WO2015118140A1

WO2015118140A1 - Package for a set of at least two components, sheet packaging material and system comprising a package and a set of at least two components

Info

Publication number: WO2015118140A1
Application number: PCT/EP2015/052602
Authority: WO
Inventors: Muriel DIDIER; Marcus-Meinolf DITTRICH; Dagmar TRAXLER
Original assignee: Sanofi-Aventis Deutschland Gmbh
Priority date: 2014-02-10
Filing date: 2015-02-09
Publication date: 2015-08-13

Abstract

The invention relates to a package (600) for a set (700) of at least two components (702, 704, 706, 708) with a first reception (602) configured to accommodate a first component (702) of the set (700) and with a second reception (604) configured to accommodate a second component (704) of the set (700), wherein the package (600) is configured to lock the second reception (704) by accommodation of the first component (702) in the first reception (602).The invention further relates to a sheet packaging material for producing a package (600), the sheet packaging material having a number of fold lines along which it can be folded to form a package (600) as described above. The invention further relates to a system (500) comprising: a package (600) as described above and a set (700) of at least two components (702, 704, 706, 708), wherein the first reception (602) of the package (600) is configured to accommodate a first component (702) of the set (700) and wherein the second reception (604) of the package (600) is configured to accommodate a second component (704) of the set (700).

Description

Package for a set of at least two components, sheet packaging material

and system comprising a package and a set of at least two components

The invention relates to a package for a set of at least two components with a first reception configured to accommodate a first component of the set and with a second reception configured to accommodate a second component of the set. The invention further relates to a sheet packaging material for producing a package and to a system comprising a package and a set of at least two components. The set of at least two components may in particular comprise a medical device or a part or parts thereof.

The medical device can be an injector, for example a hand-held injector, especially a pen- type injector, that is an injector of the kind that provides for administration by injection of medicinal products from one or more multidose cartridges. In particular, the present invention relates to such injectors where a user may set the dose.

The drug agents may be contained in two or more multiple dose reservoirs, containers or packages, each containing independent (single drug compound) or pre-mixed (co-formulated multiple drug compounds) drug agents.

Certain disease states require treatment using one or more different medicaments. Some drug compounds need to be delivered in a specific relationship with each other in order to deliver the optimum therapeutic dose. The present patent application is of particular benefit where combination therapy is desirable, but not possible in a single formulation for reasons such as, but not limited to, stability, compromised therapeutic performance and toxicology.

For example, in some cases it may be beneficial to treat a diabetic with a long acting insulin (also may be referred to as the first or primary medicament) along with a glucagon-like peptide-1 such as GLP-1 or GLP-1 analog (also may be referred to as the second drug or secondary medicament). Accordingly, there exists a need to provide devices for the delivery of two or more medicaments in a single injection or delivery step that is simple for the user to perform without complicated physical manipulations of the drug delivery device. The proposed drug delivery device provides separate storage containers or cartridge retainers for two or more active drug agents. These active drug agents are then combined and/or delivered to the patient during a single delivery procedure. These active agents may be administered together in a combined dose or alternatively, these active agents may be combined in a sequential manner, one after the other. The drug delivery device also allows for the opportunity of varying the quantity of the medicaments. For example, one fluid quantity can be varied by changing the properties of the injection device (e.g., setting a user variable dose or changing the device's "fixed" dose). The second medicament quantity can be changed by manufacturing a variety of secondary drug containing packages with each variant containing a different volume and/or

concentration of the second active agent.

The drug delivery device may have a single dispense interface. This interface may be configured for fluid communication with a primary reservoir and with a secondary reservoir of medicament containing at least one drug agent. The drug dispense interface can be a type of outlet that allows the two or more medicaments to exit the system and be delivered to the patient.

The combination of compounds from separate reservoirs can be delivered to the body via a double-ended needle assembly. This provides a combination drug injection system that, from a user's perspective, achieves drug delivery in a manner that closely matches the currently available injection devices that use standard needle assemblies. One possible delivery procedure may involve the following steps:

1 . Attach a dispense interface to a distal end of the electro-mechanical injection device. The dispense interface comprises a first and a second proximal needle. The first and second needles pierce a first reservoir containing a primary compound and a second reservoir containing a secondary compound, respectively.

2. Attach a dose dispenser, such as a double-ended needle assembly, to a distal end of the dispense interface. In this manner, a proximal end of the needle assembly is in fluidic communication with both the primary compound and secondary compound. 3. Dial up/set a desired dose of the primary compound from the injection device, for example, via a graphical user interface (GUI).

4. After the user sets the dose of the primary compound, the micro-processor controlled control unit may determine or compute a dose of the secondary compound and preferably may determine or compute this second dose based on a previously stored therapeutic dose profile. It is this computed combination of medicaments that will then be injected by the user. The therapeutic dose profile may be user selectable. Alternatively, the user can dial or set a desired dose of the secondary compound.

5. Optionally, after the second dose has been set, the device may be placed in an armed condition. The optional armed condition may be achieved by pressing and/or holding an ΌΚ" or an "Arm" button on a control panel. The armed condition may be provided for a predefined period of time during which the device can be used to dispense the combined dose.

6. Then, the user will insert or apply the distal end of the dose dispenser (e.g. a double ended needle assembly) into the desired injection site. The dose of the combination of the primary compound and the secondary compound (and potentially a third medicament) is administered by activating an injection user interface (e.g. an injection button).

Both medicaments may be delivered via one injection needle or dose dispenser and in one injection step. This offers a convenient benefit to the user in terms of reduced user steps compared to administering two separate injections.

Medical devices such as the drug delivery device described above are often complex devices that require a number of different components to function properly, such as for example the device as such, a dispense interface, a needle assembly, cartridges containing medicaments and the like. When using such a device for the first time, the user therefore usually has to assemble different components in a correct manner so that the device functions properly. There may also be components which do not have to be assembled with the device, but which are however necessary for using the device, such as for example an electric device charger in order to charge a battery of the device before use. Such devices are therefore often provided with a package comprising a set of a plurality of components. When a user opens such a package for the first time, he then usually has to perform a number of steps in a given order in order to assemble the device correctly and/or prepare the device for first use. For example, some medical devices require the user to connect the device to an electronic charger before any other step is done. This may be necessary because the internal rechargeable battery is disconnected from the electronics of the device for the duration of the shelf life. On first use, the user then has to connect the device to the charger which establishes an electronical connection between the rechargeable battery and the device electronics. This design of a device ensures that the pre-charged battery does not discharge during the shelf life and that the internal clock of the device, for example for indicating the maximum lifetime of the device, does not start before the first activation on first use. Thus, to use the device the user is required to perform a couple of steps in a specific order, before he is able to use the functionalities provided by the device.

Medical devices are often used by persons without particular medical and/or technical skills such as for example patients themselves. Therefore, packages for complex devices, such as for medical devices, often contain a manual with instructions for the first use in order to ensure that the steps necessary to use the device are performed correctly by the patients.

However, it was found that if such a manual is placed in the package, it is often ignored by the users. In particular, user studies showed that the first action of users is often to remove the manual and to put it aside, thereby removing it from the field of view so that it went out of the users' mind.

