Abstract:
The present invention relates to a drug delivery for dispensing of a dose of a medicament comprising:
       a housing, adapted to receive a drive mechanism,   a cartridge holder to receive a cartridge comprising a medicament, and   a protective cap adapted to at least partially enclose a distal end section of the cartridge holder and being pivot mounted on the housing or on the cartridge holder.

Description:
CROSS REFERENCE TO RELATED APPLICATIONS 
       [0001]    The present application is a U.S. National Phase Application pursuant to 35 U.S.C. §371 of International Application No. PCT/EP2012/055055 filed Mar. 22, 2012, which claims priority to European Patent Application No. 11159305.9 filed Mar. 23, 2011. The entire disclosure contents of these applications are herewith incorporated by reference into the present application. 
     
    
     FIELD OF INVENTION 
       [0002]    The present invention relates to a drug delivery device adapted to administer a dose of a medicament by way of injection. In particular, the invention refers to pen-type injectors for dispensing a predefined dose of a medicament. 
         [0003]    It is therefore an object of the present invention to provide a drug delivery device being less susceptible to damage and providing an easy and unambiguous handling when in use. It is a further object to encourage or even to oblige the user to make use of protection caps for protecting the distal end section of a cartridge holder, which is typically adapted to receive a piercing assembly. Moreover, it is a particular object of the invention, to prevent damage or loss of the protective cap of a drug delivery device. 
       BACKGROUND 
       [0004]    Drug delivery devices for setting and dispensing multiple doses of a liquid medicament are as such well-known in the art. Generally, such devices have substantially a similar purpose as that of an ordinary syringe. 
         [0005]    Drug delivery devices, in particular pen-type injectors have to meet a number of user specific requirements. For instance, with patients&#39; suffering a chronic disease e.g. diabetes, the patient may be physically infirm and may also have impaired vision. Therefore, suitable drug delivery devices need to be robust in construction and should be easy to use. Furthermore, manipulation and general handling of the device and its components should be intelligible and understandable. Moreover, a dose setting and a dose dispensing procedure must be easy to operate and unambiguous. When the device is of disposable type, it should be inexpensive to manufacture and easy to dispose. In order to meet these requirements, the number of parts and steps required to utilize the device should be kept to a minimum. 
         [0006]    Typically, the medicament to be administered is provided in a cartridge comprising a moveable piston or bung mechanically interacting with a piston rod of a drive mechanism of the drug delivery device. By applying thrust to the piston in distal direction, a pre-defined amount of the liquid medicament can be expelled from the cartridge. 
         [0007]    In particular for elderly or physically infirm users, the overall handling of the device, in particular in a home medication environment should be simple and highly reliable. Typically, drug delivery devices and in particular pen-type injectors comprise a multi-component housing. A distal end section which is adapted to be releasably coupled with a needle assembly is typically protected by a removable protective cap. 
         [0008]    For instance, document US 2008/0108951 A1 discloses a storage system for a needleless delivery device syringe and a hypodermic needle adapted for attachment and use with the pen device. There, the storage system comprises a pen needle storage cap that includes a collar which removably snap-fits to a dust sleeve, and which in turn removably snap-fits to the pen delivery device syringe. 
         [0009]    Document GB 418 131 A further discloses an opened syringe, having a syringe body and a hinged part, which is pivotally connected with the syringe body by means of a slide. 
         [0010]    Document GB 2 461 732 A shows a side loading pen injector comprising a hinged cartridge cover and a plunger. There, the cartridge cover has a pawl engaging with teeth on the outside of a push rod connected to a plunger. 
         [0011]    Moreover, document EP 1 346 739 A1 shows a shield hingedly mounted to a distal end of a cartridge holder, which can rotate from an initial configuration into a protected position, where a needle attached to distal end of the cartridge holder is shielded. 
         [0012]    In practical use, it may occur, that some of these housing components get lost or immobilize in the course of a dose dispensing or cartridge replacement procedure. For instance, the pen body housing, the cartridge holder and/or the protective cap due to their overall cylindrical geometry may roll away and may drop down from a support structure, e.g. from a table. Hence, In this way, loose and detached components of the drug delivery device may get lost and the end user laboriously would have to look for them 
       SUMMARY 
       [0013]    The drug delivery device according to the invention is adapted to dispense a dose of a medicament, e.g. insulin or heparin. The device comprises a housing which is adapted to receive and to house a drive mechanism. The device further comprises a cartridge holder to receive a cartridge containing a medicament. Typically, the cartridge is designed as a carpule, as a vial or as an ampoule and comprises a pierceable seal at a distal end as well as a moveable piston serving as a proximal seal. By way of a piston rod to be operably engaged with the proximally located piston, distally directed pressure can be applied to the piston in order to expel a pre-defined amount of the medicament via the distally located seal, which is typically pierced or intersected by a piercing element, like an injection needle or cannula. The distally directed forward movement of the piston rod is controlled and conducted by the drive mechanism. 
