ATE288893T1 - Polymorphe form von atorvastatin-calcium - Google Patents

Polymorphe form von atorvastatin-calcium

Info

Publication number
ATE288893T1
ATE288893T1 AT00978744T AT00978744T ATE288893T1 AT E288893 T1 ATE288893 T1 AT E288893T1 AT 00978744 T AT00978744 T AT 00978744T AT 00978744 T AT00978744 T AT 00978744T AT E288893 T1 ATE288893 T1 AT E288893T1
Authority
AT
Austria
Prior art keywords
atorvastatin calcium
polymorphous form
polymorphous
pharmaceutical compositions
dosage forms
Prior art date
Application number
AT00978744T
Other languages
English (en)
Inventor
Ari Ayalon
Michal Levinger
Sofia Roytblat
Valerie Niddam
Revital Lifshitz
Judith Aronhime
Original Assignee
Teva Pharma
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 Pharma filed Critical Teva Pharma
Application granted granted Critical
Publication of ATE288893T1 publication Critical patent/ATE288893T1/de

Links

Classifications

    • 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
    • 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
    • A61P3/00Drugs for disorders of the metabolism
    • A61P3/06Antihyperlipidemics
AT00978744T 1999-11-17 2000-11-16 Polymorphe form von atorvastatin-calcium ATE288893T1 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US16615399P 1999-11-17 1999-11-17
PCT/US2000/031555 WO2001036384A1 (en) 1999-11-17 2000-11-16 Polymorphic form of atorvastatin calcium

Publications (1)

Publication Number Publication Date
ATE288893T1 true ATE288893T1 (de) 2005-02-15

Family

ID=22602039

Family Applications (2)

Application Number Title Priority Date Filing Date
AT04027375T ATE478665T1 (de) 1999-11-17 2000-11-16 Verfahren zur herstellung einer polymorphen form von atorvastatin calcium
AT00978744T ATE288893T1 (de) 1999-11-17 2000-11-16 Polymorphe form von atorvastatin-calcium

Family Applications Before (1)

Application Number Title Priority Date Filing Date
AT04027375T ATE478665T1 (de) 1999-11-17 2000-11-16 Verfahren zur herstellung einer polymorphen form von atorvastatin calcium

Country Status (20)

Country Link
EP (3) EP1235799B1 (de)
JP (2) JP2003514798A (de)
KR (1) KR20020063190A (de)
CN (1) CN1423634A (de)
AT (2) ATE478665T1 (de)
AU (1) AU783002B2 (de)
CA (1) CA2392096C (de)
CZ (1) CZ20021642A3 (de)
DE (2) DE60044884D1 (de)
ES (2) ES2349364T3 (de)
HR (1) HRP20020429B8 (de)
HU (1) HUP0203257A3 (de)
IL (2) IL149681A0 (de)
PL (1) PL355805A1 (de)
PT (2) PT1235799E (de)
SI (2) SI1235799T1 (de)
SK (1) SK286789B6 (de)
WO (1) WO2001036384A1 (de)
YU (1) YU35802A (de)
ZA (1) ZA200203755B (de)

Families Citing this family (55)

