AU2006261087B2 - Process for preparing amorphous rosuvastatin calcium free of impurities - Google Patents

Process for preparing amorphous rosuvastatin calcium free of impurities Download PDF

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Publication number
AU2006261087B2
AU2006261087B2 AU2006261087A AU2006261087A AU2006261087B2 AU 2006261087 B2 AU2006261087 B2 AU 2006261087B2 AU 2006261087 A AU2006261087 A AU 2006261087A AU 2006261087 A AU2006261087 A AU 2006261087A AU 2006261087 B2 AU2006261087 B2 AU 2006261087B2
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AU
Australia
Prior art keywords
rosuvastatin
calcium
salt
process according
group
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.)
Ceased
Application number
AU2006261087A
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English (en)
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AU2006261087A1 (en
Inventor
Zdenko Casar
Marko Zlicar
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.)
Lek Pharmaceuticals dd
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Lek Pharmaceuticals dd
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 date
Application filed by Lek Pharmaceuticals dd filed Critical Lek Pharmaceuticals dd
Publication of AU2006261087A1 publication Critical patent/AU2006261087A1/en
Application granted granted Critical
Publication of AU2006261087B2 publication Critical patent/AU2006261087B2/en
Ceased legal-status Critical Current
Anticipated expiration legal-status Critical

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D239/00—Heterocyclic compounds containing 1,3-diazine or hydrogenated 1,3-diazine rings
    • C07D239/02—Heterocyclic compounds containing 1,3-diazine or hydrogenated 1,3-diazine rings not condensed with other rings
    • C07D239/24—Heterocyclic compounds containing 1,3-diazine or hydrogenated 1,3-diazine rings not condensed with other rings having three or more double bonds between ring members or between ring members and non-ring members
    • C07D239/28—Heterocyclic compounds containing 1,3-diazine or hydrogenated 1,3-diazine rings not condensed with other rings having three or more 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, directly attached to ring carbon atoms
    • C07D239/32—One oxygen, sulfur or nitrogen atom
    • C07D239/42—One nitrogen atom
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/10—Drugs for disorders of the cardiovascular system for treating ischaemic or atherosclerotic diseases, e.g. antianginal drugs, coronary vasodilators, drugs for myocardial infarction, retinopathy, cerebrovascula insufficiency, renal arteriosclerosis

Landscapes

  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
AU2006261087A 2005-06-24 2006-06-22 Process for preparing amorphous rosuvastatin calcium free of impurities Ceased AU2006261087B2 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SI200500188 2005-06-24
SIP200500188 2005-06-24
PCT/EP2006/006007 WO2006136407A1 (en) 2005-06-24 2006-06-22 Process for preparing amorphous rosuvastatin calcium free of impurities

Publications (2)

Publication Number Publication Date
AU2006261087A1 AU2006261087A1 (en) 2006-12-28
AU2006261087B2 true AU2006261087B2 (en) 2010-09-30

Family

ID=37038337

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2006261087A Ceased AU2006261087B2 (en) 2005-06-24 2006-06-22 Process for preparing amorphous rosuvastatin calcium free of impurities

Country Status (8)

Country Link
US (1) US9150518B2 (https=)
EP (2) EP1912952B1 (https=)
JP (1) JP5146965B2 (https=)
CN (2) CN102807530B (https=)
AU (1) AU2006261087B2 (https=)
CA (1) CA2612587C (https=)
IL (1) IL187483A (https=)
WO (1) WO2006136407A1 (https=)

Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CA2537271A1 (en) 2003-08-28 2005-03-17 Teva Pharmaceutical Industries, Ltd. Process for preparation of rosuvastatin calcium
CA2546701C (en) 2003-11-24 2010-07-27 Teva Pharmaceutical Industries Ltd. Crystalline ammonium salts of rosuvastatin
CN1894221B (zh) 2003-12-02 2012-08-08 特瓦制药工业有限公司 用于表征罗苏伐他汀的参照标准品
US7612203B2 (en) 2005-02-22 2009-11-03 Teva Pharmaceutical Industries Ltd. Rosuvastatin and salts thereof free of rosuvastatin alkylether and a process for the preparation thereof
KR20070062996A (ko) 2005-08-16 2007-06-18 테바 파마슈티컬 인더스트리즈 리미티드 결정성 로수바스타틴 중간체
EP2024341B1 (en) 2006-05-03 2015-12-02 MSN Laboratories Private Limited Novel process for statins and its pharmaceutically acceptable salts thereof
US8404841B2 (en) 2006-10-09 2013-03-26 Msn Laboratories Limited Process for the preparation of statins and their pharmaceutically acceptable salts thereof
US8318933B2 (en) * 2006-10-31 2012-11-27 Aurobindo Pharma Ltd Process for preparing rosuvastatin calcium
WO2008096257A1 (en) 2007-02-08 2008-08-14 Aurobindo Pharma Limited An improved process for preparation of rosuvastatin calcium
JP2010501643A (ja) 2007-07-12 2010-01-21 テバ ファーマシューティカル インダストリーズ リミティド 薄膜蒸発及び化学的手法によるロスバスタチン中間体の精製
EP2138165A1 (en) 2008-06-27 2009-12-30 KRKA, tovarna zdravil, d.d., Novo mesto Pharmaceutical composition comprising a statin
SI2309992T1 (en) 2008-06-27 2018-03-30 Krka, Tovarna Zdravil, D.D., Novo Mesto A pharmaceutical composition comprising a statin
PL2387566T3 (pl) * 2009-01-14 2014-10-31 Krka Tovarna Zdravil D D Novo Mesto Sposób przygotowania rosuwastatyny
EP2389365A1 (en) * 2009-01-15 2011-11-30 Egis Gyógyszergyár Nyilvánosan Müködö Process for the preparation of rosuvastatin salts
WO2010089770A2 (en) 2009-01-19 2010-08-12 Msn Laboratories Limited Improved process for the preparation of highly pure (3r,5s)-7-[2-cyclopropyl-4-(4-fluorophenyl) quinolin-3-yl]-3,5-dihydroxy-6(e)-heptenoic acid and pharmaceutically acceptable salts thereof
EP2336116A1 (en) * 2009-12-16 2011-06-22 LEK Pharmaceuticals d.d. Process for the preparation of key intermediates for the synthesis of rosuvastatin or pharmaceutically acceptable salts thereof
US8987444B2 (en) 2010-01-18 2015-03-24 Msn Laboratories Private Limited Process for the preparation of amide intermediates and their use thereof
HU230987B1 (hu) 2010-11-29 2019-08-28 Egis Gyógyszergyár Nyrt. Eljárás nagy tisztaságú gyógyszeripari intermedierek előállítására
WO2012073256A1 (en) 2010-11-29 2012-06-07 Cadila Healthcare Limited Salts of rosuvastatin
HU229260B1 (en) * 2010-11-29 2013-10-28 Egis Gyogyszergyar Nyrt Process for preparation of rosuvastatin salts
WO2012176218A1 (en) * 2011-06-24 2012-12-27 Ind-Swift Laboratories Limited Process for preparing rosuvastatin calcium through novel amine salt
CZ306425B6 (cs) * 2012-05-16 2017-01-18 Zentiva, K.S. Způsob přípravy vápenaté soli pitavastatinu
EP2978744A1 (en) 2013-03-29 2016-02-03 DSM Sinochem Pharmaceuticals Netherlands B.V. Amine salts of pitavastatin and rosuvastatin
EP2978743B1 (en) * 2013-03-29 2019-11-27 Centrient Pharmaceuticals Netherlands B.V. Amine salts of pravastatin and rosuvastatin
RO129060B1 (ro) 2013-04-25 2014-11-28 Antibiotice S.A. Compoziţie farmaceutică stabilă cu rosuvastatină calcică amorfă
EP3103878A4 (en) 2014-02-06 2017-08-16 API Corporation Rosuvastatin calcium and process for producing intermediate thereof
KR101660249B1 (ko) * 2014-07-11 2016-09-28 주식회사 경보제약 고순도 로수바스타틴 칼슘염의 제조 방법
KR102060318B1 (ko) * 2019-03-26 2019-12-30 (주)헥사파마텍 신규의 중간체, 이의 제조방법, 및 이를 이용한 로수바스타틴 칼슘염의 제조방법

Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0521471A1 (en) * 1991-07-01 1993-01-07 Shionogi Seiyaku Kabushiki Kaisha Pyrimidine derivatives as HMG-CoA reductase inhibitors
WO2001060804A1 (en) * 2000-02-15 2001-08-23 Astrazeneca Ab Crystalline salts of 7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-(3r,5s)-3,5-dihydroxyhept-6-enoic acid
US20030114685A1 (en) * 2001-08-16 2003-06-19 Valerie Niddam-Hildesheim Processes for preparing calcium salt forms of statins
WO2003097614A2 (en) * 2002-05-21 2003-11-27 Ranbaxy Laboratories Limited Process for the preparation of rosuvastatin
WO2004014872A1 (en) * 2002-08-13 2004-02-19 Astrazeneca Uk Limited Process for preparing the calcium salt of rosuvastatin
WO2004052867A1 (en) * 2002-12-10 2004-06-24 Ranbaxy Laboratories Limited Process for the preparation of rosuvastatin
WO2005023778A2 (en) * 2003-08-28 2005-03-17 Teva Pharmaceutical Industries Ltd. Process for preparation of rosuvastatin calcium
WO2005040134A1 (en) * 2003-10-22 2005-05-06 Ranbaxy Laboratories Limited Process for the preparation of amorphous rosuvastatin calcium
WO2005042522A1 (en) * 2003-10-24 2005-05-12 Astrazeneca Uk Limited Process for the manufacture of the calcium salt of rosuvatatin (e)-7-`4- (4-fluorophenyl) -6-isopropyl-2-`methyl (methylsulfonyl) amino ! pyrimidin -5-yl ! (3r, 5s) -3, 5-dihydroxyhept-6-enoic acid and crystalline intermediates thereof
WO2005051921A1 (en) * 2003-11-24 2005-06-09 Teva Pharmaceutical Industries Ltd. Crystalline ammonium salts of rosuvastatin
WO2005054207A1 (en) * 2003-12-04 2005-06-16 Glenmark Pharmaceuticals Limited Process for the preparation of pyrimidine derivatives
WO2005077917A1 (en) * 2004-01-19 2005-08-25 Ranbaxy Laboratories Limited Amorphous salts of rosuvastatin
WO2005077916A1 (en) * 2004-01-19 2005-08-25 Ranbaxy Laboratories Limited Salts of hmg-coa reductase inhibitors and use thereof
WO2005092867A2 (en) * 2004-03-26 2005-10-06 Avecia Pharmaceuticals Limited Process and intermediate compounds useful in the preparation of statins, particularly rosuvastatin

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5312914A (en) * 1987-02-17 1994-05-17 Ciba-Geigy Corp Process for the manufacture of 4-acetoxy-3-hydroxyethyl-azetidinone
GB9900339D0 (en) 1999-01-09 1999-02-24 Zeneca Ltd Chemical compounds
GB9903472D0 (en) * 1999-02-17 1999-04-07 Zeneca Ltd Chemical process
US7199144B2 (en) * 2003-04-21 2007-04-03 Teva Pharmaceuticals Industries, Ltd. Process for the preparation of valsartan and intermediates thereof
CZ200486A3 (cs) * 2004-01-16 2005-08-17 Zentiva, A.S. Způsob výroby hemivápenaté soli (E)-7-[4-(4-fluorfenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxy-6-heptenové kyseliny
WO2006136408A2 (en) * 2005-06-24 2006-12-28 Lek Pharmaceuticals D.D. Process for preparing pure amorphous rosuvastatin calcium

