Assembly comprising a drug delivery device and an electronic module and method for recharging an electrical energy storage

Abstract

The present disclosure relates to an assembly of a drug delivery device (1) and an electronic add-on module (2) with a rechargeable electrical energy storage (23) further comprising an electrical generator (3). A first component (30) of the electrical generator (3) is motion-linked to a housing (10, 42) of the drug delivery device (1) and a second component (31) of the electrical generator (3) is motion-linked to an actuation member (11, 12, 41) of the drug delivery device (1) which is rotatable during dose setting and / or dose dispensing. The electrical generator (3) is electrically connectable to the rechargeable electrical energy storage (23) of the electronic module (2). The present disclosure further relates to a method for recharging an electrical energy storage (23) by means of the electrical generator (3).

Description

[0001] Description

[0002] ASSEMBLY COMPRISING A DRUG DELIVERY DEVICE AND AN ELECTRONIC MODULE AND METHOD FOR RECHARGING AN ELECTRICAL ENERGY STORAGE

[0003] The present disclosure is generally directed to an assembly with an electronic system, e.g. an electronic module, and with a drug delivery device, e.g. with a pen-type injection device. The disclosure is further directed to a method for recharging an energy storage of an electronic module.

[0004] Electronic add-on modules for, e.g. releasable, attachment to drug delivery devices are generally known and often used to measure relevant data with respect to dose setting and / or dose dispensing. Alternatively, it is known to build an electronic module into a drug delivery device.

[0005] An exemplary data collection device for attachment to an injection device is shown in WO 2016 / 198516 A1. Further injection monitoring modules are known from WO 2020 / 217094 A1 , WO 2021 / 140352 A1 and WO 2021 / 214 275 A1. The modules typically comprise two portions, wherein one portion is attached and rotationally constrained to a dose dial grip of an injection device to measure for example rotational relative movement between components of the modules and / or the injection devices.

[0006] Such known modules typically comprise an energy storage, e.g. a battery, supplying power to the different electronic components of the module. The lifespan of such batteries is limited and thus also limits the lifespan of the module. Alternatively, the battery can be replaced, which is often inconvenient.

[0007] WO 2019 / 145415 A1 proposes the use of a rechargeable battery for a monitoring device to be used with a drug delivery device. In order to recharge the battery, the core element of the monitoring device is equipped with a charging or connection port connected to the battery, for example, a USB charging port. However, such a port can cause problems such as the ingress of dirt or moisture.

[0008] Further, EP 2 455 120 A1 proposes a medical device equipped with a mechanical-electrical transducing means allowing to generate electric energy on demand simply by a user-driven actuation. The mechanical-electrical transducing means are muscle operable, so that a user

[0009] 3. Dezember 2025 S 100 P 555 WO becomes enabled to generate required electric power on demand. The mechanical-electrical transducing means of EP 2 455 120 A1 comprise a dynamo being operably engaged with an actuating member to be driven and actuated by a user of the device by pulling and / or pushing the actuating member. The actuating member can be radially displaced or pivoted in order to transduce mechanical into electrical energy. Thus, recharging the battery requires a separate actuation of the dynamo which differs from the usual operation of the device. This may be difficult for some user.

[0010] US 2007135756 A1 , US 2018339113 A1 and US 2023191039 A1 show further examples of drug delivery devices comprising means for generating electrical energy.

[0011] Based on the aforementioned problems, it is an object of the present disclosure to provide an improved electronic module and an improved assembly comprising a drug delivery device and an electronic module prolonging the lifespan of the module.

[0012] This object is essentially solved by an assembly according to claim 1 and a method according to claim 15.

[0013] An according to the present disclosure comprises a drug delivery device, an electronic module and an electrical generator. The electronic module is configured for use with a drug delivery device, especially with a pen-type injection device, which comprises a housing and an actuation member which is axially and / or rotationally moveable with respect to the housing during dose setting and / or dose dispensing. For example, the actuation member may be a dose dial grip which is rotated in order to set a variable dose and which rotates back or which is pushed axially back without rotation during dose dispensing. Such a dose dial grip may be axially fixed to the housing such that it is only allowed to rotate or it may be guided on a helical path such that it moves axially during rotation. The dose dial grip may have the additional function of a trigger or actuator initiating and / or causing dose dispensing. As an alternative, the actuation member may be a separate dose button having the function of a trigger or actuator initiating and / or causing dose dispensing. The drug delivery device may have a longitudinal axis, e.g. the center axis of a cylindrical housing, and this axis may be the reference for the above mentioned movements. For example, the dose dial grip may be at least rotationally moveable about the longitudinal axis of the housing during dose setting and / or during dose dispensing. Further, an optional dose button may be at least axially moveable parallel to the longitudinal axis of the housing, e.g. for causing or triggering dose dispensing.

[0014] 3. Dezember 2025 S 100 P 555 WO The electronic module may be integrated in or build in the drug delivery device or it may be a separate component which is permanently or releasably attachable to the drug delivery device, for example to the actuation member of the drug delivery device.

