WO2017118661A1 - Dispositif d'administration de médicament pourvu d'une fonction de maintien rotative - Google Patents

Dispositif d'administration de médicament pourvu d'une fonction de maintien rotative Download PDF

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Publication number
WO2017118661A1
WO2017118661A1 PCT/EP2017/050143 EP2017050143W WO2017118661A1 WO 2017118661 A1 WO2017118661 A1 WO 2017118661A1 EP 2017050143 W EP2017050143 W EP 2017050143W WO 2017118661 A1 WO2017118661 A1 WO 2017118661A1
Authority
WO
WIPO (PCT)
Prior art keywords
cap
drug delivery
delivery device
housing
radial projection
Prior art date
Application number
PCT/EP2017/050143
Other languages
English (en)
Inventor
Matthew Meredith Jones
Robert Veasey
Original Assignee
Sanofi
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Sanofi filed Critical Sanofi
Publication of WO2017118661A1 publication Critical patent/WO2017118661A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3202—Devices for protection of the needle before use, e.g. caps
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M2005/3103—Leak prevention means for distal end of syringes, i.e. syringe end for mounting a needle
    • A61M2005/3104—Caps for syringes without needle
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/178—Syringes
    • A61M5/31—Details
    • A61M5/32—Needles; Details of needles pertaining to their connection with syringe or hub; Accessories for bringing the needle into, or holding the needle on, the body; Devices for protection of needles
    • A61M5/3205—Apparatus for removing or disposing of used needles or syringes, e.g. containers; Means for protection against accidental injuries from used needles
    • A61M5/321—Means for protection against accidental injuries by used needles
    • A61M5/3213—Caps placed axially onto the needle, e.g. equipped with finger protection guards

