DE60031882T2 - Verfahren zur herstellung von amorphem atorvastatin-calcium - Google Patents

Verfahren zur herstellung von amorphem atorvastatin-calcium Download PDF

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Publication number
DE60031882T2
DE60031882T2 DE60031882T DE60031882T DE60031882T2 DE 60031882 T2 DE60031882 T2 DE 60031882T2 DE 60031882 T DE60031882 T DE 60031882T DE 60031882 T DE60031882 T DE 60031882T DE 60031882 T2 DE60031882 T2 DE 60031882T2
Authority
DE
Germany
Prior art keywords
atorvastatin calcium
calcium
amorphous
amorphous atorvastatin
mixture
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.)
Expired - Fee Related
Application number
DE60031882T
Other languages
German (de)
English (en)
Other versions
DE60031882D1 (de
Inventor
Zoltán Greff
Nagy Kotay
Jozsef Barkoczy
Gyula Simig
László BALAZS
Imre Doman
Zoltán RAtkai
Peter Seres
Kirallyi Szent
Ferenc Bartha
Györgyi VERECZKEYNE DONATH
Kálmán NAGY
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.)
Egyt Gyogyszervegyeszeti Gyar
Egis Gyógyszergyár Zrt
Original Assignee
Egyt Gyogyszervegyeszeti Gyar
Egis Gyógyszergyár Zrt
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 Egyt Gyogyszervegyeszeti Gyar, Egis Gyógyszergyár Zrt filed Critical Egyt Gyogyszervegyeszeti Gyar
Publication of DE60031882D1 publication Critical patent/DE60031882D1/de
Application granted granted Critical
Publication of DE60031882T2 publication Critical patent/DE60031882T2/de
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

Links

Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D207/00—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D207/02—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D207/30—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members
    • C07D207/34—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pyrrole Compounds (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
DE60031882T 1999-10-18 2000-10-17 Verfahren zur herstellung von amorphem atorvastatin-calcium Expired - Fee Related DE60031882T2 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
HU9903634 1999-10-18
HU9903634A HU226640B1 (en) 1999-10-18 1999-10-18 Process for producing amorphous atorvastatin calcium salt
PCT/HU2000/000106 WO2001028999A1 (en) 1999-10-18 2000-10-17 Process for the preparation of amorphous atorvastatin calcium

Publications (2)

Publication Number Publication Date
DE60031882D1 DE60031882D1 (de) 2006-12-28
DE60031882T2 true DE60031882T2 (de) 2007-07-05

Family

ID=90014241

Family Applications (1)

Application Number Title Priority Date Filing Date
DE60031882T Expired - Fee Related DE60031882T2 (de) 1999-10-18 2000-10-17 Verfahren zur herstellung von amorphem atorvastatin-calcium

Country Status (17)

Country Link
EP (1) EP1235800B1 (enExample)
JP (1) JP2003512354A (enExample)
KR (1) KR100664353B1 (enExample)
CN (1) CN1157374C (enExample)
AT (1) ATE345327T1 (enExample)
AU (1) AU1166301A (enExample)
CA (1) CA2388018C (enExample)
CZ (1) CZ300071B6 (enExample)
DE (1) DE60031882T2 (enExample)
HR (1) HRP20020334B1 (enExample)
HU (1) HU226640B1 (enExample)
PL (1) PL354604A1 (enExample)
RS (1) RS50473B (enExample)
RU (1) RU2255932C2 (enExample)
SK (1) SK286861B6 (enExample)
UA (1) UA72777C2 (enExample)
WO (1) WO2001028999A1 (enExample)