Studies further show, that when patients are interacting for the first time with an electronical medical device, they make reference to their knowledge on other electronical devices. When there are operating differences between the actual device and the mental model, however this may result in use errors. It was also found that patients can be confused by a package containing a significant amount of components to be used or assembled for operating the device as it is not evident which component has to be used first.

In the light of the above, it is an object of the present invention to provide a package for a set of at least two components, a sheet packaging material for producing such a package and a system comprising such a package and a set of at least two components, which facilitate correct first use of the components.

This object is at least in part solved according to the invention by means of a package for a set of at least two components with a first reception configured to accommodate a first component of the set and with a second reception configured to accommodate a second component of the set, wherein the package is configured to lock the second reception by accommodation of the first component in the first reception.

The package is a package for a set of at least two components. The at least two components may be parts of a device that have to be assembled for using the device, such as for example a drug delivery device, a dispense interface, a needle assembly, cartridges containing medicaments, a device cap or the like. The at least two components may also comprise two separate devices which have to be used together, such as for example a medical device and an electric device charger for charging a device battery. The set may comprise two or more components, in particular at least three or at least four components. In particular, the set may comprise an injection device, a dispense interface, a needle assembly and/or an electric device charger. The package is preferably formed as one piece.

The package comprises a first reception configured to accommodate a first component of the set and a second reception configured to accommodate a second component of the set. The first and the second reception are preferably adapted in dimensions and shape to the first and second components to be packaged within the package, so that the first and second component may be safely stored within the first and second reception. For example, the first and/or second reception each may have a box-like shape.

The package is further configured to lock the second reception by accommodation of the first component in the first reception. Locking the second reception is understood to mean that a user cannot take out of the second reception a component being accommodated therein, in particular the second component.

The package is configured to lock the second reception by accommodation of the first component in the first reception. This is understood to mean that the package is configured such that the second reception may be locked by means of the presence of the first component within the first reception. If for example the first component is accommodated in the first reception, a user then would have to take the first component out of the first reception in order to unlock the second reception, in particular for accessing a component being accommodated therein.

By configuring the package to lock the second reception by accommodation of the first component in the first reception, the package forces a user to first take out of the package a first component being accommodated in the first reception before he can take out a second component being accommodated in the second reception. In this way, the package guides the user to take the respective components out of the package in a predefined order, which order may correspond to the order in which the individual components have to be used. For example, the order may correspond to an assembly order in which the components have to be assembled.

In this way the package facilitates first use of the components and reduces the risk of incorrect first use, in particular if the user does not pay attention to a manual or if he is a technical or medical layman. The object described above is further at least in part solved by a sheet packaging material for producing a package, the sheet packaging material having a number of fold lines along which it can be folded to form a package as described above. Such a sheet packaging material allows producing the package described above in an economic manner and with well-established techniques for mass production. For example, the sheet packaging material may be made from cardboard material.

The object described above is further at least in part solved by a system comprising a package as described above and a set of at least two components, wherein the first reception of the package is configured to accommodate a first component of the set and wherein the second reception of the package is configured to accommodate a second component of the set. In particular the first and/or second reception may be adapted in dimensions and shape to accommodate the first and/or second component of the set, respectively. In the following, a number of embodiments are described for the package, the sheet packaging material for producing such a package and the system comprising such a package and a set of at least two components. Although some of the embodiments are described with reference to the package, they may also be applied to the sheet packaging material or to the system and vice versa. In particular, the sheet packaging material may be configured such, for example by comprising according fold lines, that a package according to the embodiments described below may be produced therewith. Furthermore, the system may comprise a package according to any one of the embodiments described below.

According to a first embodiment the package is a folding box, in particular a cardboard folding box. This allows providing the package for a set of at least two components in an economic manner. In particular, there exist well-established production techniques for mass production of folding boxes that may be adapted for such a package. The folding box is preferably produced from an according sheet packaging material for producing such a package.

According to a further embodiment, the package comprises a locking element configured to lock the second reception and the locking element comprises a cover part configured to cover the second reception when locked. For example the locking element may be formed as one piece with the package. When the second reception is locked, the cover part physically prevents access to the second reception, so that a user cannot take out a component from the second reception. Preferably, the locking element is moveable between a locked and an unlocked position, wherein the second reception is locked in the locked position and wherein the second reception is unlocked in the unlocked position. In particular, the locking element is configured to lock the second reception by accommodation of the first componenent in the first reception. To this end the locking element may be configured to be blocked in the locked position by accommodation of the first component in the first reception. For example, the locking element may be blocked by the first component when accommodated in the first reception. If the package is a folding box, the locking part may for example at least in part be provided by a foldable part of the folding box, for example by a flap.

According to a further embodiment of the package, the locking element comprises a locking part being configured to be coupled to the first reception when the second reception is locked. For example, the locking part may be configured as a flap or a tongue that is coupled to the first reception when the second reception is locked, in particular when the locking element is in the locked position. The body part being coupled to the first reception is understood to mean that the locking part is arranged in a specific and fixed position with respect to the first reception. For example, the locking part may be configured to be blocked by the first component when the first component is accommodated in the first reception. In this way, the locking part and thus the locking element cannot be moved when the first component is accommodated in the first reception so that the second reception is locked. Providing such a locking part allows a more flexible arrangement of the first and second reception with respect to each other since the locking part may transfer the blocking effect of the the first component to the entire locking element. Furthermore, coupling the locking part with the first reception allows implementation of a simple and direct mechanism to prevent unlocking of the second reception while the first component is accommodated in the first reception.

According to a further embodiment of the package, the locking part is configured to form at least part of the first reception when the second reception is locked. For example, the locking part may form a side wall and/or the bottom of the first reception when the second reception is locked. The locking part may also be arranged at a side wall and/or at the bottom of the first reception when the second reception is locked. This embodiment allows a direct coupling of the locking part to the first reception in a constructive simple manner which is easy to implement with the package.

According to a further embodiment, the package comprises a box part containing the first and second reception and a lid part for covering the box part, wherein the lid part is preferably connected to the box part and movable relative to the box part between an open and a closed position. For example, the box part and the lid part may be connected to each other by means of a foldable hinge, so that the lid part may be folded away to open the box similar to opening the cover page of a book.

According to a further embodiment of the package, the lid part comprises a face being arrangeable adjacent to the first reception when in the open position, and an instruction manual is arranged on this face of the lid part. The instruction manual may for example be an instruction of first use. A face being arrangeable adjacent to the first reception is understood to mean that the face and the first reception may be arranged next to each other in such a way that they both may be inspected from the same field of view. Preferably, the face and the first reception are arrangeable in essentially the same or essentially parallel planes when the lid part is in the open position.

By arranging the instruction manual in this way, the user has the manual in a position where he can immediately have access to it for assembling or operating the components within the package after opening the package. In this way, the manual remains close to the

components in the package and in particular within the field of view of the user and can assist the user by showing for example a quick start guide on the cover page. Preferably, the instruction manual is attached to the face to prevent that the user removes the manual and puts it aside.

