Cartridge packaging

Abstract

The present disclosure relates to a cartridge packaging (1) with an outer shell and at least one cartridge (2) filled with a liquid drug for use in a pen type drug delivery device. The shell is a packaging with a bottom wall (3), two side walls (4), a front wall (5), a back wall (6), a top wall (7) and a closing flap (8) made of a single piece blank (10) of e.g. cardboard. The shell further comprises at least one tear-off strip (9) hinged to at least the closing flap (8) by one or more weakened lines (11).

Description

[0001] Description

[0002] CARTRIDGE PACKAGING

[0003] The present disclosure is generally directed to improvements in the sustainability of a packaging suitable for storing one or more spare cartridges filled with a liquid drug, e.g. for use in a pen type drug delivery device.

[0004] Pen type drug delivery devices have application where regular injection by persons without formal medical training occurs. This is increasingly common among patients having e.g. diabetes where self-treatment enables such patients to conduct effective management of their disease. In certain types of drug delivery devices, such as pen type devices, cartridges filled with a liquid drug are used. These cartridges are housed in a cartridge holder or cartridge housing. To dispense a dose of drug from such a cartridge, the drug delivery device has a dose setting and drive mechanism that uses a piston rod or lead screw moving in a distal direction and pressing the bung distally which expels a certain set dose of drug from the cartridge. Some of these devices are intended to be reused when the cartridge is empty by replacing the empty cartridge by a new cartridge, e.g. as disclosed in WO 2014 / 033195 A1. For such a cartridge replacement, spare cartridges are provided which have to be stored in a packaging reducing the risk of contamination of the cartridge and providing sufficient protection to avoid breaking of the cartridges which are often made of glass. For example, insulin cartridges are typically provided in thermoformed blister packs with an aluminium lid foil for each item.

[0005] WO 2014 / 096146 A1 generally refers to an outer packaging for two drug delivery devices, wherein one of these drug delivery devices is received in a separate inner packaging. This inner packaging forms an outer shell closed in a tamper proof manner and comprises walls. A portion of the back wall is formed as a tear-off strip. This strip is hinged to a closing flap via a weakened line.

[0006] 16. Dezember 2025 S 100 P 558 WO It is an object of the present disclosure to provide an improved cartridge packaging that stores and protects at least one cartridge.

[0007] This object is solved with a cartridge packaging according to claim 1.

[0008] A cartridge packaging according to the present disclosure is substantially a set of a shell and one or more cartridges filled with a liquid drug, e.g. for use in a drug delivery device. The cartridge packaging has an outer shell closed in a tamper proof manner which is configured to store or house at least one cartridge filled with a liquid drug. A shell closed in a tamper proof manner means that opening the shell requires that an element, typically a seal or tear-off member, is broken and / or removed, thereby permitting a user to easily detect if the packaging was opened. Preferably, the shell is a substantially cuboidal boxshaped container, e.g. a packaging with a bottom wall, two side walls, a front wall, a back wall, a top wall and a closing flap. The packaging according to the present disclosure is made from a foldable material with sufficient stiffness, e.g. a cardboard or paper-pulp material, like corrugated cardboard. Preferably, the packaging is made of a pre-cut single piece blank of cardboard. This means that the packaging may be erected from a single blank without having to join different blanks. This facilitates the production process. The shell further comprises at least one tear-off strip hinged to at least the closing flap by one or more weakened lines. A weakened line is a line of reduced structural strength permitting or facilitating severing the blank along the weakened line. Weakened lines may be perforated, notched or incised lines or lines with reduced material thickness. Removal or severing or the weakened line(s) is an indicator for a user that the packaging was opened before and is not in its original state or condition.

