Autoinjector
Patent Information
- Application Number
- DE202025103813
- Authority / Receiving Office
- DE · DE
- Patent Type
- Utility models
- Current Assignee / Owner
- Filing Date
- 2025-07-04
- Publication Date
- 2025-09-04
- Estimated Expiration
- 2035-07-31
Smart Images

Figure 00000000_0000_ABST
Abstract
Description
[0001] The present disclosure relates to a drug delivery device, in particular an auto-injector.
[0002] Auto-injectors for self-medication by patients often have an elongated, essentially cylindrical housing. However, this can have the disadvantage that the devices are difficult to grip, do not sit securely on a surface, and the device status cannot be clearly determined.
[0003] These problems and disadvantages are solved by the present invention. In particular, the present invention provides an auto-injector that, through specific features, prevents rolling away. Furthermore, the device status can be clearly displayed and gripping the device is simplified.
[0004] The invention is defined in the independent claim. Dependent claims describe preferred embodiments.
[0005] The present invention relates to an auto-injector comprising: a substantially elongated housing extending along a longitudinal axis, an activation element provided at a distal end of the housing remote from a drug delivery site, and a cap removably attached to a proximal side of the housing. The auto-injector comprises a first anti-roll element on an outer peripheral surface of the housing and a second anti-roll element on an outer peripheral surface of the cap, which extend along the longitudinal axis and are configured to stop or prevent the auto-injector from rolling about the longitudinal axis upon contact with a surface. When the cap is attached to the housing, the first and second anti-roll elements are flush aligned along the longitudinal axis.
[0006] Preferably, the first and second anti-roll elements are each formed by a projection.
[0007] Preferably, the second anti-roll element extends from a distal end of the cap over at least 50%, preferably at least 75% of a length of the cap.
[0008] Preferably, the first anti-roll element is formed on a proximal contact surface of the housing with the cap and extends in the distal direction.
[0009] Preferably, a length of the first roll-prevention element is less than 50%, preferably less than 20% and more preferably less than 10% of a length of the second roll-prevention element.
[0010] Preferably, the first and second anti-roll elements are each formed by a flattened region.
[0011] Preferably, the activation element has a flattened region that is flush with the first anti-roll element.
[0012] Preferably, the first and second anti-roll elements extend substantially over an entire length of the auto-injector.
[0013] Preferably, the housing and the cap are substantially cylindrical.
[0014] Preferably, the housing has at least one lateral opening, wherein the opening is configured to enable a status check of a medication container arranged in the housing and / or a piston arranged in the medication container.
[0015] Preferably, the at least one opening is arranged in a proximal part of the housing, which can be exposed by removing the cap.
[0016] Preferably, the housing comprises a display arranged on an outer peripheral surface of the housing and configured to display a status of the auto-injector.
[0017] Preferably, the status includes at least one of a medication fill level or a medication readiness.
[0018] Preferably, the activation element comprises a rotary knob which is rotatable about the longitudinal axis of the housing.
[0019] Preferably, a proximal end of the rotary knob and a distal end of the housing each include an alignment feature that may or may not be flush depending on a rotational position of the rotary knob.
[0020] Preferably, the alignment features are configured to indicate a dose setting of the auto-injector.
[0021] Preferably, the alignment features and the display are aligned on a line along the longitudinal axis.
[0022] Preferably, the rotary knob comprises a structured surface, in particular a grip surface grooved in the direction of the longitudinal axis.
[0023] Preferably, the activation element has a larger circumference than the housing and / or the cap.
[0024] Preferably, the activation element comprises a push button arranged within the rotary knob.
[0025] Preferably, the push button is locked in a first position of the rotary knob and can be actuated in a second position of the rotary knob.
[0026] Preferably, the push button does not protrude from the rotary knob in the first position of the rotary knob and protrudes from the rotary knob in the distal direction when the rotary knob is rotated to the second position so that it can be actuated.
[0027] Preferably, the push button is configured to start medication delivery when pressed by a user.
[0028] The invention will now be described in more detail with reference to the drawings, in which identical or similar elements are designated by the same reference numerals. Fig. 1 a front view of an autoinjector according to an embodiment, Fig. 2 a side view of an auto-injector according to an embodiment, Fig. 3 a perspective view of an auto-injector according to an embodiment, Fig. 4 a perspective view of an auto-injector according to Fig. 3 with protective cap removed, Fig. 5 is a perspective view of an auto-injector according to an embodiment, Fig. 6 a cross-sectional view according to an embodiment, and Fig. 7 a perspective view of an auto-injector according to another embodiment.
