JP6571166B2 - アリピプラゾールプロドラッグ組成物 - Google Patents

アリピプラゾールプロドラッグ組成物 Download PDF

Info

Publication number
JP6571166B2
JP6571166B2 JP2017509024A JP2017509024A JP6571166B2 JP 6571166 B2 JP6571166 B2 JP 6571166B2 JP 2017509024 A JP2017509024 A JP 2017509024A JP 2017509024 A JP2017509024 A JP 2017509024A JP 6571166 B2 JP6571166 B2 JP 6571166B2
Authority
JP
Japan
Prior art keywords
composition
aripiprazole
particle size
less
polysorbate
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.)
Active
Application number
JP2017509024A
Other languages
English (en)
Japanese (ja)
Other versions
JP2017524021A (ja
JP2017524021A5 (cg-RX-API-DMAC10.html
Inventor
フィリップ クレッスウェル、
フィリップ クレッスウェル、
マガリ ヒッキー、
マガリ ヒッキー、
エレイヌ リヴァーシッジ、
エレイヌ リヴァーシッジ、
デヴッド マンサー、
デヴッド マンサー、
マイケル、 ジュニア パルミエリ、
マイケル、 ジュニア パルミエリ、
サラ モントミニー パケット、
サラ モントミニー パケット、
クリストファー パーキン、
クリストファー パーキン、
グレッグ スミス、
グレッグ スミス、
ブライアン スタインバーグ、
ブライアン スタインバーグ、
ライアン ターンクリフ、
ライアン ターンクリフ、
タレク ゼイダン、
タレク ゼイダン、
エサン ピー． キャッシュ、
エサン ピー． キャッシュ、
マージエ エル． ハード、
マージエ エル． ハード、
Original Assignee
アルカーメス ファーマ アイルランド リミテッド
アルカーメス ファーマ アイルランド リミテッド
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=JP6571166(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by アルカーメス ファーマ アイルランド リミテッド, アルカーメス ファーマ アイルランド リミテッド filed Critical アルカーメス ファーマ アイルランド リミテッド
Publication of JP2017524021A publication Critical patent/JP2017524021A/ja
Publication of JP2017524021A5 publication Critical patent/JP2017524021A5/ja
Application granted granted Critical
Publication of JP6571166B2 publication Critical patent/JP6571166B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

Classifications

    • 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
    • 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
    • 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
    • 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
    • A61K9/14—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

Landscapes

  • 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)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Biomedical Technology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Psychiatry (AREA)
  • Dermatology (AREA)
  • Biochemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Molecular Biology (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)
JP2017509024A 2014-08-18 2015-08-17 アリピプラゾールプロドラッグ組成物 Active JP6571166B2 (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201462038665P 2014-08-18 2014-08-18
EP14181328.7 2014-08-18
EP14181328 2014-08-18
US62/038,665 2014-08-18
PCT/EP2015/068872 WO2016026822A1 (en) 2014-08-18 2015-08-17 Aripiprazole prodrug compositions

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2019145176A Division JP6826167B2 (ja) 2014-08-18 2019-08-07 アリピプラゾールプロドラッグ組成物

Publications (3)

Publication Number Publication Date
JP2017524021A JP2017524021A (ja) 2017-08-24
JP2017524021A5 JP2017524021A5 (cg-RX-API-DMAC10.html) 2018-09-06
JP6571166B2 true JP6571166B2 (ja) 2019-09-04

Family

ID=51352472

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2017509024A Active JP6571166B2 (ja) 2014-08-18 2015-08-17 アリピプラゾールプロドラッグ組成物

Country Status (20)

Country Link
US (1) US12642798B2 (cg-RX-API-DMAC10.html)
EP (2) EP3508196B1 (cg-RX-API-DMAC10.html)
JP (1) JP6571166B2 (cg-RX-API-DMAC10.html)
CN (3) CN112494492B (cg-RX-API-DMAC10.html)
AU (1) AU2015306198B2 (cg-RX-API-DMAC10.html)
BR (1) BR112017002926A2 (cg-RX-API-DMAC10.html)
CY (1) CY1124625T1 (cg-RX-API-DMAC10.html)
DK (1) DK3508196T3 (cg-RX-API-DMAC10.html)
ES (1) ES2884849T3 (cg-RX-API-DMAC10.html)
HR (1) HRP20211271T1 (cg-RX-API-DMAC10.html)
HU (1) HUE055711T2 (cg-RX-API-DMAC10.html)
IL (2) IL292079B2 (cg-RX-API-DMAC10.html)
MX (1) MX371417B (cg-RX-API-DMAC10.html)
PL (2) PL3508196T3 (cg-RX-API-DMAC10.html)
PT (1) PT3508196T (cg-RX-API-DMAC10.html)
RS (2) RS58746B2 (cg-RX-API-DMAC10.html)
RU (1) RU2705376C2 (cg-RX-API-DMAC10.html)
SI (2) SI3508196T1 (cg-RX-API-DMAC10.html)
SM (2) SMT202100481T1 (cg-RX-API-DMAC10.html)
WO (1) WO2016026822A1 (cg-RX-API-DMAC10.html)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021059604A (ja) * 2014-08-18 2021-04-15 アルカーメス ファーマ アイルランド リミテッド アリピプラゾールプロドラッグ組成物

