EP4680311A1

EP4680311A1 - Cap module for a drug delivery device, and drug delivery device

Info

Publication number: EP4680311A1
Application number: EP24708503.8A
Authority: EP
Inventors: Pei Yu Chao
Original assignee: SHL Medical AG
Current assignee: SHL Medical AG
Priority date: 2023-03-14
Filing date: 2024-03-06
Publication date: 2026-01-21
Also published as: WO2024188764A1

Abstract

A cap module (10) for a drug delivery device comprises a cap (n) and a delivery member shield remover (12) mounted to the cap (11). The delivery member shield remover (12) comprises a metal wire arrangement. The metal wire arrangement is configured to engage with a delivery member shield of the drug delivery device and to remove the delivery member shield in response to a removal of the cap module (10) from the drug delivery device.

Description

CAP MODULE FOR A DRUG DELIVERY DEVICE, AND DRUG DELIVERY DEVICE

TECHNICAL FIELD

The present disclosure generally relates to the technical field of drug injection devices.

BACKGROUND

Drug injection devices, also referred to as drug delivery devices, such as autoinjectors, are known in the art for dispensing a drug to an injection site of a patient. Such injection devices typically comprise a housing and a cap, the cap being located at a proximal end of the drug injection device. The drug injection device accommodates a drug container e.g. a syringe. The syringe may comprises a delivery member on its proximal side, e.g., a needle or a nozzle. The delivery member may for example be fitted with a delivery member shield and the cap comprises a delivery member shield remover configured to remove the delivery member shield.

The cap and the delivery member shield are removably attached to the housing to shield the delivery member of the syringe. To dispense the drug, the cap and the delivery member shield are removed from the housing to expose the delivery member. The delivery member is then inserted into the patient at the injection site to dispense the drug.

Existing delivery member shield removers are implemented as iron tubes or circular iron sheets. These solutions are intensive in material and, hence, costs, and require a complex manufacturing and/or assembling process.

SUMMARY

Reference should now be made to the appended claims.

In the present disclosure, when the term “distal direction” is used, this refers to the direction pointing away from the dose delivery site during use of the drug delivery device. When the term “distal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which during use of the drug delivery device is/are located furthest away from the dose delivery site. Correspondingly, when the term “proximal direction” is used, this refers to the direction pointing towards the dose delivery site during use of the drug delivery device. When the term “proximal part/end” is used, this refers to the part/end of the delivery device, or the parts/ends of the members thereof, which during use of the drug delivery device is/are located closest to the dose delivery site.

Further, the terms “longitudinal”, “longitudinally”, “axially” and “axial” refer to a direction extending from the proximal end to the distal end and along the device or components thereof, typically in the direction of the longest extension of the device and/or component.

Similarly, the terms “transverse”, “transversal” and “transversally” refer to a direction generally perpendicular to the longitudinal direction.

Further, the terms “circumference”, “circumferential”, or “circumferentially” refer to a circumference or a circumferential direction relative to an axis, typically a central axis extending in the direction of the longest extension of the device and/or component. Similarly, “radial” or “radially” refer to a direction extending radially relative to the axis, and “rotation”, “rotational” and “rotationally” refer to rotation relative to the axis.

According to a first aspect of the present invention, a cap module is provided for a drug delivery device. The cap module comprises a cap and a delivery member shield remover mounted to the cap. The delivery member shield remover comprises a metal wire arrangement. The metal wire may be an iron wire, or a wire made from stainless steel, e.g. from SAE 304 stainless steel. The metal wire arrangement preferably is made by bending one or more metal wires to the desired geometrical structure/s. Since the delivery member shield remover comprises, and preferably consists of a metal wire arrangement the manufacturing and assembly of such delivery member shield remover is facilitated compared to iron pipe shells of the art. In addition, such metal wire arrangement is light weight compared to delivery member shield removers of the art. The metal wire arrangement can be fabricated in one or two pieces, as will be explained later on, and can easily be bent to the desired shape.