         [0014]    The distal end section of the cartridge holder typically comprises a threaded socket adapted to receive a correspondingly threaded disposable piercing assembly. After use of the device, the piercing assembly is to be detached from the cartridge holder and is intended to be discarded. Since the distal end face of the cartridge holder provides direct access to the penetrable seal of the cartridge it should be protected against environmental influences, in particular against dust and moisture. 
         [0015]    In order to protect the cartridge holder and in particular its distally located end section, a protective cap is provided which is adapted to least partially enclose or cover the distal end section of the cartridge holder. The protective cap is pivot mounted on the housing or on the cartridge holder. It cannot be detached therefrom and can therefore not get lost or otherwise damaged during use or maintenance of the drug delivery device. 
         [0016]    Generally, the protective cap comprises a cupped geometry. It is pivot mounted on the housing or on the cartridge holder with a proximally located end section. This way, the distally located end section is free to move relative to the cartridge holder. It can simply flapped or turned away in order to provide access to the distal portion of the cartridge holder. When flapped away and transferred into a position of use, the piercing assembly can be mounted on the cartridge holder and a dose setting and dose dispensing procedure may be conducted. 
         [0017]    According to a preferred embodiment, the protective cap is firmly connected to the housing or to the cartridge holder. By way of the pivot mount, the protective cap remains permanently attached to the housing or to the cartridge holder of the drug delivery device. It may even be advantageous, when the protective cap is transferable in a position of use, which does not allow to set the drug delivery device aside in a storage container. Hence, for laying away the drug delivery device after use, the user may be obliged to remove and to discard the disposable piercing assembly in order to return the protective cap into its initial position on the cartridge holder. In particular, the size and geometry of the protective cap requires disassembly of the piercing assembly prior to put the protective cap on the cartridge holder. 
         [0018]    According to a further preferred embodiment, the pivot axis of the protective cap extends substantially perpendicular to the longitudinal extent of the housing and/or the longitudinal extent of the cartridge holder. Typically, the housing, the cartridge holder and/or the protective cap are of substantially cylindrical geometry. The pivot axis of the protective cap preferably extends in a transverse plane and in radial direction with respect to the cylinder long axis of housing, cartridge holder and/or protective cap. Furthermore, the pivot axis intersects the long axis of the drug delivery device. This way, starting from an initial configuration, the protective cap can be flapped away in a sideward directed motion into a position of use, in which the drug delivery device is ready to set and/or to dispense a dose of the medicament. 
         [0019]    For the pivot motion of the protective cap, it is of further benefit, when the cap comprises at least one lateral slit facing towards and/or away from a pivot direction. Typically, the at least one lateral slit corresponds in size with the dimension of the cartridge holder. This way, a sideward directed pivot motion of cartridge holder and protective cap is enabled. 
         [0020]    Additionally, the lateral slit may be provided with sealing elements, such like flexible lips or other flexible closure means, like a brush strip allowing for a pivoting displacement of the protective cap relative to the cartridge holder or housing, respectively. 
         [0021]    Moreover, it is even of further benefit, when the protective cap comprises two lateral slits arranged on opposite side wall sections of the protective cap. The second lateral slit may face towards the initial pivot direction whereas a second lateral slit may face in opposite direction. In this context, the initial pivot direction denotes the direction the cap is turned to when pivoted from an initial position to a position of use. This way, even a pivot angle of about 180° can be realized allowing to bring the protective cap in overlapping arrangement with the proximally located housing. The first slit is thus adapted to receive the circumference of the housing while the second slit corresponds with the geometry of the cartridge holder. 
         [0022]    According to another preferred embodiment, the protective cap and the housing and/or the protective cap and the cartridge holder comprise mutually corresponding fixing means. By way of such fixing means, providing e.g. a positive or frictional interlocking of the protective cap with the housing and/or with the cartridge holder, the cap can be fixed and secured in an initial configuration and/or in a position of use. It is of particular benefit, when the position of use of the protective cap substantially overlaps with the housing of the drug delivery device. Gripping and general handling of the device and its functions can be facilitated in this way. 
         [0023]    According to another aspect, the protective cap is slidingly guided on the housing or on the cartridge holder. Starting from an initial configuration, in which the protective cap at least partially covers the cartridge holder, the protective cap may be slidingly displaced initially in distal direction with respect to the cartridge holder in order to enable a pivoting of the protective cap with respect to the cartridge holder. Subsequently, the cap may be pivoted towards the proximal end section of the drug delivery device, hence along the initial pivot direction. In order to receive the proximal end section of the housing, the cap may be slidingly displaced in the opposite, hence, proximal direction and may cover the proximal end of the housing. Subsequently, e.g. for fixing the housing and the protective cap, the cap may be displaced in distal direction along a sliding guide. 
