EP1425287A4 - Processes for preparing calcium salt forms of statins - Google Patents

Processes for preparing calcium salt forms of statins

Info

Publication number
EP1425287A4
EP1425287A4 EP02759374A EP02759374A EP1425287A4 EP 1425287 A4 EP1425287 A4 EP 1425287A4 EP 02759374 A EP02759374 A EP 02759374A EP 02759374 A EP02759374 A EP 02759374A EP 1425287 A4 EP1425287 A4 EP 1425287A4
Authority
EP
European Patent Office
Prior art keywords
statins
processes
calcium salt
salt forms
preparing calcium
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.)
Withdrawn
Application number
EP02759374A
Other languages
German (de)
French (fr)
Other versions
EP1425287A1 (en
Inventor
Valerie Niddam-Hildesheim
Revital Lifshitz-Liron
Rami Lidor-Hadas
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.)
Teva Pharmaceutical Industries Ltd
Original Assignee
Teva Pharmaceutical Industries Ltd
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
Priority claimed from US10/037,412 external-priority patent/US6528661B2/en
Application filed by Teva Pharmaceutical Industries Ltd filed Critical Teva Pharmaceutical Industries Ltd
Publication of EP1425287A1 publication Critical patent/EP1425287A1/en
Publication of EP1425287A4 publication Critical patent/EP1425287A4/en
Withdrawn legal-status Critical Current

Links

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
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D207/00—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D207/02—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D207/30—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two double bonds between ring members or between ring members and non-ring members
    • C07D207/34—Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom with only hydrogen or carbon atoms directly attached to the ring nitrogen atom having two 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, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D209/00—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D209/02—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom condensed with one carbocyclic ring
    • C07D209/04—Indoles; Hydrogenated indoles
    • C07D209/10—Indoles; Hydrogenated indoles with substituted hydrocarbon radicals attached to carbon atoms of the hetero ring
    • C07D209/18—Radicals substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
    • C07D209/24—Radicals substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals with an alkyl or cycloalkyl radical attached to the ring nitrogen atom
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D213/00—Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members
    • C07D213/02—Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members
    • C07D213/04—Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom
    • C07D213/24—Heterocyclic compounds containing six-membered rings, not condensed with other rings, with one nitrogen atom as the only ring hetero atom and three or more double bonds between ring members or between ring members and non-ring members having three double bonds between ring members or between ring members and non-ring members having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen or carbon atoms directly attached to the ring nitrogen atom with substituted hydrocarbon radicals attached to ring carbon atoms
    • C07D213/54—Radicals substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
    • C07D213/55—Acids; Esters
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D215/00—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems
    • C07D215/02—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom
    • C07D215/12—Heterocyclic compounds containing quinoline or hydrogenated quinoline ring systems having no bond between the ring nitrogen atom and a non-ring member or having only hydrogen atoms or carbon atoms directly attached to the ring nitrogen atom with substituted hydrocarbon radicals attached to ring carbon atoms
    • C07D215/14—Radicals substituted by oxygen atoms
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D309/00—Heterocyclic compounds containing six-membered rings having one oxygen atom as the only ring hetero atom, not condensed with other rings
    • C07D309/16—Heterocyclic compounds containing six-membered rings having one oxygen atom as the only ring hetero atom, not condensed with other rings having one double bond between ring members or between a ring member and a non-ring member
    • C07D309/28—Heterocyclic compounds containing six-membered rings having one oxygen atom as the only ring hetero atom, not condensed with other rings having one double bond between ring members or between a ring member and a non-ring member with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
    • C07D309/30—Oxygen atoms, e.g. delta-lactones
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
    • Y02P20/00—Technologies relating to chemical industry
    • Y02P20/50—Improvements relating to the production of bulk chemicals
    • Y02P20/55—Design of synthesis routes, e.g. reducing the use of auxiliary or protecting groups

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (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)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Obesity (AREA)
  • Urology & Nephrology (AREA)
  • Vascular Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Pyrane Compounds (AREA)
  • Low-Molecular Organic Synthesis Reactions Using Catalysts (AREA)
  • Quinoline Compounds (AREA)
  • Pyridine Compounds (AREA)
  • Pyrrole Compounds (AREA)
  • Indole Compounds (AREA)
EP02759374A 2001-08-16 2002-08-16 Processes for preparing calcium salt forms of statins Withdrawn EP1425287A4 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US31281201P 2001-08-16 2001-08-16
US312812P 2001-08-16
US37412 2001-10-24
US10/037,412 US6528661B2 (en) 2000-11-16 2001-10-24 Hydrolysis of [R(R*,R*)]-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino) carbonyl]-1H-pyrrole-1-heptanoic acid esters with calcium hydroxide
PCT/US2002/026012 WO2003016317A1 (en) 2001-08-16 2002-08-16 Processes for preparing calcium salt forms of statins

