ES2312307T1 - Forma cristalina de atorvastatina calcica estable tras almacenamiento. - Google Patents

Forma cristalina de atorvastatina calcica estable tras almacenamiento. Download PDF

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Publication number
ES2312307T1
ES2312307T1 ES07776925T ES07776925T ES2312307T1 ES 2312307 T1 ES2312307 T1 ES 2312307T1 ES 07776925 T ES07776925 T ES 07776925T ES 07776925 T ES07776925 T ES 07776925T ES 2312307 T1 ES2312307 T1 ES 2312307T1
Authority
ES
Spain
Prior art keywords
atorvastatin
crystalline form
storage
stable
calcica
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.)
Pending
Application number
ES07776925T
Other languages
English (en)
Inventor
Judith Aronhime
Ramy Lindor-Hadas
Valerie Niddam-Hildesheim
Shlomit Wizel
Revital Lifshitz-Liron
Michael Pinchasov
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 ES2312307T1 publication Critical patent/ES2312307T1/es
Pending legal-status Critical Current

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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
    • 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

Landscapes

  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Health & Medical Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Obesity (AREA)
  • Diabetes (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (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

Forma cristalina de atorvastatina hemicálcica, caracterizada porque presenta un patrón de difracción de rayos x en polvo que presenta unos picos a 6,9, 9,3, 9,6, 16,3, 17,1, 19,2, 20,0, 21,6, 22,4, 23,9, 24,7, 25,6 y 26,5 ñ 0,2 grados 2theta, que es estable contra la formación de atorvastatina cálcica epoxi dihidroxi (AED).

Claims (4)

1. Forma cristalina de atorvastatina hemicálcica, caracterizada porque presenta un patrón de difracción de rayos x en polvo que presenta unos picos a 6,9, 9,3, 9,6, 16,3, 17,1, 19,2, 20,0, 21,6, 22,4, 23,9, 24,7, 25,6 y 26,5 \pm 0,2 grados 2\theta, que es estable contra la formación de atorvastatina cálcica epoxi dihidroxi (AED).
2. Forma cristalina de atorvastatina hemicálcica según la reivindicación 1, que contiene menos de aproximadamente 0,01% (p/p) de AED tras el almacenamiento a una temperatura de aproximadamente 40ºC a una humedad relativa de aproximadamente 75% para un periodo de por lo menos aproximadamente 1 mes.
3. Forma cristalina de atorvastatina hemicálcica según la reivindicación 1, que contiene menos de aproximadamente 0,01% (p/p) de AED tras el almacenamiento a una temperatura de aproximadamente 25ºC a una humedad relativa de aproximadamente 60ºC durante un periodo de por lo menos aproximadamente 6 meses.
4. Forma cristalina de atorvastatina hemicálcica según cualquiera de las reivindicaciones 1 a 3, que es un isopropanolato o un etalonato.
ES07776925T 2006-05-09 2007-05-08 Forma cristalina de atorvastatina calcica estable tras almacenamiento. Pending ES2312307T1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
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
US431183 2006-05-09

Publications (1)

Publication Number Publication Date
ES2312307T1 true ES2312307T1 (es) 2009-03-01

Family

ID=38512661

Family Applications (1)

Application Number Title Priority Date Filing Date
ES07776925T Pending ES2312307T1 (es) 2006-05-09 2007-05-08 Forma cristalina de atorvastatina calcica estable tras almacenamiento.

Country Status (11)

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

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NZ529557A (en) * 2001-06-29 2005-05-27 Warner Lambert Co 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)
MX2007014329A (es) 2005-12-13 2008-03-19 Teva Pharma Forma cristalina de hemi-calcio de atorvastatina y procesos para la preparacion de ella.
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
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).
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)
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
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
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
BRPI0513396A (pt) * 2004-07-16 2008-05-06 Lek Pharmaceuticals produtos de degradação oxidativa de atorvastatina de cálcio
US20060063826A1 (en) * 2004-07-22 2006-03-23 Revital Lifshitz-Liron Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation
CA2579997A1 (en) * 2004-09-28 2006-04-06 Teva Pharmaceutical Industries Ltd. Process for preparing forms of atorvastatin calcium substantially free of impurities

Also Published As

Publication number Publication date
DE07776925T1 (de) 2008-07-03
JP2009500429A (ja) 2009-01-08
US20070265456A1 (en) 2007-11-15
DE07776925T8 (de) 2009-04-30
WO2007133597A9 (en) 2008-01-24
CA2649708A1 (en) 2007-11-22
KR20080015510A (ko) 2008-02-19
IL194876A0 (en) 2009-08-03
WO2007133597A1 (en) 2007-11-22
CN101437791A (zh) 2009-05-20
BRPI0702876A2 (pt) 2011-03-15
JP2007302665A (ja) 2007-11-22
EP2024331A1 (en) 2009-02-18

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