SI1235799T1 - Polymorphic form of atorvastatin calcium - Google Patents
Polymorphic form of atorvastatin calciumInfo
- Publication number
- SI1235799T1 SI1235799T1 SI200030648T SI200030648T SI1235799T1 SI 1235799 T1 SI1235799 T1 SI 1235799T1 SI 200030648 T SI200030648 T SI 200030648T SI 200030648 T SI200030648 T SI 200030648T SI 1235799 T1 SI1235799 T1 SI 1235799T1
- Authority
- SI
- Slovenia
- Prior art keywords
- atorvastatin calcium
- polymorphic form
- pharmaceutical compositions
- dosage forms
- relates
- 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
- 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 | |
| PCT/US2000/031555 WO2001036384A1 (en) | 1999-11-17 | 2000-11-16 | Polymorphic form of atorvastatin calcium |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| SI1235799T1 true SI1235799T1 (en) | 2005-06-30 |
Family
ID=22602039
Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI200030648T SI1235799T1 (en) | 1999-11-17 | 2000-11-16 | Polymorphic form of atorvastatin calcium |
| SI200031061T SI1535613T1 (sl) | 1999-11-17 | 2000-11-16 | Postopek za pripravo polimorfne oblike atorvastatin kalcija |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| SI200031061T SI1535613T1 (sl) | 1999-11-17 | 2000-11-16 | Postopek za pripravo polimorfne oblike atorvastatin kalcija |
Country Status (20)
| Country | Link |
|---|---|
| EP (3) | EP1235799B1 (https=) |
| JP (2) | JP2003514798A (https=) |
| KR (1) | KR20020063190A (https=) |
| CN (1) | CN1423634A (https=) |
| AT (2) | ATE478665T1 (https=) |
| AU (1) | AU783002B2 (https=) |
| CA (1) | CA2392096C (https=) |
| CZ (1) | CZ20021642A3 (https=) |
| DE (2) | DE60044884D1 (https=) |
| ES (2) | ES2234699T3 (https=) |
| HR (1) | HRP20020429B8 (https=) |
| HU (1) | HUP0203257A3 (https=) |
| IL (2) | IL149681A0 (https=) |
| PL (1) | PL355805A1 (https=) |
| PT (2) | PT1535613E (https=) |
| SI (2) | SI1235799T1 (https=) |
| SK (1) | SK286789B6 (https=) |
| WO (1) | WO2001036384A1 (https=) |
| YU (1) | YU35802A (https=) |
| ZA (1) | ZA200203755B (https=) |
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 |
| KR100704213B1 (ko) * | 2000-11-03 | 2007-04-10 | 테바 파마슈티컬 인더스트리즈 리미티드 | 아토르바스타틴 헤미-칼슘 ｖｉｉ형 |
| 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 |
| CA2622477A1 (en) | 2000-12-27 | 2002-07-04 | Teva Pharmaceutical Industries Ltd. | Crystalline forms of atorvastatin |
| 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) |
| BR0210666A (pt) * | 2001-06-29 | 2004-10-05 | Warner Lambert Co | Formas cristalinas do sal de cálcio do ácido [r-(r*,r*)]-2-(4-fluorofenil)-beta, delta-dihidróxi-5-(1-metiletil)-3-fenil-4-[(fenilamino)c arbonil]-1h-pirrol-1-heptanóico (2:1) (atorvastatina) |
| US7074818B2 (en) | 2001-07-30 | 2006-07-11 | Dr. Reddy's Laboratories Limited | Crystalline forms VI and VII of Atorvastatin calcium |
| AU2002255479B2 (en) | 2001-07-30 | 2008-09-11 | Dr. Reddy's Laboratories Ltd. | Crystalline forms VI and VII of atorvastatin clacium |
| 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 | |
| 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 |
| HRP20040767A2 (en) | 2002-02-19 | 2004-12-31 | Teva Pharma | Desolvating solvates of atorvastatin hemi-calcium |
| 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 |
| WO2004050618A2 (en) * | 2002-11-28 | 2004-06-17 | 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 |
| US20050271717A1 (en) | 2003-06-12 | 2005-12-08 | Alfred Berchielli | Pharmaceutical compositions of atorvastatin |
| CA2465693A1 (en) * | 2003-06-12 | 2004-12-12 | Warner-Lambert Company Llc | Pharmaceutical compositions of atorvastatin |
| US7655692B2 (en) | 2003-06-12 | 2010-02-02 | Pfizer Inc. | Process for forming amorphous 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 |
| CA2649054A1 (en) | 2004-05-05 | 2005-11-10 | Pfizer Products Inc. | Salt forms of [r-(r*,r*)]-2-(4-fluorophenyl)-.beta., .delta.-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1h-pyrrole-1-heptanoic acid |
| JP2008506764A (ja) | 2004-07-20 | 2008-03-06 | ワーナー−ランバート カンパニー リミテッド ライアビリティー カンパニー | ［Ｒ−（Ｒ＊，Ｒ＊）］−２−（４−フルオロフェニル）−β、δ−ジヒドロキシ−５−（１−メチルエチル）−３−フェニル−４−［（フェニルアミノ）カルボニル］−１Ｈ−ピロール−１−ヘプタン酸カルシウム塩（２：１）の新規形態 |
| WO2006037125A1 (en) | 2004-09-28 | 2006-04-06 | Teva Pharmaceutical Industries Ltd. | Process for preparing forms of atorvastatin calcium substantially free of impurities |
| CN101039906A (zh) | 2004-10-18 | 2007-09-19 | 特瓦制药工业有限公司 | 通过将盐溶解于有机溶剂并除去该溶剂来制备无定形阿托伐他汀半钙的方法，所述有机溶剂为醇和酮和 /或酯的混合物 |
