JP2004510817A5 - - Google Patents

Download PDF

Info

Publication number: JP2004510817A5
Authority: JP; Japan
Prior art keywords: pravastatin; sodium; composition; impurities; substantially pure
Prior art date: 2001-10-05
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

Application number

JP2002533858A

Other languages

English (en)

Japanese (ja)

Other versions

JP3737801B2 (ja

JP2004510817A (ja

Filing date

2001-10-05

Publication date

2005-10-20

2001-10-05 Application filed filed Critical

2001-10-05 Priority claimed from PCT/US2001/031230 external-priority patent/WO2002030415A1/en

2004-04-08 Publication of JP2004510817A publication Critical patent/JP2004510817A/ja

2005-10-20 Publication of JP2004510817A5 publication Critical patent/JP2004510817A5/ja

2006-01-25 Application granted granted Critical

2006-01-25 Publication of JP3737801B2 publication Critical patent/JP3737801B2/ja

2021-10-05 Anticipated expiration legal-status Critical

Status Expired - Fee Related legal-status Critical Current

Links

229960001495 Pravastatin Sodium Drugs 0.000 claims 45
VWBQYTRBTXKKOG-IYNICTALSA-M pravastatin sodium Chemical compound [Na+].C1=C[C@H](C)[C@H](CC[C@@H](O)C[C@@H](O)CC([O-])=O)[C@H]2[C@@H](OC(=O)[C@@H](C)CC)C[C@H](O)C=C21 VWBQYTRBTXKKOG-IYNICTALSA-M 0.000 claims 45
229960002965 Pravastatin Drugs 0.000 claims 37
TUZYXOIXSAXUGO-PZAWKZKUSA-N Pravastatin Chemical compound C1=C[C@H](C)[C@H](CC[C@@H](O)C[C@@H](O)CC(O)=O)[C@H]2[C@@H](OC(=O)[C@@H](C)CC)C[C@H](O)C=C21 TUZYXOIXSAXUGO-PZAWKZKUSA-N 0.000 claims 37
239000000203 mixture Substances 0.000 claims 32
239000012535 impurity Substances 0.000 claims 25
239000003960 organic solvent Substances 0.000 claims 16
239000002253 acid Substances 0.000 claims 14
150000003863 ammonium salts Chemical class 0.000 claims 13
OQARDMYXSOFTLN-PZAWKZKUSA-N [(1S,3S,7S,8S,8aR)-3-hydroxy-8-[2-[(2R,4R)-4-hydroxy-6-oxooxan-2-yl]ethyl]-7-methyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl] (2S)-2-methylbutanoate Chemical compound C([C@H]1[C@@H](C)C=CC2=C[C@@H](O)C[C@@H]([C@H]12)OC(=O)[C@@H](C)CC)C[C@@H]1C[C@@H](O)CC(=O)O1 OQARDMYXSOFTLN-PZAWKZKUSA-N 0.000 claims 12
239000002585 base Substances 0.000 claims 9
159000000000 sodium salts Chemical class 0.000 claims 9
238000000855 fermentation Methods 0.000 claims 8
230000004151 fermentation Effects 0.000 claims 8
150000003839 salts Chemical class 0.000 claims 8
239000011780 sodium chloride Substances 0.000 claims 8
125000000217 alkyl group Chemical group 0.000 claims 7
QAOWNCQODCNURD-UHFFFAOYSA-N Sulfuric acid Chemical compound OS(O)(=O)=O QAOWNCQODCNURD-UHFFFAOYSA-N 0.000 claims 6
239000012296 anti-solvent Substances 0.000 claims 6
238000000354 decomposition reaction Methods 0.000 claims 6
HEMHJVSKTPXQMS-UHFFFAOYSA-M sodium hydroxide Chemical group [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 6
239000000243 solution Substances 0.000 claims 6
238000000605 extraction Methods 0.000 claims 5
244000005700 microbiome Species 0.000 claims 5