[0029] In the present disclosure, the term "distal direction" refers to the direction away from the dosage delivery site during use of the medication delivery device. The term "distal portion / distal end" refers to the portion / end of the delivery device or the portions / ends of its elements that are farthest from the dosage delivery site during use of the medication delivery device. Similarly, the term "proximal direction" refers to the direction toward the dosage delivery site during use of the medication delivery device. When used, the term "proximal portion / proximal end" refers to the portion / end of the delivery device or the portions / ends of its elements that are closest to the dosage delivery site during use of the medication delivery device.
[0030] The terms “longitudinal” and “axial” refer to a direction extending from the proximal end to the distal end and along the device or its components, typically in the direction of the longest dimension of the device and / or component (longitudinal axis, z-axis).
[0031] Similarly, the terms “transverse,” “cross,” and “transversal” refer to a direction that is generally perpendicular to the longitudinal direction (xy plane).
[0032] Additionally, the terms "circumference," "circumferential," or "revolving" refer to a circumference or circumferential direction relative to an axis, typically a central / longitudinal axis, that extends in the direction of the longest dimension of the device and / or component. Similarly, "radial" or "radial" refers to a direction extending radially relative to the axis, and "rotation," "rotating," and "rotary" refer to rotation relative to the axis.
[0033] In general, all terms used in the claims are to be interpreted according to their usual meaning in the technical field, unless expressly defined otherwise herein. All references to an element, device, part, component, means, etc. are to be interpreted openly and refer to at least one instance of the element, device, part, component, means, etc., unless expressly stated otherwise.
[0034] Fig. 1 shows a front view of an auto-injector according to an embodiment and Fig. 2 shows a side view of the autoinjector. Fig. Figure 3 shows a perspective view of the auto-injector. The figures show an example of the delivery state of the auto-injector for handover to patients.
[0035] The internal functioning of such an auto-injector is known to those skilled in the art and will not be explained further here. Typically, such an auto-injector comprises a medication reservoir and a plunger, which is spring-loaded, for example, to dispense medication from the reservoir. The auto-injector can be designed with or without a needle.
[0036] The auto-injector has a substantially elongated housing 2 extending along a longitudinal axis. An activation element 3 is provided at a distal end of the housing 2, remote from a medication delivery site. The auto-injector further comprises a cap 1 removably attached to a proximal side of the housing 2. The auto-injector has a first anti-roll element 21 on an outer peripheral surface of the housing 2 and a second anti-roll element 11 on an outer peripheral surface of the cap 1, which extend along the longitudinal axis and are configured to stop or prevent the auto-injector from rolling about the longitudinal axis upon contact with a surface. The anti-roll elements 21, 11 can also be referred to as anti-roll elements 21, 11.
[0037] When the cap 1 is attached to the housing 2, the first and second anti-roll elements 21, 11 are flush aligned along the longitudinal axis. This means that the first and second anti-roll elements 21, 22 are aligned. "Flush aligned along the longitudinal axis" here means that, when the cap is in place, the first and second anti-roll elements 21, 11 are seamlessly and continuously aligned along the length of the auto-injector, without any significant step, gap, or projection between them. Put more simply: When the cap is in place, the two anti-roll elements form an overall seamless and aligned surface that runs in the same direction as the length of the injector.
[0038] According to the Fig. In the embodiment shown in Figures 1 to 6, the first and second anti-roll elements 21, 11 are each formed by a projection. That is, the anti-roll elements 21, 11 protrude from an outer peripheral surface of the housing 2 and the cap 1, respectively, in the radial direction (in the y-axis direction in the figures).
[0039] If the auto-injector shown is placed on a base, a support, or a surface, especially a smooth surface such as a table, the auto-injector can be prevented from rolling away because, upon rotation about the longitudinal axis, the anti-roll elements 21, 11 strike the support, thus blocking further rotation. If the auto-injector begins to roll from a previously stable position, the anti-roll elements 21, 11 can stop such a rolling movement.