[0009] The cartridge packaging, e.g. being a cardboard packaging, is suitable for storing insulin cartridges and other drug cartridges avoiding thermoformed blister packs with aluminium lid foil for each item. The elimination of the blister pack makes the packaging significantly more environmentally sustainable than the existing insulin cartridge packaging solutions. In other words, the packaging according to the present disclosure is a solution constructed from more sustainable materials and processes (e.g. cardboard). In more detail, the packaging provides several sustainability benefits: Eliminating the need for thermoformed blister packs reduces the energy use and carbon generation associated with

[0010] 16. Dezember 2025 S 100 P 558 WO their production and disposal as part of the packaging. Further, recycling streams are not so readily available for polymer and / or aluminium blister packs, compared to cardboard, which can be processed within standard domestic waste streams. In addition, the shell of the packaging is a mono-material packaging, which simplifies recycling, removing the need for disassembly to separate different material types. This reduces the energy used during recycling and increases the quantity of material that may be efficiently recycled. Still further, the packaging is more compact than the existing designs, which increases the packaging density and efficiency of the refrigerated supply chain, reducing energy use and carbon generation.

[0011] The cartridge packaging according to the present disclosure may have the closing flap hinged to the top wall by a first folding line and folded onto at least the front wall. For example, the closing flap and / or the top wall may be opened as a lid permitting access to the interior of the packaging for removal of the cartridge(s). A bonding portion of the closing flap is joint to the front wall and / or to the bottom wall to keep the packaging closed. For example, the bonding portion may be a portion of the closing flap facing away from the top wall, e.g. near a free edge of the closing flap. The connection between the closing flap and the front wall and / or the bottom wall may comprise a strip and / or one or more dots of glue or hotmelt or an adhesive tape.

[0012] The tear-off strip may be defined by two weakened lines running or extending between the first folding line and the bonding portion of the closing flap joint to the front wall. For example, the weakened lines run substantially parallel to each other and parallel to the first folding line. In other words, removal of the tear-off strip by severing the weakened lines separates the bonding portion of the closing flap from the rest of the closing flap such that this portion of the closing flap which is hinged to the top wall may be opened as a lid, e.g. together with the top wall.

[0013] As an alternative, the tear-off strip may be defined by two weakened lines running or extending from the edge of the closing flap facing away from the top wall through the closing flap and over the first folding line into the top wall. In this example, the weakened lines may run substantially parallel to each other and perpendicular to the first folding line. In addition, the ends of weakened lines facing away from the edge of the closing

[0014] 16. Dezember 2025 S 100 P 558 WO flap may be connected by a further weakened line. In this arrangement, removal of the tear-off strip by severing the weakened lines creates an opening in the packaging permitting removal of the cartridge. Especially if more than one cartridge is stored in the packaging, this arrangement permits removal of one cartridge, while the other cartridge^) may remain enclosed in the packaging. For example, one tear-off strip may be provided for each cartridge in order to create individual openings for individual removal of each cartridge. In other words, the single piece blank may comprise a separate tear- off strip for each cartridge.

[0015] The cartridge packaging may have a withdrawal cut-out in the front wall which is covered by the closing flap. After removal of the tear-off strip and, e.g. opening of a lid portion formed by the closing flap and / or the top wall, the cut-out facilitates access to the cartridge^) and removal thereof.

[0016] According to a further aspect of the disclosure, the cartridge packaging may comprise at least two cartridges, e.g. three cartridges, filled with a liquid drug for use in a pen type drug delivery device. In this case it may be desirable to avoid damage of the cartridges during storing or transport due to direct contact of the cartridges. Separator flaps may be provided interposed between the cartridges to avoid direct contact. For example, the single piece blank further comprises such separator flaps. In more detail, the separator flaps may be provided hinged to one side wall via at least one spacer flap folded onto the front wall or onto the back wall. For example, a pair of two separator flaps may be folded onto each other and may extend substantially parallel to the side walls. In addition or as an alternative, two separator flaps may be held parallel to each other and to the side walls by an intermediate flap.

[0017] If at least two, e.g. three, cartridges are provided in the cartridge packaging the cartridges may be arranged in a row parallel to each other in the packaging such that the longitudinal axes of the cartridges are parallel to the front wall or such that the longitudinal axes of the cartridges are parallel to the top wall.