* Cited by examiner, † Cited by third party
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PL362472A1 (en) * 2000-11-03 2004-11-02 Teva Pharma Atorvastatin hemi-calcium form vii
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
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)
CA2450111C (en) * 2001-06-29 2006-02-07 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
EP1414796A1 (de) 2001-07-30 2004-05-06 Dr. Reddy's Laboratories Ltd. Kristalline formen vi und vii des kalzium atorvastatins
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
MXPA04007939A (es) * 2002-02-15 2004-11-26 Teva Pharma Formas cristalinas novedosas de hemi-calcio de atorvastatina y procesos para su preparacion; procesos novedosos para la preparacion de hemi-calcio de atorvastatina en sus formas i, viii i ix.
CN100379723C (zh) 2002-02-19 2008-04-09 特瓦制药工业有限公司 阿托伐他汀半钙脱溶剂的方法和基本上不含有机溶剂的阿托伐他汀半钙
ES2315510T3 (es) * 2002-06-13 2009-04-01 Novartis Ag Sales de calcio de estatinas derivadas del indol.
GB0218781D0 (en) 2002-08-13 2002-09-18 Astrazeneca Ab Chemical process
WO2004050618A2 (en) * 2002-11-28 2004-06-17 Teva Pharmaceutical Industries Ltd. Crystalline form f of atorvastatin hemi-calcium salt
EP1424324A1 (de) * 2002-11-28 2004-06-02 Teva Pharmaceutical Industries Limited Kristalline Form F von Atorvastatin
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
US20050271717A1 (en) 2003-06-12 2005-12-08 Alfred Berchielli Pharmaceutical compositions of atorvastatin
CA2465693A1 (en) * 2003-06-12 2004-12-12 Warner-Lambert Company Llc Pharmaceutical compositions of atorvastatin
US7655692B2 (en) 2003-06-12 2010-02-02 Pfizer Inc. Process for forming amorphous 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
ES2739493T3 (es) 2004-05-05 2020-01-31 Pfizer Prod Inc Formas de sal de de atorvastatina con benetamina
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
DE202005020841U1 (de) 2004-09-28 2006-08-31 Teva Pharmaceutical Industries Ltd. Formen von Atorvastatin-Calcium, die im wesentlichen frei von Verunreinigungen sind
DE05810535T1 (de) 2004-10-18 2007-04-19 Teva Pharmaceutical Industries Ltd. Verfahren zur herstellung von amorphem atorvastatin-hemi-calcium durch lösen des salzes in einem organischen lösungsmittel, bei dem es sich um eine mischung enes alkohols und eines ketons und/oder eines esters handelt, und entfernen des lösungsmittels
AU2005298383A1 (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.
US20090208539A1 (en) 2004-11-22 2009-08-20 Adel Penhasi 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
BRPI0614280A2 (pt) 2005-08-15 2009-08-04 Arrow Int Ltd atorvastatina sódica cristalina e amorfa
CA2547216A1 (en) 2005-09-21 2007-03-21 Renuka D. Reddy Process for annealing amorphous atorvastatin
EP1808162A1 (de) 2005-11-21 2007-07-18 Teva Pharmaceutical Industries Ltd. Pharmazeutische Formulierung von Atorvastatin
EP1923057A1 (de) 2005-11-21 2008-05-21 Teva Pharmaceutical Industries Ltd Pharmazeutische Atorvastatin-Formulierung
US8084488B2 (en) 2005-11-21 2011-12-27 Pfizer Inc. Forms of [R-(R*,R*)]-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid magnesium
TW200745026A (en) 2005-12-13 2007-12-16 Teva Pharma Crystal form of atorvastatin hemi-calcium and processes for preparation thereof
EP1810667A1 (de) 2006-01-20 2007-07-25 KRKA, tovarna zdravil, d.d., Novo mesto Pharmazeutische Zusammensetzung enthaltend amorphes Atorvastatin
EP1986997A4 (de) * 2006-02-22 2010-09-15 Matrix Lab Ltd Neue kristalline form von atorvastatin-hemicalcium
KR101012917B1 (ko) * 2007-03-02 2011-02-08 동아제약주식회사 피롤 헵탄산 화합물의 신규한 결정형
EP2170841A1 (de) 2007-06-29 2010-04-07 Merck Generics (UK) Limited Verfahren zur einführung einer hydroxyethoxy-seitenkette in bosentan
WO2009007856A2 (en) * 2007-07-11 2009-01-15 Actavis Group Ptc Ehf Novel polymorph of atorvastatin calcium and use thereof for the preparation of amorphous atorvastatin calcium
CA2703230A1 (en) 2007-10-24 2009-04-30 Generics [Uk] Limited Novel crystalline forms
US8785461B2 (en) 2008-02-08 2014-07-22 Generics [Uk] Limited Process for preparing bosentan
EP2350028A1 (de) 2008-11-03 2011-08-03 Generics [UK] Limited Hplc-methode zur analyse von bosentan und verwandten substanzen und die verwendung dieser substanzen als referenzstandards und marker
EP2373609B1 (de) * 2008-12-19 2013-10-16 KRKA, D.D., Novo Mesto Verwendung amphiphiler verbindungen zur kontrollierten kristallisation von statinen und statinzwischenprodukten
EP2327682A1 (de) * 2009-10-29 2011-06-01 KRKA, D.D., Novo Mesto Verwendung von amphiphilen Verbindungen zur gesteuerten Kristallisation von Statinen und Statin Zwischenprodukte.
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
PE20160945A1 (es) 2013-11-15 2016-09-26 Akebia Therapeutics Inc Formas solidas de acido {[5-(3-clorofenil)-3-hidroxipiridin-2-carbonil]amino}acetico, composiciones, y usos de las mismas
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

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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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PT1148049E (pt) * 1995-07-17 2005-02-28 Warner Lambert Co Formas cristalinas de hemi-sal de calcio do acido [r-(r*,r*)]-2-(4-fluorofenil)-beta,delta-dihidroxi-5-(1-metiletil)-3-fenil-4-[(fenilamino)-carbonil)-1h-pirrole-1-heptanoico (atorvastatina)

Also Published As

Publication number Publication date
SI1235799T1 (en) 2005-06-30
CN1423634A (zh) 2003-06-11
DE60044884D1 (de) 2010-10-07
PL355805A1 (en) 2004-05-17
SK286789B6 (sk) 2009-05-07
HRP20020429B8 (en) 2007-03-31
YU35802A (sh) 2005-07-19
EP1535613B1 (de) 2010-08-25
EP1235799B1 (de) 2005-02-09
CA2392096C (en) 2008-07-15
AU783002B2 (en) 2005-09-15
HRP20020429A2 (en) 2004-04-30
ZA200203755B (en) 2004-05-26
EP2206497A1 (de) 2010-07-14
SK6742002A3 (en) 2003-05-02
SI1535613T1 (sl) 2010-12-31
JP2003514798A (ja) 2003-04-22
HUP0203257A3 (en) 2003-05-28
AU1617301A (en) 2001-05-30
PT1235799E (pt) 2005-05-31
PT1535613E (pt) 2010-10-04
ES2349364T3 (es) 2010-12-30
EP1535613A3 (de) 2005-08-31
JP2009102439A (ja) 2009-05-14
HUP0203257A2 (hu) 2003-01-28
WO2001036384A1 (en) 2001-05-25
IL149681A (en) 2007-06-17
KR20020063190A (ko) 2002-08-01
HRP20020429B1 (en) 2006-05-31
ES2234699T3 (es) 2005-07-01
DE60018100D1 (en) 2005-03-17
CZ20021642A3 (cs) 2003-05-14
IL149681A0 (en) 2002-11-10
ATE478665T1 (de) 2010-09-15
DE60018100T2 (de) 2005-09-15
EP1535613A2 (de) 2005-06-01
EP1235799A4 (de) 2003-05-28
CA2392096A1 (en) 2001-05-25
EP1235799A1 (de) 2002-09-04

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