CN101208307B - 制备不含杂质的无定型罗苏伐他汀钙的方法 - Google Patents

制备不含杂质的无定型罗苏伐他汀钙的方法 Download PDF

Info

Publication number
CN101208307B
CN101208307B CN2006800228524A CN200680022852A CN101208307B CN 101208307 B CN101208307 B CN 101208307B CN 2006800228524 A CN2006800228524 A CN 2006800228524A CN 200680022852 A CN200680022852 A CN 200680022852A CN 101208307 B CN101208307 B CN 101208307B
Authority
CN
China
Prior art keywords
superstatin
salt
calcium
ammonium salt
water
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 - Fee Related
Application number
CN2006800228524A
Other languages
English (en)
Chinese (zh)
Other versions
CN101208307A (zh
Inventor
Z·卡萨尔
M·兹利采
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.)
Filing date
Publication date
Application filed by Lek Pharmaceuticals dd filed Critical Lek Pharmaceuticals dd
Priority to CN201210328276.3A priority Critical patent/CN102807530B/zh
Publication of CN101208307A publication Critical patent/CN101208307A/zh
Application granted granted Critical
Publication of CN101208307B publication Critical patent/CN101208307B/zh
Expired - Fee Related legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Images

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)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (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)
  • Veterinary Medicine (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)
CN2006800228524A 2005-06-24 2006-06-22 制备不含杂质的无定型罗苏伐他汀钙的方法 Expired - Fee Related CN101208307B (zh)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201210328276.3A CN102807530B (zh) 2005-06-24 2006-06-22 制备不含杂质的无定型罗苏伐他汀钙的方法

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

Related Child Applications (1)

Application Number Title Priority Date Filing Date
CN201210328276.3A Division CN102807530B (zh) 2005-06-24 2006-06-22 制备不含杂质的无定型罗苏伐他汀钙的方法

Publications (2)

Publication Number Publication Date
CN101208307A CN101208307A (zh) 2008-06-25
CN101208307B true CN101208307B (zh) 2012-10-17

Family

ID=37038337

Family Applications (2)

Application Number Title Priority Date Filing Date
CN2006800228524A Expired - Fee Related CN101208307B (zh) 2005-06-24 2006-06-22 制备不含杂质的无定型罗苏伐他汀钙的方法
CN201210328276.3A Expired - Fee Related CN102807530B (zh) 2005-06-24 2006-06-22 制备不含杂质的无定型罗苏伐他汀钙的方法

Family Applications After (1)

Application Number Title Priority Date Filing Date
CN201210328276.3A Expired - Fee Related CN102807530B (zh) 2005-06-24 2006-06-22 制备不含杂质的无定型罗苏伐他汀钙的方法

Country Status (8)

