Injection device

Abstract

The invention relates to an injection device (1), comprising: a housing (2) containing a dose setting mechanism; a cartridge holder (3) containing a cartridge with a medicament; and a heat shrink label (8), the heat shrink label comprising information (9) and / or a symbol about the medicament. The injection device (1) is a disposable injection device (1), wherein the cartridge holder (3) is inseparably locked to the housing (2). The heat shrink label (8) is heat shrunk on the housing (2) and the cartridge holder (3) so that it at least partially covers the housing (2) and the cartridge holder (3).

Description

[0001] The present invention relates generally to a drug delivery device (eg, an injection device for selecting and dispensing several user-variable doses of a medicament), and more particularly to a disposable injection device.

[0002] Pen-type drug delivery devices are suitable for situations where regular injections are performed by personnel without formal medical training. This may become increasingly common in patients with diabetes, for whom self-treatment enables these patients to effectively manage their disease. In practice, such drug delivery devices allow the user to individually select and dispense several user-variable doses of a medicament. The present invention further relates to autoinjectors, syringes and so-called fixed dose devices, which only allow a predetermined dose to be dispensed, without the possibility of increasing or decreasing the set dose.

[0003] There are basically two types of drug delivery devices: resettable devices (i.e., reusable) and non-resettable devices (i.e., disposable). For example, disposable pen delivery devices are supplied as self-contained devices. Such stand-alone devices do not have a removable pre-filled cartridge. Rather, the pre-filled cartridge cannot be removed and replaced from these devices without destroying the device itself. Therefore, such disposable devices do not need to have a resettable dose setting mechanism. The present invention relates to disposable devices.

[0004] These types of pen delivery devices (so named because they are generally similar to enlarged fountain pens) generally include three main elements: a cartridge section, which includes a cartridge generally contained in a housing or holder; a needle assembly connected to one end of the cartridge section; and a dosing section connected to the other end of the cartridge section. The cartridge (often referred to as an ampoule) typically includes a reservoir filled with a medicament (e.g., insulin), a removable rubber-type stopper or obstruction at one end of the cartridge reservoir, and a top with a pierceable rubber seal at the other end (usually a necked end). A curled annular metal band is typically used to hold the rubber seal in place. The cartridge housing can typically be made of plastic, while the cartridge reservoir has historically been made of glass.

[0005] The needle assembly is typically a replaceable double-ended needle assembly. Before injection, the replaceable double-ended needle assembly is attached to one end of the cartridge assembly, the dose is set, and the set dose is then administered. Such a removable needle assembly can be screwed or pushed (i.e., snapped) onto the pierceable sealed end of the cartridge assembly.

[0006] The dosing section or dose setting mechanism is typically the portion of a pen device used to set (select) a dose. During the injection process, the spindle or piston rod contained in the dose setting mechanism presses against the bung or stopper of the cartridge. This force causes the medicament contained in the cartridge to be injected through the attached needle assembly. After the injection, the needle assembly is removed and discarded as most drug delivery device and / or needle assembly manufacturers and suppliers generally recommend.

[0007] A further distinction in drug delivery device types relates to the drive mechanism: there are devices that are manually driven, for example by the user applying a force to an injection button; there are devices that are driven by a spring or the like; and devices that combine both concepts, i.e. spring-assisted devices that still require the user to apply the injection force. Spring-type devices include preloaded springs and springs that are loaded by the user during dose selection. Some stored energy devices use a combination of spring preload and additional energy provided by the user, for example during dose setting.

[0008] WO 2012 / 020084 A2 discloses a reusable drug delivery device with a cartridge holder, the cartridge holder comprising a cartridge or similar reservoir filled with a medicament. If the medicament in the cartridge runs out, the cartridge can be replaced. In order to replace the empty cartridge, the user needs to remove the cartridge holder from the dose setting mechanism. The heat shrink label is positioned on a portion of the cartridge and a portion of the connector so that the heat shrink member maintains the connector on the reservoir. The size of the connector is determined to cooperate with the drug delivery device (the cartridge holder or dose setting member of the drug delivery device), thereby preventing the inadvertent cross-use of the cartridge assembly and the inadvertent cross-use of the medicament.