[0015] According to the present disclosure the electronic module comprises a rechargeable electrical energy storage, a sensor arrangement, a processor and an electrical generator. The sensor arrangement may be configured to detect a relative movement, for example a movement between the housing and the actuation member, especially during dose setting and / or dose dispensing. The processor may be connected to the energy storage and to the sensor arrangement and configured to determine a status of the drug delivery device and / or a dose amount based on the movement detected by the sensor arrangement. The energy storage is further connected to the electrical generator which is configured to transduce mechanical energy into electrical energy.

[0016] The electrical generator may comprise at least a first component which, when the electronic module is used with the drug delivery device, is motion-linked to the housing and at least a second component which, when the electronic module is used with the drug delivery device, is motion-linked to the actuation member. The term motion-linked as used herein includes any direct or indirect coupling which results in a motion of one component part in at least one direction caused by a motion of another component part. This includes examples in which the component parts are integrated in or permanently or releasably fixed to each other. It further includes examples in which the motion of the two component parts is not identical, e.g. motions with different speeds as in a gear box. A motion-linked coupling may further result in transmitting only a rotation while allowing relative axial movement between two component parts or vice versa.

[0017] Due to the provision of the electrical generator with components motion linked to the housing and to the actuation member of the drug delivery device, the relative movements of the actuation member with respect to the housing occurring during and / or required for dose setting and / or dose dispensing may be used to simultaneously generate electrical energy for recharging the energy storage. In other words, the assembly according to the present disclosure is based on the idea of generating electrical energy for recharging the energy storage of the electronic module during use of the drug delivery device for dose setting and / or dose dispensing. This avoids ports or openings for recharging the energy storage via external sources and has the benefit of not requiring additional steps for recharging the energy storage. Thus, intuitive use of the drug delivery device is enough to provide the required energy for the electronic module and its functions.

[0018] 3. Dezember 2025 S 100 P 555 WO In the assembly according to the present disclosure, the first component may comprise one of an induction coil or a magnet and the second component may comprise one of a magnet or an induction coil which are arranged such that electrical energy is generated by the relative movement of the induction coil and the magnet with respect to each other. For example, the electrical generator may be a dynamo or an alternator with a semiconductor rectifier. Dynamos are suitable for use in low power applications, particularly where low voltage DC is required, as in electronic modules for drug delivery devices. Although an alternator with a semiconductor rectifier may be slightly less efficient in these applications, this is a suitable alternative to a dynamo. The energy storage of the electronic module may be of any suitable type of energy storage. For example, the energy storage may comprise a rechargeable battery or a capacitor.

[0019] In the assembly according to the present disclosure, the first component of the electrical generator may be integrated in or coupled to the housing and the second component of the electrical generator may be integrated in or coupled to the actuation member. This may include examples in which an induction coil or a magnet is injection molded into the housing and / or into the actuation member, e.g. a into a dose dial grip, a dispense button or a number sleeve coupled to the dose dial grip. In an alternative example of the assembly, the first component is integrated in or coupled to the housing and the second component is arranged interposed between the housing and the actuation member and rotationally constrained to the actuation member. In these cases, where the two components of the electrical generator are integrated in or coupled to components of the drug delivery device, an interface between the drug delivery device and the electronic module may be used to transfer energy generated in or at the drug delivery device to the module. If the module is releasably attachable to the drug delivery device, the interface should be releasable, too. Otherwise, a permanent, e.g. wired, connection between the generator and the electronic module is suitable.

[0020] In the assembly, the energy storage, the sensor arrangement and / or the processor may be integrated in or permanently coupled to the drug delivery device. In other words, the electronic module may be provided integrated in the drug delivery device, for example into the housing or into the actuation member. As an alternative, the energy storage, the sensor arrangement and / or the processor may be integrated in a casing of the electronic module which is configured to be permanently or releasably coupled to the drug delivery device.

[0021] The electronic module may further comprise a first portion and a second portion, wherein the first portion is configured for, e.g. releasable, attachment to the actuation member of the drug delivery device such that the first portion follows movement of the actuation member and vice

[0022] 3. Dezember 2025 S 100 P 555 WO versa when attached to the drug delivery device, and wherein the second portion is coupled to the first portion allowing relative rotational movement and relative axial movement with respect to the first portion. In this example, the first portion may be configured to be used as a user interface for operating a dose dial grip of the drug delivery device, while the second portion may be configured to be used as a user interface for operating a separate dose button of the drug delivery device.

[0023] For example, the first component of the electrical generator may be integrated in or coupled to the housing and the second component of the electrical generator may be integrated in or coupled to the first portion of the electronic module. As an alternative example, first component of the electrical generator may be integrated in or coupled to the second portion of the electronic module and the second component of the electrical generator may be integrated in or coupled to the first portion of the electronic module.

[0024] As mentioned above, the electronic module may be, e.g. releasably, attached to the drug delivery device by fastening means, for example, interacting mechanical coupling elements or by frictional or elastic engagement. In more detail, the present disclosure relates to an add-on electronic module that can be embodied as a re-usable clip-on module with a suitably configured pen injector for the purpose of recording doses that are delivered from the pen. This functionality may be of value to a wide variety of device users as a memory aid or to support detailed logging of dose history. It is envisaged that the electronic module could be configured to be connectable to a mobile device, or similar, to enable the dose history to be downloaded from the module on a periodic basis. The module may comprise electronics for detecting and / or calculating the size of a selected and / or dispensed dose.