[0040] Furthermore, the anti-roll elements 21, 11, when aligned flush, can indicate whether the cap 1 is properly attached to the housing 2 and simplify gripping of the cap 1 or the entire injector.
[0041] The second anti-roll element 11 may extend from a distal end of the cap 1 over at least 50%, preferably at least 75% of a length of the cap 1.
[0042] The first anti-roll element 21 may be formed on a proximal contact surface of the housing 2 with the cap 1 and extend in the distal direction. In other words, when the cap 1 is placed on the housing 2, the first and second anti-roll elements 21, 11 abut one another and are aligned flush with one another, as described above.
[0043] A length of the first anti-roll element 21 of the housing 2 may, for example, be less than 50%, preferably less than 20% and more preferably less than 10% of a length of the second anti-roll element 11 of the cap 1.
[0044] A total length of the first and second roll-preventing elements 21, 11 may be between 15-100% of a total length of the auto-injector, preferably 20-100% and more preferably 25-100%.
[0045] The housing 2 and the cap 1 can be substantially cylindrical. The same applies to the activation element 3. However, the invention can be applied to other shapes, such as housings with oval cross-sections.
[0046] Fig. Figure 4 shows the auto-injector described above with the cap 1 removed. In this state, medication delivery is possible. The cap 1 can be replaced after use and attached to the housing 2 by means of a thread, snap connection, or similar.
[0047] According to the exemplary embodiment shown, the housing 2 can have a proximal housing part 23 and a distal housing part 22. The proximal housing part 23 and the distal housing part 22 can be formed integrally. The proximal housing part 23 can be formed by a tubular element, and the distal housing part can be formed by another tubular element that adjoins the proximal housing part 23. The proximal housing part 23 can have a smaller diameter than the distal housing part 22. The proximal housing part 23 can be covered by the cap 1 in a delivery state, or when the cap 1 is attached. The first anti-roll element 21 can thus be arranged at or near a proximal end of the distal housing part 22.
[0048] The housing 2 may have at least one lateral opening 26, wherein the opening 26 is configured to enable a status check of a medication container arranged in the housing 2 and / or a piston arranged in the medication container. As shown in Fig. As shown in Figure 4, the at least one opening 26 can be arranged in the proximal part 23 of the housing, which can be exposed by removing the cap 1. Additionally or alternatively, such an opening can also be arranged in the distal housing part 22. Preferably, two opposing openings 26 are provided (offset by 180°).
[0049] Furthermore, the housing 2 can have a display 25 arranged on an outer peripheral surface of the housing 2 and configured to display a status of the auto-injector. The status can include at least one of a medication fill level, dose setting, medication readiness, etc. The status indicated on the display 25 can change, for example, upon rotation of the rotary knob 31 (see below).
[0050] The activation element 3 may comprise a rotary knob 31 which is rotatable about the longitudinal axis of the housing 2.
[0051] A proximal end of the rotary knob 31 and a distal end of the housing 2 may each include an alignment feature (activation element alignment feature 34 and housing alignment feature 24) that may or may not be aligned depending on a rotational position of the rotary knob 31.
[0052] In the Fig. 1, Fig. 3 and Fig. 4, only the housing alignment feature 24 is visible, with the activation element alignment feature 34 being arranged on a remote side. By rotating the rotary knob 31, a state as in Fig. 5, in which the activation element alignment feature 34 and the housing alignment feature 24 are aligned flush with each other.
[0053] This can, for example, indicate readiness, a dose setting, or a locked state of the auto-injector. In the embodiment shown, the auto-injector is ready to deliver medication when the alignment features 24, 34 are aligned. A required rotation of the rotary knob 31 for activation can include, but is not limited to, 90°, 180°, or 360°. The rotation of the rotary knob 31 can also influence the amount of dose to be delivered.
[0054] The rotary knob 31 can include a textured surface to simplify operation, particularly rotation. This can be configured, for example, as a grip surface grooved in the direction of the longitudinal axis. The activation element 3 can have a larger circumference than the housing 2 and / or the cap 1. A radial distance of an outer side of the anti-roll elements 21, 11 with respect to the longitudinal axis (a radial elevation of the anti-roll elements in the y-direction) can be less than or equal to a maximum radius of the activation element 3.
