WO2022203830A1 - Drug delivery device - Google Patents

Drug delivery device Download PDF

Info

Publication number
WO2022203830A1
WO2022203830A1 PCT/US2022/018596 US2022018596W WO2022203830A1 WO 2022203830 A1 WO2022203830 A1 WO 2022203830A1 US 2022018596 W US2022018596 W US 2022018596W WO 2022203830 A1 WO2022203830 A1 WO 2022203830A1
Authority
WO
WIPO (PCT)
Prior art keywords
plunger
drug delivery
delivery device
drug
collapsible
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.)
Ceased
Application number
PCT/US2022/018596
Other languages
English (en)
French (fr)
Inventor
Jan Jensen
Lars Eilertsen
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.)
Amgen Inc
Original Assignee
Amgen Inc
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 Amgen Inc filed Critical Amgen Inc
Priority to JP2023557717A priority Critical patent/JP2024510668A/ja
Priority to US18/550,647 priority patent/US20240165338A1/en
Priority to CN202280023369.7A priority patent/CN117136083A/zh
Priority to AU2022241961A priority patent/AU2022241961A1/en
Priority to BR112023019565A priority patent/BR112023019565A2/pt
Priority to IL305535A priority patent/IL305535A/en
Priority to MX2023011160A priority patent/MX2023011160A/es
Priority to EP22711773.6A priority patent/EP4313213A1/en
Priority to CA3212183A priority patent/CA3212183A1/en
Publication of WO2022203830A1 publication Critical patent/WO2022203830A1/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61M5/31—Details
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • 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
    • 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
    • A61M2005/2086—Automatic syringes, e.g. with automatically actuated piston rod, with automatic needle injection, filling automatically having piston damping means, e.g. axially or rotationally acting retarders
    • 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
    • A61M2005/3143—Damping means for syringe components executing relative movements, e.g. retarders or attenuators slowing down or timing syringe mechanisms
    • 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
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • 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
    • A61M2205/02—General characteristics of the apparatus characterised by a particular materials
    • A61M2205/0216—Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
    • 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
    • A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
    • A61M5/31511—Piston or piston-rod constructions, e.g. connection of piston with piston-rod
    • A61M5/31515—Connection of piston with piston rod

