amino acid residue. The added and/or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and/or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable, have been added to the naturally occurring peptide.

Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N- palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N-palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega- carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(w- carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

Examples of GLP-1, GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211, CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP- 2929, ZP-3022, ZP-DI-70, TT-401 (Pegapamodtide), BHM-034. MOD-6030, CAM-2036, DA- 15864, ARI-2651 , ARI-2255, Tirzepatide (LY3298176), Bamadutide (SAR425899), Exenatide- XTEN and Glucagon-Xten.

An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

Examples of polysaccharides include a glucosaminoglycane, a hyaluronic acid, a heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulphated polysaccharide, e.g. a poly-sulphated form of the above-mentioned polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a poly-sulphated low molecular weight heparin is enoxaparin sodium. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

The term “antibody”, as used herein, refers to an immunoglobulin molecule or an antigenbinding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and/or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and/or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full- length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and immunoglobulin single variable domains. Additional examples of antigen-binding antibody fragments are known in the art.

The term “immunoglobulin single variable domain” (ISV), interchangeably used with “single variable domain”, defines immunoglobulin molecules wherein the antigen binding site is present on, and formed by, a single immunoglobulin domain. As such, immunoglobulin single variable domains are capable of specifically binding to an epitope of the antigen without pairing with an additional immunoglobulin variable domain. The binding site of an immunoglobulin single variable domain is formed by a single heavy chain variable domain (VH domain or VHH domain) or a single light chain variable domain (VL domain). Hence, the antigen binding site of an immunoglobulin single variable domain is formed by no more than three CDRs.

An immunoglobulin single variable domain (ISV) can be a heavy chain ISV, such as a VH (derived from a conventional four-chain antibody), or VHH (derived from a heavy-chain antibody), including a camelized VH or humanized VHH. For example, the immunoglobulin single variable domain may be a (single) domain antibody, a "dAb" or dAb or a Nanobody® ISV (such as a VHH, including a humanized VHH or camelized VH) or a suitable fragment thereof. [Note: Nanobody® is a registered trademark of Ablynx N.V.]; other single variable domains, or any suitable fragment of any one thereof.

“VHH domains”, also known as VHHs, VHH antibody fragments, and VHH antibodies, have originally been described as the antigen binding immunoglobulin variable domain of “heavy chain antibodies” (i.e. , of “antibodies devoid of light chains”; Hamers-Casterman et al. 1993 (Nature 363: 446-448). The term “VHH domain” has been chosen in order to distinguish these variable domains from the heavy chain variable domains that are present in conventional 4- chain antibodies (which are referred to herein as “VH domains”) and from the light chain variable domains that are present in conventional 4-chain antibodies (which are referred to herein as “VL domains”). For a further description of VHH’s, reference is made to the review article by Muyldermans 2001 (Reviews in Molecular Biotechnology 74: 277-302).

For the term “dAb’s” and “domain antibody”, reference is for example made to Ward et al. 1989 (Nature 341 : 544), to Holt et al. 2003 (Trends Biotechnol. 21: 484); as well as to WO 2004/068820, WO 2006/030220, WO 2006/003388. It should also be noted that, although less preferred in the context of the present invention because they are not of mammalian origin, single variable domains can be derived from certain species of shark (for example, the so-called “IgNAR domains”, see for example WO 2005/18629).

The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab). Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

Those of skill in the art will understand that modifications (additions and/or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user).

As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

Brief description of the drawings

In the following, numerous examples of a medicament containers, sets and kits are shown and described in greater detail by making reference to the drawings, in which: Fig. 1 schematically illustrates an example of a medicament container in a sectional view according to line l-l in Fig. 2,

Fig. 2 illustrates the medicament container according to the arrow II in Fig. 1,

Fig. 3 illustrates another medicament container substantially identical to the medicament container shown in Fig. 1,

Fig. 4 illustrates a set of one medicament container and another medicament container before connecting to one another,

Fig. 5 illustrates the set of Fig. 4 after connecting to one another,

Fig. 6 illustrates a set of multiple medicament containers after connecting to one another in a row assembly,

Fig. 7 illustrates a kit comprising a first medicament container, a second medicament container and an adapter,

Fig. 8 illustrates the kit of Fig. 7 during interconnecting the first and the second medicament container via the adapter,

Fig. 9 illustrates multiple medicament containers after connecting to one another in a row assembly via multiple adapters,

Fig. 10 an adapter for connecting a first medicament container and another medicament container,

Fig. 11 another adapter for connecting a first medicament container and another medicament container.

