ES2564807T3 - Proceso para preparación de rosuvastatina de calcio amorfa pura - Google Patents

Proceso para preparación de rosuvastatina de calcio amorfa pura Download PDF

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Publication number
ES2564807T3
ES2564807T3 ES06754502.0T ES06754502T ES2564807T3 ES 2564807 T3 ES2564807 T3 ES 2564807T3 ES 06754502 T ES06754502 T ES 06754502T ES 2564807 T3 ES2564807 T3 ES 2564807T3
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ES
Spain
Prior art keywords
rosuvastatin
calcium
amorphous calcium
preparation
pure amorphous
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.)
Active
Application number
ES06754502.0T
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English (en)
Other versions
ES2564807T5 (es
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
Original Assignee
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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Application filed by Lek Pharmaceuticals dd filed Critical Lek Pharmaceuticals dd
Publication of ES2564807T3 publication Critical patent/ES2564807T3/es
Application granted granted Critical
Publication of ES2564807T5 publication Critical patent/ES2564807T5/es
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
    • 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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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Cardiology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

Un proceso para producir rosuvastatina de calcio amorfa, que incluye: a) hidrólisis de un alquil éster C1 a C5 de rosuvastatina con hidróxido de sodio en presencia de tetrahidrofurano o con una base en presencia de una mezcla de tetrahidrofurano y agua, para obtener una solución de rosuvastatina de sodio, b) conversión de la rosuvastatina de sodio así obtenida, con una fuente de calcio para obtener rosuvastatina de calcio, c) proceso de nueva digestión en agua de la rosuvastatina de calcio obtenida, d) agitación de la rosuvastatina de calcio obtenida, y e) aislamiento de rosuvastatina de calcio amorfa.

Description

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Claims (1)

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ES06754502T 2005-06-24 2006-06-22 Proceso para preparación de rosuvastatina de calcio amorfa pura Active ES2564807T5 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
SI200500187 2005-06-24
SI200500187 2005-06-24
PCT/EP2006/006008 WO2006136408A2 (en) 2005-06-24 2006-06-22 Process for preparing pure amorphous rosuvastatin calcium

Publications (2)

Publication Number Publication Date
ES2564807T3 true ES2564807T3 (es) 2016-03-29
ES2564807T5 ES2564807T5 (es) 2019-02-26

Family

ID=37440674

Family Applications (1)

Application Number Title Priority Date Filing Date
ES06754502T Active ES2564807T5 (es) 2005-06-24 2006-06-22 Proceso para preparación de rosuvastatina de calcio amorfa pura

Country Status (12)

Country Link
US (1) US8207333B2 (es)
EP (1) EP1915349B2 (es)
JP (1) JP5416403B2 (es)
CN (1) CN101203496B (es)
AU (1) AU2006261088B2 (es)
CA (1) CA2611920C (es)
ES (1) ES2564807T5 (es)
HU (1) HUE027012T2 (es)
IL (1) IL187578A0 (es)
PL (1) PL1915349T5 (es)
SI (1) SI1915349T1 (es)
WO (1) WO2006136408A2 (es)