This arrangement of the instruction manual may also be advantageous for other packages in order to facilitate unpacking such a package and/or assembling and/or operating

components which are packaged within the package. Therefore, the object described above is also at least in part solved by a package comprising at least one reception configured to accommodate a component, wherein the package comprises a box part containing the at least one reception, wherein the package further comprises a lid part for covering the box part, wherein the lid part is connected to the box part and moveable relative to the box part between an open and a closed position, wherein the lid part comprises a face being arrangeable adjacent to the first reception when in the open position, and wherein an instruction manual is arranged on this face of the lid part. The package may in particular be a folding box, for example a cardboard folding box.

According to a further embodiment, the package comprises a viewing window configured to allow visual inspection of the second reception when locked. With the viewing window, the user may examine a component within the second reception even if the second reception is locked. In this way, it may for example be visually verified that the correct component is accommodated within the second reception without unlocking the second reception components. A viewing window also allows inspecting whether a component is broken or missing. The package may also comprise multiple viewing windows, in particular viewing windows for multiple receptions for accommodating components. According to a further embodiment of the package, the first and or the second reception comprises a carrier being configured to fixate the first and/or the second component within the first and/or the second reception. Such a carrier may for example be a separate element with undercuts or notches to fixate a component within the respective reception, in particular during transport or storing. The carrier may also be one-piece with the package. For example, the package may be a folding box comprising additional flaps or straps as carrier to fixate a component within a respective reception.

According to a further embodiment of the package, the package may comprise more than two receptions, for example at least three or at least four receptions, each reception being configured to accommodate a respective component. In particular, the package may comprise a third reception configured to accommodate a third component of the set, wherein the package is configured to lock the third reception by accommodation of the first component in the first reception and/or by accommodation of the second component in the second reception. For example, the package may comprise a second locking element configured to lock the third reception with a cover part configured to cover the third reception and a locking part forming at least part of the second reception when the third reception is locked. In this way the package allows the user to take three different components out of the package only in a predefined order. In an according embodiment of the system, the set comprises a third component which may for example be accommodated in the third reception. According to a further embodiment of the system, the first component of the set is

accommodated in the first reception of the package and the second component of the set is accommodated in the second reception of the package. Only when the user has removed the first component from the first reception, he will then be able to access the second component within the second reception. Preferably the first reception and/or the second reception are adapted to the first and/or second component in dimensions and shape in order to accommodate the first and/or second component, respectively.

The first component of the set accommodated in the first reception is preferably a component that has to be used together with or prior to the second component in the second reception when operating the device for the first time. For example, the first component may be an electric device charger and the second component may be a medical device or part thereof. In this way the user may be guided to charge the medical device before taking any other step. The first component may also have to be assembled with a device before using the second component or assembling the second component with the device.

According to a further embodiment, the package is adapted for packaging a medical device, in particular a medicament injection device. In an according embodiment of the system, at least one component of the set is a medical device, in particular a medicament injection device, or a part thereof. For example at least one component may be part of a medicament injection device or a medicament injection device. A medical device, such as for example a medicament injection device, often comprises of a plurality of individual components that have to be assembled on first use. Since incorrect assembling and thus incorrect functioning of a medical device may result in severe health risks and since medical devices are often used by patients without particular technical or medical skills, the package described above is particularly suitable for medical devices to ensure correct assembly and/or first operation of the device.

These as well as other advantages of various aspects of the present invention will become apparent to those of ordinary skill in the art by reading the following detailed description, with appropriate reference to the accompanying drawings, in which:

Fig. 1 illustrates a perspective view of a delivery device with an end cap of the

device removed; illustrates a perspective view of the delivery device distal end showing the cartridge; Fig. 3 illustrates a perspective view of the delivery device illustrated in Fig. 1 or 2 with one cartridge retainer in an open position;

Fig. 4 illustrates a dispense interface and a dose dispenser that may be removably mounted on a distal end of the delivery device illustrated in Fig. 1 ;

Fig. 5 illustrates the dispense interface and the dose dispenser illustrated in Fig. 4 mounted on a distal end of the delivery device illustrated in Fig. 1 ;

Fig. 6 illustrates one arrangement of a needle assembly that may be mounted on a distal end of the delivery device;

Fig. 7 illustrates a perspective view of the dispense interface illustrated in Fig. 4;

Fig. 8 illustrates another perspective view of the dispense interface illustrated in Fig.

4;

Fig. 9 illustrates a cross-sectional view of the dispense interface illustrated in Fig. 4;

Fig. 10 illustrates an exploded view of the dispense interface illustrated in Fig. 4;

Fig. 1 1 illustrates a cross-sectional view of the dispense interface and needle

assembly mounted onto a drug delivery device, such as the device illustrated in Fig. 1 ;

Fig. 12 illustrates an example embodiment for a system with a package and a set of components packaged within the package; and

Fig. 13a-e illustrate a sequence of unpacking components from the package illustrated in

Fig. 12.

The drug delivery device illustrated in Fig. 1 comprises a main body 14 that extends from a proximal end 16 to a distal end 15. At the distal end 15, a removable end cap or cover 18 is provided. This end cap 18 and the distal end 15 of the main body 14 work together to provide a snap fit or form fit connection so that once the cover 18 is slid onto the distal end 15 of the main body 14, this frictional fit between the cap and the main body outer surface 20 prevents the cover from inadvertently falling off the main body.

The main body 14 contains a micro-processor control unit, an electro-mechanical drive train, and at least two medicament reservoirs. When the end cap or cover 18 is removed from the device 10 (as illustrated in Fig. 1 ), a dispense interface 200 is mounted to the distal end 15 of the main body 14, and a dose dispenser (e.g., a needle assembly) is attached to the interface. The drug delivery device 10 can be used to administer a computed dose of a second medicament (secondary drug compound) and a variable dose of a first medicament (primary drug compound) through a single needle assembly, such as a double ended needle assembly.

The drive train may exert a pressure on the bung of each cartridge, respectively, in order to expel the doses of the first and second medicaments. For example, a piston rod may push the bung of a cartridge forward a pre-determined amount for a single dose of medicament. When the cartridge is empty, the piston rod is retracted completely inside the main body 14, so that the empty cartridge can be removed and a new cartridge can be inserted.

A control panel region 60 is provided near the proximal end of the main body 14. Preferably, this control panel region 60 comprises a digital display 80 along with a plurality of human interface elements that can be manipulated by a user to set and inject a combined dose. In this arrangement, the control panel region comprises a first dose setting button 62, a second dose setting button 64 and a third button 66 designated with the symbol ΌΚ." In addition, along the most proximal end of the main body, an injection button 74 is also provided (not visible in the perspective view of Fig. 1 ). The user interface of the drug delivery device may comprise additional buttons, such as a "menu" button, a "back" button, or a "light" button to switch on an illumination of the display.

The cartridge holder 40 can be removably attached to the main body 14 and may contain at least two cartridge retainers 50 and 52. Each retainer is configured so as to contain one medicament reservoir, such as a glass cartridge. Preferably, each cartridge contains a different medicament.