Patent Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0521471A1 (en) * 1991-07-01 1993-01-07 Shionogi Seiyaku Kabushiki Kaisha Pyrimidine derivatives as HMG-CoA reductase inhibitors
WO2001060804A1 (en) * 2000-02-15 2001-08-23 Astrazeneca Ab Crystalline salts of 7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl]-(3r,5s)-3,5-dihydroxyhept-6-enoic acid
US20030114685A1 (en) * 2001-08-16 2003-06-19 Valerie Niddam-Hildesheim Processes for preparing calcium salt forms of statins
WO2003097614A2 (en) * 2002-05-21 2003-11-27 Ranbaxy Laboratories Limited Process for the preparation of rosuvastatin
WO2004014872A1 (en) * 2002-08-13 2004-02-19 Astrazeneca Uk Limited Process for preparing the calcium salt of rosuvastatin
WO2004052867A1 (en) * 2002-12-10 2004-06-24 Ranbaxy Laboratories Limited Process for the preparation of rosuvastatin
WO2005023778A2 (en) * 2003-08-28 2005-03-17 Teva Pharmaceutical Industries Ltd. Process for preparation of rosuvastatin calcium
WO2005040134A1 (en) * 2003-10-22 2005-05-06 Ranbaxy Laboratories Limited Process for the preparation of amorphous rosuvastatin calcium
WO2005042522A1 (en) * 2003-10-24 2005-05-12 Astrazeneca Uk Limited Process for the manufacture of the calcium salt of rosuvatatin (e)-7-`4- (4-fluorophenyl) -6-isopropyl-2-`methyl (methylsulfonyl) amino ! pyrimidin -5-yl ! (3r, 5s) -3, 5-dihydroxyhept-6-enoic acid and crystalline intermediates thereof
WO2005051921A1 (en) * 2003-11-24 2005-06-09 Teva Pharmaceutical Industries Ltd. Crystalline ammonium salts of rosuvastatin
WO2005054207A1 (en) * 2003-12-04 2005-06-16 Glenmark Pharmaceuticals Limited Process for the preparation of pyrimidine derivatives
WO2005077917A1 (en) * 2004-01-19 2005-08-25 Ranbaxy Laboratories Limited Amorphous salts of rosuvastatin
WO2005077916A1 (en) * 2004-01-19 2005-08-25 Ranbaxy Laboratories Limited Salts of hmg-coa reductase inhibitors and use thereof
WO2005092867A2 (en) * 2004-03-26 2005-10-06 Avecia Pharmaceuticals Limited Process and intermediate compounds useful in the preparation of statins, particularly rosuvastatin

Also Published As

Publication number Publication date
CA2612587A1 (en) 2006-12-28
IL187483A (en) 2014-08-31
CN101208307B (zh) 2012-10-17
CA2612587C (en) 2013-02-19
EP1912952B1 (en) 2014-10-15
WO2006136407A1 (en) 2006-12-28
AU2006261087A1 (en) 2006-12-28
JP2008546730A (ja) 2008-12-25
CN101208307A (zh) 2008-06-25
EP2508514A1 (en) 2012-10-10
IL187483A0 (en) 2008-02-09
JP5146965B2 (ja) 2013-02-20
US9150518B2 (en) 2015-10-06
EP2508514B1 (en) 2017-10-18
CN102807530B (zh) 2015-08-05
CN102807530A (zh) 2012-12-05
EP1912952A1 (en) 2008-04-23
US20090111839A1 (en) 2009-04-30

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Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)
MK14 Patent ceased section 143(a) (annual fees not paid) or expired