Assembly for drug delivery device

Abstract

1. An assembly (1) for a drug delivery device, comprising: a housing unit (2) for receiving a reservoir and a dispensing mechanism configured to dispense liquid drug contents from the reservoir during a dispensing operation; a cap (3) releasably coupled to the housing unit (2); a first information feature (4) having a coded first content; and a second information feature (5), wherein the first information feature (4) is visible and / or machine-readable when the cap (3) is coupled to the housing unit (2) and is removable together with the cap (3) from the housing unit (2) or becomes unreadable when the cap (3) is detached from the housing unit (2); the dispensing mechanism has two distinct states: a first state in which the dispensing mechanism is in a ready-to-dose state and a second state in which the dispensing mechanism is in a dispensed state; and the second information feature (5) is invisible in the first state and visible in the second state.

Description

[Technical field]

[0001] The present disclosure relates to assemblies, for example for drug delivery devices. [Background technology]

[0002] Portable or carry-on drug delivery devices are often used in emergency situations where there is little time to administer a saving dose of drug to a patient. A frequent alternative use is self-administration by a patient, e.g., a patient without medical training. Therefore, unintentional use of a used drug delivery device can have devastating consequences for the patient's health. It is therefore desirable to provide a drug delivery device whose appearance clearly distinguishes between used and unused states. Summary of the Invention [Problem to be solved by the invention]

[0003] Drug delivery devices are known in the prior art, and whether the device has been used can be determined by a thorough external inspection. Sometimes, investigators must visually inspect remote devices or small features to determine whether the device has been used. However, even such drug delivery devices offer little security. Since the evaluation of such drug delivery devices is time-consuming, especially when the number of drug delivery devices is large, the examination can quickly tire out the investigators entrusted with the evaluation, which of course significantly increases the risk of incorrect evaluation by the investigators. [Means for solving the problem]

[0004] It is an object of the present invention to provide an improved assembly for a drug delivery device. Preferably, an assembly should be provided which makes it easy to determine whether the device has been used.

[0005] According to the present invention, an assembly for a drug delivery device is provided, comprising a housing unit and a cap releasably coupled to the housing unit, the housing unit comprising a housing for receiving a reservoir and a dispensing mechanism configured to dispense liquid drug contents from the reservoir during a dispensing operation, the cap at least partially covering a distal dispensing end of the assembly when coupled to the housing unit and uncovered when the cap is detached from the housing unit. The cap is coupled to the housing of the housing unit, for example, by a snap feature. The assembly further comprises a first information feature having a coded first content, the first information feature being machine readable to read the first content from the first information feature. The assembly may comprise a second information feature, for example, machine readable. The first information feature is visible and / or machine readable when the cap is coupled to the housing unit and can be removed with the cap from the housing unit or is unreadable when the cap is detached from the housing unit. The dispensing mechanism can have two different states: a first state in which the dispensing mechanism is in a ready-to-dispense state, and a second state in which the dispensing mechanism is in a dispensed state. The second information feature is invisible in the first state and visible in the second state. The assembly can be a drug delivery device. When the reservoir is disposed in the housing, the assembly can be a drug delivery device ready to dispense the contents of the reservoir from the device. In the assembly, the reservoir can be received or not received in the housing. The reservoir can be a syringe, for example a pre-filled syringe.

[0006] In the context of the present disclosure, the term "distal dispensing end" may refer to an end region of the assembly designed to be directed or abut a target surface, e.g., a skin portion of a patient, during a dispensing operation. The term "dispensing operation" may conveniently refer to a process that the dispensing mechanism performs to dispense a drug from a reservoir of the assembly by operation of the dispensing mechanism. The drug is administered, e.g., via a needle, into a subcutaneous area of ​​the patient. The dispensing mechanism is spring-driven. The drug delivery device may be a disposable device that is discarded after the reservoir is emptied. The device may be a single-use device that is discarded after performing only one dispensing operation to dispense a single dose.

[0007] In the context of this disclosure, the term "ready to dispense" can refer to the state of the assembly before a dispensing operation is commenced or initiated. In this state, the reservoir can be disposed within the housing or not. In the latter case, the dispensing mechanism performs the movements necessary for the dispensing operation but does not dispense liquid medication from the device.

[0008] In the context of the present disclosure, the term "dosed state" can mean the state after a dosing operation, preferably after the first or last dosing operation that the dosing mechanism is designed to perform in case multiple operations are possible. The assembly is configured to perform a single dosing operation or multiple dosing operations.

[0009] In the context of this disclosure, the term machine-readable can mean a structure or a function that conveys information, preferably coded information. To read the information, the structure is subjected to a reading procedure, preferably using a reader device. For example, the structure is scanned by the reader device. The reader device may be an optical reader, for example one that utilizes a light source, preferably a monochromatic light source, such as a semiconductor-based, LED or semiconductor laser, for the scanning procedure. The light can be visible light and / or have a specific color, for example red. To read the information from the structure, a decoding procedure may be required. In other words, without the decoding procedure, the information cannot be read. The decoding procedure is performed either in the reader device or in a processor device, for example a workstation, server, or PC, operably connected to the reader device. The decoded information is displayed to the user on a display.

