ES2304140T3 - Formas cristalinas de sodio de fluvastatina. - Google Patents
Formas cristalinas de sodio de fluvastatina. Download PDFInfo
- Publication number
- ES2304140T3 ES2304140T3 ES02794517T ES02794517T ES2304140T3 ES 2304140 T3 ES2304140 T3 ES 2304140T3 ES 02794517 T ES02794517 T ES 02794517T ES 02794517 T ES02794517 T ES 02794517T ES 2304140 T3 ES2304140 T3 ES 2304140T3
- Authority
- ES
- Spain
- Prior art keywords
- intensity
- crystalline polymorph
- relative humidity
- powder diffraction
- characteristic
- 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.)
- Expired - Lifetime
Links
- DGAQECJNVWCQMB-PUAWFVPOSA-M Ilexoside XXIX Chemical compound C[C@@H]1CC[C@@]2(CC[C@@]3(C(=CC[C@H]4[C@]3(CC[C@@H]5[C@@]4(CC[C@@H](C5(C)C)OS(=O)(=O)[O-])C)C)[C@@H]2[C@]1(C)O)C)C(=O)O[C@H]6[C@@H]([C@H]([C@@H]([C@H](O6)CO)O)O)O.[Na+] DGAQECJNVWCQMB-PUAWFVPOSA-M 0.000 title description 18
- 239000011734 sodium Substances 0.000 title description 14
- 229910052708 sodium Inorganic materials 0.000 title description 14
- 239000013078 crystal Substances 0.000 title description 3
- FJLGEFLZQAZZCD-JUFISIKESA-N (3S,5R)-fluvastatin Chemical compound C12=CC=CC=C2N(C(C)C)C(\C=C\[C@H](O)C[C@H](O)CC(O)=O)=C1C1=CC=C(F)C=C1 FJLGEFLZQAZZCD-JUFISIKESA-N 0.000 title 1
- 238000000634 powder X-ray diffraction Methods 0.000 claims abstract description 18
- -1 3- (4-fluorophenyl) -1- (1-methylethyl) -1H-indole-2-yl Chemical group 0.000 claims abstract description 12
- NASFKTWZWDYFER-UHFFFAOYSA-N sodium;hydrate Chemical compound O.[Na] NASFKTWZWDYFER-UHFFFAOYSA-N 0.000 claims abstract 6
- ZGGHKIMDNBDHJB-NRFPMOEYSA-M (3R,5S)-fluvastatin sodium Chemical compound [Na+].C12=CC=CC=C2N(C(C)C)C(\C=C\[C@@H](O)C[C@@H](O)CC([O-])=O)=C1C1=CC=C(F)C=C1 ZGGHKIMDNBDHJB-NRFPMOEYSA-M 0.000 claims description 36
- 229960000868 fluvastatin sodium Drugs 0.000 claims description 17
- 238000002360 preparation method Methods 0.000 claims description 14
- 238000000034 method Methods 0.000 claims description 12
- 239000002253 acid Substances 0.000 claims description 9
- 239000008194 pharmaceutical composition Substances 0.000 claims description 4
- 150000003839 salts Chemical class 0.000 claims 5
- 229960003765 fluvastatin Drugs 0.000 description 18
- 239000000203 mixture Substances 0.000 description 9
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 9
- 238000004108 freeze drying Methods 0.000 description 7
- 239000000843 powder Substances 0.000 description 7
- KEAYESYHFKHZAL-UHFFFAOYSA-N Sodium Chemical class [Na] KEAYESYHFKHZAL-UHFFFAOYSA-N 0.000 description 6
- 239000007864 aqueous solution Substances 0.000 description 6
- 238000002425 crystallisation Methods 0.000 description 4
- 230000008025 crystallization Effects 0.000 description 4
- 150000001875 compounds Chemical class 0.000 description 3
- 150000004677 hydrates Chemical class 0.000 description 3
- 239000000463 material Substances 0.000 description 3
- 239000003960 organic solvent Substances 0.000 description 3
- 239000000725 suspension Substances 0.000 description 3
- CABVTRNMFUVUDM-VRHQGPGLSA-N (3S)-3-hydroxy-3-methylglutaryl-CoA Chemical compound O[C@@H]1[C@H](OP(O)(O)=O)[C@@H](COP(O)(=O)OP(O)(=O)OCC(C)(C)[C@@H](O)C(=O)NCCC(=O)NCCSC(=O)C[C@@](O)(CC(O)=O)C)O[C@H]1N1C2=NC=NC(N)=C2N=C1 CABVTRNMFUVUDM-VRHQGPGLSA-N 0.000 description 2
- HVYWMOMLDIMFJA-DPAQBDIFSA-N cholesterol Chemical compound C1C=C2C[C@@H](O)CC[C@]2(C)[C@@H]2[C@@H]1[C@@H]1CC[C@H]([C@H](C)CCCC(C)C)[C@@]1(C)CC2 HVYWMOMLDIMFJA-DPAQBDIFSA-N 0.000 description 2
- 239000000428 dust Substances 0.000 description 2
- 239000007900 aqueous suspension Substances 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 238000001035 drying Methods 0.000 description 1
- 239000003112 inhibitor Substances 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000004570 mortar (masonry) Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 238000001556 precipitation Methods 0.000 description 1
- 239000012047 saturated solution Substances 0.000 description 1
- 159000000000 sodium salts Chemical class 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
- 238000009331 sowing Methods 0.000 description 1