239000007864 aqueous solution Substances 0.000 claims 4
238000002425 crystallisation Methods 0.000 claims 4
230000005712 crystallization Effects 0.000 claims 4
FGKJLKRYENPLQH-UHFFFAOYSA-M isocaproate Chemical group CC(C)CCC([O-])=O FGKJLKRYENPLQH-UHFFFAOYSA-M 0.000 claims 4
238000001953 recrystallisation Methods 0.000 claims 4
XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
NLXLAEXVIDQMFP-UHFFFAOYSA-N ammonia chloride Chemical compound [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 claims 3
BDAGIHXWWSANSR-UHFFFAOYSA-N formic acid Chemical compound OC=O BDAGIHXWWSANSR-UHFFFAOYSA-N 0.000 claims 3
238000000034 method Methods 0.000 claims 3
239000008194 pharmaceutical composition Substances 0.000 claims 3
FFWSICBKRCICMR-UHFFFAOYSA-N 5-Methyl-2-hexanone Chemical compound CC(C)CCC(C)=O FFWSICBKRCICMR-UHFFFAOYSA-N 0.000 claims 2
QTBSBXVTEAMEQO-UHFFFAOYSA-N Acetic acid Natural products CC(O)=O QTBSBXVTEAMEQO-UHFFFAOYSA-N 0.000 claims 2
230000002378 acidificating Effects 0.000 claims 2
239000003637 basic solution Substances 0.000 claims 2
239000000284 extract Substances 0.000 claims 2
238000004108 freeze drying Methods 0.000 claims 2
239000001963 growth media Substances 0.000 claims 2
239000003456 ion exchange resin Substances 0.000 claims 2
229920003303 ion-exchange polymer Polymers 0.000 claims 2
125000004108 n-butyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])C([H])([H])* 0.000 claims 2
125000004123 n-propyl group Chemical group [H]C([H])([H])C([H])([H])C([H])([H])* 0.000 claims 2
230000001376 precipitating Effects 0.000 claims 2
238000005185 salting out Methods 0.000 claims 2
239000002904 solvent Substances 0.000 claims 2
125000000218 acetic acid group Chemical group C(C)(=O)* 0.000 claims 1
125000005907 alkyl ester group Chemical group 0.000 claims 1
235000019270 ammonium chloride Nutrition 0.000 claims 1
150000001732 carboxylic acid derivatives Chemical class 0.000 claims 1
239000002552 dosage form Substances 0.000 claims 1
235000019253 formic acid Nutrition 0.000 claims 1
238000009472 formulation Methods 0.000 claims 1
150000007522 mineralic acids Chemical class 0.000 claims 1
QDHHCQZDFGDHMP-UHFFFAOYSA-N monochloramine Chemical group ClN QDHHCQZDFGDHMP-UHFFFAOYSA-N 0.000 claims 1

JP2002533858A 2000-10-05 2001-10-05 プラバスタチンラクトン及びエピプラバスタチンを実質的に含まないプラバスタチンナトリウム、並びにそれを含む組成物 Expired - Fee Related JP3737801B2 (ja)

Applications Claiming Priority (2)

Application Number	Priority Date	Filing Date	Title
US23827800P	2000-10-05	2000-10-05
PCT/US2001/031230 WO2002030415A1 (en)	2000-10-05	2001-10-05	Pravastatin sodium substantially free of pravastatin lactone and epi-pravastatin, and compositions containing same

Related Child Applications (2)

Application Number	Title	Priority Date	Filing Date
JP2004278522A Division JP2005013238A (ja)	2000-10-05	2004-09-24	プラバスタチンラクトン及びエピプラバスタチンを実質的に含まないプラバスタチンナトリウムの製造方法
JP2005237299A Division JP2006036781A (ja)	2000-10-05	2005-08-18	プラバスタチンラクトン及びエピプラバスタチンを実質的に含まないプラバスタチンナトリウムの製造方法

