DE60034946T2 - Verfahren zur herstellung von amorphem atorvastatin kalzium - Google Patents

Verfahren zur herstellung von amorphem atorvastatin kalzium Download PDF

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Publication number
DE60034946T2
DE60034946T2 DE60034946T DE60034946T DE60034946T2 DE 60034946 T2 DE60034946 T2 DE 60034946T2 DE 60034946 T DE60034946 T DE 60034946T DE 60034946 T DE60034946 T DE 60034946T DE 60034946 T2 DE60034946 T2 DE 60034946T2
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DE
Germany
Prior art keywords
solvent
atorvastatin calcium
amorphous
atorvastatin
tetrahydrofuran
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 - Lifetime
Application number
DE60034946T
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German (de)
English (en)
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DE60034946D1 (de
Inventor
Yatendra Kumar
Rajesh Kumar B-26 THAPER
S. M. Kumar
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Ranbaxy Laboratories Ltd
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Ranbaxy Laboratories Ltd
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Application filed by Ranbaxy Laboratories Ltd filed Critical Ranbaxy Laboratories Ltd
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Publication of DE60034946D1 publication Critical patent/DE60034946D1/de
Publication of DE60034946T2 publication Critical patent/DE60034946T2/de
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D207/00Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D207/02Heterocyclic 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
    • C07D207/30Heterocyclic 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
    • C07D207/34Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (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)
DE60034946T 1999-05-25 2000-01-06 Verfahren zur herstellung von amorphem atorvastatin kalzium Expired - Lifetime DE60034946T2 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
IN775DE1999 IN191236B (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html) 1999-05-25 1999-05-25
INDE077599 1999-05-25
PCT/IB2000/000014 WO2000071116A1 (en) 1999-05-25 2000-01-06 Process for the production of amorphous atorvastatin calcium

Publications (2)

Publication Number Publication Date
DE60034946D1 DE60034946D1 (de) 2007-07-05
DE60034946T2 true DE60034946T2 (de) 2008-01-17

Family

ID=11091180

Family Applications (1)

Application Number Title Priority Date Filing Date
DE60034946T Expired - Lifetime DE60034946T2 (de) 1999-05-25 2000-01-06 Verfahren zur herstellung von amorphem atorvastatin kalzium

Country Status (15)

Country Link
US (2) US6528660B1 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
EP (1) EP1185264B1 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
CN (2) CN1196679C (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
AT (1) ATE362759T1 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
AU (1) AU778962B2 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
BR (1) BR0010923A (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
DE (1) DE60034946T2 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
DK (1) DK1185264T3 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
ES (1) ES2284472T3 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
HK (1) HK1045118A1 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
IN (1) IN191236B (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
MY (1) MY133511A (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
PT (1) PT1185264E (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
WO (1) WO2000071116A1 (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)
ZA (1) ZA200109656B (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html)

Families Citing this family (45)

