CA2426632C - Atorvastatin hemi-calcium form vii - Google Patents

Atorvastatin hemi-calcium form 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
Authority
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
Other languages
English (en)
French (fr)
Other versions
CA2426632A1 (en
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
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 CA2426632A1 publication Critical patent/CA2426632A1/en
Application granted granted Critical
Publication of CA2426632C publication Critical patent/CA2426632C/en
Anticipated expiration legal-status Critical
Expired - Fee Related legal-status Critical Current

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Classifications

    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D405/00Heterocyclic 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
    • C07D405/02Heterocyclic 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
    • C07D405/06Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/40Heterocyclic 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/06Anti-spasmodics, e.g. drugs for colics, esophagic dyskinesia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00Drugs for disorders of the cardiovascular system
    • A61P9/10Drugs 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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07DHETEROCYCLIC COMPOUNDS
    • C07D207/00Heterocyclic compounds containing five-membered rings not condensed with other rings, with one nitrogen atom as the only ring hetero atom
    • C07D207/02Heterocyclic 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
    • C07D207/30Heterocyclic 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
    • C07D207/34Heterocyclic 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

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Epidemiology (AREA)
  • Vascular Medicine (AREA)
  • Urology & Nephrology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Cardiology (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Pyrrole Compounds (AREA)
CA 2426632 2000-11-03 2001-11-05 Atorvastatin hemi-calcium form vii Expired - Fee Related CA2426632C (en)

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 (en) 2000-11-03 2001-11-05 Atorvastatin hemi-calcium form vii

Publications (2)

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

Family

ID=22928549

Family Applications (1)

Application Number Title Priority Date Filing Date
CA 2426632 Expired - Fee Related CA2426632C (en) 2000-11-03 2001-11-05 Atorvastatin hemi-calcium form vii

Country Status (18)

Country Link
US (1) US6605636B2 (cs)
EP (1) EP1332130A4 (cs)
JP (1) JP2004513956A (cs)
KR (1) KR100704213B1 (cs)
CN (1) CN1535139A (cs)
AU (1) AU4150602A (cs)
CA (1) CA2426632C (cs)
CZ (1) CZ20031495A3 (cs)
HR (1) HRP20030442A2 (cs)
HU (1) HUP0303765A2 (cs)
IL (2) IL155734A0 (cs)
IS (1) IS6798A (cs)
MX (1) MXPA03003900A (cs)
NO (1) NO20031986L (cs)
PL (1) PL362472A1 (cs)
SK (1) SK6592003A3 (cs)
WO (1) WO2002041834A2 (cs)
ZA (1) ZA200303972B (cs)

