DE07776925T1 - Kristalline Form eines nach der Lagerung stabilen Atorvastatin-Calciums - Google Patents
Kristalline Form eines nach der Lagerung stabilen Atorvastatin-Calciums Download PDFInfo
- 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
- Authority
- DE
- Germany
- Prior art keywords
- calcium
- crystalline form
- atorvastatin hemi
- storage
- crystalline
- 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.)
- Granted
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
- 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)
- 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.
- 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.
- 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.
- Kristalline Form von Atorvastatin-Hemi-Calcium nach einem der Ansprüche 1 bis 3, welche ein Isopropanolat oder ein Ethanolat ist.
- Pharmazeutische Zusammensetzung, welche das Atorvastatin-Hemi-Calcium nach einem der vorangegangenen Ansprüche umfaßt.
- Kristallines Atorvastatin-Hemi-Calcium nach einem der Ansprüche 1 bis 4 zur Verwendung in der Therapie.
- Kristallines Atorvastatin-Hemi-Calcium nach einem der Ansprüche 1 bis 4 zur Verwendung beim Reduzieren von Cholesterol oder LDL.
- Verwendung eines kristallinen Atorvastatin-Hemi-Calciums nach einem der Ansprüche 1 bis 4 für die Herstellung eines Medikaments zum Reduzieren von Cholesterol oder LDL.
Applications Claiming Priority (3)
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 |
US20060431183 | 2006-05-09 | ||
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 |
Family
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)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
UA74075C2 (en) * | 2001-06-29 | 2005-10-17 | Warner Lambert Co | NOVEL CRYSTALLINE FORMS [R-(R*,R*)]-2-(4-FLUOROPHENYL)-b, d-DIHYDROXY-5-(1-METHYLETHYL)-3-PHENYL-4-[(PHENYLAMINO)CARBONYL]-1??-PYRROLE-1-HEPTANOIC ACID CALCIUM SALT (2:1)(ATORVASTATIN) (VARIANTS) |
TW200745026A (en) | 2005-12-13 | 2007-12-16 | Teva Pharma | Crystal form of atorvastatin hemi-calcium and processes for preparation thereof |
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)
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) |
SI0848705T1 (en) * | 1995-07-17 | 2002-04-30 | Warner-Lambert Company | Crystalline r-(r*,r*))-2-(4-fluorophenyl)-beta,delta-dihydroxy-5-(1-methylethyl)-3-phenyl-4- (phenylamino)carbonyl)-1h-pyrrole-1-heptanoic acid hemi calcium salt (atorvastatin) |
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 (de) * | 2002-02-15 | 2005-05-18 | Teva Pharma | Neue kristallformen von atorvastatin-hemicalcium und verfahren zu deren herstellung, sowie neue verfahren zur herstellung der formen i, viii und ix von atorvastatin-hemicalcium |
CA2475123A1 (en) * | 2002-02-19 | 2003-08-28 | Teva Pharmaceutical Industries Ltd. | Desolvating solvates of atorvastatin hemi-calcium |
AU2005263550C1 (en) * | 2004-07-16 | 2013-01-17 | Lek Pharmaceuticals D.D. | Oxidative degradation products of atorvastatin calcium |
CA2575243A1 (en) * | 2004-07-22 | 2006-02-02 | Teva Pharmaceutical Industries Ltd. | Novel crystal forms of atorvastatin hemi-calcium and processes for their preparation |
TWI321132B (en) * | 2004-09-28 | 2010-03-01 | Teva Pharma | Process for preparing forms of atorvastatin calcium substantially free of impurities |
-
2006
- 2006-05-09 US US11/431,183 patent/US20070265456A1/en not_active Abandoned
-
2007
- 2007-05-08 WO PCT/US2007/011236 patent/WO2007133597A1/en active Application Filing
- 2007-05-08 ES ES07776925T patent/ES2312307T1/es active Pending
- 2007-05-08 JP JP2008520455A patent/JP2009500429A/ja active Pending
- 2007-05-08 DE DE07776925T patent/DE07776925T8/de active Active
- 2007-05-08 CN CNA2007800164419A patent/CN101437791A/zh active Pending
- 2007-05-08 CA CA002649708A patent/CA2649708A1/en not_active Abandoned
- 2007-05-08 KR KR1020087000648A patent/KR20080015510A/ko not_active Application Discontinuation
- 2007-05-08 EP EP07776925A patent/EP2024331A1/de not_active Withdrawn
- 2007-05-08 BR BRPI0702876-8A patent/BRPI0702876A2/pt not_active IP Right Cessation
- 2007-05-09 JP JP2007124711A patent/JP2007302665A/ja active Pending
-
2008
- 2008-10-23 IL IL194876A patent/IL194876A0/en unknown
Also Published As
Publication number | Publication date |
---|---|
ES2312307T1 (es) | 2009-03-01 |
IL194876A0 (en) | 2009-08-03 |
CA2649708A1 (en) | 2007-11-22 |
WO2007133597A1 (en) | 2007-11-22 |
US20070265456A1 (en) | 2007-11-15 |
CN101437791A (zh) | 2009-05-20 |
JP2009500429A (ja) | 2009-01-08 |
WO2007133597A9 (en) | 2008-01-24 |
DE07776925T8 (de) | 2009-04-30 |
BRPI0702876A2 (pt) | 2011-03-15 |
JP2007302665A (ja) | 2007-11-22 |
KR20080015510A (ko) | 2008-02-19 |
EP2024331A1 (de) | 2009-02-18 |
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Legal Events
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8596 | Reprint of erroneous front page |