Preparation assembly and method of preparing a liquid medicament

Abstract

A preparation assembly (10) for preparing a liquid medicament, the preparation assembly (10) comprising a plurality of preparation containers (12), wherein the preparation containers (12) are arranged in a row to form a row arrangement (13) extending along a first direction (D1), wherein the preparation containers (12) are fluidically separated from each other, wherein each preparation container (12) of the row arrangement (13) is mechanically connected to an adjacent preparation container (12) of the row arrangement (13), each preparation container (12) comprising: a medicament chamber (20) comprising a medicament chamber cavity configured to hold a medicament (6), a diluent chamber (30) comprising a diluent chamber cavity configured to hold a diluent (8), a barrier (40) between the medicament chamber (20) and the diluent chamber (30), wherein the barrier (40) is transferable from a fluid impermeable state to a fluid permeable state.

Description

[0001] Preparation assembly and method of preparing a liquid medicament

[0002] Description

[0003] Field

[0004] The present disclosure relates to a preparation assembly for preparing a liquid medicament. In further aspects the present disclosure relates to a method of preparing a liquid medicament and a system for preparing a liquid medicament.

[0005] Background

[0006] Patients suffering from certain diseases like, for example, hemophilia or requiring enzyme replacement therapy have to take regular intravenous (IV) infusions. The infusions often have to be mixed and prepared, sometimes to the specific needs of the patient, (and sometimes a short time before drug administration) which may include reconstitution of the drug powder from multiple vials using an exact amount of sterile liquids like water and / or saline. As this preparation process is typically complex and tedious, it is usually performed by a health care professional in a clinic or pharmacy, potentially using lab equipment.

[0007] Generally, administering a medicament by way of infusion may require a rather clean or sterile environment. A patient may therefore have to regularly visit an ambulance or health care center.

[0008] Self-medication or home-medication for administering a medicament through infusion or injection is and remains quite challenging but is very attractive for patients thereby avoiding problems and circumstances involved in visiting a health care center. With home- or self- medication a patient or user, e.g. intending to establish a vascular access to a patient's body, may be obliged to use only one hand, which might be rather cumbersome and thus challenging.

[0009] In addition, it is often required to establish or maintain a clean and / or sterile environment especially in the field of home-medication or self-medication as well as providing of a clean and sterile storage environment for medicaments and medicament containers, medical device accessory and medical devices. It is therefore desirable to provide improvements in the field of home medication or self- medication, which allow a user or caregiver to prepare and to administer a medicament by way of injection or infusion. It is further desirable to provide an improved storage and transportation of medical devices, medicaments, medical device accessory and the like components required for home- or self-medication. Furthermore, there should be provided improvements in guiding and assisting a user in conducting or executing numerous steps in the course of preparing medicaments and / or in the course of preparing administering of a medicament, e.g. by way of infusion or injection.

[0010] In addition, it is often required to adjust the dosing of the medicament to be administered based on the patient weight. It is therefore desirable to provide improvements facilitating the dosing of the medicament.

[0011] Summary

[0012] In one aspect there is provided a preparation assembly for preparing a liquid medicament, e.g. a liquid medicament for intravenous infusion. The preparation assembly comprises a plurality of preparation containers, wherein the preparation containers are arranged in a row to form a row arrangement, wherein the row arrangement extends along a first direction. The preparation containers are fluidically separated from each other, wherein each preparation container of the row arrangement is mechanically connected to an adjacent preparation container of the row arrangement. Each preparation container comprises a medicament chamber comprising a medicament chamber cavity configured to hold a medicament, e.g. a lyophilized and / or freeze- dried medicament. Each preparation container further comprises a diluent chamber comprising a diluent chamber cavity configured to hold a diluent. The diluent may be a reconstitution liquid, e.g. in form of water for injection or saline. Each preparation container further comprises a barrier between the medicament chamber and the diluent chamber, wherein the barrier is transferable from a fluid impermeable state to a fluid permeable state.

[0013] Making use of the preparation assembly preparing of a liquid medicament may be facilitated and / or accelerated. Making use of the preparation assembly preparation of a liquid medicament may be conducted in each preparation container separately and independently, as the preparation containers are fluidically separated from each other. By this, a preparation of a liquid medicament may be conducted in at least one preparation container of the plurality of preparation containers by transferring the barrier of the at least one preparation container from the fluid impermeable state to the fluid permeable state to allow a fluid transfer between the diluent chamber cavity and the medicament chamber cavity to prepare a liquid medicament in the at least one preparation container.

[0014] The barriers of the remaining preparation containers of the plurality of preparation containers may remain in the fluid impermeable state, such that a fluid transfer between the diluent chamber and the medicament chamber of the remaining preparation containers is prevented by the respective barrier. Thus, making use of the preparation assembly a liquid medicament may be prepared in one or more of the plurality of preparation containers independently of the remaining preparation containers of the plurality of preparation containers. This way, the remaining preparation containers may be used to prepare a liquid medicament at a later time.