* 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
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
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
WO2002057228A1 (en) * 2001-01-17 2002-07-25 Biocon India Limited Atorvastatin calcium
SI20814A (sl) * 2001-01-23 2002-08-31 LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. Priprava amorfnega atorvastatina
IN190564B (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html) * 2001-04-11 2003-08-09 Cadila Heathcare Ltd
HUP0400381A2 (hu) * 2001-06-29 2004-09-28 Warner-Lambert Company Llc [R-(R*,R*)]-2-(4fluorfenil)-béta, delta-dihidroxi-5-(1-metiletil)-3-fenil-4-[(fenilamino)karbonil]-1H-pirrol-1-heptánsav 2:1 arányú kalciumsójának (atorvasztatin) kristályos formái
US7563911B2 (en) 2001-08-31 2009-07-21 Morepen Laboratories Ltd. Process for the preparation of amorphous atorvastin calcium salt (2:1)
UA77990C2 (en) * 2001-12-12 2007-02-15 Crystalline calcium salt of (2:1) [r-(r*,r*)]-2-(4-fluorophenyl)-?,?-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrroleheptanic acid
CZ296967B6 (cs) 2002-02-01 2006-08-16 Zentiva, A.S. Zpusob výroby amorfní formy hemivápenaté soli (3R,5R) 7-[3-fenyl-4-fenylkarbamoyl-2-(4-fluorfenyl)-5-isopropylpyrrol-1-yl]-3,5-dihydroxyheptanové kyseliny (atorvastatinu)
ITMI20020907A1 (it) * 2002-04-29 2003-10-29 Chemi Spa Processo di preparazione della forma amorfa del sale di calcio della atorvastatina
AU2002356423A1 (en) * 2002-05-28 2003-12-12 Cadila Healthcare Limited Process for the preparation of amorphous atorvastatin calcium
BRPI0409292A (pt) 2003-04-11 2006-04-11 Lek Pharmaceuticals processo para a preparação de sal de cálcio amorfo de atorvastatina
CN100434133C (zh) * 2003-04-29 2008-11-19 欧加农股份有限公司 反溶剂凝固方法
US7790197B2 (en) 2003-06-09 2010-09-07 Warner-Lambert Company Llc Pharmaceutical compositions of atorvastatin
US20050271717A1 (en) 2003-06-12 2005-12-08 Alfred Berchielli Pharmaceutical compositions of atorvastatin
US7655692B2 (en) 2003-06-12 2010-02-02 Pfizer Inc. Process for forming amorphous atorvastatin
CA2456430A1 (en) * 2004-01-28 2005-07-28 Brantford Chemicals Inc. Improved process for the preparation of amorphous atorvastatin calcium
CZ298382B6 (cs) * 2004-03-10 2007-09-12 Zentiva, A. S. Zpusob prípravy amorfní formy hemivápenaté soli atorvastatinu a její stabilizace
EP1727795B1 (en) 2004-03-17 2012-02-15 Ranbaxy Laboratories Limited Process for the production of atorvastatin calcium in amorphous form
US7241800B2 (en) * 2004-03-17 2007-07-10 Mai De Ltd. Anhydrous amorphous form of fluvastatin sodium
RU2330840C1 (ru) * 2004-04-16 2008-08-10 Пфайзер Продактс Инк. Способ получения аморфного кальций аторвастатина
JP2007536373A (ja) 2004-05-05 2007-12-13 ファイザー・プロダクツ・インク アトルバスタチンの塩形態
HUE029911T2 (en) * 2004-07-16 2017-04-28 Lek Pharmaceuticals Products of atorvastatin calcium oxidative degradation
JP2008506764A (ja) 2004-07-20 2008-03-06 ワーナー−ランバート カンパニー リミテッド ライアビリティー カンパニー [R−(R*,R*)]−2−(4−フルオロフェニル)−β、δ−ジヒドロキシ−5−(1−メチルエチル)−3−フェニル−4−[(フェニルアミノ)カルボニル]−1H−ピロール−1−ヘプタン酸カルシウム塩(2:1)の新規形態
EP1784389A4 (en) 2004-08-27 2009-03-25 Biocon Ltd PROCESS FOR THE PREPARATION OF AMORPHIC ATORVASTATIN CALCIUM
CN101039906A (zh) * 2004-10-18 2007-09-19 特瓦制药工业有限公司 通过将盐溶解于有机溶剂并除去该溶剂来制备无定形阿托伐他汀半钙的方法,所述有机溶剂为醇和酮和 /或酯的混合物
CN101048141A (zh) * 2004-10-28 2007-10-03 沃尼尔·朗伯有限责任公司 形成非晶形的阿托伐他汀的方法
WO2006048888A1 (en) * 2004-11-01 2006-05-11 Jubilant Organosys Limited Novel process for the preparation of amorphous atorvastatin calcium salt
WO2006054308A2 (en) 2004-11-22 2006-05-26 Dexcel Pharma Technologies Ltd. Stable atorvastatin formulations
WO2007052296A2 (en) * 2005-08-23 2007-05-10 Kopran Research Laboratories Ltd A process of preparing amorphous atorvastatin calcium
US20090216029A1 (en) * 2005-09-16 2009-08-27 Yatendra Kumar Process for the production of atorvastatin calcium in amorphous form
CA2547216A1 (en) * 2005-09-21 2007-03-21 Renuka D. Reddy Process for annealing amorphous atorvastatin
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
US20100113802A1 (en) * 2006-11-02 2010-05-06 Cadila Pharmaceuticals Limited Process for preparing amorphous atorvastatin hemi calcium salt and its itermediate
US7834195B2 (en) 2007-01-24 2010-11-16 Apotex Pharmachem Inc. Atorvastatin calcium propylene glycol solvates
JP2010534644A (ja) * 2007-07-27 2010-11-11 シプラ・リミテッド 医薬組成物およびその製造方法
EP2075246A1 (en) 2007-12-27 2009-07-01 M. J. Institute of Research A process for preparation of amorphous form of atorvastatin hemi-calcium salt
CN101684090B (zh) * 2008-09-27 2012-12-05 广东东阳光药业有限公司 一种制备无定形阿托伐他汀钙的方法
US8115015B2 (en) 2009-01-26 2012-02-14 Cadila Healthcare Limited Process for the preparation of amorphous atorvastatin calcium
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
WO2016055934A1 (en) * 2014-10-09 2016-04-14 Glenmark Pharmaceuticals Limited Amorphous form of lomitapide mesylate