Publications (3)

Publication Number	Publication Date
JP2004510817A JP2004510817A (ja)	2004-04-08
JP2004510817A5 true JP2004510817A5 (de)	2005-10-20
JP3737801B2 JP3737801B2 (ja)	2006-01-25

Family

ID=22897222

Family Applications (6)

Application Number	Title	Priority Date	Filing Date
JP2002533858A Expired - Fee Related JP3737801B2 (ja)	2000-10-05	2001-10-05	プラバスタチンラクトン及びエピプラバスタチンを実質的に含まないプラバスタチンナトリウム、並びにそれを含む組成物
JP2004278522A Withdrawn JP2005013238A (ja)	2000-10-05	2004-09-24	プラバスタチンラクトン及びエピプラバスタチンを実質的に含まないプラバスタチンナトリウムの製造方法
JP2005237299A Pending JP2006036781A (ja)	2000-10-05	2005-08-18	プラバスタチンラクトン及びエピプラバスタチンを実質的に含まないプラバスタチンナトリウムの製造方法
JP2009191951A Withdrawn JP2009268479A (ja)	2000-10-05	2009-08-21	プラバスタチンラクトン及びエピプラバスタチンを実質的に含まないプラバスタチンナトリウムの製造方法
JP2013011711A Withdrawn JP2013128486A (ja)	2000-10-05	2013-01-25	プラバスタチンラクトン及びエピプラバスタチンを実質的に含まないプラバスタチンナトリウムの製造方法
JP2015152088A Pending JP2015212300A (ja)	2000-10-05	2015-07-31	プラバスタチンラクトン及びエピプラバスタチンを実質的に含まないプラバスタチンナトリウムの製造方法

Family Applications After (5)

Application Number	Title	Priority Date	Filing Date
JP2004278522A Withdrawn JP2005013238A (ja)	2000-10-05	2004-09-24	プラバスタチンラクトン及びエピプラバスタチンを実質的に含まないプラバスタチンナトリウムの製造方法
JP2005237299A Pending JP2006036781A (ja)	2000-10-05	2005-08-18	プラバスタチンラクトン及びエピプラバスタチンを実質的に含まないプラバスタチンナトリウムの製造方法
JP2009191951A Withdrawn JP2009268479A (ja)	2000-10-05	2009-08-21	プラバスタチンラクトン及びエピプラバスタチンを実質的に含まないプラバスタチンナトリウムの製造方法
JP2013011711A Withdrawn JP2013128486A (ja)	2000-10-05	2013-01-25	プラバスタチンラクトン及びエピプラバスタチンを実質的に含まないプラバスタチンナトリウムの製造方法
JP2015152088A Pending JP2015212300A (ja)	2000-10-05	2015-07-31	プラバスタチンラクトン及びエピプラバスタチンを実質的に含まないプラバスタチンナトリウムの製造方法

Country Status (18)

