HRP20020429B8 - Polymorphic form of atorvastatin calcium - Google Patents
Polymorphic form of atorvastatin calciumInfo
- Publication number
- HRP20020429B8 HRP20020429B8 HR20020429A HRP20020429A HRP20020429B8 HR P20020429 B8 HRP20020429 B8 HR P20020429B8 HR 20020429 A HR20020429 A HR 20020429A HR P20020429 A HRP20020429 A HR P20020429A HR P20020429 B8 HRP20020429 B8 HR P20020429B8
- Authority
- HR
- Croatia
- Prior art keywords
- atorvastatin calcium
- polymorphic form
- theta
- peak
- hydrate
- 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 abstract 2
- 238000002441 X-ray diffraction Methods 0.000 abstract 1
- 239000007787 solid 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
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 (3)
Publication Number | Publication Date |
---|---|
HRP20020429A2 HRP20020429A2 (en) | 2004-04-30 |
HRP20020429B1 HRP20020429B1 (en) | 2006-05-31 |
HRP20020429B8 true HRP20020429B8 (en) | 2007-03-31 |
Family
ID=22602039
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HR20020429A HRP20020429B8 (en) | 1999-11-17 | 2002-05-16 | Polymorphic form of atorvastatin calcium |
Country Status (20)
Country | Link |
---|---|
EP (3) | EP1235799B1 (pt) |
JP (2) | JP2003514798A (pt) |
KR (1) | KR20020063190A (pt) |
CN (1) | CN1423634A (pt) |
AT (2) | ATE478665T1 (pt) |
AU (1) | AU783002B2 (pt) |
CA (1) | CA2392096C (pt) |
CZ (1) | CZ20021642A3 (pt) |
DE (2) | DE60044884D1 (pt) |
ES (2) | ES2349364T3 (pt) |
HR (1) | HRP20020429B8 (pt) |
HU (1) | HUP0203257A3 (pt) |
IL (2) | IL149681A0 (pt) |
PL (1) | PL355805A1 (pt) |
PT (2) | PT1235799E (pt) |
SI (2) | SI1235799T1 (pt) |
SK (1) | SK286789B6 (pt) |
WO (1) | WO2001036384A1 (pt) |
YU (1) | YU35802A (pt) |
ZA (1) | ZA200203755B (pt) |
Families Citing this family (55)
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 |
WO2002051804A1 (en) | 2000-12-27 | 2002-07-04 | Ciba Specialty Chemicals Holding Inc. | 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) |
CA2450111C (en) * | 2001-06-29 | 2006-02-07 | 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 |
EP1414796A1 (en) | 2001-07-30 | 2004-05-06 | Dr. Reddy's Laboratories Ltd. | Crystalline forms vi and vii of atorvastatin calcium |
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 | |
MXPA04007939A (es) * | 2002-02-15 | 2004-11-26 | Teva Pharma | Formas cristalinas novedosas de hemi-calcio de atorvastatina y procesos para su preparacion; procesos novedosos para la preparacion de hemi-calcio de atorvastatina en sus formas i, viii i ix. |
CN100379723C (zh) | 2002-02-19 | 2008-04-09 | 特瓦制药工业有限公司 | 阿托伐他汀半钙脱溶剂的方法和基本上不含有机溶剂的阿托伐他汀半钙 |
ES2315510T3 (es) * | 2002-06-13 | 2009-04-01 | Novartis Ag | Sales de calcio de estatinas derivadas del 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 |
ES2739493T3 (es) | 2004-05-05 | 2020-01-31 | Pfizer Prod Inc | Formas de sal de de atorvastatina con benetamina |
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 |
DE202005020841U1 (de) | 2004-09-28 | 2006-08-31 | Teva Pharmaceutical Industries Ltd. | Formen von Atorvastatin-Calcium, die im wesentlichen frei von Verunreinigungen sind |
DE05810535T1 (de) | 2004-10-18 | 2007-04-19 | Teva Pharmaceutical Industries Ltd. | Verfahren zur herstellung von amorphem atorvastatin-hemi-calcium durch lösen des salzes in einem organischen lösungsmittel, bei dem es sich um eine mischung enes alkohols und eines ketons und/oder eines esters handelt, und entfernen des lösungsmittels |
AU2005298383A1 (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. |
US20090208539A1 (en) | 2004-11-22 | 2009-08-20 | Adel Penhasi | 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 |
BRPI0614280A2 (pt) | 2005-08-15 | 2009-08-04 | Arrow Int Ltd | atorvastatina sódica cristalina e amorfa |
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 |