[0025] The drug delivery device comprises at least a housing with a container configured to receive a drug or a cartridge filled with a drug. Further, the drug delivery device comprises a dose setting and dispensing unit wherein the actuating member may be part of this unit. For example, the dose setting and dispensing unit comprises a dose dial grip which is, at least rotationally, e.g. helically, moveable with respect to the housing during dose dispensing and a dose button at least axially moveable with respect to the housing for causing dose dispensing. The dose button may have a T-shape in cross-section with a proximal end surface that serves as a pressure surface and a central shaft that extends distally. The dose setting and dispensing unit may comprise further components, e.g. a plunger which may be at least axially, e.g. helically, moveable with respect to the housing during dose dispensing.

[0026] 3. Dezember 2025 S 100 P 555 WO If the electronic module is a releasable add-on module, the module of the present disclosure may be suitable to be used with a wide variety of different drug delivery devices, preferably pen injectors, that all exhibit a similar behavior when dispensing a dose, in that: (a) the dial grip rotates relative to the housing during dispense, with a rotation angle related to the amount of dose dispensed, and (b) the dial grip or a separate dose button is prevented from rotating relative to the housing, or is free to rotate but not driven so that any relative rotation is likely to be small. In this case, as the module is intended to be independent of the type of drug delivery device, the present disclosure is not limited to any details of the mechanism of the delivery device.

[0027] Although not required in the context of the present disclosure, the drug delivery device may optionally comprise further components such as a drive sleeve, a number sleeve, a clutch, a cap, a needle, a spring, a lead screw or the like, interacting with the dose button, the dose dial grip, the drive sleeve, the plunger and / or the housing, for example as disclosed in WO 2004 / 078239 A1. However, the present disclosure is not limited to the drug delivery device of WO 2004 / 078239 A1. Other suitable drug delivery devices to be used are described e.g. in EP 1 570 876 B1 , EP 2 814 547 B1 , EP 2 890 434 B1 , WO 2005 / 018721 A1 , WO 2009 / 132777 A1 , WO 2014 / 033195 A1 , US 5,693,027 A, US 6,663,602 B2, US 7,241 ,278 B2 or US 9,937,294 B2.

[0028] If the drug delivery device has a similar working principle as in the example of WO 2004 / 078239 A1 , during dose setting components of the drug delivery device may perform the following movements. A housing may be stationary and may be used as a reference system for the further movements of other components. A plunger may be stationary and may be guided in a housing thread. A drive sleeve may be provided rotationally coupled to the dose dial grip during dose setting and rotationally constrained to the housing during dose dispensing. In other words, the drive sleeve may be guided in the housing to perform a purely axial movement during dose dispensing. The drive sleeve may perform a helical movement, i.e. a combined axial and rotational movement, and may be in threaded engagement with the plunger. A dial grip may perform a helical movement. A dose button may be free to rotate but axially constrained to the drive sleeve. For example, the dose button may be axially retained to the drive sleeve by a clutch. An optional clutch may perform a helical movement and may couple a number sleeve to the drive sleeve. An optional clutch spring may perform an axial movement and may be guided in housing splines and may click over clutch teeth. An optional number sleeve may be permanently fixed on the dial grip and may perform a helical movement and may be guided in a housing thread. An optional last dose nut may perform a helical movement on a drive sleeve track of the drive sleeve and may be rotationally constrained to the

[0029] 3. Dezember 2025 S 100 P 555 WO housing. Hence, the last dose nut may perform axial movement relative to the housing and a helical movement with respect to the drive sleeve.

[0030] During dose dispensing components of the drug delivery device may perform the following movements. The housing may remain stationary as a reference system for the further movements of other components. The plunger may perform a helical movement and may be guided in the housing thread. The drive sleeve may perform a pure axial movement and may be in threaded engagement with the plunger. The dose dial grip may perform a helical movement and may be permanently fixed on the number sleeve. The dose button may perform an axial movement if coupled to the drive sleeve and / or the clutch. The optional clutch may perform pure axial movement and may de-couple the number sleeve from the drive sleeve. The optional clutch spring may perform pure axial movement and may be rotationally constrained to the clutch due to a pressure applied to the dose button. The optional number sleeve may perform a helical movement and may be guided in the housing thread. The optional last dose nut may maintain its axial position on the drive sleeve track and may be rotationally constrained to the housing.

[0031] If the electronic add-on module comprises at least a first portion and a second portion, the first portion may define an auxiliary dose dial grip. Further, the first portion may be configured to be permanently or releasably attached to the dose dial grip of the drug delivery device, such that the first portion follows the, e.g. helical, movement of the dose dial grip when attached to the drug delivery device. Hence, when the auxiliary dose dial grip is attached to the dose dial grip and is for example rotated during dose setting and / or dose dispensing, the dose dial grip of the drug delivery device is also rotated. The drug delivery device may extend from a distal region, provided for example with a needle, to a proximal region, provided for example with the dose dial grip and / or a dose button. If the electronic add-on module is releasably attached to the drug delivery device, the longitudinal axis of the drug delivery device may be in line with a center axis of the e.g. substantially cylindrical module.