[0018] The single piece blank of the cartridge packaging may further comprise connecting flaps. Such connection flaps may be provided hinged to a wall. One or more walls may be

[0019] 16. Dezember 2025 S 100 P 558 WO provided with connection flaps. The connection flaps may be arranged to close edges of the packaging by partially overlapping with a wall.

[0020] According to a further independent aspect of the present disclosure, the septum end of each cartridge may be covered by a separate sealing tab releasably attached to the cartridge. This minimizes the risk of contamination of the septum end of the cartridge. Such a sealed tab feature may be bonded to the cartridge aluminium ferrule, or heat sealed to the end of a polymer cartridge.

[0021] The terms “drug” or “medicament” are used synonymously herein and describe a pharmaceutical formulation containing one or more active pharmaceutical ingredients or pharmaceutically acceptable salts or solvates thereof, and optionally a pharmaceutically acceptable carrier. An active pharmaceutical ingredient (“API”), in the broadest terms, is a chemical structure that has a biological effect on humans or animals. In pharmacology, a drug or medicament is used in the treatment, cure, prevention, or diagnosis of disease or used to otherwise enhance physical or mental well-being. A drug or medicament may be used for a limited duration, or on a regular basis for chronic disorders.

[0022] As described below, a drug or medicament can include at least one API, or combinations thereof, in various types of formulations, for the treatment of one or more diseases. Examples of API may include small molecules having a molecular weight of 500 Da or less; polypeptides, peptides and proteins (e.g., hormones, growth factors, antibodies, antibody fragments, and enzymes); carbohydrates and polysaccharides; and nucleic acids, double or single stranded DNA (including naked and cDNA), RNA, antisense nucleic acids such as antisense DNA and RNA, small interfering RNA (siRNA), ribozymes, genes, and oligonucleotides. Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more drugs are also contemplated.

[0023] The drug or medicament may be contained in a primary package or “drug container” adapted for use with a drug delivery device. The drug container may be, e.g., a cartridge, syringe, reservoir, or other solid or flexible vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more drugs. For example, in some instances, the chamber may be designed to store a drug for at least

[0024] 16. Dezember 2025 S 100 P 558 WO one day (e.g., 1 to at least 30 days). In some instances, the chamber may be designed to store a drug for about 1 month to about 2 years. Storage may occur at room temperature (e.g., about 20°C), or refrigerated temperatures (e.g., from about - 4°C to about 4°C). In some instances, the drug container may be or may include a dual-chamber cartridge configured to store two or more components of the pharmaceutical formulation to-be-administered (e.g., an API and a diluent, or two different drugs) separately, one in each chamber. In such instances, the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components prior to and / or during dispensing into the human or animal body. For example, the two chambers may be configured such that they are in fluid communication with each other (e.g., by way of a conduit between the two chambers) and allow mixing of the two components when desired by a user prior to dispensing. Alternatively or in addition, the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.

[0025] The drugs or medicaments contained in the drug delivery devices as described herein can be used for the treatment and / or prophylaxis of many different types of medical disorders. Examples of disorders include, e.g., diabetes mellitus or complications associated with diabetes mellitus such as diabetic retinopathy, thromboembolism disorders such as deep vein or pulmonary thromboembolism. Further examples of disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and / or rheumatoid arthritis. Examples of APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (anti-diabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.

[0026] Examples of APIs for the treatment and / or prophylaxis of type 1 or type 2 diabetes mellitus or complications associated with type 1 or type 2 diabetes mellitus include an insulin, e.g., human insulin, or a human insulin analogue or derivative, a glucagon-like peptide (GLP-1), GLP-1 analogues or GLP-1 receptor agonists, or an analogue or derivative thereof, a dipeptidyl peptidase-4 (DPP4) inhibitor, or a pharmaceutically acceptable salt or solvate thereof, or any mixture thereof. As used herein, the terms “analogue” and “derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, by deleting and / or exchanging at least one amino acid residue

[0027] 16. Dezember 2025 S 100 P 558 WO occurring in the naturally occurring peptide and / or by adding at least one amino acid residue. The added and / or exchanged amino acid residue can either be codable amino acid residues or other naturally occurring residues or purely synthetic amino acid residues. Insulin analogues are also referred to as "insulin receptor ligands". In particular, the term ..derivative” refers to a polypeptide which has a molecular structure which formally can be derived from the structure of a naturally occurring peptide, for example that of human insulin, in which one or more organic substituent (e.g. a fatty acid) is bound to one or more of the amino acids. Optionally, one or more amino acids occurring in the naturally occurring peptide may have been deleted and / or replaced by other amino acids, including non-codeable amino acids, or amino acids, including non-codea- ble, have been added to the naturally occurring peptide.

