PE20050810A1 - Proceso para fabricar aripiprazol esteril de tamano de particula promedio deseado - Google Patents

Proceso para fabricar aripiprazol esteril de tamano de particula promedio deseado

Info

Publication number
PE20050810A1
PE20050810A1 PE2004001020A PE2004001020A PE20050810A1 PE 20050810 A1 PE20050810 A1 PE 20050810A1 PE 2004001020 A PE2004001020 A PE 2004001020A PE 2004001020 A PE2004001020 A PE 2004001020A PE 20050810 A1 PE20050810 A1 PE 20050810A1
Authority
PE
Peru
Prior art keywords
aripiprazole
jet
current
particle size
solution
Prior art date
Application number
PE2004001020A
Other languages
English (en)
Inventor
Margaret Gleeson
Soojin Kim
San Kiang
Donald Kientzler
Original Assignee
Bristol Myers Squibb Co
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=34549310&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=PE20050810(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Bristol Myers Squibb Co filed Critical Bristol Myers Squibb Co
Publication of PE20050810A1 publication Critical patent/PE20050810A1/es

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61J—CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE
    • A61J3/00—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms
    • A61J3/02—Devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms into the form of powders
    • 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
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D9/00—Crystallisation
    • B01D9/0004—Crystallisation cooling by heat exchange
    • B01D9/0009—Crystallisation cooling by heat exchange by direct heat exchange with added cooling fluid
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D9/00—Crystallisation
    • B01D9/005—Selection of auxiliary, e.g. for control of crystallisation nuclei, of crystal growth, of adherence to walls; Arrangements for introduction thereof
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D9/00—Crystallisation
    • B01D9/005—Selection of auxiliary, e.g. for control of crystallisation nuclei, of crystal growth, of adherence to walls; Arrangements for introduction thereof
    • B01D9/0054—Use of anti-solvent
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D9/00—Crystallisation
    • B01D9/0063—Control or regulation
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01D—SEPARATION
    • B01D9/00—Crystallisation
    • B01D9/0081—Use of vibrations, e.g. ultrasound
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01J—CHEMICAL OR PHYSICAL PROCESSES, e.g. CATALYSIS OR COLLOID CHEMISTRY; THEIR RELEVANT APPARATUS
    • B01J2/00—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic
    • B01J2/02—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by dividing the liquid material into drops, e.g. by spraying, and solidifying the drops
    • B01J2/06—Processes or devices for granulating materials, e.g. fertilisers in general; Rendering particulate materials free flowing in general, e.g. making them hydrophobic by dividing the liquid material into drops, e.g. by spraying, and solidifying the drops in a liquid medium
    • 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
    • C07D215/227—Oxygen atoms attached in position 2 or 4 only one oxygen atom which is attached in position 2
    • 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

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Crystallography & Structural Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Physics & Mathematics (AREA)
  • Thermal Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Quinoline Compounds (AREA)
  • Medicinal Preparation (AREA)