[0032] The second portion of the electronic add-on module may be coupled to the first portion allowing relative rotational movement about the first longitudinal axis and relative axial movement parallel to the first longitudinal axis with respect to the first portion. The second portion may be at least partially arranged inside the first portion and / or may be retained in the first portion. The second portion may be retained in the first portion by clips that engage in a groove. In addition, the second portion may define an auxiliary dose button abutting the dose button of the drug delivery device. Hence, when a user applies pressure onto the auxiliary dose button, the pressure is directly transferred onto the dose button of the drug delivery device. Consequently, the

[0033] 3. Dezember 2025 S 100 P 555 WO second portion is configured to apply pressure onto the dose button of the drug delivery device, when attached.

[0034] According to the present disclosure, the processor of the electronic module may be connected to the sensor arrangement configured to detect a relative rotational movement between the first portion and the second portion or between the first portion and the dose dial grip. The processor may be further connected to at least a second sensor arrangement which may be configured to detect a relative rotational movement between the first portion and the dose button or a component part rotationally coupled to the dose button. If the processor is configured to determine the amount of dose dispensed based on the relative rotational movement detected by the sensor arrangement and based on the relative rotational movement detected by the second sensor arrangement, the electronic monitoring of the rotation of the dial grip and the dose button permits to more accurately calculate the size of the dose delivered. In more detail, any rotation of the second portion of the module relative to the first portion inadvertently caused by a user during dose dispensing may be detected and adjusted in the determination of the size of the dose delivered. Thus, a detection of the size of the dose delivered by the processor based on the relative rotations detected by both sensors is likely to be identical to the actual relative rotation of the dial grip to the housing with a rotation angle of the dial grip to the housing being related to the amount of dose dispensed.

[0035] According to a further independent aspect of the present disclosure, the sensor arrangement comprises at least one light source and at least one optical sensor configured to generate a signal, e.g. voltage signal, based on detection of light, e.g. light reflected or interrupted by an encoder surface of the first portion, the second portion or the dose dial grip. For example, the sensor arrangement may comprise at least two light sources and at least two optical sensors, each configured to generate a voltage signal based on detection of light reflected from an encoder surface, e.g. a ring of encoder flag segments distributed about an inwardly facing cylindrical surface, of the first portion.

[0036] An encoder surface may be any surface or arrangement which has portions of a higher reflectivity and portions of a lower reflectivity, or alternatively which has portions of a higher light transmission and portions of a lower light transmission. For example, one or more reflective type sensor(s) may be used together with regions of reflectivity and absorption present on the target component(s). In more detail, the first portion of the module may comprise regions of reflectivity and regions of absorption as encoder regions wherein the at least one optical sensor is configured and arranged to sense the regions of reflectivity. More specifically, a series of first encoder flag segments may be made from black material and a series of second encoder

[0037] 3. Dezember 2025 S 100 P 555 WO flag segments may be made from white material. Additionally, or alternatively, the encoder flag segments may comprise different surface finishes to increase or decrease reflectivity. The encoder flag segments may for example be twin-shot molded. The sensor arrangement may be part of and / or located on the second portion and the first portion may comprise an encoder surface, e.g. an encoder ring facing radially inwards towards the sensor arrangement.

[0038] As an alternative, the sensor arrangement may comprises at least one optical flow sensor configured to detect the magnitude and direction of rotation from a surface e.g. of the dose button or a component part rotationally constrained to the housing. However, the use of these specific sensor implementations is not a limitation of the present disclosure. Rather, the sensors) could use any previously described optical arrangement of reflective targets and optical sensor types. Alternatively, different types of sensors could be used such as: accelerometers, gyroscopes, light sensors, sound sensors, pressure sensors, temperature sensors, proximity sensor, infrared sensor, ultrasonic sensor, colour sensor, humidity sensor, tilt sensor, optical flow sensors, magnetic / Hall effect sensor, radiation sensor, lidar, electrical current sensor, optical sensors, force / torque sensors, strain gauges, mechanical switches.

[0039] The electronic module may be configured such that it may be switched from a first state having lower energy consumption into a second state having higher energy consumption. This may be achieved by operation of the electronic module, especially by actuating the microswitch. The first state may be a sleeping mode and the second mode may be a detection and / or communication mode. As an alternative, an electronic control unit may issue a command, e.g. a signal, to another unit of the electronic dose recording system such that this unit is switched on or rendered operational.

[0040] According to one aspect, the electronic module may comprise a microswitch configured to be operated by axial movement of the second portion relative to the housing of the drug delivery device. Further, the operation of the microswitch may wake up electronic components of the electronic module and / or the drug delivery device. In other words, axial movement of the second portion in the distal direction may operate the microswitch. The microswitch may be electrically connected to electronic components arranged in the drug delivery device and / or the electronic module such as a display, a sensor arrangement, a wireless module configured to transmit and receive data or the like. Non-continuous activation of these electronic components may protect the electrical power source so that it lasts longer.