During one or more of

• an assembly of the cap module to the housing of the drug delivery device,

• an assembled state of the drug delivery device, and

• a removal of the cap module from the housing of the drug delivery device, the metal wire arrangement is preferably configured to engage with a delivery member shield of the drug delivery device. The delivery member shield of the drug delivery device preferably is implemented as a cover for covering the delivery member which preferably is a needle or a nozzle. The delivery member shield protects the delivery member as well as humans handling the container or the drug delivery device. In one embodiment, the delivery member shield is removably attached to a container holding the drug. In the assembled state, the cap module is a part of the drug delivery device. For using the drug delivery device, i.e. for performing an injection of the drug into the recipient’s body, the cap module and the delivery member shield have to be removed from the rest of the drug delivery device. The removal of the cap module and the delivery member shield exposes the delivery member and allows for an injection.

In the assembled state, the delivery member shield remover is preferably engaged with the delivery member shield, i.e. is coupled to the delivery member shield. This coupling preferably includes a contact between the delivery member shield and the delivery member shield remover. Preferably, the coupling includes a clip fit of the delivery member shield in the metal wire arrangement, such that the delivery member shield is at least co-held by the delivery member shield, in addition to the coupling of the delivery member shield with the container. In a different embodiment, the delivery member shield remover is not engaged with the delivery member shield in the assembled state but engages during removal of the cap module from the drug delivery device.

Preferably, the metal wire arrangement in addition or alternatively comprises a hook arrangement comprising at least one, preferably two hook members coupling the delivery member shield remover to the delivery member shield at least during removal of the cap module from the drug delivery device. Hence, the delivery member shield remover is arranged with respect to the delivery member shield such that at least when the cap module and hence the delivery member shield remover is pulled away from the housing in proximal direction, the delivery member shield remover hooks to or into the delivery member shield and detaches the delivery member shield from the rest of the drug delivery device.

For all these functions of the delivery member shield remover, the metal wire arrangement can be an ideal solution for implementation, for example in view of its geometrical variability during manufacturing, its low cost associated with its low volume and the possibility to build the delivery member shield remover from a simple metal wire.

The cap module, as well as the drug delivery device, and most if not all components therein extend along a longitudinal axis between a proximal end and a distal end. In the assembled state, the cap module is removably attached to a proximal end of a housing of the drug delivery device. In this respect, the cap preferably comprises a shell that is configured to be removably attached with its distal end to the proximal end of the housing of the drug delivery device. In addition, the cap comprises a cover extending transversally to the longitudinal axis. The cover is configured to cover the open proximal end of the housing of the drug delivery device. The shell of the cap preferably extends from the cover in distal direction. The metal wire arrangement preferably is mounted to the cap in a non-removable fashion and extends from one of the cover and the shell in distal direction. In a preferred embodiment, the metal wire arrangement is non-removably integrated into the cap, e.g. injection moulded into the cover of the cap. In a different embodiment, the metal wire arrangement is non-removably attached to a base, e.g. by way of insert moulding, while the base is attached to the cap, and preferably is attached to the cover of the cap, e.g. by one of gluing, a press fit, etc.

Preferably, the metal wire arrangement comprises a first clip member and a second clip member extending in distal direction and arranged distant from each other in radial direction. The first and second clip member form a clip configured to clip the delivery member shield between the first and second clip member at least during assembly of the cap module to the drug delivery device. Preferably, proximal ends of the first and second clip members are mounted to the cap, while distal ends of the first and second clip members are free ends and are deflectable in radial direction. Preferably, a radial distance between the proximal ends of the first and second clip member is smaller than a radial distance between the free ends of the first and second clip member. Hence, the clip members preferably extend in distal direction inclined relative to the longitudinal axis. Accordingly, the free ends of the clip members define a space to insert the delivery shield member between the two clip members. Upon pushing the delivery member shield further in proximal direction between the clip members, the delivery member shield is clipped. More than two clip members may be provided in the metal wire arrangement if deemed necessary.