| WO2006046109A1 (en) | 2004-10-28 | 2006-05-04 | Warner-Lambert Company Llc | 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. |
| WO2006054308A2 (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 |
| EP1924555B1 (en) * | 2005-08-15 | 2014-10-08 | Arrow International Limited | Process for the preparation of crystalline 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 |
| ATE466840T1 (de) | 2005-11-21 | 2010-05-15 | Warner Lambert Co | Neue formen von är-(r*,r*)ü-2-(4-fluorphenyl)-b,d-dihydroxy-5-( -methylethyl)-3-phenyl-4- ä(phenylamino)carbonylü-1h-pyrrol-1-heptansäure magnesium |
| US8080672B2 (en) | 2005-12-13 | 2011-12-20 | 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 |
| AU2007219107B2 (en) * | 2006-02-22 | 2012-12-06 | Mylan Laboratories Ltd. | New crystalline form of Atorvastatin hemi-calcium |
| JP2010520273A (ja) * | 2007-03-02 | 2010-06-10 | ドン・ア・ファーム・カンパニー・リミテッド | ピロリルヘプタン酸誘導体の新規な結晶形態 |
| US8664390B2 (en) | 2007-06-29 | 2014-03-04 | Generics (Uk) Limited | Process for the introduction of hydroxyethoxy side chain in bosentan |
| 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 |
| NZ585438A (en) | 2007-10-24 | 2012-09-28 | Generics Uk Ltd | Novel crystalline forms of 4-tert-butyl-N-[6-(2-hydroxyethoxy)-5-(2-methoxyphenoxy)-2-(2-pyrimidinyl)-pyrimidin-4-yI]-benzenesulfonamide |
| CA2712860C (en) | 2008-02-08 | 2014-11-18 | Abhay Gaitonde | Process for preparing bosentan |
| CA2741928A1 (en) | 2008-11-03 | 2010-06-03 | Generics [Uk] Limited | Hplc method for the analysis of bosentan and related substances and use of these substances as reference standards and markers |
| EP2373609B1 (en) * | 2008-12-19 | 2013-10-16 | KRKA, D.D., Novo Mesto | Use of amphiphilic compounds for controlled crystallization of statins and statin intermediates |
| 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 |
| 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 |
| MY180626A (en) | 2013-11-15 | 2020-12-03 | 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 |
| JP3254219B2 (ja) * | 1993-01-19 | 2002-02-04 | ワーナー−ランバート・コンパニー | 安定な経口用のｃｉ−９８１製剤およびその製法 |
| GEP20002029B (en) | 1995-07-17 | 2000-04-10 | Warner Lambert Company Us | (54) Crystalline [R-(R*,R*,]–2-(4-Fluorophenyl)-Beta,Delta-Dihydroxy-5-(1-Methyl-Ethyl)-3-Phenyl–4-{Phenylamino) Carbonyl} - 1H - Pyrrole - 1 - Heptanoic Acid Hemi Calcium Salt (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 ES ES00978744T patent/ES2234699T3/es not_active Expired - Lifetime
- 2000-11-16 PT PT04027375T patent/PT1535613E/pt unknown
- 2000-11-16 KR KR1020027006304A patent/KR20020063190A/ko not_active Ceased
- 2000-11-16 PL PL00355805A patent/PL355805A1/xx not_active Application Discontinuation
- 2000-11-16 ES ES04027375T patent/ES2349364T3/es not_active Expired - Lifetime
- 2000-11-16 SI SI200030648T patent/SI1235799T1/xx unknown
- 2000-11-16 EP EP00978744A patent/EP1235799B1/en not_active Expired - Lifetime
- 2000-11-16 CZ CZ20021642A patent/CZ20021642A3/cs unknown
- 2000-11-16 EP EP10157435A patent/EP2206497A1/en not_active Withdrawn
- 2000-11-16 YU YU35802A patent/YU35802A/sh unknown
- 2000-11-16 HU HU0203257A patent/HUP0203257A3/hu unknown
- 2000-11-16 EP EP04027375A patent/EP1535613B1/en not_active Expired - Lifetime
- 2000-11-16 DE DE60044884T patent/DE60044884D1/de not_active Expired - Lifetime
- 2000-11-16 JP JP2001538875A patent/JP2003514798A/ja not_active Withdrawn
- 2000-11-16 AT AT04027375T patent/ATE478665T1/de not_active IP Right Cessation
- 2000-11-16 SI SI200031061T patent/SI1535613T1/sl unknown
- 2000-11-16 AT AT00978744T patent/ATE288893T1/de not_active IP Right Cessation
- 2000-11-16 DE DE60018100T patent/DE60018100T2/de not_active Expired - Lifetime
- 2000-11-16 IL IL14968100A patent/IL149681A0/xx active IP Right Grant
- 2000-11-16 SK SK674-2002A patent/SK286789B6/sk not_active IP Right Cessation
- 2000-11-16 AU AU16173/01A patent/AU783002B2/en not_active Ceased
- 2000-11-16 CA CA002392096A patent/CA2392096C/en not_active Expired - Fee Related
- 2000-11-16 HR HR20020429A patent/HRP20020429B8/xx not_active IP Right Cessation
- 2000-11-16 WO PCT/US2000/031555 patent/WO2001036384A1/en not_active Ceased
- 2000-11-16 PT PT00978744T patent/PT1235799E/pt unknown
- 2000-11-16 CN CN00818409A patent/CN1423634A/zh active Pending
-
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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