[0009] An example of a disposable injection device with an outer housing containing a dose setting mechanism is known from WO 2014 / 033197 A1. In this device, the outer housing is a generally tubular element having a distal portion forming a cartridge holder for receiving a cartridge and a proximal portion forming an outer body. The outer housing is transparent, while the outer body is provided with an opaque layer. The opaque layer covers most of the outer body except for the transparent window.

[0010] In a disposable drug delivery device, a dose setting mechanism is typically adapted to the cartridge and the medicament contained therein, enabling a user to accurately set and dispense a certain amount of medicament using the drug delivery device. Therefore, replacing a cartridge may have a negative impact on dose accuracy and may therefore lead to health problems. It is desirable to prevent a user from replacing an empty cartridge in a disposable drug delivery device with a cartridge that is not suitable for the corresponding dose setting mechanism. It is also desirable to display any attempt to manipulate the drug delivery device.

[0011] It is therefore an object of the present invention to provide an improved injection device having a mechanism for preventing accidental use of a manipulated device.

[0012] This object is solved by an injection device as defined in claim 1 .

[0013] The injection device preferably comprises: a housing including a dose setting mechanism; a cartridge holder, the cartridge holder containing a cartridge with a medicament; and a heat shrink label, the heat shrink label including information and / or symbols about the medicament. In a disposable injection device according to one aspect of the present invention, the cartridge holder is inseparably locked to the housing. In other words, in such a disposable injection device, the housing and the cartridge holder are integrally formed, locked or permanently attached to each other so that the cartridge holder should not be removed from the housing by the user of the injection device. If the heat shrink label is heat shrunk on the housing and the cartridge holder so that it at least partially covers the housing and the cartridge holder, the label can be used to show whether the device is in its original state. A damaged label indicates that the device may have been manipulated. According to an embodiment, the label that at least partially covers the housing and the cartridge holder can be a label that at least covers the interface between the cartridge holder and the housing or the bridge or transition zone between the cartridge holder and the housing.

[0014] In a disposable injection device, the housing and the cartridge holder may be formed as an integral component. As an alternative, the cartridge holder may be permanently attached to the housing, for example by means of snap features, welding, gluing, etc. In addition to indicating whether the device may have been manipulated, providing a heat shrink label provides additional strength to prevent removal of the cartridge holder from the housing.

[0015] In conventional injection devices, information and / or symbols about medicament are usually provided by means of adhesive labels or by printing on the outer surface of the device. Placing adhesive labels in the correct position on the device is sometimes difficult, and depending on the material used for housing or cartridge holder, it may be difficult to permanently provide information and / or symbols by printing. In contrast, heat shrink labels have the additional benefit of promoting permanent provision of information and / or symbols. Information and / or symbols can not only include information about medicament, such as the name of medicament and / or manufacturer and / or dealer, the name of active ingredient, concentration and / or quantity, production and / or expiration date, but also can include at least one color code, at least one scale, at least one frame, at least one indicator, etc. Information and / or symbols can be visible and / or touchable (e.g., in Braille). Further, information and / or symbols allowing tactile distinction can be provided.

[0016] According to one aspect of the invention, the heat shrink label has the form of a sheath at least partially covering the housing and the cartridge holder. By such a sleeve-like configuration of the label, it is easy to insert the device into the sheath, thereby placing the label in a predetermined position. The sleeve-like form of the sheath is suitable for completely covering the area of ​​the device where the cartridge holder is attached to the housing or the cartridge holder continues into the housing. Therefore, the label in the form of a sheath is suitable for shielding the area of ​​the device where any manipulation is most likely to occur.

[0017] The heat shrink label may include at least a transparent or translucent portion positioned on the housing to overlap a window provided in the housing. Additionally or alternatively, the heat shrink label may form a window covering an aperture in the housing. Such a window is typically used in conjunction with a dose setting mechanism to display the current set dose of the device. For example, a number sleeve or display sleeve may be moved relative to the housing during the dose setting process of the device so that a number or symbol corresponding to the set dose is visible through a window or peephole of the housing.

[0018] The information and / or symbols are preferably printed on the inner surface of the heat shrink label. Compared with conventional adhesive labels, this can prevent the information on the label from being lost due to wear or tear. For example, the information and / or symbols include a scale positioned on the cartridge holder and information about the medicament positioned on the housing. This facilitates the production of the cartridge holder and the housing, as there is no need to provide the information and / or symbols and align them separately on the cartridge holder and the housing. Further, the outer surface of the heat shrink label can be painted in whole or in part to give the device.