In addition, at the distal end of the cartridge holder 40, the drug delivery device illustrated in Fig. 1 includes a dispense interface 200. As will be described in relation to Fig. 4, in one arrangement, this dispense interface 200 includes a main outer body 212 that is removably attached to a distal end 42 of the cartridge housing 40. As can be seen in Fig. 1 , a distal end 216 may be configured so as to allow a dose dispenser, such as a conventional pen type injection needle assembly, to be removably mounted to the drug delivery device 10. Once the device is turned on, the digital display 80 shown in Fig. 1 illuminates and provides the user certain device information, preferably information relating to the medicaments contained within the cartridge holder 40. For example, the user is provided with certain information relating to both the primary medicament (Drug A) and the secondary medicament (Drug B).

As shown in Fig. 3, the first and second cartridge retainers 50, 52 may be hinged cartridge retainers. These hinged retainers allow user access to the cartridges. Fig. 3 illustrates a perspective view of the cartridge holder 40 illustrated in Fig. 1 with the first hinged cartridge retainer 50 in an open position. Fig. 3 illustrates how a user might access the first cartridge 90 by opening up the first retainer 50 and thereby having access to the first cartridge 90.

As mentioned above when discussing Fig. 1 , a dispense interface 200 can be coupled to the distal end of the cartridge holder 40. Fig. 4 illustrates a flat view of the dispense interface 200 unconnected to the distal end of the cartridge holder 40. A dose dispenser or needle assembly 400 that may be used with the interface 200 is also illustrated and is provided in a protective outer cap 420.

In Fig. 5, the dispense interface 200 illustrated in Fig. 4 is shown coupled to the cartridge holder 40. The axial attachment means 48 between the dispense interface 200 and the cartridge holder 40 can be any known axial attachment means to those skilled in the art, including snap locks, snap fits, snap rings, keyed slots, and combinations of such

connections. The connection or attachment between the dispense interface and the cartridge holder may also contain additional features (not shown), such as connectors, stops, splines, ribs, grooves, pips, clips and the like design features, that ensure that specific hubs are attachable only to matching drug delivery devices. Such additional features would prevent the insertion of a non-appropriate secondary cartridge to a non-matching injection device.

Fig. 5 also illustrates the needle assembly 400 and protective cover 420 coupled to the distal end of the dispense interface 200 that may be screwed onto the needle hub of the interface 200. Fig. 6 illustrates a cross sectional view of the double ended needle assembly 400 mounted on the dispense interface 200 in Fig. 5. The needle assembly 400 illustrated in Fig. 6 comprises a double ended needle 406 and a hub 401 . The double ended needle or cannula 406 is fixedly mounted in a needle hub 401. This needle hub 401 comprises a circular disk shaped element which has along its periphery a circumferential depending sleeve 403. Along an inner wall of this hub member 401 , a thread 404 is provided. This thread 404 allows the needle hub 401 to be screwed onto the dispense interface 200 which, in one preferred arrangement, is provided with a

corresponding outer thread along a distal hub. At a center portion of the hub element 401 there is provided a protrusion 402. This protrusion 402 projects from the hub in an opposite direction of the sleeve member. A double ended needle 406 is mounted centrally through the protrusion 402 and the needle hub 401 . This double ended needle 406 is mounted such that a first or distal piercing end 405 of the double ended needle forms an injecting part for piercing an injection site (e.g., the skin of a user).

Similarly, a second or proximal piercing end 408 of the needle assembly 400 protrudes from an opposite side of the circular disc so that it is concentrically surrounded by the sleeve 403. In one needle assembly arrangement, the second or proximal piercing end 408 may be shorter than the sleeve 403 so that this sleeve to some extent protects the pointed end of the back sleeve. The needle cover cap 420 illustrated in Fig. 4 and 5 provides a form fit around the outer surface 403 of the hub 401.

Referring now to Fig. 4 to 1 1 , one preferred arrangement of this interface 200 will now be discussed. In this one preferred arrangement, this interface 200 comprises:

a. a main outer body 210,

b. an first inner body 220,

c. a second inner body 230,

d. a first piercing needle 240,

e. a second piercing needle 250,

f. a valve seal 260, and

g. a septum 270.

The main outer body 210 comprises a main body proximal end 212 and a main body distal end 214. At the proximal end 212 of the outer body 210, a connecting member is configured so as to allow the dispense interface 200 to be attached to the distal end of the cartridge holder 40. Preferably, the connecting member is configured so as to allow the dispense interface 200 to be removably connected the cartridge holder 40. In one preferred interface arrangement, the proximal end of the interface 200 is configured with an upwardly extending wall 218 having at least one recess. For example, as may be seen from Fig. 8, the upwardly extending wall 218 comprises at least a first recess 217 and a second recess 219.

Preferably, the first and the second recesses 217, 219 are positioned within this main outer body wall so as to cooperate with an outwardly protruding member located near the distal end of the cartridge housing 40 of the drug delivery device 10. For example, this outwardly protruding member 48 of the cartridge housing may be seen in Fig. 4 and 5. A second similar protruding member is provided on the opposite side of the cartridge housing. As such, when the interface 200 is axially slid over the distal end of the cartridge housing 40, the outwardly protruding members will cooperate with the first and second recess 217, 219 to form an interference fit, form fit, or snap lock. Alternatively, and as those of skill in the art will recognize, any other similar connection mechanism that allows for the dispense interface and the cartridge housing 40 to be axially coupled could be used as well. The main outer body 210 and the distal end of the cartridge holder 40 act to form an axially engaging snap lock or snap fit arrangement that could be axially slid onto the distal end of the cartridge housing. In one alternative arrangement, the dispense interface 200 may be provided with a coding feature so as to prevent inadvertent dispense interface cross use. That is, the inner body of the hub could be geometrically configured so as to prevent an inadvertent cross use of one or more dispense interfaces.

A mounting hub is provided at a distal end of the main outer body 210 of the dispense interface 200. Such a mounting hub can be configured to be releasably connected to a needle assembly. As just one example, this connecting means 216 may comprise an outer thread that engages an inner thread provided along an inner wall surface of a needle hub of a needle assembly, such as the needle assembly 400 illustrated in Fig. 6. Alternative releasable connectors may also be provided such as a snap lock, a snap lock released through threads, a bayonet lock, a form fit, or other similar connection arrangements. The dispense interface 200 further comprises a first inner body 220. Certain details of this inner body are illustrated in Fig. 8-1 1 . Preferably, this first inner body 220 is coupled to an inner surface 215 of the extending wall 218 of the main outer body 210. More preferably, this first inner body 220 is coupled by way of a rib and groove form fit arrangement to an inner surface of the outer body 210. For example, as can be seen from Fig. 9, the extending wall 218 of the main outer body 210 is provided with a first rib 213a and a second rib 213b. This first rib 213a is also illustrated in Fig. 10. These ribs 213a and 213b are positioned along the inner surface 215 of the wall 218 of the outer body 210 and create a form fit or snap lock engagement with cooperating grooves 224a and 224b of the first inner body 220. In a preferred arrangement, these cooperating grooves 224a and 224b are provided along an outer surface 222 of the first inner body 220. In addition, as can be seen in Fig. 8-10, a proximal surface 226 near the proximal end of the first inner body 220 may be configured with at least a first proximally positioned piercing needle 240 comprising a proximal piercing end portion 244. Similarly, the first inner body 220 is configured with a second proximally positioned piercing needle 250 comprising a proximally piercing end portion 254. Both the first and second needles 240, 250 are rigidly mounted on the proximal surface 226 of the first inner body 220.