Detailed description

Figs. 1-6 illustrate a first example of a medicament container 10, wherein Figs. 4-6 illustrate a set of medicament containers 10 according to the first example in a status before interconnecting of the medicament containers 10 (Fig.4) and after interconnecting of the medicament containers 10 (Figs. 5-6).

The medicament container 10 comprises an elongated shape, elongated in a longitudinal direction, wherein the medicament container 10 has a distal end and a proximal end, wherein the distal end and the proximal end are opposing in the longitudinal direction of the medicament container 10. The medicament container 10 comprises a container wall 20 enclosing a cavity 30, wherein a lyophilized medicament 1 is contained in the cavity 30. The container wall 20 comprises a first wall portion 40 and a second wall portion 50, wherein the first wall portion 40 and the second wall portion 50 are opposing wall portions of the container wall 20, wherein the distal end comprises the second wall portion 50 and the proximal end comprises the first wall portion 40. The medicament container 10 comprises an inlet 41 for a fluid, e.g. a reconstitution liquid, at the first wall portion 40 of the container wall 20. A first closure 42 is non-detachably fixed, e.g. sealed, to the first wall portion 40, thereby fluid-tight closing the inlet 41. The medicament container 10 further comprises an outlet 51 for the fluid at the second wall portion 50 of the container wall 20. A second closure 52 is non-detachably fixed, e.g. sealed, to the second wall portion 50, thereby fluid-tight closing the outlet 51.

The first closure 42 is at least one of breakable or pierceable by a first breaking or piercing feature 55’ and wherein the second closure 52 is at least one of breakable or pierceable by a second breaking or piercing feature 45’. Breaking or piercing the first closure 42 allows inflow of a fluid, e.g. a solvent or diluent, into the cavity 30 through the inlet 41. This way, the medicament 1 contained in the cavity 30 may be dissolved, reconstituted or diluted. Breaking or piercing of the second closure 52 allows outflow of the fluid, form the cavity 30 through the outlet 51. This way, a fluid content contained in the cavity 30, e.g. the reconstituted or diluted medicament, may be withdraw from the cavity 30 through the outlet 51. Thus, the medicament container 10 may allow inflow and outflow of a fluid at different portions of the container wall 20. After inflow of the fluid into the cavity 30, the medicament container 10 may be gently rotated or shaken to ensure proper distribution or resolving of the medicament 1.

By breaking or piercing both, the first closure 42 and the second closure 52, flushing the medicament container 10 from the inlet 41 through the cavity 30 to the outlet 51 with a reconstitution liquid may be performed thereby transferring the medicament 1 from the cavity 30 through the outlet 51 by way of the reconstitution liquid flowing from the inlet 41 to the outlet 51. This way, the medicament container 10 allows inflow of the fluid, flushing the cavity 30 and outflow of the fluid without changing flow direction, thus by an unidirectional flow. So, in contrast to a medicament container comprising a single opening serving for both, inlet and outlet, the medicament container 10 as describe above may allow using an unidirectional flow in order to dissolve or reconstitute the medicament 1 and transfer of the dissolved or reconstituted medicament 1 to another device, e.g. a subsequent medicament container 10 as described above or an infusion bag.