[0010] The above-mentioned assembly further provides an assembly for a drug delivery device that allows a clear and rapid detection and / or differentiation between a ready-to-dose state and a dosed state, for example by the visibility or non-visibility of the second and / or first information features. The first information feature is coupled to the cap, so that differentiation is possible even when the cap is removed. The first and preferably second information features are further machine-readable, so that even large quantities of drug delivery devices can be quickly and reliably identified. This significantly reduces the risk of attempting to use or reuse an assembly in a dosed state.

[0011] In a preferred embodiment, the first content encoded in the first information feature is capable of indicating a first state of the dispensing mechanism.

[0012] In a preferred embodiment, the second information feature is capable of indicating a second state of the dispensing mechanism.

[0013] Thus, based on the information content of the information feature, it can be determined, for example, whether an assembly has been used.

[0014] In a preferred embodiment, the second information feature may have second content encoded therein, and is preferably machine readable to read the second content from the second information feature.

[0015] Because the second information feature is machine readable, even large quantities of drug delivery devices can be quickly and reliably identified, which significantly reduces the risk of using a pre-dosed drug delivery device.

[0016] In a preferred embodiment, a first coded content of the first information function may indicate a first state of the dispensing mechanism and / or a second coded content of the second information function may indicate a second state of the dispensing mechanism.

[0017] It is therefore possible to determine whether an assembly has been used based on the information content of the information function, although a decoding procedure may need to be performed to obtain the respective information.

[0018] In a preferred embodiment, the assembly may include a movable member. The second information feature is disposed on the movable member. The movable member may be in a first position, e.g., relative to the housing, when the dispensing mechanism is in a first state. The movable member may be in a second position, e.g., relative to the housing, when the dispensing mechanism is in a second state. The first position may be different from the second position. The movable member is configured or movable to move from a first position to a second position when the liquid drug contents from the reservoir are dispensed in a dispensing operation and / or after the dispensing operation is completed. The movable member may be a member of the dispensing mechanism that moves during the dispensing operation and / or a member that moves after the dispensing operation is completed. In the first position of the movable member, the second information feature is covered by the housing, which is preferably opaque. In the second position, the movable member is visible, e.g., because it protrudes from the housing or is aligned with a window or window portion provided in the housing.

[0019] For example, by providing the second information feature on the movable member, by attaching the second information feature to the member, it can be ensured that the second information feature is only visible when the dispensing operation has been completed.

[0020] In a preferred embodiment, the movable member can be a plunger configured to or configured to expel liquid drug contents from the reservoir to the distal dispensing end of the assembly during a dispensing operation. Movement of the plunger can expel the liquid drug from the dispensing end. The housing can include a window portion. The second information feature and / or the plunger can be visible through the window portion in a second state of the dispensing mechanism and cannot be seen through the window portion in a first state of the dispensing mechanism. The plunger can be part of the dispensing mechanism.

[0021] If the second information feature is located on the plunger, it may be readily visible to a user and / or reliably readable in the second condition.

[0022] In a preferred embodiment, the movable member is a needle cover. The needle cover is arranged to cover the needle of the assembly, preferably after the dosing operation is completed. The needle cover can be movably connected to the housing and / or be part of the housing unit. In a first state, the needle cover can protrude from the housing. The needle cover can move towards the housing to initiate the dosing operation. The needle cover is configured to move, for example by a spring, relative to the housing and / or to a second position after the dosing operation is completed. During dosing, the needle can be displaced relative to the housing. Preferably, the needle cover covers the needle at least after the dosing operation is completed and the assembly is removed from the user. In this position, the needle cover can protrude further from the housing than before the injection is started.

[0023] One advantage of the needle cover is that it both protects the needle from damage and the user from injuries due to accidental touching of the needle. Preferably, the needle cover fulfills this function in the ready-to-dose and / or dosed states. By attaching a second information function to the needle cover, the two effects can be combined. On the one hand, it is achieved that the second information function is only visible in the second state, when the assembly is in the dosed state, for example by the needle cover protruding further from the housing after the operation is completed than in the first state. On the other hand, in the second state, it is ensured that the user is protected from needle sticks and / or needle stick injuries. The needle cover preferably does not move to the second position until the assembly is lifted from the target surface (e.g., skin part).

[0024] In a preferred embodiment, the movable member can be a syringe or a cartridge. The syringe can include a needle. The syringe can be a pre-filled syringe. The cartridge is needleless and can be moved into fluid communication with the needle during a dispensing operation.

[0025] In a preferred embodiment, the movable member can be a trigger member configured to be actuated to trigger or initiate a dispensing operation. To trigger a dispensing operation, the trigger member can be moved relative to the housing away from an initial position, e.g., to a first position. When pressure on the trigger member is released, the trigger member can be moved, e.g., by a spring in the trigger member, back to the initial position, preferably beyond the initial position, to a second position. In the second position, the trigger member can protrude further from the housing than in the initial position. Since it is no longer covered by the housing, a second information function is arranged in that area of ​​the trigger member that is now uncovered. The trigger member can be a trigger button.