[0015] Therefore, making use of the preparation assembly, a first dose of a liquid medicament may be prepared short time before a first administration by preparing a liquid medicament in one or more of the plurality of preparation containers for an administration of the first dose at a first time. The same preparation assembly may be used to prepare a second dose of the liquid medicament short time before a second administration by preparing the liquid medicament in one or more of the remaining preparation containers of the plurality of preparation containers for an administration of the second dose at a second time. By this, the same preparation assembly may be used to prepare a first liquid medicament at a first time and at a second liquid medicament a second time, such that the first liquid medicament and the second liquid medicament may be prepared short time before administering the respective liquid medicament to the patient.

[0016] In a further example, the preparation assembly may contain a daily dosage of a medicament to be administered to the patient on one day, wherein the administration to the patient should be conducted at different times that are distributed throughout the day, e.g. a first dose of the medicament in the morning and a second dose the medicament in the afternoon.

[0017] In a further example, a number of adjacent preparation containers of the plurality of preparation containers may form a first set, wherein the preparation containers of the first set provide a first liquid medicament. Another number of adjacent preparation containers of the plurality of preparation containers may form a second set, wherein the preparation containers of the second set provide a second liquid medicament. Making use of multiple sets of preparation containers, different liquid medicaments to be administrated at different times may be provided by a single preparation assembly. In a further example, the preparation assembly may be used to prepare an individual dose of a liquid medicament. For example, each preparation container of the preparation assembly may contain a single dose of the medicament. When preparing the liquid medicament in the respective preparation containers a single dose of a liquid medicament is thus prepared in the respective preparation container. By preparing the liquid medicaments in a certain number of preparation containers and pooling the prepared liquid medicaments prepared in these preparation containers, an individual dose of the liquid medicament is may be obtained consisting of the certain number of single doses. This way, preparation of an individual dose of the liquid medicament may be facilitated. For example, the number of preparation containers to be used may be determined on the basis of the patient’s weight.

[0018] The preparation containers may be substantially identical.

[0019] The preparation assembly may contain at least five preparation containers, e.g. at least ten preparation container or least twenty preparation containers.

[0020] The preparation assembly may have a belt-like form.

[0021] The row arrangement of the preparation containers may be periodical.

[0022] At least one medicament chamber cavity may hold, e.g. comprise or contain, a medicament, e.g. freeze-dried and / or lyophilized medicament. Each medicament chamber cavity may hold, e.g. comprise or contain, a medicament, e.g. freeze-dried and / or lyophilized medicament.

[0023] At least one medicament chamber cavity may hold, e.g. comprise or contain, a liquid medicament that has to be diluted by the diluent in order to prepare a liquid medicament that may be delivered to the patient, e.g. via infusion or injection. Each medicament chamber cavity may hold, e.g. comprise or contain, a liquid medicament that has to be diluted by the diluent in order to prepare a liquid medicament that may be delivered to the patient, e.g. via infusion or injection.

[0024] At least one medicament chamber cavity may hold, e.g. comprise or contain, a single dose of a medicament. Each medicament chamber cavity may hold, e.g. comprise or contain, a single dose of a medicament. At least one diluent chamber cavity may hold, e.g. comprise or contain, a diluent, e.g. a reconstitution liquid. Each diluent chamber cavity may hold, e.g. comprise or contain, a diluent, e.g. a reconstitution liquid.

[0025] The diluent chamber cavity and the medicament chamber cavity of each preparation container may be arranged along a second direction, wherein the second direction runs inclined to the first direction. The second direction may run perpendicular to the first direction. This way, a number density of the preparation containers along the first direction may be enhanced and thus a greater number of medicament containers may be present at a given extent of the preparation assembly in the first direction.

[0026] The diluent chamber cavity and the medicament chamber cavity may be arranged along the first direction. This way, a rather small extent of the preparation assembly in a direction perpendicular to the first direction may be achieved.

[0027] Each preparation container may comprise a connection channel that merges into the diluent chamber cavity and into the medicament chamber cavity, wherein the barrier is located in the connection channel.

[0028] The barrier may comprise at least one of a breakable seal and a valve. The barrier may be transferable from the fluid impermeable state to the fluid permeable state in response to a break of the breakable seal. Breaking of the breakable seal may be induced by applying mechanical force to the barrier. Breaking of the breakable seal may be induced by an increase of a pressure inside at least one of the medicament chamber cavity and the diluent chamber cavity above a predefined pressure threshold. The breakable seal may comprise a welding seal. The valve may be transferable from a closed state to an open state, wherein the barrier is transferable from the fluid impermeable state to the fluid permeable state by transferring the valve from the closed state to the open state. The valve may comprise a check valve.

[0029] Each diluent chamber may comprise a diluent filling port for filling the diluent into the diluent chamber cavity. The diluent filling port may be closed by a septum, which may be penetrable by a filling device, such as a filling needle. This way the diluent can be introduced and deposited inside the diluent chamber cavity. The first filling port may be closed or sealed or even resealed. Each medicament chamber may comprise a medicament filling port for filling a medicament into the medicament chamber cavity. The medicament filling port may be closed by a septum, which may be penetrable by filling device, such as a filling needle.

[0030] At least one of the medicament chamber and the diluent chamber of each preparation container may comprise an outlet port to withdraw and / or expel the liquid medicament from at least one of the medicament chamber cavity and the diluent chamber cavity of each preparation container.

[0031] The outlet port may be provided with a connector, such as a Luer-type connector or Luer-type coupling, by way of which a fluid transferring line, such as an infusion line, may be fluidically coupled to the medicament chamber cavity and the diluent chamber cavity.