Country	Link
EP (1)	EP1330245A4 (de)
JP (6)	JP3737801B2 (de)
KR (1)	KR20030059173A (de)
CN (1)	CN1468098A (de)
AU (1)	AU2002211462A1 (de)
CA (1)	CA2422744A1 (de)
CZ (1)	CZ20031166A3 (de)
HR (1)	HRP20030347A2 (de)
HU (1)	HUP0400913A2 (de)
IL (1)	IL155194A0 (de)
IS (1)	IS6766A (de)
MX (1)	MXPA03002963A (de)
NO (1)	NO20031532L (de)
NZ (1)	NZ525631A (de)
PL (1)	PL361230A1 (de)
SK (1)	SK5232003A3 (de)
WO (1)	WO2002030415A1 (de)
ZA (1)	ZA200302313B (de)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
KR20030026920A (ko) *	1999-11-30	2003-04-03	비오갈 기오기스제르갸르 알티.	발효 브로스로부터 스타틴 화합물의 수집 방법
EP1798214A3 (de) *	1999-11-30	2007-08-01	Teva Gyogyszergyár Zártköruen Muködo Részvenytarsaság	Verfahren zur Gewinnung von Statinverbindungen aus einer Fermentationsbrühe
SI1265604T1 (sl) *	1999-11-30	2007-04-30	Sag Teva Gyogyszergyar Zartkoe	Postopek za ponovno pridobivanje statinskih spojin iz fermentacije brozge
US7001919B2 (en)	1999-12-14	2006-02-21	Teva Gyogyszergyar Reszvenytarsasag	Forms of pravastatin sodium
CA2422744A1 (en) *	2000-10-05	2002-04-18	Biogal Gyogyszergyar Rt.	Pravastatin sodium substantially free of pravastatin lactone and epi-pravastatin, and compositions containing same
JP3236282B1 (ja) *	2000-10-16	2001-12-10	三共株式会社	プラバスタチンを精製する方法
GB0218781D0 (en)	2002-08-13	2002-09-18	Astrazeneca Ab	Chemical process
EP1452519A1 (de) *	2003-02-25	2004-09-01	Balkanpharma-Razgrad AD	Verfahren zur Isolierung und Reinigung von Pravastatin-Natriumsalz
GB0312896D0 (en)	2003-06-05	2003-07-09	Astrazeneca Ab	Chemical process
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
DE202004020671U1 (de) *	2003-11-24	2005-12-08	Teva Gyogyszergyar Reszvenytarsasag	Pravastatin
NZ552389A (en)	2004-08-06	2009-05-31	Transform Pharmaceuticals Inc	Statin pharmaceutical compositions and related methods of treatment
ES2254028B1 (es) *	2004-11-29	2007-03-01	Ercros Industrial, S.A.	Procedimiento para la obtencion de pravastatina sodica purificada.
EP1851223A1 (de) *	2005-02-25	2007-11-07	Teva Pharmaceutical Industries Ltd	Verfahren zur reinigung von tadalafil
JP4813841B2 (ja) *	2005-07-25	2011-11-09	キユーピー株式会社	プラバスタチンナトリウムの製造方法
HU229260B1 (en) *	2010-11-29	2013-10-28	Egis Gyogyszergyar Nyrt	Process for preparation of rosuvastatin salts
CN114031496B (zh) *	2021-11-30	2024-09-27	广东蓝宝制药有限公司	一种高纯度普伐他汀1,1,3,3-四甲基丁胺的制备方法

Family Cites Families (25)