[0026] In a preferred embodiment, the needle cover can function as a trigger member.

[0027] In a preferred embodiment, the first information feature is permanently altered when the cap is removed, for example by removing the cap from the housing, such that after removal of the cap the encoded first content can preferably no longer be read from the altered first information feature, even if the cap is reattached to the housing.

[0028] Reattaching the cap to the housing after a dispensing operation may give the erroneous impression that the assembly is still ready to dispense. By permanently changing the first information feature, for example by at least partially or completely destroying the first information feature when removing the cap, for example by tearing the label on which the feature resides, erroneous determinations regarding the current state of the device can be avoided. The inability to read can be an (additional) indicator of the state of the assembly.

[0029] In a preferred embodiment, the assembly may include an information carrier coupled to the cap and / or housing unit, the first information feature being preferably at least partially or completely arranged on the information carrier. For example, an information carrier configured as a ring may establish a connection between the cap and the housing. In this way, the information carrier may function as a connector.

[0030] Attaching the first information feature to the information carrier may be cheaper than, for example, engraving or etching the first information feature into a surface of the cap and / or housing unit.

[0031] In a preferred embodiment, the information carrier may be encapsulated.

[0032] The information carrier may thus function to seal the interface between the cap and the housing unit when the cap is connected to the housing unit.

[0033] In a preferred embodiment, at least one of the first and second information features, or both information features, may include or be a two-dimensional barcode.

[0034] Barcodes can help eliminate the possibility of human error during information reading. Scanning of barcodes is fast and reliable. Furthermore, using a barcode system reduces the training time of the person responsible for identifying drug delivery devices.

[0035] In a preferred embodiment, at least one of the first and second information features, or both information features, is a QR code. (Registered Trademark) or a QR code (Registered Trademark) It can be.

[0036] QR Code (Registered Trademark)The QR code can be scanned with a smartphone or any other phone with scanning capabilities. (Registered Trademark) is highly versatile and can encode almost any kind of data, including numbers, alphabets, special characters and binary. (Registered Trademark) can be scanned extremely quickly, which is particularly beneficial when large numbers of drug delivery devices need to be scanned.

[0037] In a preferred embodiment, the assembly can be an autoinjector. The autoinjector can include a drive spring that can be part of the dispensing mechanism, such as moving a plunger relative to the housing. The autoinjector can be a single-dose injector, i.e. a device that is used only once to deliver a single dose. Here, information about the current state of the mechanism is particularly advantageous.

[0038] Autoinjectors are easy to use and well suited for self-administration by the patient or for administration by untrained personnel.

[0039] Embodiments will now be described, by way of example only, with reference to the accompanying drawings, in which: [Brief description of the drawings]

[0040] [Figure 1A] FIG. 1 is a schematic side view of an autoinjector with a cap attached to a housing unit of the autoinjector according to a first embodiment of the present invention. [Figure 1B] FIG. 1B is a schematic side view of the autoinjector of FIG. 1A with the cap removed from the housing unit. [Figure 2A] FIG. 11 is a schematic side view of an autoinjector with a cap attached to a housing unit of the autoinjector according to a second embodiment of the present invention. [Figure 2B] FIG. 2B is a schematic side view of the autoinjector of FIG. 2A with the cap removed from the housing unit. [Figure 3A] FIG. 13 is a schematic side view of a housing unit of an autoinjector according to a third embodiment of the present invention in a ready-to-administer state. [Figure 3B] FIG. 3B is a schematic side view of the housing unit of FIG. 3A in a dispensed state. [Figure 4A] FIG. 11 is a schematic side view of a housing unit of an autoinjector according to a fourth embodiment of the present invention in a ready-to-administer state. [Figure 4B] FIG. 4B is a schematic side view of the housing unit of FIG. 4A in a dispensed state. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0041] The drug delivery devices described herein are configured to inject a drug into a patient. For example, delivery can be subcutaneous, intramuscular, or intravenous. Such devices can be operated by the patient or a caregiver such as a nurse or doctor, and can include various types of safety syringes, pen injectors, or autoinjectors.

[0042] The autoinjector can include a drive spring that can be part of the dispensing mechanism, such as moving a plunger relative to the housing. The autoinjector can be a single-dose injector, e.g., a device that is used only once to deliver a single dose.

[0043] The devices can include cartridge-based systems that require puncturing a sealed ampoule prior to use. The amount of drug delivered using these various devices can range from about 0.5 ml to about 2 ml. Yet other devices can include large volume devices ("LVD") or patch pumps that are configured to deliver a "large" amount of drug (usually about 2 ml to about 10 ml) upon attachment to a patient's skin for a period of time (e.g., about 5 minutes, about 15 minutes, about 30 minutes, about 60 minutes, or about 120 minutes).