[0032] At least one of the diluent chamber and the medicament chamber may be squeezable. By this, transferring a fluid, e.g. the diluent, between the medicament chamber cavity and the diluent chamber cavity may be conducted by squeezing the diluent chamber and / or medicament chamber.

[0033] The barrier may be configured such that the barrier may be transferred from the fluid impermeable state to the fluid permeable state by squeezing the preparation container in the region of the barrier.

[0034] According to a further example the barrier may be configured such that the barrier may be transferred from the fluid impermeable state to the fluid permeable state by increasing the pressure inside at least one of the diluent chamber cavity and the medicament chamber cavity by squeezing of at least one of the diluent chamber and the medicament chamber. By this, transferring of the barrier into the fluid permeable state and transferring of the fluid between the diluent chamber cavity and the medicament chamber cavity may be conducted in a single squeezing step or a single squeezing process.

[0035] According to a further example the breakable seal may be configured to break in response to an increase of a pressure inside at least one of the diluent chamber cavity and the medicament chamber cavity.

[0036] According to a further example the valve may be configured to be transferred into the open state in response to an increase of a pressure inside at least one of the diluent chamber cavity and the medicament chamber cavity. According to further example the preparation assembly may comprise a flexible bag, wherein the flexible bag may comprise a plurality of medicament chamber wall portions confining the medicament chamber cavities of the plurality of preparation containers and a plurality of diluent chamber wall portions confining the diluent chamber cavities of the plurality of preparation containers.

[0037] A material of the flexible bag may be a deformable plastic material, which is pharmaceutically inert.

[0038] The preparation assembly may comprise a front layer and a back layer, wherein the front layer is sectionwise sealed to the back layer such that the medicament chamber cavities and the diluent chamber cavities of the plurality of preparation containers are formed between the front layer and the back layer.

[0039] Each preparation container may be permanently fluidically separated from the adjacent preparation container by a sealed seam.

[0040] Each preparation container may be circumferentially enclosed by a sealed seam.

[0041] The front layer may comprise a plurality of medicament chamber wall front portions and a plurality of diluent chamber front wall portions, wherein the back layer comprises a plurality of medicament chamber wall back portions and a plurality of diluent chamber wall back portions, wherein the plurality of medicament chamber wall front portions and the plurality of medicament chamber wall back portions confine the medicament chamber cavities and wherein the plurality of diluent chamber wall front portions and the plurality of diluent chamber wall back portions confine the medicament chamber cavities. This way, manufacturing of the preparation assembly may be facilitated. The front layer and the back layer may be manufactured separately, e.g. in form of stripes. The front layer and the back layer and / or the respective stripes may be aligned over one another and sectionwise sealed such that the medicament chamber cavities and the diluent chamber cavities of the plurality of preparation containers are formed between the front layer and the back layer in the unsealed regions. Ports, such as the medicament filling port, the diluent filling port and the outlet port may be placed between the front layer and the back layer before sealing the front layer to the back layer.

[0042] Manufacturing processes known in the context of infusion bags may also be adapted to the manufacturing process of the preparation assembly. In some examples the medicament, e.g., a lyophilized drug, e.g., in form of a pellet of a lyophilized medicament may be placed between the back layer and the front layer before the back and front layers are mutually connected or sealed.

[0043] In a further example, at least one medicament chamber wall back portion of the plurality medicament chamber wall back portions may comprise a depression or curved portion. The medicament may be inserted in the depression or curved portion before sealing the front layer to the back layer. This way, filling of the medicament chamber cavities with the medicament may be facilitated.

[0044] At least one diluent chamber wall back portion of the plurality diluent chamber wall back portions may comprise a depression or curved portion. The diluent may be inserted in the depression or curved portion before sealing the front layer to the back layer. This way, filling of the diluent chamber cavities with the diluent may be facilitated.

[0045] At least one of the front layer and the back layer may be flexible. This way squeezable medicament chambers and squeezable diluent chambers may be realized.

[0046] At least one of the front layer and the back layer may be transparent. By this, an optical control of the content inside of the medicament chamber cavities and inside of the diluent chamber cavities may be permitted, e.g. to check a correct filling of the medicament chamber cavities, to check a correct filling of the diluent chamber cavities, to check the transfer of fluid between the diluent chamber cavity and the medicament chamber cavity during the preparation process, to check a dissolving process of the medicament in the diluent or the mixing process of the diluent and the medicament.

[0047] A material of the front layer may be a deformable plastic material, which is pharmaceutically inert.

[0048] A material of the back layer may be a deformable plastic material, which is pharmaceutically inert.

[0049] In another example, the preparation assembly may comprise a first outer edge and a second outer edge, wherein the second outer edge is opposite to the first outer edge. The outer edges may comprise a sealed seam. At least one of the medicament filling port, the diluent filling port and the outlet port may be located at the first outer edge and / or the second outer edge.

[0050] The first outer edge and the second outer edge may extend along the first direction, wherein at least one of the first outer edge and the second outer edge comprises a periodic engagement structure extending along the first direction.

[0051] The engagement structure may comprise a perforation, e.g. in the form of sprocket holes.

