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WO2025132685A1 - Système d'administration de médicament - Google Patents

Système d'administration de médicament Download PDF

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Publication number
WO2025132685A1
WO2025132685A1 PCT/EP2024/087257 EP2024087257W WO2025132685A1 WO 2025132685 A1 WO2025132685 A1 WO 2025132685A1 EP 2024087257 W EP2024087257 W EP 2024087257W WO 2025132685 A1 WO2025132685 A1 WO 2025132685A1
Authority
WO
WIPO (PCT)
Prior art keywords
needle cover
shuttle
cassette
cartridge
needle
Prior art date
Legal status (The legal status 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 status listed.)
Pending
Application number
PCT/EP2024/087257
Other languages
English (en)
Inventor
Tobias CHARLES
Alexander Hee-Hanson
Thomas LEVER
Gregory SALE
Robert Wilson
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Sanofi SA
Original Assignee
Sanofi SA
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 SA filed Critical Sanofi SA
Publication of WO2025132685A1 publication Critical patent/WO2025132685A1/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M5/2033—Spring-loaded one-shot injectors with or without automatic needle insertion
    • 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
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/3271—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position
    • A61M5/3272—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel with guiding tracks for controlled sliding of needle protective sleeve from needle exposing to needle covering position having projections following labyrinth paths
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/206—With automatic needle insertion
    • 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
    • A61M5/20—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically
    • A61M2005/2073—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically preventing premature release, e.g. by making use of a safety lock
    • A61M2005/208—Release is possible only when device is pushed against the skin, e.g. using a trigger which is blocked or inactive when the device is not pushed against the skin
    • 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
    • A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
    • A61M2005/2403—Ampoule inserted into the ampoule holder
    • 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
    • A61M5/3243—Means for protection against accidental injuries by used needles being axially-extensible, e.g. protective sleeves coaxially slidable on the syringe barrel
    • A61M5/326—Fully automatic sleeve extension, i.e. in which triggering of the sleeve does not require a deliberate action by the user
    • A61M2005/3267—Biased sleeves where the needle is uncovered by insertion of the needle into a patient's body
    • 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
    • A61M2205/00—General characteristics of the apparatus
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/123—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with incorporated reservoirs

