CN115379842A - 阿立哌唑注射制剂的施用方法 - Google Patents

阿立哌唑注射制剂的施用方法 Download PDF

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Publication number
CN115379842A
CN115379842A CN202180026022.3A CN202180026022A CN115379842A CN 115379842 A CN115379842 A CN 115379842A CN 202180026022 A CN202180026022 A CN 202180026022A CN 115379842 A CN115379842 A CN 115379842A
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CN
China
Prior art keywords
aripiprazole
salt
injection
patient
formulation
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
CN202180026022.3A
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English (en)
Chinese (zh)
Inventor
马修·哈林
王晓峰
王燕琳
阿拉什·劳菲尼亚
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.)
Otsuka Pharmaceutical Co Ltd
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Otsuka Pharmaceutical Co Ltd
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.)
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Publication date
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=75581573&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN115379842(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Otsuka Pharmaceutical Co Ltd filed Critical Otsuka Pharmaceutical Co Ltd
Publication of CN115379842A publication Critical patent/CN115379842A/zh
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
    • A61K9/0012Galenical 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
    • 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
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/32Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/36Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38Cellulose; Derivatives thereof
    • 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
    • A61K9/0053Mouth and digestive tract, i.e. intraoral and peroral administration
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurosurgery (AREA)
  • Biomedical Technology (AREA)
  • Neurology (AREA)
  • Psychiatry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Inorganic Chemistry (AREA)
  • Physiology (AREA)
  • Nutrition Science (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Hospice & Palliative Care (AREA)
CN202180026022.3A 2020-04-01 2021-04-01 阿立哌唑注射制剂的施用方法 Pending CN115379842A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063003544P 2020-04-01 2020-04-01
US63/003,544 2020-04-01
PCT/JP2021/014192 WO2021201238A1 (en) 2020-04-01 2021-04-01 Methods of administering an aripiprazole injectable preparation

Publications (1)

Publication Number Publication Date
CN115379842A true CN115379842A (zh) 2022-11-22

Family

ID=75581573

Family Applications (3)

Application Number Title Priority Date Filing Date
CN202180026022.3A Pending CN115379842A (zh) 2020-04-01 2021-04-01 阿立哌唑注射制剂的施用方法
CN202180025911.8A Pending CN115397420A (zh) 2020-04-01 2021-04-01 阿立哌唑治疗的剂量起始方法
CN202411916296.1A Pending CN119792290A (zh) 2020-04-01 2021-04-01 阿立哌唑治疗的剂量起始方法

Family Applications After (2)

Application Number Title Priority Date Filing Date
CN202180025911.8A Pending CN115397420A (zh) 2020-04-01 2021-04-01 阿立哌唑治疗的剂量起始方法
CN202411916296.1A Pending CN119792290A (zh) 2020-04-01 2021-04-01 阿立哌唑治疗的剂量起始方法

Country Status (16)

Country Link
US (6) US20230129919A1 (https=)
EP (3) EP4467194A3 (https=)
JP (4) JP7733000B2 (https=)
KR (3) KR20220161402A (https=)
CN (3) CN115379842A (https=)
AU (2) AU2021248212A1 (https=)
BR (2) BR112022018721A2 (https=)
CA (3) CA3163321C (https=)
ES (1) ES2995466T3 (https=)
HR (1) HRP20241574T1 (https=)
HU (1) HUE069157T2 (https=)
MX (2) MX2022012354A (https=)
PL (1) PL4125903T3 (https=)
TW (3) TW202523329A (https=)
WO (2) WO2021201238A1 (https=)
ZA (1) ZA202210633B (https=)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20050032811A1 (en) * 2003-08-06 2005-02-10 Josiah Brown Methods for administering aripiprazole
HUE069157T2 (hu) 2020-04-01 2025-02-28 Otsuka Pharma Co Ltd Eljárások aripiprazol kezelések adagoláskezdésére
CA3197997A1 (en) 2023-03-17 2025-01-23 Otsuka Pharmaceutical Co., Ltd. METHODS FOR DISPERSING INJECTABLE PREPARATIONS OF ARIPIPRAZOLE
CN120957722A (zh) 2023-04-26 2025-11-14 大塚制药株式会社 用阿立哌唑治疗精神分裂症或i型双相障碍的剂量启动

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190099494A1 (en) * 2012-04-23 2019-04-04 Otsuka Pharmaceutical Co., Ltd. Injectable preparation