Abstract

DONDE EL PROCESO COMPRENDE: a) PROPORCIONAR UNA CORRIENTE DE CHORRO DE UNA SOLUCION DE ARIPIPRAZOL EN UN SOLVENTE ORGANICO; b) PROPORCIONAR UNA CORRIENTE DE CHORRO DE ANTI-SOLVENTE, EL CUAL ES CAPAZ DE INICIAR LA PRECIPITACION DEL ARIPIPRAZOL DE LA SOLUCION Y ESTA A UNA TEMPERATURA MENOR A LA CORRIENTE DE (a); c) PROVOCAR QUE AMBAS CORRIENTES DE CHORRO CHOQUEN ENTRE SI Y SE GOLPEEN UNA CONTRA LA OTRA PARA CREAR UNA TURBULENCIA ELEVADA EN SU PUNTO DE IMPACTO, CADA CORRIENTE DE CHORRO TENIENDO UNA VELOCIDAD LINEAL SUFICIENTE PARA LOGRAR UN MICROMEZCLADO DE INTENSIDAD ELEVADA DE CADA CORRIENTE PREVIO A LA NUCLEACION, PARA PRODUCIR UNA SUSPENSION DE CRISTALES DE MONOHIDRATO DE ARIPIPRAZOL; Y, d) RECUPERAR LOS CRISTALES DE MONOHIDRATO DE ARIPIPRAZOL DE TAMANO DE PARTICULA PEQUENO DESEADO, ENTRE 25 MICRONES Y 100 MICRONES, Y DE DISTRIBUCION ESTRECHA DE TAMANO DE PARTICULA. LA NUCLEACION Y LA PRODUCCION DE CRISTALES SE HACE CON ENERGIA ULTRASONICA. EL SOLVENTE ORGANICO ES ETANOL, METANOL, ACETATO DE ETILO, ACETONA, ACETONITRILO, ACIDO ACETICO O ALCOHOL ISOPROPILICO, O MEZCLAS DE LOS MISMOS. EL ANTI-SOLVENTE ES AGUA A UNA TEMPERATURA ENTRE 2°C Y 40°C. LA SOLUCION DE ARIPIPRAZOL ES CALENTADA A UNA TEMPERATURA ENTRE 70°C Y 85°C. AMBAS CORRIENTES CHOCAN ENTRE SI A UNA VELOCIDAD DE FLUJO ENTRE 0,2 Y 0,3 Kg/min EN DONDE SE EMPLEAN BOQUILLAS DE DIAMETRO INTERNO DE 0,0508 cm. EL ARIPIPRAZOL PRODUCIDO ES UN AGENTE ANTI-PSICOTICO ATIPICO UTIL EN EL TRATAMIENTO DE LA ESQUIZOFRENIA
PE2004001020A 2003-10-23 2004-10-25 Proceso para fabricar aripiprazol esteril de tamano de particula promedio deseado PE20050810A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US51388603P 2003-10-23 2003-10-23

Publications (1)

Publication Number Publication Date
PE20050810A1 true PE20050810A1 (es) 2005-09-25

Family

ID=34549310

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2004001020A PE20050810A1 (es) 2003-10-23 2004-10-25 Proceso para fabricar aripiprazol esteril de tamano de particula promedio deseado

Country Status (16)

Country Link
US (3) US20050152981A1 (es)
EP (1) EP1675593B1 (es)
JP (1) JP4875984B2 (es)
KR (1) KR101121345B1 (es)
CN (1) CN1871007A (es)
AR (1) AR046142A1 (es)
AU (1) AU2004284904B2 (es)
BR (1) BRPI0415754A (es)
CA (1) CA2543248C (es)
CO (1) CO5670354A2 (es)
ES (1) ES2632499T3 (es)
IL (1) IL175008A (es)
MX (1) MXPA06004333A (es)
PE (1) PE20050810A1 (es)
TW (1) TWI371274B (es)
WO (1) WO2005041970A1 (es)