The medicament container 10 comprises a first fastener 46 at the first wall portion 40 and a second fastener 56 at the second wall portion 50. The first fastener 46 comprises a first engaging structure and the second fastener 56 comprises a second engaging structure, wherein the first engaging structure 46 is complementary to the second engaging structure 56. Fig. 3 illustrates another medicament container 10’, wherein the another medicament container may be substantially identical to the medicament container 10, e.g. with respect to the first and the second wall portions 40, 50. The medicament container 10’ comprises another container wall 20’ enclosing another cavity 30’, wherein another lyophilized medicament 1 is contained in the another cavity 30’. The another container wall 20’ having another first wall portion 40’ and another second wall portion 50’. The another medicament container 10’ comprises another inlet 4T at the another first wall portion 40’ of the another container wall 20’. Another first closure 42’ is non-detachably fixed to the another first wall portion 40’, thereby fluid-tight closing the another inlet 4T. The another medicament container 10’ further comprises another outlet 5T for the fluid at the another second wall portion 50’ of the another container wall 20’.

Another second closure 52’ is non-detachably fixed to the another second wall portion 50’, thereby fluid-tight closing the another outlet 5T. The another first closure 42’ is at least one of breakable or pierceable by another first breaking or piercing feature 55 and wherein the another second closure 52’ is at least one of breakable or pierceable by another second breaking or piercing feature 45 to allow a fluid flow through the another medicament container 10’ from the another inlet 4T through the another cavity 30’ to the another outlet 5T. The another medicament container 10 comprises another first fastener 46 at the first wall portion 40 and another second fastener 56 at the second wall portion 50. The another first fastener 46 comprises another first engaging structure and the another second fastener 56 comprises another second engaging structure, the another first engaging structure 46 is complementary shaped to the another second engaging structure 56.

The medicament container 10 comprises the another first breaking or piercing feature 55 located at the second wall portion 50 and the another second breaking or piercing feature 45 located at the first wall portion 40. The another medicament container 10’ comprises the first breaking or piercing feature 55’ located at the another second wall portion 50’ and the second breaking or piercing feature 45’ located at the another first wall portion 40’. The first breaking or piercing feature 55’ is configured to break or pierce the first closure 42 of the medicament container 10 and the another second breaking or piercing feature 45 is configured to break or pierce the another first closure 42’ of the another medicament container 10’ during fastening of the another second wall portion 50’ of the another container wall 20’ of the another medicament container 10’ relative to the first wall portion 40 of the container wall 20 of the medicament container 10 as illustrated in Fig. 5. The first engaging structure 46 is complementary shaped to the another second engaging structure 56’ and a positive-locking fit is provided between the first fastener 46 of the medicament container 10 and the another second fastener 56’ of the another medicament container 10’ as illustrated in Fig. 5. Via interconnecting multiple medicament containers 10.1,... , 10.N a row assembly can be achieved as illustrated in Fig. 6, wherein the connection progress keeps the permanent integrity of the connected medicament containers 10.1,... , 10.N. The interconnected medicament containers 10.1,... , 10.N allow to reconstitute the lyophilized medicaments 1 contained in each container 10.1,... , 10. N in one step by a liquid flow from the inlet 41 of the medicament container 10.1 at a first end of the assembly of medicament containers 10.1 ,... , 10. N to the outlet 51 of the medicament container 10.N at the second end of the assembly of medicament containers 10.1,... , 10. N. This arrangement allows sequentially flushing the cavities 30 and pooling of the medicaments 1 contained in each medicament container 10.1,... , 10.N with an unidirectional fluid flow.

Fig. 7 illustrates a kit comprising a first medicament container 110 of a second example, a second medicament container 110’ substantially identical to the first medicament container 110 and an adapter 200.

The first medicament container 110 comprises a container wall 120 enclosing a cavity 130, wherein a lyophilized medicament 1 is contained in the cavity 130. The container wall 120 comprises a first wall portion 140 and a second wall portion 150. The medicament container 110 comprises an inlet 141 at the first wall portion 140 of the container wall 120. A first closure 142 is non-detachably fixed to the first wall portion 140, thereby fluid-tight closing the inlet 141. The first medicament container 110 further comprises an outlet 151 for the fluid at the second wall portion 150 of the container wall 120. A second closure 152 is non-detachably fixed to the second wall portion 150, thereby fluid-tight closing the outlet 151. The first closure 142 is at least one of breakable or pierceable by a first breaking or piercing feature 255 and wherein the second closure 152 is at least one of breakable or pierceable by a second breaking or piercing feature 245 to allow a fluid flow through the first medicament container 110 from the inlet 141 through the cavity 130 to the outlet 151.