Families Citing this family (31)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7411075B1 (en) 2000-11-16 2008-08-12 Teva Pharmaceutical Industries Ltd. Polymorphic form of atorvastatin calcium
SI20425A (sl) * 1999-12-10 2001-06-30 LEK tovarna farmacevtskih in kemi�nih izdelkov d.d. Priprava amorfnega atorvastatina
US7501450B2 (en) 2000-11-30 2009-03-10 Teva Pharaceutical Industries Ltd. Crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms
IL156055A0 (en) 2000-11-30 2003-12-23 Teva Pharma Novel crystal forms of atorvastatin hemi calcium and processes for their preparation as well as novel processes for preparing other forms
WO2002057229A1 (en) 2001-01-19 2002-07-25 Biocon India Limited FORM V CRYSTALLINE [R-(R*,R*)]-2-(4-FLUOROPHENYL)-ß,$G(D)-DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1H-PYRROLE-1- HEPTANOIC ACID HEMI CALCIUM SALT. (ATORVASTATIN)
DE10135493A1 (de) * 2001-07-20 2003-01-30 Jobst Krauskopf Pharmazeutische Zusammensetzung zur Behandlung von Hypercholesterinämie
JP2005500351A (ja) 2001-07-30 2005-01-06 ドクター・レディーズ・ラボラトリーズ・リミテッド 結晶形態ｖｉおよびｖｉｉのアトルバスタチンカルシウム
EP1485343B1 (en) * 2002-03-18 2009-12-23 Biocon Limited Amorphous hmg-coa reductase inhibitors of desired particle size
RU2309141C2 (ru) * 2002-03-18 2007-10-27 Байокон Лимитид АМОРФНЫЕ ИНГИБИТОРЫ ГМГ-КоА-РЕДУКТАЗЫ И СПОСОБ ИХ ПОЛУЧЕНИЯ
ITMI20020907A1 (it) * 2002-04-29 2003-10-29 Chemi Spa Processo di preparazione della forma amorfa del sale di calcio della atorvastatina
WO2003099785A1 (en) * 2002-05-28 2003-12-04 Cadila Healthcare Limited Process for the preparation of amorphous atorvastatin calcium
HU227041B1 (en) * 2003-03-24 2010-05-28 Richter Gedeon Nyrt Process for the synthesis of amorphous atorvastatin calcium
US7790197B2 (en) 2003-06-09 2010-09-07 Warner-Lambert Company Llc Pharmaceutical compositions of atorvastatin
US7655692B2 (en) 2003-06-12 2010-02-02 Pfizer Inc. Process for forming amorphous atorvastatin
US20050271717A1 (en) 2003-06-12 2005-12-08 Alfred Berchielli Pharmaceutical compositions of atorvastatin
CZ298382B6 (cs) * 2004-03-10 2007-09-12 Zentiva, A. S. Zpusob prípravy amorfní formy hemivápenaté soli atorvastatinu a její stabilizace
CA2560252C (en) 2004-03-17 2009-08-04 Ranbaxy Laboratories Limited Process for the production of atorvastatin calcium in amorphous form
JP2007532622A (ja) * 2004-04-16 2007-11-15 ファイザー・プロダクツ・インク 非晶質アトルバスタチン・カルシウムの形成方法
CN1692906A (zh) * 2004-04-30 2005-11-09 鲁南制药集团股份有限公司 治疗高血脂症的组合物
EP3581564A1 (en) 2004-05-05 2019-12-18 Pfizer Products Inc. Diethylamine salt forms of [r-(r*,r*)]-2-(4-fluorophenyl)-beta, delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoic acid
WO2006008091A2 (en) * 2004-07-16 2006-01-26 Lek Pharmaceuticals D.D. Oxidative degradation products of atorvastatin calcium
CA2754932C (en) 2004-07-20 2014-04-01 Warner-Lambert Company Llc Novel forms of [r-(r*,r*)]-2-(4-fluorophenyl)-.beta.,.delta.-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoic acid calcium salt (2:1)
TW200825092A (en) * 2004-09-28 2008-06-16 Teva Pharma A method for reducing the level of AED in atorvastatin calcium sample
KR20090033405A (ko) * 2004-10-18 2009-04-02 테바 파마슈티컬 인더스트리즈 리미티드 알콜 및 케톤 및/또는 에스테르의 혼합물인 유기 용매에 아토르바스타틴 헤미-칼슘 염을 용해시키고 용매를 제거하여 비결정형 아토르바스타틴 헤미-칼슘을 제조하는 방법
MX2007004722A (es) 2004-10-28 2007-06-15 Warner Lambert Co Procedimiento para formar atorvastatina amorfa.
ES2304335T3 (es) 2005-11-21 2010-05-19 Warner-Lambert Company Llc Formas nuevas del acido (r-(r*,r*))-2-(4-fluorofenil)-b,b-dihidroxi-5-(1-metiletil)-3-fenil-4-((fenilamino)carbonil)1h-pirrol-1-heptanoico, de magnesio.
EP1810667A1 (en) 2006-01-20 2007-07-25 KRKA, tovarna zdravil, d.d., Novo mesto Pharmaceutical composition comprising amorphous atorvastatin
KR100833439B1 (ko) * 2007-01-02 2008-05-29 씨제이제일제당 (주) 비결정형 아토르바스타틴 칼슘의 개선된 제조방법
CZ201039A3 (cs) 2010-01-19 2011-07-27 Zentiva, K. S Zpusob prumyslové výroby amorfní formy hemivápenaté soli (3R,5R) 7-[3-fenyl-4-fenylkarbamoyl-2-(4-fluorfenyl)-5-isopropylpyrrol-1-yl]-3,5-dihydroxyheptanové kyseliny (atorvastatinu) s vysokým specifickým povrchem a jeho použití v lékové forme
HUP1000299A2 (hu) 2010-06-08 2012-02-28 Nanoform Cardiovascular Therapeutics Ltd Nanostrukturált Atorvastatint, gyógyszerészetileg elfogadott sóit és kokristályait tartalmazó készítmény és eljárás elõállításukra
CN103274985B (zh) * 2010-12-03 2016-03-09 上海科州药物研发有限公司 一种阿托伐他汀氨基酸盐