Families Citing this family (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US10016415B2 (en) 2014-08-18 2018-07-10 Alkermes Pharma Ireland Limited Aripiprazole prodrug compositions
SMT202100481T1 (it) 2014-08-18 2021-09-14 Alkermes Pharma Ireland Ltd Composizioni per profarmaci di aripiprazolo
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
AU2019230014B2 (en) * 2018-03-05 2024-11-28 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
WO2022260064A1 (ja) 2021-06-08 2022-12-15 中外製薬株式会社 ジヒドロピリダジン－３，５－ジオン誘導体を含有する製剤

Family Cites Families (34)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5145684A (en) * 1991-01-25 1992-09-08 Sterling Drug Inc. Surface modified drug nanoparticles
NZ248813A (en) 1992-11-25 1995-06-27 Eastman Kodak Co Polymeric grinding media used in grinding pharmaceutical substances
US5336507A (en) 1992-12-11 1994-08-09 Sterling Winthrop Inc. Use of charged phospholipids to reduce nanoparticle aggregation
US5718388A (en) 1994-05-25 1998-02-17 Eastman Kodak Continuous method of grinding pharmaceutical substances
TW384224B (en) 1994-05-25 2000-03-11 Nano Sys Llc Method of preparing submicron particles of a therapeutic or diagnostic agent
US5662883A (en) 1995-01-10 1997-09-02 Nanosystems L.L.C. Microprecipitation of micro-nanoparticulate pharmaceutical agents
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
US5534270A (en) 1995-02-09 1996-07-09 Nanosystems Llc Method of preparing stable drug nanoparticles
US5543133A (en) 1995-02-14 1996-08-06 Nanosystems L.L.C. Process of preparing x-ray contrast compositions containing nanoparticles
US5510118A (en) 1995-02-14 1996-04-23 Nanosystems Llc Process for preparing therapeutic compositions containing nanoparticles
ES2306452T3 (es) 1995-10-17 2008-11-01 Jagotec Ag Aporte de farmacos insolubles.
GB9622173D0 (en) 1996-10-24 1996-12-18 Glaxo Group Ltd Particulate Products
JP2005508939A (ja) * 2001-10-12 2005-04-07 エラン ファーマ インターナショナル，リミティド 即時放出および徐放特性を組み合わせて有する組成物
US20050032811A1 (en) * 2003-08-06 2005-02-10 Josiah Brown Methods for administering aripiprazole
BRPI0415531B8 (pt) * 2003-10-23 2021-05-25 Otsuka Pharma Co Ltd formulação de aripiprazol injetável estéril de liberação controlada e método para a sua preparação
DE10350717A1 (de) * 2003-10-30 2005-06-02 Boehringer Ingelheim Pharma Gmbh & Co. Kg Verwendung von Tyrosinkinase-Inhibitoren zur Behandlung inflammatorischer Prozesse
EP1679065A1 (en) 2005-01-07 2006-07-12 OctoPlus Sciences B.V. Controlled release compositions for interferon based on PEGT/PBT block copolymers
WO2007035348A2 (en) * 2005-09-15 2007-03-29 Elan Pharma International, Limited Nanoparticulate aripiprazole formulations
US20120238553A1 (en) 2009-01-27 2012-09-20 Neurosearch A/S Novel benzodioxolyl-oxadiazolyl-diazabicyclononane derivatives and their medical use
JP5732453B2 (ja) 2009-06-25 2015-06-10 アルカーメス ファーマ アイルランド リミテッド Ｎｈ酸性化合物のプロドラッグ
PT2445502T (pt) 2009-06-25 2017-09-22 Alkermes Pharma Ireland Ltd Compostos heterocíclicos para o tratamento de distúrbios neurológicos e psicológicos
CA3035442C (en) * 2009-06-25 2022-07-19 Alkermes Pharma Ireland Limited Prodrugs of nh-acidic compounds
ES2972387T3 (es) * 2011-03-18 2024-06-12 Alkermes Pharma Ireland Ltd Composiciones farmacéuticas que comprenden ésteres de sorbitán
CA2867121C (en) * 2012-03-19 2021-05-25 Alkermes Pharma Ireland Limited Pharmaceutical compositions comprising fatty acid esters
WO2013142202A1 (en) 2012-03-19 2013-09-26 Alkermes Pharma Ireland Limited Pharmaceutical compositions comprising glycerol esters
US9999670B2 (en) 2012-03-19 2018-06-19 Alkermes Pharma Ireland Limited Pharmaceutical compositions comprising benzyl alcohol
JP6654042B2 (ja) 2012-09-19 2020-02-26 アルカームス ファーマ アイルランド リミテッド 貯蔵安定性が改善された医薬組成物
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
AU2015231278B2 (en) 2014-03-20 2020-01-23 Alkermes Pharma Ireland Limited Aripiprazole formulations having increased injection speeds
US10016415B2 (en) 2014-08-18 2018-07-10 Alkermes Pharma Ireland Limited Aripiprazole prodrug compositions
SMT202100481T1 (it) 2014-08-18 2021-09-14 Alkermes Pharma Ireland Ltd Composizioni per profarmaci di aripiprazolo
SMT202100212T1 (it) 2014-08-25 2021-07-12 Alkermes Pharma Ireland Ltd Processo di cristallizzazione di derivati di aripiprazolo in formulazioni a rilascio prolungato per il trattamento di schizofrenia
CN105012236A (zh) 2015-08-10 2015-11-04 深圳市泛谷药业有限公司 一种长效非水载体注射液及其制备方法