Definitions

  • the body portion of the plunger may have a hollow tubular shape.
  • the body portion may include a non-metal material, such as a thermoplastic material.
  • the drug delivery device 10 is operable for self-administration by a patient or for administration by caregiver or a formally trained healthcare provider (e.g., a doctor or nurse).
  • a formally trained healthcare provider e.g., a doctor or nurse.
  • the exemplary the drug delivery devices shown in the figures may take the form of an autoinjector or pen-type injector, and, as such, may be held in the hand of the user over the duration of drug delivery, but may also or alternatively be suitable for other drug delivery devices and/or configurations.
  • the delivery state may correspond to the configuration of the drug delivery device 10 while drug delivery, also referred to herein as dosing, is in progress
  • the postdelivery state may correspond to the configuration of the drug delivery device 10 after drug delivery is complete and/or when a stopper is arranged in an end-of-dose position in a drug storage container
  • the housing 12 may be pre-loaded with the drug storage container 20, e.g., by a manufacturer, or alternatively, loaded with the drug storage container 20 by a user prior to use of the drug delivery device 10.
  • the drug storage container 20 may include a rigid wall defining an internal bore or reservoir. The wall may be made of glass or plastic.
  • a stopper 24 may be moveably disposed in the drug storage container 20 such that it can move in a distal direction along the longitudinal axis A between proximal end and a distal end of the drug storage container 20.
  • the shock absorbing portion 44 may be formed of an elastomeric material that includes inherent damping properties.
  • the shock absorbing portion 44 may have a diameter and outer shape similar to the body portion 39 of the plunger 26, such as an elastomeric disc or cylinder at the distal end of the plunger 26.
  • a volume of the drug 22 included in the reservoir of the drug storage container 20 may be equal to 1 mL, or equal to approximately (e g., ⁇ 10%) 1 mL, or equal to 2.5 mL, or equal to approximately (e.g., ⁇ 10%) 2.5 mL, or equal to 3 mL, or equal to approximately (e g., ⁇ 10%) 3 mL, or less than or equal to approximately (e.g., ⁇ 10%) 1 mL, or less than or equal to approximately (e.g., ⁇ 10%) 2 mL, or less than or equal to approximately (e.g., ⁇ 10%) 3 mL, or less than or equal to approximately (e.g., ⁇ 10%) 4 mL, or less than approximately (e g., ⁇ 10%) 5 mL, or less than or equal to approximately (e.g., ⁇ 10%) 10 mL, or within a range between approximately (e.g., ⁇ 10%) 1
  • the shock absorbing portion may reduce the impact energy of the plunger / stopper interaction by approximately 1 %, approximately 2%, approximately 3%, approximately 4%, approximately 5%, approximately 6%, approximately 8%, approximately 10%, approximately 12%, approximately 15%, or any suitable amount
  • a 20N spring with a free height of 3 mm i.e., if the gap 18 shown in Fig. 2 is 3 mm
  • the shock absorbing portion may reduce the impact energy by about 10% (e.g., by about 0.006 Joules).
  • Erythropoiesis stimulating proteins include, but are not limited to, Epogen® (epoetin alfa), Aranesp® (darbepoetin alfa), Dynepo® (epoetin delta), Mircera® (methyoxy polyethylene glycol-epoetin beta), Hematide®, MRK- 2578, INS-22, Retacrit® (epoetin zeta), Neorecormon® (epoetin beta), Silapo® (epoetin zeta), Binocrit® (epoetin alfa), epoetin alfa Hexal, Abseamed® (epoetin alfa), Ratioepo® (epoetin theta), Eporatio® (epoetin theta), Biopoin® (epoetin theta), epoetin alfa,
  • proteins are the specific proteins set forth below, including fusions, fragments, analogs, variants or derivatives thereof: OPGL specific antibodies, peptibodies, related proteins, and the like (also referred to as RANKL specific antibodies, peptibodies and the like), including fully humanized and human OPGL specific antibodies, particularly fully humanized monoclonal antibodies; Myostatin binding proteins, peptibodies, related proteins, and the like, including myostatin specific peptibodies; IL-4 receptor specific antibodies, peptibodies, related proteins, and the like, particularly those that inhibit activities mediated by binding of IL-4 and/or IL-13 to the receptor; Interleukin 1-receptor 1 (“IL1-R1”) specific antibodies, peptibodies, related proteins, and the like; Ang2 specific antibodies, peptibodies, related proteins, and the like; NGF specific antibodies, peptibodies, related proteins, and the like; CD22
  • IL1-R1 Interleuk
  • the drug delivery device may contain or be used with Kyprolis® (carfilzomib), (2S)-N-((S)-1-((S)-4-methyl-1-((R)-2-methyloxiran-2-yl)-1-oxopentan-2-ylcarbamoyl)-2-phenylethyl)-2- ((S)-2-(2-morpholinoacetamido)-4-phenylbutanamido)-4-methylpentanamide, or another product containing carfilzomib for the treatment of multiple myeloma.
  • Kyprolis® carfilzomib
  • the drug delivery device may contain or be used with ParsabivTM (etelcalcetide HCI, KAI-4169) or another product containing etelcalcetide HCI for the treatment of secondary hyperparathyroidism (sHPT) such as in patients with chronic kidney disease (KD) on hemodialysis.
  • ParsabivTM etelcalcetide HCI, KAI-4169
  • sHPT secondary hyperparathyroidism
  • KD chronic kidney disease

Landscapes

  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
PCT/US2022/018596 2021-03-25 2022-03-03 Drug delivery device Ceased WO2022203830A1 (en)

Priority Applications (9)

Application Number Priority Date Filing Date Title
JP2023557717A JP2024510668A (ja) 2021-03-25 2022-03-03 薬物送達デバイス
US18/550,647 US20240165338A1 (en) 2021-03-25 2022-03-03 Drug delivery device
CN202280023369.7A CN117136083A (zh) 2021-03-25 2022-03-03 药物递送装置
AU2022241961A AU2022241961A1 (en) 2021-03-25 2022-03-03 Drug delivery device
BR112023019565A BR112023019565A2 (pt) 2021-03-25 2022-03-03 Dispositivo de administração de fármacos
IL305535A IL305535A (en) 2021-03-25 2022-03-03 Drug delivery device
MX2023011160A MX2023011160A (es) 2021-03-25 2022-03-03 Dispositivo de administracion de farmacos.
EP22711773.6A EP4313213A1 (en) 2021-03-25 2022-03-03 Drug delivery device
CA3212183A CA3212183A1 (en) 2021-03-25 2022-03-03 Drug delivery device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202163166080P 2021-03-25 2021-03-25
US63/166,080 2021-03-25

Publications (1)

Publication Number Publication Date
WO2022203830A1 true WO2022203830A1 (en) 2022-09-29

Family

ID=80820338

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2022/018596 Ceased WO2022203830A1 (en) 2021-03-25 2022-03-03 Drug delivery device

Country Status (10)