[0052] Via the periodic engagement structure, transporting and steadying of the preparation assembly may be achieved. For example, the periodic engagement structure may allow steadying the preparation assembly during application of a mechanical force to at least one preparation container for transferring the fluid between the diluent chamber cavity and the medicament chamber cavity or expelling or withdrawing the liquid medicament from at least one of the diluent chamber cavity and the medicament chamber cavity. Further, the periodic engagement structure may allow transporting of the preparation assembly along the first direction, e.g. in order to transport the preparation assembly into and out of a preparation device. The preparation device may be configured to receive at least one preparation container of the plurality of preparation containers and to interact with the received at least one preparation container, e.g. in order to conduct process steps for preparing the liquid medicament in the received at least one preparation container and / or to expel or withdraw the liquid medicament form the received at least one preparation container.

[0053] In the engagement structure may be configured to engage with a conveying actuator, wherein the conveying actuator may be configured to move the preparation assembly along the first direction. The conveying actuator may also be configured to steady the preparation assembly during conducting a preparation process.

[0054] The conveying actuator may comprise at least one sprocket, wherein the at least one sprocket comprises teeth that are configured to mesh with the periodic engagement structure. The at least one sprocket may be rotated in order to transport the preparation assembly along the first direction. The rotation of the at least one sprocket may be stopped in order to steadying the preparation assembly.

[0055] In another aspect the present disclosure relates to a method of preparing a liquid medicament. The method comprises using a preparation assembly as described above, wherein each medicament chamber cavity holds, e.g. comprises, contains or is filled with, a medicament, wherein each diluent chamber cavity holds, e.g. comprises, contains or is filled with, a diluent. The method further comprises transferring the barrier of at least one preparation container of the plurality of preparation containers from the fluid impermeable state to the fluid permeable state to allow a fluid transfer between the diluent chamber cavity and the medicament chamber cavity of the at least one preparation container. The method further comprises at least one of transferring the diluent from the diluent chamber cavity to the medicament chamber cavity of the at least one preparation container and transferring the medicament from the medicament chamber cavity to the diluent chamber cavity of the at least one preparation container to prepare the liquid medicament in the at least one preparation container.

[0056] The method of preparing a liquid medicament makes use of the preparation assembly as described above. Insofar, all effects, features and benefits as described above in connection with the preparation assembly equally apply to the method and vice versa.

[0057] The medicament may be a lyophilized and / or freeze-dried medicament. The medicament may also be liquid medicament that has to be diluted by the diluent in order to prepare a liquid medicament that may be delivered to the patient, e.g. via infusion or injection.

[0058] The diluent may be a reconstitution liquid. The diluent may be water for injection or a saline.

[0059] The method may further comprise expelling or withdrawing the liquid medicament from the at least one preparation container, e.g. via the outlet port.

[0060] The method may further comprise transporting the preparation assembly along the first direction. The method may further comprise transferring the barrier of at least one other preparation container of the plurality of preparation containers from the fluid impermeable state to the fluid permeable state to allow a fluid transfer between the diluent chamber cavity and the medicament chamber cavity of the at least one other preparation container. The method may further comprise at least one of transferring the diluent from the diluent chamber cavity to the medicament chamber cavity of the at least one other preparation container and transferring the medicament from the medicament chamber cavity to the diluent chamber cavity of the at least one other preparation container to prepare the liquid medicament in the at least one other preparation container.

[0061] The method may further comprise expelling or withdrawing the liquid medicament from the at least one other preparation container, e.g. via the outlet port. The method may further comprise pooling or mixing the liquid medicament prepared in the at least one preparation container and the liquid medicament prepared in the at least one other preparation container outside of the preparation assembly.

[0062] In another aspect the present disclosure relates to a system for preparing a liquid medicament. The system comprises a preparation assembly as described above and a preparation device for preparing the liquid medicament. The preparation device comprises an expelling unit, wherein the expelling unit is configured to apply a mechanical force to at least one of the diluent chamber and the medicament chamber of at least one preparation container to transfer at least one of the diluent and the medicament from one of the diluent chamber cavity and the medicament chamber cavity into the other one of the diluent chamber cavity and the medicament chamber cavity.

[0063] The system comprises a preparation assembly as described above. Insofar, all effects, features and benefits as described above in connection with the preparation assembly equally apply to the system and vice versa.

[0064] Making use of the preparation device the preparation of the liquid medicament using the preparation assembly may be facilitated and automated.

[0065] The expelling unit may be configured to apply the mechanical force such that the liquid medicament is expelled from the preparation container, e.g. via the outlet port.

[0066] In the expelling unit may comprise a pressing device configured to apply the mechanical force to at least one of the diluent chamber and the medicament chamber of the at least one preparation container.

[0067] The pressing device may comprise at least one roller. The roller may be configured to squeeze at least one of the diluent chamber and the medicament chamber of the at least one preparation container.

