Packaging Container

Abstract

The disclosure refers to a packaging container (81, 281) comprising a tubular housing (83, 283) and a plunger stopper (82, 282) moveable within the housing (83, 283), wherein at least a section of an outer surface of the plunger stopper (82, 282) being in contact with an inner surface of the housing (83, 283) comprises a silicone-free coating (88, 288) which reduces break loose and/or gliding forces. The disclosure further describes a system comprising this packaging container (81, 281) and a formulation (87, 287) within the packaging container containing one or more pharmaceutically active compound and/or carrier as well as a drug delivery device comprising this system.

Claims

1-14. (canceled)

15. A packaging container comprising a tubular housing and a plunger stopper moveable within the tubular housing, wherein at least a first section of an outer surface of the plunger stopper is in contact with an inner surface of the tubular housing, and the first section of the outer surface of the plunger stopper comprises a silicone-free coating which reduces break loose and/or gliding forces, wherein the tubular housing comprises glass.

16. The packaging container of claim 15, wherein the coating of the plunger stopper comprises at least one compound selected from the group consisting of: PTFE, ETFE, PVF, PVDF, PCTFE, PFA and FEP.

17. The packaging container of claim 15, wherein at least a second section of an outer surface of the plunger stopper comprises the silicone-free coating, wherein the second section faces an inner volume of the packaging container.

18. The packaging container of claim 15, wherein at least a part of the inner surface of the tubular housing comprises a silicone coating, wherein the silicone coating is bound to the inner surface of the tubular housing by annealing.

19. The packaging container of claim 15, wherein the inner surface of the tubular housing comprises no coating.

20. The packaging container of claim 15, wherein at least a part of the inner surface of the tubular housing comprises a silicone-free coating.

21. The packaging container of claim 15, wherein the plunger stopper has a cylindrical form.

22. The packaging container of claim 15, wherein the plunger stopper has a conical form.

23. The packaging container of claim 15, wherein the plunger stopper comprises a recess within a surface of the plunger stopper, the surface of the plunger stopper being opposite the inner volume of the packaging container.

24. The packaging container of claim 15, wherein the packaging container contains a formulation, wherein the formulation comprises one or more pharmaceutically active compounds and/or carriers.

25. The packaging container of claim 15, wherein the packaging container comprises a seal located at a distal end of the tubular housing, the distal end of the tubular housing being opposite to the plunger stopper, wherein the seal is pierceable by a needle, for discharging a formulation.

26. The packaging container of claim 15, wherein the packaging container is at least one of a cartridge or a pre-filled syringe.

27. A system comprising a packaging container, and a formulation within the packaging container containing one or more pharmaceutically active compounds and/or carriers, the packaging container comprising: a tubular housing and a plunger stopper moveable within the tubular housing, wherein at least a first section of an outer surface of the plunger stopper is in contact with an inner surface of the tubular housing, and the first section of the outer surface of the plunger stopper comprises a silicone-free coating which reduces break loose and/or gliding forces, wherein the tubular housing comprises glass.

28. The system of claim 27, wherein the formulation contains one or more of the following: human Insulin, or a human insulin analogue or one of its derivatives, wherein the insulin analogue is Gly(A21), Arg(B31), Arg(B32) human insulin, Lys(B3), Glu(B29) human insulin, Lys(B28), Pro(B29) human insulin, Asp(B28) human insulin, Ala(B26) human insulin, Des(B28-B30) human insulin, Des(B27) human insulin, Des(B30) human insulin, or 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, and wherein Insulin derivatives include 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-(-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(-carboxyheptadecanoyl) human insulin; Lysozyme, Factor VIII, -lactoglobulin (drug carrier), recombinant human growth hormone, albutropin, darbepoetin alfa, keratinocyte growth factor 2 (KGF-2), -casein, Ribonuclease A, bovine serum albumin (drug carrier), concanavalin A, bevacizumab, ranibizumab, albinterferon 2b, abatacept, adalimumab, monomeric anti-streptavidin IgG1, any immunoglobulin, GLP-1-Agonist.

29. The system of claim 27, wherein at least a second section of an outer surface of the plunger stopper comprises the silicone-free coating, wherein the second section faces an inner volume of the packaging container.

