CA2431068A1 - Crystalline forms of atorvastatin - Google Patents
Crystalline forms of atorvastatin Download PDFInfo
- Publication number
- CA2431068A1 CA2431068A1 CA002431068A CA2431068A CA2431068A1 CA 2431068 A1 CA2431068 A1 CA 2431068A1 CA 002431068 A CA002431068 A CA 002431068A CA 2431068 A CA2431068 A CA 2431068A CA 2431068 A1 CA2431068 A1 CA 2431068A1
- Authority
- CA
- Canada
- Prior art keywords
- crystalline forms
- atorvastatin
- directed
- present
- forms
- 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
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Abstract
The present invention is directed to new crystalline forms of Atorvastatin calcium (2:1), referred to hereinafter as polymorphic Forms X, A, B, B2, C, D
and E. Furthermore, the present invention is directed to processes for the preparation of these crystalline forms and pharmaceutical compositions comprising the crystalline forms.
and E. Furthermore, the present invention is directed to processes for the preparation of these crystalline forms and pharmaceutical compositions comprising the crystalline forms.
Priority Applications (6)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CA002622697A CA2622697A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002623599A CA2623599A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002622477A CA2622477A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002626317A CA2626317A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002622727A CA2622727A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002623600A CA2623600A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP00811249 | 2000-12-27 | ||
EP00811249.2 | 2000-12-27 | ||
PCT/EP2001/015012 WO2002051804A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
Related Child Applications (6)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002626317A Division CA2626317A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002622477A Division CA2622477A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002622697A Division CA2622697A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002623599A Division CA2623599A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002623600A Division CA2623600A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002622727A Division CA2622727A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2431068A1 true CA2431068A1 (en) | 2002-07-04 |
CA2431068C CA2431068C (en) | 2008-06-10 |
Family
ID=8175112
Family Applications (7)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002622477A Abandoned CA2622477A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002626317A Abandoned CA2626317A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002623599A Abandoned CA2623599A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002622697A Abandoned CA2622697A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002623600A Abandoned CA2623600A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002622727A Abandoned CA2622727A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002431068A Expired - Fee Related CA2431068C (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
Family Applications Before (6)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002622477A Abandoned CA2622477A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002626317A Abandoned CA2626317A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002623599A Abandoned CA2623599A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002622697A Abandoned CA2622697A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002623600A Abandoned CA2623600A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
