PT1235799E - Forma polimorfica de atorvastatina-calcio - Google Patents

Forma polimorfica de atorvastatina-calcio

Info

Publication number
PT1235799E
PT1235799E PT00978744T PT00978744T PT1235799E PT 1235799 E PT1235799 E PT 1235799E PT 00978744 T PT00978744 T PT 00978744T PT 00978744 T PT00978744 T PT 00978744T PT 1235799 E PT1235799 E PT 1235799E
Authority
PT
Portugal
Prior art keywords
polymoric
atorvastatin
calcium
pharmaceutical compositions
dosage forms
Prior art date
Application number
PT00978744T
Other languages
English (en)
Inventor
Revital Lifshitz
Judith Aronhime
Ayalon Ari
Levinger Michal
Roytblat Sofia
Niddam Valerie
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
Publication of PT1235799E publication Critical patent/PT1235799E/pt

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

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)
PT00978744T 1999-11-17 2000-11-16 Forma polimorfica de atorvastatina-calcio PT1235799E (pt)

Applications Claiming Priority (1)

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

Publications (1)

Publication Number Publication Date
PT1235799E true PT1235799E (pt) 2005-05-31

Family

ID=22602039

Family Applications (2)

Application Number Title Priority Date Filing Date
PT04027375T PT1535613E (pt) 1999-11-17 2000-11-16 Processo de preparação de uma forma polimórfica de atorvastatina de cálcio
PT00978744T PT1235799E (pt) 1999-11-17 2000-11-16 Forma polimorfica de atorvastatina-calcio

Family Applications Before (1)

Application Number Title Priority Date Filing Date
PT04027375T PT1535613E (pt) 1999-11-17 2000-11-16 Processo de preparação de uma forma polimórfica de atorvastatina de cálcio

Country Status (20)

Country Link
EP (3) EP2206497A1 (pt)
JP (2) JP2003514798A (pt)
KR (1) KR20020063190A (pt)
CN (1) CN1423634A (pt)
AT (2) ATE288893T1 (pt)
AU (1) AU783002B2 (pt)
CA (1) CA2392096C (pt)
CZ (1) CZ20021642A3 (pt)
DE (2) DE60018100T2 (pt)
ES (2) ES2234699T3 (pt)
HR (1) HRP20020429B8 (pt)
HU (1) HUP0203257A3 (pt)
IL (2) IL149681A0 (pt)
PL (1) PL355805A1 (pt)
PT (2) PT1535613E (pt)
SI (2) SI1535613T1 (pt)
SK (1) SK286789B6 (pt)
WO (1) WO2001036384A1 (pt)
YU (1) YU35802A (pt)
ZA (1) ZA200203755B (pt)

Families Citing this family (55)