30. The system of claim 27, wherein at least at a part of the inner surface of the tubular housing comprises a silicone coating, wherein the silicone coating is bound to the inner surface of the tubular housing by annealing.

31. A drug delivery device comprising: a container holder; a packaging container secured in the container holder, the packaging container comprising: a tubular housing and a plunger stopper moveable within the tubular housing, wherein at least a first section of an outer surface of the plunger stopper is in contact with an inner surface of the tubular housing, and the first section of the outer surface of the plunger stopper comprises a silicone-free coating which reduces break loose and/or gliding forces, wherein the tubular housing comprises glass, and a formulation within the packaging container containing one or more pharmaceutically active compounds and/or carriers.

32. The drug delivery device of claim 31, comprising an expelling mechanism configured to displace the plunger stopper in order to expel the formulation from the packaging container.

33. The system of claim 31, wherein at least a second section of an outer surface of the plunger stopper comprises the silicone-free coating, wherein the second section faces an inner volume of the packaging container.

34. The drug delivery device of claim 31, wherein at least at a part of the inner surface of the tubular housing comprises a silicone coating, wherein the silicone coating is bound to the inner surface of the tubular housing by annealing.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0028] A non-limiting, exemplary embodiment of the disclosure will now be described with reference to the accompanying drawings, in which:

[0029] FIG. 1 shows a drug delivery device with a system and a cap attached in accordance with the disclosure in a side view;

[0030] FIG. 2 shows the drug delivery device of FIG. 1 with the cap removed and a dose of 79 units dialed;

[0031] FIG. 3 shows the components of the drug delivery device of FIG. 1 in an exploded view;

[0032] FIG. 4 shows a system with a packaging container in accordance with the disclosure in a perspective view;

[0033] FIG. 5 shows an example of plunger stopper of the packaging container in a longitudinal section;

[0034] FIG. 6 shows another example of plunger stopper of the packaging container in a longitudinal section;

[0035] FIG. 7 shows another drug delivery device with a system in accordance with the disclosure in a longitudinal section; and

[0036] FIG. 8 shows experimental results comparing the break loose and gliding forces for a prior art system (dashed line) and a system according to the disclosure (solid line) printed as a function of the gliding distance shortly after manufacturing of the respective system.

[0037] FIG. 9 shows experimental results comparing the break loose and gliding forces for a prior art system (dashed line) and a system according to the disclosure (solid line) printed as a function of the gliding distance after 6 months of storage at 5 C. for the respective system.

DETAILED DESCRIPTION

[0038] FIGS. 1 and 2 show a drug delivery device 1 in the form of an injection pen. The device has a distal end (lower end in FIG. 1) and a proximal end (upper end in FIG. 1). The component parts of the drug delivery device 1 are shown in FIG. 3 in more detail. The drug delivery device 1 comprises an outer housing part 10, an inner body 20, a piston rod 30, a driver 40, a nut 50, a display member 60, a button 70, a cartridge holder 80 for receiving a packaging container in form of a cartridge 81, a clutch 90, a clicker 100, a spring 110, a cap 120 and a window insert 130. A needle arrangement (not shown) comprising a needle hub and a needle cover may be provided as additional components, which can be exchanged as explained above. The piston rod 30 comprises a bearing 31. The driver comprises a distal driver part 41, a proximal driver part 42 and a coupler 43. The display member 60 comprises a number sleeve 61 and a dial sleeve 62. The clicker comprises a distal clicker part 101, a proximal clicker part 102 and a spring 103.

[0039] The outer housing part 10 is a generally tubular element having a distal part for attaching the inner body 20. Further, an aperture is provided for receiving window insert 130. The outer body 10 provides the user with a surface to grip and react against during dispense.

[0040] The inner body 20 is a generally tubular element having different diameter regions. The inner body 20 is received in the outer body 10 and permanently fixed therein to prevent any relative movement of the inner body 20 with respect to the outer body 10. The inner body has the functions to house the drive mechanism within, guiding the clickers and the last dose nut 50 via internal splines, to provide an internal thread through which the piston rod 30 (lead screw) is driven, to support and guide the number sleeve 61 and the dial sleeve 62 on an external thread form, to secure the cartridge holder 80 and to secure the outer body 10 and the window insert 130.