During removal of the cap module, the clip members act as hook members given that each hook member hooks to or into the delivery member shield such that the delivery member shield and the metal wire arrangement are coupled. This results in the delivery member shield being removed from the container or syringe in response to removing the cap module from the rest of the drug delivery device. In geometrical terms, it is preferred that the metal wire arrangement comprises two metal wire loops extending from the cap in distal direction. Each metal wire loop comprises two longitudinal portions extending in distal direction and a transversal portion connecting distal ends of the two longitudinal portions. Each metal wire loop is preferably made from a single wire, e.g. by way of bending. In a different embodiment, the at least two metal wire loops are made from a single wire.

In particular the longitudinal portions of each metal wire loop contribute to the clip function of the delivery member shield remover in view of being radially deflectable, while also the transversal portion can do so. Primarily the distal portion of each of the metal wire loops contribute to the hook function, while also the longitudinal portion can do so.

Given that after assembly of the cap module to the housing of the drug delivery device, it is primarily the transversal portions of the metal wire loops that are coupled to or into or behind the delivery member shield, different geometries maybe provided for the transversal portions. Specifically, the circumferential shape of the delivery member shell may impact the design of the transversal portions. In one embodiment, each transversal portion is embodied as a straight line, preferably for being arranged behind the delivery member shield in distal direction in an assembled state. In a different embodiment, each transversal portion comprises a portion bowed radially outwards, in particular for engaging with a circumferential recess in the delivery member shield.

According to another aspect of the present invention, a drug delivery device is provided comprising a cap module according to any of the preceding embodiments. In addition, a housing, e.g. a tubular housing, is configured to enclose a container for storing the drug. The cap module is preferably removably attached to the proximal end of the housing. This state represents an assembled state of the drug delivery device. In such assembled state, it is preferred that the container holding the drug is arranged in the housing and the delivery member - such as a needle - is arranged at the proximal end of the drug container for expelling the drug e.g. in response to a stopper arranged within the preferably tubular container being actuated by a plunger rod. And it is preferred that the delivery member shield - such as a needle cover - is provided and is mounted to the proximal end of the container. The container including the delivery member preferably is a syringe. Accordingly, in such assembled state, the delivery member shield remover is engaged with the delivery member shield.

Generally, all terms used in the claims are to be interpreted according to their ordinary meaning in the technical field, unless explicitly defined otherwise herein. All references to a/an/the element, apparatus, member, component, means, etc. are to be interpreted openly as referring to at least one instance of the element, apparatus, member component, means, etc., unless explicitly stated otherwise.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments of the present disclosure will now be described by way of example only and with reference to the following accompanying drawings, wherein

Figure 1 illustrates a cross-sectional view of a drug delivery device, according to an embodiment of the present invention;

Figure 2 illustrates a cap module according to an embodiment of the present invention, in two perspective views a) and b), in a top view c) and in a side view d);

Figure 3 illustrates a cap module according to another embodiment of the present invention, in a perspective view; Figure 4 illustrates a perspective view of a sub-assembly as used in a drug delivery device in an assembled state, according to an embodiment of the present invention, including a transparent view of a syringe; and

Figure 5 illustrates a perspective view of a sub-assembly as used in a drug delivery device in an assembled state, according to another embodiment of the present invention, including a transparent view of a syringe.

DETAILED DESCRIPTION

Same components and elements are referred to by the same reference signs across all Figures.

Figure 1 shows a cross-sectional view of a drug delivery device 100 according to an embodiment of the invention. The drug delivery device 100 is an autoinjector in the present example. The drug delivery device 100 extends along a longitudinal axis A-A between a proximal end P, where the drug is ejected, and a distal end D. The drug delivery device 100 comprises a housing 13. The housing 13 is hollow and may be generally tubular, although other shapes are possible. The housing 13 extends along the longitudinal axis A-A between the proximal end P and the distal end D. The housing 13 also comprises an optional window 134 through which a user can see the drug to be injected. The drug delivery device 100 further comprises a cap module 10, shown in more details in Figure 2. The cap module 10 comprises a cap 11 and a delivery member shield remover 12.

