DE07776925T1 - Kristalline Form eines nach der Lagerung stabilen Atorvastatin-Calciums - Google Patents

Kristalline Form eines nach der Lagerung stabilen Atorvastatin-Calciums Download PDF

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Publication number
DE07776925T1
DE07776925T1 DE07776925T DE07776925T DE07776925T1 DE 07776925 T1 DE07776925 T1 DE 07776925T1 DE 07776925 T DE07776925 T DE 07776925T DE 07776925 T DE07776925 T DE 07776925T DE 07776925 T1 DE07776925 T1 DE 07776925T1
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Germany
Prior art keywords
calcium
crystalline form
atorvastatin hemi
storage
crystalline
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DE07776925T
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DE07776925T8 (de
Inventor
Judith Aronhime
Ramy Lindor-Hadas
Valerie Niddam-Hildesheim
Shlomit Wizel
Revital Lifshitz-Liron
Michael Pinchasov
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Teva Pharmaceutical Industries Ltd
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Teva Pharmaceutical Industries Ltd
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Publication of DE07776925T1 publication Critical patent/DE07776925T1/de
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    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/06—Antihyperlipidemics
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07D—HETEROCYCLIC COMPOUNDS
    • C07D493/00—Heterocyclic compounds containing oxygen atoms as the only ring hetero atoms in the condensed system
    • C07D493/02—Heterocyclic compounds containing oxygen atoms as the only ring hetero atoms in the condensed system in which the condensed system contains two hetero rings
    • C07D493/04—Ortho-condensed systems

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  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Pyrrole Compounds (AREA)

Abstract

Kristalline Form von Atorvastatin-Hemi-Calcium, gekennzeichnet durch ein Pulverröntgenbeugungsmuster mit Peaks bei 6,9, 9,3, 9,6, 16,3, 17,1, 19,2, 20,0, 21,6, 22,4, 23,9, 24,7, 25,6 und 26,5 ± 0,2 Grad 2θ, die gegen die Bildung von Atorvastatin-calciumepoxydihydroxy (AED) stabil ist.

Claims (8)

  1. Kristalline Form von Atorvastatin-Hemi-Calcium, gekennzeichnet durch ein Pulverröntgenbeugungsmuster mit Peaks bei 6,9, 9,3, 9,6, 16,3, 17,1, 19,2, 20,0, 21,6, 22,4, 23,9, 24,7, 25,6 und 26,5 ± 0,2 Grad 2θ, die gegen die Bildung von Atorvastatin-calciumepoxydihydroxy (AED) stabil ist.
  2. Kristalline Form von Atorvastatin-Hemi-Calcium nach Anspruch 1, welche nach Lagerung bei einer Temperatur von etwa 40°C bei einer relativen Feuchte von etwa 75% für wenigstens etwa einen Monat weniger als etwa 0,01% (w/w) AED enthält.
  3. Kristalline Form von Atorvastatin-Hemi-Calcium nach Anspruch 1, welche nach Lagerung bei einer Temperatur von etwa 25°C bei einer relativen Feuchte von etwa 60% für wenigstens etwa 6 Monate weniger als etwa 0,01% (w/w) AED enthält.
  4. Kristalline Form von Atorvastatin-Hemi-Calcium nach einem der Ansprüche 1 bis 3, welche ein Isopropanolat oder ein Ethanolat ist.
  5. Pharmazeutische Zusammensetzung, welche das Atorvastatin-Hemi-Calcium nach einem der vorangegangenen Ansprüche umfaßt.
  6. Kristallines Atorvastatin-Hemi-Calcium nach einem der Ansprüche 1 bis 4 zur Verwendung in der Therapie.
  7. Kristallines Atorvastatin-Hemi-Calcium nach einem der Ansprüche 1 bis 4 zur Verwendung beim Reduzieren von Cholesterol oder LDL.
  8. Verwendung eines kristallinen Atorvastatin-Hemi-Calciums nach einem der Ansprüche 1 bis 4 für die Herstellung eines Medikaments zum Reduzieren von Cholesterol oder LDL.
DE07776925T 2006-05-09 2007-05-08 Kristalline Form eines nach der Lagerung stabilen Atorvastatin-Calciums Active DE07776925T8 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US20060431183 2006-05-09
US11/431,183 US20070265456A1 (en) 2006-05-09 2006-05-09 Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation as well as novel processes for preparing other forms
PCT/US2007/011236 WO2007133597A1 (en) 2006-05-09 2007-05-08 Crystalline form of atorvastatin calcium stable after storage

