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
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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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Obesity (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 (enExample)
EP (2) EP2508514B1 (enExample)
JP (1) JP5146965B2 (enExample)
CN (2) CN102807530B (enExample)
AU (1) AU2006261087B2 (enExample)
CA (1) CA2612587C (enExample)
IL (1) IL187483A (enExample)
WO (1) WO2006136407A1 (enExample)

Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1562912A2 (en) 2003-08-28 2005-08-17 Teva Pharmaceutical Industries Limited Process for preparation of rosuvastatin calcium
TW200526596A (en) 2003-11-24 2005-08-16 Teva Pharma Crystalline ammonium salts of rosuvastatin
CA2546894C (en) 2003-12-02 2009-09-08 Teva Pharmaceutical Industries Ltd. Reference standard for characterization of rosuvastatin
JP2008526781A (ja) 2005-02-22 2008-07-24 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 ロスバスタチンの製造
KR20070062996A (ko) 2005-08-16 2007-06-18 테바 파마슈티컬 인더스트리즈 리미티드 결정성 로수바스타틴 중간체
WO2007125547A2 (en) * 2006-05-03 2007-11-08 Manne Satyanarayana Reddy Novel process for statins and its pharmaceutically acceptable salts thereof
SI2086945T1 (sl) 2006-10-09 2016-05-31 Msn Laboratories Private Limited Novi postopek za pripravo statinov in njihovih farmacevtsko sprejemljivih soli
EP2079712A2 (en) * 2006-10-31 2009-07-22 Aurobindo Pharma Limited An improved process for preparing rosuvastatin calcium
EP2125754B1 (en) 2007-02-08 2012-04-11 Aurobindo Pharma Limited Process for preparation of rosuvastatin calcium
US20090069563A1 (en) 2007-07-12 2009-03-12 Valerie Niddam-Hildesheim Rosuvastatin intermediates and their preparation
HRP20180077T1 (hr) 2008-06-27 2018-02-23 Krka, Tovarna Zdravil D.D., Novo Mesto Farmaceutski sastav koji sadrži statin
EP2138165A1 (en) 2008-06-27 2009-12-30 KRKA, tovarna zdravil, d.d., Novo mesto Pharmaceutical composition comprising a statin
SI2752407T1 (sl) * 2009-01-14 2016-07-29 Krka, Tovarna Zdravil, D.D., Novo Mesto Kristalni kalcijev rosuvastatin trihidrat
BRPI1005147A2 (pt) 2009-01-15 2019-09-24 Egis Gyogyszergyar Nyilvanosan Muekoedoe Reszvenytarsasag processo de preparação de sais de rosuvastatina
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
WO2011086584A2 (en) 2010-01-18 2011-07-21 Msn Laboratories Limited Improved 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
US9630906B2 (en) 2013-03-29 2017-04-25 Dsm Sinochem Pharmaceuticals Netherlands B.V. Amine salts of pitavastatin and rosuvastatin
US9676729B2 (en) 2013-03-29 2017-06-13 Dsm Sinochem Pharmaceuticals Netherlands B.V. Amine salts of pitavastatin and rosuvastatin
RO129060B1 (ro) 2013-04-25 2014-11-28 Antibiotice S.A. Compoziţie farmaceutică stabilă cu rosuvastatină calcică amorfă
US9695130B2 (en) 2014-02-06 2017-07-04 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
WO2005077916A1 (en) * 2004-01-19 2005-08-25 Ranbaxy Laboratories Limited Salts of hmg-coa reductase inhibitors and use thereof
WO2005077917A1 (en) * 2004-01-19 2005-08-25 Ranbaxy Laboratories Limited Amorphous salts of rosuvastatin
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
JP5416403B2 (ja) * 2005-06-24 2014-02-12 レツク・フアーマシユーテイカルズ・デー・デー 純粋な非結晶ロスバスタチンカルシウムの調製方法

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
WO2005077916A1 (en) * 2004-01-19 2005-08-25 Ranbaxy Laboratories Limited Salts of hmg-coa reductase inhibitors and use thereof
WO2005077917A1 (en) * 2004-01-19 2005-08-25 Ranbaxy Laboratories Limited Amorphous salts of rosuvastatin
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
CA2612587C (en) 2013-02-19
JP5146965B2 (ja) 2013-02-20
US20090111839A1 (en) 2009-04-30
IL187483A0 (en) 2008-02-09
WO2006136407A1 (en) 2006-12-28
CN102807530B (zh) 2015-08-05
EP2508514B1 (en) 2017-10-18
EP1912952A1 (en) 2008-04-23
EP2508514A1 (en) 2012-10-10
CA2612587A1 (en) 2006-12-28
IL187483A (en) 2014-08-31
CN101208307B (zh) 2012-10-17
JP2008546730A (ja) 2008-12-25
CN101208307A (zh) 2008-06-25
CN102807530A (zh) 2012-12-05
AU2006261087A1 (en) 2006-12-28
US9150518B2 (en) 2015-10-06
EP1912952B1 (en) 2014-10-15

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Legal Events

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