[0028] Examples of insulin analogues are Gly(A21), Arg(B31), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin (insulin glulisine); Lys(B28), Pro(B29) human insulin (insulin lispro); Asp(B28) human insulin (insulin aspart); human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Vai 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.

[0029] Examples of insulin derivatives are, for example, B29-N-myristoyl-des(B30) human insulin, Lys(B29) (N- tetradecanoyl)-des(B30) human insulin (insulin detemir, Levemir®); B29-N-palmitoyl-des(B30) human insulin; B29-N-myristoyl human insulin; B29-N-pal- mitoyl human insulin; B28-N-myristoyl LysB28ProB29 human insulin; B28-N-palmitoyl- LysB28ProB29 human insulin; B30-N-myristoyl-ThrB29LysB30 human insulin; B30-N- palmitoyl- ThrB29LysB30 human insulin; B29-N-(N-palmitoyl-gamma-glutamyl)- des(B30) human insulin, B29-N-omega-carboxypentadecanoyl-gamma-L-glutamyl- des(B30) human insulin (insulin degludec, Tresiba®); B29-N-(N-lithocholyl-gamma-glu- tamyl)-des(B30) human insulin; B29-N-(w-carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(w-carboxyheptadecanoyl) human insulin.

[0030] Examples of GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example, Lixisenatide (Lyxumia®), Exenatide (Exendin-4, Byetta®, Bydureon®, a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide (Vic- toza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rEx- endin-4, CJC-1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpegle- natide), HM-15211 , CM-3, GLP-1 Eligen, ORMD-0901, NN-9423, NN-9709, NN-9924,

[0031] 16. Dezember 2025 S 100 P 558 WO NN-9926, NN-9927, Nodexen, Viador-GLP-1, CVX-096, ZYOG-1 , ZYD-1 , GSK- 2374697, DA-3091 , MAR-701 , MAR709, ZP-2929, ZP-3022, ZP-DI-70, TT-401 (Pega- pamodtide), BHM-034. MOD-6030, CAM-2036, DA-15864, ARI-2651 , ARI-2255, Tir- zepatide (LY3298176), Bamadutide (SAR425899), Exenatide-XTEN and Glucagon- Xten.

[0032] An example of an oligonucleotide is, for example: mipomersen sodium (Kynamro®), a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia or RG012 for the treatment of Alport syndrom.

[0033] Examples of DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Sax- agliptin, Berberine.

[0034] Examples of hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Fol litropi n, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.

[0035] Examples of polysaccharides include 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 polysaccharide, 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. An example of a hyaluronic acid derivative is Hylan G-F 20 (Synvisc®), a sodium hyaluronate.

[0036] The term “antibody”, as used herein, refers to an immunoglobulin molecule or an anti- gen-binding portion thereof. Examples of antigen-binding portions of immunoglobulin molecules include F(ab) and F(ab')2 fragments, which retain the ability to bind antigen. The antibody can be polyclonal, monoclonal, recombinant, chimeric, de-immunized or humanized, fully human, non-human, (e.g., murine), or single chain antibody. In some embodiments, the antibody has effector function and can fix complement. In some embodiments, the antibody has reduced or no ability to bind an Fc receptor. For example, the antibody can be an isotype or subtype, an antibody fragment or mutant, which does not support binding to an Fc receptor, e.g., it has a mutagenized or deleted Fc receptor binding region. The term antibody also includes an antigen-binding molecule based on

[0037] 16. Dezember 2025 S 100 P 558 WO tetravalent bispecific tandem immunoglobulins (TBTI) and / or a dual variable region anti- body-like binding protein having cross-over binding region orientation (CODV).

