WO2005023778A3 - Process for preparation of rosuvastatin calcium - Google Patents

Process for preparation of rosuvastatin calcium Download PDF

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Publication number
WO2005023778A3
WO2005023778A3 PCT/US2004/027530 US2004027530W WO2005023778A3 WO 2005023778 A3 WO2005023778 A3 WO 2005023778A3 US 2004027530 W US2004027530 W US 2004027530W WO 2005023778 A3 WO2005023778 A3 WO 2005023778A3
Authority
WO
WIPO (PCT)
Prior art keywords
rosuvastatin calcium
preparation
impurities
substantially free
present
Prior art date
Application number
PCT/US2004/027530
Other languages
French (fr)
Other versions
WO2005023778A2 (en
Inventor
Valerie Niddam-Hildesheim
Greta Sterimbaum
Original Assignee
Teva Pharma
Valerie Niddam-Hildesheim
Greta Sterimbaum
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 Teva Pharma, Valerie Niddam-Hildesheim, Greta Sterimbaum filed Critical Teva Pharma
Priority to EP04782093A priority Critical patent/EP1562912A2/en
Priority to CA002537271A priority patent/CA2537271A1/en
Publication of WO2005023778A2 publication Critical patent/WO2005023778A2/en
Publication of WO2005023778A3 publication Critical patent/WO2005023778A3/en
Priority to IL173858A priority patent/IL173858A0/en

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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

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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)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)

Abstract

The present invention provides processes for preparing rosuvastatin calcium salt substantially free of impurities on an industrial scale (I).
PCT/US2004/027530 2003-08-28 2004-08-24 Process for preparation of rosuvastatin calcium WO2005023778A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP04782093A EP1562912A2 (en) 2003-08-28 2004-08-24 Process for preparation of rosuvastatin calcium
CA002537271A CA2537271A1 (en) 2003-08-28 2004-08-24 Process for preparation of rosuvastatin calcium
IL173858A IL173858A0 (en) 2003-08-28 2006-02-21 Process for preparation of rosuvastatin calcium

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US49876403P 2003-08-28 2003-08-28
US60/498,764 2003-08-28
US53467804P 2004-01-06 2004-01-06
US60/534,678 2004-01-06

Publications (2)

Publication Number Publication Date
WO2005023778A2 WO2005023778A2 (en) 2005-03-17
WO2005023778A3 true WO2005023778A3 (en) 2005-06-16

Family

ID=34278611

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2004/027530 WO2005023778A2 (en) 2003-08-28 2004-08-24 Process for preparation of rosuvastatin calcium

Country Status (6)

Country Link
US (1) US7396927B2 (en)
EP (1) EP1562912A2 (en)
CA (2) CA2657076A1 (en)
IL (1) IL173858A0 (en)
TW (2) TW200518756A (en)
WO (1) WO2005023778A2 (en)

Families Citing this family (33)

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GB0218781D0 (en) 2002-08-13 2002-09-18 Astrazeneca Ab Chemical process
GB0312896D0 (en) 2003-06-05 2003-07-09 Astrazeneca Ab Chemical process
CA2657076A1 (en) 2003-08-28 2005-03-17 Teva Pharmaceutical Industries Ltd. Process for the preparation of rosuvastatin calcium
GB0324791D0 (en) 2003-10-24 2003-11-26 Astrazeneca Ab Chemical process
CA2546701C (en) * 2003-11-24 2010-07-27 Teva Pharmaceutical Industries Ltd. Crystalline ammonium salts of rosuvastatin
US7851624B2 (en) 2003-12-24 2010-12-14 Teva Pharamaceutical Industries Ltd. Triol form of rosuvastatin and synthesis of rosuvastatin
US20070179166A1 (en) * 2003-12-24 2007-08-02 Valerie Niddam-Hildesheim Process for preparation of statins with high syn to anti ratio
CA2576196A1 (en) 2004-08-06 2006-02-16 Transform Pharmaceuticals, Inc. Novel statin pharmaceutical compositions and related methods of treatment
TWI353981B (en) * 2005-02-22 2011-12-11 Teva Pharma Preparation of rosuvastatin
SI1915349T1 (en) 2005-06-24 2016-05-31 Lek Pharmaceuticals D.D. Process for preparing pure amorphous rosuvastatin calcium
JP5146965B2 (en) * 2005-06-24 2013-02-20 レツク・フアーマシユーテイカルズ・デー・デー Method for preparing amorphous rosuvastatin calcium free of impurities
CZ299215B6 (en) * 2005-06-29 2008-05-21 Zentiva, A. S. Process for preparing hemi-calcium salt of rosuvastatin, i.e. (E)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl](3R,5S)-3,5-dihydroxy-6-heptenoic acid
US20070099994A1 (en) * 2005-08-16 2007-05-03 Valerie Niddam-Hildesheim Rosuvastatin calcium with a low salt content
US7868169B2 (en) 2005-08-16 2011-01-11 Teva Pharmaceutical Industries, Ltd. Crystalline rosuvastatin intermediate
KR20090113920A (en) * 2005-10-03 2009-11-02 테바 파마슈티컬 인더스트리즈 리미티드 Diastereomeric purification of rosuvastatin
US7351853B2 (en) * 2006-01-23 2008-04-01 Albion Advanced Nutrition Method of manufacturing a granular mineral composition
WO2007099561A1 (en) * 2006-02-27 2007-09-07 Cadila Healthcare Limited Process for preparing rosuvastatin calcium
WO2007125547A2 (en) * 2006-05-03 2007-11-08 Manne Satyanarayana Reddy Novel process for statins and its pharmaceutically acceptable salts thereof
EP1948618A1 (en) * 2006-09-18 2008-07-30 Teva Pharmaceutical Industries Ltd. Crystalline rosuvastatin calcium
HUE028475T2 (en) 2006-10-09 2016-12-28 Msn Laboratories Private Ltd Novel process for the preparation of statins and their pharmaceutically acceptable salts thereof
WO2008053334A2 (en) * 2006-10-31 2008-05-08 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
EP2178890A1 (en) * 2007-07-12 2010-04-28 Teva Pharmaceutical Industries Ltd. Purification of rosuvastatin intermediate by thin film evaporation and chemical method
WO2009143776A1 (en) 2008-05-27 2009-12-03 常州制药厂有限公司 Preparation method of rosuvastatin calcium and its intermediates
CN102317267A (en) * 2009-01-15 2012-01-11 埃吉斯药物股份公开有限公司 Process for the preparation of rosuvastatin salts
US8487105B2 (en) 2009-01-19 2013-07-16 Msn Laboratories Limited Process for preparing pitavastatin, intermediates and pharmaceuctically 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 (en) 2010-11-29 2019-08-28 Egis Gyógyszergyár Nyrt. Process for the preparation of pharmaceutical intermediates with high purity
WO2012143308A1 (en) 2011-04-18 2012-10-26 Basf Se Multicomponent crystalline system of rosuvastatin calcium salt and vanillin
MX368148B (en) * 2013-03-14 2019-09-20 Boryung Pharm Pharmaceutical combination drug.
US9850213B2 (en) * 2013-11-25 2017-12-26 Jiangxi Boya Seehot Pharmaceutical Co., Ltd. Method for preparing rosuvastatin sodium
CN104788387A (en) * 2015-04-17 2015-07-22 浙江海森药业有限公司 Preparation method for high-purity rosuvastatin calcium
CN109580789B (en) * 2017-09-28 2021-06-22 安徽省庆云医药股份有限公司 Method for separating and measuring rosuvastatin tert-butyl ester and optical isomer thereof by liquid chromatography