CA002622727A Abandoned CA2622727A1 (en) | 2000-12-27 | 2001-12-19 | Crystalline forms of atorvastatin |
Country Status (23)
Country | Link |
---|---|
US (4) | US7538136B2 (en) |
EP (2) | EP1345896B1 (en) |
JP (2) | JP2004516311A (en) |
KR (1) | KR100790766B1 (en) |
CN (1) | CN1273449C (en) |
AT (1) | ATE420070T1 (en) |
AU (1) | AU2002224952B2 (en) |
CA (7) | CA2622477A1 (en) |
CZ (1) | CZ20032019A3 (en) |
DE (1) | DE60137364D1 (en) |
ES (1) | ES2319870T3 (en) |
HR (1) | HRP20030607A2 (en) |
HU (1) | HUP0302519A3 (en) |
IL (1) | IL156280A0 (en) |
IS (1) | IS6859A (en) |
MX (1) | MXPA03005879A (en) |
NO (1) | NO20032758D0 (en) |
NZ (1) | NZ527048A (en) |
PL (1) | PL365312A1 (en) |
PT (1) | PT1345896E (en) |
SK (1) | SK9532003A3 (en) |
WO (1) | WO2002051804A1 (en) |
ZA (1) | ZA200304297B (en) |
Families Citing this family (37)
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 |
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 |
CA2622477A1 (en) * | 2000-12-27 | 2002-07-04 | Teva Pharmaceutical Industries Ltd. | Crystalline forms of atorvastatin |
EP1423364B1 (en) * | 2001-06-29 | 2015-11-04 | 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 |
EE200400048A (en) * | 2001-07-30 | 2004-04-15 | Dr. Reddy's Laboratories Ltd. | Crystalline Forms VI and VII of Atorvastatin Calcium |
EP1425287A4 (en) * | 2001-08-16 | 2005-09-07 | Teva Pharma | Processes for preparing calcium salt forms of statins |
EP1572638A4 (en) * | 2001-08-31 | 2010-05-05 | Morepen Lab Ltd | An improved process for the preparation of amorphous atorvastatin calcium salt (2:1) |
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 | |
CN100406436C (en) * | 2002-02-15 | 2008-07-30 | 特瓦制药工业有限公司 | 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 |
WO2003070665A2 (en) | 2002-02-19 | 2003-08-28 | Teva Pharmaceutical Industries Ltd. | Desolvating solvates of atorvastatin hemi-calcium |
WO2004022053A1 (en) * | 2002-09-03 | 2004-03-18 | Morepen Laboratories Limited | Atorvastatin calcium form vi or hydrates thereof |
AU2003297594A1 (en) * | 2002-11-28 | 2004-06-23 | Teva Pharmaceutical Industries Ltd. | Crystalline form f of atorvastatin hemi-calcium salt |
EP1424324A1 (en) * | 2002-11-28 | 2004-06-02 | Teva Pharmaceutical Industries Limited | Crystalline form F of Atorvastatin hemi-calcium salt |
US7655692B2 (en) | 2003-06-12 | 2010-02-02 | Pfizer Inc. | Process for forming amorphous atorvastatin |
US20050271717A1 (en) | 2003-06-12 | 2005-12-08 | Alfred Berchielli | Pharmaceutical compositions of atorvastatin |
EP1761489A1 (en) * | 2004-03-17 | 2007-03-14 | Ranbaxy Laboratories Limited | Crystalline form of atorvastatin hemi calcium |
WO2005092852A1 (en) | 2004-03-17 | 2005-10-06 | Ranbaxy Laboratories Limited | Process for the production of atorvastatin calcium in amorphous form |
ES2739493T3 (en) | 2004-05-05 | 2020-01-31 | Pfizer Prod Inc | Salt forms of atorvastatin with benetamine |
EP1767625A4 (en) | 2004-06-11 | 2007-12-05 | Ginkgo Biomedical Res Inst Co | Activity regulator for interferon producing cell |
WO2006008091A2 (en) * | 2004-07-16 | 2006-01-26 | Lek Pharmaceuticals D.D. | Oxidative degradation products of atorvastatin calcium |
CA2754932C (en) | 2004-07-20 | 2014-04-01 | Warner-Lambert Company Llc | Novel 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) |
NZ554541A (en) | 2004-10-28 | 2011-01-28 | Warner Lambert Co | 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. |