[0019] Preferably, the heat shrink label consists of PET (polyethylene terephthalate) or OPP (oriented polypropylene). Additionally or alternatively, the heat shrink label consists of and / or is provided with a layer that inhibits the transmission of actinic light. This has the benefit of protecting the medicament contained in the cartridge. Further, the heat shrink label may have a photochromic function, for example, providing a color change due to exposure to sunlight. Still further, the heat shrink label may consist of a biodegradable material.

[0020] Further, the heat shrink label may include electronic components and / or maintain electronic components on the housing and / or on the cartridge holder. For example, the heat shrink label may include a temperature measurement strip. In another example, the heat shrink label may position and maintain an additional device or component in or on the disposable injection device, preferably on its housing. Such additional devices or components may include a communication unit for sending and / or receiving data, a display unit for indicating a target dose value and / or an actual dose value, a readout unit for recording values, at least one sensor for detecting the position, state, motion, direction of motion and / or acceleration of at least one component of the injection device, or the like. The heat shrink label may be used as the only fastener for such components, or may be used in addition to additional attachment devices.

[0021] According to a further aspect of the invention, the heat shrink label may include at least one weakened line that allows a portion of the heat shrink label to be disconnected and removed. The weakened line may be a perforated line, a cut line, a discontinuous line and / or a line that is thinner or made of a weaker material. The at least one weakened line may be provided with a tear strip or tap that facilitates disconnection of the heat shrink label along a predetermined line. The at least one weakened line may extend, for example, axially, circumferentially and / or radially.

[0022] For example, the cartridge holder includes an interface for attaching a needle on the cartridge holder, wherein the heat shrink label includes a first cap portion covering the interface for attaching the needle, and wherein at least one weakening line is positioned to allow disconnection and removal of the first cap portion. In addition or as an alternative, the dose setting mechanism may include a dose setting member protruding from the housing, wherein the heat shrink label includes a second cap portion covering the dose setting member, and wherein at least one weakening line is positioned to allow disconnection and removal of the second cap portion. Further, the disposable injection device may include a component that must be activated and / or manipulated to start a dose setting procedure and / or a dose dispensing procedure. This component may be a separate component or may be the same as the dose setting component. In the case where this component is a separate part, the portion of the heat shrink label provided with a weakening line may cover this component. In other words, a portion of the heat shrink label may be used as a tamper-proof closure for the device or a portion thereof.

[0023] According to the present invention, the label is heat shrunk onto the injection device.In addition, the heat shrink label can be glued or welded onto the housing and / or on the cartridge holder.

[0024] In an embodiment of the present invention, the dose setting mechanism of the injection device is generally designed and functions as described in WO 2014 / 033197 A1.

[0025] The injection device typically comprises a cartridge containing a medicament. As used herein, the term "medicament" means a pharmaceutical preparation comprising at least one pharmaceutically active compound,

[0026] In one embodiment, the pharmaceutically active compound has a molecular weight of up to 1500 Da, and / or is a peptide, protein, polysaccharide, vaccine, DNA, RNA, enzyme, antibody or antibody fragment, hormone or oligonucleotide, or a mixture of the above pharmaceutically active compounds,

[0027] Wherein in other embodiments, the pharmaceutically active compound can be used to treat and / or prevent diabetes or complications associated with diabetes (such as diabetic retinopathy), thromboembolic disease (such as deep vein or pulmonary thromboembolism), acute coronary syndrome (ACS), angina pectoris, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis,

[0028] Wherein in another embodiment, the pharmaceutically active compound comprises at least one peptide for the treatment and / or prevention of diabetes or complications associated with diabetes (such as diabetic retinopathy),

[0029] In other embodiments, the pharmaceutically active compound includes at least one human insulin or human insulin analog or derivative, glucagon-like peptide (GLP-1) or an analog or derivative thereof, or exendin-3 or exendin-4, or an analog or derivative of exendin-3 or exendin-4.

[0030] Insulin analogs 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 in which the proline at position B28 is replaced by Asp, Lys, Leu, Val or Ala, and in which 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.