[0044] The devices described herein can also be customized to operate within required specifications in combination with a particular drug. For example, the device can be customized to inject the drug within a certain period of time (e.g., about 3 to about 20 seconds for an autoinjector, about 10 to about 60 minutes for an LVD). Other specifications can include low or minimal levels of discomfort, or specific conditions related to human factors, shelf life, expiration date, biocompatibility, environmental considerations, etc. Such variables can result from a variety of factors, such as, for example, drugs in the viscosity range of about 3 cP to about 50 cP. As a result, drug delivery devices often include hollow needles ranging in size from about 25 gauge to about 31 gauge. Common sizes are 27 and 29 gauge.

[0045] The delivery device described herein may also include one or more automated features. For example, one or more of needle insertion, drug injection, and needle retraction may be automated. One or more energy sources provide energy for one or more automated steps. The energy sources may include, for example, mechanical, pneumatic, chemical, or electrical energy. For example, the mechanical energy sources may include springs, levers, elastomers, or other mechanical mechanisms for storing or releasing energy. One or more energy sources may be integrated into a single device. The device may further include gears, valves, or other mechanisms that convert energy into motion of one or more parts of the device.

[0046] The one or more automated features of the autoinjector are each activated via an activation mechanism. Such activation mechanisms may include one or more of a button, lever, needle sleeve, or other activation components. Activation of the automated feature may be a one-step or multi-step process. That is, the user may be required to activate one or more activation components to trigger the automated feature. For example, in a one-step process, the user may depress a needle sleeve or cover against the user's body to trigger injection of the medication. Other devices may require multi-step activation of the automated feature. For example, the user may be required to depress a button to retract a needle shield to trigger an injection.

[0047] Additionally, activation of an automated function may activate one or more subsequent automated functions, thereby forming an activation sequence. For example, activation of a first automated function may activate at least two of needle insertion, medication injection, and needle retraction. Additionally, some devices may require a specific sequence of steps to perform one or more automated functions. Other devices may operate in a sequence of independent steps.

[0048] Some delivery devices can include one or more features of a safety syringe, a pen injector, or an autoinjector. For example, a delivery device can include a mechanical energy source configured to automatically inject a medication (as typically found in an autoinjector) and a dose setting mechanism (as typically found in a pen injector).

[0049] According to some embodiments of the present disclosure, an exemplary assembly 1 for a drug delivery device is shown in Figures 1A, 1B, 2A, 2B, 3A, 3B, 4A, and 4B. Each of the exemplary assemblies 1 is configured to inject a drug into a patient's body, respectively. The assemblies 1 shown in Figures 1A, 1B, 2A, 2B, 3A, 3B, 4A, and 4B typically include a housing unit 2 including a housing that receives a reservoir and a dispensing mechanism and / or elements of the dispensing mechanism, such as a plunger and / or a spring, configured to dispense a liquid drug content from the reservoir during a dispensing operation, and a cap 3 releasably coupled to the housing 2 and at least partially covers a distal dispensing end of the assembly 1 when coupled to the housing unit 2 and is uncovered when the cap 3 is removed from the housing. The housing unit 2 of the illustrated assembly 1 further includes a cap 3 (not shown in FIGS. 3A, 3B, 4A and 4B), a first information feature 4 (not shown in FIGS. 3A, 3B, 4A and 4B) having a first coded content and being machine readable to read the first content from the first information feature 4, the coded first content of which indicates a first state of the dispensing mechanism in which the dispensing mechanism is in a ready-to-dose state, and a second information feature 5 (not shown in FIGS. 1A, 1B, 2A and 2B) indicating a second state of the dispensing mechanism in which the dispensing mechanism is in a dispensed state. Further, the second information feature 5 has a second coded content and is machine readable to read the second content from the second information feature 5, the coded second content of which can indicate a second state of the dispensing mechanism in which the dispensing mechanism is in a dispensed state. In addition to this, the housing unit 2 of the illustrated assembly 1 includes a window portion 7. Also, except for the embodiment of Figures 3A and 3B, the window portion 7 may be dispensed with.

[0050] To read out the information or content from the respective machine-readable information features, the structure can or must be subject to a reading procedure, preferably using a reader device. For example, the structure is scanned by the reader device. The reader device may be an optical reader, for example one that utilizes a light source, preferably semiconductor-based, such as a monochromatic light source, such as an LED or a semiconductor laser, for the scanning procedure. The light can be visible light and / or have a specific color, for example red. To read out the information from the structure, a decoding procedure may be required. In other words, without the decoding procedure, the information cannot be read out. The decoding procedure is executed either in the reader device or in a processor device, for example a workstation, server or PC, operably connected to the reader device. The decoded information is displayed to the user on a display.

[0051] In the illustrated embodiment of FIGS. 1A, 1B, 2A and 2B, the first information feature 4 is a QR code (Registered Trademark) which is disposed on the information carrier. The information feature is provided on a label or sticker attached to the information carrier or is integrated into the information carrier. The information carrier can be a rigid member or can be conformable to the outer surface of the cap and / or housing unit. However, other data representations, for example other variants of a barcode, preferably multi-dimensional, for example two-dimensional, can be suitable for the information feature. For example, an information carrier configured as a ring can establish a connection between the cap 3 and the housing 2. In this way, the information carrier can function as a connector. Alternatively or additionally, the information carrier can be a seal. In this case, the information carrier can serve to seal the contact surface between the cap 3 and the housing unit 2 when the cap 3 is connected to the housing unit 2.