Publications (2)

Publication Number Publication Date
EP1425287A1 EP1425287A1 (en) 2004-06-09
EP1425287A4 true EP1425287A4 (en) 2005-09-07

Family

ID=26714105

Family Applications (1)

Application Number Title Priority Date Filing Date
EP02759374A Withdrawn EP1425287A4 (en) 2001-08-16 2002-08-16 Processes for preparing calcium salt forms of statins

Country Status (17)

Country Link
EP (1) EP1425287A4 (en)
JP (2) JP4188826B2 (en)
CN (1) CN100430405C (en)
AU (1) AU2002324715B2 (en)
CA (1) CA2450820C (en)
CZ (1) CZ2004337A3 (en)
HR (1) HRPK20040255B3 (en)
HU (1) HUP0500616A3 (en)
IL (2) IL160077A0 (en)
IS (1) IS7148A (en)
MX (1) MXPA04001451A (en)
NO (1) NO20041082L (en)
NZ (1) NZ529913A (en)
PL (1) PL370407A1 (en)
SK (1) SK1402004A3 (en)
TR (1) TR200302281T2 (en)
WO (1) WO2003016317A1 (en)

Families Citing this family (55)

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US7411075B1 (en) 2000-11-16 2008-08-12 Teva Pharmaceutical Industries Ltd. Polymorphic form of atorvastatin calcium
ES2313999T3 (en) * 2000-11-16 2009-03-16 Teva Pharmaceutical Industries Ltd. STERE HYDROLYSIS OF ACID (R (R *, R *)) - 2- (4-FLUOROPHENIL) -BETA, DELTA-DIHIDROXI-5- (1-METHYLETY) -3-PHENYL-4 - ((PHENYLAMINE) CARBON) -1H-PIRROL-1-HEPTANOIC WITH CALCICO HYDROXIDE.
IL156055A0 (en) 2000-11-30 2003-12-23 Teva Pharma Novel crystal forms of atorvastatin hemi calcium and processes for their preparation as well as novel processes for preparing other forms
US7501450B2 (en) 2000-11-30 2009-03-10 Teva Pharaceutical Industries Ltd. Crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms
WO2002057229A1 (en) 2001-01-19 2002-07-25 Biocon India Limited FORM V CRYSTALLINE [R-(R*,R*)]-2-(4-FLUOROPHENYL)-ß,$G(D)-DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1H-PYRROLE-1- HEPTANOIC ACID HEMI CALCIUM SALT. (ATORVASTATIN)
US7361772B2 (en) 2001-08-16 2008-04-22 Biocon Limited Process for the production of atorvastatin calcium
CA2412012C (en) 2001-11-20 2011-08-02 Ed. Geistlich Soehne Ag Fuer Chemische Industrie Resorbable extracellular matrix containing collagen i and collagen ii for reconstruction of cartilage
ATE452871T1 (en) 2002-03-18 2010-01-15 Biocon Ltd AMORPHOUS HMG-COA REDUCTASE INHIBITORS WITH DESIRED PARTICLE SIZE
EA200401533A1 (en) * 2002-05-21 2005-06-30 Ранбакси Лабораторис Лимитед METHOD OF OBTAINING ROSUVASTATIN
US7179942B2 (en) 2002-07-05 2007-02-20 Bicon Limited Halo-substituted active methylene compounds
GB0218781D0 (en) * 2002-08-13 2002-09-18 Astrazeneca Ab Chemical process
PL376557A1 (en) * 2003-02-12 2006-01-09 Ciba Specialty Chemicals Holding Inc. Crystalline forms of pitavastatin calcium
AU2003231926A1 (en) 2003-04-22 2004-11-19 Biocon Limited NOVEL PROCESS FOR STEREOSELECTIVE REDUCTION OF ss-KETOESTERS
GB0312896D0 (en) 2003-06-05 2003-07-09 Astrazeneca Ab Chemical process
EP2522656A3 (en) * 2003-07-25 2013-03-20 Redx Pharma Limited Process and Intermediate Compounds Useful in the Preparation of Statins, Particularly Atorvastatin
AU2003269477A1 (en) * 2003-08-26 2005-03-10 Biocon Limited Novel process for preparation of 7-(3-(4-fluorophenyl)-1-(1-methylethyl)-1h-indol-2-yl)-3, 5-dihydroxy-6-heptenoic acid sodium salt
EP1816126A1 (en) * 2003-08-28 2007-08-08 Teva Pharmaceutical Industries Limited Process for preparation of rosuvastatin calcium
EP1562912A2 (en) * 2003-08-28 2005-08-17 Teva Pharmaceutical Industries Limited Process for preparation of rosuvastatin calcium
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US8455640B2 (en) 2006-05-03 2013-06-04 Msn Laboratories Limited Process for statins and its pharmaceutically acceptable salts thereof
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
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US8912333B2 (en) * 2010-11-12 2014-12-16 Hetero Research Foundation Polymorphs of pitavastatin calcium
HU229260B1 (en) * 2010-11-29 2013-10-28 Egis Gyogyszergyar Nyrt Process for preparation of rosuvastatin salts
CN102875504A (en) * 2011-07-13 2013-01-16 华南理工大学 Application of 4,5,6,7-tetrahydro pravastatin and salts thereof in cardiovascular diseases
CN102302452B (en) * 2011-09-14 2012-11-21 海南美大制药有限公司 Pitavastatin calcium lipid solid preparation
CN102796036B (en) * 2012-09-12 2014-06-04 江苏阿尔法药业有限公司 Preparation method of atorvastatin calcium
CN103724278B (en) * 2013-12-12 2019-03-29 江苏阿尔法药业有限公司 The preparation method of Statins intermediate and its derivative
WO2015119261A1 (en) * 2014-02-06 2015-08-13 株式会社エーピーアイ コーポレーション Rosuvastatin calcium and process for producing intermediate thereof
KR20160126700A (en) 2015-04-24 2016-11-02 미래파인켐 주식회사 New Statin intermediate, the preparation of the same and the preparation of Rosuvastatin using the same
CN105111173B (en) * 2015-06-26 2017-06-23 上海应用技术学院 Statin fluorine-containing derivant and application thereof
CN105017231B (en) * 2015-06-26 2018-01-26 上海应用技术学院 Polysubstituted fluorine-containing trim of indoles statin and application thereof
US10676441B2 (en) 2015-08-05 2020-06-09 Api Corporation Method for producing pitavastatin calcium
CN111362856B (en) * 2020-04-29 2023-08-18 福建海西新药创制股份有限公司 Method for producing atorvastatin calcium by utilizing micro-reaction device

