SI1535613T1 - Postopek za pripravo polimorfne oblike atorvastatin kalcija - Google Patents
Postopek za pripravo polimorfne oblike atorvastatin kalcijaInfo
- Publication number
- SI1535613T1 SI1535613T1 SI200031061T SI200031061T SI1535613T1 SI 1535613 T1 SI1535613 T1 SI 1535613T1 SI 200031061 T SI200031061 T SI 200031061T SI 200031061 T SI200031061 T SI 200031061T SI 1535613 T1 SI1535613 T1 SI 1535613T1
- Authority
- SI
- Slovenia
- Prior art keywords
- preparing
- atorvastatin calcium
- polymorphic form
- pharmaceutical compositions
- atorvastatin
- Prior art date
Links
- OJRHUICOVVSGSY-RXMQYKEDSA-N (2s)-2-chloro-3-methylbutan-1-ol Chemical compound CC(C)[C@H](Cl)CO OJRHUICOVVSGSY-RXMQYKEDSA-N 0.000 title abstract 2
- 229960001770 atorvastatin calcium Drugs 0.000 title 1
- 238000004519 manufacturing process Methods 0.000 title 1
- 239000002552 dosage form Substances 0.000 abstract 1
- 239000008194 pharmaceutical composition Substances 0.000 abstract 1
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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/40—Heterocyclic 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
-
- 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
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)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US16615399P | 1999-11-17 | 1999-11-17 | |
| EP04027375A EP1535613B1 (en) | 1999-11-17 | 2000-11-16 | Process for preparing a polymorphic form of atorvastatin calcium |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SI1535613T1 true SI1535613T1 (sl) | 2010-12-31 |
Family
ID=22602039
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI200031061T SI1535613T1 (sl) | 1999-11-17 | 2000-11-16 | Postopek za pripravo polimorfne oblike atorvastatin kalcija |
| SI200030648T SI1235799T1 (en) | 1999-11-17 | 2000-11-16 | Polymorphic form of atorvastatin calcium |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI200030648T SI1235799T1 (en) | 1999-11-17 | 2000-11-16 | Polymorphic form of atorvastatin calcium |
Country Status (20)
| Country | Link |
|---|---|
| EP (3) | EP2206497A1 (enExample) |
| JP (2) | JP2003514798A (enExample) |
| KR (1) | KR20020063190A (enExample) |
| CN (1) | CN1423634A (enExample) |
| AT (2) | ATE288893T1 (enExample) |
| AU (1) | AU783002B2 (enExample) |
| CA (1) | CA2392096C (enExample) |
| CZ (1) | CZ20021642A3 (enExample) |
| DE (2) | DE60044884D1 (enExample) |
| ES (2) | ES2349364T3 (enExample) |
| HR (1) | HRP20020429B8 (enExample) |
| HU (1) | HUP0203257A3 (enExample) |
| IL (2) | IL149681A0 (enExample) |
| PL (1) | PL355805A1 (enExample) |
| PT (2) | PT1235799E (enExample) |
| SI (2) | SI1535613T1 (enExample) |
| SK (1) | SK286789B6 (enExample) |
| WO (1) | WO2001036384A1 (enExample) |
| YU (1) | YU35802A (enExample) |
| ZA (1) | ZA200203755B (enExample) |
Families Citing this family (56)
| 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 |
| 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 |
| 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 |
| KR100790766B1 (ko) * | 2000-12-27 | 2008-01-03 | 테바 파마슈티컬 인더스트리즈 리미티드 | 아토르바스타틴의 결정 형태, 이의 제조방법 및 이를 포함하는 약제학적 조성물 |
| 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) |
| 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 |
| JP2005500351A (ja) * | 2001-07-30 | 2005-01-06 | ドクター・レディーズ・ラボラトリーズ・リミテッド | 結晶形態viおよびviiのアトルバスタチンカルシウム |
| 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 | |