[0038] The terms “fragment” or “antibody fragment” refer to a polypeptide derived from an antibody polypeptide molecule (e.g., an antibody heavy and / or light chain polypeptide) that does not comprise a full-length antibody polypeptide, but that still comprises at least a portion of a full-length antibody polypeptide that is capable of binding to an antigen. Antibody fragments can comprise a cleaved portion of a full length antibody polypeptide, although the term is not limited to such cleaved fragments. Antibody fragments that are useful in the present invention include, for example, Fab fragments, F(ab')2 fragments, scFv (single-chain Fv) fragments, linear antibodies, monospecific or multispecific antibody fragments such as bispecific, trispecific, tetraspecific and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), monovalent or multivalent antibody fragments such as bivalent, trivalent, tetravalent and multivalent antibodies, minibodies, chelating recombinant antibodies, tribodies or bibodies, intrabodies, nanobodies, small modular immunopharmaceuticals (SMIP), binding-domain immunoglobulin fusion proteins, camelized antibodies, and VHH containing antibodies. Additional examples of antigenbinding antibody fragments are known in the art.

[0039] The terms “Complementarity-determining region” or “CDR” refer to short polypeptide sequences within the variable region of both heavy and light chain polypeptides that are primarily responsible for mediating specific antigen recognition. The term “framework region” refers to amino acid sequences within the variable region of both heavy and light chain polypeptides that are not CDR sequences, and are primarily responsible for maintaining correct positioning of the CDR sequences to permit antigen binding. Although the framework regions themselves typically do not directly participate in antigen binding, as is known in the art, certain residues within the framework regions of certain antibodies can directly participate in antigen binding or can affect the ability of one or more amino acids in CDRs to interact with antigen.

[0040] Examples of antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).

[0041] Pharmaceutically acceptable salts of any API described herein are also contemplated for use in a drug or medicament in a drug delivery device. Pharmaceutically acceptable salts are for example acid addition salts and basic salts.

[0042] 16. Dezember 2025 S 100 P 558 WO Those of skill in the art will understand that modifications (additions and / or removals) of various components of the APIs, formulations, apparatuses, methods, systems and embodiments described herein may be made without departing from the full scope and spirit of the present invention, which encompass such modifications and any and all equivalents thereof.

[0043] An example drug delivery device may involve a needle-based injection system as described in Table 1 of section 5.2 of ISO 11608-1 :2014(E). As described in ISO 11608- 1 :2014(E), needle-based injection systems may be broadly distinguished into multidose container systems and single-dose (with partial or full evacuation) container systems. The container may be a replaceable container or an integrated non-replaceable container.

[0044] As further described in ISO 11608-1 :2014(E), a multi-dose container system may involve a needle-based injection device with a replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). Another multi-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In such a system, each container holds multiple doses, the size of which may be fixed or variable (pre-set by the user). As further described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with a replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation). As also described in ISO 11608-1 :2014(E), a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container. In one example for such a system, each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation). In a further example, each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

[0045] In the following, non-limiting, examples of a cartridge packaging are described in more detail by making reference to the drawings, in which:

[0046] 16. Dezember 2025 S 100 P 558 WO Figure 1 shows a perspective view of a closed cartridge packaging according to a first example of the present disclosure;

[0047] Figure 2 shows a perspective view of the cartridge packaging of Figure 1 after being opened;

[0048] Figure 2A shows a detail of the cartridge packaging of Figure 1 ;

[0049] Figure 3 shows a blank for the cartridge packaging of Figure 1 ;

[0050] Figure 4 shows details of the cartridges;

[0051] Figure 5 shows a perspective view of a closed cartridge packaging according to a second example of the present disclosure;

[0052] Figure 6 shows a perspective view of the cartridge packaging of Figure 5 after being opened;

[0053] Figure 6A shows a detail of the cartridge packaging of Figure 5;

[0054] Figure 7 shows a blank for the cartridge packaging of Figure 5;

[0055] Figure 8 shows a perspective view of a closed cartridge packaging according to a third example of the present disclosure;

[0056] Figure 9 shows a perspective view of the cartridge packaging of Figure 8 after being opened; and

[0057] Figure 10 shows a back side view of the closed cartridge packaging of Figure 8.