* Cited by examiner, † Cited by third party
Publication number	Priority date	Publication date	Assignee	Title
US3378441A (en) *	1963-10-17	1968-04-16	S B Penick & Company	Tetraene antibiotic purification
JPS5221594B2 (de) *	1973-09-29	1977-06-11
AU509313B2 (en) *	1975-02-07	1980-05-08	Beecham Group Plc	Clavulanic acid
US4231938A (en) *	1979-06-15	1980-11-04	Merck & Co., Inc.	Hypocholesteremic fermentation products and process of preparation
JPS572240A (en) *	1980-06-06	1982-01-07	Sankyo Co Ltd	Ml-236b derivative
MX7065E (es) *	1980-06-06	1987-04-10	Sankyo Co	Un procedimiento microbiologico para preparar derivados de ml-236b
JPS5889191A (ja) *	1981-11-20	1983-05-27	Sankyo Co Ltd	３−ヒドロキシ−ｍｌ−２３６ｂ誘導体の製造法
JPS5890509A (ja) *	1981-11-25	1983-05-30	Sankyo Co Ltd	高コレステロ−ル血症治療用組成物
JPH01190661A (ja) *	1988-01-22	1989-07-31	Konishi Kagaku Kogyo Kk	４，４′−ジヒドロキシジフエニルスルホンの精製法
JP2739328B2 (ja) *	1988-09-14	1998-04-15	日本ケミファ株式会社	ベンズイミダゾール化合物の精製方法
US5202029A (en) *	1991-03-13	1993-04-13	Caron Kabushiki Kaisha	Process for purification of hmg-coa reductase inhibitors
NZ250609A (en) *	1992-12-28	1995-07-26	Sankyo Co	Hexahydronaphthalene esters and ring closed lactones; preparation and medicaments
JPH06256278A (ja) *	1993-03-03	1994-09-13	Nissan Chem Ind Ltd	光学活性α−カルバモイルアルカン酸誘導体およびその製法
CA2126365C (en) *	1993-07-06	1999-08-24	Steven W. Felman	Recovery of citric acid from impure process streams by addition of strong acids and salts thereof
MX9604372A (es) *	1994-03-31	1997-06-28	Pfizer	Procedimiento para la recuperacion de natamicina.
AU6820096A (en) *	1995-08-03	1997-03-05	Gist-Brocades B.V.	Selective process for the deacylation of acylated compounds
JPH09124655A (ja) *	1995-11-01	1997-05-13	Sankyo Co Ltd	新規スクアレンシンターゼ阻害活性化合物
EP0877089A1 (de) *	1997-05-07	1998-11-11	Gist-Brocades B.V.	Verfahren zur Herstellung eines Inhibitors der Hmg-Coa Reduktase
SI20072A (sl) *	1998-09-18	2000-04-30	LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d.	Postopek za pridobivanje inhibitorjev HMG-CoA reduktaze
SI20070A (sl) *	1998-09-18	2000-04-30	LEK, tovarna farmacevtskih in kemi�nih izdelkov, d.d.	Nove soli inhibitorjev HMG-CoA reduktaze
JP2000229855A (ja) *	1998-12-07	2000-08-22	Satoshi Takebe	プラバスタチンナトリウム錠
KR20060061406A (ko) *	1999-02-03	2006-06-07	인스티튜트 포 드럭 리서치 리미티드	프라바스타틴을 제조하기 위한 미생물학적인 방법
HUP9902352A1 (hu) *	1999-07-12	2000-09-28	Gyógyszerkutató Intézet Kft.	Eljárás pravasztatin mikrobiológiai előállítására
KR20030026920A (ko) *	1999-11-30	2003-04-03	비오갈 기오기스제르갸르 알티.	발효 브로스로부터 스타틴 화합물의 수집 방법
CA2422744A1 (en) *	2000-10-05	2002-04-18	Biogal Gyogyszergyar Rt.	Pravastatin sodium substantially free of pravastatin lactone and epi-pravastatin, and compositions containing same

2001
- 2001-10-05 CA CA002422744A patent/CA2422744A1/en not_active Abandoned
- 2001-10-05 EP EP01979511A patent/EP1330245A4/de not_active Withdrawn
- 2001-10-05 JP JP2002533858A patent/JP3737801B2/ja not_active Expired - Fee Related
- 2001-10-05 HU HU0400913A patent/HUP0400913A2/hu not_active IP Right Cessation
- 2001-10-05 AU AU2002211462A patent/AU2002211462A1/en not_active Abandoned
- 2001-10-05 MX MXPA03002963A patent/MXPA03002963A/es not_active Application Discontinuation
- 2001-10-05 SK SK523-2003A patent/SK5232003A3/sk unknown
- 2001-10-05 CN CNA018168604A patent/CN1468098A/zh active Pending
- 2001-10-05 KR KR10-2003-7004764A patent/KR20030059173A/ko not_active IP Right Cessation
- 2001-10-05 IL IL15519401A patent/IL155194A0/xx unknown
- 2001-10-05 PL PL01361230A patent/PL361230A1/xx unknown
- 2001-10-05 WO PCT/US2001/031230 patent/WO2002030415A1/en not_active Application Discontinuation
- 2001-10-05 NZ NZ525631A patent/NZ525631A/en unknown
- 2001-10-05 CZ CZ20031166A patent/CZ20031166A3/cs unknown
2003
- 2003-03-25 ZA ZA200302313A patent/ZA200302313B/en unknown
- 2003-04-01 IS IS6766A patent/IS6766A/is unknown
- 2003-04-04 NO NO20031532A patent/NO20031532L/no not_active Application Discontinuation
- 2003-05-02 HR HR20030347A patent/HRP20030347A2/xx not_active Application Discontinuation
2004
- 2004-09-24 JP JP2004278522A patent/JP2005013238A/ja not_active Withdrawn
2005
- 2005-08-18 JP JP2005237299A patent/JP2006036781A/ja active Pending
2009
- 2009-08-21 JP JP2009191951A patent/JP2009268479A/ja not_active Withdrawn
2013
- 2013-01-25 JP JP2013011711A patent/JP2013128486A/ja not_active Withdrawn
2015
- 2015-07-31 JP JP2015152088A patent/JP2015212300A/ja active Pending