[0068] The pressing device may be configured to apply a pressure to at least one of the diluent chamber and the medicament chamber above a predefined pressure threshold sufficient to transfer the barrier of the at least one preparation container from the fluid impermeable state to the fluid permeable state. The preparation assembly may comprise a first outer edge and the second outer edge, wherein the second outer edge is opposite to the first outer edge, wherein the first outer edge and the second outer edge extend along the first direction. At least one of the first outer edge and the second outer edge may comprise a periodic engagement structure extending along the first direction. The preparation device may comprise a conveying actuator, wherein the conveying actuator is configured to move the preparation assembly through the preparation device along the first direction, e.g. by engaging with the periodic engagement structure. By this, the preparation assembly may be transported through the preparation device. Via the conveying actuator the preparation containers may be successively transported into the expelling unit and out of the expelling unit along the first direction. The transporting of the preparation assembly along the first direction may be conducted discontinuously, e.g. the transporting may be stopped once at least one preparation container is received in the expelling unit. The preparation assembly may be steadied by stopping the conveying actuator. Once at the preparation assembly is steadied the expelling unit may start acting on the at least one preparation container. After completion of the preparation process and / or expelling and / or withdrawing process conducted by the expelling unit the conveying actuator may be actuated in order to transport the at least one preparation container out of the expelling unit and at least one other preparation container into the expelling unit.

[0069] The actuator may comprise at least one sprocket, wherein the at least one sprocket comprises teeth that are configured to mesh with the periodic engagement structure.

[0070] The expelling unit may be configured to sequentially squeeze the diluent chamber and the medicament chamber of the at least one preparation container that is received in the expelling unit. The sequential squeezing may be conducted such that the diluent is transferred from the diluent chamber cavity into the medicament chamber cavity by squeezing the diluent chamber to prepare a liquid medicament within the medicament chamber cavity and such that the liquid medicament is subsequentially transferred out of the medicament chamber cavity, e.g. via the outlet port, by subsequent squeezing of the medicament chamber.

[0071] 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.

[0072] 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.

[0073] 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.

[0074] 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.

[0075] 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.

[0076] 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.

[0077] 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.

[0078] 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.

[0079] 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.

[0080] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0081] 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.

[0082] 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.

[0083] 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).

[0084] 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.

[0085] 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.

[0086] 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.

[0087] “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: 546-548). 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).

[0088] For the term “dAb’s” and “domain antibody”, reference is for example made to Ward et al. 1989 (Nature 341 : 554), 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).

[0089] 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.

[0090] 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).

[0091] 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.

[0092] 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.

[0093] 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).

[0094] 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).

[0095] Brief description of the drawings

[0096] In the following, examples of preparation assemblies and a system for preparing a liquid medicament are described in greater detail by making reference to the drawings, in which:

[0097] Fig. 1 schematically shows a preparation assembly in a top view, Fig. 2 schematically shows a cross section along A-A of Fig. 1, Fig. 3 schematically shows a cross section along B-B of Fig. 1, Fig. 4 schematically shows a portion of the preparation assembly shown in Fig. 1 in a top view, Fig. 5 schematically shows a system comprising the preparation assembly shown in Fig. 1 and a preparation device in a top view,

[0098] Fig. 6 schematically shows the system shown in Fig. 5 in a side view,

[0099] Fig. 7 schematically shows a portion of the system shown in Fig. 5 in a top view in a first state, Fig. 8 schematically shows a portion of the system shown in Fig. 5 in a top view in a second state,

[0100] Fig. 9 schematically shows the portion of the system shown in Fig. 7 in a top view in a third state,

[0101] Fig. 10 schematically shows the portion of the system shown in Fig. 7 in a top view in a fourth state,

[0102] Fig. 11 schematically shows another preparation assembly in a top view.

[0103] Detailed description

[0104] A preparation assembly 10 as shown in Figs. 1-10 can be used for preparing a liquid medicament 6’. The preparation assembly 10 comprises a plurality of substantially identical preparation containers 12. In Fig. 1 only three preparation containers 12 are shown for clarity reasons.

[0105] The preparation containers 12 arranged in a row to form a row arrangement 13 extending along a first direction D1. Each preparation container 12 comprises a medicament chamber 20 comprising a medicament chamber cavity 21, wherein each medicament chamber cavity 21 contains a lyophilized medicament 6. Each preparation container 12 further comprises a diluent chamber 30 comprising a diluent chamber cavity 31. Diluent chamber cavity 31 contains a liquid diluent, e.g. a reconstitution liquid for reconstituting the lyophilized medicament 6. The medicament chamber 20 and the diluent chamber 30 are arranged in a second direction D2 that runs perpendicular to the first direction D1. Each preparation container 12 further comprises a barrier 40 between the medicament chamber 20 and the diluent chamber 30, wherein the barrier 40 is transferable from a fluid impermeable state to a fluid permeable state. When in a fluid impermeable state a fluid transfer between the diluent chamber cavity 31 and the medicament chamber cavity 21 is prevented by the barrier 40. When in the fluid permeable state a fluid transfer between the diluent chamber cavity 31 and the medicament chamber cavity 21 through the barrier 40 is allowed.

[0106] The barrier 40 is located in a connection channel 44 that merges into the diluent chamber cavity 31 and into the medicament chamber cavity 21. Each barrier 40 comprises a breakable seal 41. Each barrier 40 is transferable from the fluid impermeable state to the fluid permeable state in response to a break of the breakable seal 41.