The cap 11 is fitted to the housing 13 for its removable attachment to the housing 13. For that purpose, the cap 11 comprises a shell 112 having a distal portion, generally annular, configured to shroud a proximal portion of the housing 13. It should be noted that the distal portion of the shell 111 of the cap 11 and the proximal portion of the housing 13 may alternatively be noncircular, as long as they have corresponding shapes. Thus, the cap 11 and the housing 13 may be assembled using a snap-fit or a friction-fit, for instance. The cap 11 further comprises a cover 111 extending transversally relative to the longitudinal axis A-A for covering the open proximal end P of the housing

13-

The drug delivery device too is configured to accommodate a, typically cylindrical, container 161 for holding the drug 164 to be injected. In the present embodiment, the container 161 is a syringe received by the housing 13 of the drug delivery device 100. The container 161 comprises a delivery member at its proximal end P, e.g., a needle or a nozzle.

The drug delivery device 100 comprises a delivery member cover 18. The delivery member cover 18 is slidably arranged in the housing 13 and protrudes from a proximal end opening of the housing 13. The delivery member cover 18 is configured to move axially relative to the housing 13 from an extended position to a retracted position in which the housing 13 receives a larger portion of the delivery member cover 18 than in the extended position. The delivery member cover 18 has a proximal tubular portion 181 and legs 182 extending distally towards the distal end D of the housing 13. The housing 13 comprises guide rails 132. The legs 182 are configured to cooperate with the guide rails 132 when the delivery member cover 18 is moved between the extended position and the retracted position.

In a preferred example, the drug delivery device 100 comprises a resilient member 19 configured to bias the delivery member cover 18 towards the extended position. The resilient member 19 may for example be a coil spring. The resilient member 19 may for example be arranged to extend inside the delivery member cover 18 between a radial surface of the delivery member cover 18 and a radial surface provided inside the housing 13.

The delivery member (not visible) is shrouded by a delivery member shield 17. The delivery member shield 17 preferably is removably mounted to the proximal end of the container 161. The delivery member shield 17 protects the delivery member during assembly of the syringe 16 into the drug delivery device 100. In one embodiment, the delivery member shield 17 is a single component made from plastics. In another embodiment, the delivery member shield 17 comprises two components, i.e. an inner flexible delivery member shield, also referred to as flexible needle shield (FNS), and an outer rigid delivery member shield, also referred to as rigid needle shield (RNS). In the latter embodiment, the rigid delivery member shield is arranged around the flexible delivery member shield in radial direction and the delivery member shield including the flexible needle shield and the rigid needle shield will be removed by the delivery member shield remover 12 in one go, preferably by engaging with the rigid needle shield only.

The delivery member shield remover 12 of the cap module 10 is configured and arranged to engage with the delivery member shield 17 during assembling the cap module 10 to the drug delivery device 100, and to entrain the delivery member shield 17 during removal of the cap module 10 from the drug delivery device 100 given that the cap module 10 is to be removed prior to any usage of the drug delivery device 100 in order to expose the delivery member, i.e. the needle. Accordingly, when the cap module 10 is removed from the housing 13, it brings with it the delivery member shield 17. In the present embodiment, the delivery member shield remover 12 is fixed to the cover 111 of the cap 11.

Presently, the delivery member shield remover 12 of the cap module 10 is a metal wire arrangement that protrudes from the cover 111 of the cap 11 in distal direction. Such delivery member shield remover 12 is easy to manufacture, leight weight and easy to assemble to the drug delivery device 100.

Turning now to Figure 2, the cap module 10 is shown in more detail, in two perspective views a) and b), in a top view c) and in a side view d).