Publication	Publication Date	Title
JP2004510817A5 (de)	2005-10-20
KR100280766B1 (ko)	2001-02-01	페닐프로피온산의 실제적으로 순수한 에난티오머의 제조방법
JP2003515334A5 (de)	2006-01-05
US6833452B2 (en)	2004-12-21	Process for the preparation of highly pure crystalline (R,S)—cefuroxime axetil
FI101965B (fi)	1998-09-30	Klavulaanihapon 2-amino-2,4,4-trimetyylipentaanisuolan käyttö klavulaa nihapon alkali- tai maa-alkalimetallisuolojen valmistuksessa
KR100200242B1 (ko)	1999-06-15	클라불란산염의 제조 방법
US10538507B2 (en)	2020-01-21	Preparation process for high-purity dabigatran etexilate
EP1302467A2 (de)	2003-04-16	Verfahren zur Herstellung von substituierten Thiazolinen und deren Zwischenprodukte
JP2004521875A5 (de)	2005-04-21
JP4954421B2 (ja)	2012-06-13	クラブラン酸塩の精製方法
KR100537732B1 (ko)	2006-04-14	클라불란산염의제조
CA2007385C (en)	1997-12-30	Process for the optical resolution of dropropizine
US7057066B2 (en)	2006-06-06	Process for producing 3-amino-2-hydroxypropionic acid derivatives
MXPA01013145A (es)	2002-06-04	Metodo para separar las bases diastereomericas de 2-( (dimetilamino) metil)-1-(3-metoxifenil)-ciclohexanol.
JP2001500114A (ja)	2001-01-09	３―ヒドロキシメチルセファロスポリンの溶媒抽出法
JP3883525B2 (ja)	2007-02-21	プラバスタチンナトリウムの精製方法
JP2001521393A (ja)	2001-11-06	クラブラン酸の薬学的に許容されるアルカリ金属塩の単離方法
JPH0374384A (ja)	1991-03-28	３ｒ‐（３‐カルボキシベンジル）‐６‐（５‐フルオロ‐２‐ベンゾチアゾリル）メトキシ‐４ｒ‐クロマノールの光学分割方法
JP2001526291A (ja)	2001-12-18	アンピシリンプロドラッグエステルの溶液の精製方法
JP3316917B2 (ja)	2002-08-19	新規フェニルアラニン塩結晶とその製造法
JPS6121939B2 (de)	1986-05-29
JP2000198779A (ja)	2000-07-18	３―アルキルフラバノノ―ル誘導体の精製法
WO2000053609A1 (en)	2000-09-14	Process for the preparation of cefuroxime
CN115594640A (zh)	2023-01-13	一种二苯甲酰二硫化硫胺的精制方法
JP2022072636A (ja)	2022-05-17	アミド化合物の製造方法