Definitions

  • the present invention relates to a medicament delivery system comprising a cartridge and reusable injector device.
  • the piston rod is biased towards the injection site to dispense the medicament.
  • the needle is covered by a needle shield and/or needle cover and the medicament delivery device is dispensed of.
  • a reusable injector device for use with a cartridge containing a pre-filled syringe, the device comprising: a housing; a needle cover shuttle displaceable within the housing against a needle cover shuttle spring; a cassette shuttle displaceable within the housing against a cassette shuttle spring; and a plunger rod configured to dispense medicament from the pre-filed syringe in use; wherein the reusable injector device is configured so that, when a cartridge for use with the device is connected thereto, the needle cover shuttle is displaceable against the needle cover shuttle spring between a primed position and a dose delivery position, distal of the primed position; and wherein the cassette shuttle is configured to advance in a proximal direction only after the needle cover shuttle has been displaced into the dose delivery position.
  • Insertion of a cartridge into the housing may distally displace the needle cover shuttle into the primed position, charging the needle cover shuttle spring.
  • the needle cover shuttle may comprise a track in its outer surface that engages a pin extending from the inner surface of the housing, so that movement of the needle cover shuttle along the longitudinal axis of the device causes the pin to traverse the track; and wherein the track comprises ramped portions configured to rotate the needle cover shuttle to cause the needle cover shuttle to lock to and unlock from a cartridge inserted into the device as the needle cover shuttle moves between different positions.
  • the track may comprise a first distal terminus which, when the pin abuts the first distal terminus, defines the primed position of the needle cover shuttle, and a second distal terminus which, when the pin abuts the second distal terminus, defines a post delivery position of the needle cover shuttle.
  • the device may be provided with an activation button pressable into the housing to begin an injection when a cartridge for use with the device is inserted into the device and the needle cover is in the dose delivery position; and wherein, when the needle cover is in the primed position, the needle cover blocks the activation button being pressed into the housing
  • the activation button is configured to hold the cassette shuttle against the cassette shuttle spring, and wherein pressing the activation button into the housing releases the cassette shuttle so that the cassette shuttle is advanced in a proximal direction by the cassette shuttle spring.
  • a cartridge for use with a reusable injector device comprising: a pre-filed syringe comprising a needle; a cassette partially housing the pre-filled syringe so that the needle extends from a proximal end of the cassette; and a needle cover extending over the proximal end of the cassette to surround the needle.
  • the cassette may comprises a clip configured to releasably engage a reusable injector device for use with the cartridge.
  • the cartridge may comprise a cap, and wherein the cap comprises a clip having a blocking element that extends through a window of the needle cover and a window of the cassette to prevent relative axial movement of the needle cover, the cassette and the cap.
  • the needle cover may comprise a needle cover pin engageable with the window of the cassette to lock the needle cover in a needle shielding position following removal of the cap.
  • a medicament delivery system in which components of the system are reusable, reducing waste. Furthermore, the invention provides a two step injection process for increased safety in which the needle cover must first be displaced before the needle is advanced.
  • the cartridge may be connected to the device by insertion of a distal end of the cartridge into an opening in the proximal end of the housing.
  • a distal end of the needle cover may engage a proximal end of the needle cover shuttle, displacing the needle cover shuttle in a distal direction and charging the needle cover shuttle spring.
  • the cassette may comprise a clip configured to releasably engage the cassette shuttle when the cartridge and device are combined. As the clip is configured to be releasable, the cartridge may still be removed from the device after combination of the cartridge and the device. This may be useful if the wrong cartridge has been selected.
  • the needle cover may be displaced into the dose delivery position by pressing a proximal end of the needle cover against an injection site until the proximal end of the needle cover and proximal end of the housing are flush.
  • the cartridge may comprises a cap, wherein the cap comprises a clip having a blocking element that extends through a window of the needle cover and a window of the cassette to prevent relative axial movement of the needle cover, the cassette and the cap.
  • the cartridge is provided in a safe and stable state prior to removal of the cap.
  • the housing may comprise a circumferential ramp depending from its inner surface that is configured to engage the clip of the cap when the cartridge and the device are combined, the clip and the ramp being configured to cooperate so that, on rotation of the cap about a longitudinal axis of the device, the clip is lifted by the ramp to remove the blocking element from the windows in the cassette and needle cover, allowing removal of the cap.
  • the needle cover may advanced in a proximal direction to the primed position by the needle cover shuttle spring.
  • the needle cover shuttle spring may be configured to proximally advance the needle cover into a post delivery position, proximal of the primed position, to conceal the needle.