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7053092B2 (en) 2001-01-29 2006-05-30 Otsuka Pharmaceutical Co., Ltd. 5-HT1a receptor subtype agonist
AR033485A1 (es) 2001-09-25 2003-12-26 Otsuka Pharma Co Ltd Sustancia medicinal de aripiprazol de baja higroscopicidad y proceso para la preparacion de la misma
US20050032811A1 (en) 2003-08-06 2005-02-10 Josiah Brown Methods for administering aripiprazole
UA82561C2 (uk) 2003-10-23 2008-04-25 Оцука Фармасьютикалз Ко., Лтд. Стерильна ін'єкційна композиція арипіпразолу з контрольованим вивільненням, спосіб її виготовлення та спосіб лікування шизофренії
UA96342C2 (en) 2007-06-25 2011-10-25 Оцука Фармасьютикал Ко., Лтд. Microspheres having core/shell structure
US10525057B2 (en) * 2013-09-24 2020-01-07 Otsuka Pharmaceutical Co., Ltd. Method of providing aripiprazole to patients having impaired CYP2D6 or CYP3A4 enzyme function
EP4082546A1 (en) 2017-05-16 2022-11-02 Bow River LLC Methods of treatment with cyp3a4 substrate drugs
EP3761983A1 (en) * 2018-03-05 2021-01-13 Alkermes Pharma Ireland Limited Aripiprazole dosing strategy
CN108498456B (zh) 2018-05-16 2021-01-01 丽珠医药集团股份有限公司 一种阿立哌唑缓释微球及其制备方法
CN110327296B (zh) 2019-08-06 2021-10-22 深圳市泛谷药业股份有限公司 一种阿立哌唑长效注射制剂及其制备方法
HUE069157T2 (hu) 2020-04-01 2025-02-28 Otsuka Pharma Co Ltd Eljárások aripiprazol kezelések adagoláskezdésére

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190099494A1 (en) * 2012-04-23 2019-04-04 Otsuka Pharmaceutical Co., Ltd. Injectable preparation

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
LESLIE CITROME等: "Aripiprazole Long-Acting Injectable Formulations for Schizophrenia: Aripiprazole Monohydrate and Aripiprazole Lauroxil", EXPERT REVIEW OF CLINICAL PHARMACOLOGY, vol. 9, no. 2, pages 169 - 186, XP055398416, DOI: 10.1586/17512433.2016.1121809 *
MARJIE L. HARD等: "Pharmacokinetic Profile of a 2-Month Dose Regimen of Aripiprazole Lauroxil: A Phase I Study and a Population Pharmacokinetic Model", CNS DRUGS, vol. 31, pages 617 - 624, XP055590498, DOI: 10.1007/s40263-017-0447-7 *
赵靖平: "中国精神分裂症防治指南", vol. 1, 31 May 2015, 中华医学电子音像出版社, pages: 71 - 73 *

Also Published As

Publication number Publication date
JP2025020306A (ja) 2025-02-12
EP3941470A1 (en) 2022-01-26
KR20240165486A (ko) 2024-11-22
TW202523329A (zh) 2025-06-16
JP7733000B2 (ja) 2025-09-02
EP4467194A3 (en) 2025-01-08
JP7584535B2 (ja) 2024-11-15
US20220160621A1 (en) 2022-05-26
MX2022012353A (es) 2022-10-31
KR102732030B1 (ko) 2024-11-20
AU2021248212A1 (en) 2022-12-01
CA3212191A1 (en) 2021-10-07
CA3163321C (en) 2023-12-19
EP4467194A2 (en) 2024-11-27
CA3163321A1 (en) 2021-10-07
WO2021201239A1 (en) 2021-10-07
TW202200142A (zh) 2022-01-01
ZA202210633B (en) 2025-01-29
US20240374506A1 (en) 2024-11-14
EP4125903B1 (en) 2024-10-09
KR20220161403A (ko) 2022-12-06
HRP20241574T1 (hr) 2025-01-31
CN115397420A (zh) 2022-11-25
US20230129919A1 (en) 2023-04-27
TWI865760B (zh) 2024-12-11
KR20220161402A (ko) 2022-12-06
US20260115131A1 (en) 2026-04-30
JP2023520004A (ja) 2023-05-15
EP4125903C0 (en) 2024-10-09
JP2023519425A (ja) 2023-05-10
TW202200141A (zh) 2022-01-01
JP2025176037A (ja) 2025-12-03
US20260034053A1 (en) 2026-02-05
TWI906279B (zh) 2025-12-01
EP4125903A1 (en) 2023-02-08
PL4125903T3 (pl) 2025-02-03
BR112022018721A2 (pt) 2022-11-01
AU2021245713A1 (en) 2022-12-01
HUE069157T2 (hu) 2025-02-28
US20230225962A1 (en) 2023-07-20
WO2021201238A1 (en) 2021-10-07
ES2995466T3 (en) 2025-02-10
CA3136727A1 (en) 2021-10-07
MX2022012354A (es) 2022-10-31
CN119792290A (zh) 2025-04-11
BR112022018647A2 (pt) 2022-11-08

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