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 PDFInfo
- 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.)
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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)
- Life Sciences & Earth Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Psychiatry (AREA)
- Biomedical Technology (AREA)
- Neurology (AREA)
- Neurosurgery (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Quinoline Compounds (AREA)
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) | CN107106556B (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) | MA40480B1 (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)
| 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 (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| NZ730571A (en) | 2012-09-19 | 2018-12-21 | Alkermes Pharma Ireland Ltd | Pharmaceutical compositions having improved storage stability |
| US10016415B2 (en) | 2014-08-18 | 2018-07-10 | Alkermes Pharma Ireland Limited | Aripiprazole prodrug compositions |
| EP3294724A4 (en) * | 2015-05-08 | 2018-11-21 | 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 |
| US20200140410A1 (en) | 2017-07-28 | 2020-05-07 | Interquim, S.A. | Process for the preparation of aripiprazole 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)
| 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 |
| CA2543242C (en) * | 2003-10-23 | 2015-04-14 | Otsuka Pharmaceutical Co., Ltd. | Controlled release sterile freeze-dried aripiprazole formulation and injectable formulation thereof |
| HUE053904T2 (hu) | 2007-12-19 | 2021-07-28 | Janssen Pharmaceutica Nv | Hosszan tartó hatású injektálható paliperidon-észterekkel kapcsolatos adagolási rendek |
| 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 |
| ES2639065T5 (es) | 2009-06-25 | 2023-01-30 | Alkermes Pharma Ireland Ltd | Compuestos heterocíclicos para el tratamiento de trastornos neurológicos y psicológicos |
| WO2012077134A1 (en) * | 2010-12-07 | 2012-06-14 | Ind-Swift Laboratories Limted | Process for preparing aripiprazole polymorphs |
| MX345460B (es) * | 2011-01-07 | 2017-02-01 | Neodyne Biosciences Inc | Dispositivos y metodos para tratamiento de heridas o de la piel. |
| PL2685979T3 (pl) | 2011-03-18 | 2017-02-28 | Alkermes Pharma Ireland Limited | Kompozycje farmaceutyczne do wstrzykiwania zawierające środek nierozpuszczalny w wodzie, środek przeciwpsychotyczny, laurynian sorbitanu i polisorbat 20 |
| AU2013235519C1 (en) * | 2012-03-19 | 2018-04-26 | Alkermes Pharma Ireland Limited | Pharmaaceutical compositions comprising fatty acid esters |
| NZ730571A (en) * | 2012-09-19 | 2018-12-21 | Alkermes Pharma Ireland Ltd | Pharmaceutical compositions having improved storage stability |
| MA40480B1 (fr) * | 2014-08-25 | 2021-08-31 | Alkermes Pharma Ireland Ltd | Procédé de cristallisation de dérivés d'aripiprazole dans des formulations à libération prolongée pour le traitement de la schizophrénie |
-
2015
- 2015-08-24 MA MA40480A patent/MA40480B1/fr unknown
- 2015-08-24 LT LTEP15836431.5T patent/LT3185867T/lt unknown
- 2015-08-24 JP JP2017530956A patent/JP6591546B2/ja active Active
- 2015-08-24 EP EP15836431.5A patent/EP3185867B1/en active Active
- 2015-08-24 PL PL15836431T patent/PL3185867T3/pl unknown
- 2015-08-24 ES ES21150116T patent/ES2994850T3/es active Active
- 2015-08-24 SM SM20210212T patent/SMT202100212T1/it unknown
- 2015-08-24 MA MA055917A patent/MA55917A/fr unknown
- 2015-08-24 AU AU2015306910A patent/AU2015306910B2/en active Active
- 2015-08-24 CN CN201580057857.XA patent/CN107106556B/zh active Active
- 2015-08-24 CA CA2959329A patent/CA2959329C/en active Active
- 2015-08-24 HU HUE15836431A patent/HUE054641T2/hu unknown
- 2015-08-24 PT PT158364315T patent/PT3185867T/pt unknown
- 2015-08-24 US US14/833,638 patent/US10064859B2/en active Active
- 2015-08-24 EP EP21150116.8A patent/EP3865476B1/en active Active
- 2015-08-24 WO PCT/US2015/046525 patent/WO2016032950A1/en not_active Ceased
- 2015-08-24 ES ES15836431T patent/ES2862098T3/es active Active
- 2015-08-24 HR HRP20210551TT patent/HRP20210551T1/hr unknown
- 2015-08-24 DK DK15836431.5T patent/DK3185867T3/da active
- 2015-08-24 CN CN202010375290.3A patent/CN111454207B/zh active Active
- 2015-08-24 SI SI201531576T patent/SI3185867T1/sl unknown
- 2015-08-24 RS RS20210433A patent/RS61709B1/sr unknown
-
2017
- 2017-02-19 IL IL250661A patent/IL250661B/en active IP Right Grant
-
2018
- 2018-07-24 US US16/043,721 patent/US10478434B2/en active Active
-
2019
- 2019-09-18 JP JP2019169473A patent/JP2019210296A/ja active Pending
- 2019-10-08 US US16/595,608 patent/US10973816B2/en active Active
-
2020
- 2020-11-04 AU AU2020264303A patent/AU2020264303B2/en active Active
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2021
- 2021-03-24 US US17/211,352 patent/US11883394B2/en active Active
- 2021-04-13 CY CY20211100318T patent/CY1124058T1/el unknown
-
2023
- 2023-12-18 US US18/543,767 patent/US20240245676A1/en active Pending
Cited By (1)
| 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 |
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