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2021059604A (ja) * 2014-08-18 2021-04-15 アルカーメス ファーマ アイルランド リミテッド アリピプラゾールプロドラッグ組成物
JP7157830B2 (ja) 2014-08-18 2022-10-20 アルカーメス ファーマ アイルランド リミテッド アリピプラゾールプロドラッグ組成物

Also Published As

Publication number Publication date
CA2957762A1 (en) 2016-02-25
RS58746B1 (sr) 2019-06-28
MX2017002029A (es) 2017-08-14
ES2884849T3 (es) 2021-12-13
RS62232B1 (sr) 2021-09-30
RU2705376C2 (ru) 2019-11-07
EP3182958B1 (en) 2019-02-27
CN112494492A (zh) 2021-03-16
AU2015306198B2 (en) 2021-02-25
RU2017108204A (ru) 2018-09-21
HRP20211271T1 (hr) 2022-01-07
PL3508196T3 (pl) 2021-12-20
CN112494492B (zh) 2023-08-25
DK3508196T3 (da) 2021-08-16
IL292079B2 (en) 2024-07-01
NZ767204A (en) 2024-02-23
CY1124625T1 (el) 2022-07-22
EP3182958A1 (en) 2017-06-28
CN106794251B (zh) 2020-12-29
JP2017524021A (ja) 2017-08-24
PL3182958T5 (pl) 2022-09-12
RS58746B2 (sr) 2022-07-29
PT3508196T (pt) 2021-08-25
EP3508196A1 (en) 2019-07-10
SMT202100481T1 (it) 2021-09-14
SI3182958T1 (sl) 2019-05-31
CN106794251A (zh) 2017-05-31
IL292079B1 (en) 2024-03-01
EP3182958B2 (en) 2022-05-18
SI3182958T2 (sl) 2022-07-29
HUE055711T2 (hu) 2021-12-28
MX371417B (es) 2020-01-29
BR112017002926A2 (pt) 2017-12-12
PL3182958T3 (pl) 2019-07-31
US12642798B2 (en) 2026-06-02
AU2015306198A1 (en) 2017-03-02
NZ728914A (en) 2023-11-24
EP3508196B1 (en) 2021-07-14
RU2017108204A3 (cg-RX-API-DMAC10.html) 2019-04-04
WO2016026822A1 (en) 2016-02-25
SMT201900236T1 (it) 2019-07-11
IL292079A (en) 2022-06-01
IL250607A0 (en) 2017-04-30
SI3508196T1 (sl) 2021-12-31
CN112641785A (zh) 2021-04-13
IL250607B (en) 2022-05-01
US20220079939A1 (en) 2022-03-17

Similar Documents

Publication Publication Date Title
US11154552B2 (en) Aripiprazole prodrug composition
US20220079939A1 (en) Aripiprazole prodrug composition
WO2018100434A1 (en) Preparation of solid cyclodextrin complexes for ophthalmic active pharmaceutical ingredient delivery
JP7157830B2 (ja) アリピプラゾールプロドラッグ組成物
US10159671B2 (en) Compositions of multiple aripiprazole prodrugs
RU2817019C2 (ru) Композиции пролекарства арипипразола
CA2957762C (en) Aripiprazole prodrug compositions
HK40049829A (en) Aripiprazole prodrug compositions
HK40049829B (en) Aripiprazole prodrug compositions
HK1235285B (en) Aripiprazole prodrug compositions
HK1235285A1 (en) Aripiprazole prodrug compositions

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20170330

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20180727

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20180727

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20190312

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20190315

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20190517

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20190709

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20190807

R150 Certificate of patent or registration of utility model

Ref document number: 6571166

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250

R250 Receipt of annual fees

Free format text: JAPANESE INTERMEDIATE CODE: R250