US8084488B2 (en) | 2005-11-21 | 2011-12-27 | Pfizer Inc. | Forms of [R-(R*,R*)]-2-(4-fluorophenyl)-β,δ-dihydroxy-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1H-pyrrole-1-heptanoic acid magnesium |
TW200745026A (en) | 2005-12-13 | 2007-12-16 | Teva Pharma | 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 |
EP1986997A4 (en) * | 2006-02-22 | 2010-09-15 | Matrix Lab Ltd | NEW CRYSTALLINE HEMI-CALCIUM FORM OF ATORVASTATIN |
KR101012917B1 (ko) * | 2007-03-02 | 2011-02-08 | 동아제약주식회사 | 피롤 헵탄산 화합물의 신규한 결정형 |
EP2170841A1 (en) | 2007-06-29 | 2010-04-07 | Merck Generics (UK) Limited | Process for 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 |
CA2703230A1 (en) | 2007-10-24 | 2009-04-30 | Generics [Uk] Limited | Novel crystalline forms |
US8785461B2 (en) | 2008-02-08 | 2014-07-22 | Generics [Uk] Limited | Process for preparing bosentan |
EP2350028A1 (en) | 2008-11-03 | 2011-08-03 | 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 |
PE20160945A1 (es) | 2013-11-15 | 2016-09-26 | Akebia Therapeutics Inc | Formas solidas de acido {[5-(3-clorofenil)-3-hidroxipiridin-2-carbonil]amino}acetico, composiciones, y usos de las mismas |
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 |
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 |
ATE178794T1 (de) * | 1993-01-19 | 1999-04-15 | Warner Lambert Co | Stabilisierte, oral anzuwendende zusammensetzung enthaltend die verbindung ci-981 und verfahren |
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) |
PT1148049E (pt) * | 1995-07-17 | 2005-02-28 | Warner Lambert Co | Formas cristalinas de hemi-sal de calcio do acido [r-(r*,r*)]-2-(4-fluorofenil)-beta,delta-dihidroxi-5-(1-metiletil)-3-fenil-4-[(fenilamino)-carbonil)-1h-pirrole-1-heptanoico (atorvastatina) |
-
2000
- 2000-11-16 AT AT04027375T patent/ATE478665T1/de not_active IP Right Cessation
- 2000-11-16 DE DE60044884T patent/DE60044884D1/de not_active Expired - Lifetime
- 2000-11-16 PL PL00355805A patent/PL355805A1/xx not_active Application Discontinuation
- 2000-11-16 SK SK674-2002A patent/SK286789B6/sk not_active IP Right Cessation
- 2000-11-16 ES ES04027375T patent/ES2349364T3/es not_active Expired - Lifetime
- 2000-11-16 CN CN00818409A patent/CN1423634A/zh active Pending
- 2000-11-16 PT PT00978744T patent/PT1235799E/pt unknown
- 2000-11-16 SI SI200030648T patent/SI1235799T1/xx unknown
- 2000-11-16 ES ES00978744T patent/ES2234699T3/es not_active Expired - Lifetime
- 2000-11-16 YU YU35802A patent/YU35802A/sh unknown
- 2000-11-16 IL IL14968100A patent/IL149681A0/xx active IP Right Grant
- 2000-11-16 AU AU16173/01A patent/AU783002B2/en not_active Ceased
- 2000-11-16 DE DE60018100T patent/DE60018100T2/de not_active Expired - Lifetime
- 2000-11-16 WO PCT/US2000/031555 patent/WO2001036384A1/en active IP Right Grant
- 2000-11-16 AT AT00978744T patent/ATE288893T1/de not_active IP Right Cessation
- 2000-11-16 EP EP00978744A patent/EP1235799B1/en not_active Expired - Lifetime
- 2000-11-16 EP EP10157435A patent/EP2206497A1/en not_active Withdrawn
- 2000-11-16 CZ CZ20021642A patent/CZ20021642A3/cs unknown
- 2000-11-16 CA CA002392096A patent/CA2392096C/en not_active Expired - Fee Related
- 2000-11-16 KR KR1020027006304A patent/KR20020063190A/ko not_active Application Discontinuation
- 2000-11-16 EP EP04027375A patent/EP1535613B1/en not_active Expired - Lifetime
- 2000-11-16 HU HU0203257A patent/HUP0203257A3/hu unknown
- 2000-11-16 PT PT04027375T patent/PT1535613E/pt unknown
- 2000-11-16 SI SI200031061T patent/SI1535613T1/sl unknown
- 2000-11-16 JP JP2001538875A patent/JP2003514798A/ja not_active Withdrawn
-
2002
- 2002-05-10 ZA ZA200203755A patent/ZA200203755B/en unknown
- 2002-05-15 IL IL149681A patent/IL149681A/en unknown
- 2002-05-16 HR HR20020429A patent/HRP20020429B8/xx not_active IP Right Cessation
-
2009
- 2009-02-12 JP JP2009030514A patent/JP2009102439A/ja active Pending
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