The first wall portion 140 comprises a conically shaped first shoulder portion 144, a first head portion 145 and a first neck portion 146, wherein the first neck portion 146 is located between the first head portion 145 and the first shoulder portion 144, wherein a first recess 143 is provided by the neck portion 146 wherein the first head portion 145 comprises the inlet 141. The second wall portion 150 comprises a conically shaped second shoulder portion 154, a second head portion 155 and a second neck portion 156, wherein the second neck portion 156 is located between the second head portion 155 and the second shoulder portion 154, wherein a second recess 153 is provided by the neck portion 156, wherein the second head portion 155 comprises the outlet 151. The second medicament container 110’ is substantially identical to the first medicament container 110. The second medicament container 110’ comprises a container wall 120’ enclosing a cavity 130’, wherein a lyophilized medicament T is contained in the cavity 130’. The container wall 120’ comprises a first wall portion 140’ and a second wall portion 15’0. The second medicament container 110’ comprises an inlet 14T at the first wall portion 140’ of the container wall 120’. A first closure 142’ is non-detachably fixed to the first wall portion 140’, thereby fluid-tight closing the inlet 14T. The second medicament container 110’ further comprises an outlet 15T for the fluid at the second wall portion 150’ of the container wall 120’. A second closure 152’ is non-detachably fixed to the second wall portion 150’, thereby fluid-tight closing the outlet 15T. The first closure 142’ is at least one of breakable or pierceable by a first breaking or piercing feature 255’ and wherein the second closure 152’ is at least one of breakable or pierceable by a second breaking or piercing feature 245’ to allow a fluid flow through the second medicament container 110’ from the inlet 14T through the cavity 130’ to the outlet 15T. The first wall portion 140’ comprises a conically shaped first shoulder portion 144’, a first head portion 145’ and a first neck portion 146’, wherein the first neck portion 146’ is located between the first head portion 145’ and the first shoulder portion 144’, wherein a first recess 143’ is provided by the neck portion 146’ wherein the first head portion 145’ comprises the inlet 14T. The second wall portion 150’ comprises a conically shaped second shoulder portion 154’, a second head portion 155’ and a second neck portion 156’, wherein the second neck portion 156’ is located between the second head portion 155’ and the second shoulder portion 154’, wherein a second recess 153’ is provided by the neck portion 156’, wherein the second head portion 155’ comprises the outlet 15T.

The adapter 200 may be used for interconnecting the first medicament container 110 and the second medicament container 110’. The adapter 200 comprises a first side 240 and a second side 250. A first connecting portion 241 is provided at the first side 240 of the adapter 200, wherein the first container connecting portion 241 is configured for fastening the second wall portion 150 of the container wall 120 of the first medicament container 110 to the adapter 200. The first connecting portion 241 comprises a first receptacle for receiving the second wall portion 150. The adapter 200 comprises a second container connecting portion 251 at the second side 250 of the adapter 200, wherein the second container connecting portion 251 is configured for fastening the first wall portion 140’ of the container wall 120’ of the second medicament container 110’ to the adapter 200. The second connecting portion 241 comprises a second receptacle for receiving the first wall portion 150’ of the second medicament container 110’. The adapter 200 comprises a needle hub 260 and an elongated needle 270, the needle hub 260 comprises the first container connecting portion 241 at the first side 240 and the second container connecting portion 251 at the second side 250. The needle 270 comprises a first end protruding from the needle hub 260 with a first needle tip 271 and a second end protruding from needle hub 260 with a second needle tip 272, wherein the first end of the needle 270 comprises the first piercing or breaking feature 255 and the second end of the of the needle 270 comprises the second piercing or breaking feature 245. During connecting the respective medicament container 110, 110’ to the adapter 200 the respective needle tip 271 , 272 pierces the respective closure 142’, 152 as illustrated in Fig. 8.