[0055] The activation element 3 can, as shown in the figures, also comprise a push button 32 arranged within the rotary knob 31. The push button 32 can be locked in a first position of the rotary knob 31 (see, for example, Fig. 1-4) and in a second position of the rotary knob 31 (see e.g. Fig. 5). As described above, the alignment features 24, 34 may indicate the first and second positions, respectively, or intermediate positions.
[0056] The auto-injector may also be configured such that the push button 32 does not protrude from the rotary knob 31 in the first position of the rotary knob 31 and protrudes distally from the rotary knob 31 when the rotary knob 31 is rotated (about the longitudinal axis) to the second position so that it can be actuated.
[0057] The push button 32 can be configured to start medication delivery when pressed by a user.
[0058] The housing alignment feature 24 (or, depending on the rotational position of the rotary knob 31, both alignment features 24, 34) and the anti-roll elements 11, 21 can be aligned on a line along the longitudinal axis. Furthermore, the housing alignment feature 24 (or, depending on the rotational position of the rotary knob 31, both alignment features 24, 34) and the display 25 can be aligned on a line along the longitudinal axis.
[0059] Fig. Figure 6 shows a sectional view of the autoinjector. As mentioned above, the internal functions of the autoinjector will not be discussed in detail in the course of this disclosure, as these are known from the prior art.
[0060] In a further embodiment, which is Fig. 7, the first and second anti-roll elements 21, 11 can each be formed by a flattened area. In the following, only differences from the embodiment described above are described, the remaining parts being equally applicable to the embodiment shown in Fig. 7 are applicable. In particular, the flattened anti-roll elements 21, 11 achieve the same advantages as described above.
[0061] The first anti-roll element 21 can extend over the entire visible length of the housing 2. That is, the first anti-roll element can extend over the length of the distal housing part 22.
[0062] Likewise, the activation element 3, in particular the rotary knob 31, can have a flattened area that is flush with the first anti-roll element 21.
[0063] Thus, the first and second anti-roll elements 21, 11 (and the flattened region of the activation element 3) can extend substantially over an entire length of the auto-injector.
[0064] The flattened area of the activation element 3 can simultaneously serve as an activation element alignment feature 34 to indicate a device status as described above.
[0065] The present disclosure thus provides an auto-injector that ensures simplified and safe use and provides status information to patients in a simple manner. Anti-roll elements can prevent or at least slow the auto-injector from rolling away on smooth surfaces. The display attached to the housing can indicate a status of the injector, such as storage / initial state, ready for dispensing, dose amount, dispensing completed, or similar. A rotary knob can have a larger circumference / diameter and / or a textured surface to simplify interaction with the rotary knob. A push button for triggering the injector can only be revealed upon rotation of the rotary knob, which can prevent unintentional activation.
[0066] Alignment features on the housing and activation element can also easily indicate device status. Furthermore, an opening can provide visibility into a medication reservoir and / or plunger movement, thus providing information about dispensing status or remaining medication.
[0067] The present invention can be applied to single-use and multi-use devices, and can accommodate a wide variety of volumes. Furthermore, the housing can be customized.
[0068] The autoinjectors shown are also well suited for an injection molding process, which has the hot runner gate at a proximal end of the cap.
[0069] Unless otherwise stated, all embodiments shown are compatible with each other and may include features of other embodiments.
[0070] Although the invention is illustrated and described in detail by means of the figures and the associated description, this illustration and this detailed description are to be understood as illustrative and exemplary and not as limiting the invention. It is understood that those skilled in the art may make changes and modifications without departing from the scope of the following claims. In particular, the invention also encompasses embodiments with any combination of features mentioned or shown above for various aspects and / or embodiments.
[0071] The invention also includes individual features in the figures, even if they are shown there in connection with other features and / or are not mentioned above.
[0072] Furthermore, the term "comprising" and derivatives thereof does not exclude other elements or steps. Likewise, the indefinite article "a" or "an" and derivatives thereof does not exclude a plurality. The functions of several features listed in the claims may be performed by a single unit. The terms "essentially," "about," "approximately," and the like, in conjunction with a property or value, specifically define the property or value. All reference signs in the claims are not to be understood as limiting the scope of the claims.
[0073] The delivery devices described herein may be used for the treatment and / or prophylaxis of one or more of many different types of diseases.