[0107] The preparation assembly 10 comprises a front layer 14 and the back layer 16, wherein the front layer 14 is sectionwise sealed to the back layer 16 such that the medicament chamber cavities 21 and the diluent chamber cavities 31 of the plurality of preparation containers 12 are formed between the front layer 14 and the back layer 16. The sectionwise sealing is such that each of the preparation containers 12 is circumferentially enclosed by s sealed seam 18. Adjacent preparation containers 12 are mechanically connected via the front layer 14 and the back layer 16 and permanently fluidically separated from each other by the respective sealed seam 18. This way there is no fluid transfer possible between adjacent preparation containers 12 of the preparation assembly 10. In other words: each preparation container 12 is fluidically isolated from the other preparation containers 12.

[0108] The front layer 14 comprises a plurality of medicament chamber wall front portions 24 and a plurality of diluent chamber front wall portions 34, wherein the back layer 16 comprises a plurality of medicament chamber wall back portions 26 and a plurality of diluent chamber wall back portions 36. The plurality of medicament chamber wall front portions 24 and the plurality of medicament chamber wall back portions 26 confine the medicament chamber cavities 21 as shown in Fig. 3. The plurality of diluent chamber wall front portions 34 and the plurality of diluent chamber wall back portions 36 confine the diluent chamber cavities 31 as shown in Fig. 3.

[0109] The front layer 14 and the back layer 16 are flexible foils, by way of which the diluent chambers 30 and the medicament chambers 20 are squeezable. The flexible foils may comprise several sublayers.

[0110] By a squeeze of the diluent chamber 30 the pressure inside the diluent chamber cavity 31 may be increased above a predefined pressure threshold sufficient to a break the breakable seal 41. Thus, by a squeeze of the diluent chamber 30 the barrier 40 may be transferred from the fluid impermeable state into the fluid permeable state and the diluent 8 contained in the diluent chamber cavity 31 can be transferred into the medicament chamber cavity 21 via the connection channel 44 through the barrier 40. When the diluent 8 contacts the lyophilized medicament 6 contained in the medicament chamber cavity 21, the lyophilized medicament 6 will dissolve in the diluent 8 and thereby the liquid medicament 6’ is prepared. This liquid medicament 6’ may be transferred into an infusion bag 60 for intravenous administration. For the purpose of transferring the liquid medicament 6’ into the infusion bag 60, each medicament chamber 20 comprises an outlet port 23 to withdraw and / or expel the liquid medicament 6’ from the medicament chamber cavity 21. This outlet port 23 may comprise a Luer-type connector or Luer-type coupling, by way of which a fluid transferring line, such as a hose, may be fluidically coupled to the medicament chamber cavity 21. An infusion bag 60 which is coupled to the outlet port 33 of one preparation container 12 via a hose is schematically shown in Figs. 7-10.

[0111] Each diluent chamber 30 comprises a diluent filling port 32 for filling the diluent 8 into the diluent chamber cavity 31. The diluent filling port 32 may be closed by a septum, which may be penetrable by a filling device, such as a filling needle.

[0112] Each medicament chamber 20 comprises a medicament filling port 22 for filling the medicament 6 into the medicament chamber cavity 21. The medicament filling port 22 may be closed by a septum, which may be penetrable by a filling device, such as a filling needle. The medicament 6 can be filled into the medicament chamber cavity 21 in a fluid form and afterwards a freeze- drying process may be conducted in order to obtain the lyophilized medicament 6 in the medicament chamber cavity 21.

[0113] The preparation assembly 10 further comprises a first outer edge 51 and a second outer edge 52. The second outer edge 52 is opposite to the first outer edge 51 in a second direction D2 that runs perpendicular to the first direction D1. The first outer edge 51 and the second outer edge 52 extend along the first direction D1. The first outer edge 51 and the second outer edge 52 each comprise a periodic engagement structure 53 extending along the first direction D1. The engagement structures 53 comprise multiple sprocket holes 54 arranged along the first direction D1.

[0114] Figs. 5-11 show a system 1 for preparing the liquid medicament 6’ making use of the assembly 10 as described above. The system 1 comprises the preparation assembly 10 as described above and a preparation device 100. The preparation device 100 comprises an expelling unit 110 and a conveying actuator 130. The expelling unit 110 is configured to apply a mechanical force to the diluent chamber 30 and the medicament chamber 20 of a preparation container 12 of the preparation assembly 10 that is received in a receiving section of the expelling unit 110. Figs. 7-10 show different states during conducting a preparation process on a preparation container 12 that is located in the receiving section of the expelling unit 110. The expelling unit 110 comprises a pressing device 120 in form of a roller. The pressing device 120 is configured to apply the mechanical force to the diluent chamber 30 and the medicament chamber 20 of the preparation container 12 that is received in the receiving section of the expelling unit 110. The pressing device 120 is configured to sequentially squeeze the diluent chamber 30 and the medicament chamber 20 of the preparation container 12 that is received in the receiving section. For this purpose, the pressing device 120 is moved from a starting position, shown in Fig. 7, along the second direction D2 into a final position, shown in Fig. 10, thereby moving across the diluent chamber 30, the connection channel 44 and the medicament chamber 20. When the pressing device 120 acts on the diluent chamber 20, the diluent chamber 20 is squeezed, by way of which the pressure inside the diluent chamber 20 is increased until the pressure is sufficient to break the breakable seal 41. By the break of the breakable seal 41 the barrier 40 is transferred from the fluid impermeable state into the fluid permeable state and thus a transfer of the diluent 8 from the diluent chamber cavity 31 into the medicament chamber cavity 21 through the barrier 40 is allowed. By subsequent squeezing the diluent chamber 20 the diluent 8 is transferred from the diluent chamber cavity 31 into the medicament chamber cavity 21 through the barrier 40 as shown in Fig. 8. Once the diluent 8 comes into contact with the lyophilized medicament 6 the lyophilized medicament 6 starts to dissolve in the diluent 8 and the liquid medicament 6’ is prepared in the medicament chamber cavity 21. After completion of the dissolving process, the liquid medicament 6’ is transferred out of the medicament chamber cavity 21 into the infusion bag 60 by moving the pressing device 120 across the medicament chamber 20.

