DE60044884D1 - Verfahren zur Herstellung einer polymorphen Form von Atorvastatin calcium - Google Patents

Verfahren zur Herstellung einer polymorphen Form von Atorvastatin calcium

Info

Publication number
DE60044884D1
DE60044884D1 DE60044884T DE60044884T DE60044884D1 DE 60044884 D1 DE60044884 D1 DE 60044884D1 DE 60044884 T DE60044884 T DE 60044884T DE 60044884 T DE60044884 T DE 60044884T DE 60044884 D1 DE60044884 D1 DE 60044884D1
Authority
DE
Germany
Prior art keywords
preparation
atorvastatin calcium
polymorphic form
pharmaceutical compositions
atorvastatin
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 - Lifetime
Application number
DE60044884T
Other languages
German (de)
English (en)
Inventor
Ari Ayalon
Michal Levinger
Sofia Roytblat
Valerie Niddam
Revital Lifshitz
Judith Aronhime
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
Application granted granted Critical
Publication of DE60044884D1 publication Critical patent/DE60044884D1/de
Anticipated expiration legal-status Critical
Expired - Lifetime 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
    • C07D207/34—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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material 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)
  • Epidemiology (AREA)
  • Obesity (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Pyrrole Compounds (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Steroid Compounds (AREA)
DE60044884T 1999-11-17 2000-11-16 Verfahren zur Herstellung einer polymorphen Form von Atorvastatin calcium Expired - Lifetime DE60044884D1 (de)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
US16615399P 1999-11-17 1999-11-17

Publications (1)

Publication Number Publication Date
DE60044884D1 true DE60044884D1 (de) 2010-10-07

Family

ID=22602039

Family Applications (2)

Application Number Title Priority Date Filing Date
DE60044884T Expired - Lifetime DE60044884D1 (de) 1999-11-17 2000-11-16 Verfahren zur Herstellung einer polymorphen Form von Atorvastatin calcium
DE60018100T Expired - Lifetime DE60018100T2 (de) 1999-11-17 2000-11-16 Polymorphe form von atorvastatin-calcium

Family Applications After (1)

Application Number Title Priority Date Filing Date
DE60018100T Expired - Lifetime DE60018100T2 (de) 1999-11-17 2000-11-16 Polymorphe form von atorvastatin-calcium

Country Status (20)

Country Link
EP (3) EP2206497A1 (enExample)
JP (2) JP2003514798A (enExample)
KR (1) KR20020063190A (enExample)
CN (1) CN1423634A (enExample)
AT (2) ATE288893T1 (enExample)
AU (1) AU783002B2 (enExample)
CA (1) CA2392096C (enExample)
CZ (1) CZ20021642A3 (enExample)
DE (2) DE60044884D1 (enExample)
ES (2) ES2349364T3 (enExample)
HR (1) HRP20020429B8 (enExample)
HU (1) HUP0203257A3 (enExample)
IL (2) IL149681A0 (enExample)
PL (1) PL355805A1 (enExample)
PT (2) PT1235799E (enExample)
SI (2) SI1535613T1 (enExample)
SK (1) SK286789B6 (enExample)
WO (1) WO2001036384A1 (enExample)
YU (1) YU35802A (enExample)
ZA (1) ZA200203755B (enExample)

Families Citing this family (56)