Citations (2)

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Publication number Priority date Publication date Assignee Title
WO2003016317A1 (en) * 2001-08-16 2003-02-27 Teva Pharmaceutical Industries Ltd. 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

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US4739073A (en) * 1983-11-04 1988-04-19 Sandoz Pharmaceuticals Corp. Intermediates in the synthesis of indole analogs of mevalonolactone and derivatives thereof
NO177005C (en) * 1988-01-20 1995-07-05 Bayer Ag Analogous process for the preparation of substituted pyridines, as well as intermediates for use in the preparation
US5177080A (en) * 1990-12-14 1993-01-05 Bayer Aktiengesellschaft Substituted pyridyl-dihydroxy-heptenoic acid and its salts
JP3233403B2 (en) * 1991-06-19 2001-11-26 塩野義製薬株式会社 Optically active intermediate and method for producing the same
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CA2657076A1 (en) 2003-08-28 2005-03-17 Teva Pharmaceutical Industries Ltd. Process for the preparation of rosuvastatin calcium
CA2546701C (en) * 2003-11-24 2010-07-27 Teva Pharmaceutical Industries Ltd. Crystalline ammonium salts of rosuvastatin
EP1797046A2 (en) 2004-09-27 2007-06-20 Ranbaxy Laboratories Limited Novel processes for preparing amorphous rosuvastatin calcium and a novel polymorphic form of rosuvastatin sodium
CA2594692A1 (en) 2005-01-31 2006-08-03 Ciba Specialty Chemicals Holding Inc. Crystalline forms of rosuvastatin calcium salt
EP1863773A1 (en) 2005-03-22 2007-12-12 Unichem Laboratories Limited Process for preparation of rosuvastatin
EP1869005A1 (en) 2005-04-04 2007-12-26 Unichem Laboratories Limited Process for preparation of calcium salt of rosuvastatin
SI1915349T1 (en) 2005-06-24 2016-05-31 Lek Pharmaceuticals D.D. Process for preparing pure amorphous rosuvastatin calcium
JP5146965B2 (en) 2005-06-24 2013-02-20 レツク・フアーマシユーテイカルズ・デー・デー Method for preparing amorphous rosuvastatin calcium free of impurities
GB0514078D0 (en) 2005-07-08 2005-08-17 Astrazeneca Uk Ltd Chemical process

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2003016317A1 (en) * 2001-08-16 2003-02-27 Teva Pharmaceutical Industries Ltd. 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

Non-Patent Citations (1)

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Title
WATANABE M ET AL: "SYNTHESIS AND BIOLOGICAL ANTIVITY OF METHANESULFONAMIDE PYRIMIDINE-AND N-METHANESULFONYL PYRROLE-SUBSTITUTED 3,5-DIHYDROXY-6-HEPTENOATES, A NOVEL SERIES OF HMG-COA REDUCTASE INHIBITORS", BIOORGANIC & MEDICINAL CHEMISTRY, ELSEVIER SCIENCE LTD, GB, vol. 5, no. 2, 1997, pages 437 - 444, XP000882043, ISSN: 0968-0896 *

Also Published As

Publication number Publication date
TW200518756A (en) 2005-06-16
IL173858A0 (en) 2006-07-05
TW200920374A (en) 2009-05-16
EP1562912A2 (en) 2005-08-17
WO2005023778A2 (en) 2005-03-17
CA2657076A1 (en) 2005-03-17
US7396927B2 (en) 2008-07-08
CA2537271A1 (en) 2005-03-17
US20050080134A1 (en) 2005-04-14

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