CA2426632C - Atorvastatine hemicalcique forme vii - Google Patents

Atorvastatine hemicalcique forme vii Download PDF

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Publication number
CA2426632C
CA2426632C CA 2426632 CA2426632A CA2426632C CA 2426632 C CA2426632 C CA 2426632C CA 2426632 CA2426632 CA 2426632 CA 2426632 A CA2426632 A CA 2426632A CA 2426632 C CA2426632 C CA 2426632C
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CA
Canada
Prior art keywords
calcium
atorvastatin hemi
form vii
hydrates
theta
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.)
Expired - Fee Related
Application number
CA 2426632
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English (en)
Other versions
CA2426632A1 (fr
Inventor
Judith Aronhime
Ramy Lidor-Hadas
Valerie Niddam
Revital Lifshitz
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
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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 CA2426632A1 publication Critical patent/CA2426632A1/fr
Application granted granted Critical
Publication of CA2426632C publication Critical patent/CA2426632C/fr
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • 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
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/06—Anti-spasmodics, e.g. drugs for colics, esophagic dyskinesia
    • 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
    • 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

Abstract

L'invention concerne une nouvelle forme d'atorvastatine hémicalcique appelée forme VII, et de nouveaux procédés de préparation de celle-ci. Selon ces procédés, une autre forme cristalline d'atorvastatine hémicalcique est suspendue dans de l'éthanol, de préférence de l'éthanol absolu, et est transformée en ladite nouvelle forme, qui est ensuite isolée. L'invention concerne en outre un procédé visant à réduire le taux plasmatique de lipoprotéines de basse densité chez des patients atteints ou susceptibles d'être atteints d'hypercholestérolémie, ainsi que des compositions et des formes posologiques permettant de mettre en oeuvre le procédé.
CA 2426632 2000-11-03 2001-11-05 Atorvastatine hemicalcique forme vii Expired - Fee Related CA2426632C (fr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US24589700P 2000-11-03 2000-11-03
US60/245,897 2000-11-03
PCT/US2001/043947 WO2002041834A2 (fr) 2000-11-03 2001-11-05 Atorvastatine hemicalcique forme vii

Publications (2)

Publication Number Publication Date
CA2426632A1 CA2426632A1 (fr) 2002-05-30
CA2426632C true CA2426632C (fr) 2008-08-05

Family

ID=22928549

Family Applications (1)

Application Number Title Priority Date Filing Date
CA 2426632 Expired - Fee Related CA2426632C (fr) 2000-11-03 2001-11-05 Atorvastatine hemicalcique forme vii

Country Status (18)

Country Link
US (1) US6605636B2 (fr)
EP (1) EP1332130A4 (fr)
JP (1) JP2004513956A (fr)
KR (1) KR100704213B1 (fr)
CN (1) CN1535139A (fr)
AU (1) AU4150602A (fr)
CA (1) CA2426632C (fr)
CZ (1) CZ20031495A3 (fr)
HR (1) HRP20030442A2 (fr)
HU (1) HUP0303765A2 (fr)
IL (2) IL155734A0 (fr)
IS (1) IS6798A (fr)
MX (1) MXPA03003900A (fr)
NO (1) NO20031986D0 (fr)
PL (1) PL362472A1 (fr)
SK (1) SK6592003A3 (fr)
WO (1) WO2002041834A2 (fr)
ZA (1) ZA200303972B (fr)

Families Citing this family (38)