[0041] The outermost diameter of the inner body 20 also forms part of the visual design and remains visible when the cap 120 is secured to the cartridge holder 80 as a ring separating the cap 120 from the outer body 10. This visible ring also has depressions which align with the cap snap features on the cartridge holder 80 to indicate that the cartridge holder has been correctly fitted.

[0042] Bayonet features on the inner body 20 guide the cartridge holder 80 into the mechanism during cartridge replacement, compressing the cartridge bias spring 110, and then push back the cartridge holder 80 a small distance in order to reduce axial play in the mechanism. Snap features inside the inner body 20 lock the cartridge holder 80 rotationally when it has been correctly fitted. The profile of these snaps aims to prevent the user from partially fitting the cartridge holder 80, the cartridge bias spring 110 ejecting the cartridge holder 80 if the snaps have not at least started to engage. A window retention nose retains the window insert 130 when the outer body 10 and window insert 130 assembly is axially inserted onto the inner body 20. Two diametrically opposite stop faces define the rotational end position for the number sleeve 61. This end position is the end of dose detent position for the minimum dose (0U).

[0043] The piston rod 30 is an elongate element having two external threads 32, 33 with opposite hand which overlap each other. One of these threads 32 engages the inner thread of the inner body 20. A disk-like bearing 31 is provided at the distal end of the piston rod 30. The bearing 31 may be a separate component as shown in FIG. 3 or may be attached to the piston rod 30 as a one-piece component via a predetermined breaking point.

[0044] The piston rod 30 transfers the dispense load from the driver 40 to the bearing 31, creating a mechanical advantage greater than 1:1 by converting the torque generated on the piston rod 30 by the driver 40 thread interface into additional axial load as the piston rod passes through the thread in the inner body 20. The piston rod 30 is reset by pressing on the bearing 31 and this in turn rotates the piston rod back into the inner body 20. This disengages and then rotates the distal drive sleeve 41, resetting the last dose nut 50 back to its starting position on the distal drive sleeve 41.

[0045] The driver 40 is a generally tubular element having in the embodiment shown in the FIG. 3 three components 41, 42, 43. The distal drive sleeve 41 engages with the piston rod thread 33 to drive the piston rod 30 through the inner body 20 during dose delivery. The distal drive sleeve 41 is also permanently connected to the coupler 43 which in turn is releasably engaged through reset clutch features to the proximal drive sleeve 42. The two halves of the drive sleeve are rotationally and axially connected during dialing and dispense, but are decoupled rotationally during device reset so that they can rotate relative to each other.

[0046] The external thread of the distal part 41 engages with the last dose nut 50. Stop faces at the distal part 41 engage with mating stop faces on the last dose nut 50 to limit the number of units that can be dialed.

[0047] The proximal drive sleeve 42 shown in FIG. 3 supports the clicker components 100 and the clutch 90 and transfers rotational movement from the dose button 90 to the coupler 43 and distal drive sleeve 41.

[0048] The coupler 43 rotationally couples the two halves of the driver 40 together during dialing and dispense, whilst allowing them to de-couple during reset.

[0049] The last dose nut 50 is provided between the inner body 20 and the distal drive sleeve 41 of driver 40. Stop faces are located on the proximal face of last dose nut 50 to limit the number of units that can be dialed if the stop faces contact stops of distal drive sleeve 41. The function of the last dose nut 50 is to prevent the user from dialing beyond a finite amount. This limit is based on the dispensable volume of the cartridge 81 and when reached, the user must replace the cartridge 81 and reset the device.

[0050] The display member 60 is a generally tubular element which is composed of number sleeve 61 and dial sleeve 62 which are snapped together during assembly to axially and rotationally constrain these two components, which thus act as a single part.

[0051] The dial sleeve 62 is assembled to the number sleeve 61 such that once assembled, no relative movement is allowed. The parts are made as separate components to enable both molding and assembly.

[0052] The button 70 serves as a dose dial grip and is retained by the clutch 90 to transfer the actions of the user to the clutch. It may also carry ratchet teeth that engage a ratchet arm on the dial sleeve 62, which serves as the dispensing clicker giving audible feedback (ratchet clicks), and an end face which serves as the dose completion stop face with the outer body 10. This end face thus serves to define the end position during dispense when it contacts the outer body 10 to provide a very positive stop improving dose accuracy.