Definitions

  • the disclosure generally relates to a drug delivery device, to a cap for a drug delivery device and to an accessory module for a drug delivery device.
  • pre-filled cartridges are used. These cartridges are housed in a housing. To dispense a certain set dose of a medicament contained in such cartridge, the drug delivery device has a dose setting element. During drug delivery, a piston rod coupled to the dose setting element presses against a piston (also commonly referred to as a "bung”, a “stopper”, or a “plunger") contained within the cartridge in order to dispense the medicament through an attached needle assembly. Activities involved in parenteral drug delivery from such drug delivery devices may include removal of a protective cap, insertion of a needle into a patient's skin, removal of the needle, shielding of the needle, preventing reuse of the device etc. Furthermore, drug delivery devices may be arranged to allow coupling with accessory modules, e.g. an electronic module for recording information related to a therapy such as type and volume of a drug and drug delivery time and date.
  • accessory modules e.g. an electronic module for recording information related to a therapy such as type and volume of a drug and drug delivery time and date.
  • the object is achieved by a drug delivery device according to claim 1 , by a cap according to claim 9 and by an accessory module according to claim 14.
  • a drug delivery comprises a housing having at least one radial projection forming a multi-retention mechanism, which provides a holding function to releasably hold a component to the housing in either rotational direction.
  • the multi-retention mechanism provides two retention functions, respectively one retention function for a component configured to be releasably coupled to the housing in either rotational direction and another retention function for another component configured to be releasably coupled to the housing in only one rotational direction.
  • a retention function in the context of this application may be a function suitable to assemble, to support and to detach a special component in an easy and reliable manner respectively.
  • the drug delivery device may be coupled with two components at different times, wherein both components can be assembled, supported and detached in an easy and reliable manner respectively by the at least one radial projection.
  • the at least one radial projection is asymmetric about its centreline.
  • the radial projection is transformed in a two dimensional view and a longitudinal axis of the drug delivery device is transformed into an axis of symmetry that represents the centreline.
  • the housing comprises an elongated shape having a housing flange on one end, wherein the at least one radial projection is arranged on a circumference section of the housing flange.
  • the housing flange may comprise a substantially rotationally symmetrical shape relative to a longitudinal axis of the housing.
  • the longitudinal axis is defined by the elongated shape of the housing.
  • the rotationally symmetrical shape of the housing flange enables more assembly freedom as a rotationally asymmetrical shape, e.g. an elliptic shape.
  • two radial projections are arranged on opposite sides of the circumference of the housing flange, wherein the radial projections are orientated mirror- inverted with respect to each other.
  • the at least one radial projection comprises a main section and an extended section.
  • At least the main section may include a ramp providing an inclined surface in the direction of the longitudinal axis.
  • the extended section may provide a rounded edge.
  • the extended section may extend the at least one radial projection in a
  • the main section may have an increased length in a direction of the longitudinal axis with respect to the extended section.
  • the at least one radial projection may comprise a substantially L- shape orientated in the circumferential direction of the housing flange.
  • a cap for a drug delivery device may comprise a cap flange for releasably engaging the housing flange of the housing, wherein the cap flange comprises at least one cap recess and wherein the at least one cap recess is configured to receive the at least one radial projection, thereby providing a cap retention function as one of the two retention functions.
  • the at least one cap recess may have dimensions for receiving the main section and the extended section of the at least one radial projection. Due to this in context with the rotationally symmetrical shape, the cap is allowed to be assembled in two rotational directions.
  • the at least one cap recess extends in both directions from its centreline at least as far as a maximum distance the at least one radial projection extends from its centreline.
  • the at least one cap recess is symmetric about its centreline.
  • the centreline of the cap recess may be defined in the same way as the centreline of the radial protrusion except the transformation of the longitudinal axis of the drug delivery device.
  • the axis of symmetry is a transformed longitudinal axis of the cap.
  • the at least one cap recess may comprise a stop provided for abutting against the at least one radial projection in a circumferential direction of the cap flange.
  • An accessory module for a drug delivery device comprises a module flange for releasably engaging the housing flange of the housing, wherein the module flange comprises at least one module recess and wherein the at least one module recess is configured to receive the at least one radial projection, thereby providing a module retention function.
  • at least a part of the one module recess has a circumferential dimension at least as wide as the radial projection, wherein the at least one module recess includes an extending part substantially corresponding to the extended section of the radial projection.
  • the width of the radial projection is a dimension of the radial projection into a circumferential direction of the housing.