[0058] The Figures show examples of a cartridge packaging. Three alternative examples of a cardboard cartridge packaging are described wherein the same reference numerals are used for identical or similar component parts or features in all examples.

[0059] 16. Dezember 2025 S 100 P 558 WO All examples have in common that the cartridge packaging 1 is configured to store three cartridges 2. However, other sizes with more or less cartridges 2 are conceivable within the scope of this disclosure.

[0060] A cartridge packaging 1 according to the present disclosure generally comprises one or more cartridges 2 and a substantially cuboidal box-shaped with a bottom wall 3, two side walls 4, a front wall 5, a back wall 6, a top wall 7 and a closing flap 8 with at least one tear-off strip 9. In the depicted example, the bottom wall 3 may consist of two different flaps hinged to the front wall 5 and the back wall 6, respectively. The shell is made of a single piece blank 10 of e.g. cardboard. The shell is erected from these pre-cut and e.g. printed cardboard components of the single piece blank 10 that are folded and bonded together.

[0061] The respective walls and flaps are hinged to each other along folding lines and / or weakened lines 11 as indicated in Figures 3 and 7. Folding lines are depicted as continuous lines whereas weakened lines are depicted as dashed lines. For example, the closing flap 8 is hinged to the top wall 7 by a first folding line 12. The single piece blank 10 further comprises connecting flaps 13 configured to close edges between the respective walls. In addition, the depicted examples of the shell of the cartridge packaging 1 comprise separator flaps 14 which are hinged to one side wall 4 via at least one spacer flap 15 folded onto the front wall 5 or onto the back wall 3 and / or via one or more intermediate flaps 16. The closing flap 8 may be provided with a bonding portion 17, e.g. with dots or lines of an adhesive, configured to join the closing flap 8 to the front wall 5. The front wall 5 may comprises a withdrawal cut-out 18 which is covered by the closing flap 8 as indicated in Figures 1 , 5 or 8.

[0062] The cartridges 2 may be made of a polymer material or may be made of glass. The septum end of each cartridge 2 may be covered by a separate a sealing tab 19 releasably attached to the cartridge 2 as indicated in Figure 4. An instruction leaflet 20 or the like user information may be retained in the shell as indicated in Figure 2A.

[0063] 16. Dezember 2025 S 100 P 558 WO The cardboard cartridge packaging of example 1 as depicted in Figures 1 to 3 comprises a shell designed as a single piece of card that requires printing on one side only. A tamper feature is provided by tear-off strip 9 which is delimited within the closing flap 8 through two weakened lines 11 in the form of perforations on the front of the pack such that the tear-off strip 9 is hinged, i.e. attached, to the closing flap 8. The tear-off strip 9 extends substantially parallel to the first folding line 12, i.e. to the upper front edge as seen in Figure 1. Only the portion below the tear-off strip 9 (as seen in Figure 1) is the bonding portion 17 of the closing flap 8 joint to the front wall 5. This tear-off strip 9 must be torn away before the shell or pack can be opened (Figure 2), and thus provides evidence of any tampering before use by the patient.

[0064] A space for the patient instruction leaflet 20 can be provided between the top of the cartridges 2 and the pack lid which is formed by the top wall 7 and the portion of the closing flap 8 directly adjacent to the first folding line 12, i.e. the upper portion of the closing flap as seen in Figure 1.

[0065] The cartridges 2, e.g. insulin filled cartridges, are stored within pockets, formed by internal separator flaps 14, that provide a number of functions: They ensure that the cartridges 2 do not damage one another during transit or storage, they stop cartridges 2 becoming loose within the shell or pack when some have been removed, and they increase the robustness of the pack during transit, storage and use. In this first example, separator flaps 14 are directly folded onto each other and extend substantially parallel to the side walls 4. The spacer flaps 15 abut the backwall 6 and hold the spacer flaps 14 in a position defining the pockets for the cartridges 2.