* 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
PT1345896E (pt) * 2000-12-27 2009-02-19 Teva Pharma Formas cristalinas de atorvastatina
RS100003A (en) * 2001-06-29 2007-02-05 Warner-Lambert Company, Crystalline forms of /r-(r*,r*)-2-(4- fluorphenyl)-beta,delta -dihydroxy-5(1- methylethyl)-phenyl-4-/phenylamino) carbonyl/-1h-pyrrole-1-heptanoic acid calcium salt (2:1) (atorvastatin)
CA2454500C (fr) * 2001-07-30 2009-11-10 Dr. Reddy's Laboratories Ltd. Formes cristallines vi et vii de calcium d'atorvastatine
US7074818B2 (en) 2001-07-30 2006-07-11 Dr. Reddy's Laboratories Limited Crystalline forms VI and VII of Atorvastatin calcium
US20060020137A1 (en) * 2001-11-29 2006-01-26 Limor Tessler Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms
ES2241507T1 (es) * 2002-02-15 2005-11-01 Teva Pharmaceutical Industries Ltd. Nuevas formas de cristal de atorvastatina semicalcica y procedimientos para su preparacion, asi como nuevos procedimientos para la preparacion de las formas i, viii y ix de atorvastatina semicalcica.
AU2003213171A1 (en) * 2002-02-19 2003-09-09 Teva Pharmaceutical Industries Ltd. Desolvating solvates of atorvastatin hemi-calcium
EP1572643A2 (fr) * 2002-11-28 2005-09-14 Teva Pharmaceutical Industries Ltd. Forme cristalline du sel hemi calcique de l'atorvastatine
EP1424324A1 (fr) * 2002-11-28 2004-06-02 Teva Pharmaceutical Industries Limited Forme cristalline F de calcium d'atorvastatine
FR2849029B1 (fr) 2002-12-20 2005-03-18 Lafon Labor Procede de preparation et formes cristallines des enantiomeres optiques du modafinil.
US7790197B2 (en) 2003-06-09 2010-09-07 Warner-Lambert Company Llc Pharmaceutical compositions of atorvastatin
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
ATE355052T1 (de) * 2003-11-18 2006-03-15 Helm Ag Verfahren zur herstellung von freifliessenden, pulverförmigen atorvastatin-adsorbaten
CA2560282A1 (fr) * 2004-03-17 2005-09-29 Ranbaxy Laboratories Limited Forme cristalline d'hemi-calcium d'atorvastatine
FI120344B (fi) 2004-03-17 2009-09-30 Ranbaxy Lab Ltd Menetelmä amorfisessa muodossa olevan atorvastatiinikalsiumin valmistamiseksi
EP1745020A2 (fr) 2004-05-05 2007-01-24 Pfizer Products Incorporated Formes salines d'acide ¬r-(r*, r*)|-2-(4-fluorophenyl)-beta, delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4-¬(phenylamino)carbonyl|-1h-pyrrole-1-heptanoique
US8044086B2 (en) * 2004-07-16 2011-10-25 Lek Pharmaceuticals D.D. Oxidative degradation products of atorvastatin calcium
MX2007000765A (es) 2004-07-20 2007-03-28 Warner Lambert Co Formas cristalinas de sal de calcio del acido (r-(r*, r*))-2- (4-fluorofenil)- beta,gama- dihidroxi-5- (1-metiletil)-3 -fenil-4-((fenilamino) (carbonil)-1ih -pirrol-1- heptanoico (2:1).
CN101124230A (zh) * 2004-09-28 2008-02-13 特瓦制药工业有限公司 制备基本无杂质的阿托伐他汀钙形式的方法
EP1716114A1 (fr) * 2004-10-18 2006-11-02 Teva Pharmaceutical Industries Ltd. Procede d'elaboration d'hemicalcium d'atorvastatine amorphe par dissolution du sel dans un solvant organique qui est un melange d'alcool et de cetone et/ou d'ester et elimination du solvant
JP2008517992A (ja) 2004-10-28 2008-05-29 ワーナー−ランバート カンパニー リミテッド ライアビリティー カンパニー アモルファスのアトルバスタチンを形成する方法
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
CA2547216A1 (fr) * 2005-09-21 2007-03-21 Renuka D. Reddy Procede de recuit de l'atorvastatine amorphe
US20070116758A1 (en) * 2005-11-21 2007-05-24 Dafna Dlugatch Atorvastatin formulation
WO2007057755A1 (fr) 2005-11-21 2007-05-24 Warner-Lambert Company Llc Nouvelles formes d’acide [r-(r*,r*)]-2-(4-fluorophenyl)-b,b-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoique magnesium
EP1966133A2 (fr) * 2005-12-13 2008-09-10 Teva Pharmaceutical Industries Ltd. Forme cristalline d hemi-calcium d atorvastatine et procedes de fabrication de celle-ci
EP1810667A1 (fr) 2006-01-20 2007-07-25 KRKA, tovarna zdravil, d.d., Novo mesto Composition pharmaceutique contenant de l'atorvastatin amorphé
CA2640573A1 (fr) * 2006-03-01 2007-09-13 Michael Pinchasov Procede de preparation d'une forme cristalline d'hemi-calcium d'atorvastatine
MX2008002804A (es) * 2006-06-28 2008-04-02 Teva Pharma Formas cristalinas de atorvastatina.
EP2473515A4 (fr) 2009-09-04 2013-11-27 Univ Toledo Procédés de fabrication de bêta-lactones optiquement pures à partir d'aldéhydes et compositions obtenues par ces procédés
KR20120011249A (ko) 2010-07-28 2012-02-07 주식회사 경보제약 아토바스타틴 헤미칼슘염의 신규한 결정형, 이의 수화물, 및 그의 제조방법
MX2021001169A (es) 2013-11-15 2023-02-10 Akebia Therapeutics Inc Formas sólidas de ácido {[5-(3-clorofenil)-3-hidroxipiridin-2-carb onil]amino}acético, composiciones, y usos de las mismas.
KR101720894B1 (ko) 2016-01-05 2017-03-30 김상우 무좀치료에 도움을 주는 건식 족욕기

