JP2023522134A - 長時間作用型アポモルフィン製剤、およびその治療送達用のインジェクター - Google Patents

長時間作用型アポモルフィン製剤、およびその治療送達用のインジェクター Download PDF

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JP2023522134A
JP2023522134A JP2023505811A JP2023505811A JP2023522134A JP 2023522134 A JP2023522134 A JP 2023522134A JP 2023505811 A JP2023505811 A JP 2023505811A JP 2023505811 A JP2023505811 A JP 2023505811A JP 2023522134 A JP2023522134 A JP 2023522134A
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Japan
Prior art keywords
pharmaceutically acceptable
apomorphine
aspects
acceptable salt
stable
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JP2023505811A
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Japanese (ja)
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JP2023522134A5 (https=
Inventor
シャンカール ハリハラン，
スケトゥ サングヴィ，
スニール グプタ，
ラフル スラナ，
イヴァン テルジッチ，
アルベルト ドーンボス，
ロブ ステーンダム，
Original Assignee
サイエンチュア， インコーポレイテッド
イノコア テクノロジーズ ベー．フェー．
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Application filed by サイエンチュア， インコーポレイテッド, イノコア テクノロジーズ ベー．フェー． filed Critical サイエンチュア， インコーポレイテッド
Publication of JP2023522134A publication Critical patent/JP2023522134A/ja
Publication of JP2023522134A5 publication Critical patent/JP2023522134A5/ja
Pending legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/47—Quinolines; Isoquinolines
    • A61K31/485—Morphinan derivatives, e.g. morphine, codeine
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1641—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647—Polyesters, e.g. poly(lactide-co-glycolide)
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61M5/19—Syringes having more than one chamber, e.g. including a manifold coupling two parallelly aligned syringes through separate channels to a common discharge assembly
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • 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
    • A61M2207/00—Methods of manufacture, assembly or production

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Dermatology (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Anesthesiology (AREA)
  • Emergency Medicine (AREA)
  • Vascular Medicine (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Hematology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Medicinal Preparation (AREA)
JP2023505811A 2020-04-10 2021-04-12 長時間作用型アポモルフィン製剤、およびその治療送達用のインジェクター Pending JP2023522134A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063008369P 2020-04-10 2020-04-10
US63/008,369 2020-04-10
PCT/US2021/026904 WO2021207737A2 (en) 2020-04-10 2021-04-12 Long-acting apomorphine formulations and injectors for therapeutic delivery of the same

Publications (2)

Publication Number Publication Date
JP2023522134A true JP2023522134A (ja) 2023-05-26
JP2023522134A5 JP2023522134A5 (https=) 2024-04-23

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ID=78023709

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JP2023505811A Pending JP2023522134A (ja) 2020-04-10 2021-04-12 長時間作用型アポモルフィン製剤、およびその治療送達用のインジェクター

Country Status (5)

Country Link
US (1) US20230137010A1 (https=)
EP (1) EP4132475A4 (https=)
JP (1) JP2023522134A (https=)
CA (1) CA3179866A1 (https=)
WO (1) WO2021207737A2 (https=)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20240315971A1 (en) * 2023-03-03 2024-09-26 Lotus Biopharma Inc. Microsphere formulations and methods of preparation thereof

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6436950B1 (en) * 1998-08-14 2002-08-20 Nastech Pharmaceutical Company, Inc. Nasal delivery of apomorphine
JP2003052819A (ja) * 2001-08-10 2003-02-25 Seikagaku Kogyo Co Ltd 薬剤充填注射器包装物およびその滅菌または殺菌方法
PT1610791E (pt) * 2003-03-31 2011-05-23 Titan Pharmaceuticals Inc Dispositivo polim?rico implant?vel para liberta??o sustentada de agonista da dopamina
CN103827177B (zh) * 2011-07-22 2016-02-10 伊诺科雷技术有限公司 用于生物活性化合物的受控释放的生物可降解的、半结晶的、相分离的、热塑性多嵌段共聚物
JP2015510818A (ja) * 2012-03-20 2015-04-13 トラスティーズ オブ タフツ カレッジ 薬物送達のための絹リザーバー
WO2014165136A1 (en) * 2013-03-12 2014-10-09 Antares Pharma, Inc. Constant volume prefilled syringes and kits thereof

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Publication number Publication date
WO2021207737A2 (en) 2021-10-14
CA3179866A1 (en) 2021-10-14
WO2021207737A3 (en) 2021-11-11
EP4132475A4 (en) 2024-04-24
US20230137010A1 (en) 2023-05-04
EP4132475A2 (en) 2023-02-15

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