[0066] If there is a risk of contamination of the septum end of the cartridge 2, the sealing tab 19 could be optionally introduced. This could be bonded to the cartridge aluminum ferrule of a glass cartridge, or heat sealed to the end of a polymer cartridge.

[0067] Wing features 21 are provided on opposite edges of top wall 7 to ensure that the lid can be retained in the closed position after the shell or pack has been opened. These wing features 21 can be inserted in slots 22 in the front wall 5. Other arrangements are possible, e.g. a lid that is similar to those typically present on a cigarette pack.

[0068] 16. Dezember 2025 S 100 P 558 WO The cardboard shell of the cartridge packaging 1 of the second example as depicted in Figures 5 to 7 is also designed as a single piece blank 10 of card that requires printing on one side only. The shell shares several attributes with the first example. It is constructed from a minimum number of separate, pre-cut and printed cardboard components that are folded and glued together. Insulin cartridges 2 are stored within pockets, formed by internal card separator flaps 14. As can be seen in Figure 6A, the separator flaps 14 extend substantially parallel to side walls 4 but are not folded directly onto each other as in the first example. Rather, in the second example, intermediate flaps 16 which abut the front wall 5 keep the separator flaps 14 spaced from each other.

[0069] In this second example each cartridge pocket is individually opened when required through the removal of a separate tear-off strip 9 from the top of the pack or shell. The tear-off strips 9 are created using perforation features as weakened lines 12 in the cardboard. Two parallel weakened lines 12 extend substantially parallel to each other and substantially perpendicular to the first folding line 12 and are connected by a further short weakened line in the top wall 7 substantially parallel to the first folding line 12. The provision of individual tear-off strips 9 has several advantages: There is separate tamper evidence for each individual cartridge 2. A user can see how many cartridges 2 have been used or are left without needing to open a separate lid. There is a reduced risk of accidentally dropping cartridges 2 out of a partially emptied pack.

[0070] Further, in this second example the bonding portion 17 comprises rather adhesive dots on the webs between tear-off strips 9 compared to an e.g. adhesive strip extending substantially parallel to the first folding line 12 in the first example.

[0071] Patient instructions could be printed onto the back wall 6 of the shell or pack, or could be provided electronically via a printed QR code to save additional paper.

[0072] The cardboard shell of the cartridge packaging 1 of the third example as depicted in Figures 8 to 10 is also designed as a single piece blank 10 of card that requires printing on one side only. The shell shares several attributes with the first and second examples. It is constructed from a minimum number of separate, pre-cut and printed

[0073] 16. Dezember 2025 S 100 P 558 WO cardboard components that are folded and glued together. Insulin cartridges 2 are stored within pockets, formed by internal card separator flaps 14 substantially as in the second example.

[0074] A tamper feature is provided by a tear-off strip 9 that must be removed before the shell or pack can be initially opened, substantially as in the first example.

[0075] In this third example the orientation of the cartridges 2 within the shell differs from the first and second example. While the septum end of the cartridges 2 and the opposite bung end are directed towards bottom wall 3 and top wall 7, respectively, in the first and second example, in the third example the septum end of the cartridges 2 faces towards the back wall 6 and the bung end faces towards the front wall 5 (see Figure 9). Thus, the top wall 7 and the bottom wall 3 are larger compared to the top wall and bottom wall of the first and second example and larger than the front wall 5 and the back wall 6 of this third example. As shown in Figure 9, the top wall 7 with the closing flap 8 may open as a door which provides increased user access to the cartridges 2 compared to access as in the first and second example.

[0076] Patient instructions could be provided on a conventional sheet 20 (not shown in Figures 8 to 10) or be printed onto the inside face of the top wall 7, rather than on a separate piece of paper, or could be provided electronically via a printed QR code.