CA2499047A1 (en) * | 2005-03-01 | 2006-09-01 | Apotex Pharmachem Inc. | Process for producing atorvastatin hemicalcium |
EP1868993B1 (en) * | 2005-04-08 | 2014-04-30 | EGIS Gyógyszergyár Nyilvánosan Müködõ Részvénytársaság | Process for the preparation of a new crystalline atorvastatin hemicalcium salt polymorph form |
CA2547216A1 (en) | 2005-09-21 | 2007-03-21 | Renuka D. Reddy | Process for annealing amorphous atorvastatin |
ATE466840T1 (en) | 2005-11-21 | 2010-05-15 | Warner Lambert Co | NEW FORMS OF ÄR-(R*,R*)Ü-2-(4-FLUORPHENYL)-B,D-DIHYDROXY-5-(-METHYLETHYL)-3-PHENYL-4-Ä(PHENYLAMINO)CARBONYLÜ-1H-PYRROLE -1-HEPTANIC ACID MAGNESIUM |
CA2633268A1 (en) | 2005-12-13 | 2007-06-21 | Teva Pharmaceutical Industries Ltd. | Crystal form of atorvastatin hemi-calcium and processes for preparation thereof |
EP1810667A1 (en) | 2006-01-20 | 2007-07-25 | KRKA, tovarna zdravil, d.d., Novo mesto | Pharmaceutical composition comprising amorphous atorvastatin |
CA2655881A1 (en) * | 2006-06-28 | 2008-01-03 | Teva Pharmaceutical Industries Ltd. | Crystalline forms of atorvastatin |
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 |
KR20120011249A (en) * | 2010-07-28 | 2012-02-07 | 주식회사 경보제약 | Novel Crystal Form of Atorvastatin Hemi-Calcium, Hydrate thereof, and Method of Producing the Same |
CN104983702A (en) * | 2015-07-23 | 2015-10-21 | 青岛蓝盛洋医药生物科技有限责任公司 | Atorvastatin calcium composition tablet for treating hypercholesterolemia |
JP2019167295A (en) * | 2016-07-04 | 2019-10-03 | ゼリア新薬工業株式会社 | Method for producing calcium salt of 1, 5-benzodiazepine compound |
Family Cites Families (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
FI94339C (en) | 1989-07-21 | 1995-08-25 | Warner Lambert Co | Process for the preparation of pharmaceutically acceptable [R- (R *, R *)] - 2- (4-fluorophenyl) -, - dihydroxy-5- (1-methylethyl) -3-phenyl-4 - [(phenylamino) carbonyl] -1H- for the preparation of pyrrole-1-heptanoic acid and its pharmaceutically acceptable salts |
SG45369A1 (en) * | 1993-01-19 | 1998-10-16 | Warner Lambert Co | Stable oral ci-981 formulation and process of preparing same |
US5298627A (en) | 1993-03-03 | 1994-03-29 | Warner-Lambert Company | Process for trans-6-[2-(substituted-pyrrol-1-yl)alkyl]pyran-2-one inhibitors of cholesterol synthesis |
HRP960312B1 (en) | 1995-07-17 | 2001-10-31 | Warner Lambert Co | NOVEL PROCESS FOR THE PRODUCTION OF AMORPHOUS /R-(R*, R*)/-2-(4-FLUOROPHENYL)-"beta", "delta"-DIHYDROXY-5-PHENYL-4-/(PHENYLAMINO)CARBONYL/-1H-PYRROLE -1-HEPTANOIC ACID CALCIUM SALT (2 : 1) |
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) |
JP3296564B2 (en) * | 1995-07-17 | 2002-07-02 | ワーナー−ランバート・コンパニー | Crystalline [R- (R ▲ *, R ▲ *)]-2- (4-fluorophenyl) -β, δ-dihydroxy-5- (1-methylethyl) -3-phenyl-4 -[(Phenylamino) carbonyl] -1H-pyrrole-1-heptanoic acid hemicalcium salt (atorvastatin) |
WO2001036384A1 (en) * | 1999-11-17 | 2001-05-25 | Teva Pharmaceutical Industries Ltd. | Polymorphic form of atorvastatin calcium |
US7411075B1 (en) * | 2000-11-16 | 2008-08-12 | Teva Pharmaceutical Industries Ltd. | Polymorphic form of atorvastatin calcium |
DE60026737T2 (en) * | 1999-12-17 | 2006-09-21 | Pfizer Science And Technology Ireland Ltd., Dun Laoghaire | PROCESS FOR PREPARING CRYSTALLINE ATORVASTINE KALCIUM |
PL362472A1 (en) * | 2000-11-03 | 2004-11-02 | Teva Pharma | Atorvastatin hemi-calcium form vii |
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 |