Preferably, this dispense interface 200 further comprises a valve arrangement. Such a valve arrangement could be constructed so as to prevent cross contamination of the first and second medicaments contained in the first and second reservoirs, respectively. A preferred valve arrangement may also be configured so as to prevent back flow and cross

contamination of the first and second medicaments.

In one preferred system, dispense interface 200 includes a valve arrangement in the form of a valve seal 260. Such a valve seal 260 may be provided within a cavity 231 defined by the second inner body 230, so as to form a holding chamber 280. Preferably, cavity 231 resides along an upper surface of the second inner body 230. This valve seal comprises an upper surface that defines both a first fluid groove 264 and second fluid groove 266. For example, Fig. 9 illustrates the position of the valve seal 260, seated between the first inner body 220 and the second inner body 230. During an injection step, this seal valve 260 helps to prevent the primary medicament in the first pathway from migrating to the secondary medicament in the second pathway, while also preventing the secondary medicament in the second pathway from migrating to the primary medicament in the first pathway. Preferably, this seal valve 260 comprises a first non-return valve 262 and a second non-return valve 268. As such, the first non-return valve 262 prevents fluid transferring along the first fluid pathway 264, for example a groove in the seal valve 260, from returning back into this pathway 264. Similarly, the second non-return valve 268 prevents fluid transferring along the second fluid pathway 266 from returning back into this pathway 266.

Together, the first and second grooves 264, 266 converge towards the non-return valves 262 and 268 respectively, to then provide for an output fluid path or a holding chamber 280. This holding chamber 280 is defined by an inner chamber defined by a distal end of the second inner body both the first and the second non return valves 262, 268 along with a pierceable septum 270. As illustrated, this pierceable septum 270 is positioned between a distal end portion of the second inner body 230 and an inner surface defined by the needle hub of the main outer body 210. The holding chamber 280 terminates at an outlet port of the interface 200. This outlet port 290 is preferably centrally located in the needle hub of the interface 200 and assists in maintaining the pierceable seal 270 in a stationary position. As such, when a double ended needle assembly is attached to the needle hub of the interface (such as the double ended needle illustrated in Fig. 6), the output fluid path allows both medicaments to be in fluid communication with the attached needle assembly.

The hub interface 200 further comprises a second inner body 230. As can be seen from Fig. 9, this second inner body 230 has an upper surface that defines a recess, and the valve seal 260 is positioned within this recess. Therefore, when the interface 200 is assembled as shown in Fig. 9, the second inner body 230 will be positioned between a distal end of the outer body 210 and the first inner body 220. Together, second inner body 230 and the main outer body hold the septum 270 in place. The distal end of the inner body 230 may also form a cavity or holding chamber that can be configured to be fluid communication with both the first groove 264 and the second groove 266 of the valve seal.

Axially sliding the main outer body 210 over the distal end of the drug delivery device attaches the dispense interface 200 to the multi-use device. In this manner, a fluid communication may be created between the first needle 240 and the second needle 250 with the primary medicament of the first cartridge and the secondary medicament of the second cartridge, respectively.

Fig. 1 1 illustrates the dispense interface 200 after it has been mounted onto the distal end 42 of the cartridge holder 40 of the drug delivery device 10 illustrated in Fig. 1. A double ended needle 400 is also mounted to the distal end of this interface. The cartridge holder 40 is illustrated as having a first cartridge containing a first medicament and a second cartridge containing a second medicament.

When the interface 200 is first mounted over the distal end of the cartridge holder 40, the proximal piercing end 244 of the first piercing needle 240 pierces the septum of the first cartridge 90 and thereby resides in fluid communication with the primary medicament 92 of the first cartridge 90. A distal end of the first piercing needle 240 will also be in fluid communication with a first fluid path groove 264 defined by the valve seal 260. Similarly, the proximal piercing end 254 of the second piercing needle 250 pierces the septum of the second cartridge 100 and thereby resides in fluid communication with the secondary medicament 102 of the second cartridge 100. A distal end of this second piercing needle 250 will also be in fluid communication with a second fluid path groove 266 defined by the valve seal 260.

Fig. 1 1 illustrates a preferred arrangement of such a dispense interface 200 that is coupled to a distal end 15 of the main body 14 of drug delivery device 10. Preferably, such a dispense interface 200 is removably coupled to the cartridge holder 40 of the drug delivery device 10.

As illustrated in Fig. 1 1 , the dispense interface 200 is coupled to the distal end of a cartridge housing 40. This cartridge holder 40 is illustrated as containing the first cartridge 90 containing the primary medicament 92 and the second cartridge 100 containing the secondary medicament 102. Once coupled to the cartridge housing 40, the dispense interface 200 essentially provides a mechanism for providing a fluid communication path from the first and second cartridges 90, 100 to the common holding chamber 280. This holding chamber 280 is illustrated as being in fluid communication with a dose dispenser. Here, as illustrated, this dose dispenser comprises the double ended needle assembly 400. As illustrated, the proximal end of the double ended needle assembly is in fluid

communication with the chamber 280.

In one preferred arrangement, the dispense interface is configured so that it attaches to the main body in only one orientation, that is it is fitted only one way round. As such as illustrated in Fig. 1 1 , once the dispense interface 200 is attached to the cartridge holder 40, the primary needle 240 can only be used for fluid communication with the primary medicament 92 of the first cartridge 90 and the interface 200 would be prevented from being reattached to the holder 40 so that the primary needle 240 could now be used for fluid communication with the secondary medicament 102 of the second cartridge 100. Such a one way around connecting mechanism may help to reduce potential cross contamination between the two medicaments 92 and 102.

A plurality of different components is necessary for operating properly a complex apparatus such as the drug delivery device 10 illustrated in Fig. 1. For injecting a medicament with drug delivery device 10, a user for example may have to assemble main body 14, dispense interface 200 and needle assembly 400 and insert cartridges 90, 100 into device 10.

Moreover, he may also have to charge a rechargeable device battery with an electric device charger before use. In particular, connecting the drug delivery device 10 to the electric charger may be necessary before an initial assembly of the drug delivery device 10 can take place, as, for instance, electrical power may be required to open the hinged cartridge retainers 50, 52 in Fig.3.

An apparatus like the drug delivery device 10 is therefore often sold as a set comprising the components which are necessary to operate the device. When opening the package for such a set for the first time, the number of different components may be confusing for the user. In particular, he may be unaware which of the components he has to use first or, if the device is disassembled into several parts, which components he has to assemble first with which other component, in order to assemble the device correctly.

For the drug delivery device 10 described herein, the correct sequence of assembly may be as follows, for example in a case where the hinged cartridge retainers 50, 52 can only be opened when no dispense interface 200 is attached:

1 . Remove electrical charger from package 600;

2. Remove drug delivery device 10 from package;

3. Connect electrical charger to the drug delivery device 10;

4. Connect electrical charger to a power outlet;

5. Disconnect electrical charger from drug delivery device 10;

6. Remove cover 18 from drug delivery device 10 to activate the latter;

7. Control drug delivery device 10 to open cartridge retainer 50;

8.