Country Link
US (1) US20240165338A1 (cg-RX-API-DMAC7.html)
EP (1) EP4313213A1 (cg-RX-API-DMAC7.html)
JP (1) JP2024510668A (cg-RX-API-DMAC7.html)
CN (1) CN117136083A (cg-RX-API-DMAC7.html)
AU (1) AU2022241961A1 (cg-RX-API-DMAC7.html)
BR (1) BR112023019565A2 (cg-RX-API-DMAC7.html)
CA (1) CA3212183A1 (cg-RX-API-DMAC7.html)
IL (1) IL305535A (cg-RX-API-DMAC7.html)
MX (1) MX2023011160A (cg-RX-API-DMAC7.html)
WO (1) WO2022203830A1 (cg-RX-API-DMAC7.html)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2024026388A1 (en) 2022-07-27 2024-02-01 Viela Bio, Inc. Formulations comprising an immunoglobulin-like transcript 7 (ilt7)-binding protein
WO2024156428A1 (en) * 2023-01-25 2024-08-02 Shl Medical Ag Plunger rod, sub-assembly and medicament delivery device
US12110324B2 (en) 2022-07-22 2024-10-08 Flagship Pioneering Innovations Vi, Llc Antigen binding molecules targeting thymic stromal lymphopoietin (TSLP)
US12648994B2 (en) 2020-04-03 2026-06-09 Viela Bio, Inc. Methods of treating immune-mediated pulmonary injury with an anti-ILT7 antibody

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20260115385A1 (en) * 2023-12-21 2026-04-30 Halozyme, Inc. Button actuated autoinjector
WO2026064497A1 (en) * 2024-09-20 2026-03-26 Halozyme, Inc. Syringe dampening mechanism

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7153507B2 (en) 2001-08-23 2006-12-26 Genmab A/S Human antibodies specific for interleukin 15 (IL-15)
US20120283662A1 (en) * 2009-09-30 2012-11-08 Sanofi-Aventis Deutschland Gmbh Method for Assembling a Drug Delivery Device, Assembly for a Drug Delivery Device and Piston Rod for a Drug Delivery Device
US20170182253A1 (en) * 2014-05-07 2017-06-29 Amgen Inc. Autoinjector with shock reducing elements
US20180043110A1 (en) * 2015-03-13 2018-02-15 Owen Mumford Limited Syringe plunger and pressure indicator
WO2019202130A1 (en) * 2018-04-19 2019-10-24 Sanofi Shock absorber for injection devices

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2902061A1 (en) * 2014-01-30 2015-08-05 Sanofi-Aventis Deutschland GmbH Medicament delivery device
CA3066399A1 (en) * 2017-06-08 2018-12-13 Amgen Inc. Torque driven drug delivery device
MA49447A (fr) * 2017-06-22 2020-04-29 Amgen Inc Réduction des impacts/chocs d'activation d'un dispositif
WO2019200003A1 (en) * 2018-04-10 2019-10-17 Nuance Designs Of Ct, Llc Autoinjector having an actuator assembly with a releif valve assembly
JP7719714B2 (ja) * 2018-10-15 2025-08-06 アムジエン・インコーポレーテツド ダンピング機構を有する薬物送達装置

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7153507B2 (en) 2001-08-23 2006-12-26 Genmab A/S Human antibodies specific for interleukin 15 (IL-15)
US20120283662A1 (en) * 2009-09-30 2012-11-08 Sanofi-Aventis Deutschland Gmbh Method for Assembling a Drug Delivery Device, Assembly for a Drug Delivery Device and Piston Rod for a Drug Delivery Device
US20170182253A1 (en) * 2014-05-07 2017-06-29 Amgen Inc. Autoinjector with shock reducing elements
US20180043110A1 (en) * 2015-03-13 2018-02-15 Owen Mumford Limited Syringe plunger and pressure indicator
WO2019202130A1 (en) * 2018-04-19 2019-10-24 Sanofi Shock absorber for injection devices

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
CAS , no. 501423-23-0

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12648994B2 (en) 2020-04-03 2026-06-09 Viela Bio, Inc. Methods of treating immune-mediated pulmonary injury with an anti-ILT7 antibody
US12110324B2 (en) 2022-07-22 2024-10-08 Flagship Pioneering Innovations Vi, Llc Antigen binding molecules targeting thymic stromal lymphopoietin (TSLP)
WO2024026388A1 (en) 2022-07-27 2024-02-01 Viela Bio, Inc. Formulations comprising an immunoglobulin-like transcript 7 (ilt7)-binding protein
WO2024156428A1 (en) * 2023-01-25 2024-08-02 Shl Medical Ag Plunger rod, sub-assembly and medicament delivery device

Also Published As

Publication number Publication date
MX2023011160A (es) 2023-09-29
US20240165338A1 (en) 2024-05-23
EP4313213A1 (en) 2024-02-07
BR112023019565A2 (pt) 2023-11-14
CA3212183A1 (en) 2022-09-29
CN117136083A (zh) 2023-11-28
IL305535A (en) 2023-10-01
AU2022241961A1 (en) 2023-09-14
JP2024510668A (ja) 2024-03-08

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