By interconnecting multiple medicament containers 110.1 , 110.2, 110.N via multiple adapters 200 a row assembly can be achieved as illustrated in Fig. 9, wherein the connection progress keeps the permanent integrity of the connected medicament containers 110.1 , 110.2, 110.N. The interconnected medicament containers 110.1, 110.2, 110. N allow to reconstitute the lyophilized medicaments 1 contained in each container 110.1, 110.2, 110.N in one step by a liquid flow from the inlet 141 of the medicament container 110.1 at a first end of the assembly of medicament containers 110.1, 110.2, HO.N to the outlet 151 of the medicament container 110. N at the second end of the assembly of medicament containers 110.1, 110.2, 110. N.

The adapter 200 illustrated in Figs. 7, 8, 9 and 10 comprises a first inner circumferential surface at the first container connecting portion 241 , wherein the first inner circumferential surface comprises a circumferential elastic deformable first projection 242, wherein the first projection 242 protrudes inwards, and the adapter 200 comprises a second inner circumferential surface at the second container connecting portion 251, wherein the second inner circumferential surface comprises a circumferential elastic deformable second projection 252, wherein the second projection 252 protrudes inwards.

The first portion 140 of the container wall 120 of the medicament container 110 comprises first outer circumferential surface, wherein the first outer circumferential surface comprises the circumferential first recess 143, wherein the second projection 252 and the first recess 143 are complementary shaped, thereby providing a positive-lock fit. The second wall portion 150 of the container wall 120 of the medicament container 110 comprises second outer circumferential surface, wherein the second outer circumferential surface comprises the circumferential second recess 153, wherein the first projection 242 and the second recess 153 are complementary shaped, thereby providing a positive-lock fit as illustrated in Fig. 8. The adapter 200 illustrated in Fig. 11 comprises a first inner circumferential surface at the first container connecting portion 241 , wherein the first inner circumferential surface comprises an elastic deformable first friction element 243, wherein the first friction element 243 and the second outer circumferential surface of the second wall portion 150 of the container wall 120 of the medicament container 110 are in contact after connecting the medicament container 110 to the first container connecting portion 241, thereby providing a frictional fit. The adapter 200 illustrated in Fig. 11 further comprises a second inner circumferential surface at the second container connecting portion 251 , wherein the second inner circumferential surface comprises an elastic deformable second friction element 253, wherein the second friction element 253 and the first outer circumferential surface of the first wall portion 140 of the container wall 120 of the medicament container 110 are in contact after connecting the medicament container 110 to the second container connecting portion 251, thereby providing a frictional fit.

Reference Numbers

1 medicament

10 medicament container

10’ another medicament container

20 container wall

30 cavity

40 first wall portion

41 inlet

42 first closure

45 another second breaking or piercing feature

46 first fastener

50 second wall portion

51 outlet

52 second closure

55 another first breaking or piercing feature

56 second fastener

110 first medicament container

110’ second medicament container

120 container wall

130 cavity

140 first wall portion

141 inlet

142 first closure

143 first recess

144 first shoulder portion

145 first head portion

146 first neck portion

150 second wall portion

151 outlet

152 second closure

153 second recess

154 second shoulder portion

155 second head portion

156 second neck portion

200 adapter

240 first side 241 first container connecting portion

242 first projection

243 first friction element

245 second breaking or piercing feature 250 second side

251 second container connecting portion

252 second projection

253 second friction element

255 first breaking or piercing feature 260 needle hub

270 needle

271 first needle tip

272 second needle tip

Claims

1. A medicament container (10) for a medicament (1), the medicament container (10) comprising: a container wall (20) enclosing a cavity (30) for the medicament (1), the container wall (20) having a first wall portion (40) and a second wall portion (50), an inlet (41) for a fluid at the fist wall portion (40) of the container wall (20), an outlet (51) for the fluid at the second wall portion (50) of the container wall (20), a first closure (42) closing the inlet (41), a second closure (52) closing the outlet (51),

- wherein the first closure (42) is at least one of breakable or pierceable by a first breaking or piercing feature (55’) and wherein the second closure (52) is at least one of breakable or pierceable by a second breaking or piercing feature (45’) to allow a fluid flow through the medicament container (10) from the inlet (41) through the cavity (30) to the outlet (51).