[0031] Insulin derivatives 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-myristoylLysB28ProB29 human insulin; B28-N-palmitoyl-LysB28ProB29 human insulin; B30-N-myristoyl-ThrB2 9LysB30 human insulin; B30-N-palmitoyl-ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-γ-glutamyl)-des(B30) human insulin; B29-N-(N-lithocholyl-γ-glutamyl)-des(B30) human insulin; B29-N-(ω-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(ω-carboxyheptadecanoyl) human insulin.

[0032] Exendin-4 refers, for example, to Exendin-4 (1-39), a peptide having the following 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.

[0033] The exendin-4 derivative is, for example, selected from the following list of compounds:

[0034] H-(Lys)4-des Pro36,des Pro37 exendin-4(1-39)-NH2,

[0035] H-(Lys)5-des Pro36,des Pro37 exendin-4(1-39)-NH2,

[0036] des Pro36 exendin-4 (1-39),

[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)14Trp(O2)25,Asp28]exendin-4(1-39),

[0044] des Pro36[Met(O)14Trp(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)14Trp(O2)25,Asp28]exendin-4(1-39),

[0052] des Pro36[Met(O)14Trp(O2)25,IsoAsp28]exendin-4(1-39),

[0053] The group -Lys6-NH2 can bind to the C-terminus of the exendin-4 derivative;

[0054] or an exendin-4 derivative having the following sequence:

[0055] des Pro36 exendin-4(1-39)-Lys6-NH2(AVE0010),

[0056] H-(Lys)6-des Pro36[Asp28] exendin-4(1-39)-Lys6-NH2,

[0057] des Asp28 Pro36,Pro37,Pro38 Exendin-4(1-39)-NH2,

[0058] H-(Lys)6-des Pro36,Pro38[Asp28]exendin-4(1-39)-NH2,

[0059] H-Asn-(Glu)5des Pro36,Pro37,Pro38[Asp28]exendin-4(1-39)-NH2,

[0060] des Pro36, Pro37, Pro38 [Asp28] exendin-4 (1-39) - (Lys) 6-NH2,

[0061] H-(Lys)6-des Pro36,Pro37,Pro38[Asp28] exendin-4(1-39)-(Lys)6-NH2,

[0062] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Asp28] exendin-4(1-39)-(Lys)6-NH2,

[0063] H-(Lys)6-des Pro36[Trp(O2)25,Asp28] exendin-4(1-39)-Lys6-NH2,

[0064] H-des Asp28 Pro36,Pro37,Pro38[Trp(O2)25]exendin-4(1-39)-NH2,

[0065] H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exendin-4(1-39)-NH2,

[0066] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28]exendin-4(1-39)-NH2,

[0067] des Pro36, Pro37, Pro38 [Trp (O2) 25, Asp28] exendin-4 (1-39) - (Lys) 6-NH2,

[0068] H-(Lys)6-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28] exendin-4(1-39)-(Lys)6-NH2,

[0069] H-Asn-(Glu)5-des Pro36,Pro37,Pro38[Trp(O2)25,Asp28] exendin-4(1-39)-(Lys)6-NH2,

[0070] H-(Lys)6-des Pro36[Met(O)14,Asp28] exendin-4(1-39)-Lys6-NH2, des Met(O)14Asp28 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)5des 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 of the above exendin-4 derivatives.

[0084] Hormones are, for example, pituitary hormones or hypothalamic hormones or regulatory active peptides as listed in Chapter 50 of the Rote Liste, 2008 edition, and their antagonists, such as gonadotropins (Follitropin, Luteinizing Hormone, Choriongonadotropin, Gametogenic Hormone), somatropine (Somatropin), desmopressin, terlipressin, gonadorelin, triptorelin, leuprorelin, buserelin, nafarelin, goserelin.

[0085] The polysaccharide is, for example, a glycosaminoglycan, hyaluronic acid, heparin, a low molecular weight heparin or an ultra-low molecular weight heparin or a derivative thereof, or a sulfated form (e.g., a polysulfated form) of the polysaccharide, and / or a pharmaceutically acceptable salt thereof. An example of a pharmaceutically acceptable salt of a polysulfated low molecular weight heparin is enoxaparin sodium.

