JP2004510817A5 - - Google Patents
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- Publication number
- JP2004510817A5 JP2004510817A5 JP2002533858A JP2002533858A JP2004510817A5 JP 2004510817 A5 JP2004510817 A5 JP 2004510817A5 JP 2002533858 A JP2002533858 A JP 2002533858A JP 2002533858 A JP2002533858 A JP 2002533858A JP 2004510817 A5 JP2004510817 A5 JP 2004510817A5
- Authority
- JP
- Japan
- Prior art keywords
- pravastatin
- sodium
- composition
- impurities
- substantially pure
- 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
- 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 82
- 229960001495 pravastatin sodium Drugs 0.000 claims 45
- TUZYXOIXSAXUGO-UHFFFAOYSA-N Pravastatin Natural products C1=CC(C)C(CCC(O)CC(O)CC(O)=O)C2C(OC(=O)C(C)CC)CC(O)C=C21 TUZYXOIXSAXUGO-UHFFFAOYSA-N 0.000 claims 37
- 229960002965 pravastatin Drugs 0.000 claims 37
- 238000000034 method Methods 0.000 claims 34
- 239000000203 mixture Substances 0.000 claims 31
- 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 pravastatin lactone 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
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical group [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 6
- 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
- 239000000243 solution Substances 0.000 claims 6
- 125000000217 alkyl group Chemical group 0.000 claims 5
- 238000000605 extraction Methods 0.000 claims 5
- 244000005700 microbiome Species 0.000 claims 5
- CSCPPACGZOOCGX-UHFFFAOYSA-N Acetone Chemical compound CC(C)=O CSCPPACGZOOCGX-UHFFFAOYSA-N 0.000 claims 4
- NLXLAEXVIDQMFP-UHFFFAOYSA-N Ammonia chloride Chemical compound [NH4+].[Cl-] NLXLAEXVIDQMFP-UHFFFAOYSA-N 0.000 claims 4
- 239000007864 aqueous solution Substances 0.000 claims 4
- 238000002425 crystallisation Methods 0.000 claims 4
- 230000008025 crystallization Effects 0.000 claims 4
- GJRQTCIYDGXPES-UHFFFAOYSA-N iso-butyl acetate Natural products CC(C)COC(C)=O GJRQTCIYDGXPES-UHFFFAOYSA-N 0.000 claims 4
- FGKJLKRYENPLQH-UHFFFAOYSA-M isocaproate Chemical group CC(C)CCC([O-])=O FGKJLKRYENPLQH-UHFFFAOYSA-M 0.000 claims 4
- OQAGVSWESNCJJT-UHFFFAOYSA-N isovaleric acid methyl ester Natural products COC(=O)CC(C)C OQAGVSWESNCJJT-UHFFFAOYSA-N 0.000 claims 4
- 238000001953 recrystallisation Methods 0.000 claims 4
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 4
- 239000008194 pharmaceutical composition Substances 0.000 claims 3
- NWUYHJFMYQTDRP-UHFFFAOYSA-N 1,2-bis(ethenyl)benzene;1-ethenyl-2-ethylbenzene;styrene Chemical compound C=CC1=CC=CC=C1.CCC1=CC=CC=C1C=C.C=CC1=CC=CC=C1C=C NWUYHJFMYQTDRP-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 effect 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 medium Substances 0.000 claims 2
- 239000003456 ion exchange resin Substances 0.000 claims 2
- 229920003303 ion-exchange polymer Polymers 0.000 claims 2
- BDAGIHXWWSANSR-UHFFFAOYSA-N methanoic acid Natural products OC=O BDAGIHXWWSANSR-UHFFFAOYSA-N 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 effect Effects 0.000 claims 2
- 238000005185 salting out Methods 0.000 claims 2
- 239000002904 solvent Substances 0.000 claims 2
- OSWFIVFLDKOXQC-UHFFFAOYSA-N 4-(3-methoxyphenyl)aniline Chemical compound COC1=CC=CC(C=2C=CC(N)=CC=2)=C1 OSWFIVFLDKOXQC-UHFFFAOYSA-N 0.000 claims 1
- 125000000218 acetic acid group Chemical group C(C)(=O)* 0.000 claims 1
- 235000019270 ammonium chloride Nutrition 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
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 (enrdf_load_stackoverflow) | 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)
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| AU1804601A (en) * | 1999-11-30 | 2001-06-12 | Biogal Gyogyszergyar Rt | Process for recovering statin compounds from a fermentation broth |
| SI1265604T1 (sl) * | 1999-11-30 | 2007-04-30 | Sag Teva Gyogyszergyar Zartkoe | Postopek za ponovno pridobivanje statinskih spojin iz fermentacije brozge |
| EP1798214A3 (en) * | 1999-11-30 | 2007-08-01 | Teva Gyogyszergyár Zártköruen Muködo Részvenytarsaság | Process for recovering statin compounds from a fermentation broth |