  • the accessory module is configured as an electronic module for recording information of the drug delivery device, such as therapy information, quantities of drug dialled and/or dispensed, dispense time and date etc.
  • Figure 1 is a schematic view of an exemplary embodiment of a drug delivery device with a cap
  • Figure 2 is a schematic perspective view of a housing of a drug delivery device and a cap coupled to the housing,
  • FIG. 3 is a further schematic perspective view of the housing and the cap according to figure 2,
  • Figure 4 is a schematic perspective view of a part of a housing of the drug delivery device according to figure 2 comprising a radial projection
  • Figure 5 is a schematic perspective view of a part of a housing of another exemplary embodiment of a drug delivery device comprising a radial projection
  • Figure 6 is a schematic perspective view of the housing relating to figure 4 comprising a further radial projection arranged opposite the other radial projection in a circumferential direction,
  • Figure 7 is a schematic view of a radial projection according to figure 5 or 6
  • Figure 8 is a schematic sectional view of an exemplary embodiment of a drug delivery device with a cap
  • Figure 9 is a schematic view of an exemplary embodiment of a drug delivery device comprising a radial projection and an accessory module during an assembly step and
  • Figure 10 is a schematic view of an exemplary embodiment of a drug delivery device comprising a radial projection and an accessory module during another assembly step.
  • Figure 1 schematically shows a simplified embodiment of a drug delivery device 1 that is configured as a pen-type device operable to deliver a variable, user-selectable dose of a medicament contained in the drug delivery device 1 .
  • the drug delivery device 1 extends axially between a proximal direction P and a distal direction D.
  • the proximal direction P refers to a direction that under use of the drug delivery device 1 is located the furthest away from a drug delivery site of a patient.
  • the distal direction D refers to a direction that under use of the drug delivery device 1 is located closest to the drug delivery site of the patient.
  • the drug delivery device 1 comprises a housing 2 adapted to receive a cartridge (not shown) and releasably coupled to a component 3, in particular a cap (referred to hereinafter as the "cap 3).
  • the drug delivery device 1 furthermore comprises a dial grip 4 for selecting a dose of medicament and a button 5 adapted to initiate drug delivery.
  • Figures 2 and 3 respectively show an exemplary embodiment of a housing 2 and a cap 3 coupled to the housing 2.
  • the housing 2 comprises an elongated shape defining a longitudinal axis A and a housing flange 2.1 arranged on a distal end of the housing 2, whereby the housing flange 2.1 is configured as an outer flange.
  • a circumference or cross section of the housing 2 or at least a circumference of the housing flange 2.1 is rotationally asymmetric with respect to the longitudinal axis A.
  • the cross section of the housing flange 2.1 is elliptic or oval.
  • the housing 2 For engaging the cap 3, the housing 2 comprises two radial projections 2.2 (one illustrated in figure 4) that are arranged opposite each other about a circumference of the housing flange 2.1 .
  • Figure 4 shows a part of the housing 2 comprising such radial projection 2.2 in a perspective view.
  • the radial projections 2.2 respectively comprise a substantially rectangular circumference, thereby protruding radially outwards from an outer circumference of the housing flange 2.1 and including a ramp providing a surface inclined in the direction of the longitudinal axis A.
  • the inclined surface increases in the proximal direction P.
  • the cap 3 comprises a cap flange 3.1 (illustrated in figure 8) arranged on a proximal end of the cap 3 adapted to engage the housing flange 2.1 .
  • the cap flange 3.1 is configured as an inner flange.
  • a circumference or cross section of the cap 3 or at least a circumference of the cap flange 3.1 is configured corresponding with the housing flange 2.1 .
  • the cross section of the cap flange 3.1 is rotationally asymmetric with respect to the longitudinal axis A.
  • the cap 3 comprises two cap recesses 3.2 (illustrated in figure 8) that are arranged opposite each other about a circumference of the cap flange 3.1 .
  • the cap recesses 3.2 respectively comprise a substantially rectangular circumference adapted to receive the radial projections 2.2.
  • the cap recesses 3.2 or the circumferential limits of the cap recesses 3.2 respectively comprise a radial stop (not shown) for abutting against the radial projections 2.2 in a circumferential direction.
  • the cap 3 Due to the rotationally asymmetrical shape of the cross section of the cap flange 3.1 and the housing flange 2.1 , the cap 3 is limited to be fitted in two possible rotational orientations.
  • a cap pocket clip 3.3 of the cap 3 is aligned with a dose window 2.3 of the housing 2 as illustrated in figure 2.
  • the cap 3 is rotated about the longitudinal axis A at an angle of 180 degrees as illustrated in figure 3.
  • detachable accessory modules 6 (illustrated in figures 9 and 10) can be fitted to the housing 2 in only one rotational orientation to ensure proper function.
  • detachable accessory modules 6 (illustrated in figures 9 and 10) can be fitted to the housing 2 in only one rotational orientation to ensure proper function.
  • the problem may be solved by two radial projections 2.2 as described below.
  • Figure 5 and 6 respectively show a part of a housing 2 of another exemplary embodiment of a drug delivery device 1 with the housing flange 2.1 and two radial projections 2.2 in a perspective view, wherein the illustrations of figure 5 and 6 show opposite sides of the drug delivery device 1.
  • the shown radial projections 2.2 form a multi-retention mechanism M, each of which is capable and operable independently to provide a holding function to releasably hold the housing 2 and a component (e.g. a cap 3 shown in figure 8 or an accessory module 6 shown in figures 9, 10) together in different rotational directions R1 or R2.