  • the needle cover shuttle may comprises a track in its outer surface that engages a pin extending from the inner surface of the housing, so that movement of the needle cover shuttle along the longitudinal axis of the device causes the pin to traverse the track; and wherein the track comprises ramped portions configured to rotate the needle cover shuttle to cause the needle cover shuttle to lock to and unlock from the needle cover as the needle cover shuttle moves between different positions.
  • Proximal movement of the needle cover from the dose delivery position to the post delivery position may cause the pin to traverse the other ramped portion of the track to cause the needle cover shuttle to unlock from the needle cover.
  • Fig. 6 is a section of the cartridge and the reusable auto injector device in an assembled preuse state
  • Figs. 8a to 8c show three positions of a cassette shuttle of the cartridge as the cartridge and the reusable auto injector device are assembled;
  • Fig. 9 is a detail view of a needle cover shuttle of the reusable auto injector device in a recharged state
  • Fig. 11 is a section of the cartridge and the reusable auto injector device in a primed pre-use state
  • Fig. 12 is a detail view of the needle cover shuttle in a primed state
  • Fig. 14 is a section of the cartridge and the reusable auto injector device in a primed and on body state
  • Fig. 15 is a detail view of the needle cover shuttle in a primed and on body state
  • Fig. 16 is a detail section showing an injection activation button and the needle cover shuttle in the primed state
  • Fig. 17 is a detail section showing the injection activation button and the needle cover shuttle in the primed and on body state;
  • Figs. 18a to 18c show three stages of operation of the injection activation button;
  • Fig. 19 is a detail view of the needle cover shuttle in a drug delivery state
  • Fig. 20 is a detail section showing an interface between the cartridge and the reusable auto injector device
  • Fig. 21 is a section of the cartridge and the reusable auto injector device in a drug delivery state
  • Fig. 22 is a detail view of the needle cover shuttle in a post delivery state
  • Fig. 23 is a section of the cartridge and the reusable auto injector device in a post delivery state;
  • Fig. 24 is a detail section showing an interface between the cartridge and the reusable auto injector device;
  • Fig. 25 is a section of the cartridge and the reusable auto injector device in a post deliver, plunger recharged state
  • Fig. 26 is a section showing the cartridge and reusable autoinjector device in post delivery separated state
  • Fig. 27 shows the cartridge pre-use
  • Fig. 28 shows the cartridge post-use
  • Fig. 29 is a detail view of the cartridge according to another embodiment of the invention.
  • Figs. 30a and 30b are schematic illustrations showing a plunger release mechanism and a plunger recharging mechanism.
  • a drug delivery device may be configured to inject a medicament into a patient.
  • delivery could be sub-cutaneous, intra-muscular, or intravenous.
  • Such a device could be operated by a patient or care-giver, such as a nurse or physician, and can include various types of safety syringe, pen-injector, or auto-injector.
  • the device can include a cartridge-based system that requires piercing a sealed ampule before use. Volumes of medicament delivered with these various devices can range from about 0.5 ml to about 2 ml.
  • Yet another device can include a large volume device (“LVD”) or patch pump, configured to adhere to a patient’s skin for a period of time (e.g., about 5, 15, 30, 60, or 120 minutes) to deliver a “large” volume of medicament (typically about 2 ml to about 10 ml).
  • LLD large volume device
  • patch pump configured to adhere to a patient’s skin for a period of time (e.g., about 5, 15, 30, 60, or 120 minutes) to deliver a “large” volume of medicament (typically about 2 ml to about 10 ml).
  • the presently described devices may also be customized in order to operate within required specifications.
  • the device may be customized to inject a medicament within a certain time period (e.g., about 3 to about 20 seconds for auto-injectors, and about 10 minutes to about 60 minutes for an LVD).
  • Other specifications can include a low or minimal level of discomfort, or to certain conditions related to human factors, shelf-life, expiry, biocompatibility, environmental considerations, etc.
  • Such variations can arise due to various factors, such as, for example, a drug ranging in viscosity from about 3 cP to about 50 cP. Consequently, a drug delivery device will often include a hollow needle ranging from about 25 to about 31 Gauge in size. Common sizes are 27 and 29 Gauge.
  • the delivery devices described herein can also include one or more automated functions. For example, one or more of needle insertion, medicament injection, and needle retraction can be automated. Energy for one or more automation steps can be provided by one or more energy sources. Energy sources can include, for example, mechanical, pneumatic, chemical, or electrical energy. For example, mechanical energy sources can include springs, levers, elastomers, or other mechanical mechanisms to store or release energy. One or more energy sources can be combined into a single device. Devices can further include gears, valves, or other mechanisms to convert energy into movement of one or more components of a device.
  • the one or more automated functions of an auto-injector may each be activated via an activation mechanism.
  • an activation mechanism can include one or more of a button, a lever, a needle sleeve, or other activation component.