[0053] The cartridge holder 80 attaches to the inner body 20 with a bayonet connection and houses the ampoule or cartridge 81 containing the medication to be dispensed. The cartridge holder 80 may include an aperture in the rear face which if gripped by the user prevents the ampoule from falling out when the cartridge holder is removed from the inner body 20. The front face is printed with a dose number scale. The threaded distal end is used to attach disposable pen needles.

[0054] A tubular clutch 90 is provided between the display member 60 and the button 70. The clutch is fixed relative to and retains the button 70 and together they travel axially relative to the proximal drive sleeve 42 when the button 70 is depressed during dispense, disengaging the clutch teeth from the dial sleeve 62. It also transfers torque from the button to the proximal drive sleeve 42, and the dialing and 0U/80U stop loads from the button via the clutch teeth to the dial sleeve and number sleeve.

[0055] The clicker 100 comprises a distal clicker part 101, a proximal clicker part 102 and a spring 103. The clutch spring 103 serves to bias the button 70 out so that at the end of a dose the button 70 pops out, re-engaging the clutch 90 with the dial sleeve 62 ready for dialing. Further, it provides the spring force for the clicker components to act as clickers and also as detent positions for the number sleeve 61. In addition, it holds the two halves of the drive sleeves 41, 42 in rotational engagement during dialing and dispense, whilst allowing them to disengage during device reset.

[0056] The distal clicker part 101 is permanently splined to the proximal drive sleeve 42 and engages with the proximal clicker part 102 which in turn is splined to the inner body 20. During dialing when the drive sleeve is rotated relative to the inner body, the two clickers 101, 102, rotate relative to each other under the compression force of the clutch spring 103. This force combined with the clicker teeth formed on the end face of each clicker provides the clicks and also the detent dialing positions.

[0057] During dispense the two clickers 101, 102 are pressed together under the dispense load and therefore prevent relative rotation between the proximal drive sleeve 42 and inner body 20, driving the piston rod forwards to deliver the dose.

[0058] The cartridge bias spring 110 is assembled as two components one after the other, the lower first and the upper second. The spring combination serves to apply an end load to the cartridge 81 at extremes of tolerance so as to bias it forwards onto the end face of the ferrule in the cartridge holder 80. This ensures that when the user removes and attaches a needle, the friction between the needle cannula and septum of the cartridge does not move the cartridge 81 axially relative to the cartridge holder 80. The bias spring 110 also acts to provide a force against which the user has to connect the cartridge holder 80 and this may add to the tactile feedback of this bayonet joint. The spring 110 also serves to eject the cartridge holder 80 if the cartridge holder is not rotated into a secure position, highlighting this error to the user.

[0059] As shown in FIG. 4, the cartridge 81 is a generally tubular element comprising a plunger stopper 82 at its proximal end which is movable within a tubular housing 83 of the cartridge 81 and closes the housing 83 at its proximal end. At its distal end the housing 83 is closed by a seal 84 which may be pierced by a needle (not shown) when the, preferably double-ended, needle is attached at the distal end of the cartridge holder 80. At its distal end, often the cartridge housing 83 has a neck portion 85 which fits into the threaded distal end of the cartridge holder 80. Between the seal 84 and the plunger stopper 82 the cartridge 81 comprises an inner volume filled with a formulation 87 containing a pharmaceutical active compound and/or carrier as indicated above.

[0060] The cartridge housing 83 is made of glass with silicone coating at its inner surface which is annealed at 280 C. to 300 C. in order to bind the silicone at the surface of the housing 83. Alternatively, the glass housing 83 may have no silicone coating at its inner surface.

[0061] The plunger stopper 82 has e.g. a cylindrical form as shown in FIG. 4 and is made of a halogenbutyl-rubber-mixture. The plunger stopper 82 comprises a coating 88 at its lateral surface which is in contact with the inner surface of the housing 83. The coating 88 is silicone-free and comprises, for example, more than 50 wt % PTFE and/or ETFE. The layer thickness of coating 88 is between 20 m and 100 m. The plunger stopper 82 may have this coating 88 at the surface 82a of the second conical section 82C which is in contact with the medicament formulation 87 within the inner volume as well.