2. The medicament container (10) according to claim 1, wherein the first wall portion (40) and the second wall portion (50) are opposing wall portions of the container wall (20).

3. The medicament container (10) according to any one of the preceding claims, wherein the first closure (42) is non-detachably fixed on or at the first wall portion (40).

4. The medicament container (10) according to any one of the preceding claims, wherein the first closure (42) is one of a seal or a closure cap non-detachably fixed on or at the first wall portion (40).

5. The medicament container (10) according to any one of the preceding claims, wherein the second closure (52) is non-detachably fixed on or at the second wall portion (50).

6. The medicament container (10) according to any one of the preceding claims, wherein the second closure (52) is one of a seal or a closure cap non-detachably fixed on or at the second wall portion (50).

7. The medicament container (10) according to any one of the preceding claims, further comprising: - another first breaking or piercing feature (55), wherein the another first breaking or piercing feature (55) is located at the second wall portion (50) of the container wall (20), wherein the another first breaking or piercing feature (55) is configured to break or pierce another first closure (42’) of another medicament container (10’) according to any one of the preceding claims during fastening of the second wall portion (50) of the container wall (20) of the medicament container (10) relative to the first wall portion (40) of the container wall (20) of the another medicament container (10’).

8. The medicament container (10) according to any one of the preceding claims, further comprising:

- another second breaking or piercing feature (45), wherein the another second breaking or piercing feature (45) is located at the first wall portion (40) of the container wall (20), wherein the another second breaking or piercing feature (45) is configured to break or pierce the second closure (52) of another medicament container (10’) according to any one of the preceding claims during fastening of the first wall portion (40) of the container wall (20) of the medicament container (10) to the second wall portion (50) of the container wall (20) of the another medicament container (10’).

9. The medicament container (10) according to any one of the preceding claims, further comprising:

- a first fastener (46) at the first wall portion (40),

- a second fastener (56) at the second wall portion (50), the first wall portion (40) being fastenable to the second wall portion (50) of another medicament container (10’) according to any one of the preceding claims, the another medicament container (10’) comprising another first fastener (46’) at the another first wall portion (40’) of the another medicament container (10’) and another second fastener (56’) at the another second wall portion (50’) of the another medicament container (10’), by the first fastener (46) at the first wall portion (40) of the medicament container (10) directly or indirectly engaging the another second fastener (56) at the another second wall portion (50) of the another medicament container (10’).

10. The medicament container (10) according to claim 9, the first fastener (46) comprising a first engaging structure and the second fastener (56) comprising a second engaging structure, the first engaging structure being complementary to the second engaging structure for providing at least one of a positive-locking fit or a frictional fit between the first fastener (46) of the medicament container (10) and the another second fastener (56) of another medicament container (10’).

11. The medicament container (10) according to any one of the preceding claims, the medicament container (10) containing a medicament (1) located within the cavity (30), the medicament (1) being a lyophilized medicament and/or a medicament powder.

12. A set of medicament containers (10), the set comprising:

- a first medicament container (10) according to any one of the preceding claims,

- a second medicament container (10’) according to any one of the preceding claims.

13. The set according to claim 12, wherein the first medicament container (10) contains a first amount of a first medicament (1) and the second medicament container (10’) contains a second amount of the first medicament (T), wherein the second amount is an integral multiple of the first amount.