9. Insert a drug cartridge of a drug A into cartridge retainer 50;Close cartridge retainer 50;

10. Control drug delivery device 10 to open cartridge retainer 52;

1 1 . Insert a drug cartridge of a drug B into cartridge retainer 52;

12. Close cartridge retainer 52;

13. Attach dispense interface 200 to drug delivery device;

14. Attach a needle assembly 400 to the dispense interface 200.

A disruption of that order until the drug delivery device 100 is connected to power might lead a user to attach the dispense interface 200 before the drug cartridges are placed into the cartridge retainers 50, 52 so that the dispense interface 200 has to be removed again rendering e.g. a single use dispense interface 200 unusable and wasted.

Fig. 12 now illustrates an example system 500 comprising a package 600 with a set 700 of at least two components 702, 704, wherein the package 600 is configured to facilitate correct first use of the components 702, 704 packaged within package 600. Figs. 13a - e further illustrates package 600 during different steps of unpacking the package, thereby showing further details of the package 600.

The first component 702 may for example be an electric device charger that is packaged in a separate packaging box as illustrated in Fig. 12. The second component 704 may for example be the drug delivery device 10 illustrated in Fig. 1 or at least a part thereof such as for example main body 14.

Package 600 is preferably a folding box, for example of a cardboard material. In particular, package 600 may be made from a sheet packaging material having a number of fold lines along which it can be folded to form the package 600. In this way package 600 may be produced in an economic manner and in large quantities.

Package 600 comprises a first reception 602 configured to accommodate the first component 702 of set 700 and a second reception 604 configured to accommodate the second component 704 of set 700. The first and second receptions 602, 604 are adapted in dimensions and shape to accommodate the first and second component 702, 704, respectively. In this example, the first and second receptions 602, 604 are essentially formed by folded cardboard sheets of which package 600 is made of.

Package 600 is a two-part package with a box part 606 containing the first and second receptions 602, 604 and with a lid part 608 for covering the box part 606. Lid part 608 is connected to the box part 606 by means of a hinge 610 so that lid part 608 may be moved between a closed position, in which lid part 608 covers box part 606, and an open position shown in Fig. 12, in which a user has access to the interior of box part 606.

Lid part 608 comprises a face 61 1 that is arranged adjacent to the first reception 602 when the lid part 608 is in the open position. Face 61 1 and the first reception 602 are then arranged next to each other in such a way that they both may be inspected from the same field of view as for example from the field of view shown in Fig. 12. Face 61 1 and first reception 602 may be arrangeable in essentially parallel planes as shown in Fig. 12, which means that the upper plane of the opening of first reception 602 is essentially parallel to the plane of face 61 1.

An instruction manual 612 is arranged on face 61 1 so that both the first reception 602 and the manual 612 are in the field of view of a user opening package 600 as shown in Fig. 12. Preferably, manual 612 comprises instructions for the user on how to unpack the components of set 700 from package 600 and/or on how to operate the components of set 700 for the first time. Manual 612 may in particular include assembly instructions for assembling at least two components of set 700.

Package 600 further comprises a locking element 614 configured to lock the second reception 604, the locking element 614 comprising a cover part 616 configured to cover second reception 604. The locking element 614 is moveable between a locked (see Fig. 12) and an unlocked position (see Fig. 13c), wherein cover part 616 covers the second reception 604 in the locked position so that a user cannot access the second component 704 accommodated in the second reception 604. Cover part 616 however comprises a viewing window 618 so that the second component 704 may be visually inspected even if the second reception 604 is locked by the locking element 614 being in the locked position. Locking element 614 further comprises a locking part 620 which in this example embodiment is configured to form the bottom and two side walls of the first reception 602 when in a locked position, i.e. when the second reception 604 is locked by the locking element 614. Due to this, the locking part 620 is blocked and therefore may not be moved relative to the first reception 602 as long as the first component 702 is accommodated within the first reception 602. The user is therefore forced to first remove first component 702 from first reception 602 before being able to move locking part 620 and cover part 616 of locking element 614 to an unlocked position in order to unlock and then access the second reception 604. In other words, locking element 614 is configured to lock the second reception 704 by

accommodation of the first component 702 in the first reception 602.

Since set 700 may comprise more than the first and second component 702, 704, package 600 comprises further receptions configured to accommodate further components of the set 700 (see Fig. 13e). Package 600 also comprises a second locking element 622 with a second cover part 623 configured to cover these further receptions. Similar to the locking element 614, also second locking element 622 is moveable between a locked (see Fig. 12) and an unlocked position (see Fig. 13e). Second locking element 622 is configured to lock the further receptions by accommodation of the second component 704 in the second reception 604. To this end, second locking element 622 comprises a second locking part 624 (see Fig. 13e) forming the bottom and two side walls of the second reception 604 when the further receptions are locked, i.e. when the second locking element 622 is in the locked position. Further details of the package 600 are now described by way of an example sequence of unpacking components of set 700 from package 600 with reference to Figs. 13 a - e.

The package 600 will usually be delivered to a user such as a patient with the lid part 608 covering box part 606. The user may then open package 600 by tilting lid part 608 around hinge 610 to a position shown in Fig. 12. Opening package 600 is therefore similar to opening a book.

Due to the locking elements 614, 622 locking the second and further receptions, the user only has access to the first component 702 being accommodated in the first reception 602. He is therefore forced to remove first component 702 first in order to get access to further components within package 600 (see Fig. 13a). In this way, the package design of package 600 assists the user to take components from the package 600 in a predefined order, in particular in an order in which the user has to assemble and/or operate the individual components for a correct first use. Manual 612, which due to its arrangement on face 61 1 is in the field of view of the user, may give the user further instructions for using the components for the first time and therefore also faciliates first use.

When the user has removed the first component 702, he is able to move locking part 620 which in Figs. 12 and 13a forms the bottom and two side walls of first reception 602 and was therefore blocked with first component 702 being accomodated in first reception 602. By wraping around locking part 620 and cover part 616, locking element 614 is moved from the locked to an unlocked position as illustrated in the sequence of Figs. 13b - c. In this way, second reception 604 is unlocked so that the user gains access to the second component 704, which he then can remove from the second reception 604 as illustrated in Fig. 13d.

Locking part 620 may comprise a grip lug 621 to facilitate wraping around of the locking part 620.

When the user has removed the second component 704 from the second reception 604, he has access to the second locking part 624 of the second locking element 622 which locking part 624 forms the bottom and two side walls of second reception 604 as illustrated in Fig.

13d. By wraping around the second locking part 624 and the second cover part 623, i.e. by moving second locking element 614 from the locked to an unlocked position, further receptions 626, 628 are unlocked so that the user has access to further components 706, 708 being accommodated in these receptions 626, 628, respectively, as shown in Fig. 13e.