[0062] The plunger stopper 82 may have a conical form at least in a section of the plunger stopper. For example, as shown in FIG. 5 the plunger stopper 82 comprises a cylindrical section 82A and a conical section 82B. The silicone-free coating 88 is provided at the outer surface of the cylindrical section 82A. The plunger stopper 82 shown in FIG. 5 may have this coating 88 at the surface 82a which is in contact with the medicament formulation 87 within the inner volume and which forms an end face of the volume as well. The surface 82a is opposite to the conical section 82B.

[0063] FIG. 6 shows another embodiment of the plunger stopper 82 comprising a cylindrical center section 82A, a first conical section 82B and a second conical (tapered) section 82C. The first conical section 82B forms the surface 82b which comes in contact with the driving element of the drug delivery device (piston rod 30 with bearing 31) similar to the embodiment shown in FIG. 5 whereas the second conical section 82C forms the surface 82a which is in contact with the medicament formulation 87 within the inner volume. The silicone-free coating 88 is provided at the outer surface of the cylindrical section 82A. The plunger stopper 82 shown in FIG. 6 may have this coating 88 at the surface 82a as well. The embodiment shown in FIG. 6 further comprises a cylindrical recess 89 within the surface 82b of the first conical section 82A. The recess 89 may comprise a thread at its inner surface.

[0064] The plunger stoppers shown in FIGS. 5 and 6 may comprise at least one lamella (lateral contact section) as explained above, for example, at the lateral surface of the cylindrical center section 82A or the (first) conical section 82B. In one embodiment the whole cylindrical center section 82A itself forms the lamella. If the (first) conical section 82B comprises one or several lamellae, in one embodiment, the lamella(e) is(are) located at the distal end of this section. The lamella(e) of the plunger stopper at least partially comprise(s) the silicone free coating 88 at its (their) surface.

[0065] In another embodiment the plunger stopper 82 may be formed analogously to the embodiment shown in FIG. 6 but with a section 82B which is cylindrical rather than conical.

[0066] The cap 120 serves to protect the cartridge holder 80 from damage and the cartridge 81 itself from dust dirt ingress on to the area around the septum. The cap is designed to accommodate a standard pen injector needle.

[0067] The window insert 130 may include a lens to magnify the dose numbers e.g. by approximately 25% from their printed size. The window insert 130 may be back printed to protect the printed surface from abrasion and also to maximize the light entering through the window aperture, giving uniform illumination of the dose numbers and white area around these numbers. Arrows may be printed adjacent to the window aperture that indicate the dose dialed.

[0068] In the following, the function of the drug delivery device and its components will be explained in more detail. For further information regarding the drug delivery device it is referred to WO 2014/033195 A1, included herein by reference.

[0069] To use the device, a user has to select a dose. In the start (at rest) condition as shown in FIGS. 1 and 2 the display member 60 indicates the number of doses dialed to the user. The number of dialed units can be viewed through the dose window 130 in the outer body 10. Due to the threaded engagement between the display member 60 and the inner body 20 rotation of the button 70 in a clockwise fashion causes the display member 60 to wind out of the device and incrementally count the number of units to be delivered.

[0070] During dose setting button 70, driver 40 and display member 60 are rotationally locked together via clutch 90. Further, button 70, driver 40 and display member 60 are axially coupled. Thus, these three components wind out of the outer housing 10 during dose setting. Clockwise rotation of the button 70 causes the driver 40 to rotate and in doing so it advances along the piston rod 30 which remains fixed throughout dialing. The clicker arrangement 100 provides tactile and audible feedback to the user when dialing doses. At the maximum settable dose of 80 units, the stop features of the outer housing part 10 and of the dial sleeve 62 engage to prevent further dialing.

[0071] The last dose nut 50 provides the function of counting the number of dispensed units. The nut 50 locks the device at the end of cartridge life and as such no more drug can be dialed by the user. The last dose nut 50 and the driver 40 are connected via a threaded interface as explained above. Further, the last dose nut 50 is assembled into splines such that the nut 50 and the inner body 20 are rotationally locked together (at all times). Rotation of the driver 40 during dialing causes the nut 50 to advance along the outer thread of the distal part. The nut 50 is free to slide axially within the inner body 20 at all times which allows advancement of the nut. At the end of life condition, stop features of the last dose nut 50 contact the corresponding features on the driver 40. The splined contact with inner body 20 reacts any torque transmitted by these stop features.