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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
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FI94339C (fi) 1989-07-21 1995-08-25 Warner Lambert Co Menetelmä farmaseuttisesti käyttökelpoisen /R-(R*,R*)/-2-(4-fluorifenyyli)- , -dihydroksi-5-(1-metyylietyyli)-3-fenyyli-4-/(fenyyliamino)karbonyyli/-1H-pyrroli-1-heptaanihapon ja sen farmaseuttisesti hyväksyttävien suolojen valmistamiseksi
HRP960313B1 (en) * 1995-07-17 2002-08-31 Warner Lambert Co Form iii crystalline (r- (r*, r*)-2- (4-fluorophenyl) -beta-delta-hydroxy-5-(1-methylethyl) -3-phenyl-4- ((phenylamino) carbonyl -1h-pyrrole-1-heptanoic acid calcium salt (2:1)
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EP1535613B1 (fr) 1999-11-17 2010-08-25 Teva Pharmaceutical Industries, Ltd. Procédé pour la préparation d'une form polymorphe de 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
PT1345896E (pt) * 2000-12-27 2009-02-19 Teva Pharma Formas cristalinas de atorvastatina
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)
RS100003A (en) * 2001-06-29 2007-02-05 Warner-Lambert Company, Crystalline forms of /r-(r*,r*)-2-(4- fluorphenyl)-beta,delta -dihydroxy-5(1- methylethyl)-phenyl-4-/phenylamino) carbonyl/-1h-pyrrole-1-heptanoic acid calcium salt (2:1) (atorvastatin)
CA2454500C (fr) * 2001-07-30 2009-11-10 Dr. Reddy's Laboratories Ltd. Formes cristallines vi et vii de calcium d'atorvastatine

Also Published As

Publication number Publication date
US6605636B2 (en) 2003-08-12
HUP0303765A2 (hu) 2004-03-01
WO2002041834A8 (fr) 2003-01-03
WO2002041834A3 (fr) 2002-07-18
EP1332130A4 (fr) 2004-01-21
WO2002041834A2 (fr) 2002-05-30
IL155734A (en) 2008-11-26
CN1535139A (zh) 2004-10-06
IL155734A0 (en) 2003-11-23
CA2426632A1 (fr) 2002-05-30
EP1332130A2 (fr) 2003-08-06
MXPA03003900A (es) 2005-02-17
HRP20030442A2 (en) 2005-06-30
NO20031986L (no) 2003-05-02
PL362472A1 (en) 2004-11-02
CZ20031495A3 (cs) 2004-01-14
KR20040005854A (ko) 2004-01-16
KR100704213B1 (ko) 2007-04-10
IS6798A (is) 2003-04-30
NO20031986D0 (no) 2003-05-02
US20020115709A1 (en) 2002-08-22
JP2004513956A (ja) 2004-05-13
AU4150602A (en) 2002-06-03
SK6592003A3 (en) 2004-01-08
ZA200303972B (en) 2004-08-23

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