EP1480950A4 - Nouvelles formes cristallines d'hemi-calcium d'atorvastatine et procedes pour leur preparation, ainsi que procedes nouveaux pour la preparation des formes i,viii et ix d'hemi-calcium d'atorvastatine - Google Patents

Nouvelles formes cristallines d'hemi-calcium d'atorvastatine et procedes pour leur preparation, ainsi que procedes nouveaux pour la preparation des formes i,viii et ix d'hemi-calcium d'atorvastatine

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Withdrawn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)
English (en)
Other versions
EP1480950A1 (fr
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/fr
Publication of EP1480950A4 publication Critical patent/EP1480950A4/fr
Withdrawn legal-status Critical Current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)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Obesity (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Epidemiology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Pyrrole Compounds (AREA)
EP03713610A 2002-02-15 2003-02-19 Nouvelles formes cristallines d'hemi-calcium d'atorvastatine et procedes pour leur preparation, ainsi que procedes nouveaux pour la preparation des formes i,viii et ix d'hemi-calcium d'atorvastatine Withdrawn EP1480950A4 (fr)

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 (fr) 2002-02-15 2003-02-19 Nouvelles formes cristallines d'hemi-calcium d'atorvastatine

Publications (2)

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

Family

ID=27760457

Family Applications (1)

Application Number Title Priority Date Filing Date
EP03713610A Withdrawn EP1480950A4 (fr) 2002-02-15 2003-02-19 Nouvelles formes cristallines d'hemi-calcium d'atorvastatine et procedes pour leur preparation, ainsi que procedes nouveaux pour la preparation des formes i,viii et ix d'hemi-calcium d'atorvastatine

Country Status (14)

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

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
MXPA04007995A (es) 2002-02-19 2004-11-26 Teva Pharma Desolvatacion de solvatos de hemicalcio de atorvastatina.
AU2003297594A1 (en) * 2002-11-28 2004-06-23 Teva Pharmaceutical Industries Ltd. Crystalline form f of atorvastatin hemi-calcium salt
US20050271717A1 (en) 2003-06-12 2005-12-08 Alfred Berchielli Pharmaceutical compositions of atorvastatin
US7655692B2 (en) 2003-06-12 2010-02-02 Pfizer Inc. Process for forming amorphous atorvastatin
CA2672554C (fr) 2004-07-20 2012-01-03 Warner-Lambert Company Llc Nouvelles formes de [r-(r*,r*)]-2-(4-fluorophenyl).beta.,.delta.-dihydroxy-5-(isopropyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoatede calcium (2:1)
DE05774589T1 (de) * 2004-07-22 2007-08-09 Teva Pharmaceutical Industries Ltd. Neue kristallformen von atorvastatin-hemi-calcium und verfahren zu deren herstellung
WO2006048894A1 (fr) * 2004-11-05 2006-05-11 Morepen Laboratories Limited Nouvelles formes cristallines de calcium d'atorvastatine et procedes de fabrication
RO200700700A8 (ro) * 2005-04-08 2015-07-30 Egis Gyogyszergyar Nyilvanosan Mukodo Reszvenytarsasag Procedeu pentru prepararea unei noi forme cristaline polimorfe a sării de hemicalciu a atorvastatinului
DE602006014193D1 (de) 2005-11-21 2010-06-17 Warner Lambert Co Neue formen von är-(r*,r*)ü-2-(4-fluorphenyl)-b,d-dihydroxy-5-(1-methylethyl)-3-phenyl-4-ä(phenylamino)carbonylü-1h-pyrrol-1-heptansäure-magnesium
BRPI0610344A2 (pt) 2005-12-13 2016-11-29 Teva Pharma forma cristalizada do atorvastatin hemi-calcium, processo para sua preparação, produto famacêutico derivado e seu uso medicinal
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
WO2008108572A1 (fr) * 2007-03-02 2008-09-12 Dong-A Pharm. Co., Ltd. Nouvelles formes cristallines de dérivés d'acide pyrrolylheptanoïque
KR20120011249A (ko) 2010-07-28 2012-02-07 주식회사 경보제약 아토바스타틴 헤미칼슘염의 신규한 결정형, 이의 수화물, 및 그의 제조방법
KR101324862B1 (ko) * 2011-07-12 2013-11-01 (주)에이에스텍 클로피도그렐 황산수소염의 구형 입자, 이를 포함하는 약학적 조성물 및 이의 제조방법
TWI665190B (zh) 2013-11-15 2019-07-11 阿克比治療有限公司 ｛［５－（３－氯苯基）－３－羥基吡啶－２－羰基］胺基｝乙酸之固體型式，其組合物及用途
CN105055357A (zh) * 2015-09-25 2015-11-18 青岛华之草医药科技有限公司 一种治疗高胆固醇血症的药物阿托伐他汀钙组合物片剂
KR101723783B1 (ko) * 2017-02-24 2017-04-07 주식회사 경보제약 아토바스타틴 헤미칼슘염의 신규한 결정형, 이의 수화물, 및 그의 제조방법