Country Link
US (1) US9150518B2 (https=)
EP (2) EP1912952B1 (https=)
JP (1) JP5146965B2 (https=)
CN (2) CN101208307B (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
WO2005023778A2 (en) 2003-08-28 2005-03-17 Teva Pharmaceutical Industries Ltd. Process for preparation of rosuvastatin calcium
EP1601658A1 (en) 2003-11-24 2005-12-07 Teva Pharmaceutical Industries Limited Crystalline ammonium salts of rosuvastatin
US7244844B2 (en) 2003-12-02 2007-07-17 Teva Pharmaceutical Industries Ltd. Reference standard for characterization of rosuvastatin
KR101020024B1 (ko) 2005-02-22 2011-03-09 테바 파마슈티컬 인더스트리즈 리미티드 로수바스타틴 알킬에테르를 함유하지 않는 로수바스타틴 및이의 염 및 이의 제조 방법
WO2007022488A2 (en) 2005-08-16 2007-02-22 Teva Pharmaceutical Industries Ltd. Crystalline rosuvastatin intermediate
US8455640B2 (en) 2006-05-03 2013-06-04 Msn Laboratories Limited 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
ES2385623T3 (es) 2007-02-08 2012-07-27 Aurobindo Pharma Limited Un procedimiento mejorado para la preparación de rosuvastatina cálcica
US20090069563A1 (en) 2007-07-12 2009-03-12 Valerie Niddam-Hildesheim Rosuvastatin intermediates and their preparation
PT2309992T (pt) 2008-06-27 2018-01-22 Krka Tovarna Zdravil D D Novo Mesto Composição farmacêutica compreendendo uma estatina
EP2138165A1 (en) 2008-06-27 2009-12-30 KRKA, tovarna zdravil, d.d., Novo mesto Pharmaceutical composition comprising a statin
EP2752407B1 (en) * 2009-01-14 2015-09-23 Krka Tovarna Zdravil, D.D., Novo Mesto Crystalline rosuvastatin calcium trihydrate
EA021942B1 (ru) * 2009-01-15 2015-10-30 Эгиш Дьёдьсердьяр Зрт. Способ изготовления солей розувастатина
US8487105B2 (en) 2009-01-19 2013-07-16 Msn Laboratories Limited Process for preparing pitavastatin, intermediates and pharmaceuctically 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
HU229260B1 (en) 2010-11-29 2013-10-28 Egis Gyogyszergyar Nyrt Process for preparation of rosuvastatin salts
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
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
MX2015013696A (es) 2013-03-29 2016-02-26 Dsm Sinochem Pharm Nl Bv Sales de amina de pitavastatina y rosuvastatina.
US9630906B2 (en) 2013-03-29 2017-04-25 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 (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1418198A (zh) * 2000-02-15 2003-05-14 阿斯特拉曾尼卡有限公司 7－[4－(4－氟苯基)－6－异丙基－2－[甲基(甲基磺酰基)氨基]嘧啶－5－基]－(3r,5s)－3,5－二羟基庚－6－烯酸的结晶盐类
WO2004014872A1 (en) * 2002-08-13 2004-02-19 Astrazeneca Uk Limited Process for preparing the calcium salt of rosuvastatin
WO2005040134A1 (en) * 2003-10-22 2005-05-06 Ranbaxy Laboratories Limited Process for the preparation of amorphous rosuvastatin calcium

Family Cites Families (17)

* 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
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
GB9900339D0 (en) 1999-01-09 1999-02-24 Zeneca Ltd Chemical compounds
GB9903472D0 (en) * 1999-02-17 1999-04-07 Zeneca Ltd Chemical process
US6777552B2 (en) * 2001-08-16 2004-08-17 Teva Pharmaceutical Industries, Ltd. Processes for preparing calcium salt forms of statins
EP1585736A2 (en) 2002-05-21 2005-10-19 Ranbaxy Laboratories, Ltd. Process for the preparation of rosuvastatin
ATE501126T1 (de) * 2002-12-10 2011-03-15 Ranbaxy Lab Ltd Verfahren zur herstellung von rosuvastatin
US7199144B2 (en) * 2003-04-21 2007-04-03 Teva Pharmaceuticals Industries, Ltd. Process for the preparation of valsartan and intermediates thereof
WO2005023778A2 (en) 2003-08-28 2005-03-17 Teva Pharmaceutical Industries Ltd. Process for preparation of rosuvastatin calcium
GB0324791D0 (en) * 2003-10-24 2003-11-26 Astrazeneca Ab Chemical process
EP1601658A1 (en) 2003-11-24 2005-12-07 Teva Pharmaceutical Industries Limited Crystalline ammonium salts of rosuvastatin
WO2005054207A1 (en) * 2003-12-04 2005-06-16 Glenmark Pharmaceuticals Limited Process for the preparation of pyrimidine derivatives
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
EP1709008A1 (en) * 2004-01-19 2006-10-11 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
GB0406757D0 (en) * 2004-03-26 2004-04-28 Avecia Ltd Process and compounds
WO2006136408A2 (en) * 2005-06-24 2006-12-28 Lek Pharmaceuticals D.D. Process for preparing pure amorphous rosuvastatin calcium

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1418198A (zh) * 2000-02-15 2003-05-14 阿斯特拉曾尼卡有限公司 7－[4－(4－氟苯基)－6－异丙基－2－[甲基(甲基磺酰基)氨基]嘧啶－5－基]－(3r,5s)－3,5－二羟基庚－6－烯酸的结晶盐类
WO2004014872A1 (en) * 2002-08-13 2004-02-19 Astrazeneca Uk Limited Process for preparing the calcium salt of rosuvastatin
WO2005040134A1 (en) * 2003-10-22 2005-05-06 Ranbaxy Laboratories Limited Process for the preparation of amorphous rosuvastatin calcium

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
全文.