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WO2000049014A1 (en) * 1999-02-17 2000-08-24 Astrazeneca Ab Process for the production of tert-butyl (e)-(6-[2- [4-(4-fluorophenyl) -6-isopropyl-2-[ methyl (methylsulfonyl) amino] pyrimidin-5-yl] vinyl](4r, 6s)-2,2-dimethyl [1,3]dioxan-4-yl) acetate
WO2002043732A1 (en) * 2000-11-30 2002-06-06 Teva Pharmaceutical Industries Ltd. Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms
WO2002043667A2 (en) * 2000-11-16 2002-06-06 Teva Pharmaceutical Industries Ltd. HYDROLYSIS OF [R(R*,R*)]-2-(4-FLUOROPHENYL)-β,δ -DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1H-PYRROLE-1-HEPTANOIC ACID ESTERS WITH CALCIUM HYDROXIDE
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WO2002051804A1 (en) * 2000-12-27 2002-07-04 Ciba Specialty Chemicals Holding Inc. Crystalline forms of atorvastatin
WO2003018547A2 (en) * 2001-08-31 2003-03-06 Morepen Laboratories Ltd. An improved process for the preparation of amorphous atorvastatin calcium salt (2:1)

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Title
See also references of WO03016317A1 *
WATANABE M ET AL: "Synthesis and biological activity of methanesulfonamide pyrimidine- and N-methanesulfonyl pyrrole-substituted 3,5-dihydroxy-6-heptenoates, a novel series of HMG-CoA reductase inhibitors", BIOORGANIC AND MEDICINAL CHEMISTRY 199702 GB LNKD- DOI:10.1016/S0968-0896(96)00248-9, vol. 5, no. 2, February 1997 (1997-02-01), pages 437 - 444, ISSN: 0968-0896 *

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CN100430405C (en) 2008-11-05
HUP0500616A2 (en) 2005-11-28
HRP20040255A2 (en) 2004-08-31
NZ529913A (en) 2005-03-24
PL370407A1 (en) 2005-05-30
IL160077A0 (en) 2004-06-20
CZ2004337A3 (en) 2005-01-12
CN1543468A (en) 2004-11-03
IL160077A (en) 2007-10-31
AU2002324715B2 (en) 2009-03-12
NO20041082L (en) 2004-03-15
CA2450820A1 (en) 2003-02-27
TR200302281T2 (en) 2004-09-21
JP4188826B2 (en) 2008-12-03
HRPK20040255B3 (en) 2006-02-28
CA2450820C (en) 2011-03-15
IS7148A (en) 2004-02-11
JP2009024008A (en) 2009-02-05
WO2003016317A1 (en) 2003-02-27
HUP0500616A3 (en) 2011-07-28
SK1402004A3 (en) 2005-01-03

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