| WO2003070702A1 (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 |
| 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 |
| ATE409476T1 (de) * | 2002-06-13 | 2008-10-15 | Novartis Pharma Gmbh | Calciumsalze von statinen aus indol |
| GB0218781D0 (en) * | 2002-08-13 | 2002-09-18 | Astrazeneca Ab | Chemical process |
| CA2508871C (en) * | 2002-11-28 | 2008-09-09 | 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 |
| 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 |
| US7655692B2 (en) | 2003-06-12 | 2010-02-02 | Pfizer Inc. | Process for forming amorphous atorvastatin |
| CA2465693A1 (en) * | 2003-06-12 | 2004-12-12 | Warner-Lambert Company Llc | Pharmaceutical compositions of atorvastatin |
| US20050271717A1 (en) | 2003-06-12 | 2005-12-08 | Alfred Berchielli | Pharmaceutical compositions of 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 |
| EP1745020A2 (en) | 2004-05-05 | 2007-01-24 | Pfizer Products Incorporated | Salt forms of atorvastatin |
| 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). |
| EP1694685A1 (en) | 2004-09-28 | 2006-08-30 | Teva Pharmaceutical Industries Ltd | Process for preparing forms of atorvastatin calcium substantially free of impurities |
| MX2007004425A (es) | 2004-10-18 | 2007-06-07 | Teva Pharma | Proceso para preparar hemi-calcio de atorvastatina amorfo disolviendo la sal en un solvente organico que es una mezcla de un alcohol y una cetona y/o un ester y removiendo el solvente. |
| KR20070067175A (ko) | 2004-10-28 | 2007-06-27 | 워너-램버트 캄파니 엘엘씨 | 무정형 아토르바스타틴 형성 방법 |
| WO2006048894A1 (en) * | 2004-11-05 | 2006-05-11 | Morepen Laboratories Limited | Novel crystalline forms of atorvastatin calcium and processes for preparing them. |
| CA2588216A1 (en) | 2004-11-22 | 2006-05-26 | Dexcel Pharma Technologies Ltd. | Stable atorvastatin formulations |
| CA2499047A1 (en) | 2005-03-01 | 2006-09-01 | Apotex Pharmachem Inc. | Process for producing atorvastatin hemicalcium |
| AU2006281229A1 (en) | 2005-08-15 | 2007-02-22 | Arrow International Limited | Crystalline and amorphous sodium atorvastatin |
| WO2007020421A1 (en) * | 2005-08-15 | 2007-02-22 | Arrow International Limited | Crystalline and amorphous sodium atorvastatin |
| CA2547216A1 (en) | 2005-09-21 | 2007-03-21 | Renuka D. Reddy | Process for annealing amorphous atorvastatin |
| EP1808162A1 (en) | 2005-11-21 | 2007-07-18 | Teva Pharmaceutical Industries Ltd. | Atorvastatin pharmaceutical formulation |
| EP1923057A1 (en) | 2005-11-21 | 2008-05-21 | Teva Pharmaceutical Industries Ltd | Atorvastatin pharmaceutical formulation |
| DE602006014193D1 (de) | 2005-11-21 | 2010-06-17 | Warner Lambert Co | Neue formen von är-(r*,r*)ü-2-(4-fluorphenyl)-b,d-dihydroxy-5-(1-methylethyl)-3-phenyl-4-ä(phenylamino)carbonylü-1h-pyrrol-1-heptansäure-magnesium |
| MX2007014329A (es) * | 2005-12-13 | 2008-03-19 | Teva Pharma | Forma cristalina de hemi-calcio de atorvastatina y procesos para la preparacion de ella. |
| 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 |
| KR101012917B1 (ko) * | 2007-03-02 | 2011-02-08 | 동아제약주식회사 | 피롤 헵탄산 화합물의 신규한 결정형 |
| CA2694242C (en) | 2007-06-29 | 2013-10-01 | Generics [Uk] Limited | Process for 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 |
| US8530488B2 (en) | 2007-10-24 | 2013-09-10 | Generics [Uk] Limited | Crystalline forms of bosentan |