[0041] The electronic module may be or may comprise an electronic dose recording system for determining, storing and / or transmitting data indicative of at least a condition of the drug delivery

[0042] 3. Dezember 2025 S 100 P 555 WO device or its use. For example, the system may detect if the drug delivery device is switched between a dose setting mode and a dose dispensing mode and vice versa. In addition or as an alternative, the system may detect if a dose is set and / or if a dose is dispensed. Still further, the system may detect the amount of dose selected and / or the amount of dose dispensed.

[0043] The electronic module may further comprise a communication unit for communicating with another device, e.g. a wireless communications interface for communicating with another device via a wireless network such as Wi-Fi or Bluetooth, or even an interface for a wired communications link, such as a socket for receiving a Universal Series Bus (USB), mini-USB or micro- USB connector. Preferably, the electronic module comprises an RF, Wi-Fi and / or Bluetooth unit as the communication unit. The communication unit may be provided as a communication interface between the electronic module and the exterior, such as other electronic devices, e.g. mobile phones, personal computers, laptops and so on. For example, dose data may be transmitted by the communication unit to the external device. The dose data may be used for a dose log or dose history established in the external device. Generally, data from the sensors may be processed either in electronics or software of the module itself, so that dose information can be presented to the user or HCP, such as whether a dose event has occurred, the time when it occurred, and the dose size. This information may be presented on an external device such as a mobile device or computer or might be presented on the module itself.

[0044] In a further aspect, the object may be solved by method for recharging the electrical energy storage of an electronic module comprising the steps of providing an assembly as defined above, moving the actuation member relative to the housing during dose setting and / or dose dispensing such that the first component and the second component of the electrical generator perform a relative movement, thereby transducing mechanical energy into electrical energy, and recharging the energy storage with the electrical energy produced by the electrical generator during dose setting and / or dose dispensing. Again, it is advantageously at least one of the movements occurring during operation of the drug delivery device, e.g. dose setting and / or dose dispensing, which simultaneously results in recharging the energy storage by means of the electrical generator.

[0045] 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

[0046] 3. Dezember 2025 S 100 P 555 WO 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.

[0047] 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.

[0048] 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., short- or 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 dual-chamber 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 dualchamber 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.

[0049] 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

[0050] 3. Dezember 2025 S 100 P 555 WO described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (anti-diabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition. Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipep- tidyl 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.

[0051] 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.

[0052] 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-pal- mitoyl-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-carbox- yheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0053] 3. Dezember 2025 S 100 P 555 WO Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lix- isenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Victoza®), Semag- lutide, 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, GRMD-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.

[0054] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cho- lesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

[0055] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.

[0056] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Fol litropi n, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0057] 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.

[0058] 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

[0059] 3. Dezember 2025 S 100 P 555 WO (TBTI) and / or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).

[0060] 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, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0061] 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.

[0062] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sari- lumab), and anti IL-4 mAb (e.g., Dupilumab).

[0063] 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.

[0064] Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof. An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608-1 :2014(E),

[0065] 3. Dezember 2025 S 100 P 555 WO needle-based 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.

[0066] 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).

[0067] 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).

[0068] The terms “axial”, “radial”, or “circumferential” as used herein may be used with respect to a longitudinal axis of the electronic module, the first portion, the second portion, the drug delivery device, the cartridge, the housing, the cartridge holder or the assembly of the drug delivery device and the electronic module, e.g. the axis which extends through the proximal and distal ends of the cartridge.

[0069] "Distal" is used herein to specify directions, ends or surfaces which are arranged or are to be arranged to face or point towards dispensing end of the drug delivery device and / or point away from, are to be arranged to face away from or face away from the proximal end. The dispensing end may be the needle end where a needle unit is or is to be mounted to the device, for example. On the other hand, “proximal” is used to specify directions, ends or surfaces which are arranged or are to be arranged to face away from or point away from the dispensing end and / or from the distal end of the electronic module or the drug delivery device or components thereof. Furthermore, when the electronic module is considered alone, the term "distal" may be used with regard to the more distal end of the electronic module, which is located closer to the dispensing end of the drug delivery device when attached to the drug delivery device, and the term "proximal" may be used with regard to the proximal end of the electronic module,

[0070] 3. Dezember 2025 S 100 P 555 WO which is located further away from the dispensing end of the drug delivery device when attached to the drug delivery device.

[0071] In the following, non-limiting, examples of the assembly of the drug delivery device and the electronic module are described in more detail by making reference to the drawings, in which:

[0072] Figure 1 shows a drug delivery device;

[0073] Figure 2 shows a partial cross section of an assembly according to a first example of the present disclosure;

[0074] Figure 3 shows a partial cross section of an assembly according to a second example of the present disclosure;

[0075] Figure 4 shows a partial cross section of an assembly according to a third example of the present disclosure; and

[0076] Figure 5 shows a sectional view of an assembly according to a fourth example of the present disclosure.

[0077] In the Figures, identical elements and components as well as identical elements and components in different examples or embodiments, i.e. elements and components acting identical or provided for the same purposes but belong to different examples, are provided with the same reference signs. An assembly according to the present disclosure comprises a drug delivery device 1 , an electronic module 2 and an electrical generator 3.