Families Citing this family (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7714129B2 (en) * 2003-12-16 2010-05-11 Teva Pharmaceutical Industries Ltd. Methods of preparing anhydrous aripiprazole form II
PL1613598T3 (pl) * 2003-12-16 2012-03-30 Teva Pharma Sposób wytwarzania krystalicznych form aripiprazolu
CA2555289A1 (en) * 2004-02-05 2005-08-25 Ben-Zion Dolitzky Process for preparing aripiprazole
US7507823B2 (en) * 2004-05-06 2009-03-24 Bristol-Myers Squibb Company Process of making aripiprazole particles
CN102627603A (zh) * 2004-11-18 2012-08-08 斯索恩有限公司 制备结晶阿立哌唑的方法
EP1933814A2 (en) * 2005-09-15 2008-06-25 Elan Pharma International Limited Nanoparticulate aripiprazole formulations
US8158152B2 (en) * 2005-11-18 2012-04-17 Scidose Llc Lyophilization process and products obtained thereby
TW200800202A (en) * 2005-12-22 2008-01-01 Teva Pharma Processes for reducing particle size of aripiprazole
CA2650395A1 (en) * 2006-04-28 2007-11-08 Schering Corporation Process for the precipitation and isolation of 6,6-dimethyl-3-aza-bicyclo [3.1.0] hexane-amide compounds by controlled precipitation and pharmaceutical formulations containing same
US8420122B2 (en) 2006-04-28 2013-04-16 Merck Sharp & Dohme Corp. Process for the precipitation and isolation of 6,6-dimethyl-3-aza-bicyclo [3.1.0] hexane-amide compounds by controlled precipitation and pharmaceutical formulations containing same
US8039621B2 (en) * 2006-10-24 2011-10-18 Cambrex Charles City, Inc. Process for preparing anhydrous Aripirazole type I
CN101172966B (zh) * 2007-04-06 2012-08-29 重庆医药工业研究院有限责任公司 一种阿立哌唑微晶的制备方法
BRPI0815382A2 (pt) * 2007-07-31 2015-02-10 Otsuka Pharma Co Ltd Métodos para a produção de suspensão de aripiprazol e formulação de secagem por congelamento
GB0909154D0 (en) * 2008-09-25 2009-07-08 Nanomaterials Tech Pte Ltd A process for making particles for delivery of drug nanoparticles
DE102009008478A1 (de) * 2009-02-11 2010-08-19 PHAST Gesellschaft für pharmazeutische Qualitätsstandards mbH Vorrichtung und Verfahren zur Herstellung pharmazeutisch hochfeiner Partikel sowie zur Beschichtung solcher Partikel in Mikroreaktoren
CN101507908B (zh) 2009-04-09 2010-12-01 北京化工大学 微通道套管式装置及其应用
NZ602674A (en) 2010-03-22 2013-10-25 Mjr Pharmjet Gmbh Method and device for producing microparticles or nanoparticles
CN101816913B (zh) * 2010-05-20 2015-10-21 吴传斌 一种微球制造方法及制造设备
TWI589301B (zh) 2010-08-24 2017-07-01 大塚製藥股份有限公司 含有碳苯乙烯基衍生物與聚矽氧油及／或聚矽氧油衍生物之懸浮液以及塊體組成物
JP5893616B2 (ja) 2010-10-18 2016-03-23 大日本住友製薬株式会社 注射用徐放性製剤
PT2667856T (pt) 2011-01-24 2021-09-02 Otsuka Pharma Co Ltd Dispositivo médico contendo uma composição de bolo compreendendo aripiprazol como um ingrediente ativo, e uma composição de bolo compreendendo aripiprazol como um ingrediente ativo
JO3410B1 (ar) * 2011-06-07 2019-10-20 Otsuka Pharma Co Ltd تركيبة أريبيبرازول مجفف بالتبريد
CN102846543B (zh) 2011-06-27 2014-11-19 上海中西制药有限公司 一种阿立哌唑药物制剂及其制备方法
CN102850268B (zh) 2011-06-27 2015-07-15 上海中西制药有限公司 阿立哌唑ⅰ型微晶、阿立哌唑固体制剂及制备方法
JOP20200109A1 (ar) 2012-04-23 2017-06-16 Otsuka Pharma Co Ltd مستحضر قابل للحقن
US9732068B1 (en) * 2013-03-15 2017-08-15 GenSyn Technologies, Inc. System for crystalizing chemical compounds and methodologies for utilizing the same
US9051268B2 (en) 2013-04-30 2015-06-09 Otsuka Pharmaceutical Co., Ltd. Oral solid preparation comprising aripiprazole and method for producing oral solid preparation comprising aripiprazole
EP3865476B1 (en) * 2014-08-25 2024-08-14 Alkermes Pharma Ireland Limited Crystallization process of aripiprazole derivatives in extended release formulations for treatment of schizophrenia
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CN111346397B (zh) * 2020-03-11 2022-03-29 天津大学 适用于溶析结晶或反应结晶的加料设备

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Also Published As

Publication number Publication date
CA2543248A1 (en) 2005-05-12
ES2632499T3 (es) 2017-09-13
MXPA06004333A (es) 2006-06-05
CN1871007A (zh) 2006-11-29
WO2005041970A1 (en) 2005-05-12
TWI371274B (en) 2012-09-01
US20050152981A1 (en) 2005-07-14
TW200518783A (en) 2005-06-16
KR20070090070A (ko) 2007-09-05
IL175008A (en) 2014-11-30
IL175008A0 (en) 2006-08-20
US20130161848A1 (en) 2013-06-27
JP2007509153A (ja) 2007-04-12
CA2543248C (en) 2013-04-02
AU2004284904B2 (en) 2010-05-20
EP1675593B1 (en) 2017-05-31
EP1675593A1 (en) 2006-07-05
CO5670354A2 (es) 2006-08-31
US9066848B2 (en) 2015-06-30
EP1675593A4 (en) 2007-04-25
AU2004284904A1 (en) 2005-05-12
US20110166352A1 (en) 2011-07-07
KR101121345B1 (ko) 2012-03-09
BRPI0415754A (pt) 2006-12-19
JP4875984B2 (ja) 2012-02-15
AR046142A1 (es) 2005-11-23

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