AU2015306910B2 - 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
AU2015306910B2
AU2015306910B2 AU2015306910A AU2015306910A AU2015306910B2 AU 2015306910 B2 AU2015306910 B2 AU 2015306910B2 AU 2015306910 A AU2015306910 A AU 2015306910A AU 2015306910 A AU2015306910 A AU 2015306910A AU 2015306910 B2 AU2015306910 B2 AU 2015306910B2
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AU
Australia
Prior art keywords
temperature
mixture
aripiprazole
formula
surface area
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AU2015306910A
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English (en)
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AU2015306910A1 (en
AU2015306910A8 (en
Inventor
Renato A. Charella
Wilfredo Morales Jr.
Jason M. Perry
Steven G. Wright
Tarek A. Zeidan
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
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Publication date
Application filed by Alkermes Pharma Ireland Ltd filed Critical Alkermes Pharma Ireland Ltd
Publication of AU2015306910A1 publication Critical patent/AU2015306910A1/en
Priority to AU2020264303A priority Critical patent/AU2020264303B2/en
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Publication of AU2015306910A8 publication Critical patent/AU2015306910A8/en
Assigned to ALKERMES PHARMA IRELAND LIMITED reassignment ALKERMES PHARMA IRELAND LIMITED Request for Assignment Assignors: ALKERMES PHARMA IRELAND LIMITED, Morales Jr., Wilfredo
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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

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  • 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)
AU2015306910A 2014-08-25 2015-08-24 Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia Active AU2015306910B2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2020264303A AU2020264303B2 (en) 2014-08-25 2020-11-04 Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia

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
AU2020264303A Division AU2020264303B2 (en) 2014-08-25 2020-11-04 Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia

Publications (3)

Publication Number Publication Date
AU2015306910A1 AU2015306910A1 (en) 2017-03-16
AU2015306910B2 true AU2015306910B2 (en) 2020-11-19
AU2015306910A8 AU2015306910A8 (en) 2020-11-19

Family

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Family Applications (2)

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AU2015306910A Active AU2015306910B2 (en) 2014-08-25 2015-08-24 Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia
AU2020264303A Active AU2020264303B2 (en) 2014-08-25 2020-11-04 Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia

Family Applications After (1)

Application Number Title Priority Date Filing Date
AU2020264303A Active AU2020264303B2 (en) 2014-08-25 2020-11-04 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

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130096089A1 (en) * 2009-06-25 2013-04-18 Alkermes Pharma Ireland Limited Heterocyclic Compounds for the Treatment of Neurological and Psychological Disorders

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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
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

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20130096089A1 (en) * 2009-06-25 2013-04-18 Alkermes Pharma Ireland Limited Heterocyclic Compounds for the Treatment of Neurological and Psychological Disorders

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
GOWDA et al., "Development and Characterization of Ground Mixtures of Aripiprazole with Hydrophilic Carriers.", IJPRBS, vol. 2, no. 6, (2013), pages 537 - 556, URL: http://www.ijprbs.com/issuedocs/2013/12/IJPRBS%20522.pdf, (2015-10-09) *

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
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
CA2959329C (en) 2023-06-27
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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Free format text: IN VOL 31 , NO 10 , PAGE(S) 1527 UNDER THE HEADING PCT APPLICATIONS THAT HAVE ENTERED THE NATIONAL PHASE - NAME INDEX UNDER THE NAME ALKERMES PHARMA IRELAND LIMITED, APPLICATION NO. 2015306910, UNDER INID (71) ADD CO-APPLICANTS WILFREDO MORALES JR.

FGA Letters patent sealed or granted (standard patent)
PC Assignment registered

Owner name: ALKERMES PHARMA IRELAND LIMITED

Free format text: FORMER OWNER(S): MORALES JR., WILFREDO; ALKERMES PHARMA IRELAND LIMITED