[0078] Figure 1 shows an exploded view of an exemplary medicament or drug delivery device 1. The drug delivery device 1 is a pen-type injector comprising a housing 10 in which a drive mechanism for dose setting and dose dispensing is arranged. The drug delivery device 1 extends from a distal point D to a proximal point P to a distal direction D along a longitudinal axis I of the drug delivery device 1. In order to set a dose for delivery a user may rotate or dial a dose dial grip 12 with respect to the housing 10, wherein the dose dial grip 12 is arranged at a proximal end of the housing 10. Thus, the dose dial grip 12 is an actuation member operable by a user. During dose setting the dose dial grip 12 may perform a helical movement, i.e. a combined axial and rotational movement, or may perform pure rotational movement. Further, the dose dial grip 12 rotates back during dose dispensing.

[0079] 3. Dezember 2025 S 100 P 555 WO The drive mechanism of the drug delivery device 1 may comprise e.g. a plunger, a drive sleeve, a clutch, a clutch spring, a number sleeve and / or a last dose nut which may move during dose setting and / or dose dispensing. Although these components are not shown in detail, for example, the drive mechanisms disclosed in EP 1 570 876, EP 2 814 547, US 9,937,294 B2 or WO 2004 / 078239 A1 represent suitable drive mechanisms for the present disclosure.

[0080] Once the dose is set by means of the dose dial grip 12, the user may press a dose button 11 arranged at the proximal end of the drug delivery device 1 in the distal direction in order to dispense the dose. When pressing the dose button 11 , the user applies a force moving the dose button 11 in the distal direction of the pen and parallel to the longitudinal axis I. This axial movement of the dose button 11 releases the drive mechanism for example by de-coupling a number sleeve from the drive sleeve, wherein irrespective of which component of the drug delivery device 1 performs a rotational movement during dose delivery, the dose dial grip 12 is coupled to a respective component in order to perform a rotational movement during dose delivery.

[0081] This rotational movement of the dose dial grip 12 during dose dispensing may be used to determine, for example, the actual dose delivered by means of an electronic module 2 as shown in Figures 2 to 4 and described here below.

[0082] The exemplary drug delivery device 1 shown in Figure 1 comprises in addition to the dose dial grip 12 and the dose button 11 an optional dosage window 13, a container 14, and a needle 15. The set dose may be displayed via the dosage window 13. The container 14 may be filled directly with a drug, for example, insulin or may be configured to receive a cartridge and thus act as a cartridge holder. The needle 15 may be affixed to the container or the receptacle. During dose dispensing the drug is dispensed through the needle 15. The needle 15 may be protected by an inner needle cap 16. In addition, the needle 15 may be protected by either an outer needle cap 17 or another cap 18.

[0083] In order for an electronic module 2 to be functionally attached to a drug delivery device 1 , i.e. attached and usable, either the drug delivery device 1 can be adapted to the electronic module 2 or, conversely, the electronic module 2 can be adapted to the drug delivery device 1. Regardless of this, the drug delivery device 1 as well as the electronic module 2 may have different examples, wherein the further description with respect to the drug delivery device 1 essentially deals with the dose button 11 and the dose dial grip 12.

[0084] 3. Dezember 2025 S 100 P 555 WO Figures 2 to 4 only show a proximal portion of the drug delivery device 1 together with the electronic module 2 and the electrical generator 3 in partially sectional views. The electronic module 2 may be an add-on module adapted to be permanently or releasably attached to the drug delivery device 1 as depicted or may be a module built into the drug delivery device 1.

[0085] The module 2 comprises a casing with a first portion 20 and a second portion 21. The first portion 20 is coupled to the dial grip 12 of the drug delivery device 1 such that rotation of the first portion 20 is transmitted to the dial grip 12. The second portion 21 is retained in the first portion 20 but can be displaced axially with respect to the first portion 20 for a limited distance. A chassis 22 is part of the second portion 21 and retains an energy storage 23, e.g. a rechargeable battery or a capacitor, and a printed circuit board assembly (PCBA) with a sensor 24 and a processor 25. The chassis 22 abuts the proximal end face of the dose button 11 of the drug delivery device 1 such that axial movement of the second portion 21 in the distal direction is transmitted via the chassis 22 to the dose button 11.

[0086] In Figures 2 to 4, a first component of the electrical generator 3, e.g. an induction coil, is indicated with reference numeral 30 and a second component, e.g. a magnet, is indicated with reference numeral 31. It should be understood that the induction coil and the magnet may be exchanged, i.e. a magnet could be provided at the position of reference numerals 30 and a coil could be provided at the positions of reference numeral 31. The induction coil 30 and the magnet 31 together form the electrical generator 3 which is electrically connected or connectable to the energy storage 23 of the module 2.

[0087] In the example depicted in Figure 2, the first component 30 of the electrical generator 3 is integrated in a component part of the drug delivery device 1 , e.g. a clutch sleeve or drive sleeve, which is rotationally constrained to the housing 10 at least during dose setting or during dose dispensing and the second component 31 of the electrical generator 3 is integrated in the first portion 20 of the module 2. As the dial grip 12 and the first portion 20 of the module 2 rotate during dose setting and during dose dispensing relative to the housing 10 and as the first component 30 of the electrical generator 3 is motion-linked to the housing 10 of the drug delivery device 1 and that the second component 31 of the electrical generator 3 is motion- linked to the actuation member 12 of the drug delivery device 1 , a relative rotation between the first component 30 and the second component 31 of the electrical generator 3 occurs during dose setting and / or dose dispensing, thereby generating electrical energy which is used to recharge the energy storage 23 of the module 2.

