EP1480950A4 - 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 - Google Patents

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

Info

Publication number
EP1480950A4
EP1480950A4 EP03713610A EP03713610A EP1480950A4 EP 1480950 A4 EP1480950 A4 EP 1480950A4 EP 03713610 A EP03713610 A EP 03713610A EP 03713610 A EP03713610 A EP 03713610A EP 1480950 A4 EP1480950 A4 EP 1480950A4
Authority
EP
European Patent Office
Prior art keywords
calcium
processes
atorvastatin hemi
novel
forms
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Withdrawn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
EP03713610A
Other languages
German (de)
French (fr)
Other versions
EP1480950A1 (en
Inventor
Limor Tessler
Judith Aronhime
Revital Lifshitz-Liron
Dalia Maidan-Hanoch
Nir Hasson
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
Application filed by Teva Pharmaceutical Industries Ltd filed Critical Teva Pharmaceutical Industries Ltd
Publication of EP1480950A1 publication Critical patent/EP1480950A1/en
Publication of EP1480950A4 publication Critical patent/EP1480950A4/en
Withdrawn legal-status Critical Current

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
    • C07D207/32—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 only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached to ring carbon atoms
    • C07D207/325—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 only hydrogen atoms, hydrocarbon or substituted hydrocarbon radicals, directly attached to ring carbon atoms with substituted hydrocarbon radicals directly attached to the ring nitrogen atom
    • C07D207/327—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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D405/00—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom
    • C07D405/02—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing two hetero rings
    • C07D405/06—Heterocyclic compounds containing both one or more hetero rings having oxygen atoms as the only ring hetero atoms, and one or more rings having nitrogen as the only ring hetero atom containing two hetero rings linked by a carbon chain containing only aliphatic carbon atoms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • 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
    • 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

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Pyrrole Compounds (AREA)
EP03713610A 2002-02-15 2003-02-19 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 Withdrawn EP1480950A4 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US35718102P 2002-02-15 2002-02-15
US357181P 2002-02-15
US42532502P 2002-11-12 2002-11-12
US425325P 2002-11-12
PCT/US2003/005384 WO2003070702A1 (en) 2002-02-15 2003-02-19 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

Publications (2)

Publication Number Publication Date
EP1480950A1 EP1480950A1 (en) 2004-12-01
EP1480950A4 true EP1480950A4 (en) 2005-05-18

Family

ID=27760457

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03713610A Withdrawn EP1480950A4 (en) 2002-02-15 2003-02-19 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

Country Status (14)

Country Link
EP (1) EP1480950A4 (en)
JP (2) JP2005519076A (en)
KR (1) KR100724515B1 (en)
CN (1) CN100406436C (en)
AU (1) AU2003217653A1 (en)
CA (1) CA2475864A1 (en)
DE (1) DE03713610T1 (en)
ES (1) ES2241507T1 (en)
HR (1) HRP20040768A2 (en)
IS (1) IS7402A (en)
MX (1) MXPA04007939A (en)
NO (1) NO20043842L (en)
PL (1) PL372303A1 (en)
WO (1) WO2003070702A1 (en)

Families Citing this family (20)

