CN112641785A - 阿立哌唑前体药物组合物 - Google Patents

阿立哌唑前体药物组合物 Download PDF

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Publication number
CN112641785A
CN112641785A CN202011448652.3A CN202011448652A CN112641785A CN 112641785 A CN112641785 A CN 112641785A CN 202011448652 A CN202011448652 A CN 202011448652A CN 112641785 A CN112641785 A CN 112641785A
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CN
China
Prior art keywords
aripiprazole
composition
less
particle size
surface stabilizer
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
CN202011448652.3A
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English (en)
Chinese (zh)
Inventor
P·克雷斯韦尔
M·希基
E·利弗西奇
D·曼瑟
M·小帕尔米耶里
S·M·帕克特
K·珀金
G·史密斯
B·斯坦伯格
R·特恩克利夫
T·扎伊丹
E·P·卡什
M·L·哈德
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.)
Alkermes Pharma Ireland Ltd
Original Assignee
Alkermes Pharma Ireland 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.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=51352472&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=CN112641785(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Alkermes Pharma Ireland Ltd filed Critical Alkermes Pharma Ireland Ltd
Publication of CN112641785A publication Critical patent/CN112641785A/zh
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
    • A61K31/495—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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • 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
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
    • A61K9/145—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic compounds
    • 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
    • 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
    • A61P25/22—Anxiolytics
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Psychiatry (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Pain & Pain Management (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CN202011448652.3A 2014-08-18 2015-08-17 阿立哌唑前体药物组合物 Pending CN112641785A (zh)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201462038665P 2014-08-18 2014-08-18
EP14181328 2014-08-18
US62/038,665 2014-08-18
EP14181328.7 2014-08-18
CN201580055491.2A CN106794251B (zh) 2014-08-18 2015-08-17 阿立哌唑前体药物组合物

Related Parent Applications (1)

Application Number Title Priority Date Filing Date
CN201580055491.2A Division CN106794251B (zh) 2014-08-18 2015-08-17 阿立哌唑前体药物组合物

Publications (1)

Publication Number Publication Date
CN112641785A true CN112641785A (zh) 2021-04-13

Family

ID=51352472

Family Applications (3)

Application Number Title Priority Date Filing Date
CN202011448652.3A Pending CN112641785A (zh) 2014-08-18 2015-08-17 阿立哌唑前体药物组合物
CN202011416673.7A Active CN112494492B (zh) 2014-08-18 2015-08-17 阿立哌唑前体药物组合物
CN201580055491.2A Active CN106794251B (zh) 2014-08-18 2015-08-17 阿立哌唑前体药物组合物

Family Applications After (2)

Application Number Title Priority Date Filing Date
CN202011416673.7A Active CN112494492B (zh) 2014-08-18 2015-08-17 阿立哌唑前体药物组合物
CN201580055491.2A Active CN106794251B (zh) 2014-08-18 2015-08-17 阿立哌唑前体药物组合物

Country Status (20)

Country Link
US (1) US20220079939A1 (https=)
EP (2) EP3182958B2 (https=)
JP (1) JP6571166B2 (https=)
CN (3) CN112641785A (https=)
AU (1) AU2015306198B2 (https=)
BR (1) BR112017002926A2 (https=)
CY (1) CY1124625T1 (https=)
DK (1) DK3508196T3 (https=)
ES (1) ES2884849T3 (https=)
HR (1) HRP20211271T1 (https=)
HU (1) HUE055711T2 (https=)
IL (2) IL292079B2 (https=)
MX (1) MX371417B (https=)
PL (2) PL3508196T3 (https=)
PT (1) PT3508196T (https=)
RS (2) RS62232B1 (https=)
RU (1) RU2705376C2 (https=)
SI (2) SI3508196T1 (https=)
SM (2) SMT202100481T1 (https=)
WO (1) WO2016026822A1 (https=)