Publications (2)

Publication Number Publication Date
DE07776925T1 true DE07776925T1 (de) 2008-07-03
DE07776925T8 DE07776925T8 (de) 2009-04-30

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ID=38512661

Family Applications (1)

Application Number Title Priority Date Filing Date
DE07776925T Active DE07776925T8 (de) 2006-05-09 2007-05-08 Kristalline Form eines nach der Lagerung stabilen Atorvastatin-Calciums

Country Status (11)

Country Link
US (1) US20070265456A1 (de)
EP (1) EP2024331A1 (de)
JP (2) JP2009500429A (de)
KR (1) KR20080015510A (de)
CN (1) CN101437791A (de)
BR (1) BRPI0702876A2 (de)
CA (1) CA2649708A1 (de)
DE (1) DE07776925T8 (de)
ES (1) ES2312307T1 (de)
IL (1) IL194876A0 (de)
WO (1) WO2007133597A1 (de)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3009423A3 (de) * 2001-06-29 2016-12-28 Warner-Lambert Company LLC Kristalline formen des calciumsalzes (2:1) von [r-(r*,r*)]-2-(4-fluorphenyl)-beta, delta -dihydroxy-5-(1-methylethyl)-3-phenyl-4-(phenylamino)carbonyl]-1h-pyrrol-1-heptansäure (atorvastatin)
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
KR20120011249A (ko) 2010-07-28 2012-02-07 주식회사 경보제약 아토바스타틴 헤미칼슘염의 신규한 결정형, 이의 수화물, 및 그의 제조방법
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

Family Cites Families (10)

* 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
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)
ES2167587T3 (es) * 1995-07-17 2002-05-16 Warner Lambert Co Forma cristalina de la sal hemicalcica del acido (r-(r*,r*))-2-(4-fluorofenil)-beta,delta-dihidroxi-5-(1-metiletil)-3-fenil-4-((fenilamino)carbonil)-1h-pirrol-1-heptanoico (atorvastatina).
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
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
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
CN1997651B (zh) * 2004-07-16 2012-06-06 力奇制药公司 阿托伐他汀钙的氧化降解产物
ES2262459T1 (es) * 2004-07-22 2006-12-01 Teva Pharmaceutical Industries Ltd Nuevas formas cristalinas de atorvastatina semicalcica y procedimientos para su preparacion.
DE05800195T1 (de) * 2004-09-28 2006-12-28 Teva Pharmaceutical Industries Ltd. Verfahren zur Herstellung von Atorvastatin-Calcium, die im wesentlichen frei von Verunreinigungen sind

Also Published As

Publication number Publication date
CA2649708A1 (en) 2007-11-22
KR20080015510A (ko) 2008-02-19
US20070265456A1 (en) 2007-11-15
ES2312307T1 (es) 2009-03-01
CN101437791A (zh) 2009-05-20
DE07776925T8 (de) 2009-04-30
BRPI0702876A2 (pt) 2011-03-15
JP2007302665A (ja) 2007-11-22
WO2007133597A9 (en) 2008-01-24
JP2009500429A (ja) 2009-01-08
WO2007133597A1 (en) 2007-11-22
IL194876A0 (en) 2009-08-03
EP2024331A1 (de) 2009-02-18

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