[0052] Figures 1A and 1B show schematic side views of an assembly 1 according to a first embodiment of the invention, where a first information feature 4 is arranged on a surface of a cap 3. In Figure 1A, the cap 3 is attached to a housing unit 2, thus making the first information feature 4 visible and indicating a first state. In Figure 1B, the cap 3 has been removed from the housing unit 2. When the cap 3 is removed by the user, the remaining parts of the assembly 1 no longer contain any information that the dispensing mechanism of the assembly 1 is in the first state.

[0053] 2A and 2B show schematic side views of an assembly 1 according to a second embodiment of the invention, in which the first information feature 4 is arranged partly on the surface of the cap 3 and partly on the surface of the housing unit 2. In FIG. 2A, the cap 3 is attached to the housing unit 2, thus the first information feature 4 is visible and shows a first state. In FIG. 2B, the cap 3 is removed from the housing unit 2. By removing the cap 3 from the housing unit 2, the first information feature 4 is permanently destroyed, so that after removing the cap 3, the coded first content can no longer be read from the destroyed first information feature 4. If the information carrier extends along the intermediate region between the cap and the housing unit, for example in the circumferential direction (not explicitly shown), the sealing of the contact surface between the cap and the housing unit is improved.

[0054] In the aforementioned embodiments, the information carrier is preferably a compatible element, preferably a sticker or label, that is applied to the cap and / or to the housing unit.

[0055] In another non-illustrated embodiment, the information carrier can be a rigid member, for example a sleeve, or an elastic member, for example a rubber seal. The information carrier is arranged, for example clamped, between the cap and the housing or housing unit when the cap is directly connected to the housing or housing unit. The information carrier is connected to the cap via a positive connection, for example a snap-fit, and is also connected to the housing unit via a positive connection, for example a snap-fit. The connections between the information carrier and the housing unit and between the cap and the information carrier are designed to be incompatible, i.e. preferably the cap cannot be directly attached to the housing unit without an intermediate information carrier. To realize operability of the device, the information carrier has to be removed from the housing unit. The connection between the information carrier and the housing and / or between the cap and the information carrier is designed to be releasable only by changing at least one of the connecting features that engage with each other to establish the connection, so that after the connection has been released the connection cannot be established again. Thus, the information carrier and / or the information feature can be for indicating the drug contained in the reservoir. The label or sticker comprises the information feature, which is preferably exclusively arranged and / or connected to the information carrier.

[0056] Figures 3A and 3B show schematic side views of a housing unit 2 according to a third embodiment of the present invention. As in the fourth embodiment of the present invention shown in Figures 4A and 4B, the housing unit 2 of the third embodiment includes a needle 9 for delivering liquid drug contents from a reservoir in a dosing operation, a needle cover 6 protectively surrounding the needle 9, and a plunger 8 for expelling the liquid drug contents from the reservoir to the distal dosing end of the assembly 1 during a dosing operation. The plunger is part of the dosing mechanism.

[0057] Fig. 3A shows the third embodiment in a first state of the dispensing mechanism, where the dispensing mechanism is in a ready-to-dose state. As in the fourth embodiment in a first state of the dispensing mechanism, shown in Fig. 4A, the second information function 5 is not visible in the first state, i.e. when the dispensing operation has not been performed and / or started. However, the second information function 5 in the second state is visible in the third embodiment shown in Fig. 3B and in the fourth embodiment shown in Fig. 4B. As a result, the second function 5 is only visible when the dispensing mechanism is in a dispensed state after the dispensing operation.

[0058] In the embodiment shown in Figures 3A, 3B, 4A and 4B, the second information feature 5 is disposed on the movable members 6, 8, which are in a first position, e.g., relative to the housing (as shown in Figures 3A and 4A) when the dispensing mechanism is in a first state, and which are in a second position, e.g., relative to the housing (as shown in Figures 3B and 4B) when the dispensing mechanism is in a second state, and which move from the first position to the second position when liquid drug contents from the reservoir are dispensed in a dispensing operation or are dispensed from the reservoir.

[0059] In a third embodiment shown in Figures 3A and 3B, the movable member is a plunger 8. As shown in Figure 3B, the second information feature 5 and the plunger 8 are visible through the window portion 7 in the second state of the dispensing mechanism, and are not visible through the window portion 7 in the first state of the dispensing mechanism, as shown in Figure 3A. In this case, the reservoir, e.g. a syringe or cartridge, is securely held in the housing unit and cannot be moved during the dispensing operation that moves the plunger relative to the reservoir. Alternatively, the movable member can be a reservoir, such as a syringe or cartridge, which moves, e.g., relative to a stationary plunger, to dispense its contents. The syringe can be equipped with a needle 9. The syringe can be a pre-filled syringe. The cartridge is needleless and can be moved to be in fluid communication with the needle 9 during the dispensing operation.