         [0024]    According to a further embodiment, the protective cap is slidingly guided in longitudinal direction relative to the cartridge holder and/or relative to the housing, to interlock and/or to release the protective cap and the housing and/or to interlock and/or to release the protective cap and the cartridge holder. A combined sliding and pivoting interconnection of protective cap with either cartridge holder or housing may inherently provide mutual interlocking and releasing of the protective cap with respect to the housing and/or with respect to the cartridge holder. 
         [0025]    Finally, the drug delivery device comprises a cartridge being at least partially filled with the medicament to be dispensed. The drug delivery device may be particularly designed as disposable device, wherein an empty cartridge is not intended to be replaced by a filled or new one. Instead, the entire device is intended to be discarded when the medicament contained in the cartridge is used up. 
         [0026]    The term “medicament”, as used herein, means a pharmaceutical formulation containing at least one pharmaceutically active compound, 
         [0027]    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, a antibody, an enzyme, an antibody, a hormone or an oligonucleotide, or a mixture of the above-mentioned pharmaceutically active compound, 
         [0028]    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, 
         [0029]    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, 
         [0030]    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 exedin-3 or exedin-4 or an analogue or derivative of exedin-3 or exedin-4. 
         [0031]    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(B 28)  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. 
         [0032]    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-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin. 
         [0033]    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-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2. 
         [0034]    Exendin-4 derivatives are for example selected from the following list of compounds: 
         [0035]    H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2, 
         [0036]    H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2, 
         [0037]    des Pro36 [Asp28] Exendin-4(1-39), 
         [0038]    des Pro36 [IsoAsp28] Exendin-4(1-39), 
         [0039]    des Pro36 [Met(O)14, Asp28] Exendin-4(1-39), 
         [0040]    des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39), 
         [0041]    des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39), 
         [0042]    des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39), 
         [0043]    des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39), 
         [0044]    des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); or 
         [0045]    des Pro36 [Asp28] Exendin-4(1-39), 
         [0046]    des Pro36 [IsoAsp28] Exendin-4(1-39), 
         [0047]    des Pro36 [Met(O)14, Asp28] Exendin-4(1-39), 
         [0048]    des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39), 
         [0049]    des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39), 
         [0050]    des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39), 
         [0051]    des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39), 
         [0052]    des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39), 
         [0053]    wherein the group -Lys6-NH2 may be bound to the C-terminus of the Exendin-4 derivative; 
         [0054]    or an Exendin-4 derivative of the sequence 
         [0055]    H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2, 
         [0056]    des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2, 
         [0057]    -(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2, 
         [0058]    H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-NH2, 
         [0059]    des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
         [0060]    H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
         [0061]    H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
         [0062]    H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2, 
         [0063]    H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2) 25 ] Exendin-4(1-39)-NH2, 
         [0064]    H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, 
         [0065]    H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-H2, 
         [0066]    des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
         [0067]    H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
         [0068]    H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
         [0069]    H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2, 
         [0070]    des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2, 
         [0071]    H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, 
         [0072]    H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, 
         [0073]    des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
         [0074]    H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
         [0075]    H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
         [0076]    H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2, 
         [0077]    H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25] Exendin-4(1-39)-NH2, 
         [0078]    H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28] Exendin-4(1-39)-NH2, 
         [0079]    H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-NH2, 
         [0080]    des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2, 
         [0081]    H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(S1-39)-(Lys)6-NH2, 
         [0082]    H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2; 
         [0083]    or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned Exedin-4 derivative. 
         [0084]    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. 
         [0085]    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. 
         [0086]    Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Acid addition salts are e.g. HCl 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&#39;s Pharmaceutical Sciences” 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of Pharmaceutical Technology. 
         [0087]    Pharmaceutically acceptable solvates are for example hydrates. 
         [0088]    It will be further apparent to those skilled in the pertinent art that various modifications and variations can be made to the present invention without departing from the spirit and scope of the invention. Further, it is to be noted, that any reference signs used in the appended claims are not to be construed as limiting the scope of the present invention. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0089]    In the following, preferred embodiments of the invention will be described in greater detail by making reference to the drawings in which: 
           [0090]      FIG. 1  illustrates a pen-type injector in a perspective view according to the prior art, 
           [0091]      FIG. 2  shows the pen-type injector according to  FIG. 1  in an exploded view, 
           [0092]      FIG. 3  shows a schematic sketch of a pen-type injector having a pivot-mounted protective cap, 
           [0093]      FIG. 4  is illustrative of the device according to  FIG. 3  with the cap in a first pivot position and 
           [0094]      FIG. 5  shows the device according to  FIGS. 3 and 4  with the cap in a second pivot position, 
           [0095]      FIG. 6  shows another embodiment of a pivot mounted protective cap hingedly attached to the cartridge holder, 
           [0096]      FIG. 7  shows the embodiment according to  FIG. 6  with the protective cap in a first pivot position, and 
           [0097]      FIG. 8  shows the drug delivery device according to  FIGS. 6 and 7  with the protective cap pivoted by about 180°. 