14. A method of preparing a liquid injectable medicament, the method comprising: using a set of medicament containers (10, 10’) according to any one of the claims 12 or 13, wherein the first medicament container (10) contains a first medicament (1) and wherein the second medicament container (10’) contains a second medicament (T), forming an assembly of interconnected medicament containers (10, 10’) by connecting the first wall portion (40’) of the second medicament container (10’) to the second wall portion (50) of the first medicament container (10) such that the outlet (51) of the first medicament container (10) is in fluid connection with the inlet (4T) of the second medicament container (10’), thereby allowing a fluid flow from first medicament container (10) into the second medicament container (10’), filling the cavity (30) of the first medicament container (10) and the cavity (30’) of the second medicament container (10’) with a liquid diluent by introducing the liquid diluent into the inlet (41) of the first medicament container (10).

15. The method according to claim 14, wherein the first medicament container (10) comprises a first breaking or piercing feature (55), wherein the first breaking or piercing feature (55) is located at the second wall portion (50) of the container wall (20), wherein the first breaking or piercing feature (55) is configured to break or pierce the first closure (42’) of the second medicament container (10’) during fastening of the second wall portion (50) of the container wall (20) of the first medicament container (10) relative to the first wall portion (40’) of the container wall (20’) of the second medicament container (10’), wherein the second medicament container (10’) comprises a second breaking or piercing feature (45’), wherein the second breaking or piercing feature (45’) is located at the first wall portion (40’) of the container wall (20’), wherein the second breaking or piercing feature (45’) is configured to break or pierce the second closure (52) of the first medicament container (10) during fastening of the second wall portion (50) of the container wall (20) of the first medicament container (10) relative to the first wall portion (40’) of the container wall (20’) of the second medicament container (1 O’).

16. A kit comprising a first medicament container (110) according to any one of claims 1 to 11 and at least one adapter (200) for connecting the first medicament container (110) to a second medicament container (110’) according to any one of claims 1 to 11, the adapter (200) comprising: a first side (240) and a second side (250), a first container connecting portion (241) at the first side (240) of the adapter (200), wherein the first container connecting portion (241) is configured for fastening the second wall portion (150) of the container wall (120) of the first medicament container (110) to the adapter (200), a second container connecting portion (251) at the second side (250) of the adapter (200), wherein the second container connecting portion (251) is configured for fastening the first wall portion (140) of the container wall (120) of the second medicament container (110) to the adapter (200).

17. The kit according to claim 16, further comprising the second medicament container (110’).

18. The kit according to claim 16 or 17, the adapter (200) comprising: the first breaking or piercing feature (55) located at the second side (150) of the adapter (200), the second breaking or piercing feature (45) located at the first side (140) of the adapter (200).

19. The kit according to claim 18, wherein the adapter (200) comprises a needle hub (260) and an elongated needle (270), wherein the needle hub (260) comprises the first container connecting portion (241) at the first side (240) and the second container connecting portion (251) at the second side (250).

20. The kit according to claim 19, the needle (270) having a first end with a first needle tip (271) and a second end with a second needle tip (272), wherein the first end of the needle (270) comprises the first piercing or breaking feature (55) and the second end of the of the needle (270) comprises the second piercing or breaking feature (45).

21. A method of preparing a liquid injectable medicament, the method comprising: using a kit according to any one of the claims 16 to 20 and a second medicament container (110’), wherein the first medicament container (110) contains a first medicament (1) and wherein the second medicament container (110’) contains a second medicament (T), - forming an assembly of interconnected medicament containers (110, 110’) by fastening the second wall portion (150) of the first medicament container (110) to the first container connecting portion (241) of the adapter (200) and by fastening the first wall portion (140’) of the second medicament container (110) to the second container connecting portion (251) of the adapter (200), such that the outlet (151) of the first medicament container (110) is in fluid connection with the inlet (14T) of the second medicament container (110’), thereby allowing a fluid flow from first medicament container (110) into the second medicament container (110’), filling the cavity (130) of the first medicament container (110) and the cavity (130’) of the second medicament container (110’) with a liquid diluent by introducing the liquid diluent into the inlet (141) of the first medicament container (110).