Second locking part 624 may comprise a grip lug 630 to facilitate wraping around of the second locking part 624. Package 600 therewith guides the user to unpack the components of set 700 from package 600 in the following order: first component 702, then second component 704 and then further components 706, 708. Preferably, the different components of set 700 are assigned to the different receptions of package 600 in such a way that the order for unpacking the components corresponds to the order in which the different components have to be used.

For example, the first component 702 may be an electric device charger and second component 704 may be a medical device if the first a user has to do is charging a battery of the medical device with the electric device charger. The further components 706, 708 may for example be cartridges containing medicaments, dispense interfaces such as dispense interface 200 illustrated in Fig. 1 , needle assemblies such as needle assembly 400 shown in Fig. 1 , a device cap or similar components that have to be used at a later step when assembling and/or operating the medical device for the first time.

Package 600 therewith facilitates unpacking of the different components in the right order and thereby reduces the risk that the user makes errors when assembling and/or operating a device for the first time. With manual 612 being arranged such, that it is in the field of view of the user when unpacking the components, the user is further guided to assemble/operate the device corectly.

Package 600 and the system 500 are therefore in particular suitable for medical devices which are often difficult to assemble or to use, are often handled by technical and medical laymen such as patients and may cause severe health risks if assembled or used incorrectly.

In the following, further embodiments 1 - 14 are described for the package, the sheet packaging material for producing such a package and the system comprising such a package and a set of at least two components: 1 . Package for a set of at least two components

with a first reception configured to accommodate a first component of the set, and with a second reception configured to accommodate a second component of the set, wherein the package is configured to lock the second reception by accommodation of the first component in the first reception.

2. Package according to embodiment 1 ,

wherein the package is a folding box, in particular a cardboard folding box. Package according to embodiment 1 or 2,

wherein the package comprises a locking element configured to lock the second reception, the locking element comprising a cover part configured to cover the second reception when locked.

Package according to one of embodiments 1 to 3,

wherein the locking element comprises a locking part configured to be coupled to the first reception when the second reception is locked.

Package according to embodiment 4,

wherein the locking part is configured to form at least part of the first reception when the second reception is locked.

Package according to one of embodiments 1 to 5,

wherein the package comprises a box part containing the first and second reception, wherein the package further comprises a lid part for covering the box part, and wherein the lid part is connected to the box part and moveable relative to the box part between an open and a closed position.

Package according to embodiment 6,

wherein the lid part comprises a face being arrangeable adjacent to the first reception when in the open position, and wherein an instruction manual is arranged on this face of the lid part.

Package according to one of embodiments 1 to 7,

wherein the package comprises a viewing window configured to allow visual inspection of the second reception when locked.

Package according to one of embodiments 1 to 8,

wherein the first and/or the second reception comprises a carrier being configured to fixate the first and/or the second component within the first and/or the second reception. 10. Package according to one of embodiments 1 to 9,

wherein the package is adapted for packaging a medical device, in particular a medicament injection device. 1 1 . Sheet packaging material for producing a package, the sheet packaging material having a number of fold lines along which it can be folded to form a package according to one of embodiments 1 to 10.

12. System comprising:

a package according to one of embodiments 1 to 10 and

a set of at least two components,

wherein the first reception of the package is configured to accommodate a first component of the set and

wherein the second reception of the package is configured to accommodate a second component of the set.

13. System according to embodiment 12,

- wherein the first component of the set is accommodated in the first reception of the package and

wherein the second component of the set is accommodated in the second reception of the package. 14. System according to embodiment 12 or 13,

wherein at least one component of the set is a medical device or a part thereof.

The term "drug" or "medicament", as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound, wherein in one embodiment the pharmaceutically active compound has a molecular weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a DNA, a RNA, an enzyme, an antibody or a fragment thereof, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, wherein in a further embodiment the pharmaceutically active compound is useful for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism, acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis, wherein in a further embodiment the pharmaceutically active compound comprises at least one peptide for the treatment and/or prophylaxis of diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, wherein in a further embodiment the pharmaceutically active compound comprises at least one human insulin or a human insulin analogue or derivative, glucagon-like peptide (GLP-1 ) or an analogue or derivative thereof, or exendin-3 or exendin-4 or an analogue or derivative of exendin-3 or exendin-4. Insulin analogues are for example Gly(A21 ), Arg(B31 ), Arg(B32) human insulin; Lys(B3),

Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val 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.

Insulin derivates are for example B29-N-myristoyl-des(B30) human insulin; 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-Y-glutamyl)-des(B30) human insulin; B29-N-(N- lithocholyl-Y-glutamyl)-des(B30) human insulin; B29-N-(oo-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(oo-carboxyhepta^-,decanoyl) human insulin.

Exendin-4 for example means Exendin-4(1 -39), a peptide of the sequence H His-Gly-Glu- Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-Val-Arg-Leu-Phe-lle-Glu- Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.

Exendin-4 derivatives are for example selected from the following list of compounds: H-(Lys)4-des Pro36, des Pro37 Exendin-4(1 -39)-NH2,

H-(Lys)5-des Pro36, des Pro37 Exendin-4(1 -39)-NH2,

des Pro36 [Asp28] Exendin-4(1 -39),

des Pro36 [lsoAsp28] Exendin-4(1 -39),

des Pro36 [Met(0)14, Asp28] Exendin-4(1 -39),

des Pro36 [Met(0)14, lsoAsp28] Exendin-4(1 -39),

des Pro36 [Trp(02)25, Asp28] Exendin-4(1 -39),

des Pro36 [Trp(02)25, lsoAsp28] Exendin-4(1 -39), des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1 -39),

des Pro36 [Met(0)14 Trp(02)25, lsoAsp28] Exendin-4(1 -39); or des Pro36 [Asp28] Exendin-4(1 -39),

des Pro36 [lsoAsp28] Exendin-4(1 -39),

des Pro36 [Met(0)14, Asp28] Exendin-4(1 -39),

des Pro36 [Met(0)14, lsoAsp28] Exendin-4(1 -39),

des Pro36 [Trp(02)25, Asp28] Exendin-4(1 -39),

des Pro36 [Trp(02)25, lsoAsp28] Exendin-4(1 -39),

des Pro36 [Met(0)14 Trp(02)25, Asp28] Exendin-4(1 -39),

des Pro36 [Met(0)14 Trp(02)25, lsoAsp28] Exendin-4(1 -39),

wherein the group -Lys6-NH2 may be bound to the C-terminus of the Exendin-4 derivative; or an Exendin-4 derivative of the sequence

H-(Lys)6-des Pro36 [Asp28] Exendin-4(1 -39)-Lys6-NH2,

des Asp28 Pro36, Pro37, Pro38Exendin-4(1 -39)-NH2,

H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1 -39)-NH2,

H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-NH2,

des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(Lys)6-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1 -39)-(Lys)6-NH2,

H-(Lys)6-des Pro36 [Trp(02)25, Asp28] Exendin-4(1 -39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Trp(02)25] Exendin-4(1 -39)-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-NH2, des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-(Lys)6-des Pro36 [Met(0)14, Asp28] Exendin-4(1 -39)-Lys6-NH2,

des Met(0)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1 -39)-NH2,

H-(Lys)6-desPro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-NH2, des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2,

H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-Lys6-des Pro36 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)-Lys6-NH2,

H-des Asp28 Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25] Exendin-4(1 -39)-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Asp28] Exendin-4(1 -39)-NH2, H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)-NH2, des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)-(Lys)6-NH2, H-(Lys)6-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(S1 -39)-(Lys)6- NH2,

H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(0)14, Trp(02)25, Asp28] Exendin-4(1 -39)- (Lys)6-NH2; or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned Exendin-4 derivative.