Family Cites Families (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
YU44680B (en) * 1982-07-30 1990-12-31 Glaxo Lab Ltd Process for obtaining very pure amorphous form of cephuroxim axetile
US5149837A (en) 1988-02-22 1992-09-22 Warner-Lambert Company Process for trans-6-[2-(substituted-pyrrol-1-yl)alkyl]pyran-2-one inhibitors of cholesterol synthesis
US5245047A (en) 1988-02-22 1993-09-14 Warner-Lambert Company Process for trans-6-[2-(substituted-pyrrol-1-yl)alkyl]pyran-2-one inhibitors of cholesterol synthesis
US5124482A (en) 1988-02-22 1992-06-23 Warner-Lambert Company Process for trans-6-(2-substituted-pyrrol-1-yl)alkyl)pyran-2-one inhibitors of cholesterol synthesis
US5003080A (en) 1988-02-22 1991-03-26 Warner-Lambert Company Process for trans-6-(2-(substituted-pyrrol-1-yl)alkyl)pryan-2-one inhibitors of cholesterol synthesis
US5097045A (en) 1989-02-01 1992-03-17 Warner-Lambert Company Process for trans-6-[2-(substituted-pyrrol-1-yl)alkyl]pyran-2-one inhibitors of cholesterol synthesis
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
US5248793A (en) 1990-10-17 1993-09-28 Warner-Lambert Company Process for the synthesis of (4R-cis)-1,1-dimethylethyl 6-iodomethyl or 6-(phenyl-substituted)sulfonyloxymethyl-2,2-dimethyl-1,3-dioxane-4-acetate
US5103024A (en) 1990-10-17 1992-04-07 Warner-Lambert Company Process for the synthesis of (4r-cis)-1,1-dimethylethyl 6-cyanomethyl-2,2-dimethyl-1,3-dioxane-4-acetate
US5298627A (en) 1993-03-03 1994-03-29 Warner-Lambert Company Process for trans-6-[2-(substituted-pyrrol-1-yl)alkyl]pyran-2-one inhibitors of cholesterol synthesis
WO1997003959A1 (en) * 1995-07-17 1997-02-06 Warner-Lambert Company Crystalline [r-(r*,r*)]-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin)
HRP960313B1 (en) * 1995-07-17 2002-08-31 Warner Lambert Co Form iii crystalline (r- (r*, r*)-2- (4-fluorophenyl) -beta-delta-hydroxy-5-(1-methylethyl) -3-phenyl-4- ((phenylamino) carbonyl -1h-pyrrole-1-heptanoic acid calcium salt (2:1)
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)
SI20425A (sl) * 1999-12-10 2001-06-30 LEK tovarna farmacevtskih in kemi�nih izdelkov d.d. Priprava amorfnega atorvastatina

Also Published As

Publication number Publication date
BR0010923A (pt) 2002-07-16
ZA200109656B (en) 2002-06-27
US6528660B1 (en) 2003-03-04
US20030149279A1 (en) 2003-08-07
AU778962B2 (en) 2004-12-23
EP1185264B1 (en) 2007-05-23
EP1185264A1 (en) 2002-03-13
ES2284472T3 (es) 2007-11-16
HK1045118A1 (zh) 2002-11-15
WO2000071116A1 (en) 2000-11-30
MY133511A (en) 2007-11-30
CN1680315A (zh) 2005-10-12
DK1185264T3 (da) 2007-08-20
DE60034946D1 (de) 2007-07-05
IN191236B (GUID-C5D7CC26-194C-43D0-91A1-9AE8C70A9BFF.html) 2003-10-11
CN1196679C (zh) 2005-04-13
ATE362759T1 (de) 2007-06-15
CN1351493A (zh) 2002-05-29
AU1996700A (en) 2000-12-12
PT1185264E (pt) 2007-07-10

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