Families Citing this family (28)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2870593B2 (ja) 1997-02-03 1999-03-17 日本電気株式会社 焦点誤差検出器
CA2537271A1 (en) 2003-08-28 2005-03-17 Teva Pharmaceutical Industries, Ltd. Process for preparation of rosuvastatin calcium
WO2005051921A1 (en) 2003-11-24 2005-06-09 Teva Pharmaceutical Industries Ltd. Crystalline ammonium salts of rosuvastatin
KR100887264B1 (ko) 2003-12-02 2009-03-06 테바 파마슈티컬 인더스트리즈 리미티드 로수바스타틴의 특성화를 위한 기준 표준물
CA2683975A1 (en) 2005-02-22 2006-08-31 Teva Pharmaceutical Industries Ltd. Rosuvastatin and salts thereof free of rosuvastatin alkylether and a process for the preparation thereof
EP2508514B1 (en) * 2005-06-24 2017-10-18 LEK Pharmaceuticals d.d. Process for preparing amorphous rosuvastatin calcium free of impurities
US7868169B2 (en) 2005-08-16 2011-01-11 Teva Pharmaceutical Industries, Ltd. Crystalline rosuvastatin intermediate
JP2008539278A (ja) 2006-09-18 2008-11-13 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 結晶性ロスバスタチンカルシウム
WO2008053334A2 (en) * 2006-10-31 2008-05-08 Aurobindo Pharma Limited An improved process for preparing rosuvastatin calcium
CA2677809A1 (en) * 2007-02-08 2008-08-14 Aurobindo Pharma Limited An improved process for preparation of rosuvastatin calcium
US20090069563A1 (en) 2007-07-12 2009-03-12 Valerie Niddam-Hildesheim Rosuvastatin intermediates and their preparation
EP2298745B1 (en) 2008-05-27 2014-09-03 Changzhou Pharmaceutical Factory Preparation method of rosuvastatin calcium and its intermediates
WO2010035284A2 (en) * 2008-09-26 2010-04-01 Matrix Laboratories Ltd An improved process for the preparation of rosuvastatin calcium
CN102282136B (zh) * 2009-01-14 2014-12-17 新梅斯托克尔卡·托瓦纳·兹德拉维尔公司 制备罗苏伐他汀的方法
BRPI1005147A2 (pt) * 2009-01-15 2019-09-24 Egis Gyogyszergyar Nyilvanosan Muekoedoe Reszvenytarsasag processo de preparação de sais de rosuvastatina
US8846915B2 (en) 2009-08-17 2014-09-30 Aurobindo Pharma Ltd. Process for the manufacture of rosuvastatin calcium using crystalline rosuvastatin ethyl ester
HU230987B1 (hu) 2010-11-29 2019-08-28 Egis Gyógyszergyár Nyrt. Eljárás nagy tisztaságú gyógyszeripari intermedierek előállítására
FR2970178B1 (fr) * 2011-01-07 2014-06-20 Liliane Therese Jacquot Promedicaments pour une delivrance specifique au niveau du foie et une meilleure tolerance
CN102070537B (zh) * 2011-01-28 2012-01-11 海南美大制药有限公司 一种瑞舒伐他汀钙化合物及其新制法
WO2013046222A2 (en) * 2011-08-10 2013-04-04 Glenmark Generics Limited A process for the preparation of amorphous rosuvastatin calcium
CN103709107B (zh) * 2012-09-29 2016-04-20 安徽省庆云医药化工有限公司 瑞舒伐他汀甲酯的新晶型及其制备方法
CN104370827B (zh) * 2013-08-13 2016-09-07 天津汉瑞药业有限公司 瑞舒伐他汀钙化合物
JP6596339B2 (ja) * 2014-02-06 2019-10-23 株式会社エーピーアイ コーポレーション ロスバスタチンカルシウム及びその中間体の製造方法
US10449210B2 (en) 2014-02-13 2019-10-22 Ligand Pharmaceuticals Inc. Prodrug compounds and their uses
CN111788196A (zh) * 2018-01-09 2020-10-16 配体药物公司 缩醛化合物及其治疗用途
CN108398501A (zh) * 2018-03-02 2018-08-14 海南通用三洋药业有限公司 一种检测瑞舒伐他汀钙有关物质的方法
CN108675931A (zh) * 2018-05-18 2018-10-19 合肥合源药业有限公司 一种低钡他汀钙及其制备方法
CN111170950A (zh) * 2020-01-16 2020-05-19 河南豫辰药业股份有限公司 一种瑞舒伐他汀钙盐的制备方法

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP2648897B2 (ja) * 1991-07-01 1997-09-03 塩野義製薬株式会社 ピリミジン誘導体
GB9903472D0 (en) 1999-02-17 1999-04-07 Zeneca Ltd Chemical process
GB0003305D0 (en) * 2000-02-15 2000-04-05 Zeneca Ltd Pyrimidine derivatives
GB0218781D0 (en) 2002-08-13 2002-09-18 Astrazeneca Ab Chemical process
GB0312896D0 (en) 2003-06-05 2003-07-09 Astrazeneca Ab Chemical process
CA2537271A1 (en) * 2003-08-28 2005-03-17 Teva Pharmaceutical Industries, Ltd. Process for preparation of rosuvastatin calcium
CN1886383A (zh) * 2003-10-22 2006-12-27 兰贝克赛实验室有限公司 无定形罗苏伐他汀钙的制备方法
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
US20080234302A1 (en) 2004-09-27 2008-09-25 Mohammad Rafeeq Novel Processes for Preparing Amorphous Rosuvastatin Calcium and a Novel Polymorphic Form of Rosuvastatin Sodium

Also Published As

Publication number Publication date
CA2611920A1 (en) 2006-12-28
EP1915349B1 (en) 2015-12-09
CA2611920C (en) 2015-05-05
HUE027012T2 (en) 2016-10-28
JP2008543899A (ja) 2008-12-04
PL1915349T3 (pl) 2016-05-31
SI1915349T1 (sl) 2016-05-31
CN101203496A (zh) 2008-06-18
CN101203496B (zh) 2011-04-20
US20080188504A1 (en) 2008-08-07
US8207333B2 (en) 2012-06-26
EP1915349B2 (en) 2018-09-12
WO2006136408A3 (en) 2007-04-19
EP1915349A2 (en) 2008-04-30
ES2564807T5 (es) 2019-02-26
AU2006261088B2 (en) 2012-11-08
IL187578A0 (en) 2008-03-20
WO2006136408A2 (en) 2006-12-28
JP5416403B2 (ja) 2014-02-12
AU2006261088A1 (en) 2006-12-28
PL1915349T5 (pl) 2019-02-28

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