Also Published As

Publication number Publication date
IL187483A (en) 2014-08-31
AU2006261087A1 (en) 2006-12-28
CA2612587A1 (en) 2006-12-28
IL187483A0 (en) 2008-02-09
CN102807530B (zh) 2015-08-05
AU2006261087B2 (en) 2010-09-30
US20090111839A1 (en) 2009-04-30
CA2612587C (en) 2013-02-19
US9150518B2 (en) 2015-10-06
EP2508514B1 (en) 2017-10-18
EP1912952B1 (en) 2014-10-15
CN102807530A (zh) 2012-12-05
JP5146965B2 (ja) 2013-02-20
CN101208307A (zh) 2008-06-25
EP2508514A1 (en) 2012-10-10
EP1912952A1 (en) 2008-04-23
WO2006136407A1 (en) 2006-12-28
JP2008546730A (ja) 2008-12-25

Similar Documents

Publication Publication Date Title
CN101208307B (zh) 制备不含杂质的无定型罗苏伐他汀钙的方法
CN101203496B (zh) 纯的无定形瑞舒伐他汀钙的制备方法
US8791259B2 (en) Process for the preparation of Tenofovir
EP2743261B1 (en) Preparation method of crystal form i of the racemate of 4-hydroxy-2-oxo-1-pyrrolidine-acetamide
JP5535082B2 (ja) ボセンタン、その多形形態及びその塩の合成方法
WO2010091877A2 (en) Process for producing ambrisentan
TW201321393A (zh) 固殺草ｐ游離酸之製造方法
WO2007000121A1 (en) A method for the production of the hemi-calcium salt of (e)-7-[4-(4-fluorophenyl)-6-isopropyl-2-[methyl(methylsulfonyl)amino]pyrimidin-5-yl](3r,5s)-3,5-dihydroxyhept-6-enoic acid
RS60392B1 (sr) Postupak za proizvodnju kristalnog oblika modifikacije a kalkobutrola
JP2013543884A (ja) 高純度の医薬品中間体の製法
CN101914052A (zh) 一种奥拉西坦化合物及其新方法
KR20140017207A (ko) 로수바스타틴 이소프로필 아민염, 이의 제조 방법 및 이를 이용한 로수바스타틴 헤미칼슘염의 제조방법
JP2007269657A (ja) α−グリセロホスホリルコリン結晶の製造方法
WO2007074475A2 (en) Novel polymorphic forms of ibandronate
EA023769B1 (ru) Способ получения солей розувастатина
KR101304640B1 (ko) 신규의 로수바스타틴 엔-메틸벤질아민 염 및 그의 제조방법
CN106674281B (zh) 一种瑞舒伐他汀中间体化合物、制备方法及其用途
US5180850A (en) Crystalline magnesium valporate and a method for the preparation thereof
US20110118467A1 (en) Process for the preparation of clopidogrel hydrogen sulfate crystalline form i
CN102336701A (zh) 硫酸卡维地洛的结晶、其制备方法及其在医药上的应用
WO2024062310A1 (en) Co-crystals derived from empagliflozin and dapagliflozin with l-proline
CA2989364C (en) Process for the preparation of enclomiphene citrate having needle shaped crystal habit.
CA2797350A1 (en) Co-crystal intermediates of rosuvastatin and methods of using same
US20130143957A1 (en) Polymorphic forms of warfarin potassium and preparations thereof
KR20140112769A (ko) 아토르바스타틴 이소프로필아민염, 이의 제조방법 및 이를 이용한 아토르바스타틴 헤미칼슘염의 제조방법

Legal Events

Date Code Title Description
C06 Publication
PB01 Publication
C10 Entry into substantive examination
SE01 Entry into force of request for substantive examination
C14 Grant of patent or utility model
GR01 Patent grant
CF01 Termination of patent right due to non-payment of annual fee

Granted publication date: 20121017

CF01 Termination of patent right due to non-payment of annual fee