Hormones are for example hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists as listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.

A polysaccharide is for example 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, 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.

Antibodies are globular plasma proteins (-150 kDa) that are also known as immunoglobulins which share a basic structure. As they have sugar chains added to amino acid residues, they are glycoproteins. The basic functional unit of each antibody is an immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimeric with two Ig units as with IgA, tetrameric with four Ig units like teleost fish IgM, or pentameric with five Ig units, like mammalian IgM.

The Ig monomer is a "Y"-shaped molecule that consists of four polypeptide chains; two identical heavy chains and two identical light chains connected by disulfide bonds between cysteine residues. Each heavy chain is about 440 amino acids long; each light chain is about 220 amino acids long. Heavy and light chains each contain intrachain disulfide bonds which stabilize their folding. Each chain is composed of structural domains called Ig domains.

These domains contain about 70-1 10 amino acids and are classified into different categories (for example, variable or V, and constant or C) according to their size and function. They have a characteristic immunoglobulin fold in which two β sheets create a "sandwich" shape, held together by interactions between conserved cysteines and other charged amino acids.

There are five types of mammalian Ig heavy chain denoted by α, δ, ε, γ, and μ. The type of heavy chain present defines the isotype of antibody; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.

Distinct heavy chains differ in size and composition; a and γ contain approximately 450 amino acids and δ approximately 500 amino acids, while μ and ε have approximately 550 amino acids. Each heavy chain has two regions, the constant region (CH) and the variable region (VH). In one species, the constant region is essentially identical in all antibodies of the same isotype, but differs in antibodies of different isotypes. Heavy chains γ, a and δ have a constant region composed of three tandem Ig domains, and a hinge region for added flexibility; heavy chains μ and ε have a constant region composed of four immunoglobulin domains. The variable region of the heavy chain differs in antibodies produced by different B cells, but is the same for all antibodies produced by a single B cell or B cell clone. The variable region of each heavy chain is approximately 1 10 amino acids long and is composed of a single Ig domain. In mammals, there are two types of immunoglobulin light chain denoted by λ and κ. A light chain has two successive domains: one constant domain (CL) and one variable domain (VL). The approximate length of a light chain is 21 1 to 217 amino acids. Each antibody contains two light chains that are always identical; only one type of light chain, κ or λ, is present per antibody in mammals.

Although the general structure of all antibodies is very similar, the unique property of a given antibody is determined by the variable (V) regions, as detailed above. More specifically, variable loops, three each the light (VL) and three on the heavy (VH) chain, are responsible for binding to the antigen, i.e. for its antigen specificity. These loops are referred to as the Complementarity Determining Regions (CDRs). Because CDRs from both VH and VL domains contribute to the antigen-binding site, it is the combination of the heavy and the light chains, and not either alone, that determines the final antigen specificity.

An "antibody fragment" contains at least one antigen binding fragment as defined above, and exhibits essentially the same function and specificity as the complete antibody of which the fragment is derived from. Limited proteolytic digestion with papain cleaves the Ig prototype into three fragments. Two identical amino terminal fragments, each containing one entire L chain and about half an H chain, are the antigen binding fragments (Fab). The third fragment, similar in size but containing the carboxyl terminal half of both heavy chains with their interchain disulfide bond, is the crystalizable fragment (Fc). The Fc contains carbohydrates, complement-binding, and FcR-binding sites. Limited pepsin digestion yields a single F(ab')2 fragment containing both Fab pieces and the hinge region, including the H-H interchain disulfide bond. F(ab')2 is divalent for antigen binding. The disulfide bond of F(ab')2 may be cleaved in order to obtain Fab'. Moreover, the variable regions of the heavy and light chains can be fused together to form a single chain variable fragment (scFv). Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Acid addition salts are e.g. HCI or HBr salts. Basic salts are e.g. salts having a cation selected from alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1 )(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6- C10-aryl group, or an optionally substituted C6-C10-heteroaryl group. Further examples of pharmaceutically acceptable salts are described in "Remington's Pharmaceutical Sciences" 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of Pharmaceutical Technology. Pharmaceutically acceptable solvates are for example hydrates.

Claims

Package (600) for a set (700) of at least two components (702, 704, 706, 708) with a first reception (602) configured to accommodate a first component (702) of the set (700), and

with a second reception (604) configured to accommodate a second component (704) of the set (700),

wherein the package (600) is configured to lock the second reception (704) by accommodation of the first component (702) in the first reception (602) and wherein the package (600) comprises a locking element (614) configured to lock the second reception (604), the locking element (614) comprising a cover part (616) configured to cover the second reception (604) when locked,

characterized in that

the locking element (614) comprises a locking part (620) configured to be coupled to the first reception (602) when the second reception (604) is locked.

Package according to claim 1 ,

wherein the package (600) is a folding box, in particular a cardboard folding box. Package according to claim 1 or 2,

wherein the locking part (620) is configured to form at least part of the first reception (602) when the second reception (604) is locked.

Package according to one of claims 1 to 3,

wherein the package (600) comprises a box part (606) containing the first and second reception (602, 604), wherein the package (600) further comprises a lid part (608) for covering the box part (606), and wherein the lid part (608) is connected to the box part (606) and moveable relative to the box part (606) between an open and a closed position.

Package according to claim 4,

wherein the lid part (608) comprises a face (61 1 ) being arrangeable adjacent to the first reception (602) when in the open position, and wherein an instruction manual (612) is arranged on this face (61 1 ) of the lid part (608).

Package according to one of claims 1 to 5,

wherein the package (600) comprises a viewing window (618) configured to allow visual inspection of the second reception (604) when locked.

Package according to one of claims 1 to 6,

wherein the first and/or the second reception (602, 604) comprises a carrier being configured to fixate the first and/or the second component (702, 704) within the first and/or the second reception (602, 604).

Package according to one of claims 1 to 7,

wherein the package (600) is adapted for packaging a medical device, in particular a medicament injection device.

Sheet packaging material for producing a package (600), the sheet packaging material having a number of fold lines along which it can be folded to form a package (600) according to one of claims 1 to 8.

System (500) comprising:

a package (600) according to one of claims 1 to 8 and

a set (700) of at least two components (702, 704, 706, 708),

wherein the first reception (602) of the package (600) is configured to accommodate a first component (702) of the set (700) and

wherein the second reception (604) of the package (600) is configured to

accommodate a second component (704) of the set (700).

System according to claim 10,

wherein the first component (702) of the set (700) is accommodated in the first reception (602) of the package (600) and

wherein the second component (704) of the set (700) is accommodated in the second reception (604) of the package (600).

12. System according to claim 10 or 1 1 ,

wherein at least one component (702, 704, 706, 708) of the set (700) is a medical device or a part thereof.