[0060] In a fourth embodiment, shown in Figures 4A and 4B, the movable member is a needle cover 6, which is arranged to cover the needle 9 (not visible in Figures 4A and 4B) of the assembly 1 after a dosing operation is completed and / or before it is started. The needle cover 6 is movably connected to the housing and / or is part of the housing unit 2.

[0061] After activation of the dispensing mechanism, e.g., via a trigger member, operation of the dispensing mechanism results in dispensing of the liquid drug content. After the dispensing operation is completed and / or the assembly is lifted from the target surface (e.g., skin portion), the needle cover 6 moves distally, e.g., by a spring, from a first position as shown in FIG. 4A, where the second information feature is not visible, to a second position as shown in FIG. 4B, where the second information feature 5 is visible on the needle cover 6. For example, the needle cover 6 can function as a trigger member. In this case, the dispensing operation is triggered when the needle cover 6 is pressed against the target surface and the housing unit moves relative to the needle cover. This movement can activate the dispensing mechanism to perform the dispensing operation. Here, the needle cover 6 can protrude from the housing in the first state. The movement of the needle cover 6 towards the housing can initiate the dispensing operation and / or the needle can penetrate the target tissue or skin. The needle cover 6 is configured to move, e.g., by a spring, relative to the housing and / or to the second position after the dispensing operation is completed. During dosing, the needle 9 may be displaced or stationary relative to the housing. As shown in Figure 4B, the needle cover 6 covers the needle 9, at least after the dosing operation is completed and the assembly is removed from the user. In this position, the needle cover 6 protrudes further from the housing than before the injection begins, thereby revealing a second information function.

[0062] However, the needle cover does not have to function as a trigger member for initiating the dosing operation, as mentioned above. Rather, the assembly / device can include a separate trigger member, e.g. a trigger button, movable, e.g. depressable, by the user relative to the housing unit to trigger the dosing operation. To trigger the dosing operation, the trigger member can be moved, e.g. from an initial position to a first position, relative to the housing. When pressure on the trigger member is released, e.g. by the user, the trigger member can return to the initial position and move, preferably beyond the initial position, to a second position, e.g. by a spring in the trigger member. In the second position, the trigger member can protrude further from the housing than in the initial position. In that area, which is not covered here, a second information feature 5 is arranged (not shown). The trigger member can thus function as a movable member with a second information feature (not shown). The trigger member comprises an information feature in addition to or instead of the needle cover. Thus, there may be only one or more "second" information features on the element that moves after initiation, during and / or completion of the dosing operation to indicate that the assembly is in a dosed state.

[0063] In the above embodiment, the second information function 5 is a QR code (Registered Trademark) However, the second information features 5 may also include other kinds of, preferably machine-readable, representations of data, such as other variants of multi-dimensional, e.g. two-dimensional, barcodes.

[0064] It should be noted that the third embodiment shown in Figures 3A and 3B, in particular the arrangement of the second information function 5, can be combined with both the first and second embodiments shown in Figures 1A, 1B, 2C and 2B, in particular the arrangement of the first information function 4. The same is true for the fourth embodiment, as shown in Figures 4A and 4B. Moreover, it is also possible to add an additional second information function 5, as in the third embodiment, to the plunger 8 of the fourth embodiment, as shown in Figures 4A and 4B. It is also natural that the configurations disclosed in the previous introductory section describing the embodiments in conjunction with the figures can be combined with the configurations described in conjunction with the exemplary embodiments shown in the figures.

[0065] The terms "drug" or "medicament" are used interchangeably herein to describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or their pharma- ceutically acceptable salts or solvates, and optionally a pharma- ceutically acceptable carrier. An active pharmaceutical ingredient ("API"), in its broadest sense, is a chemical structure that has a biological effect on humans or animals. In pharmacology, drugs or medicines are used to treat, cure, prevent, or diagnose diseases or otherwise improve physical or mental well-being. Drugs or medicines can be used for a limited duration or periodically for chronic disorders.

[0066] As described below, a drug or agent may include at least one API or a combination thereof in various types of formulations for the treatment of one or more diseases. Examples of APIs may include small molecules with molecular weights of 500 Da or less, polypeptides, peptides, and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes), carbohydrates and polysaccharides, as well as nucleic acids, double-stranded 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.

[0067] The drug or agent can be contained in a primary package or "drug container" adapted for use in a drug delivery device. The drug container can be, for example, a cartridge, syringe, reservoir, or other rigid or flexible vessel configured to provide a chamber suitable for storage (e.g., short-term or long-term storage) of one or more drugs. For example, in some cases, the chamber can be designed to store the drug for at least one day (e.g., from one day to at least 30 days). In some cases, the chamber can be designed to store the drug for about one month to about two years. Storage can be at room temperature (e.g., about 20°C) or at refrigerated temperatures (e.g., from about -4°C to about 4°C). In some cases, the drug container can be or include a dual-chamber cartridge configured to separately store two or more components of a pharmaceutical formulation to be administered (e.g., an API and a diluent, or two different drugs), one in each chamber. In such cases, the two chambers of the dual-chamber cartridge can be configured to allow mixing between the two or more components before and / or during administration to the human or animal body. For example, the two chambers can be configured to be in fluid communication with each other (e.g., via a conduit between the two chambers) and to optionally allow mixing of the two components by a user prior to administration. Alternatively or additionally, the two chambers can be configured to allow mixing upon administration of the components to the human or animal body.