[0086] Antibodies are globular plasma proteins (about 150 kDa), also called immunoglobulins, that share a basic structure. They are glycoproteins because of the addition of sugar chains to amino acid residues. The basic functional unit of each antibody is the immunoglobulin (Ig) monomer (containing only one Ig unit); secreted antibodies can also be dimers with two Ig units (such as IgA), tetramers with four Ig units (such as bony fish IgM), or pentamers with five Ig units (such as mammalian IgM).

[0087] The Ig monomer is a "Y" shaped molecule composed of four polypeptide chains; two identical heavy chains and two identical light chains are 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. The heavy and light chains each contain intrachain disulfide bonds that stabilize their folding. Each chain is composed of domains called Ig domains. These domains contain about 70-110 amino acids and are divided into different categories (such as variable regions or V regions and constant regions or C regions) based on their size and function. These domains have a characteristic immunoglobulin fold, in which two beta folds are "sandwiched" and held together by interactions between conserved cysteines and other charged amino acids.

[0088] There are five types of mammalian Ig heavy chains, denoted α, δ, ε, γ, and μ. The type of heavy chain present defines the antibody's isotype; these chains are found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.

[0089] The size and composition of different heavy chains vary; α and γ contain about 450 amino acids, and δ contains about 500 amino acids, while μ and ε contain about 550 amino acids. Each heavy chain has two regions, a constant region (CH) and a variable region (VH). In one species, the constant region is essentially the same in all antibodies of the same isotype, but different in antibodies of different isotypes. Heavy chains γ, α and δ have a constant region consisting of three tandem Ig domains, and a hinge region for increased flexibility; heavy chains μ and ε have a constant region consisting of four immunoglobulin domains. The variable region of the heavy chain is different 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 about 110 amino acids long and consists of a single Ig domain.

[0090] In mammals, there are two types of immunoglobulin light chains, denoted by λ and κ. A light chain has two consecutive domains: a constant domain (CL) and a variable domain (VL). The approximate length of a light chain is 211 to 217 amino acids. Each antibody contains two light chains that are always identical; in mammals, only one type of light chain, κ or λ, exists for each antibody.

[0091] Although the general structure of all antibodies is very similar, the unique properties of a given antibody are determined by the variable (V) regions as detailed above. More specifically, the variable loops (three per light chain (VL) and three on the heavy chain (VH)) are responsible for binding to the antigen, i.e., for its antigen specificity. These loops are called complementarity determining regions (CDRs). Because the CDRs from the VH domain and the VL domain constitute the antigen binding site, it is the combination of the heavy and light chains (rather than each alone) that determines the final antigen specificity.

[0092] "Antibody fragments" include at least one antigen-binding fragment as defined above, and exhibit essentially the same function and specificity as the complete antibody from which they are derived. Limited proteolysis with papain cleaves the Ig prototype into three fragments. Two identical amino-terminal fragments are antigen-binding fragments (Fab), each containing a complete L chain and about half of an H chain. The third fragment is a crystallizable fragment (Fc), which is similar in size but contains the carboxyl-terminal half of the two heavy chains and their interchain disulfide bonds. Fc contains carbohydrates, complement binding sites, and FcR binding sites. Limited pepsin digestion produces a single F(ab')2 fragment, which contains both the Fab segment and the hinge region, including the HH interchain disulfide bonds. F(ab')2 is divalent for antigen binding. The disulfide bonds of F(ab')2 can be cleaved to obtain Fab'. In addition, the variable regions of the heavy and light chains can be fused together to form a single-chain variable fragment (scFv).

[0093] Pharmaceutically acceptable salts are, for example, acid addition salts and alkaline salts. Acid addition salts are, for example, HCl salts or HBr salts. Alkaline salts are, for example, salts with cations selected from: alkali or alkaline, for example, Na+, or K+, or Ca2+, or ammonium ions N+(R1)(R2)(R3)(R4), wherein R1 to R4 represent, independently of one another: hydrogen, optionally substituted C1-C6-alkyl groups, optionally substituted C2-C6-alkenyl groups, optionally substituted C6-C10-aryl groups, or optionally substituted C6-C10-heteroaryl groups. Other examples of pharmaceutically acceptable salts are described in the following documents: "Remington's Pharmaceutical Sciences" 17th edition Alfonso R.Gennaro (ed.), Mark Publishing Company, Easton, Pa., USA, 1985 and Encyclopedia of Pharmaceutical Technology.