[0115] After the liquid medicament 6’ is transferred into the infusion bag 60 the pressing device 120 is moved back into the starting position and the preparation assembly 10 is moved along the first direction D1 , by way of which the next preparation container 12 is transported into the receiving section of the expelling unit 110 and the preceding preparation container 12 is transported out of the receiving section of the expelling unit 110. For this purpose the preparation device 100 comprises a conveying actuator 130. The conveying actuator 130 comprises sprockets 131, wherein each sprocket 131 comprises teeth that are configured to mesh with the periodic engagement structure 53. When the sprockets 131 are rotated the preparation assembly 10 is moved along the first direction D1 as illustrated in Fig. 6.

[0116] Fig. 11 shows another example of a preparation assembly 10. The preparation assembly 10 shown in Fig. 11 is substantially identical to the preparation assembly 10 as shown in Fig. 1. In contrast to the preparation assembly 10 as shown in Fig. 1, the diluent chamber 30 and the medicament chamber 20 are arranged along the first direction D1. Further, the barrier 40 does not comprise breakable seal 41, but a valve 42, wherein the valve 42 is transferable from a closed state to an open state. In the closed state a fluid transfer through the valve 42 is blocked and in the open state a fluid transfer through the valve 42 is allowed. This way the barrier 40 is transferable from the fluid impermeable state to the fluid permeable state by transferring the valve 42 from the closed state into the open state.

[0117] Reference Numbers

[0118] 1 system

[0119] 6 medicament

[0120] 6’ liquid medicament

[0121] 8 diluent

[0122] 10 preparation assembly

[0123] 12 preparation container

[0124] 13 row arrangement

[0125] 18 sealed seam

[0126] 20 medicament chamber

[0127] 21 medicament chamber cavity

[0128] 22 medicament filling port

[0129] 23 outlet port

[0130] 24 medicament chamber wall front portion

[0131] 26 medicament chamber wall back portion

[0132] 30 diluent chamber

[0133] 31 diluent chamber cavity

[0134] 32 diluent filling port

[0135] 34 diluent chamber wall front portion

[0136] 36 diluent chamber wall back portion

[0137] 40 barrier

[0138] 41 breakable seal

[0139] 42 valve

[0140] 44 channel

[0141] 51 first outer edge

[0142] 52 second outer edge

[0143] 53 engagement structure

[0144] 54 sprocket hole

[0145] 60 infusion bag

[0146] 100 preparation device

[0147] 110 expelling unit

[0148] 120 pressing device

[0149] 130 conveying actuator

[0150] 131 sprocket

[0151] D1 first direction

[0152] D2 second direction

Claims

Claims1. A preparation assembly (10) for preparing a liquid medicament (6’), the preparation assembly (10) comprising a plurality of preparation containers (12), wherein the preparation containers (12) are arranged in a row to form a row arrangement (13) extending along a first direction (D1), wherein the preparation containers (12) are fluidically separated from each other, wherein each preparation container (12) of the row arrangement (13) is mechanically connected to an adjacent preparation container (12) of the row arrangement (13), each preparation container (12) comprising: a medicament chamber (20) comprising a medicament chamber cavity (21) configured to hold a medicament (6), a diluent chamber (30) comprising a diluent chamber cavity (31) configured to hold a diluent (8), a barrier (40) between the medicament chamber (20) and the diluent chamber (30), wherein the barrier (40) is transferable from a fluid impermeable state to a fluid permeable state.

2. The preparation assembly (10) according to claim 1 , wherein each medicament chamber cavity (21) holds a freeze-dried and / or lyophilized medicament (6).

3. The preparation assembly (10) according to claim 1 or claim 2, wherein the liquid medicament (6’) is a liquid medicament to be delivered to a patient via infusion or injection.

4. The preparation assembly (10) according to any one of the preceding claims, wherein diluent chamber cavity (31) and the medicament chamber cavity (21) of each preparation container (12) are arranged along a second direction (D2), wherein the second direction (D2) runs inclined to the first direction (D1).

5. The preparation assembly (10) according to claim 4, wherein the second direction (D2) runs perpendicular to the first direction (D 1 ).

6. The preparation assembly (10) according to any one of the preceding claims, wherein the barrier (40) comprises at least one of a breakable seal (41) and a valve (42), wherein the barrier (40) is transferable from the fluid impermeable state to the fluid permeable state in response to a break of the breakable seal (41), wherein the valve (40) is transferable from a closed state to an open state, wherein the barrier (40) is transferable from the fluid impermeablestate to the fluid permeable state by transferring the valve (42) from the closed state to the open state.