Citations (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1997003958A1 (fr) * 1995-07-17 1997-02-06 Warner-Lambert Company Forme cristalline iii d'hemi-sel de calcium d'acide [r-(r*,r*)]-2(4-fluorophenyl)-beta-delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoique (atorvastatine)
WO1997003959A1 (fr) * 1995-07-17 1997-02-06 Warner-Lambert Company Formes cristallines d'hemi-sel de calcium d'acide [r-(r*,r*)]-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoique (atorvastatine)
WO2001036384A1 (fr) * 1999-11-17 2001-05-25 Teva Pharmaceutical Industries Ltd. Forme polymorphe de calcium d'atorvastatine
WO2001044180A1 (fr) * 1999-12-17 2001-06-21 Warner Lambert Research And Development Ireland Limited Procede de production a l'echelle industrielle de sel d'hemi-calcium trihydrate d'atorvastatine cristallise
WO2001044181A1 (fr) * 1999-12-17 2001-06-21 Warner Lambert Research And Development Ireland Limited Procede pour produire de l'atorvastatine calcique cristallin
WO2002041834A2 (fr) * 2000-11-03 2002-05-30 Teva Pharmaceutical Industries, Ltd. Atorvastatine hemicalcique forme vii
WO2002043732A1 (fr) * 2000-11-30 2002-06-06 Teva Pharmaceutical Industries Ltd. Nouvelles formes cristallines d'hemi-calcium d'atorvastatine et leurs procedes de preparation, et nouveaux procedes de preparation d'autres formes
WO2002051804A1 (fr) * 2000-12-27 2002-07-04 Ciba Specialty Chemicals Holding Inc. Formes cristallines d'atorvastatine
WO2002057229A1 (fr) * 2001-01-19 2002-07-25 Biocon India Limited FORME V CRISTALLINE DE SEL HEMICALCIQUE D'ACIDE [R-(R*,R*)]-2-(4-FLUOROPHENYL)-ß,$G(D)-DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1H-PYRROLE-1-HEPTANOIQUE (ATORVASTATINE)
WO2003004470A1 (fr) * 2001-06-29 2003-01-16 Warner-Lambert Company Llc Formes cristallines de sel hemicalcique d'acide [r-(r*,r*)]-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoique (atorvastatine)
WO2003011826A1 (fr) * 2001-07-30 2003-02-13 Dr. Reddy's Laboratories Ltd. Formes cristallines vi et vii de calcium d'atorvastatine
WO2003050085A1 (fr) * 2001-12-12 2003-06-19 Ivax Corporation Sel de calcium cristallin (2:1)de l'acide [r-(r*,r*)]-2-(4-fluorophenyl)-$g(b),$g(d)-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-heptanoique
WO2004022053A1 (fr) * 2002-09-03 2004-03-18 Morepen Laboratories Limited Forme vi de calcium d'atorvastatine ou hydrates de cette derniere
WO2004050618A2 (fr) * 2002-11-28 2004-06-17 Teva Pharmaceutical Industries Ltd. Forme cristalline