  • the multi-retention mechanism M provides two retention functions, respectively one retention function for a component, e.g. the cap 3, configured to be releasably coupled to the housing 2 in one of two rotational directions R1 , R2 and another retention function for another component, e.g. the accessory module 6, configured to be releasably coupled to the housing 2 in only one rotational direction R2.
  • the radial projections 2.2 respectively comprise a ramp providing a surface inclined in the direction of the longitudinal axis A as described before. Thus, the inclined surfaces increase in the proximal direction P. Furthermore, the radial projections 2.2 respectively comprise a main section 2.2.1 and an extended section 2.2.2. At least the main section 2.2.1 includes the inclined surface as described before. Additionally, the extended section 2.2.2 includes the inclined surface as well and may further comprise rounded edges. The main section 2.2.1 and the extended section 2.2.2 respectively comprise a substantially rectangular circumference, thereby being interconnected to each other without a break.
  • the main section 2.2.1 has an increased length in a direction of the longitudinal axis A with respect to the extended section 2.2.2, thus the extended section 2.2.2 forms a shoulder of the main section 2.2.1 extending the radial protrusion 2.2 in the circumferential direction with respect to the main section 2.2.1 .
  • the radial projections 2.2 respectively comprise an L- shape orientated in the circumferential direction of the housing flange 2.1 , wherein by comparison of figure 5 and 6, the radial projections 2.2 are orientated mirror-inverted with respect to each other.
  • Figure 7 shows one of the radial projections 2.2 in a two-dimensional view.
  • the radial projection 2.2 is transformed in a two dimensional view and the longitudinal axis A is transformed into an axis of symmetry A' in order to explain the shape of the radial protrusion 2.2 in another way.
  • Two main ledges 2.2.1 .1 , 2.2.1.2 run symmetrical with respect to the axis of symmetry A'.
  • One main ledge 2.2.1.1 and one extended ledge 2.2.2.1 run asymmetrical with respect to the axis of symmetry A'.
  • a further extended ledge 2.2.2.2 runs perpendicular to the longitudinal axis A and thus, the further extended ledge 2.2.2.2 runs perpendicular to a mounting direction of the cap 3.
  • Figure 8 shows the drug delivery device 1 as described in the figures 5 to 7 in a sectional view VIII of figure 7 with a cap 3.
  • the cap recesses 3.2 are respectively configured with increased dimensions with respect to the cap recess 3.2 described in figures 2 to 4. Therefore, the cap recesses 3.2 comprise
  • Figures 9 and 10 respectively show a part of the housing 2, in particular the housing flange 2.1 and one radial projection 2.2 as described before during assembly of another component 6, in particular an accessory module (referred to hereinafter as the "accessory module 6).
  • the accessory module 6 is configured as an electronic module 6.1 .
  • the electronic module 6.1 is adapted to record information of the drug delivery device 1 , e.g. date and time of any treatment related activity such as quantities of drug dialled and/or dispensed, dispense time etc.
  • the electronic module 6.1 comprises a module flange 6.1 .1 with a module recess 6.1.2 on an end of the module flange 6.1 .1 facing the drug delivery device 1 .
  • the module recess 6.1.2 comprises a shape equally to the shape of the radial projection 2.2 but with increased dimensions.
  • a width of a main part 6.1 .2.1 of the module recess 6.1 .2 in a circumferential direction according to a mounted level of the electronic module 6.1 corresponds with a width of the radial protrusion 2.2 including the extended section 2.2.2 in the
  • An extended part 6.1 .2.2 of the module recess 6.1 .2 is configured as a stepped extension providing an abutting ledge 6.1.2.2.1 to predetermine a mounting orientation of the electronic module 6.1 .
  • a mounting orientation of the electronic module 6.1 is incorrect, because the abutting ledge 6.1 .2.2.1 abuts the extended ledge 2.2.2.2 running perpendicular to the longitudinal axis A.
  • the housing flange 2.1 comprises mounting edges 2.4 predetermining a mounting orientation of the electronic module 6.1 as well, the electronic module 6.1 cannot be mounted to the drug delivery device 1 in the orientation as illustrated in figure 9.
  • Figure 10 illustrates the electronic module 6.1 in a correct mounting orientation and completely mounted to the housing 2, wherein the main part 6.1 .2.1 receives the radial projection 2.2.
  • the configuration of the radial protrusion 2.2 and the module recess 6.1 .2 as described before enables a correct mounting orientation of the electronic module 6.1 , thus the electronic module 6.1 cannot incorrectly engage the housing 2.
  • a cap 3 is allowed to engage the housing 2 in two mounting orientations.
  • the radial projections 2.2 are only subtly different from the related art and do not detrimentally affect other functions of the drug delivery device 1 when the electronic module 6.1 is not attached to the housing 2.
  • a drug or medicament can include at least one small or large molecule, or combinations thereof, in various types of formulations, for the treatment of one or more diseases.
  • exemplary pharmaceutically active compounds may include small molecules; 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
  • Nucleic acids may be incorporated into molecular delivery systems such as vectors, plasmids, or liposomes. Mixtures of one or more of these drugs are also contemplated.
  • a drug delivery device shall encompass any type of device or system configured to dispense a drug into a human or animal body.
  • a drug delivery device may be an injection device (e.g., syringe, pen injector, auto injector, large-volume device, pump, perfusion system, or other device configured for intraocular, subcutaneous, intramuscular, or intravascular delivery), skin patch (e.g., osmotic, chemical, micro-needle), inhaler (e.g., nasal or pulmonary), implantable (e.g., coated stent, capsule), or feeding systems for the gastrointestinal tract.