* Cited by examiner, † Cited by third party
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US7411075B1 (en) 2000-11-16 2008-08-12 Teva Pharmaceutical Industries Ltd. Polymorphic form of atorvastatin calcium
PL362472A1 (en) * 2000-11-03 2004-11-02 Teva Pharma Atorvastatin hemi-calcium form vii
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
KR100790766B1 (ko) * 2000-12-27 2008-01-03 테바 파마슈티컬 인더스트리즈 리미티드 아토르바스타틴의 결정 형태, 이의 제조방법 및 이를 포함하는 약제학적 조성물
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)
EP1423364B1 (en) * 2001-06-29 2015-11-04 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)
US7074818B2 (en) 2001-07-30 2006-07-11 Dr. Reddy's Laboratories Limited Crystalline forms VI and VII of Atorvastatin calcium
JP2005500351A (ja) * 2001-07-30 2005-01-06 ドクター・レディーズ・ラボラトリーズ・リミテッド 結晶形態ｖｉおよびｖｉｉのアトルバスタチンカルシウム
UA77990C2 (en) * 2001-12-12 2007-02-15 Crystalline calcium salt of (2:1) [r-(r*,r*)]-2-(4-fluorophenyl)-?,?-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrroleheptanic acid
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
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
ATE409476T1 (de) * 2002-06-13 2008-10-15 Novartis Pharma Gmbh Calciumsalze von statinen aus indol
GB0218781D0 (en) * 2002-08-13 2002-09-18 Astrazeneca Ab Chemical process
CA2508871C (en) * 2002-11-28 2008-09-09 Teva Pharmaceutical Industries Ltd. Crystalline form f of atorvastatin hemi-calcium salt
EP1424324A1 (en) * 2002-11-28 2004-06-02 Teva Pharmaceutical Industries Limited Crystalline form F of Atorvastatin hemi-calcium salt
GB0312896D0 (en) 2003-06-05 2003-07-09 Astrazeneca Ab Chemical process
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
CA2465693A1 (en) * 2003-06-12 2004-12-12 Warner-Lambert Company Llc Pharmaceutical compositions of atorvastatin
US20050271717A1 (en) 2003-06-12 2005-12-08 Alfred Berchielli Pharmaceutical compositions of atorvastatin
UY28501A1 (es) 2003-09-10 2005-04-29 Astrazeneca Uk Ltd Compuestos químicos
GB0324791D0 (en) 2003-10-24 2003-11-26 Astrazeneca Ab Chemical process
EP1745020A2 (en) 2004-05-05 2007-01-24 Pfizer Products Incorporated Salt forms of atorvastatin
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).
EP1694685A1 (en) 2004-09-28 2006-08-30 Teva Pharmaceutical Industries Ltd Process for preparing forms of atorvastatin calcium substantially free of impurities
MX2007004425A (es) 2004-10-18 2007-06-07 Teva Pharma Proceso para preparar hemi-calcio de atorvastatina amorfo disolviendo la sal en un solvente organico que es una mezcla de un alcohol y una cetona y/o un ester y removiendo el solvente.
KR20070067175A (ko) 2004-10-28 2007-06-27 워너-램버트 캄파니 엘엘씨 무정형 아토르바스타틴 형성 방법
WO2006048894A1 (en) * 2004-11-05 2006-05-11 Morepen Laboratories Limited Novel crystalline forms of atorvastatin calcium and processes for preparing them.
CA2588216A1 (en) 2004-11-22 2006-05-26 Dexcel Pharma Technologies Ltd. Stable atorvastatin formulations
CA2499047A1 (en) 2005-03-01 2006-09-01 Apotex Pharmachem Inc. Process for producing atorvastatin hemicalcium
AU2006281229A1 (en) 2005-08-15 2007-02-22 Arrow International Limited Crystalline and amorphous sodium atorvastatin
WO2007020421A1 (en) * 2005-08-15 2007-02-22 Arrow International Limited Crystalline and amorphous sodium atorvastatin
CA2547216A1 (en) 2005-09-21 2007-03-21 Renuka D. Reddy Process for annealing amorphous atorvastatin
EP1808162A1 (en) 2005-11-21 2007-07-18 Teva Pharmaceutical Industries Ltd. Atorvastatin pharmaceutical formulation
EP1923057A1 (en) 2005-11-21 2008-05-21 Teva Pharmaceutical Industries Ltd Atorvastatin pharmaceutical formulation
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
MX2007014329A (es) * 2005-12-13 2008-03-19 Teva Pharma Forma cristalina de hemi-calcio de atorvastatina y procesos para la preparacion de ella.
EP1810667A1 (en) 2006-01-20 2007-07-25 KRKA, tovarna zdravil, d.d., Novo mesto Pharmaceutical composition comprising amorphous atorvastatin
US20090240064A1 (en) * 2006-02-22 2009-09-24 Venkata Panakala Rao Gogulapati Crystalline form of atorvastatin hemi-calcium
KR101012917B1 (ko) * 2007-03-02 2011-02-08 동아제약주식회사 피롤 헵탄산 화합물의 신규한 결정형
CA2694242C (en) 2007-06-29 2013-10-01 Generics [Uk] Limited Process for introduction of hydroxyethoxy side chain in bosentan
EP2185527A2 (en) * 2007-07-11 2010-05-19 Actavis Group PTC EHF Novel polymorph of atorvastatin calcium and use thereof for the preparation of amorphous atorvastatin calcium
US8530488B2 (en) 2007-10-24 2013-09-10 Generics [Uk] Limited Crystalline forms of bosentan
AU2009211159B2 (en) 2008-02-08 2013-02-07 Generics [Uk] Limited Process for preparing bosentan
NZ593117A (en) 2008-11-03 2013-03-28 Generics Uk Ltd HPLC METHOD FOR THE ANALYSIS OF BOSENTAN AND RELATED SUBSTANCES AND USE OF THESE SUBSTANCES AS REFERENCE STANDARDS AND MARKERS Chromatography mass spectrometry fragmentation
EP2327682A1 (en) * 2009-10-29 2011-06-01 KRKA, D.D., Novo Mesto Use of amphiphilic compounds for controlled crystallization of statins and statin intermediates
SI2373609T1 (sl) * 2008-12-19 2013-12-31 Krka, D.D., Novo Mesto Uporaba amfifilnih spojin za kontrolirano kristalizacijo statinov in intermediatov statinov
CZ201039A3 (cs) 2010-01-19 2011-07-27 Zentiva, K. S Zpusob prumyslové výroby amorfní formy hemivápenaté soli (3R,5R) 7-[3-fenyl-4-fenylkarbamoyl-2-(4-fluorfenyl)-5-isopropylpyrrol-1-yl]-3,5-dihydroxyheptanové kyseliny (atorvastatinu) s vysokým specifickým povrchem a jeho použití v lékové forme
KR20120011249A (ko) 2010-07-28 2012-02-07 주식회사 경보제약 아토바스타틴 헤미칼슘염의 신규한 결정형, 이의 수화물, 및 그의 제조방법
CN102249978A (zh) * 2011-06-09 2011-11-23 浙江金立源药业有限公司 阿托伐他汀钙的ky晶型及制备方法
CN103483238B (zh) * 2013-08-20 2014-12-31 蚌埠丰原医药科技发展有限公司 阿托伐他汀钙三水合物的制备方法
AU2014348523B2 (en) 2013-11-15 2019-01-03 Akebia Therapeutics, Inc. Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof
CN104945300B (zh) * 2015-06-17 2017-05-10 北京嘉林药业股份有限公司 一种ⅰ型阿托伐他汀钙的纯化方法
CN105085362B (zh) * 2015-09-18 2018-01-05 浙江海森药业有限公司 高纯度结晶型阿托伐他汀钙的制备方法
WO2025147589A1 (en) 2024-01-05 2025-07-10 Osanni Bio, Inc. Implants, compositions, and methods for treating retinal diseases and disorders