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FI94339C (fi) * 1989-07-21 1995-08-25 Warner Lambert Co Menetelmä farmaseuttisesti käyttökelpoisen /R-(R*,R*)/-2-(4-fluorifenyyli)- , -dihydroksi-5-(1-metyylietyyli)-3-fenyyli-4-/(fenyyliamino)karbonyyli/-1H-pyrroli-1-heptaanihapon ja sen farmaseuttisesti hyväksyttävien suolojen valmistamiseksi
ES2072468T3 (es) * 1990-05-11 1995-07-16 American Cyanamid Co Nuevos arilpirroles n-acilados utiles como agentes insecticidas, acaricidas, nematicidas y molusquicidas.
HRP960312B1 (en) * 1995-07-17 2001-10-31 Warner Lambert Co NOVEL PROCESS FOR THE PRODUCTION OF AMORPHOUS /R-(R*, R*)/-2-(4-FLUOROPHENYL)-"beta", "delta"-DIHYDROXY-5-PHENYL-4-/(PHENYLAMINO)CARBONYL/-1H-PYRROLE -1-HEPTANOIC ACID CALCIUM SALT (2 : 1)
SK284973B6 (sk) * 1996-09-20 2006-03-02 Meiji Seika Kaisha Ltd. Kryštalická forma Cefditoren pivoxylu a spôsob jej výroby

Also Published As

Publication number Publication date
HK1050199A1 (en) 2003-06-13
KR20020063166A (ko) 2002-08-01
DE60031882D1 (de) 2006-12-28
HRP20020334A2 (en) 2004-02-29
WO2001028999A1 (en) 2001-04-26
HUP9903634A2 (hu) 2001-12-28
CN1157374C (zh) 2004-07-14
PL354604A1 (en) 2004-01-26
EP1235800A1 (en) 2002-09-04
HUP9903634D0 (en) 1999-12-28
SK286861B6 (sk) 2009-06-05
RS50473B (sr) 2010-03-02
CA2388018A1 (en) 2001-04-26
CA2388018C (en) 2008-04-08
JP2003512354A (ja) 2003-04-02
AU1166301A (en) 2001-04-30
ATE345327T1 (de) 2006-12-15
SK5192002A3 (en) 2002-11-06
KR100664353B1 (ko) 2007-01-02
HU226640B1 (en) 2009-05-28
UA72777C2 (en) 2005-04-15
CN1379760A (zh) 2002-11-13
RU2255932C2 (ru) 2005-07-10
YU28302A (sh) 2005-06-10
HRP20020334B1 (hr) 2007-12-31
HUP9903634A3 (en) 2002-01-28
CZ20021256A3 (cs) 2002-08-14
EP1235800B1 (en) 2006-11-15
CZ300071B6 (cs) 2009-01-21

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Legal Events

Date Code Title Description
8364 No opposition during term of opposition
8339 Ceased/non-payment of the annual fee