[0077] 16. Dezember 2025 S 100 P 558 WO Reference Numerals

[0078] 1 cartridge packaging

[0079] 2 cartridge

[0080] 3 bottom wall

[0081] 4 side wall

[0082] 5 front wall

[0083] 6 back wall

[0084] 7 top wall

[0085] 8 closing flap

[0086] 9 tear-off strip

[0087] 10 blank

[0088] 11 weakened line

[0089] 12 first folding line

[0090] 13 connecting flap

[0091] 14 separator flap

[0092] 15 spacer flap

[0093] 16 intermediate flap

[0094] 17 bonding portion

[0095] 18 withdrawal cut-out

[0096] 19 sealing tab

[0097] 20 instruction leaflet

[0098] 21 wing

[0099] 22 slot

[0100] 16. Dezember 2025 S 100 P 558 WO

Claims

Claims1. A cartridge packaging with an outer shell closed in a tamper proof manner and comprising at least one cartridge (2) filled with a liquid drug for use in a pen type drug delivery device, characterized in that the shell is a packaging with a bottom wall (3), two side walls (4), a front wall (5), a back wall (6), a top wall (7) and a closing flap (8) made of a single piece blank (10) of cardboard or paper-pulp, and in that the shell further comprises at least one tear-off strip (9) hinged to at least the closing flap (8) by one or more weakened lines (11).

2. The cartridge packaging according to claim 1 , wherein the closing flap (8) is hinged to the top wall (7) by a first folding line (12) and is folded onto the front wall (5), and wherein a bonding portion (17) of the closing flap (8) facing away from the top wall (7) is joint to the front wall (5) or to the bottom wall (3).

3. The cartridge packaging according to claim 2, wherein the tear-off strip (9) is defined by two weakened lines (11) running between the first folding line (12) and the bonding portion (17) of the closing flap (8) joint to the front wall (5).

4. The cartridge packaging according to claim 3, wherein the weakened lines (11) run substantially parallel to each other and parallel to the first folding line (12).

5. The cartridge packaging according to claim 2, wherein the tear-off strip (9) is defined by two weakened lines (11) running from the edge of the closing flap (8) facing away from the top wall (7) through the closing flap (8) and over the first folding line (12) into the top wall (7).

6. The cartridge packaging according to claim 5, wherein the weakened lines (11) run substantially parallel to each other and perpendicular to the first folding line (12).

16. Dezember 2025 S 100 P 558 WO7. The cartridge packaging according to claim 5 or 6, wherein the ends of weakened lines (11) facing away from the edge of the closing flap (8) are connected by a further weakened line.

8. The cartridge packaging according to any one of the preceding claims, wherein the front wall (5) comprises a withdrawal cut-out (18) covered by the closing flap (8).

9. The cartridge packaging according to any one of the preceding claims comprising at least two cartridges (2) filled with a liquid drug for use in a pen type drug delivery device, wherein the single piece blank (10) further comprises separator flaps (14).

10. The cartridge packaging according to claims 5 and 9, wherein the single piece blank (10) comprises a separate tear-off strip (9) for each cartridge (2).11 . The cartridge packaging according to any one of claims 9 or 10, wherein the separator flaps (14) are hinged to one of the side walls (4) via at least one spacer flap (15) folded onto the front wall (5) or onto the back wall (3).

12. The cartridge packaging according to any one of claims 9 to 11 , wherein a pair of two separator flaps (14) is folded onto each other and extends substantially parallel to the side walls (4), and / or wherein two separator flaps (14) are held parallel to each other and to the side walls (4) by an intermediate flap (16).

13. The cartridge packaging according to any one of claims 9 to 12, wherein the cartridges (2) are arranged in a row parallel to each other in the packaging such that the longitudinal axes of the cartridges (2) are parallel to the front wall (5) or are parallel to the top wall (7).

14. The cartridge packaging according to any one of the preceding claims, wherein the single piece blank (10) further comprises connecting flaps (13).

16. Dezember 2025 S 100 P 558 WO15. The cartridge packaging according to any one of the preceding claims, wherein the septum end of each cartridge (2) is covered by a separate a sealing tab (19) releas- ably attached to the cartridge (2).

16. Dezember 2025 S 100 P 558 WO

Images