Beginning with the perspective view of the cap module 10 in FIG. 2a), the corresponding cap 11 comprises, as previously detailed, a cover 111 and a shell 112 protruding from the cover 111 in distal direction. In particular the shell instance via a snap-fit or a friction-fit attachment. Hence, a distal rim of the shell 112 may be configured as interface member to interact with a proximal end of the housing 13, as is e.g. illustrated in FIG. 1. Presently, an inner suface of the shell 112 comprises flexible ribs extending in parallel to the longitudinal axis A-A. These ribs preferably absorb energy in case the drug delivery device 100 is dropped and suffers an impact from its proximal end P.

The delivery member shield remover 12 presently comprises two members 121 and 122. With respect to the functionionality, these members 121 and 122, or portions of, are referred to as clip members 121c, 122c and/or as hook members 121H, 122H. When its comes to the physical shape of these members 121, 122, they are also referred to as metal wire loops 121L, 122L, given that these members 121, 122 are shaped as loops protruding from the cover 111 of the cap 11. The first metal wire loop 121L comprises two longitudinal portions 1212L protruding from the cover 111 and extening in distal direction, not necessarily in parallel to the longitudinal axis A-A, but in direction of. Distal ends of the two longitudinal portions 1212L are connected via a transversal portion 1211L of the first metal wire loop 121L. Given that the first metal wire loop 121L is made from a metal wire, the portions i2iiLand 1212L represent integral portions of the same wire rather than separate wire pieces attached to each other. However, subject to geometrical and/or manufacturing needs, the first metal wire loop 121L may also be assembled by individual pieces of wire. The second metal wire loop 122L comprises two longitudinal portions 1222L protruding from the cover 111 and extening in distal direction, not necessarily in parallel to the longitudinal axis A-A, but in direction of. Distal ends of the two longitudinal portions 1222L are connected via a transversal portion 1221L of the first metal wire loop 122L. Given that the second metal wire loop 122L is made from a metal wire, the portions I22i and 1222L represent integral portions of the same wire rather than separate wire pieces attached to each other. However, subject to geometrical and/or manufacturing needs, the second metal wire loop 122L may also be assembled by individual pieces of wire. In the subsequent views b), c) and d) of the cap module io in FIG. 2, some reference signs are omitted for the purpose of a better illustration. In the perspective view of FIG. 2b), the interior of the cap module io may be better apprehended. In the centre of the cover in, a base 123 is arranged from which base 123 the metal wire loops 121L, 122L extend from. The base 123 preferably is attached to the cover 111, e.g. by means of gluing or a press fit. Accordingly, the delivery member shield remover 12 preferably is preassembled with the base 123 prior to mounting this configuration into the cap 11. In one embodiment, the delivery member shield remover 12 is injection molded into the base 123. In a different embodiment, the delivery member shield remover 12 is directly press fit into the cover 111 absent a separate base. In a further embodiment, the delivery member shield remover 12 is injection moulded into the cap 11.

In the top view of FIG. 2c) it becomes apparent that a distance between the two metal wire loops 121L, 122L expands from the bottom, i.e. the proximal end, to the top, i.e. the distal end. While the distance di at the bottom is small, the distance d2 exceeds the distance di at the bottom.

This characteristic may also be derived from the side view of FIG. 2d). From this side view, it can also be derived that the delivery member shell remover 12 excels the shell 112 of the cap 11 in lenght along the longitudinal axis A-A.

Figure 3 illustrates a cap module 10 according to another embodiment of the present invention, in a perspective view. The cap module 10 is identical to the cap module 20 of Figure 2, except for the transversal portions 1211L and 1212L of the metal wire loops 121L, 122L. While in Fig. 2, the transversal portions 1211L and 1212L are of pure straight shape, the transversal portions 1211L and 1212L of Fig. 3 show a bulge in the transversal plane in the centre of these portions 1211L and 1212L. Each bulge bows radially outwards. As will be explained in connection with Figures 4 and 5, the transversal portions 1211L and 1212L act as hook portion for entraining the delivery member shell in response to removing the cap module from the drug delivery device. While the shape of the transversal portions 1211L and i2i2Lof Fig. 2 are preferably used to get behind the delivery member shell in distal direction in an assembled state, the shape of the the transversal portions 1211L and I2i2 of Fig. 3 are preferably used to snap into recesses in the circumference of the delivery member shell, and thereby engage with the delivery member shell.