* 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
CA2426632C (en) * 2000-11-03 2008-08-05 Teva Pharmaceutical Industries, Ltd. 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
CA2626317A1 (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)
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)
KR20040019043A (ko) 2001-07-30 2004-03-04 닥터 레디스 레보러터리즈 리미티드 아토바스탄틴 칼슘의 결정형 ⅵ 및 ⅶ
US7074818B2 (en) 2001-07-30 2006-07-11 Dr. Reddy's Laboratories Limited Crystalline forms VI and VII of Atorvastatin calcium
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
EP1480950A4 (en) * 2002-02-15 2005-05-18 Teva Pharma NOVEL HEMI-CALCIUM CRYSTALLINE FORMS OF ATORVASTATIN AND METHODS FOR THEIR PREPARATION, AS WELL AS NEW METHODS FOR THE PREPARATION OF FORORVASTATIN HEMI-CALCIUM FORMS I, VIII AND IX
US7122681B2 (en) 2002-02-19 2006-10-17 Teva Pharmaceutical Industries, Ltd. Desolvation process for the production of atorvastatin hemi-calcium essentially free of bound organic solvent
DE60323835D1 (de) * 2002-06-13 2008-11-13 Novartis Ag Calciumsalze von statinen aus indol
GB0218781D0 (en) 2002-08-13 2002-09-18 Astrazeneca Ab Chemical process
EP1424324A1 (en) * 2002-11-28 2004-06-02 Teva Pharmaceutical Industries Limited Crystalline form F of Atorvastatin hemi-calcium salt
EP1572643A2 (en) * 2002-11-28 2005-09-14 Teva Pharmaceutical Industries Ltd. 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
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
JP2007536373A (ja) 2004-05-05 2007-12-13 ファイザー・プロダクツ・インク アトルバスタチンの塩形態
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).
MX2007003652A (es) 2004-09-28 2009-02-16 Teva Pharma Proceso para preparar formas de calcio de atorvastatina sustancialmente libre de impurezas.
US20060106230A1 (en) 2004-10-18 2006-05-18 Michael Pinchasov Processes for preparing amorphous atorvastatin hemi-calcium
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 (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
CN101268047B (zh) * 2005-08-15 2012-11-07 箭锋国际有限公司 结晶和无定形阿托伐他汀钠
BRPI0614279A2 (pt) 2005-08-15 2012-11-06 Arrow Int Ltd atorvastatina sódica cristalina e amorfa
CA2547216A1 (en) 2005-09-21 2007-03-21 Renuka D. Reddy Process for annealing amorphous atorvastatin
PT1957452E (pt) 2005-11-21 2010-05-25 Warner Lambert Co Novas formas de ácido [r-(r*,r*)]-2-(4-fluorofenil)-b,b--di-hidroxi-5-(1-metiletil)-3-fenil-4-[(fenilamino)-carbonil]-1h-pirrole-1-heptanóico magnésico
EP1923057A1 (en) 2005-11-21 2008-05-21 Teva Pharmaceutical Industries Ltd Atorvastatin pharmaceutical formulation
EP1808162A1 (en) 2005-11-21 2007-07-18 Teva Pharmaceutical Industries Ltd. Atorvastatin pharmaceutical formulation
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
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
EP2132171A4 (en) * 2007-03-02 2010-11-17 Dong A Pharm Co Ltd NOVEL CRYSTALLINE FORMS OF PYRROLYLHEPTANOIC ACID DERIVATIVES
US8664390B2 (en) 2007-06-29 2014-03-04 Generics (Uk) Limited Process for the 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
JP2011500780A (ja) 2007-10-24 2011-01-06 ジェネリクス・(ユーケー)・リミテッド 新規結晶形
PT2245018T (pt) 2008-02-08 2017-12-05 Generics Uk Ltd Processo para preparar bosentano
EP2350028A1 (en) 2008-11-03 2011-08-03 Generics [UK] Limited Hplc method for the analysis of bosentan and related substances and use of these substances as reference standards and markers
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
MA39033A1 (fr) 2013-11-15 2017-11-30 Akebia Therapeutics Inc Formes solides d'acide {[5-(3-chlorophényl)-3-hydroxypyridine-2-carbonyl] amino}acétique, compositions et leurs utilisations
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
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
CA2150372C (en) * 1993-01-19 2002-08-20 Nancy L. Mills Stable oral ci-981 formulation and process of preparing same
EE03606B1 (et) * 1995-07-17 2002-02-15 Warner-Lambert Company Kristalliline [R-(R*,R*)]-2-(4-fluorofenüül)-beeta, delta-dihüdroksü-5-(1-metüületüül)-3-fenüül-4-[(fenüülamino)karbonüül]-1H-pürrool-1-hept aanhappehemikaltsiumsool (atorvastatiin)
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
YU35802A (sh) 2005-07-19
HRP20020429A2 (en) 2004-04-30
PL355805A1 (en) 2004-05-17
SI1235799T1 (en) 2005-06-30
PT1535613E (pt) 2010-10-04
EP1235799B1 (en) 2005-02-09
EP1535613A2 (en) 2005-06-01
HUP0203257A2 (hu) 2003-01-28
AU783002B2 (en) 2005-09-15
DE60018100T2 (de) 2005-09-15
KR20020063190A (ko) 2002-08-01
DE60018100D1 (en) 2005-03-17
SI1535613T1 (sl) 2010-12-31
WO2001036384A1 (en) 2001-05-25
EP1535613B1 (en) 2010-08-25
CN1423634A (zh) 2003-06-11
EP2206497A1 (en) 2010-07-14
SK6742002A3 (en) 2003-05-02
HRP20020429B8 (en) 2007-03-31
HRP20020429B1 (en) 2006-05-31
AU1617301A (en) 2001-05-30
IL149681A (en) 2007-06-17
ES2234699T3 (es) 2005-07-01
CA2392096C (en) 2008-07-15
ATE478665T1 (de) 2010-09-15
ZA200203755B (en) 2004-05-26
EP1535613A3 (en) 2005-08-31
ATE288893T1 (de) 2005-02-15
ES2349364T3 (es) 2010-12-30
SK286789B6 (sk) 2009-05-07
CZ20021642A3 (cs) 2003-05-14
DE60044884D1 (de) 2010-10-07
JP2009102439A (ja) 2009-05-14
IL149681A0 (en) 2002-11-10
EP1235799A4 (en) 2003-05-28
JP2003514798A (ja) 2003-04-22
EP1235799A1 (en) 2002-09-04
CA2392096A1 (en) 2001-05-25
HUP0203257A3 (en) 2003-05-28

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