JP2024507528A - ルラシドンを含むミクロスフェア製剤ならびにその製造方法および使用方法 - Google Patents

ルラシドンを含むミクロスフェア製剤ならびにその製造方法および使用方法 Download PDF

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JP2024507528A
JP2024507528A JP2023550249A JP2023550249A JP2024507528A JP 2024507528 A JP2024507528 A JP 2024507528A JP 2023550249 A JP2023550249 A JP 2023550249A JP 2023550249 A JP2023550249 A JP 2023550249A JP 2024507528 A JP2024507528 A JP 2024507528A
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microsphere
lurasidone
polymeric
microspheres
lactide
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JP2024507528A5 (enExample
Inventor
スペンサー、コリン
バイヤー、グリフィン
リッチー、トレイシー
スミス、マーク
デリシア、ニコラス
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オークウッド ラボラトリーズ，エル．エル．シー．
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Publication of JP2024507528A publication Critical patent/JP2024507528A/ja
Publication of JP2024507528A5 publication Critical patent/JP2024507528A5/ja
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    • 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/496—Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
    • 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
    • A61K9/1682—Processes
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5005—Wall or coating material
    • A61K9/5021—Organic macromolecular compounds
    • A61K9/5031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, 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
    • A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50—Microcapsules having a gas, liquid or semi-solid filling; Solid microparticles or pellets surrounded by a distinct coating layer, e.g. coated microspheres, coated drug crystals
    • A61K9/5089—Processes
    • 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
    • A61P25/18—Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • 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
    • A61P25/24—Antidepressants

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Psychiatry (AREA)
  • Organic Chemistry (AREA)
  • Neurology (AREA)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biomedical Technology (AREA)
  • Inorganic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
JP2023550249A 2021-02-24 2022-02-24 ルラシドンを含むミクロスフェア製剤ならびにその製造方法および使用方法 Pending JP2024507528A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202163152943P 2021-02-24 2021-02-24
US63/152,943 2021-02-24
US202263267403P 2022-02-01 2022-02-01
US63/267,403 2022-02-01
PCT/US2022/070807 WO2022183196A1 (en) 2021-02-24 2022-02-24 Microsphere formulations comprising lurasidone and methods for making and using the same

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JP2024507528A true JP2024507528A (ja) 2024-02-20
JP2024507528A5 JP2024507528A5 (enExample) 2025-02-25

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US (1) US11992559B2 (enExample)
EP (1) EP4297753A4 (enExample)
JP (1) JP2024507528A (enExample)
KR (1) KR20230157365A (enExample)
AU (1) AU2022226584A1 (enExample)
CA (1) CA3210098A1 (enExample)
IL (1) IL304650A (enExample)
MX (1) MX2023009754A (enExample)
WO (1) WO2022183196A1 (enExample)

Families Citing this family (1)

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Publication number Priority date Publication date Assignee Title
CN119424341A (zh) * 2023-08-02 2025-02-14 珠海市华海康医药科技有限责任公司 一种注射用药物缓释微球及其制备方法

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US20160030351A1 (en) * 2013-03-15 2016-02-04 Tracy Richey Sustained release microspheres and method of producing same
WO2018015915A1 (en) * 2016-07-22 2018-01-25 Cadila Healthcare Limited A parenteral controlled release composition of an atypical antipsychotic agent

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EP0724432B1 (en) 1993-10-22 2002-09-18 Genentech, Inc. Methods and compositions for microencapsulation of antigens for use as vaccines
ATE288270T1 (de) 1993-11-19 2005-02-15 Janssen Pharmaceutica Nv Mikroverkapselte 1,2-benzazole
PT1615959E (pt) 2003-04-10 2013-08-29 Evonik Corp Um método para a produção de micropartículas à base de emulsão
WO2005009356A2 (en) 2003-07-15 2005-02-03 Pr Pharmaceuticals, Inc. Method for the preparation of controlled release formulations
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WO2006134864A1 (ja) 2005-06-13 2006-12-21 Dainippon Sumitomo Pharma Co., Ltd. 可溶化型製剤
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AU2010339689B2 (en) 2010-01-07 2015-02-19 Alkermes Pharma Ireland Limited Quaternary ammonium salt prodrugs
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IL304650A (en) 2023-09-01
US20220265562A1 (en) 2022-08-25
AU2022226584A1 (en) 2023-08-17
EP4297753A1 (en) 2024-01-03
CA3210098A1 (en) 2022-09-01
MX2023009754A (es) 2023-08-30
EP4297753A4 (en) 2025-01-01
US11992559B2 (en) 2024-05-28
WO2022183196A1 (en) 2022-09-01
KR20230157365A (ko) 2023-11-16

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