       
    
    
     DETAILED DESCRIPTION 
       [0098]      FIG. 1  schematically illustrates a drug delivery device  10  according to the prior art designed as a pen-type injector. The device  10  comprises a proximal housing component  12  as well as a distal housing component  14 . The distal housing component  14  may be designed as a protective cap, alternatively as a cartridge holder  18  to keep a cartridge  26  filled with a medicament in position. At a proximal end  15 , the drug delivery device comprises a dose button  16  by way of which a dose to be dispensed by the device  10  can be individually selected and dispensed. The distal end  17  of the drug delivery device  10  and in particular the distal section of a cartridge holder  18  is adapted to be releasably coupled with a piercing assembly, such like an injection needle, in order to dispense a pre-defined amount of the liquid medicament by way of injection. Therefore, distally located end section  17  of the cartridge holder  18  comprises a threaded socket. The cartridge holder  18  further comprises at least one inspection window  19  in order to visually inspect the filing level of the cartridge  26 . 
         [0099]    The cartridge  26  itself is at least partially filled with a medicament to be dispensed by the device  10 . The cartridge  26  comprises a distally located seal  28  adapted to be intersected or pierced by a piercing assembly, which is not particularly illustrated here. Towards its proximal end section the cartridge  26  comprises a displacable seal in form of a piston to become operably engaged with the piston rod  30  of a drive mechanism arranged in the proximal housing component  12 . 
         [0100]    In  FIG. 3 , a simplified view of a drug delivery device  10  according to the present invention is illustrated. The device  10  comprises a proximally located housing component  12  and a protective cap  14  at least partially covering the distally located directed and downward pointing cartridge holder  18 . The protective cap  14  is pivot mounted by way of a hinge  20  on a distal portion of the housing  12 . As illustrated in the course of  FIGS. 3 to 5 , the protective cap  14  starting from an initial configuration as shown in  FIG. 3  can be flapped away in a sideward direction  36  in order to provide access to the cartridge holder  18  and its distal end portion  32 . The protective cap  14  is connected with the hinge  20  near its proximal portion in order to enable a respective displacement of its distal portion relative to the cartridge holder  18 . 
         [0101]    In order to provide and to enable a pivoting motion of the protective cap  14 , the cap itself comprises at least one lateral slit  22 , which, in  FIGS. 3 to 5 , is only indicated. Said lateral slit or through opening  22  is arranged on a lateral side wall portion of the protective cap  14  facing away from the initial pivot direction  36  as indicated in  FIG. 3 . This way, the cartridge holder  18  with its distal end section  32  may penetrate said slit or through opening  22  when the protective cap  14  is flapped away. Similarly, when starting from a position of use as indicated in  FIG. 5 , said lateral opening  22  in the protective cap  14  allows to receive the cartridge holder  18  of the drug delivery device  10 . 
         [0102]    In the embodiment according to the  FIGS. 6 to 8 , the protective cap  34  is pivot mounted on the cartridge holder  18 . Furthermore, the protective cap  34  comprises two oppositely located slits or through openings  22 ,  24 . By way of the second through opening  24  facing towards the pivot direction  36 , the protective cap  34  can even be pivoted or rotated by about 180°. The cap  34  may therefore receive the proximally located housing  12  of the drug delivery device  10 . In such a position of use as indicated in  FIG. 8 , an easy and intuitive handling of the drug delivery device  10  can be provided. 
         [0103]    Additionally or according to another embodiment, the protective cap  34  may even be slidingly supported relative to the cartridge holder  18  and/or relative to the housing  12  in distal and/or proximal direction as indicated by the double-tipped arrow  38  in  FIG. 6 . By way of a longitudinal, distally or proximally directed relative displacement of protective cap  34  and cartridge holder  18 , mutual interlocking of protective cap  34  and cartridge holder  18  and/or interlocking of protective cap  34  with the housing  12  can be provided. Hence, unintentional pivoting of the protective cap  34  relative to the cartridge holder  18  or relative to the housing  12  can be impeded. Additionally, by providing a translational displacement between cartridge holder  18  and protective cap  34  or between housing  12  and protective cap  34 , the size and geometry of the lateral slit or slits  22 ,  24  can be adapted accordingly.