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WO2004050618A3 - Crystalline form f of atorvastatin hemi-calcium salt - Google Patents

Crystalline form f of atorvastatin hemi-calcium salt Download PDF

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Publication number
WO2004050618A3
WO2004050618A3 PCT/US2003/038090 US0338090W WO2004050618A3 WO 2004050618 A3 WO2004050618 A3 WO 2004050618A3 US 0338090 W US0338090 W US 0338090W WO 2004050618 A3 WO2004050618 A3 WO 2004050618A3
Authority
WO
WIPO (PCT)
Prior art keywords
crystalline form
calcium salt
atorvastatin hemi
atorvastatin
hemi
Prior art date
Application number
PCT/US2003/038090
Other languages
French (fr)
Other versions
WO2004050618A8 (en
WO2004050618A2 (en
Inventor
Fritz Blatter
Martin Szelagiewicz
Der Schaaf Paul Adriaan Van
Original Assignee
Teva Pharma
Fritz Blatter
Martin Szelagiewicz
Der Schaaf Paul Adriaan Van
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 EP02406037A external-priority patent/EP1424324A1/en
Application filed by Teva Pharma, Fritz Blatter, Martin Szelagiewicz, Der Schaaf Paul Adriaan Van filed Critical Teva Pharma
Priority to EP03812471A priority Critical patent/EP1572643A2/en
Priority to AU2003297594A priority patent/AU2003297594A1/en
Priority to CA002508871A priority patent/CA2508871C/en
Publication of WO2004050618A2 publication Critical patent/WO2004050618A2/en
Publication of WO2004050618A3 publication Critical patent/WO2004050618A3/en
Publication of WO2004050618A8 publication Critical patent/WO2004050618A8/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
    • 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)
  • Pyrrole Compounds (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

The present invention is directed to the novel polymorphic Form F of Atorvastatin calcium, processes for the preparation thereof and pharmaceutical compositions comprising this crystalline form.
PCT/US2003/038090 2002-11-28 2003-11-26 Crystalline form f of atorvastatin hemi-calcium salt WO2004050618A2 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
EP03812471A EP1572643A2 (en) 2002-11-28 2003-11-26 Crystalline form f of atorvastatin hemi-calcium salt
AU2003297594A AU2003297594A1 (en) 2002-11-28 2003-11-26 Crystalline form f of atorvastatin hemi-calcium salt
CA002508871A CA2508871C (en) 2002-11-28 2003-11-26 Crystalline form f of atorvastatin hemi-calcium salt

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
EP02406037A EP1424324A1 (en) 2002-11-28 2002-11-28 Crystalline form F of Atorvastatin hemi-calcium salt
EP02406037.8 2002-11-28
EP03405110 2003-02-20
EP03405110.2 2003-02-20

Publications (3)

Publication Number Publication Date
WO2004050618A2 WO2004050618A2 (en) 2004-06-17
WO2004050618A3 true WO2004050618A3 (en) 2004-07-15
WO2004050618A8 WO2004050618A8 (en) 2005-07-14

Family

ID=32471910

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2003/038090 WO2004050618A2 (en) 2002-11-28 2003-11-26 Crystalline form f of atorvastatin hemi-calcium salt

Country Status (4)

Country Link
EP (1) EP1572643A2 (en)
AU (1) AU2003297594A1 (en)
CA (1) CA2508871C (en)
WO (1) WO2004050618A2 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100881103B1 (en) 2004-09-28 2009-02-02 테바 파마슈티컬 인더스트리즈 리미티드 Method for preparing a form of atorvastatin calcium that is substantially free of impurities

Families Citing this family (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7411075B1 (en) 2000-11-16 2008-08-12 Teva Pharmaceutical Industries Ltd. Polymorphic form of atorvastatin calcium
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
PL372303A1 (en) * 2002-02-15 2005-07-11 Teva Pharmaceutical Industries Ltd. Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation, as well as novel processes for preparing atorvastatin hemi-calcium forms i, viii and ix
HUE029911T2 (en) * 2004-07-16 2017-04-28 Lek Pharmaceuticals Oxidative degradation products of atorvastatin calcium
CA2701710C (en) 2004-07-20 2013-08-27 Warner-Lambert Company Llc Novel forms of [r-(r*,r*)]-2-(4-fluorophenyl)-.beta.,.delta.-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoic acid calcium salt (2:1)
WO2006012499A2 (en) * 2004-07-22 2006-02-02 Teva Pharmaceutical Industries Ltd. Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation
WO2006048894A1 (en) * 2004-11-05 2006-05-11 Morepen Laboratories Limited Novel crystalline forms of atorvastatin calcium and processes for preparing them.
JP2008530146A (en) 2005-12-13 2008-08-07 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 Crystalline form of atorvastatin and hemi-calcium and method for preparing the same
KR20080031487A (en) * 2006-06-28 2008-04-08 테바 파마슈티컬 인더스트리즈 리미티드 Crystalline Form of Atorvastatin
US7915302B2 (en) * 2007-03-02 2011-03-29 Dong-A Pharm. Co., Ltd. Crystal forms of pyrrolylheptanoic acid derivatives
US20100260851A1 (en) * 2007-07-11 2010-10-14 Actavis Group Ptc Ehf Novel Polymorph of Atorvastatin Calcium and Use Thereof for the Preparation of Amorphous Atorvastatin Calcium
RU2016123382A (en) 2013-11-15 2017-12-20 Экебиа Терапьютикс, Инк. SOLID FORMS {{5- (3-CHLOROPHENYL) -3-HYDROXYPYRIDIN-2-CARBONYL] AMINO} ACETIC ACID, THEIR COMPOSITION AND USE

Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997003958A1 (en) * 1995-07-17 1997-02-06 Warner-Lambert Company Form iii crystalline (r-(r*,r*)-2-(4-fluorophenyl)-beta-delta-dihydroxy-5-(1-methyl-ethyl)-3-phenyl-4-((phenylamino)carbonyl)-1h-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin)
WO1997003959A1 (en) * 1995-07-17 1997-02-06 Warner-Lambert Company Crystalline [r-(r*,r*)]-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin)
WO2001036384A1 (en) * 1999-11-17 2001-05-25 Teva Pharmaceutical Industries Ltd. Polymorphic form of atorvastatin calcium
WO2001044181A1 (en) * 1999-12-17 2001-06-21 Warner Lambert Research And Development Ireland Limited A process for producing crystalline atorvastatin calcium
WO2001044180A1 (en) * 1999-12-17 2001-06-21 Warner Lambert Research And Development Ireland Limited A factory scale process for producing crystalline atorvastatin trihydrate hemi calcium salt
WO2002041834A2 (en) * 2000-11-03 2002-05-30 Teva Pharmaceutical Industries, Ltd. Atorvastatin hemi-calcium form vii
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
WO2002051804A1 (en) * 2000-12-27 2002-07-04 Ciba Specialty Chemicals Holding Inc. Crystalline forms of atorvastatin
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)
WO2003004470A1 (en) * 2001-06-29 2003-01-16 Warner-Lambert Company Llc Crystalline forms of 'r-(r*,r*)!-2-(4-fluorophenyl)-beta, delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-'phenylamino)carbonyl!-1h-pyrrole-1-heptanoic acid calcium salt (2:1) (atorvastatin)
WO2003011826A1 (en) * 2001-07-30 2003-02-13 Dr. Reddy's Laboratories Ltd. Crystalline forms vi and vii of atorvastatin calcium
WO2003070702A1 (en) * 2002-02-15 2003-08-28 Teva Pharmaceutical Industries Ltd. Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation, as well as novel processes for preparing atorvastatin hemi-calcium forms i, viii and ix
WO2004022053A1 (en) * 2002-09-03 2004-03-18 Morepen Laboratories Limited Atorvastatin calcium form vi or hydrates thereof

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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

Patent Citations (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997003958A1 (en) * 1995-07-17 1997-02-06 Warner-Lambert Company Form iii crystalline (r-(r*,r*)-2-(4-fluorophenyl)-beta-delta-dihydroxy-5-(1-methyl-ethyl)-3-phenyl-4-((phenylamino)carbonyl)-1h-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin)
WO1997003959A1 (en) * 1995-07-17 1997-02-06 Warner-Lambert Company Crystalline [r-(r*,r*)]-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin)
WO2001036384A1 (en) * 1999-11-17 2001-05-25 Teva Pharmaceutical Industries Ltd. Polymorphic form of atorvastatin calcium
WO2001044181A1 (en) * 1999-12-17 2001-06-21 Warner Lambert Research And Development Ireland Limited A process for producing crystalline atorvastatin calcium
WO2001044180A1 (en) * 1999-12-17 2001-06-21 Warner Lambert Research And Development Ireland Limited A factory scale process for producing crystalline atorvastatin trihydrate hemi calcium salt
WO2002041834A2 (en) * 2000-11-03 2002-05-30 Teva Pharmaceutical Industries, Ltd. Atorvastatin hemi-calcium form vii
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
WO2002051804A1 (en) * 2000-12-27 2002-07-04 Ciba Specialty Chemicals Holding Inc. Crystalline forms of atorvastatin
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)
WO2003004470A1 (en) * 2001-06-29 2003-01-16 Warner-Lambert Company Llc Crystalline forms of 'r-(r*,r*)!-2-(4-fluorophenyl)-beta, delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-'phenylamino)carbonyl!-1h-pyrrole-1-heptanoic acid calcium salt (2:1) (atorvastatin)
WO2003011826A1 (en) * 2001-07-30 2003-02-13 Dr. Reddy's Laboratories Ltd. Crystalline forms vi and vii of atorvastatin calcium
WO2003070702A1 (en) * 2002-02-15 2003-08-28 Teva Pharmaceutical Industries Ltd. Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation, as well as novel processes for preparing atorvastatin hemi-calcium forms i, viii and ix
WO2004022053A1 (en) * 2002-09-03 2004-03-18 Morepen Laboratories Limited Atorvastatin calcium form vi or hydrates thereof

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of EP1572643A2 *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR100881103B1 (en) 2004-09-28 2009-02-02 테바 파마슈티컬 인더스트리즈 리미티드 Method for preparing a form of atorvastatin calcium that is substantially free of impurities

Also Published As

Publication number Publication date
CA2508871A1 (en) 2004-06-17
WO2004050618A8 (en) 2005-07-14
AU2003297594A1 (en) 2004-06-23
AU2003297594A8 (en) 2004-06-23
WO2004050618A2 (en) 2004-06-17
EP1572643A2 (en) 2005-09-14
CA2508871C (en) 2008-09-09

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