| AU2009211159B2 (en) | 2008-02-08 | 2013-02-07 | Generics [Uk] Limited | Process for preparing bosentan |
| NZ593117A (en) | 2008-11-03 | 2013-03-28 | Generics Uk Ltd | HPLC METHOD FOR THE ANALYSIS OF BOSENTAN AND RELATED SUBSTANCES AND USE OF THESE SUBSTANCES AS REFERENCE STANDARDS AND MARKERS Chromatography mass spectrometry fragmentation |
| 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 |
| AU2014348523B2 (en) | 2013-11-15 | 2019-01-03 | Akebia Therapeutics, Inc. | Solid forms of {[5-(3-chlorophenyl)-3-hydroxypyridine-2-carbonyl]amino}acetic acid, compositions, and uses thereof |
| 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 |
| WO2025147589A1 (en) | 2024-01-05 | 2025-07-10 | Osanni Bio, Inc. | Implants, compositions, and methods for treating retinal diseases and disorders |
Family Cites Families (5)
| 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 |
| SG45369A1 (en) * | 1993-01-19 | 1998-10-16 | Warner Lambert Co | Stable oral ci-981 formulation and process of preparing same |
| DE69634054T2 (de) * | 1995-07-17 | 2005-12-08 | Warner-Lambert Co. | Kristalline (R-(R*, R*))-2-(4-Fluorophenyl)-β, δ-Dihydroxy-5-(1-Methylethyl)-3-Phenyl-4-((Phenylamino)Carbonyl)-1H-Pyrrol-1-Heptancarbonsäure Hemi Calcium Salz (Atorvastatin) |
| 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) |
-
2000
- 2000-11-16 SI SI200031061T patent/SI1535613T1/sl unknown
- 2000-11-16 EP EP10157435A patent/EP2206497A1/en not_active Withdrawn
- 2000-11-16 YU YU35802A patent/YU35802A/sh unknown
- 2000-11-16 DE DE60044884T patent/DE60044884D1/de not_active Expired - Lifetime
- 2000-11-16 KR KR1020027006304A patent/KR20020063190A/ko not_active Ceased
- 2000-11-16 AT AT00978744T patent/ATE288893T1/de not_active IP Right Cessation
- 2000-11-16 AT AT04027375T patent/ATE478665T1/de not_active IP Right Cessation
- 2000-11-16 SI SI200030648T patent/SI1235799T1/xx unknown
- 2000-11-16 PL PL00355805A patent/PL355805A1/xx not_active Application Discontinuation
- 2000-11-16 JP JP2001538875A patent/JP2003514798A/ja not_active Withdrawn
- 2000-11-16 PT PT00978744T patent/PT1235799E/pt unknown
- 2000-11-16 EP EP04027375A patent/EP1535613B1/en not_active Expired - Lifetime
- 2000-11-16 ES ES04027375T patent/ES2349364T3/es not_active Expired - Lifetime
- 2000-11-16 HR HR20020429A patent/HRP20020429B8/xx not_active IP Right Cessation
- 2000-11-16 CZ CZ20021642A patent/CZ20021642A3/cs unknown
- 2000-11-16 EP EP00978744A patent/EP1235799B1/en not_active Expired - Lifetime
- 2000-11-16 CA CA002392096A patent/CA2392096C/en not_active Expired - Fee Related
- 2000-11-16 IL IL14968100A patent/IL149681A0/xx active IP Right Grant
- 2000-11-16 CN CN00818409A patent/CN1423634A/zh active Pending
- 2000-11-16 HU HU0203257A patent/HUP0203257A3/hu unknown
- 2000-11-16 SK SK674-2002A patent/SK286789B6/sk not_active IP Right Cessation
- 2000-11-16 PT PT04027375T patent/PT1535613E/pt unknown
- 2000-11-16 DE DE60018100T patent/DE60018100T2/de not_active Expired - Lifetime
- 2000-11-16 ES ES00978744T patent/ES2234699T3/es not_active Expired - Lifetime
- 2000-11-16 WO PCT/US2000/031555 patent/WO2001036384A1/en not_active Ceased
- 2000-11-16 AU AU16173/01A patent/AU783002B2/en not_active Ceased
-
2002
- 2002-05-10 ZA ZA200203755A patent/ZA200203755B/en unknown
- 2002-05-15 IL IL149681A patent/IL149681A/en unknown
-
2009
- 2009-02-12 JP JP2009030514A patent/JP2009102439A/ja active Pending
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