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
HRP20190642T2 (hr) * 2014-08-18 2022-07-08 Alkermes Pharma Ireland Limited Pripravci aripiprazolskog predlijeka
US10016415B2 (en) 2014-08-18 2018-07-10 Alkermes Pharma Ireland Limited Aripiprazole prodrug compositions
CA3014788A1 (en) * 2016-02-17 2017-08-24 Alkermes Pharma Ireland Limited Compositions of multiple aripiprazole prodrugs
CN110025572A (zh) * 2018-01-11 2019-07-19 四川科伦药物研究院有限公司 月桂酰阿立哌唑混悬剂及其制备方法
EP3761983A1 (en) * 2018-03-05 2021-01-13 Alkermes Pharma Ireland Limited Aripiprazole dosing strategy
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
EP4353233A4 (en) 2021-06-08 2025-06-25 Chugai Seiyaku Kabushiki Kaisha PREPARATION CONTAINING A DIHYDROPYRIDAZINE-3,5-DIONE DERIVATIVE

Citations (7)

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Publication number Priority date Publication date Assignee Title
WO2003030872A2 (en) * 2001-10-12 2003-04-17 Elan Pharma International Ltd. Compositions having a combination of particles for immediate release and for controlled release
WO2005041973A1 (de) * 2003-10-30 2005-05-12 Boehringer Ingelheim International Gmbh Verwendung von tyrosinkinase-inhibitoren zur behandlung inflammatorischer prozesse
WO2007035348A2 (en) * 2005-09-15 2007-03-29 Elan Pharma International, Limited Nanoparticulate aripiprazole formulations
CA3035442A1 (en) * 2009-06-25 2010-12-29 Alkermes Pharma Ireland Limited Prodrugs of nh-acidic compounds
CN102133171A (zh) * 2003-08-06 2011-07-27 阿尔克姆斯有限公司 延缓释放阿立哌唑的可注射组合物
US20120238552A1 (en) * 2011-03-18 2012-09-20 Alkermes, Inc. Pharmaceutical compositions comprising sorbitan esters
CN103393594A (zh) * 2013-08-22 2013-11-20 万特制药(海南)有限公司 一种新的阿立哌唑的制剂组合物

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US5336507A (en) 1992-12-11 1994-08-09 Sterling Winthrop Inc. Use of charged phospholipids to reduce nanoparticle aggregation
TW384224B (en) 1994-05-25 2000-03-11 Nano Sys Llc Method of preparing submicron particles of a therapeutic or diagnostic agent
US5718388A (en) 1994-05-25 1998-02-17 Eastman Kodak Continuous method of grinding pharmaceutical substances
US5665331A (en) 1995-01-10 1997-09-09 Nanosystems L.L.C. Co-microprecipitation of nanoparticulate pharmaceutical agents with crystal growth modifiers
US5560932A (en) 1995-01-10 1996-10-01 Nano Systems L.L.C. Microprecipitation of nanoparticulate pharmaceutical agents
US5662883A (en) 1995-01-10 1997-09-02 Nanosystems L.L.C. Microprecipitation of micro-nanoparticulate pharmaceutical agents
US5534270A (en) 1995-02-09 1996-07-09 Nanosystems Llc Method of preparing stable drug nanoparticles
US5510118A (en) 1995-02-14 1996-04-23 Nanosystems Llc Process for preparing therapeutic compositions containing nanoparticles
US5543133A (en) 1995-02-14 1996-08-06 Nanosystems L.L.C. Process of preparing x-ray contrast compositions containing nanoparticles
ATE386506T1 (de) 1995-10-17 2008-03-15 Jagotec Ag Verabreichung unlöslicher arzneistoffe
GB9622173D0 (en) 1996-10-24 1996-12-18 Glaxo Group Ltd Particulate Products
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
US8431576B2 (en) 2009-06-25 2013-04-30 Alkermes Pharma Ireland Limited Heterocyclic compounds for the treatment of neurological and psychological disorders
ES2950418T3 (es) * 2012-03-19 2023-10-09 Alkermes Pharma Ireland Ltd Composiciones farmacéuticas que comprenden alcohol bencílico
ES2765036T3 (es) * 2012-03-19 2020-06-05 Alkermes Pharma Ireland Ltd Composiciones farmacéuticas que comprenden esteres de ácidos grasos
EP2897592B1 (en) * 2012-09-19 2020-02-19 Alkermes Pharma Ireland Limited Pharmaceutical compositions having improved storage stability