Figure 4 illustrates a perspective view of a sub-assembly as used in a drug delivery device, in an assembled state, according to an embodiment of the present invention. The corresponding syringe 16 is illustrated transparent. The cap module 10 preferably is the cap module 10 of Figure 2. Housing and other components of the drug delivery device are omitted in this subassembly view for illustration purposes.

The container 161 holds the drug 164. At the distal end of the container 161, a flange 162 is provided for being supported by the housing. In view of the transparent illustration of the syringe 16, a stopper 163 is visible inside the container 161, which stopper is slidable in proximal direction along longitudinal axis A-A. The stopper 163 preferably is driven by a plunger rod (not shown), thereby pressing the drug 164 out of the container 161 via a delivery member 165 in form of a needle. In response to a plunger rod pushing the stopper 163 in proximal direction, the drug 164 is expelled via the delivery member 165 at the proximal end of the container 161. The delivery member 165 is protected by a delivery member shell 17, e.g. made from plastics.

The present illustration of Figure 4 shows an assembled state of the cap module 10 and the container 161, such as also presented in Figure 1. Accordingly, the cap module 10 is attached to the housing by having moved the cap module 10 with its open distal end in distal direction to / onto the housing. In response to such movement, the two metal wire loops 121L, 122L deflect in radial direction in view of the cone shaped delivery member shell 17. Accordingly, the members 121 and 122 acts as clip at least during assembly of the cap module 10 onto the housing. Accordingly, the metal wire loops 121L, 122L are also referred to as clip members 121c, 122c. In the present embodiment, the clip members 121c, 122c may, after attachement of the cap module io to the housing of the drug delivery device rest in a position as shown in Figure 4. Either, the clip members 12 lc, 122c transit to a fully relaxed state and no longer are biased by the delivery member shell 17. Or, the clip members 121c, 122c remain in a biased state, at least to some extent. In any case, if the drug delivery device is prepared for usage and the cap module 10 is removed from the drug delivery device by pulling the cap module 10 from the housing in proximal direction, the metal wire loops 121L, 122L act as hook members 121H, 122H, such that the transversal portions 1211L, 1221L pull the delivery member shell 17 from the container 161, thereby exposing the delivery member 165. The delivery member shell 17 remains trapped in the metal wire arrangement of the delivery member shell remover 12.

Figure 5 illustrates a perspective view of a sub-assembly as used in a drug delivery device in an assembled state, according to another embodiment of the present invention, including a transparent view of a container involved. The only difference with respect to the embodiment of Figure 4 is that in the embodiment of Figure 5 the modified cap module 10 of Figure 3 is applied.

The drug delivery devices described herein can be used for the treatment and/or prophylaxis of one or more of many different types of disorders.

Exemplary disorders include, but are not limited to: rheumatoid arthritis, inflammatory bowel diseases (e.g. Crohn’s disease and ulcerative colitis), hypercholesterolaemia and/or dyslipidemia, cardiovascular disease, diabetes (e.g. type 1 or 2 diabetes), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjogren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anaemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anaemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behcet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g., age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g., osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplant, acute hypoglycaemia, obesity, anaphylaxis, allergies, sickle cell disease, Alzheimer’s disease, Parkinson’s disease, dementia with Lewy bodies, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g., primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g., Pompe disease, Fabry disease, Gaucher disease), growth factor deficiencies, hormone deficiencies, coagulation disorders (e.g., hemophilia, von Willebrand disease, Factor V Leiden), and cancer.

Exemplary types of drugs that could be included in the delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapies, radioisotopes and/or nuclear medicines, diagnostic agents, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogues, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology medications such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro- apoptotic proteins, anti-apoptotic proteins, T-cell receptors, B-cell receptors, or costimulatory proteins.

Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those exhibiting a proposed mechanism of action, such as human epidermal growth factor receptor 2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-i (GLP-i) modulators, glucose-dependent insulinotropic polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, Ci esterase modulators, bradykinin modulators, C-C chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF), P-selectin modulators, neonatal Fc receptor (FcRn) modulators, calcitonin generelated peptide (CGRP) modulators, epidermal growth factor receptor (EGFR) modulators, cluster of differentiation 79B (CD79B) modulators, tumor- associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B-cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-1/PD-L1) inhibitors/modulators, B-lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, Blymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin-domain containing-3 (TIM-3) modulators, T cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators, poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte-activation gene 3 (LAG3; also known as cluster of differentiation 223 or CD223) antagonists, cluster of differentiation 276 (CD276 or B7-H3) antigen modulators, cluster of differentiation 47 (CD47) antagonists, cluster of differentiation 30 (CD30) modulators, cluster of differentiation 73 (CD73) modulators, cluster of differentiation 66 (CD66) modulators, cluster of differentiation W137 (CDW137) agonists, cluster of differentiation 158 (CD158) modulators, cluster of differentiation 27 (CD27) modulators, cluster of differentiation 58 (CD58) modulators, cluster of differentiation 80 (CD80) modulators, cluster of differentiation 33 (CD33) modulators, cluster of differentiation 159 (CD159 or NKG2) modulators, glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig- like receptor (KIR) modulators, growth arrest-specific protein 6 (GAS6)/AXL pathway modulators, A proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B-lymphocyte cell adhesion molecule modulators, cluster of differentiation W123 (CDW123) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cellular receptor 2 (HAVCR2) antagonists, cancer-testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily, member 4 (TNFRSF4 or 0X40) modulators, adenosine receptor modulators, inducible T cell co-stimulator (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumorinfiltrating lymphocytes (TIL) therapies, or T-cell receptor (TCR) therapies. Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-ia, interferon beta-ib, peginterferon beta-ia, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-rzaa, ixekizumab, and immune globulins.

Exemplary drugs that could be included in the delivery devices described herein may also include, but are not limited to, oncology treatments such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan-nxki, pertuzumab, transtuzumabpertuzumab, alemtuzumab, belantamab mafodotin-blmf, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90- Yttrium-ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab, or margetuximab.

Exemplary drugs that could be included in the delivery devices described herein include “generic” or biosimilar equivalents of any of the foregoing, and the foregoing molecular names should not be construed as limiting to the “innovator” or “branded” version of each, as in the non-limiting example of innovator drug adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumab-adaz.

Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as an alkylating agent, plant alkaloid, antitumor antibiotic, antimetabolite, or topoisomerase inhibitor, enzyme, retinoid, or corticosteroid. Exemplary chemotherapy drugs include, by way of example but not limitation, 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine, or vinorelbine.

Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g. hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g. diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% Normal Saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer’s solution, Heparin Lock Flush solution, 100 U/mL Heparin Lock Flush Solution, or 5000 U/mL Heparin Lock Flush Solution.

Pharmaceutical formulations including, but not limited to, any drug described herein are also contemplated for use in the delivery devices described herein, for example pharmaceutical formulations comprising a drug as listed herein (or a pharmaceutically acceptable salt of the drug) and a pharmaceutically acceptable carrier. Such formulations may include one or more other active ingredients (e.g., as a combination of one or more active drugs), or may be the only active ingredient present, and may also include separately administered or co-formulated dispersion enhancers (e.g. an animal-derived, humanderived, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients. Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-medication treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mF0LF0X6, mFOLFOXy, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, MiniCHOP, Maxi-CHOP, VR-CAP, Dose-Dense CHOP, EPOCH, Dose-Adjusted EPOCH, REPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA/CO, EMA/EP, EP/EMA, TP/TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C- MOPP, GCD, GEMOX, CAV, DTPACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE, ADOC, or PE.

Various modifications to the embodiments described are possible and will occur to those skilled in the art without departing from the invention which is defined by the following claims.