  • the presently described drugs may be particularly useful with injection devices that include a needle, e.g., a small gauge needle.
  • 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 vessel configured to provide a suitable chamber for storage (e.g., short- or long-term storage) of one or more pharmaceutically active compounds.
  • the chamber may be designed to store a drug for at least one day (e.g., 1 to at least 30 days).
  • 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).
  • the drug container may be or may include a dual-chamber cartridge configured to store two or more components of a drug formulation (e.g., a drug and a diluent, or two different types of drugs) separately, one in each chamber.
  • the two chambers of the dual-chamber cartridge may be configured to allow mixing between the two or more components of the drug or medicament prior to and/or during dispensing into the human or animal body.
  • 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.
  • the two chambers may be configured to allow mixing as the components are being dispensed into the human or animal body.
  • the drug delivery devices and drugs described herein can be used for the treatment and/or prophylaxis of many different types of disorders.
  • Exemplary 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 exemplary disorders are acute coronary syndrome (ACS), angina, myocardial infarction, cancer, macular degeneration, inflammation, hay fever, atherosclerosis and/or rheumatoid arthritis.
  • ACS acute coronary syndrome
  • angina myocardial infarction
  • cancer macular degeneration
  • inflammation hay fever
  • atherosclerosis and/or rheumatoid arthritis.
  • Exemplary drugs for the treatment and/or prophylaxis of diabetes mellitus or complications associated with 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.
  • the term "derivative” refers to any substance which is sufficiently structurally similar to the original substance so as to have substantially similar functionality or activity (e.g., therapeutic effectiveness).
  • Exemplary insulin analogues are Gly(A21 ), Arg(B31 ), Arg(B32) human insulin (insulin glargine); Lys(B3), Glu(B29) human insulin; Lys(B28), Pro(B29) human insulin; Asp(B28) human insulin; human insulin, wherein proline in position B28 is replaced by Asp, Lys, Leu, Val or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human insulin and Des(B30) human insulin.
  • Exemplary 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-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-(N-lithocholyl- gamma-glutamyl)-des(B30) human insulin; B29-N-(oo-carboxyheptadecanoyl)-des(B30) human insulin and B29
  • GLP-1 , GLP-1 analogues and GLP-1 receptor agonists are, for example: Lixisenatide / AVE0010 / ZP10 / Lyxumia, Exenatide / Exendin-4 / Byetta / Bydureon / ITCA 650 / AC-2993 (a 39 amino acid peptide which is produced by the salivary glands of the Gila monster), Liraglutide / Victoza, Semaglutide, Taspoglutide, Syncria / Albiglutide, Dulaglutide, rExendin-4, CJC-1 134-PC, PB- 1023, TTP-054, Langlenatide / HM-1 1260C, CM-3, GLP-1 Eligen, ORMD-0901 , NN-9924, NN- 9926, NN-9927, Nodexen, Viador-GLP-1 , CVX-096, ZYOG-1 , ZYD-1 , GSK-2374697,
  • An exemplary oligonucleotide is, for example: mipomersen / Kynamro, a cholesterol-reducing antisense therapeutic for the treatment of familial hypercholesterolemia.
  • DPP4 inhibitors are Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.
  • hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin,
  • Exemplary 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.
  • antibody refers to an immunoglobulin molecule or an antigen- binding portion thereof.
  • 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.
  • the antibody has effector function and can fix complement.
  • the antibody has reduced or no ability to bind an Fc receptor.
  • 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.
  • fragment refers 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, and multispecific antibodies (e.g., diabodies, triabodies, tetrabodies), 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 antigen-binding antibody fragments are known in the art.
  • CDR complementarity-determining region
  • 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.
  • 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.
  • Exemplary antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).
  • anti PCSK-9 mAb e.g., Alirocumab
  • anti IL-6 mAb e.g., Sarilumab
  • anti IL-4 mAb e.g., Dupilumab
  • the compounds described herein may be used in pharmaceutical formulations comprising (a) the compound(s) or pharmaceutically acceptable salts thereof, and (b) a pharmaceutically acceptable carrier.
  • the compounds may also be used in pharmaceutical formulations that include one or more other active pharmaceutical ingredients or in pharmaceutical formulations in which the present compound or a pharmaceutically acceptable salt thereof is the only active ingredient.
  • the pharmaceutical formulations of the present disclosure encompass any formulation made by admixing a compound described herein and a pharmaceutically acceptable carrier.
  • Pharmaceutically acceptable salts of any drug described herein are also contemplated for use in drug delivery devices.
  • Pharmaceutically acceptable salts are for example acid addition salts and basic salts. Acid addition salts are e.g. HCI or HBr salts.
  • Basic salts are e.g.
  • salts having a cation selected from an alkali or alkaline earth metal, e.g. Na+, or K+, or Ca2+, or an ammonium ion N+(R1 )(R2)(R3)(R4), wherein R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 -C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10- heteroaryl group.
  • R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 -C6-alkyl group, an optionally substituted C2-C6-alkenyl group, an optionally substituted C6-C10-aryl group, or an optionally substituted C6-C10- heteroaryl group.
  • R1 to R4 independently of each other mean: hydrogen, an optionally substituted C1 -C6-alkyl group
  • solvates are for example hydrates or alkanolates such as methanolates or ethanolates.