[0088] 3. Dezember 2025 S 100 P 555 WO In the example depicted in Figure 3, the first component 30 of the electrical generator 3 is integrated in the housing 10 of the drug delivery device 1 and the second component 31 of the electrical generator 3 is interposed in an annular gap between the housing 10 and a number sleeve which is rotationally constrained to the dial grip 12. The second component 31 is rotationally constrained to the dial grip 12 and may be axially constrained to the housing 10 such that it only rotates without axial translation. As the dial grip 12 rotates during dose setting and during dose dispensing relative to the housing 10, a relative rotation between the first component 30 and the second component 31 of the electrical generator 3 occurs during dose setting and dose dispensing, thereby generating electrical energy which is used to recharge the energy storage 23 of the module 2. In more detail, the second component 31 of the generator may be placed inside the number sleeve and rotationally constrained with it such that component 31 rotates together with number sleeve but doesn’t move axially. Electric connections may be placed inside number sleeve and may end with two metal contacts / plates on the flat surface of the dose button 11. The module 2 may have corresponding counterpart contacts to supply energy generated in generator 3 to energy storage 23 of the module 2.

[0089] In the example depicted in Figure 4, the first component 30 of the electrical generator 3 is integrated in the dose button 11 which is rotationally constrained to the housing 10 of the drug delivery device 1 during dose dispensing and the second component 31 of the electrical generator 3 is integrated in the dial grip 12. As the dial grip 12 rotates during dose setting and during dose dispensing relative to the housing 10, a relative rotation between the first component 30 and the second component 31 of the electrical generator 3 occurs during dose dispensing, thereby generating electrical energy which is used to recharge the energy storage 23 of the module 2.

[0090] While Figures 2 to 4 depict examples in which at least one of the components of the electrical generator 3 is integrated into a component part of the drug delivery device 1 , the first component 30 and the second component 31 can be both provided in or on component parts of the module 2, e.g. on the first portion 20 which rotates during dose setting and during dose dispensing with the dial grip 12 and on the second portion 21 which may be rotationally constrained to the dose button 11 or which may not rotate due to internal frictions during dose dispensing such that a relative rotation occurs at least during dose dispensing.

[0091] In the examples depicted in Figures 2 to 4, the dial grip 12 of the drug delivery device 1 is an actuation member operable by a user which is motion linked to one of the components of the electrical generator 3. However, other designs of the drug delivery device 1 may result in other component parts of the drug delivery device 1 , e.g. button 11 , being the actuation member

[0092] 3. Dezember 2025 S 100 P 555 WO motion linked to one of the components of the electrical generator 3. In still further alternatives of the drug delivery device 1 , the button 11 and the dial grip 12 may be one single component part which then forms an actuation member operable by a user and motion linked to one of the components of the electrical generator 3.

[0093] Further, while the examples depicted in Figures 2 to 4 depict the electrical generator 3 as a dynamo transducing mechanical energy caused by relative rotation into electrical energy, the electrical generator 3 may transduce mechanical energy caused by relative axial movement or a combined rotational and axial movement into electrical energy.

[0094] Figure 5 shows a further example which is similar to that of Figure 2, however on the basis of a different drug delivery device 1 , e.g. a drug delivery device as disclosed in WO 2014 / 033195 A1. Unlike the examples of Figures 2 to 4, this drug delivery device 40 comprises a dose dial grip 41 operable during dose setting and during dose dispensing without an additional dose button. This dose dial grip 41 is rotatable with respect to a housing component 42 to set a dose and which is rotationally constrained to the housing 42 but may be pushed (displaced) axially thereto during dose dispensing. Further, a dial sleeve 43 which may carry numbers or the like indicia of a dose display is arranged in the housing 42 to be rotatable during dose setting and during dose dispensing. Thus, a relative rotation between the dose dial grip 41 and the dial sleeve 43 occurs during dose dispensing. An electronic module 2 may be attached to the dose dial grip 41 to be rotationally constrained to the dose dial grip 41.

[0095] An electrical generator 3 is provided by a coil 30 connected to a not shown energy storage of the module 2 and a magnet 31 which is part of or rotationally constrained to the dial sleeve 43. As the coil 30 is provided in the module 2 it is rotationally stationary during dose dispensing while the magnet 31 rotates with the dial sleeve 43, so electrical energy is being generated in electrical generator 3.