[0094] Pharmaceutically acceptable solvates are, for example, hydrates.

[0095] Non-limiting exemplary embodiments of the present invention will now be described with reference to the accompanying drawings, in which:

[0096] Figure 1 Schematically shows an injection device according to the prior art;

[0097] Figure 2 schematically illustrates an injection device according to the prior art with the cap removed and a dose set; and

[0098] Figure 3 Schematic diagram showing the heat shrinkage according to Figure 1 label on the injection device.

[0099] refer to Figure 1 and Figure 2 , shows a disposable injection device as disclosed in WO 2014 / 033197 A1. The device has a distal end ( Figure 1 The upper end) and the proximal end ( Figure 1 The injection device 1 comprises a housing 2 and a cartridge holder 3 which is securely connected to the housing 2 or is an integral part of the housing 2. A cartridge (not shown) containing a medicament is received in the cartridge holder 3. Figure 1 In the embodiment, a removable cap 4 covers the cartridge holder 3. Figure 2 In the embodiment, the cap 4 is removed.

[0100] The disposable injection device 1 further comprises a dose setting mechanism arranged in the housing 2. A dose setting member 5 of the dose setting mechanism protrudes from the housing 2 such that a user can grasp the dose setting member 5 and move it relative to the housing 2 during dose setting. Figure 1 The state in which the dose is set to zero (ie the rest state of the device) is depicted, the dose being visible through a window or aperture 6 in the housing 2. In contrast, in Figure 2 A larger dose has been set by moving (eg rotating) the dose setting member 5 relative to the housing 2 .

[0101] The distal end of the cartridge holder 3 is provided with a threaded interface 7 for attaching a needle assembly (not shown) to the cartridge holder.

[0102] Figure 3 A transparent heat shrink label 8 in the form of a transparent sheath is depicted, into which the housing 2 and the cartridge holder 3 can be inserted. The heat shrink label 8 can be securely attached to the injection device 1 by heat shrinking the label 8 onto the housing 2 and the cartridge holder 3. When heat is applied to the label 8, the label shrinks and adapts to the outer contours of the housing 2 and the cartridge holder 3. Thus, the label 8 is securely fitted onto the housing 2 and the cartridge holder 3. In addition, the label 8 can be further fixed to the housing 2 and the cartridge holder 3 by an adhesive. Since the label 8 at least partially covers the housing 2 and the cartridge holder 3, it will be necessary to remove the label 8 before forcibly removing the cartridge holder 3 from the housing 2 or destroying it.

[0103] The heat shrink label 8 is made of a sufficiently strong and durable material to maintain the label 8 on the disposable injection device 1 for the intended use of the device. Suitable materials include, but are not limited to, PET or OPP. The heat shrink label 8 may be composed of a material that inhibits the transmission of actinic light and / or may be provided with a layer that inhibits the transmission of actinic light. Preferably, the heat shrink label 8 is composed of a single layer of material that can be printed and / or painted. As an alternative, the heat shrink label 8 may include several layers of material.

[0104] exist Figure 3 In the depicted exemplary embodiment, the scale 9 is printed on the inside of the label 8, so that the scale 9 is visible through the transparent label 8. Further, the transparent label 8 allows the user to read the dosage number visible through the window or aperture 6 of the housing 2. Additionally or alternatively, further information and / or symbols (e.g. about the medicament) may be printed on the inside of the label 8. Still further, the outside of the label 8 may be at least partially painted. Weakened lines 10 in the form of perforations are provided near the distal end and near the proximal end of the label 8, respectively.

[0105] exist Figure 3In the depicted exemplary embodiment, the label 8 has a length that is not only suitable for covering the housing 2 and the cartridge holder 3, but also further suitable for covering the dose setting member 5 and the threaded interface 7 when heat shrunk onto the injection device 1. Therefore, the label 8 forms a first cap part 11 covering the threaded interface 7 and a second cap part 12 covering the dose setting member 5. The corresponding weakening line 10 is designed to allow the cap parts 11, 12 to be disconnected and removed from the rest of the label 8. In other words, the label 8 further forms a tamper-evident closure for the injection device 1.

