CA2959329C - Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia - Google Patents

Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia Download PDF

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Publication number
CA2959329C
CA2959329C CA2959329A CA2959329A CA2959329C CA 2959329 C CA2959329 C CA 2959329C CA 2959329 A CA2959329 A CA 2959329A CA 2959329 A CA2959329 A CA 2959329A CA 2959329 C CA2959329 C CA 2959329C
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CA
Canada
Prior art keywords
temperature
mixture
aripiprazole
surface area
formula
Prior art date
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Active
Application number
CA2959329A
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English (en)
French (fr)
Other versions
CA2959329A1 (en
Inventor
Wilfredo Morales Jr.
Tarek A. Zeidan
Renato A. Chiarella
Steven G. Wright
Jason M. Perry
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.)
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Publication of CA2959329A1 publication Critical patent/CA2959329A1/en
Application granted granted Critical
Publication of CA2959329C publication Critical patent/CA2959329C/en
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Classifications

    • 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
    • A61K31/00Medicinal preparations containing organic active ingredients
    • 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D215/00Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
    • C07D215/02Heterocyclic 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
    • C07D215/16Heterocyclic 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
    • C07D215/20Oxygen atoms
    • C07D215/22Oxygen atoms attached in position 2 or 4
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D401/00Heterocyclic 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
    • C07D401/02Heterocyclic 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
    • C07D401/12Heterocyclic 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)
CA2959329A 2014-08-25 2015-08-24 Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia Active CA2959329C (en)

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

Publications (2)

Publication Number Publication Date
CA2959329A1 CA2959329A1 (en) 2016-03-03
CA2959329C true CA2959329C (en) 2023-06-27

Family

ID=55347322

Family Applications (1)

Application Number Title Priority Date Filing Date
CA2959329A Active CA2959329C (en) 2014-08-25 2015-08-24 Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia

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)

Families Citing this family (9)

* Cited by examiner, † Cited by third party
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
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
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)

* 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
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

Also Published As

Publication number Publication date
US10478434B2 (en) 2019-11-19
AU2015306910A1 (en) 2017-03-16
HRP20210551T1 (hr) 2021-08-20
ES2994850T3 (en) 2025-02-03
MA55917A (fr) 2022-03-16
RS61709B1 (sr) 2021-05-31
AU2015306910B2 (en) 2020-11-19
US20190015408A1 (en) 2019-01-17
EP3185867B1 (en) 2021-01-13
WO2016032950A1 (en) 2016-03-03
US20160051546A1 (en) 2016-02-25
PT3185867T (pt) 2021-04-12
AU2015306910A8 (en) 2020-11-19
CN107106556A (zh) 2017-08-29
CA2959329A1 (en) 2016-03-03
SI3185867T1 (sl) 2021-08-31
CY1124058T1 (el) 2022-05-27
US20240245676A1 (en) 2024-07-25
HUE054641T2 (hu) 2021-09-28
US20200108063A1 (en) 2020-04-09
US11883394B2 (en) 2024-01-30
SMT202100212T1 (it) 2021-07-12
US10064859B2 (en) 2018-09-04
CN111454207A (zh) 2020-07-28
CN111454207B (zh) 2024-10-18
IL250661B (en) 2020-04-30
IL250661A0 (en) 2017-04-30
EP3865476B1 (en) 2024-08-14
AU2020264303A1 (en) 2020-11-26
AU2020264303B2 (en) 2022-10-13
EP3185867A1 (en) 2017-07-05
ES2862098T3 (es) 2021-10-07
EP3865476A1 (en) 2021-08-18
NZ729479A (en) 2021-03-26
JP2017526747A (ja) 2017-09-14
US20210205302A1 (en) 2021-07-08
DK3185867T3 (da) 2021-03-15
EP3185867A4 (en) 2018-01-24
JP2019210296A (ja) 2019-12-12
US10973816B2 (en) 2021-04-13
LT3185867T (lt) 2021-06-10
JP6591546B2 (ja) 2019-10-16
CN107106556B (zh) 2020-06-05
PL3185867T3 (pl) 2021-11-22
MA40480B1 (fr) 2021-08-31

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