[0068] The drugs or agents contained in the drug delivery devices described herein can be used for the treatment and / or prevention of many different types of medical disorders. Examples of disorders include, for example, diabetes or complications associated with diabetes, such as diabetic retinopathy, thromboembolic disorders, such as deep vein thromboembolism or pulmonary thromboembolism. Further examples of disorders are acute coronary syndromes (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those found in handbooks such as Rote Liste 2014 (e.g., but not limited to, Main Groups 12 (antidiabetic agents) or 86 (oncology agents)) and the Merck Index, 15th edition.

[0069] Examples of APIs for the treatment and / or prevention of type 1 or type 2 diabetes or complications associated with type 1 or type 2 diabetes include insulin, e.g., human insulin, or a human insulin analog or derivative, glucagon-like peptide (GLP-1), a GLP-1 analog or GLP-1 receptor agonist, analog or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharma-ceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms "analog" and "derivative" refer to a polypeptide having a molecular structure that is formally derivable from the structure of a naturally occurring peptide, e.g., the structure of human insulin, by deletion and / or replacement of at least one amino acid residue present in the naturally occurring peptide and / or by addition of at least one amino acid residue. The added and / or replaced amino acid residues can be either codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogs are also referred to as "insulin receptor ligands". In particular, the term "derivative" refers to a polypeptide having a molecular structure formally derivable from the structure of a naturally occurring peptide, for example the molecular structure of human insulin in which one or more organic substituents (e.g., fatty acids) are attached to one or more of the amino acids. Optionally, one or more amino acids present in the naturally occurring peptide are deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codeable ones, are added to the naturally occurring peptide.

[0070] 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 in which the proline in position B28 may be replaced by Asp, Lys, Leu, Val or Ala and in which the Lys in position B29 may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.

[0071] Examples of insulin derivatives are e.g. B29-N-myristoyl-des(B30) human insulin, Lys(B29)(N-tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin. ; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)-des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl-des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0072] Examples of GLP-1, GLP-1 analogs and GLP-1 receptor agonists include, for example, lixisenatide (Lyxumia®), exenatide (exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide produced by the salivary glands of the flatfish), liraglutide (Victoza®), semaglutide, taspoglutide, albiglutide (Syncria®), dulaglutide (Trulicity®), rexendin- 4, CJC-1134-PC, PB-1023, TTP-054, langrenatide / HM-11260C, CM-3, GLP-1 Erigen, ORMD-0901, NN-9924, NN-9926, NN-9927, nodexene, Viadol-GLP-1, CVX-096, ZYOG-1, ZYD-1, GSK-2374697, DA-3091, MAR-701, MAR709, ZP-2929, ZP-3022, TT-401, BHM-034, MOD-6030, CAM-2036, DA-15864, ARI-2651, ARI-2255, exenatide-XTEN and glucagon-Xten.

[0073] An example of an oligonucleotide is, for example, the cholesterol-lowering antisense therapeutic mipomersen sodium (Kynamro®) for the treatment of familial hypercholesterolemia.

[0074] Examples of DPP4 inhibitors are vidagliptin, sitagliptin, denagliptin, saxagliptin, berberine.

[0075] Examples of hormones include pituitary or hypothalamic hormones or regulatory active peptides and their antagonists, such as gonadotropins (follitropin, lutropin, chorion gonadotropin, menotropin), somatropine (somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, and goserelin.

[0076] Examples of polysaccharides include glycosaminoglycans, hyaluronic acid, heparin, low molecular weight heparin or very low molecular weight heparin or their derivatives, or sulfated polysaccharides, such as the above-mentioned polysaccharides in polysulfated form, and / or their pharmaceutically acceptable salts.An example of a pharmaceutically acceptable salt of polysulfated low molecular weight heparin is enoxaparin sodium.An example of a hyaluronic acid derivative is Hylan G-F20 (Synvisc®), sodium hyaluronate.

[0077] The term "antibody" as used herein refers to an immunoglobulin molecule or an antigen-binding portion thereof. Examples of antigen-binding portions of an immunoglobulin molecule include F(ab) and F(ab')2 fragments that retain the ability to bind to an antigen. An antibody can be a polyclonal antibody, a monoclonal antibody, a recombinant antibody, a chimeric antibody, a deimmunized or humanized antibody, a fully human antibody, a non-human (e.g., murine) antibody, or a single chain antibody. In some embodiments, an antibody has effector function and is capable of fixing complement. In some embodiments, an antibody has reduced or no binding ability to Fc receptors. For example, an antibody can be an isotype or subtype, an antibody fragment, or a mutant that does not support binding to Fc receptors, e.g., with a mutation or deletion of the Fc receptor binding region. The term antibody also includes antigen-binding molecules based on tetravalent bispecific tandem immunoglobulins (TBTIs) and / or dual variable region antibody-like binding proteins (CODVs) with crossover binding region orientation.

