JP6591546B2 - 統合失調症治療用の持続放出型製剤におけるアリピプラゾール誘導体の結晶化プロセス - Google Patents

統合失調症治療用の持続放出型製剤におけるアリピプラゾール誘導体の結晶化プロセス Download PDF

Info

Publication number
JP6591546B2
JP6591546B2 JP2017530956A JP2017530956A JP6591546B2 JP 6591546 B2 JP6591546 B2 JP 6591546B2 JP 2017530956 A JP2017530956 A JP 2017530956A JP 2017530956 A JP2017530956 A JP 2017530956A JP 6591546 B2 JP6591546 B2 JP 6591546B2
Authority
JP
Japan
Prior art keywords
temperature
mixture
aripiprazole
surface area
crystallized particles
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
JP2017530956A
Other languages
English (en)
Japanese (ja)
Other versions
JP2017526747A (ja
JP2017526747A5 (enExample
Inventor
ウィルフレド・モラレス・ジュニア
タレク・エー・ゼイダーン
レナート・エー・チャレラ
スティーヴン・ジー・ライト
ジェイソン・エム・ペリー
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.)
Individual
Original Assignee
Individual
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
Application filed by Individual filed Critical Individual
Publication of JP2017526747A publication Critical patent/JP2017526747A/ja
Publication of JP2017526747A5 publication Critical patent/JP2017526747A5/ja
Application granted granted Critical
Publication of JP6591546B2 publication Critical patent/JP6591546B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
    • C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
    • C07D215/16—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C07D215/20—Oxygen atoms
    • C07D215/22—Oxygen atoms attached in position 2 or 4
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D401/00—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom
    • C07D401/02—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings
    • C07D401/12—Heterocyclic compounds containing two or more hetero rings, having nitrogen atoms as the only ring hetero atoms, at least one ring being a six-membered ring with only one nitrogen atom containing two hetero rings linked by a chain containing hetero atoms as chain links

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Psychiatry (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Quinoline Compounds (AREA)
JP2017530956A 2014-08-25 2015-08-24 統合失調症治療用の持続放出型製剤におけるアリピプラゾール誘導体の結晶化プロセス Active JP6591546B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201462041341P 2014-08-25 2014-08-25
US62/041,341 2014-08-25
PCT/US2015/046525 WO2016032950A1 (en) 2014-08-25 2015-08-24 Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia

Related Child Applications (1)

Application Number Title Priority Date Filing Date
JP2019169473A Division JP2019210296A (ja) 2014-08-25 2019-09-18 統合失調症治療用の持続放出型製剤におけるアリピプラゾール誘導体の結晶化プロセス

Publications (3)

Publication Number Publication Date
JP2017526747A JP2017526747A (ja) 2017-09-14
JP2017526747A5 JP2017526747A5 (enExample) 2019-09-12
JP6591546B2 true JP6591546B2 (ja) 2019-10-16

Family

ID=55347322

Family Applications (2)

Application Number Title Priority Date Filing Date
JP2017530956A Active JP6591546B2 (ja) 2014-08-25 2015-08-24 統合失調症治療用の持続放出型製剤におけるアリピプラゾール誘導体の結晶化プロセス
JP2019169473A Pending JP2019210296A (ja) 2014-08-25 2019-09-18 統合失調症治療用の持続放出型製剤におけるアリピプラゾール誘導体の結晶化プロセス

Family Applications After (1)

Application Number Title Priority Date Filing Date
JP2019169473A Pending JP2019210296A (ja) 2014-08-25 2019-09-18 統合失調症治療用の持続放出型製剤におけるアリピプラゾール誘導体の結晶化プロセス

Country Status (20)

Country Link
US (5) US10064859B2 (enExample)
EP (2) EP3185867B1 (enExample)
JP (2) JP6591546B2 (enExample)
CN (2) CN111454207B (enExample)
AU (2) AU2015306910B2 (enExample)
CA (1) CA2959329C (enExample)
CY (1) CY1124058T1 (enExample)
DK (1) DK3185867T3 (enExample)
ES (2) ES2994850T3 (enExample)
HR (1) HRP20210551T1 (enExample)
HU (1) HUE054641T2 (enExample)
IL (1) IL250661B (enExample)
LT (1) LT3185867T (enExample)
MA (2) MA55917A (enExample)
PL (1) PL3185867T3 (enExample)
PT (1) PT3185867T (enExample)
RS (1) RS61709B1 (enExample)
SI (1) SI3185867T1 (enExample)
SM (1) SMT202100212T1 (enExample)
WO (1) WO2016032950A1 (enExample)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019210296A (ja) * 2014-08-25 2019-12-12 アルカームス ファーマ アイルランド リミテッド 統合失調症治療用の持続放出型製剤におけるアリピプラゾール誘導体の結晶化プロセス

Families Citing this family (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2972387T3 (es) 2011-03-18 2024-06-12 Alkermes Pharma Ireland Ltd Composiciones farmacéuticas que comprenden ésteres de sorbitán
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
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
WO2016181406A1 (en) * 2015-05-08 2016-11-17 Davuluri Ramamohan Rao Improved process for the preparation of aripiprazole with reduced particle size
WO2018104953A1 (en) * 2016-12-07 2018-06-14 Msn Laboratories Private Limited, R&D Center Improved process for the preparation of 7-{4-[4-(2,3-dichlorophenyl)-piperazin-1-yl]butoxy}-2oxo-3,4-dihydro-2h-quinolin-1-yl)methyl dodecanoate
ES2903278T3 (es) 2017-07-28 2022-03-31 Interquim Sa Procedimiento para la preparación de aripiprazol lauroxil
CN110218209B (zh) * 2018-03-02 2022-09-30 上海现代药物制剂工程研究中心有限公司 一种依匹哌唑月桂酸酯的晶型a、其制备方法及应用
AU2019230014B2 (en) 2018-03-05 2024-11-28 Alkermes Pharma Ireland Limited Aripiprazole dosing strategy
CN113105389B (zh) * 2021-04-16 2022-04-08 江苏海洋大学 一种阿立哌唑药物共晶及其制备方法