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
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
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
CA2622477A1 (en) * 2000-12-27 2002-07-04 Teva Pharmaceutical Industries Ltd. Crystalline forms of atorvastatin
BR0210666A (pt) 2001-06-29 2004-10-05 Warner Lambert Co Formas cristalinas do sal de cálcio do ácido [r-(r*,r*)]-2-(4-fluorofenil)-beta, delta-dihidróxi-5-(1-metiletil)-3-fenil-4-[(fenilamino)c arbonil]-1h-pirrol-1-heptanóico (2:1) (atorvastatina)
AU2002255479B2 (en) * 2001-07-30 2008-09-11 Dr. Reddy's Laboratories Ltd. Crystalline forms VI and VII of atorvastatin clacium
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
CA2475864A1 (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
HRP20040767A2 (en) * 2002-02-19 2004-12-31 Teva Pharma Desolvating solvates of atorvastatin hemi-calcium
EP1424324A1 (en) * 2002-11-28 2004-06-02 Teva Pharmaceutical Industries Limited Crystalline form F of Atorvastatin hemi-calcium salt
WO2004050618A2 (en) * 2002-11-28 2004-06-17 Teva Pharmaceutical Industries Ltd. Crystalline form f of atorvastatin hemi-calcium salt
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
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
PT1532975E (pt) * 2003-11-18 2007-04-30 Helm Ag Processo para a preparação de advorvidos de atorvastatina fluídos em pó
WO2005092852A1 (en) 2004-03-17 2005-10-06 Ranbaxy Laboratories Limited Process for the production of atorvastatin calcium in amorphous form
WO2005090301A1 (en) * 2004-03-17 2005-09-29 Ranbaxy Laboratories Limited Crystalline form of atorvastatin hemi calcium
CA2649054A1 (en) 2004-05-05 2005-11-10 Pfizer Products Inc. Salt forms of [r-(r*,r*)]-2-(4-fluorophenyl)-.beta., .delta.-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoic acid
CA2573969C (en) * 2004-07-16 2014-02-04 Lek Pharmaceuticals D.D. Oxidative degradation products of atorvastatin calcium
JP2008506764A (ja) 2004-07-20 2008-03-06 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 [R−(R*,R*)]−2−(4−フルオロフェニル)−β、δ−ジヒドロキシ−5−(1−メチルエチル)−3−フェニル−4−[(フェニルアミノ)カルボニル]−1H−ピロール−1−ヘプタン酸カルシウム塩(2:1)の新規形態
WO2006037125A1 (en) * 2004-09-28 2006-04-06 Teva Pharmaceutical Industries Ltd. Process for preparing forms of atorvastatin calcium substantially free of impurities
CN101039906A (zh) * 2004-10-18 2007-09-19 特瓦制药工业有限公司 通过将盐溶解于有机溶剂并除去该溶剂来制备无定形阿托伐他汀半钙的方法,所述有机溶剂为醇和酮和 /或酯的混合物
WO2006046109A1 (en) 2004-10-28 2006-05-04 Warner-Lambert Company Llc Process for forming amorphous atorvastatin
WO2006048894A1 (en) * 2004-11-05 2006-05-11 Morepen Laboratories Limited Novel crystalline forms of atorvastatin calcium and processes for preparing them.
SK288276B6 (sk) * 2005-04-08 2015-06-02 Egis Gyógyszergyár, Nyilvánosan Működő Részvénytársaság Spôsob prípravy kryštalickej polymorfnej formy hemivápenatej soli atorvastatínu
CA2547216A1 (en) * 2005-09-21 2007-03-21 Renuka D. Reddy Process for annealing amorphous atorvastatin
RU2395280C2 (ru) * 2005-11-21 2010-07-27 Тева Фармасьютикл Индастриес Лтд. Фармацевтическая лекарственная форма аторвастатина
ATE466840T1 (de) 2005-11-21 2010-05-15 Warner Lambert Co Neue formen von är-(r*,r*)ü-2-(4-fluorphenyl)-b,d-dihydroxy-5-( -methylethyl)-3-phenyl-4- ä(phenylamino)carbonylü-1h-pyrrol-1-heptansäure magnesium
US8080672B2 (en) 2005-12-13 2011-12-20 Teva Pharmaceutical Industries Ltd. Crystal form of atorvastatin hemi-calcium and processes for preparation thereof
EP1810667A1 (en) 2006-01-20 2007-07-25 KRKA, tovarna zdravil, d.d., Novo mesto Pharmaceutical composition comprising amorphous atorvastatin
EP1877375A1 (en) * 2006-03-01 2008-01-16 Teva Pharmaceutical Industries Ltd Process for preparing a crystalline form of atorvastatin hemi-calcium
US20090018182A1 (en) * 2006-06-28 2009-01-15 Sigalit Levi Crystalline forms of atorvastatin
EP2473515A4 (en) 2009-09-04 2013-11-27 Univ Toledo PROCESS FOR PREPARING OPTICALLY PURE BETA LACTONS FROM ALDEHYDE AND COMPOSITIONS MADE THEREOF
KR20120011249A (ko) 2010-07-28 2012-02-07 주식회사 경보제약 아토바스타틴 헤미칼슘염의 신규한 결정형, 이의 수화물, 및 그의 제조방법
MY180626A (en) 2013-11-15 2020-12-03 Akebia Therapeutics Inc Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof
KR101720894B1 (ko) 2016-01-05 2017-03-30 김상우 무좀치료에 도움을 주는 건식 족욕기

Family Cites Families (12)

* 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
US5245047A (en) 1988-02-22 1993-09-14 Warner-Lambert Company Process for trans-6-[2-(substituted-pyrrol-1-yl)alkyl]pyran-2-one inhibitors of cholesterol synthesis
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
GEP20002029B (en) * 1995-07-17 2000-04-10 Warner Lambert Company Us (54) 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)
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)
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)
ES2234699T3 (es) * 1999-11-17 2005-07-01 Teva Pharmaceutical Industries Ltd. Forma polimorfica de atorvastatina calcio.
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
CA2622477A1 (en) * 2000-12-27 2002-07-04 Teva Pharmaceutical Industries Ltd. 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)
BR0210666A (pt) * 2001-06-29 2004-10-05 Warner Lambert Co Formas cristalinas do sal de cálcio do ácido [r-(r*,r*)]-2-(4-fluorofenil)-beta, delta-dihidróxi-5-(1-metiletil)-3-fenil-4-[(fenilamino)c arbonil]-1h-pirrol-1-heptanóico (2:1) (atorvastatina)
AU2002255479B2 (en) * 2001-07-30 2008-09-11 Dr. Reddy's Laboratories Ltd. Crystalline forms VI and VII of atorvastatin clacium

Also Published As

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

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