[0074] Example diseases include, but are not limited to: rheumatoid arthritis, inflammatory bowel disease (e.g., Crohn's disease and ulcerative colitis), hypercholesterolemia and / or dyslipidemia, cardiovascular disease, diabetes (e.g., type 1 or type 2), psoriasis, psoriatic arthritis, spondyloarthritis, hidradenitis suppurativa, Sjögren's syndrome, migraine, cluster headache, multiple sclerosis, neuromyelitis optica spectrum disorder, anemia, thalassemia, paroxysmal nocturnal hemoglobinuria, hemolytic anemia, hereditary angioedema, systemic lupus erythematosus, lupus nephritis, myasthenia gravis, Behçet's disease, hemophagocytic lymphohistiocytosis, atopic dermatitis, retinal diseases (e.g. age-related macular degeneration, diabetic macular edema), uveitis, infectious diseases, bone diseases (e.g.Osteoporosis, osteopenia), asthma, chronic obstructive pulmonary disease, thyroid eye disease, nasal polyps, transplantation, acute hypoglycemia, obesity, anaphylaxis, allergies, sickle cell anemia, Alzheimer's disease, Parkinson's disease, Lewy body dementia, systemic infusion reactions, immunoglobulin E (IgE)-mediated hypersensitivity reactions, cytokine release syndrome, immune deficiencies (e.g. primary immunodeficiency, chronic inflammatory demyelinating polyneuropathy), enzyme deficiencies (e.g. Pompe disease, Fabry disease, Gaucher disease), growth factor deficiency, hormone deficiency, coagulation disorders (e.g. hemophilia, von Willebrand disease, Factor V Leiden) and cancer.
[0075] Example types of drugs that could be included in the delivery devices described herein include, but are not limited to, small molecules, hormones, cytokines, blood products, enzymes, vaccines, anticoagulants, immunosuppressants, antibodies, antibody-drug conjugates, neutralizing antibodies, reversal agents, radioligand therapies, radioisotopes and / or nuclear medicine preparations, diagnostics, bispecific antibodies, proteins, fusion proteins, peptibodies, polypeptides, pegylated proteins, protein fragments, nucleotides, protein analogs, protein variants, protein precursors, protein derivatives, chimeric antigen receptor T cell therapies, cell or gene therapies, oncolytic viruses, or immunotherapies.
[0076] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, immuno-oncology or bio-oncology drugs such as immune checkpoints, cytokines, chemokines, clusters of differentiation, interleukins, integrins, growth factors, coagulation factors, enzymes, enzyme inhibitors, retinoids, steroids, signaling proteins, pro-apoptotic proteins, anti-apoptotic proteins, T cell receptors, B cell receptors, or costimulatory proteins.
[0077] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, those having a proposed mechanism of action, such as human epidermal growth factor receptor-2 (HER-2) receptor modulators, interleukin (IL) modulators, interferon (IFN) modulators, complement modulators, glucagon-like peptide-1 (GLP-1) modulators, glucose-dependent insulintropin polypeptide (GIP) modulators, cluster of differentiation 38 (CD38) modulators, cluster of differentiation 22 (CD22) modulators, C1 esterase modulators, bradykinin modulators, CC chemokine receptor type 4 (CCR4) modulators, vascular endothelial growth factor (VEGF) modulators, B-cell activating factor (BAFF) modulators, P-selectin modulators, modulators of the neonatal Fc receptor (FcRn), calcitonin gene-related peptide (CGRP) modulators, modulators of the epidermal growth factor receptor (EGFR),Modulators of cluster of differentiation 79B (CD79B), modulators of tumor-associated calcium signal transducer 2 (Trop-2) modulators, cluster of differentiation 52 (CD52) modulators, B cell maturation antigen (BCMA) modulators, enzyme modulators, platelet-derived growth factor receptor A (PDGFRA) modulators, cluster of differentiation 319 (CD319 or SLAMF7) modulators, programmed cell death protein 1 and programmed death-ligand 1 (PD-1 / PD-L1) inhibitors / modulators, B lymphocyte antigen cluster of differentiation 19 (CD19) inhibitors, B lymphocyte antigen