Claims

1. Cap module (io) for a drug delivery device (100), the cap module (io) comprising a cap (n), and a delivery member shield remover (12) mounted to the cap (11), wherein the delivery member shield remover (12) comprises a metal wire arrangement configured to engage with a delivery member shield (17) of the drug delivery device (100) and to remove the delivery member shield (17) in response to a removal of the cap module (10) from the drug delivery device (100).

2. Cap module (10) according to claim 1, extending along a longitudinal axis (A-A) between a proximal end (P) and a distal end (D), wherein the cap (11) comprises a cover (111) extending transversally to the longitudinal axis (A-A) and configured to cover an open proximal end of a housing (13) of the drug delivery device (100), wherein the cap (11) comprises a shell (112) extending from the cover (111) in distal direction, and wherein the metal wire arrangement extends from one of the cover (111) and the shell (112) in distal direction.

3. Cap module (10) according to claim 1 or claim 2, wherein the delivery member shield remover (12) consists of the metal wire arrangement.

4. Cap module (10) according to any of the preceding claims, wherein the metal wire arrangement comprises a first clip member (121c) and a second clip member (122c) extending in distal direction and arranged distant from each other in radial direction, wherein the first and second clip member (121c, 122c) represent a clip configured to clip the delivery member shield (17) between the first and second clip member (121c, 122c) at least during assembly of the cap module (io) to the drug delivery device (100).

5. Cap module (io) according to claim 4, wherein proximal ends of the first and second clip member (121c, 122c) are mounted to the cap (11), wherein distal ends of the first and second clip member (121c, 122c) are free ends and deflectable in radial direction.

6. Cap module (10) according to claim 5, wherein a radial distance (di) between the proximal ends of the first and second clip member (121c, 122c) is smaller than a radial distance (d2) between the free ends of the first and second clip member (121c, 122c).

7. Cap module (10) according to and or the preceding claims, wherein the metal wire arrangement comprises at least one hook member (121H, 122H) at its distal end configured to entrain the delivery member shield (17) during removal of the cap module (10) from the drug delivery device (100).

8. Cap module (10) according to any of the preceding claims, wherein the metal wire arrangement comprises two metal wire loops (121L, 122L) extending from the cap (11) in distal direction, wherein each metal wire loop (121L, 122L) comprises two longitudinal portions (1212L, 1222L) extending in distal direction and a transversal portion (1211L, 1221L) connecting distal ends of the two longitudinal portions (1212L, 1222L).

9. Cap module (10) according to a combination of the claims 4, 7 and 8, wherein each metal wire loop (121L, 122L) represents one of the clip members (121c, 122) and one of the hook members (121H, 122H).

10. Cap module according (10) to claim 8 or claim 9, wherein each transversal portion (1211L, 1221L) is a straight portion. n. Cap module (io) according to claim 8 or claim 9, wherein each transversal portion (1211L, 1221L) includes a curved shape adapted to a circumference of the delivery member shield (17), preferably wherein the curved shape of each transversal portion (1211L, 1221L) is bowed radially outwards.

12. Cap module (10) according to claim 2, comprising a base (123) made from plastics the metal wire arrangement is mounted to, wherein the base (123) is mounted to the cover (111).

13. Drug delivery device (100), extending along a longitudinal axis (A-A) between a proximal end (P) and a distal end (D), and comprising a housing (13) configured to enclose a container (161) for storing the drug (164), and a cap module (10) according to any of the preceding claims, the cap module (10) being arranged at a proximal end of the housing (13).

14. Drug delivery device (100) according to claim 13, comprising a container (161) located within the housing (12) and storing the drug

(164), a delivery member (165) arranged at the proximal end of the container (161) for expelling the drug (164), a delivery member shield (17) arranged to shroud the delivery member

(165), wherein the cap module (10) is removable mounted to the housing (13), wherein the delivery member shield remover (12) is engaged with the delivery member shield (17).

15. Drug delivery device (100) according to claim 13 or claim 14, comprising a syringe (16) including the container (161) and the delivery member (165), wherein the delivery member shield (17) is removable attached to the syringe (16).