[0072] With the desired dose dialed, the device 1 is ready for dose dispensing. This basically requires pushing button 70 which will result in a disengagement of the clutch 90 from dial sleeve 62 thus allowing relative rotation between the display member 60 and the button 70. In all conditions the driver 40 and the button 70 are rotationally locked together by engagement of arms, fingers and by splines engaging corresponding splines on proximal drive sleeve 42. Thus, with the clutch 90 disengaged (button 70 pushed in) button 70 and driver 40 are rotationally locked together with the button 70, the driver 40 and the display member 60 still being axially coupled.

[0073] When dispensing a dose, the dose button 70 and clutch 90 are moved axially relative to the mechanism compressing the clutch spring 103. Because the proximal clicker part 102 is splined to the inner body 20 and the axial load passing through clicker teeth locks the distal clicker part 101 in rotation to the proximal clicker part 102, the mechanism is forced to move axially whilst the dial sleeve 62 and number sleeve 61 are free to spin back into the outer housing 10. The interaction of mating threads between the piston rod 30, driver 40 and inner body 20 delivers a mechanical advantage of, for example, 2:1. In other words, axially advancing driver 40 causes the piston rod 30 to rotate which due to the threaded engagement of piston rod 30 with the inner body 20 advances the piston rod. The piston rod 30 drives the plunger stopper 82 of the cartridge 81 into distal direction so that the medicament formulation 87 containing the one or more pharmaceutically active compound and/or carrier is ejected from the needle attached at the distal end of the cartridge holder 80. Due to the superior break loose and gliding force properties of the plunger stopper 82 (caused by the silicone-free coating 88) the plunger stopper 82 moves easy and constant without bucking. During dose dispensing a dispense clicker is active which involves button 70 and display member 60. The dispense clicker provides primarily audible feedback to the user that drug is being dispensed. Better performance results are especially achieved for stored and aged samples. For the conventional primary packaging system the break loose and gliding forces of the plunger stopper 82 get higher for aged cartridges 81, whereas for the primary packaging system according to the present disclosure the break loose and gliding forces of the plunger stopper 82 of the aged cartridge 81 remain at same values as for the new cartridge 81.

[0074] At this point the dose is complete and when the user removes the force from the end of the dose button 70, the clutch spring 103 pushes this dose button 70 rearwards, re-engaging the teeth between the clutch and the dial sleeve.

[0075] Resetting the device starts with removal of the cartridge holder 80 and replacing an empty cartridge with a full cartridge 81. As the cartridge holder is re-attached, the plunger stopper 82 of the new cartridge contacts bearing 31, thus pushing piston rod 30 back into the housing. Initially, the piston rod 30 screws into the inner body 20, thereby axially disengaging the coupler 43 from the proximal drive sleeve 42 against the biasing force of spring 103. Once disengaged the coupler 43 is free to start rotating together with distal drive sleeve 41 and continues to do so as the cartridge holder 80 is moved axially into engagement with the inner body 20. Thus, the distal drive sleeve 41 rotates with respect to the proximal drive sleeve 42 which is still rotationally constrained in inner body 20 as clicker parts 101 and 102 are pressed together by compressed spring 103. As the distal drive sleeve 41 rotates, last dose nut 50 is reset to its (distal) start position. Coupling the cartridge holder 80 to inner body 20 backs off the mechanism due to the bayonet structure allowing re-engagement of the proximal drive sleeve 42 with coupler 43 and thus the distal drive sleeve 41. Now, an injection may be provided using the new cartridge.

[0076] FIG. 7 shows another embodiment of a drug delivery device, namely a pump device 201. The pump device 201 comprises a device housing 210, a pump drive 201, a plunger rod 230, a primary container 281 comprising a cannula 290 (needle assembly), a plunger stopper 282 and a flanged cap 285 with a sealing disc.

[0077] The primary container 281 is similar to the cartridge 81 of the injection pen 1 which is described above, wherein the sealing disc of the flanged cap 285 is similar to the seal 84. In particular, the primary container 281 comprises a formulation 287 containing a pharmaceutical active compound and/or carrier as indicated above and a container housing 283. Further, the construction of the container housing 283 and of the plunger stopper 282 with a coating 288 and their functioning is similar to the respective elements (housing 83, plunger stopper 82) of the cartridge 82 of the injection pen 1 including all above described embodiments of the injection pen and the plunger stopper 82. Accordingly, it is referred to the explanations above with regard to the injection pen 1 and the plunger stopper 82.