  • Activation of an automated function may be a one-step or multi-step process. That is, a user may need to activate one or more activation components in order to cause the automated function. For example, in a one-step process, a user may depress a needle sleeve against their body in order to cause injection of a medicament.
  • Other devices may require a multi-step activation of an automated function. For example, a user may be required to depress a button and retract a needle shield in order to cause injection.
  • activation of one automated function may activate one or more subsequent automated functions, thereby forming an activation sequence.
  • activation of a first automated function may activate at least two of needle insertion, medicament injection, and needle retraction.
  • Some devices may also require a specific sequence of steps to cause the one or more automated functions to occur.
  • Other devices may operate with a sequence of independent steps.
  • square and ramped refer to planar surfaces that extend perpendicular and obliquely to the longitudinal axis of either the cartridge or injector device.
  • distal refers to a location that is relatively closer to a site of injection, and the term “proximal” refers to a location that is relatively further away from the injection site.
  • the removed cartridge 200 is visibly different to the cartridge before use, indicating that the cartridge is spent and is not for use, but disposal only.
  • Fig. 27 shows the cartridge 200 before use and
  • Fig. 28 shows the cartridge 200 post use.
  • the removed cartridge 200 is without a cap
  • 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.
  • 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.
  • the drug or medicament may be contain 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., shorter long-term storage) of one or more drugs.
  • 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 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.
  • 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 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.
  • ACS acute coronary syndrome
  • APIs and drugs are those as described in handbooks such as Rote Liste 2014, for example, without limitation, main groups 12 (antidiabetic drugs) or 86 (oncology drugs), and Merck Index, 15th edition.
  • 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.
  • an insulin e.g., human insulin, or a human insulin analogue or derivative
  • GLP-1 glucagon-like peptide
  • DPP4 dipeptidyl peptidase-4
  • 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 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 ligand”".
  • insulin analogues examples include 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.
  • 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-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-omega- carboxypentadecanoyl-gamma-L-g
  • 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 (Victoza®), Semaglutide, Taspoglutide, Albiglutide (Syncria®), Dulaglutide (Trulicity®), rExendin-4, CJC- 1134-PC, PB-1023, TTP-054, Langlenatide / HM-11260C (Efpeglenatide), HM-15211 , CM-3, GLP-1 Eligen, ORMD-0901 , NN-9423, NN-9709, NN-9924, NN-9926, NN-9927, Nodexen, Viador-GLP-1 , CVX-096, ZYOG-1 , ZYD-1 ,
  • 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 yndromem.
  • DPP4 inhibitors are Linagliptin, Vildagliptin, Sitagliptin, Denagliptin, Saxagliptin, Berberine.
  • hormones include hypophysis hormones or hypothalamus hormones or regulatory active peptides and their antagonists, such as Gonadotropine (Follitropin, Lutropin, Choriongonadotropin, Menotropin), Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin, Triptorelin, Leuprorelin, Buserelin, Nafarelin, and Goserelin.
  • Gonadotropine Follitropin, Lutropin, Choriongonadotropin, Menotropin
  • Somatropine Somatropin
  • Desmopressin Terlipressin
  • Gonadorelin Triptorelin
  • Leuprorelin Buserelin
  • Nafarelin Nafarelin
  • Goserelin Goserelin.
  • 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.
  • 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 antigenbinding portion thereof.
  • antigen-binding portions of immunoglobulin molecules include F(ab) and F(a")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.
  • the term antibody also includes an antigen-binding molecule based on tetravalent bispecific tandem immunoglobulins (TBTI) and/or a dual variable region antibody-like binding protein having cross-over binding region orientation (CODV).
  • TBTI tetravalent bispecific tandem immunoglobulins
  • CODV cross-over binding region orientation
  • 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(a")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 antigen-binding antibody fragments are known in the art.
  • SMIP small modular immunopharmaceuticals
  • 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.
  • antibodies are anti PCSK-9 mAb (e.g., Alirocumab), anti IL-6 mAb (e.g., Sarilumab), and anti IL-4 mAb (e.g., Dupilumab).
  • PCSK-9 mAb e.g., Alirocumab
  • anti IL-6 mAb e.g., Sarilumab
  • anti IL-4 mAb e.g., Dupilumab
  • 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.
  • 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 :201 €). As described in ISO 11608-1 :2014(E), needlebased injection systems may be broadly distinguished into multi-dose 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.
  • 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).
  • a single-dose container system may involve a needle-based injection device with a replaceable container.
  • each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation).
  • each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).
  • a single-dose container system may involve a needle-based injection device with an integrated non-replaceable container.
  • each container holds a single dose, whereby the entire deliverable volume is expelled (full evacuation).
  • each container holds a single dose, whereby a portion of the deliverable volume is expelled (partial evacuation).