Abstract

La présente invention concerne un dispositif d'administration de médicament (1) comprenant un logement (2) présentant au moins une saillie radiale (2.2) formant un mécanisme à retenue multiple, qui fournit une fonction de maintien pour maintenir de manière amovible un composant (3, 6) sur le logement (2) dans des sens de rotation différents (R1, R2). La présente invention concerne également un capuchon (3) pour un dispositif d'administration de médicament (1) et un module accessoire (6) pour un dispositif d'administration de médicament (1).
PCT/EP2017/050143 2016-01-04 2017-01-04 Dispositif d'administration de médicament pourvu d'une fonction de maintien rotative WO2017118661A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP16305003 2016-01-04
EP16305003.2 2016-01-04

Publications (1)

Publication Number Publication Date
WO2017118661A1 true WO2017118661A1 (fr) 2017-07-13

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Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113853223A (zh) * 2019-03-29 2021-12-28 赛诺菲 药物递送装置和用于组装的方法

Citations (5)

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Publication number Priority date Publication date Assignee Title
GB2064964A (en) * 1979-12-12 1981-06-24 Nat Res Dev Syringe
EP1346739A1 (fr) * 2002-03-20 2003-09-24 Becton, Dickinson and Company Protection pivotable pour dispositifs d'aiguille
EP2688612A1 (fr) * 2011-03-23 2014-01-29 Sanofi-Aventis Deutschland GmbH Dispositif d'administration de médicament avec capuchon protecteur pivotant
US20150231325A1 (en) * 2007-09-07 2015-08-20 Mallinckrodt Llc Power injector with movable joint-integrated signal transmission connector
US20150367075A1 (en) * 2013-01-29 2015-12-24 Sanofi-Aventis Deutschland Gmbh Drug delivery device

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2064964A (en) * 1979-12-12 1981-06-24 Nat Res Dev Syringe
EP1346739A1 (fr) * 2002-03-20 2003-09-24 Becton, Dickinson and Company Protection pivotable pour dispositifs d'aiguille
US20150231325A1 (en) * 2007-09-07 2015-08-20 Mallinckrodt Llc Power injector with movable joint-integrated signal transmission connector
EP2688612A1 (fr) * 2011-03-23 2014-01-29 Sanofi-Aventis Deutschland GmbH Dispositif d'administration de médicament avec capuchon protecteur pivotant
US20150367075A1 (en) * 2013-01-29 2015-12-24 Sanofi-Aventis Deutschland Gmbh Drug delivery device

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN113853223A (zh) * 2019-03-29 2021-12-28 赛诺菲 药物递送装置和用于组装的方法

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