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WO2007118873A3 - Polymorphs of atorvastatin sodium and magnesium salts - Google Patents

Polymorphs of atorvastatin sodium and magnesium salts Download PDF

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Publication number
WO2007118873A3
WO2007118873A3 PCT/EP2007/053687 EP2007053687W WO2007118873A3 WO 2007118873 A3 WO2007118873 A3 WO 2007118873A3 EP 2007053687 W EP2007053687 W EP 2007053687W WO 2007118873 A3 WO2007118873 A3 WO 2007118873A3
Authority
WO
WIPO (PCT)
Prior art keywords
polymorphs
magnesium salts
atorvastatin sodium
atorvastatin
sodium
Prior art date
Application number
PCT/EP2007/053687
Other languages
French (fr)
Other versions
WO2007118873A2 (en
Inventor
Vesna Kroselj
Matej Smrkolj
Renata Osolnik
Jaroslav Tihi
Rok Zupet
Anton Stimac
Original Assignee
Krka Tovarna Zdravil D D Novo
Vesna Kroselj
Matej Smrkolj
Renata Osolnik
Jaroslav Tihi
Rok Zupet
Anton Stimac
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 Krka Tovarna Zdravil D D Novo, Vesna Kroselj, Matej Smrkolj, Renata Osolnik, Jaroslav Tihi, Rok Zupet, Anton Stimac filed Critical Krka Tovarna Zdravil D D Novo
Priority to EP07728152A priority Critical patent/EP2049479A2/en
Publication of WO2007118873A2 publication Critical patent/WO2007118873A2/en
Publication of WO2007118873A3 publication Critical patent/WO2007118873A3/en

Links

Classifications

    • 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
    • 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

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (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)

Abstract

Polymorph and amorphous forms of atorvastatin sodium and hemi-magnesium, processes for their preparation and pharmaceutical compositions comprising them are described.
PCT/EP2007/053687 2006-04-14 2007-04-16 Polymorphs of atorvastatin sodium and magnesium salts WO2007118873A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
EP07728152A EP2049479A2 (en) 2006-04-14 2007-04-16 Polymorphs of atorvastatin sodium and magnesium salts

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SI200600098A SI22255A (en) 2006-04-14 2006-04-14 New polymorphs of statine salts and their application in pharmaceutical formulations
SIP-200600098 2006-04-14

Publications (2)

Publication Number Publication Date
WO2007118873A2 WO2007118873A2 (en) 2007-10-25
WO2007118873A3 true WO2007118873A3 (en) 2007-12-06

Family

ID=38180700

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2007/053687 WO2007118873A2 (en) 2006-04-14 2007-04-16 Polymorphs of atorvastatin sodium and magnesium salts

Country Status (3)

Country Link
EP (1) EP2049479A2 (en)
SI (1) SI22255A (en)
WO (1) WO2007118873A2 (en)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20100222405A1 (en) * 2005-05-03 2010-09-02 Yatendar Kumar Magnesium salts of hmg-coa reductase inhibitors
WO2008053495A1 (en) * 2006-10-30 2008-05-08 Lupin Limited A novel crystalline form of atorvastatin sodium
IS8587A (en) * 2006-12-27 2008-06-28 Actavis Group Hf. Atorvastatin pharmaceutical combination
CZ300047B6 (en) * 2007-03-02 2009-01-21 Zentiva, A. S. Pharmaceutical composition containing atorvastatin as active substance
WO2009063476A1 (en) * 2007-11-16 2009-05-22 Biocon Limited A crystalline form of atorvastatin hemi magnesium salt and a process thereof
EP2130819A3 (en) 2008-04-10 2009-12-23 Ranbaxy Laboratories Limited Crystalline forms of atorvastatin magnesium
WO2009157005A1 (en) * 2008-06-26 2009-12-30 Biocon Limited Crystalline forms of atorvastatin hemi-magnesium salt and a process thereof
KR20120011249A (en) 2010-07-28 2012-02-07 주식회사 경보제약 Novel crystalline forms of atorvastatin hemicalcium salts, hydrates thereof, and methods for preparing the same

