KR20230157365A - 루라시돈을 포함하는 마이크로스피어 제제 및 이의 제조 및 사용 방법 - Google Patents

루라시돈을 포함하는 마이크로스피어 제제 및 이의 제조 및 사용 방법 Download PDF

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Publication number
KR20230157365A
KR20230157365A KR1020237032096A KR20237032096A KR20230157365A KR 20230157365 A KR20230157365 A KR 20230157365A KR 1020237032096 A KR1020237032096 A KR 1020237032096A KR 20237032096 A KR20237032096 A KR 20237032096A KR 20230157365 A KR20230157365 A KR 20230157365A
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KR
South Korea
Prior art keywords
microsphere
lurasidone
polymer
microspheres
glycolide
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Pending
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KR1020237032096A
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English (en)
Korean (ko)
Inventor
콜린 스펜서
그리핀 베이어
트레시 리치
마크 스미스
니콜라스 데루시아
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오크우드 레버러토리즈, 엘엘씨
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Publication of KR20230157365A publication Critical patent/KR20230157365A/ko
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605Excipients; Inactive ingredients
    • A61K9/1629Organic macromolecular compounds
    • A61K9/1641Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poloxamers
    • A61K9/1647Polyesters, e.g. poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495Heterocyclic 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
    • A61K31/496Non-condensed piperazines containing further heterocyclic rings, e.g. rifampin, thiothixene or sparfloxacin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/30Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/34Macromolecular 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5005Wall or coating material
    • A61K9/5021Organic macromolecular compounds
    • A61K9/5031Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, poly(lactide-co-glycolide)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/48Preparations in capsules, e.g. of gelatin, of chocolate
    • A61K9/50Microcapsules 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
    • A61K9/5089Processes
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/18Antipsychotics, i.e. neuroleptics; Drugs for mania or schizophrenia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00Drugs for disorders of the nervous system
    • A61P25/24Antidepressants

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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)
  • Neurosurgery (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Inorganic Chemistry (AREA)
  • Psychiatry (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Organic Chemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Nitrogen Condensed Heterocyclic Rings (AREA)
KR1020237032096A 2021-02-24 2022-02-24 루라시돈을 포함하는 마이크로스피어 제제 및 이의 제조 및 사용 방법 Pending KR20230157365A (ko)

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

Publications (1)

Publication Number Publication Date
KR20230157365A true KR20230157365A (ko) 2023-11-16

Family

ID=82900191

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020237032096A Pending KR20230157365A (ko) 2021-02-24 2022-02-24 루라시돈을 포함하는 마이크로스피어 제제 및 이의 제조 및 사용 방법

Country Status (9)

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

Families Citing this family (1)

* Cited by examiner, † Cited by third party
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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US5288502A (en) 1991-10-16 1994-02-22 The University Of Texas System Preparation and uses of multi-phase microspheres
DE69431404T2 (de) 1993-10-22 2003-04-30 Genentech Inc., San Francisco Verfahren zur mikroverkapselung von antigenen und verwendung der zusammensetzungen als impfstoffe
CN1074923C (zh) 1993-11-19 2001-11-21 詹森药业有限公司 微囊密封的3-哌啶基取代的1,2-苯并异唑类和1,2-苯并异噻唑类
ES2427092T3 (es) 2003-04-10 2013-10-28 Evonik Corporation Un método para la producción de micropartículas a base de emulsión
CN1852687B (zh) 2003-07-15 2014-01-22 赢创有限公司 控释组合物的制备方法
ES2600554T3 (es) 2003-07-18 2017-02-09 Oakwood Laboratories L.L.C. Prevención de la reducción del peso molecular del polímero, de la formación de impurezas y de la gelificación en composiciones poliméricas
JP5165240B2 (ja) 2003-07-23 2013-03-21 ピーアール ファーマシューティカルズ, インコーポレイテッド 徐放組成物
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ES2420479T3 (es) 2006-08-31 2013-08-23 Sk Chemicals, Co., Ltd. Procedimiento para la producción de microesferas cargadas con fármacos y microesferas cargadas con fármacos producidas mediante el mismo
WO2009085952A1 (en) 2007-12-20 2009-07-09 Brookwood Pharmaceuticals, Inc. Process for preparing microparticles having a low residual solvent volume
SG176735A1 (en) 2009-06-10 2012-01-30 Sunovion Pharmaceuticals Inc Histamine h3 inverse agonists and antagonists and methods of use thereof
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US10335366B2 (en) * 2010-05-31 2019-07-02 Laboratorios Farmacéuticos Rovi, S.A. Risperidone or paliperidone implant formulation
EP2629775A4 (en) 2010-10-18 2014-06-11 Dainippon Sumitomo Pharma Co INJECTABLE FORMULATION WITH DELAYED RELEASE
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ES2950418T3 (es) 2012-03-19 2023-10-09 Alkermes Pharma Ireland Ltd Composiciones farmacéuticas que comprenden alcohol bencílico
WO2014076712A2 (en) 2012-11-14 2014-05-22 Hetero Research Foundation Lurasidone hydrochloride solid dispersion
WO2014144309A1 (en) * 2013-03-15 2014-09-18 Oakwood Laboratories Sustained release microspheres and method of producing the same
US9636308B2 (en) 2013-03-15 2017-05-02 Oakwood Laboratories LLC High drug load buprenorphine microspheres and method of producing same
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US9943484B2 (en) * 2013-06-20 2018-04-17 Pharmathen S.A. Preparation of polylactide-polyglycolide microparticles having a sigmoidal release profile
KR102373288B1 (ko) * 2013-12-03 2022-03-10 인트라-셀룰라 써래피스, 인코퍼레이티드. 신규한 방법
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Also Published As

Publication number Publication date
WO2022183196A1 (en) 2022-09-01
US20220265562A1 (en) 2022-08-25
US11992559B2 (en) 2024-05-28
CA3210098A1 (en) 2022-09-01
EP4297753A1 (en) 2024-01-03
AU2022226584A1 (en) 2023-08-17
EP4297753A4 (en) 2025-01-01
IL304650A (en) 2023-09-01
MX2023009754A (es) 2023-08-30
JP2024507528A (ja) 2024-02-20

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PA0105 International application

Patent event date: 20230919

Patent event code: PA01051R01D

Comment text: International Patent Application

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PA0201 Request for examination

Patent event code: PA02012R01D

Patent event date: 20250207

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