[0078] For administration of medicine (formulation 287) the prefilled primary container 281 is inserted into the housing 210 of the pump device 200. The housing 210 is typically made of plastic material. After insertion of the primary container 281 into the pump device 200, the sealing disc is pierced by the cannula 290 (needle assembly) and the medicament formulation 287 is administered by energizing the pump drive 201 electrically or actuating the pump drive 201 manually (by pressing at the housing) in order to advance the plunger rod 230 (similar to the piston rod 30 of the injection pen 1) thereby driving the plunger stopper 282. The dosing is provided e.g. by pushing a button at the device housing 210. The operation of the plunger stopper 282, the primary container 281 and the cannula 290 (needle assembly) of the pump device 200 is similar to respective elements of the above described injection pen 1.

[0079] With regard to FIGS. 8 and 9 a performance test of the disclosed system with regard to a prior art system is explained. The applied test procedure is according to DIN EN ISO 11608-3:2001-05.

[0080] The prior art system (standard packaging) is a Lantus 3 ml cartridge. The prior art system comprises a 3 ml cylindrical cartridge made of siliconized pharmaceutical glass type I (65 to 72 wt % SiO.sub.2, 5 to 9 wt % Na.sub.2O, less than or equal to 4 wt % CaO, 14 wt % B.sub.2O.sub.3 and 8 to 13 wt % other components). The plunger stopper of the prior art system has a cylindrical form made of Bromobutyl type I, with a silicone coating on all surfaces of the plunger stopper. The cap of the prior art cartridge is composed of an aluminium layer and an integrated laminate sealing disc comprising bromobutyl and polyisopren.

[0081] The prior art system is compared with the disclosed system having a 3 ml siliconized glass cartridge, a chlorobutyl plunger stopper with a silicone-free flurotec coating, and a cap with a laminated sealing disk. The silicone-free coating comprises more than 50 wt % PTFE and has a thickness of approximately 50 m. The plunger stopper has basically the form of the stopper shown in FIG. 6 but does not comprise the cylindrical recess 89. The silicone-free coating covers the surfaces 82a of the second conical section 82C which is in contact with the medicament formulation, the outer surface of the cylindrical section 82A and a distal part of the lateral surface of the first conical section 82B. The silicone-free coating does not cover the proximal end of the lateral surface of the first conical section 82B which is in contact with the driving element of the drug delivery device. A punching edge located at the proximal end of the first conical section 82B is not covered with the silicone-free coating. Along the cylindrical section 82A and the first conical section 82B there are two lamellae at the lateral surface of the plunger stopper both covered with the silicone-free coating. The disclosed system cartridge contains Lantus as the prior art system.

[0082] The Lantus composition is in both cases the composition used in the year 2017.

[0083] The performance test was conducted with 20 samples for the prior art system and the disclosed system using Ametek Lloyd instrument LF plus. The measuring length was 41 mm. As a needle cannula in both cases a BD Micro-Fine Ultra 0.3312.7 mm was used.

[0084] FIG. 8 shows a comparison of the performance after manufacturing (time point 0) of the prior art system and the disclosed system. It can be derived from the diagram, that the break loose force for both systems is approximately the same. At a short distance the gliding force for the prior art system is slightly smaller compared with the disclosed system, whereas from a longer distance on, the gliding force is the same for both systems.

[0085] FIG. 9 depicts the performance test of the systems after 6 month storage of the 20 samples for each system at 5 C. The performance test was conducted with 20 samples for the prior art system and the disclosed system using Ametek Lloyd instrument LF plus. The measuring length was 41 mm. As a needle cannula in both cases a BD Micro-Fine Ultra 0.3312.7 mm was used. The diagram shows that the break loose force of the prior art system is considerably higher than the break loose force of the disclosed system. At short distances, the gliding force of the prior art system is slightly smaller compared with the disclosed system, whereas at long distances, the gliding force of the disclosed system is smaller than the gliding force of the prior art system.