| SK8312002A3 (en) | 1999-12-14 | 2003-05-02 | Biogal Gyogyszergyar | Novel forms of pravastatin sodium |
| MXPA03002963A (es) * | 2000-10-05 | 2005-01-25 | Biogal Gyogyszergyar | Pravastatina de sodio sustancialmente libre de pravastatina lactona y epi-pravastatina, y composiciones que la contienen. |
| 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 (en) * | 2003-02-25 | 2004-09-01 | Balkanpharma-Razgrad AD | Method for the isolation and purification of pravastatin sodium |
| 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 |
| DE04811862T1 (de) | 2003-11-24 | 2006-03-02 | Teva Gyogyszergyar Reszvenytarsasag | Verfahren zur Reinigung von Pravastatin |
| EP1786414A4 (en) | 2004-08-06 | 2008-04-09 | Transform Pharmaceuticals Inc | NEW PHARMACEUTICAL STATIN COMPOSITIONS AND RELEVANT TREATMENT PROCEDURES |
| ES2254028B1 (es) * | 2004-11-29 | 2007-03-01 | Ercros Industrial, S.A. | Procedimiento para la obtencion de pravastatina sodica purificada. |
| CA2599458A1 (en) * | 2005-02-25 | 2006-08-31 | Teva Pharmaceutical Industries Ltd. | Process of purifying 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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US3378441A (en) * | 1963-10-17 | 1968-04-16 | S B Penick & Company | Tetraene antibiotic purification |
| JPS5221594B2 (enrdf_load_stackoverflow) * | 1973-09-29 | 1977-06-11 | ||
| SE421796B (sv) * | 1975-02-07 | 1982-02-01 | Glaxo Lab Ltd | Forfarande for rening av klavulansyra och dess salter |
| US4231938A (en) * | 1979-06-15 | 1980-11-04 | Merck & Co., Inc. | Hypocholesteremic fermentation products and process of preparation |
| DK149080C (da) * | 1980-06-06 | 1986-07-28 | Sankyo Co | Fremgangsmaade til fremstilling af derivater af ml-236b-carboxylsyre |
| JPS572240A (en) * | 1980-06-06 | 1982-01-07 | Sankyo Co Ltd | Ml-236b derivative |
| 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 |
| ATE159051T1 (de) * | 1994-03-31 | 1997-10-15 | Cultor Oy | Verfahren zur rückgewinnung von natamycin |
| 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 (en) * | 1997-05-07 | 1998-11-11 | Gist-Brocades B.V. | HMG-CoA reductase inhibitor preparation process |
| 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 |
| HK1042686B (en) * | 1999-02-03 | 2005-10-14 | Institute For Drug Research Ltd. | Microbial process for preparing pravastatin |
| HUP9902352A1 (hu) * | 1999-07-12 | 2000-09-28 | Gyógyszerkutató Intézet Kft. | Eljárás pravasztatin mikrobiológiai előállítására |
| AU1804601A (en) * | 1999-11-30 | 2001-06-12 | Biogal Gyogyszergyar Rt | Process for recovering statin compounds from a fermentation broth |
| MXPA03002963A (es) * | 2000-10-05 | 2005-01-25 | Biogal Gyogyszergyar | Pravastatina de sodio sustancialmente libre de pravastatina lactona y epi-pravastatina, y composiciones que la contienen. |
-
2001
- 2001-10-05 MX MXPA03002963A patent/MXPA03002963A/es not_active Application Discontinuation
- 2001-10-05 WO PCT/US2001/031230 patent/WO2002030415A1/en not_active Ceased
- 2001-10-05 PL PL01361230A patent/PL361230A1/xx unknown
- 2001-10-05 HR HR20030347A patent/HRP20030347A2/xx not_active Application Discontinuation
- 2001-10-05 AU AU2002211462A patent/AU2002211462A1/en not_active Abandoned
- 2001-10-05 HU HU0400913A patent/HUP0400913A2/hu not_active IP Right Cessation
- 2001-10-05 EP EP01979511A patent/EP1330245A4/en not_active Withdrawn
- 2001-10-05 CZ CZ20031166A patent/CZ20031166A3/cs unknown
- 2001-10-05 NZ NZ525631A patent/NZ525631A/en unknown
- 2001-10-05 JP JP2002533858A patent/JP3737801B2/ja not_active Expired - Fee Related
- 2001-10-05 IL IL15519401A patent/IL155194A0/xx unknown
- 2001-10-05 KR KR10-2003-7004764A patent/KR20030059173A/ko not_active Abandoned
- 2001-10-05 SK SK523-2003A patent/SK5232003A3/sk unknown
- 2001-10-05 CA CA002422744A patent/CA2422744A1/en not_active Abandoned
- 2001-10-05 CN CNA018168604A patent/CN1468098A/zh active Pending
-
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
-
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
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