[0106] Although Figure 3 The embodiment has been explained with two weakened lines 10 formed to the respective cap portions of the label 8 , but alternative embodiments may include only a single weakened line 10 or may have no weakened line 10 .

[0107] Although not in Figure 3 , a heat shrink label 8 may be used to locate, secure and / or maintain components in and / or on the disposable injection device 1. In particular, the heat shrink label 8 may be used to maintain electronic components (e.g., a temperature sensing strip) on the housing 2 or cartridge holder 3.

[0108] Reference numerals

[0109] 1 Injection device

[0110] 2 Housing

[0111] 3 Cartridge holder

[0112] 4 Caps

[0113] 5 Dose setting member

[0114] 6 Windows

[0115] 7 Interface

[0116] 8 Heat Shrink Labels

[0117] 9 scale

[0118] 10 Weakness line

[0119] 11. First cap part

[0120] 12 Second cap part

Claims

1. An injection device comprising - a housing (2) containing a dose setting mechanism, - a cartridge holder (3) containing a cartridge with a medicament, and - a heat shrink label (8) comprising information (9) and / or a symbol about the medicament, It is characterized in that The cartridge holder (3) is inseparably locked to the housing (2), and the heat shrink label (8) is heat shrunk onto the housing (2) and the cartridge holder (3) so that it at least partially covers the interface or bridge area between the housing (2) and the cartridge holder (3) and the cartridge holder (3) and the housing (2).

2. The injection device according to claim 1, characterized in that The heat shrink label (8) has the form of a sheath at least partially enveloping the housing (2) and the cartridge holder (3).

3. The injection device according to claim 1 or 2, characterized in that: The heat shrink label (8) comprises at least a transparent or translucent portion, wherein the transparent or translucent portion is positioned on the housing (2) and overlaps with a window (6) provided in the housing (2).

4. The injection device according to claim 1 or 2, characterized in that: The information (9) and / or symbols are printed on the inner surface of the heat shrink label (8).

5. The injection device according to claim 1 or 2, characterized in that: The information and / or symbols include graduations located on the cartridge holder (3) and information about the medicament located on the housing (2).

6. The injection device according to claim 1 or 2, characterized in that: The outer surface of the heat shrink label (8) is partially painted.

7. The injection device according to claim 1 or 2, characterized in that: The heat shrink label (8) is made of PET or OPP.

8. The injection device according to claim 1 or 2, characterized in that: The heat shrink label (8) consists of and / or is provided with a layer that inhibits the transmission of actinic light.

9. The injection device according to claim 1 or 2, characterized in that: The heat shrink label (8) includes electronic components and / or maintains electronic components on the housing (2) and / or on the cartridge holder (3).

10. The injection device according to claim 9, characterized in that The heat shrink label (8) comprises a temperature measuring strip.

11. The injection device according to claim 1 or 2, characterized in that: The heat shrink label (8) comprises at least one weakening line (10) which allows for the breaking and removal of portions (11, 12) of the heat shrink label (8).

12. The injection device according to claim 11, characterized in that The cartridge holder (3) comprises an interface (7) for attaching a needle on the cartridge holder (3), wherein the heat shrink label (8) comprises a first cap portion (11) covering the interface (7) for attaching a needle, and wherein the at least one weakening line (10) is positioned to allow disconnection and removal of the first cap portion (11).

13. The injection device according to claim 11, characterized in that The dose setting mechanism comprises a dose setting member (5) protruding from the housing (2), wherein the heat shrink label (8) comprises a second cap part (12) covering the dose setting member (5), and wherein the at least one weakening line (10) is positioned to allow breaking and removal of the second cap part (12).

14. The injection device according to claim 1 or 2, characterized in that: The heat shrink label (8) is glued or welded to the housing (2) and / or to the cartridge holder (3).

15. The injection device according to claim 1 or 2, characterized in that: The agent is insulin or growth hormone.

16. The injection device according to claim 1 or 2, characterized in that: The heat shrink label (8) at least partially covers the interface between the cartridge holder (3) and the housing (2) or the bridge or transition area between the cartridge holder (3) and the housing (2).

17. The injection device according to claim 1 or 2, characterized in that: The injection device is a disposable injection device.

18. The injection device according to claim 1 or 2, characterized in that: The cartridge holder (3) is permanently attached to the housing (2) by means of snap features, welding or gluing.

Images