[0078] The term "fragment" or "antibody fragment" refers to a polypeptide (e.g., antibody heavy and / or light chain polypeptide) derived from an antibody polypeptide molecule that does not include the full-length antibody polypeptide but includes at least a portion of the full-length antibody polypeptide that is still capable of binding to an antigen. An antibody fragment can include truncated portions of a full-length antibody polypeptide, but the term is not limited to such truncated fragments. Antibody fragments 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 (SMIPs), binding domain immunoglobulin fusion proteins, camelized antibodies, and VHH-containing antibodies. Additional examples of antigen-binding antibody fragments are known in the art.

[0079] The term "complementarity determining region" or "CDR" refers to short polypeptide sequences in the variable regions 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 in the variable regions of both heavy and light chain polypeptides that are not CDR sequences and are primarily responsible for maintaining the proper arrangement of CDR sequences to allow antigen binding. Although framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues in the framework regions of a particular antibody may be directly involved in antigen binding or may affect the ability of one or more amino acids in the CDR to interact with an antigen.

[0080] Exemplary antibodies are anti-PCSK-9 mAbs (e.g., alirocumab), anti-IL-6 mAbs (e.g., sarilumab), and anti-IL-4 mAbs (e.g., dupilumab).

[0081] Pharmaceutically acceptable salts of any of the APIs described herein are contemplated for use in the drug or medicament in the drug delivery device. Pharmaceutically acceptable salts include, for example, acid addition salts and base salts.

[0082] Those skilled in the art will appreciate that modifications (addition and / or deletions) of the various components of the APIs, formulas, devices, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the invention, which encompasses such modifications and all equivalents.

Claims

1. An assembly (1) for a drug delivery device comprising: a housing unit (2) including a housing receiving a reservoir and a dispensing mechanism configured to dispense a liquid drug content from the reservoir during a dispensing operation; a cap (3) releasably connected to the housing unit (2), the cap (3) at least partially covering the distal dosing end of the assembly (1) when connected to the housing unit (2) and uncovering the distal dosing end of the assembly (1) when the cap (3) is detached from the housing unit; and a first information feature (4) having a first content encoded thereon, the first information feature (4) being machine readable to read the first content from the first information feature (4); The second information function (5) where the first information feature (4) is visible when the cap (3) is connected to the housing unit (2) and / or the first information feature (4) is machine readable and can be removed together with the cap (3) from the housing unit (2); or the first information feature (4) is unreadable when the cap (3) is removed from the housing unit (2); the dispensing mechanism has two distinct states, a first state in which the dispensing mechanism is in a ready-to-dose state and a second state in which the dispensing mechanism is in a dispensed state, the second information feature (5) being invisible in the first state and visible in the second state, the assembly (1) further comprising: the assembly (1) including a movable member, wherein a second information feature (5) is disposed on the movable member, the movable member being in a first position when the dispensing mechanism is in a first state, the movable member being in a second position when the dispensing mechanism is in a second state, the movable member being configured to move from the first position to the second position during and / or after completion of the dispensing operation, and the movable member being a trigger member that, when activated, triggers the dispensing operation.

2. 2. The assembly (1) of claim 1, wherein the coded first content of the first information function (4) indicates a first state of the dispensing mechanism and the second information function (5) indicates a second state of the dispensing mechanism.

3. Assembly (1) according to claim 1, wherein the second information feature (5) has a second content encoded therein and is machine readable to read the second content from the second information feature (5).

4. 4. The assembly (1) of claim 3, wherein a first coded content of the first information function (4) indicates a first state of the dispensing mechanism and a second coded content of the second information function (5) indicates a second state of the dispensing mechanism.

5. Assembly (1) according to any one of claims 1 to 4, wherein the movable member is a needle cover (6) arranged to cover a needle (9) of the assembly (1).

6. 6. An assembly (1) according to any one of claims 1 to 5, wherein upon removal of the cap (3), the first information feature (4) is permanently altered, so that after removal of the cap (3), the coded first content is no longer readable from the altered first information feature.

7. 7. The assembly (1) according to any one of claims 1 to 6, comprising an information carrier connected to a cap (3) and / or a housing unit (2), wherein a first information feature (4) is arranged on the information carrier.

8. 8. An assembly (1) according to claim 7, wherein the information carrier serves to seal the interface between the cap and the housing unit when the cap is connected to the housing unit.

9. Assembly (1) according to any one of the preceding claims, wherein at least one of the first information feature (4) and the second information feature (5) is a two-dimensional barcode.

10. Assembly (1) according to any one of the preceding claims, wherein at least one of the first information feature (4) and the second information feature (5) is a QR code.

11. Assembly (1) according to any one of claims 1 to 10, which is an autoinjector comprising a reservoir, the reservoir containing a liquid drug.

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