[0096] 3. Dezember 2025 S 100 P 555 WO Reference Numerals

[0097] 1 drug delivery device

[0098] 2 electronic module

[0099] 3 electrical generator

[0100] 10 housing

[0101] 11 dose button

[0102] 12 dose dial grip

[0103] 13 display window

[0104] 14 container

[0105] 15 needle

[0106] 16 inner needle cap

[0107] 17 outer needle cap

[0108] 18 cap

[0109] 20 first portion

[0110] 21 second portion

[0111] 22 chassis

[0112] 23 energy storage

[0113] 24 sensor

[0114] 25 processor (printed circuit board assembly I PCBA)

[0115] 30 coil

[0116] 31 magnet

[0117] 41 dose dial grip

[0118] 42 housing

[0119] 43 dial sleeve

[0120] D distal end

[0121] P proximal end

[0122] I longitudinal axis

[0123] 3. Dezember 2025 S 100 P 555 WO

Claims

Claims1. An assembly of a drug delivery device (1) and an electronic module (2), wherein the drug delivery device (1) comprises a housing (10, 42) with a longitudinal axis (I) and an actuation member (11 , 12, 41) which is axially and / or rotationally moveable with respect to the longitudinal axis (I) of the housing (10, 42) during dose setting and / or dose dispensing, wherein the electronic module (2) comprises a rechargeable electrical energy storage (23), a sensor arrangement (24) configured to detect a relative movement between the housing (10) and the actuation member (11 , 12), and a processor (25) connected to the energy storage (23) and to the sensor arrangement (24) and configured to determine a status of the drug delivery device (1) and / or a dose amount based on the movement detected by the sensor arrangement (24), and wherein the drug delivery device (1) and / or the electronic module (2) further comprises an electrical generator (3) with at least a first component (30) and at least a second component (31) which are movable relative to each other, and which are configured to transduce mechanical energy caused by the relative movement into electrical energy, characterized in that the first component (30) of the electrical generator (3) is motion-linked to the housing (10) of the drug delivery device (1) and that the second component (31) of the electrical generator (3) is motion-linked to the actuation member (11 , 12, 41) of the drug delivery device (1) and that the electrical generator (3) is electrically connectable to the rechargeable electrical energy storage (23) of the electronic module (2).

2. The assembly according to claim 1 , wherein the first component (30) comprises one of an induction coil or a magnet and the second component (31) comprises one of a magnet or an induction coil.

3. The assembly according to any one of the preceding claims, which is a dynamo or an alternator with a semiconductor rectifier.

4. The assembly according to any one of the preceding claims, wherein the energy storage (23) comprises a rechargeable battery or a capacitor.

5. The assembly according to any one of the preceding claims, wherein the sensor arrangement (24) comprises a at least one light source and at least one optical sensor configured to generate a signal based on detection of light reflected or interrupted by an encoded surface.

3. Dezember 2025 S 100 P 555 WO6. The assembly according to any one of the preceding claims, wherein the first component (30) is integrated in or coupled to the housing (10, 42) and wherein the second component (31) is integrated in or coupled to the actuation member (11 , 12, 41).

7. The assembly according to any one of the preceding claims, wherein the first component (30) is integrated in or coupled to the housing (10, 42) and wherein the second component (31) is arranged interposed between the housing (10, 42) and the actuation member (11 , 12, 41) and rotationally constrained to the actuation member (11 , 12, 41).

8. The assembly according to any one of the preceding claims, wherein the energy storage (23), the sensor arrangement (24) and / or the processor (25) are integrated in or permanently coupled to the drug delivery device (1).

9. The assembly according to any one of claims 1 to 7, wherein the energy storage (23), the sensor arrangement (24) and / or the processor (25) are integrated in a casing (20, 21 , 22) of the electronic module (2) configured to be coupled to the drug delivery device (1).

10. The assembly according to claim 9, the electronic module (2) further comprising a first portion (20) and a second portion (21), wherein the first portion (20) is configured for, e.g. releasable, attachment to the actuation member (11 , 12) of the drug delivery device (1) such that the first portion follows movement of the actuation member (11 , 12, 41) and vice versa when attached to the drug delivery device, and wherein the second portion (21) is coupled to the first portion (20) allowing relative rotational movement and relative axial movement with respect to the first portion (20).

11. The assembly according to claim 12, wherein the first component (30) is integrated in or coupled to the housing (10, 42) and wherein the second component (31) is integrated in or coupled to the first portion (20) or wherein the first component (30) is integrated in or coupled to the second portion (21) and wherein the second component (31) is integrated in or coupled to the first portion (20).

12. The assembly according to any one of the preceding claims, wherein the actuation member (12) of the drug delivery device comprises a dose dial grip (12) at least rotationally moveable about the longitudinal axis (I) of the housing during dose dispensing.

3. Dezember 2025 S 100 P 555 WO13. The assembly according to any one of the preceding claims, wherein the actuation member (11) of the drug delivery device comprises a dose button (11) or dial grip (41) at least axially moveable parallel to the longitudinal axis (I) of the housing for causing dose dispensing.

14. The assembly according to any one of the preceding claims, wherein the drug delivery device comprises a container (15) configured to receive a drug or a cartridge filled with a drug.

15. Method for recharging the electrical energy storage (23) of an electronic module (2) comprising the steps:• providing an assembly according to any one of claims 1 to 14,• moving the actuation member (11 , 12, 41) relative to the housing (10, 42) during dose setting and / or dose dispensing such that the first component (30) and the second component (31) of the electrical generator (3) perform a relative movement, thereby transducing mechanical energy into electrical energy,• recharging the energy storage (23) with the electrical energy produced by the electrical generator (3) during dose setting and / or dose dispensing.

3. Dezember 2025 S 100 P 555 WO

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