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
WO1997003958A1 (fr) * 1995-07-17 1997-02-06 Warner-Lambert Company Forme cristalline iii d'hemi-sel de calcium d'acide [r-(r*,r*)]-2(4-fluorophenyl)-beta-delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoique (atorvastatine)
WO1997003959A1 (fr) * 1995-07-17 1997-02-06 Warner-Lambert Company Formes cristallines d'hemi-sel de calcium d'acide [r-(r*,r*)]-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoique (atorvastatine)
WO2001036384A1 (fr) * 1999-11-17 2001-05-25 Teva Pharmaceutical Industries Ltd. Forme polymorphe de calcium d'atorvastatine
WO2001044180A1 (fr) * 1999-12-17 2001-06-21 Warner Lambert Research And Development Ireland Limited Procede de production a l'echelle industrielle de sel d'hemi-calcium trihydrate d'atorvastatine cristallise
WO2001044181A1 (fr) * 1999-12-17 2001-06-21 Warner Lambert Research And Development Ireland Limited Procede pour produire de l'atorvastatine calcique cristallin
WO2002041834A2 (fr) * 2000-11-03 2002-05-30 Teva Pharmaceutical Industries, Ltd. Atorvastatine hemicalcique forme vii
WO2002043732A1 (fr) * 2000-11-30 2002-06-06 Teva Pharmaceutical Industries Ltd. Nouvelles formes cristallines d'hemi-calcium d'atorvastatine et leurs procedes de preparation, et nouveaux procedes de preparation d'autres formes
WO2002051804A1 (fr) * 2000-12-27 2002-07-04 Ciba Specialty Chemicals Holding Inc. Formes cristallines d'atorvastatine
WO2002057229A1 (fr) * 2001-01-19 2002-07-25 Biocon India Limited FORME V CRISTALLINE DE SEL HEMICALCIQUE D'ACIDE [R-(R*,R*)]-2-(4-FLUOROPHENYL)-ß,$G(D)-DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1H-PYRROLE-1-HEPTANOIQUE (ATORVASTATINE)
WO2003004470A1 (fr) * 2001-06-29 2003-01-16 Warner-Lambert Company Llc Formes cristallines de sel hemicalcique d'acide [r-(r*,r*)]-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoique (atorvastatine)
WO2003011826A1 (fr) * 2001-07-30 2003-02-13 Dr. Reddy's Laboratories Ltd. Formes cristallines vi et vii de calcium d'atorvastatine
WO2003050085A1 (fr) * 2001-12-12 2003-06-19 Ivax Corporation Sel de calcium cristallin (2:1)de l'acide [r-(r*,r*)]-2-(4-fluorophenyl)-$g(b),$g(d)-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-heptanoique
WO2004022053A1 (fr) * 2002-09-03 2004-03-18 Morepen Laboratories Limited Forme vi de calcium d'atorvastatine ou hydrates de cette derniere
WO2004050618A2 (fr) * 2002-11-28 2004-06-17 Teva Pharmaceutical Industries Ltd. Forme cristalline

Non-Patent Citations (1)

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

Also Published As

Publication number Publication date
MXPA04007939A (es) 2004-11-26
IS7402A (is) 2004-08-13
KR100724515B1 (ko) 2007-06-04
KR20040081202A (ko) 2004-09-20
EP1480950A1 (fr) 2004-12-01
JP2005519076A (ja) 2005-06-30
CN100406436C (zh) 2008-07-30
CA2475864A1 (fr) 2003-08-28
AU2003217653A1 (en) 2003-09-09
CN1646490A (zh) 2005-07-27
ES2241507T1 (es) 2005-11-01
JP2009235083A (ja) 2009-10-15
NO20043842L (no) 2004-09-14
HRP20040768A2 (en) 2005-06-30
WO2003070702A1 (fr) 2003-08-28
DE03713610T1 (de) 2005-10-20
PL372303A1 (en) 2005-07-11

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