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5510118A (en) * 1995-02-14 1996-04-23 Nanosystems Llc Process for preparing therapeutic compositions containing nanoparticles
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
TWI371274B (en) * 2003-10-23 2012-09-01 Bristol Myers Squibb Co Process for making sterile aripiprazole of desired mean particle size
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
CA2655335C (en) 2007-12-19 2016-09-06 Janssen Pharmaceutica N.V. Prolonged-release injectable suspensions of paliperidone palmitate, and dosage forms and delivery systems incorporating same
US20110003823A1 (en) 2008-08-01 2011-01-06 Alpha Synergy Development, Inc. Compositions and methods for treatment of diseases and conditions associated with vasodilation and/or vascular leakage
PT2445502T (pt) 2009-06-25 2017-09-22 Alkermes Pharma Ireland Ltd Compostos heterocíclicos para o tratamento de distúrbios neurológicos e psicológicos
WO2012077134A1 (en) * 2010-12-07 2012-06-14 Ind-Swift Laboratories Limted Process for preparing aripiprazole polymorphs
AU2012204174B2 (en) * 2011-01-07 2016-07-21 Neodyne Biosciences, Inc. Wound or skin treatment devices and methods
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
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
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

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2019210296A (ja) * 2014-08-25 2019-12-12 アルカームス ファーマ アイルランド リミテッド 統合失調症治療用の持続放出型製剤におけるアリピプラゾール誘導体の結晶化プロセス

Also Published As

Publication number Publication date
US11883394B2 (en) 2024-01-30
US10064859B2 (en) 2018-09-04
AU2020264303B2 (en) 2022-10-13
DK3185867T3 (da) 2021-03-15
US20210205302A1 (en) 2021-07-08
SMT202100212T1 (it) 2021-07-12
NZ729479A (en) 2021-03-26
PL3185867T3 (pl) 2021-11-22
MA40480B1 (fr) 2021-08-31
EP3185867A1 (en) 2017-07-05
HUE054641T2 (hu) 2021-09-28
HRP20210551T1 (hr) 2021-08-20
AU2015306910A8 (en) 2020-11-19
US20160051546A1 (en) 2016-02-25
IL250661B (en) 2020-04-30
CA2959329A1 (en) 2016-03-03
JP2019210296A (ja) 2019-12-12
LT3185867T (lt) 2021-06-10
AU2015306910A1 (en) 2017-03-16
EP3865476B1 (en) 2024-08-14
IL250661A0 (en) 2017-04-30
PT3185867T (pt) 2021-04-12
JP2017526747A (ja) 2017-09-14
US10973816B2 (en) 2021-04-13
EP3185867B1 (en) 2021-01-13
CN111454207B (zh) 2024-10-18
ES2994850T3 (en) 2025-02-03
CN107106556B (zh) 2020-06-05
CY1124058T1 (el) 2022-05-27
SI3185867T1 (sl) 2021-08-31
CN107106556A (zh) 2017-08-29
US20190015408A1 (en) 2019-01-17
WO2016032950A1 (en) 2016-03-03
ES2862098T3 (es) 2021-10-07
US20240245676A1 (en) 2024-07-25
MA55917A (fr) 2022-03-16
AU2015306910B2 (en) 2020-11-19
US10478434B2 (en) 2019-11-19
EP3185867A4 (en) 2018-01-24
US20200108063A1 (en) 2020-04-09
EP3865476A1 (en) 2021-08-18
CA2959329C (en) 2023-06-27
AU2020264303A1 (en) 2020-11-26
RS61709B1 (sr) 2021-05-31
CN111454207A (zh) 2020-07-28

Similar Documents

Publication Publication Date Title
JP2019210296A (ja) 統合失調症治療用の持続放出型製剤におけるアリピプラゾール誘導体の結晶化プロセス
JP2020513023A (ja) ルマテペロンｐ−トシラートの非晶質形態および固体分散体
WO2022001820A1 (zh) 杂环类化合物的晶型及其制备方法和应用
JP4490116B2 (ja) ステロイド結晶の製造法、この方法によって得られた結晶および得られた結晶の医薬製剤における使用
US7417044B2 (en) Tadalafil having a large particle size and a process for preparation thereof
CN101163704A (zh) 大粒径他达那非及其制备方法
HK40057525B (en) Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia
HK40057525A (en) Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia
HK1246636A1 (en) Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia
HK1246636B (en) Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia
NZ729479B2 (en) Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia
ES2886152T3 (es) Un procedimiento mejorado para la preparación de pirfenidona
CN1812767A (zh) 一种制备药用有效成分晶体的方法以及由该方法获得的晶体和晶体在药剂制备中的应用
HK1090287A (en) Process for production of crystals of a medicinally effective ingredient, crystals obtained thereby and their use in pharmaceutical preparations

Legal Events

Date Code Title Description
A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20180814

A977 Report on retrieval

Free format text: JAPANESE INTERMEDIATE CODE: A971007

Effective date: 20190418

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20190507

A524 Written submission of copy of amendment under article 19 pct

Free format text: JAPANESE INTERMEDIATE CODE: A524

Effective date: 20190801

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: 20190819

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20190918

R150 Certificate of patent or registration of utility model

Ref document number: 6591546

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