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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
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
SG45369A1 (en) * 1993-01-19 1998-10-16 Warner Lambert Co Stable oral ci-981 formulation and process of preparing same
DE69634054T2 (de) * 1995-07-17 2005-12-08 Warner-Lambert Co. Kristalline (R-(R*, R*))-2-(4-Fluorophenyl)-β, δ-Dihydroxy-5-(1-Methylethyl)-3-Phenyl-4-((Phenylamino)Carbonyl)-1H-Pyrrol-1-Heptancarbonsäure Hemi Calcium Salz (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)

Also Published As

Publication number Publication date
PT1535613E (pt) 2010-10-04
HUP0203257A3 (en) 2003-05-28
EP1535613B1 (en) 2010-08-25
ES2349364T3 (es) 2010-12-30
AU1617301A (en) 2001-05-30
EP1235799A4 (en) 2003-05-28
PL355805A1 (en) 2004-05-17
DE60018100D1 (en) 2005-03-17
KR20020063190A (ko) 2002-08-01
CA2392096C (en) 2008-07-15
JP2009102439A (ja) 2009-05-14
IL149681A0 (en) 2002-11-10
EP2206497A1 (en) 2010-07-14
EP1535613A3 (en) 2005-08-31
JP2003514798A (ja) 2003-04-22
CA2392096A1 (en) 2001-05-25
CZ20021642A3 (cs) 2003-05-14
SK286789B6 (sk) 2009-05-07
YU35802A (sh) 2005-07-19
HRP20020429A2 (en) 2004-04-30
AU783002B2 (en) 2005-09-15
ATE478665T1 (de) 2010-09-15
HRP20020429B1 (en) 2006-05-31
EP1235799A1 (en) 2002-09-04
HUP0203257A2 (hu) 2003-01-28
ATE288893T1 (de) 2005-02-15
WO2001036384A1 (en) 2001-05-25
ZA200203755B (en) 2004-05-26
DE60018100T2 (de) 2005-09-15
EP1235799B1 (en) 2005-02-09
SI1235799T1 (en) 2005-06-30
EP1535613A2 (en) 2005-06-01
IL149681A (en) 2007-06-17
ES2234699T3 (es) 2005-07-01
HRP20020429B8 (hr) 2007-03-31
CN1423634A (zh) 2003-06-11
SI1535613T1 (sl) 2010-12-31
SK6742002A3 (en) 2003-05-02
PT1235799E (pt) 2005-05-31

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