Citations (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4681893A (en) * 1986-05-30 1987-07-21 Warner-Lambert Company Trans-6-[2-(3- or 4-carboxamido-substituted pyrrol-1-yl)alkyl]-4-hydroxypyran-2-one inhibitors of cholesterol synthesis
EP0409281A1 (en) * 1989-07-21 1991-01-23 Warner-Lambert Company (R-(R*R*))-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl-3-phenyl-4((phenylamino)-carbonyl)-1H-pyrrole-1-heptanoic acid, its lactone form and salts thereof
EP1336405A1 (en) * 2002-02-14 2003-08-20 Ranbaxy Laboratories, Ltd. Formulations of atorvastatin stabilized with alkali metal additions
WO2004046105A2 (en) * 2002-11-15 2004-06-03 Teva Pharmaceutical Industries Ltd. Synthesis of 3,5-dihydroxy-7-pyrrol-1-yl heptanoic acids
EP1577297A1 (en) * 2004-03-17 2005-09-21 Ranbaxy Laboratories, Ltd. Process for the production of atorvastatin calcium in amorphous form
WO2005105738A2 (en) * 2004-05-05 2005-11-10 Pfizer Products Inc. Salt forms of atorvastatin
CN1749248A (en) * 2005-08-15 2006-03-22 浙江新东港药业股份有限公司 Process for preparing high purity atorvastatin calcium
CN1749247A (en) * 2005-08-15 2006-03-22 浙江新东港药业股份有限公司 Process for preparing high purity crystal atorvastatin sodium
WO2006054308A2 (en) * 2004-11-22 2006-05-26 Dexcel Pharma Technologies Ltd. Stable atorvastatin formulations
WO2006084474A2 (en) * 2005-02-10 2006-08-17 Lifecycle Pharma A/S A stable pharmaceutical composition comprising a fixed dose combination of fenofibrate and an hmg-coa reductase inhibitor
GB2424880A (en) * 2005-04-06 2006-10-11 Generics Crystalline forms of atorvastatin sodium, processes for their preparation and their use in inhibiting HMG-CoA reductase
WO2006117761A2 (en) * 2005-05-03 2006-11-09 Ranbaxy Laboratories Limited Magnesium salts of hmg-coa reductase inhibitors
WO2007020413A1 (en) * 2005-08-15 2007-02-22 Arrow International Limited Crystalline and amorphous sodium atorvastatin
WO2007020241A2 (en) * 2005-08-19 2007-02-22 BSH Bosch und Siemens Hausgeräte GmbH Dishwasher platform
WO2007052296A2 (en) * 2005-08-23 2007-05-10 Kopran Research Laboratories Ltd A process of preparing amorphous atorvastatin calcium
WO2007057755A1 (en) * 2005-11-21 2007-05-24 Warner-Lambert Company Llc Novel forms of [r-(r*,r*)]-2-(4-fluorophenyl)-b,b-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-hept anoic acid magnesium
WO2007063551A1 (en) * 2005-11-29 2007-06-07 Biocon Limited POLYMORPHS OF [R-(R*, R*)]-2-(4-FLUOROPHENYL)-β,δ-DIHYDROXY-5-(l-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-lH-PYRROLE-l-HEPTANOIC ACID MAGNESIUM SALT (2: 1)

Patent Citations (17)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4681893A (en) * 1986-05-30 1987-07-21 Warner-Lambert Company Trans-6-[2-(3- or 4-carboxamido-substituted pyrrol-1-yl)alkyl]-4-hydroxypyran-2-one inhibitors of cholesterol synthesis
EP0409281A1 (en) * 1989-07-21 1991-01-23 Warner-Lambert Company (R-(R*R*))-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl-3-phenyl-4((phenylamino)-carbonyl)-1H-pyrrole-1-heptanoic acid, its lactone form and salts thereof
EP1336405A1 (en) * 2002-02-14 2003-08-20 Ranbaxy Laboratories, Ltd. Formulations of atorvastatin stabilized with alkali metal additions
WO2004046105A2 (en) * 2002-11-15 2004-06-03 Teva Pharmaceutical Industries Ltd. Synthesis of 3,5-dihydroxy-7-pyrrol-1-yl heptanoic acids
EP1577297A1 (en) * 2004-03-17 2005-09-21 Ranbaxy Laboratories, Ltd. Process for the production of atorvastatin calcium in amorphous form
WO2005105738A2 (en) * 2004-05-05 2005-11-10 Pfizer Products Inc. Salt forms of atorvastatin
WO2006054308A2 (en) * 2004-11-22 2006-05-26 Dexcel Pharma Technologies Ltd. Stable atorvastatin formulations
WO2006084474A2 (en) * 2005-02-10 2006-08-17 Lifecycle Pharma A/S A stable pharmaceutical composition comprising a fixed dose combination of fenofibrate and an hmg-coa reductase inhibitor
GB2424880A (en) * 2005-04-06 2006-10-11 Generics Crystalline forms of atorvastatin sodium, processes for their preparation and their use in inhibiting HMG-CoA reductase
WO2006117761A2 (en) * 2005-05-03 2006-11-09 Ranbaxy Laboratories Limited Magnesium salts of hmg-coa reductase inhibitors
CN1749247A (en) * 2005-08-15 2006-03-22 浙江新东港药业股份有限公司 Process for preparing high purity crystal atorvastatin sodium
CN1749248A (en) * 2005-08-15 2006-03-22 浙江新东港药业股份有限公司 Process for preparing high purity atorvastatin calcium
WO2007020413A1 (en) * 2005-08-15 2007-02-22 Arrow International Limited Crystalline and amorphous sodium atorvastatin
WO2007020241A2 (en) * 2005-08-19 2007-02-22 BSH Bosch und Siemens Hausgeräte GmbH Dishwasher platform
WO2007052296A2 (en) * 2005-08-23 2007-05-10 Kopran Research Laboratories Ltd A process of preparing amorphous atorvastatin calcium
WO2007057755A1 (en) * 2005-11-21 2007-05-24 Warner-Lambert Company Llc Novel forms of [r-(r*,r*)]-2-(4-fluorophenyl)-b,b-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-hept anoic acid magnesium
WO2007063551A1 (en) * 2005-11-29 2007-06-07 Biocon Limited POLYMORPHS OF [R-(R*, R*)]-2-(4-FLUOROPHENYL)-β,δ-DIHYDROXY-5-(l-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-lH-PYRROLE-l-HEPTANOIC ACID MAGNESIUM SALT (2: 1)

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
DATABASE WPI Week 200676, Derwent World Patents Index; AN 2006-728252, XP002440592 *
DATABASE WPI Week 200676, Derwent World Patents Index; AN 2006-728253, XP002440593 *

Also Published As

Publication number Publication date
EP2049479A2 (en) 2009-04-22
WO2007118873A2 (en) 2007-10-25
SI22255A (en) 2007-10-31

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