* 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
IL163594A0 (en) 2002-02-19 2005-12-18 Teva Pharma Processes for desolvating solvates of atorvastatinhemi-calcium and atorvastatin hemi-calcium essentially free of organic solvent
AU2003297594A1 (en) * 2002-11-28 2004-06-23 Teva Pharmaceutical Industries Ltd. Crystalline form f of atorvastatin hemi-calcium salt
US7655692B2 (en) 2003-06-12 2010-02-02 Pfizer Inc. Process for forming amorphous atorvastatin
US20050271717A1 (en) 2003-06-12 2005-12-08 Alfred Berchielli Pharmaceutical compositions of atorvastatin
CA2573771C (en) 2004-07-20 2011-05-10 Warner-Lambert Company Llc Novel forms of [r-(r*,r*)]-2-(4-fluorophenyl)-.beta., .gamma.-dihydroxy-5-(1-menthylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoic acid calcium salt (2:1)
DE202005020766U1 (en) * 2004-07-22 2006-10-05 Teva Pharmaceutical Industries Ltd. New crystal forms of atorvastatin hemi-calcium
WO2006048894A1 (en) * 2004-11-05 2006-05-11 Morepen Laboratories Limited Novel crystalline forms of atorvastatin calcium and processes for preparing them.
RU2409563C2 (en) * 2005-04-08 2011-01-20 Эгиш Дьёдьсердьяр Ньильваношан Мюкёдё Ресвеньтаршашаг Novel polymorphous form of crystalline hemicalcium salt of atorvastatin
DE602006014193D1 (en) 2005-11-21 2010-06-17 Warner Lambert Co NEW FORMS OF A R- (R *, R *) U-2- (4-FLUORPHENYL) -B, D-DIHYDROXY-5- (1-METHYLETHYL) -3-PHENYL-4-E (PHENYLAMINO) CARBONYLU-1H- pYRROLE-1-heptanoic MAGNESIUM
KR20100023059A (en) 2005-12-13 2010-03-03 테바 파마슈티컬 인더스트리즈 리미티드 Crystal form of atorvastatin hemi-calcium and processes for preparation thereof
US20070265456A1 (en) * 2006-05-09 2007-11-15 Judith Aronhime Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms
EP2132171A4 (en) 2007-03-02 2010-11-17 Dong A Pharm Co Ltd Novel crystal forms of pyrrolylheptanoic acid derivatives
KR20120011249A (en) 2010-07-28 2012-02-07 주식회사 경보제약 Novel Crystal Form of Atorvastatin Hemi-Calcium, Hydrate thereof, and Method of Producing the Same
KR101324862B1 (en) * 2011-07-12 2013-11-01 (주)에이에스텍 Spherical particle of clopidogrel bisulfate, pharmaceutical composition comprising the same and method of preparation thereof
MX2021001169A (en) 2013-11-15 2023-02-10 Akebia Therapeutics Inc Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl] amino}acetic acid, compositions, and uses thereof.
CN105055357A (en) * 2015-09-25 2015-11-18 青岛华之草医药科技有限公司 Atorvastatin calcium composition tablet for treating hypercholesteremia
KR101723783B1 (en) * 2017-02-24 2017-04-07 주식회사 경보제약 Novel Crystal Form of Atorvastatin Hemi-Calcium, Hydrate thereof, and Method of Producing the Same

Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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)
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)
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
WO2003050085A1 (en) * 2001-12-12 2003-06-19 Ivax Corporation CRYSTALLINE [R-(R*,R*)]-2-(4-FLUOROPHENYL)-β,δ-DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1H-PYRROLE-HEPTANOIC ACID CALCIUM SALT (2:1)
WO2004022053A1 (en) * 2002-09-03 2004-03-18 Morepen Laboratories Limited Atorvastatin calcium form vi or hydrates thereof
WO2004050618A2 (en) * 2002-11-28 2004-06-17 Teva Pharmaceutical Industries Ltd. Crystalline form f of atorvastatin hemi-calcium salt

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6087511A (en) * 1996-07-16 2000-07-11 Warner-Lambert Company Process for the production of amorphous [R-(R*,R*)]-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl )-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid) calcium salt (2:1)

Patent Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
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)
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)
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
WO2003050085A1 (en) * 2001-12-12 2003-06-19 Ivax Corporation CRYSTALLINE [R-(R*,R*)]-2-(4-FLUOROPHENYL)-β,δ-DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1H-PYRROLE-HEPTANOIC ACID CALCIUM SALT (2:1)
WO2004022053A1 (en) * 2002-09-03 2004-03-18 Morepen Laboratories Limited Atorvastatin calcium form vi or hydrates thereof
WO2004050618A2 (en) * 2002-11-28 2004-06-17 Teva Pharmaceutical Industries Ltd. Crystalline form f of atorvastatin hemi-calcium salt

Non-Patent Citations (1)

* Cited by examiner, † Cited by third party
Title
See also references of WO03070702A1 *

Also Published As

Publication number Publication date
CA2475864A1 (en) 2003-08-28
CN1646490A (en) 2005-07-27
JP2005519076A (en) 2005-06-30
HRP20040768A2 (en) 2005-06-30
DE03713610T1 (en) 2005-10-20
AU2003217653A1 (en) 2003-09-09
JP2009235083A (en) 2009-10-15
NO20043842L (en) 2004-09-14
PL372303A1 (en) 2005-07-11
ES2241507T1 (en) 2005-11-01
EP1480950A1 (en) 2004-12-01
IS7402A (en) 2004-08-13
MXPA04007939A (en) 2004-11-26
CN100406436C (en) 2008-07-30
KR20040081202A (en) 2004-09-20
KR100724515B1 (en) 2007-06-04
WO2003070702A1 (en) 2003-08-28

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