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Environmental & Geological Engineering (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

L'invention concerne un système d'administration de médicament (10) comprenant un dispositif injecteur réutilisable (100) et une cartouche (200) destinée à être utilisée avec le dispositif injecteur réutilisable. La cartouche et le dispositif peuvent être combinés pour l'administration de médicament et peuvent être séparés par la suite. La cartouche comprend : une seringue pré-remplie (230) comprenant une aiguille (233) ; une cassette (210) logeant partiellement la seringue pré-remplie de sorte que l'aiguille s'étende à partir d'une extrémité proximale de la cassette ; et un couvercle d'aiguille (240) s'étendant sur l'extrémité proximale de la cassette pour entourer l'aiguille. Le dispositif injecteur réutilisable comprend : un boîtier (110) ; une navette de couvercle d'aiguille (120) déplaçable à l'intérieur du boîtier contre un ressort navette de couvercle d'aiguille (120s) ; une navette de cassette (150) déplaçable à l'intérieur du boîtier contre un ressort de navette de cassette (150s) ; et une tige de piston (170) configurée pour distribuer un médicament à partir de la seringue pré-remplie lors de l'utilisation. Lorsque la cartouche et le dispositif injecteur réutilisable sont combinés, le couvercle d'aiguille vient en prise avec la navette de couvercle d'aiguille et la cassette vient en prise avec la navette de cassette. L'aiguille peut être déplacée contre le ressort de navette de couvercle d'aiguille entre une position amorcée, dans laquelle le couvercle d'aiguille s'étend à partir d'une extrémité proximale du boîtier, et une position de distribution de dose, distale par rapport à la position amorcée. La navette de cassette est configurée pour faire avancer la cassette dans une direction proximale de sorte que l'aiguille s'étende à partir d'une extrémité proximale du couvercle d'aiguille uniquement après que le couvercle d'aiguille a été déplacé dans la position de distribution de dose.
PCT/EP2024/087257 2023-12-21 2024-12-18 Système d'administration de médicament Pending WO2025132685A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
EP23315476 2023-12-21
EP23315476.4 2023-12-21

Publications (1)

Publication Number Publication Date
WO2025132685A1 true WO2025132685A1 (fr) 2025-06-26

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Country Link
WO (1) WO2025132685A1 (fr)

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130138048A1 (en) * 2010-03-09 2013-05-30 Sanofi-Aventis Deutschland Gmbh Autoinjector
US20130296796A1 (en) * 2010-12-21 2013-11-07 Sanofi-Aventis Deutschland Gmbh Auto-Injector
US20130324924A1 (en) * 2011-02-18 2013-12-05 Sanofi-Aventis Deutschland Gmbh Auto-Injector
US20160175524A1 (en) * 2012-10-18 2016-06-23 Sanofi-Aventis Deutschland Gmbh Auto-injector
US20200376200A1 (en) * 2014-02-10 2020-12-03 E3D A.C.A.L.Ltd Semi disposable auto injector
US20210038815A1 (en) * 2015-08-27 2021-02-11 E3D A.C.A.L Ltd Reusable automatic injection device
US20220280725A1 (en) * 2018-10-05 2022-09-08 Phillips-Medisize A/S Auto injector with cassette

Patent Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130138048A1 (en) * 2010-03-09 2013-05-30 Sanofi-Aventis Deutschland Gmbh Autoinjector
US20130296796A1 (en) * 2010-12-21 2013-11-07 Sanofi-Aventis Deutschland Gmbh Auto-Injector
US20130324924A1 (en) * 2011-02-18 2013-12-05 Sanofi-Aventis Deutschland Gmbh Auto-Injector
US20160175524A1 (en) * 2012-10-18 2016-06-23 Sanofi-Aventis Deutschland Gmbh Auto-injector
US20200376200A1 (en) * 2014-02-10 2020-12-03 E3D A.C.A.L.Ltd Semi disposable auto injector
US20210038815A1 (en) * 2015-08-27 2021-02-11 E3D A.C.A.L Ltd Reusable automatic injection device
US20220280725A1 (en) * 2018-10-05 2022-09-08 Phillips-Medisize A/S Auto injector with cassette

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