CA2622477A1 (en) * | 2000-12-27 | 2002-07-04 | Teva Pharmaceutical Industries Ltd. | Crystalline forms of atorvastatin |
WO2002057228A1 (en) | 2001-01-17 | 2002-07-25 | Biocon India Limited | Atorvastatin calcium |
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) |
SI20814A (en) | 2001-01-23 | 2002-08-31 | LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d. | Preparation of amorphous atorvastatin |
SI20848A (en) | 2001-03-14 | 2002-10-31 | Lek, Tovarna Farmacevtskih In Kemijskih Izdelkov, D.D. | Pharmaceutical formulation containing atorvastatin calcium |
EP1423364B1 (en) * | 2001-06-29 | 2015-11-04 | 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) |
EE200400048A (en) * | 2001-07-30 | 2004-04-15 | Dr. Reddy's Laboratories Ltd. | Crystalline Forms VI and VII of Atorvastatin Calcium |
-
2001
- 2001-12-19 CA CA002622477A patent/CA2622477A1/en not_active Abandoned
- 2001-12-19 CA CA002626317A patent/CA2626317A1/en not_active Abandoned
- 2001-12-19 MX MXPA03005879A patent/MXPA03005879A/en active IP Right Grant
- 2001-12-19 SK SK953-2003A patent/SK9532003A3/en unknown
- 2001-12-19 AT AT01994809T patent/ATE420070T1/en not_active IP Right Cessation
- 2001-12-19 CZ CZ20032019A patent/CZ20032019A3/en unknown
- 2001-12-19 IL IL15628001A patent/IL156280A0/en not_active IP Right Cessation
- 2001-12-19 EP EP01994809A patent/EP1345896B1/en not_active Expired - Lifetime
- 2001-12-19 EP EP08016057A patent/EP2000461A1/en not_active Withdrawn
- 2001-12-19 KR KR1020037008685A patent/KR100790766B1/en not_active IP Right Cessation
- 2001-12-19 CA CA002623599A patent/CA2623599A1/en not_active Abandoned
- 2001-12-19 AU AU2002224952A patent/AU2002224952B2/en not_active Ceased
- 2001-12-19 DE DE60137364T patent/DE60137364D1/en not_active Expired - Fee Related
- 2001-12-19 JP JP2002552901A patent/JP2004516311A/en not_active Withdrawn
- 2001-12-19 NZ NZ527048A patent/NZ527048A/en unknown
- 2001-12-19 CN CNB018215017A patent/CN1273449C/en not_active Expired - Fee Related
- 2001-12-19 PT PT01994809T patent/PT1345896E/en unknown
- 2001-12-19 CA CA002622697A patent/CA2622697A1/en not_active Abandoned
- 2001-12-19 US US10/130,197 patent/US7538136B2/en not_active Expired - Fee Related
- 2001-12-19 CA CA002623600A patent/CA2623600A1/en not_active Abandoned
- 2001-12-19 ES ES01994809T patent/ES2319870T3/en not_active Expired - Lifetime
- 2001-12-19 WO PCT/EP2001/015012 patent/WO2002051804A1/en active IP Right Grant
- 2001-12-19 PL PL01365312A patent/PL365312A1/en not_active Application Discontinuation
- 2001-12-19 CA CA002622727A patent/CA2622727A1/en not_active Abandoned
- 2001-12-19 HU HU0302519A patent/HUP0302519A3/en unknown
- 2001-12-19 CA CA002431068A patent/CA2431068C/en not_active Expired - Fee Related
-
2003
- 2003-06-02 ZA ZA200304297A patent/ZA200304297B/en unknown
- 2003-06-17 NO NO20032758A patent/NO20032758D0/en not_active Application Discontinuation
- 2003-06-24 IS IS6859A patent/IS6859A/en unknown
- 2003-07-25 HR HR20030607A patent/HRP20030607A2/en not_active Application Discontinuation
-
2004
- 2004-06-02 US US10/860,084 patent/US20040220255A1/en not_active Abandoned
-
2006
- 2006-05-09 US US11/431,184 patent/US20060205805A1/en not_active Abandoned
-
2009
- 2009-04-17 US US12/386,413 patent/US20090281162A1/en not_active Abandoned
- 2009-05-27 JP JP2009127757A patent/JP2009221216A/en active Pending
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Legal Events
Date | Code | Title | Description |
---|---|---|---|
EEER | Examination request | ||
MKLA | Lapsed |