7. The preparation assembly (10) according to any one of the preceding claims, wherein each diluent chamber (30) comprises a diluent filling port (32) for filling the diluent (8) into the diluent chamber cavity (31).

8. The preparation assembly (10) according to any one of the preceding claims, wherein each medicament chamber (20) comprises a medicament filling port (22) for filling a medicament (6) into the medicament chamber cavity (21).

9. The preparation assembly (10) according to any one of the preceding claims, wherein at least one of the medicament chamber (20) and the diluent chamber (30) of each medicament container (12) comprises an outlet port (23) to withdraw and / or expel the liquid medicament (6’) from at least one of the medicament chamber cavity (21) and the diluent chamber cavity (31) of each preparation container (12).

10. The preparation assembly (10) according to any one of the preceding claims, wherein at least one of the diluent chamber (30) and the medicament chamber (20) is squeezable.

11. The preparation assembly (10) according to any one of claims 6 to 10, wherein at least one of the breakable seal (41) is configured to break and the valve (42) is configured to be transferred into the open state in response to an increase of a pressure inside at least one of the diluent chamber cavity (31) and the medicament chamber cavity (21).

12. The preparation assembly (10) according to any one of the preceding claims, wherein the preparation assembly (10) comprises a front layer (14) and a back layer (16), wherein the front layer (14) is sectionwise sealed to the back layer (16) such that the medicament chamber cavities (21) and the diluent chamber cavities (31) of the plurality of preparation containers (12) are formed between the front layer (14) and the back layer (16).

13. The preparation assembly (10) according to claim 12, wherein at least one of the front layer (14) and the back layer (16) is flexible.

14. The preparation assembly (10) according to any one of the preceding claims, wherein the preparation assembly (10) comprises a first outer edge (51) and a second outer edge (52), wherein the second outer edge (42) is opposite to the first outer edge (41), wherein the firstouter edge (51) and the second outer edge (52) extend along the first direction (D1), wherein at least one of the first outer edge (51) and the second outer edge (52) comprises a periodic engagement structure (53) extending along the first direction (D1).

15. The preparation assembly (10) according to claim 14, wherein the engagement structure (53) comprises a perforation.

16. The preparation assembly (10) according to claim 15, wherein the perforation is in the form of sprocket holes.

17. The preparation assembly (10) according to any one of claims 14 to 16, wherein the engagement structure (53) is configured to engage with a conveying actuator (130), wherein the conveying actuator (130) is configured to move the preparation assembly (10) along the first direction (D1).

18. A method of preparing a liquid medicament (6’), the method comprising:- using a preparation assembly (10) according to any one of the preceding claims, wherein each medicament chamber cavity (21) holds a medicament (6), wherein each diluent chamber cavity (31) holds a diluent (8),- transferring the barrier (40) of at least one preparation container (12) of the plurality of preparation containers (12) from the fluid impermeable state to the fluid permeable state to allow a fluid transfer between the diluent chamber cavity (31) and the medicament chamber cavity (21) of the at least one preparation container (12),- at least one of transferring the diluent (8) from the diluent chamber cavity (31) to the medicament chamber cavity (21) of the at least one preparation container (12) and transferring the medicament (6) from the medicament chamber cavity (21) to the diluent chamber cavity (31) of the at least one preparation container (12) to prepare the liquid medicament (6’) in the at least one preparation container (12).

19. The method according to claim 18, the method further comprising:- transporting the preparation assembly (10) along the first direction (D1),- transferring the barrier of at least one other preparation container (12) of the plurality of preparation containers (12) from the fluid impermeable state to the fluid permeable state to allow a fluid transfer between the diluent chamber cavity (31) and the medicament chamber cavity (31) of the at least one other preparation container,- at least one of transferring the diluent (8) from the diluent chamber cavity (31) to the medicament chamber cavity (21) of the at least one other preparation container (12) andtransferring the medicament (6) from the medicament chamber cavity (21) to the diluent chamber cavity (31) of the at least one other preparation container (12) to prepare the liquid medicament (6’) in the at least one other preparation container (12).

20. A system (1) for preparing a liquid medicament (6’), the system comprising a preparation assembly (10) according to any one of claims 1 to 17 and a preparation device (100) for preparing the liquid medicament (6’), wherein the preparation device (100) comprises an expelling unit (110), wherein the expelling unit (110) is configured to apply a mechanical force to at least one of the diluent chamber (30) and the medicament chamber (20) of at least one preparation container (12) to transfer at least one of the diluent (8) and the medicament (6) from one of the diluent chamber cavity (31) and the medicament chamber cavity (21) into the other one of the diluent chamber cavity (31) and the medicament chamber cavity (21).

21. The system (1) according to claim 20, wherein the preparation assembly (10) comprises a first outer edge (51) and a second outer edge (52), wherein the second outer edge (52) is opposite to the first outer edge (51), wherein the first outer edge (51) and the second outer edge (52) extend along the first direction (D1), wherein at least one of the first outer edge (51) and the second outer edge (52) comprises a periodic engagement structure (53) extending along the first direction (D1), wherein the preparation device (100) comprises a conveying actuator (130), wherein the conveying actuator (130) is configured to move the preparation assembly (10) through the preparation device (100) along the first direction (D1) by engaging with the periodic engagement structure (53).

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