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WO2003030872A2 (en) * 2001-10-12 2003-04-17 Elan Pharma International Ltd. Compositions having a combination of particles for immediate release and for controlled release
CN102133171A (zh) * 2003-08-06 2011-07-27 阿尔克姆斯有限公司 延缓释放阿立哌唑的可注射组合物
WO2005041973A1 (de) * 2003-10-30 2005-05-12 Boehringer Ingelheim International Gmbh Verwendung von tyrosinkinase-inhibitoren zur behandlung inflammatorischer prozesse
WO2007035348A2 (en) * 2005-09-15 2007-03-29 Elan Pharma International, Limited Nanoparticulate aripiprazole formulations
CA3035442A1 (en) * 2009-06-25 2010-12-29 Alkermes Pharma Ireland Limited Prodrugs of nh-acidic compounds
US20120238552A1 (en) * 2011-03-18 2012-09-20 Alkermes, Inc. Pharmaceutical compositions comprising sorbitan esters
CN103561746A (zh) * 2011-03-18 2014-02-05 奥克梅斯制药爱尔兰有限公司 包含脱水山梨糖醇酯的药物组合物
CN103393594A (zh) * 2013-08-22 2013-11-20 万特制药(海南)有限公司 一种新的阿立哌唑的制剂组合物

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ABDELBARY, ALY A.: "Effect of fixed aqueous layer thickness of polymeric stabilizers on zeta potential and stability of aripiprazole nanosuspensions", 《 PHARMACEUTICAL DEVELOPMENT AND TECHNOLOGY》, vol. 18, no. 2, 3 April 2013 (2013-04-03), pages 730 - 735 *
王洪允: "阿立哌唑片在中国健康人体的单剂和多剂药动学研究", 《 中国新药杂志》, vol. 22, no. 7, 15 April 2013 (2013-04-15), pages 814 - 818 *

Also Published As

Publication number Publication date
NZ767204A (en) 2024-02-23
AU2015306198B2 (en) 2021-02-25
IL292079B1 (en) 2024-03-01
CN112494492B (zh) 2023-08-25
MX2017002029A (es) 2017-08-14
CN106794251B (zh) 2020-12-29
NZ728914A (en) 2023-11-24
IL292079A (en) 2022-06-01
AU2015306198A1 (en) 2017-03-02
JP2017524021A (ja) 2017-08-24
DK3508196T3 (da) 2021-08-16
US20220079939A1 (en) 2022-03-17
PL3182958T5 (pl) 2022-09-12
IL292079B2 (en) 2024-07-01
SI3182958T1 (sl) 2019-05-31
MX371417B (es) 2020-01-29
RS62232B1 (sr) 2021-09-30
EP3182958B2 (en) 2022-05-18
SMT202100481T1 (it) 2021-09-14
CN112494492A (zh) 2021-03-16
HUE055711T2 (hu) 2021-12-28
SMT201900236T1 (it) 2019-07-11
RU2017108204A3 (https=) 2019-04-04
RU2705376C2 (ru) 2019-11-07
SI3182958T2 (sl) 2022-07-29
SI3508196T1 (sl) 2021-12-31
EP3182958B1 (en) 2019-02-27
EP3182958A1 (en) 2017-06-28
WO2016026822A1 (en) 2016-02-25
PL3508196T3 (pl) 2021-12-20
JP6571166B2 (ja) 2019-09-04
EP3508196A1 (en) 2019-07-10
RS58746B1 (sr) 2019-06-28
EP3508196B1 (en) 2021-07-14
IL250607A0 (en) 2017-04-30
CY1124625T1 (el) 2022-07-22
PT3508196T (pt) 2021-08-25
PL3182958T3 (pl) 2019-07-31
RS58746B2 (sr) 2022-07-29
ES2884849T3 (es) 2021-12-13
BR112017002926A2 (pt) 2017-12-12
IL250607B (en) 2022-05-01
CA2957762A1 (en) 2016-02-25
CN106794251A (zh) 2017-05-31
HRP20211271T1 (hr) 2022-01-07
RU2017108204A (ru) 2018-09-21

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