cluster of differentiation 20 (CD20) modulators, cluster of differentiation 3 (CD3) modulators, cytotoxic T lymphocyte-associated Protein 4 (CTLA-4) inhibitors, T-cell immunoglobulin and mucin domain-containing-3 (TIM-3) modulators, T-cell immunoreceptor with Ig and ITIM domains (TIGIT) modulators, V-domain Ig suppressor of T-cell activation (VISTA) modulators, indoleamine 2,3-dioxygenase (IDO or INDO) modulators,Poliovirus receptor-related immunoglobulin domain-containing protein (PVRIG) modulators, lymphocyte activation gene 3 (LAG3; also known as Cluster of Differentiation 223 or CD223) antagonists, Cluster of Differentiation 276 (CD276 or B7-H3) antigen modulators, Cluster of Differentiation 47 (CD47) antagonists, Cluster of Differentiation 30 (CD30) modulators, Cluster of Differentiation 73 (CD73) modulators, Cluster of Differentiation 66 (CD66) modulators, Cluster of Differentiation w137 (CDw137) agonists, Cluster of Differentiation 158 (CD158) modulators, Cluster of Differentiation 27 (CD27) modulators, Cluster of Differentiation 58 (CD58) modulators, Cluster of Differentiation 80 (CD80) modulators, Cluster of Differentiation 33 (CD33) modulators, Cluster of Differentiation 159 (CD159 or NKG2) modulators, Glucocorticoid-induced TNFR-related (GITR) protein modulators, Killer Ig-like receptor (KIR) modulators,Growth arrest-specific protein 6 (GAS6) / AXL pathway modulators, proliferation-inducing ligand (APRIL) receptor modulators, human leukocyte antigen (HLA) modulators, epidermal growth factor receptor (EGFR) modulators, B lymphocyte cell adhesion molecule modulators, cluster of differentiation w123 (CDw123) modulators, Erbb2 tyrosine kinase receptor modulators, endoglin modulators, mucin modulators, mesothelin modulators, hepatitis A virus cell receptor 2 (HAVCR2) antagonists, cancer testis antigen (CTA) modulators, tumor necrosis factor receptor superfamily member 4 (TNFRSF4 or OX40) modulators, adenosine receptor modulators, inducible T-cell co-stimulators (ICOS) modulators, cluster of differentiation 40 (CD40) modulators, tumor-infiltrating lymphocyte (TIL) therapies, or T-cell receptor (TCR) therapies.
[0078] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to: etanercept, abatacept, adalimumab, evolocumab, exenatide, secukinumab, erenumab, galcanezumab, fremanezumab-vfrm, alirocumab, methotrexate (amethopterin), tocilizumab, interferon beta-1a, interferon beta-1b, peginterferon beta-1a, sumatriptan, darbepoetin alfa, belimumab, sarilumab, semaglutide, dupilumab, reslizumab, omalizumab, glucagon, epinephrine, naloxone, insulin, amylin, vedolizumab, eculizumab, ravulizumab, crizanlizumab-tmca, certolizumab pegol, satralizumab, denosumab, Romosozumab, benralizumab, emicizumab, tildrakizumab, ocrelizumab, ofatumumab, natalizumab, mepolizumab, risankizumab-RZAA, ixekizumab and immunoglobulins.
[0079] Exemplary pharmaceuticals that could be contained in the delivery devices described herein include, but are not limited to, cancer drugs such as ipilimumab, nivolumab, pembrolizumab, atezolizumab, durvalumab, avelumab, cemiplimab, rituximab, trastuzumab, ado-trastuzumab emtansine, fam-trastuzumab deruxtecan NXKI, pertuzumab, transtuzumab pertuzumab, alemtuzumab, belantamab mafodotin BLMF, bevacizumab, blinatumomab, brentuximab vedotin, cetuximab, daratumumab, elotuzumab, gemtuzumab ozogamicin, 90-yttrium ibritumomab tiuxetan, isatuximab, mogamulizumab, moxetumomab pasudotox, obinutuzumab, ofatumumab, Olaratumab, panitumumab, polatuzumab vedotin, ramucirumab, sacituzumab govitecan, tafasitamab or margetuximab.
[0080] Exemplary drugs that could be contained in the delivery devices described herein include "generic" or biosimilar equivalents of the aforementioned drugs, and the above molecular designations should not be construed as limiting to the "innovator" or "brand" version of each individual active ingredient, such as in the non-limiting example of the innovator drug adalimumab and biosimilars such as adalimumab-afzb, adalimumab-atto, adalimumab-adbm, and adalimumabadaz.
[0081] Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, those used for adjuvant or neoadjuvant chemotherapy, such as alkylating agents, plant alkaloids, antitumor antibiotics, antimetabolites or topoisomerase inhibitors, enzymes, retinoids, or corticosteroids. Examples of chemotherapeutic agents include 5-fluorouracil, cisplatin, carboplatin, oxaliplatin, doxorubicin, daunorubicin, idarubicin, epirubicin, paclitaxel, docetaxel, cyclophosphamide, ifosfamide, azacitidine, decitabine, bendamustine, bleomycin, bortezomib, busulfan, cabazitaxel, carmustine, cladribine, cytarabine, dacarbazine, etoposide, fludarabine, gemcitabine, irinotecan, leucovorin, melphalan, methotrexate, pemetrexed, mitomycin, mitoxantrone, temsirolimus, topotecan, valrubicin, vincristine, vinblastine or vinorelbine.
[0082] Exemplary drugs that could be included in the delivery devices described herein also include, but are not limited to, analgesics (e.g., acetaminophen), antipyretics, corticosteroids (e.g., hydrocortisone, dexamethasone, or methylprednisolone), antihistamines (e.g., diphenhydramine or famotidine), antiemetics (e.g., ondansetron), antibiotics, antiseptics, anticoagulants, fibrinolytics (e.g., recombinant tissue plasminogen activator [r-TPA]), antithrombolytics, or diluents such as sterile water for injection (SWFI), 0.9% normal saline, 0.45% normal saline, 5% dextrose in water, 5% dextrose in 0.45% normal saline, Lactated Ringer's solution, Heparin Lock Rinse Solution, 100 U / ml Heparin Lock Rinse Solution, or 5000 U / ml Heparin Lock Rinse Solution.
[0083] Pharmaceutical formulations, including but not limited to any pharmaceuticals described herein, are also intended for use in the delivery devices described herein, for example, pharmaceutical formulations containing a pharmaceutical compound listed herein (or a pharmaceutically acceptable salt of the compound) and a pharmaceutically acceptable carrier. Such formulations may contain one or more other active ingredients (e.g., as a combination of one or more active ingredients) or may be the sole active ingredient present, and may also contain separately administered or co-formulated dispersion enhancers (e.g., an animal, human, or recombinant hyaluronidase enzyme), concentration modifiers or enhancers, stabilizers, buffers, or other excipients.
[0084] Exemplary drugs that could be included in the delivery devices described herein include, but are not limited to, a multi-drug treatment regimen such as AC, Dose-Dense AC, TCH, GT, EC, TAC, TC, TCHP, CMF, FOLFOX, mFOLFOX6, mFOLFOX7, FOLFCIS, CapeOx, FLOT, DCF, FOLFIRI, FOLFIRINOX, FOLFOXIRI, IROX, CHOP, R-CHOP, RCHOP-21, Mini-CHOP, Maxi-CHOP, VR-CAP, Dose-Intensive CHOP, EPOCH, Dose-Adjusted EPOCH, R-EPOCH, CODOX-M, IVAC, HyperCVAD, R-HyperCVAD, SC-EPOCH-RR, DHAP, ESHAP, GDP, ICE, MINE, CEPP, CDOP, GemOx, CEOP, CEPP, CHOEP, CHP, GCVP, DHAX, CALGB 8811, HIDAC, MOpAD, 7 + 3, 5 +2, 7 + 4, MEC, CVP, RBAC500, DHA-Cis, DHA-Ca, DHA-Ox, RCVP, RCEPP, RCEOP, CMV, DDMVAC, GemFLP, ITP, VIDE, VDC, VAI, VDC-IE, MAP, PCV, FCR, FR, PCR, HDMP, OFAR, EMA / CO, EMA / EP, EP / EMA, TP / TE, BEP, TIP, VIP, TPEx, ABVD, BEACOPP, AVD, Mini-BEAM, IGEV, C-MOPP, GCD, GEMOX, CAV, DT-PACE, VTD-PACE, DCEP, ATG, VAC, VelP, OFF, GTX, CAV, AD, MAID, AIM, VAC-IE,ADOC or PE., List of reference symbols 1 cap 11 Second anti-roll element 2 housings 21 First anti-roll element 22 Distal housing part 23 Proximal housing part 24 Housing alignment element 25 Advertisement 26 Opening 3 Activation element 31 Rotary knob 32 push button 34 Activation element alignment element
Claims
[1] An auto-injector that has: a substantially elongated housing (2) extending along a longitudinal axis; an activation element (3) provided at a distal end of the housing (2) remote from a drug delivery site; and a cap (1) removably attached to a proximal side of the housing (2); wherein the auto-injector comprises a first anti-roll element (21) on an outer peripheral surface of the housing (2) and a second anti-roll element (11) on an outer peripheral surface of the cap (1), which extend along the longitudinal axis and are configured to stop or prevent the auto-injector from rolling about the longitudinal axis upon contact with a base; and wherein, when the cap (1) is attached to the housing (2), the first and second anti-roll elements (21, 11) are aligned flush along the longitudinal axis. [2] Auto-injector according to claim 1, wherein the first and second rolling prevention elements (21, 11) are each formed by a projection. [3] Auto-injector according to claim 1 or 2, wherein the second anti-roll element (11) extends from a distal end of the cap (1) over at least 50%, preferably at least 75% of a length of the cap (1). [4] Auto-injector according to one of claims 1 to 3, wherein the first rolling prevention element (21) is formed on a proximal contact surface of the housing (2) with the cap (1) and extends in the distal direction. [5] Auto-injector according to one of the claims 1 to 4, wherein a length of the first roll-prevention element (21) is less than 50%, preferably less than 20% and more preferably less than 10% of a length of the second roll-prevention element (11). [6] Auto-injector according to claim 1, wherein the first and second anti-roll elements (21, 11) are each formed by a flattened region. [7] Auto-injector according to claim 6, wherein the activation element (3) has a flattened region which is aligned flush with the first anti-roll element (21). [8] Auto-injector according to one of the claims 6 or 7, wherein the first and second anti-roll elements (21, 11) extend substantially over an entire length of the auto-injector. [9] Auto-injector according to one of claims 1 to 8, wherein the housing (2) and the cap (1) are substantially cylindrical. [10] Auto-injector according to one of the claims 1 to 9, wherein the housing (2) has at least one lateral opening (26), wherein the opening (26) is configured to enable a status check of a medicament container arranged in the housing (2) and / or of a piston arranged in the medicament container. [11] Auto-injector according to claim 10, wherein the at least one opening (26) is arranged in a proximal part of the housing (2, 23) which can be exposed by removing the cap (1). [12] Auto-injector according to one of claims 1 to 11, wherein the housing (2) has a display (25) arranged on an outer peripheral surface of the housing (2) and configured to display a status of the auto-injector. [13] Auto-injector according to claim 12, wherein the status comprises at least one of a medication fill level or a medication dispensing readiness. [14] Auto-injector according to one of claims 1 to 13, wherein the activation element (3) comprises a rotary knob (31) which is rotatable about the longitudinal axis of the housing (2). [15] Auto-injector according to claim 14, wherein a proximal end of the rotary knob (31) and a distal end of the housing (2, 22) each include an alignment feature (34, 24) which are aligned or not aligned depending on a rotational position of the rotary knob (31). [16] The auto-injector of claim 15, wherein the alignment features (34, 24) are configured to indicate a dose setting of the auto-injector. [17] Auto-injector according to one of claims 15 or 16, wherein the alignment features (34, 24) and the indicator (25) are aligned on a line along the longitudinal axis. [18] Auto-injector according to one of the claims 14 to 17, wherein the rotary knob (31) comprises a structured surface, in particular a grip surface grooved in the direction of the longitudinal axis. [19] Auto-injector according to one of the claims 1 to 18, wherein the activation element (3) has a larger circumference than the housing (2) and / or the cap (1). [20] Auto-injector according to one of claims 14 to 19, wherein the activation element (3) comprises a push button (32) arranged within the rotary knob (31). [21] Auto-injector according to claim 20, wherein the push button (32) is locked in a first position of the rotary knob (31) and can be actuated in a second position of the rotary knob (31). [22] Auto-injector according to one of the claims 20 or 21, wherein the push button (32) does not protrude from the rotary knob (31) in the first position of the rotary knob (31) and protrudes from the rotary knob (31) in the distal direction upon rotation of the rotary knob (31) into the second position so that it can be actuated. [23] Auto-injector according to one of claims 20 to 22, wherein the push button (32) is configured to start a drug delivery when actuated by a user.