- 238000001228 spectrum Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 230000009466 transformation Effects 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07F—ACYCLIC, CARBOCYCLIC OR HETEROCYCLIC COMPOUNDS CONTAINING ELEMENTS OTHER THAN CARBON, HYDROGEN, HALOGEN, OXYGEN, NITROGEN, SULFUR, SELENIUM OR TELLURIUM
- C07F1/00—Compounds containing elements of Groups 1 or 11 of the Periodic Table
- C07F1/04—Sodium compounds
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D209/00—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom
- C07D209/02—Heterocyclic compounds containing five-membered rings, condensed with other rings, with one nitrogen atom as the only ring hetero atom condensed with one carbocyclic ring
- C07D209/04—Indoles; Hydrogenated indoles
- C07D209/10—Indoles; Hydrogenated indoles with substituted hydrocarbon radicals attached to carbon atoms of the hetero ring
- C07D209/18—Radicals substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals
- C07D209/24—Radicals substituted by carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals with an alkyl or cycloalkyl radical attached to the ring nitrogen atom
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Obesity (AREA)
- Hematology (AREA)
- Diabetes (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Indole Compounds (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP01810756 | 2001-08-03 | ||
| EP01810756 | 2001-08-03 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| ES2304140T3 true ES2304140T3 (es) | 2008-09-16 |
Family
ID=8184071
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| ES02794517T Expired - Lifetime ES2304140T3 (es) | 2001-08-03 | 2002-07-25 | Formas cristalinas de sodio de fluvastatina. |
Country Status (16)
| Country | Link |
|---|---|
| US (1) | US6696479B2 (https=) |
| EP (1) | EP1429757B8 (https=) |
| JP (2) | JP4681808B2 (https=) |
| KR (1) | KR100975782B1 (https=) |
| CN (2) | CN1536999B (https=) |
| AR (1) | AR036205A1 (https=) |
| AT (1) | ATE391502T1 (https=) |
| AU (1) | AU2002333271B2 (https=) |
| CA (1) | CA2454072A1 (https=) |
| DE (1) | DE60226044T2 (https=) |
| ES (1) | ES2304140T3 (https=) |
| HU (1) | HUP0401141A3 (https=) |
| IL (2) | IL159861A0 (https=) |
| PL (1) | PL366905A1 (https=) |
| RU (1) | RU2334738C2 (https=) |
| WO (1) | WO2003013512A2 (https=) |
Families Citing this family (24)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US7087631B2 (en) * | 2002-07-18 | 2006-08-08 | Inotek Pharmaceuticals Corporation | Aryltetrazole compounds, and compositions thereof |
| AU2003250086A1 (en) * | 2002-07-26 | 2004-02-23 | Ciba Specialty Chemicals Holging Inc. | Crystalline polymorphic and amorphous forms of benazepril hydrochloride |
| WO2004096765A2 (en) * | 2003-05-01 | 2004-11-11 | Morepen Laboratories Ltd. | A novel crystalline polymorph of fluvastatin sodium and a process for preparing it |
| US7368468B2 (en) * | 2003-06-18 | 2008-05-06 | Teva Pharmaceutical Industries Ltd. | Fluvastatin sodium crystal forms XIV, LXXIII, LXXIX, LXXX and LXXXVII, processes for preparing them, compositions containing them and methods of using them |
| US7368581B2 (en) | 2003-06-18 | 2008-05-06 | Teva Pharmaceutical Industries Ltd. | Process for the preparation of fluvastatin sodium crystal from XIV |
| JP4037898B2 (ja) * | 2003-06-18 | 2008-01-23 | テバ ファーマシューティカル インダストリーズ リミティド | フルバスタチンナトリウム結晶形ｘｉｖ、ｌｘｘｉｉｉ、ｌｘｘｉｘ、ｌｘｘｘ及びｘｘｘｖｉｉ型、それらの調製方法、それらを含有する組成物及びそれらの使用方法 |
| US7892354B2 (en) * | 2003-10-06 | 2011-02-22 | Solvias Ag | Process for the parallel detection of crystalline forms of molecular solids |
| WO2005037787A1 (en) * | 2003-10-16 | 2005-04-28 | Ciba Specialty Chemicals Holding Inc. | Crystalline form of fluvastatin sodium |
| US7851624B2 (en) * | 2003-12-24 | 2010-12-14 | Teva Pharamaceutical Industries Ltd. | Triol form of rosuvastatin and synthesis of rosuvastatin |
| US20070179166A1 (en) * | 2003-12-24 | 2007-08-02 | Valerie Niddam-Hildesheim | Process for preparation of statins with high syn to anti ratio |
| WO2005080332A1 (en) * | 2004-01-14 | 2005-09-01 | Cadila Healthcare Limited | Novel form of fluvastatin sodium |
| US20070173536A1 (en) * | 2004-02-06 | 2007-07-26 | Ciba Specialty Chemicals Holding Inc. | Crystalline forms of zolmitriptan |
| US7241800B2 (en) | 2004-03-17 | 2007-07-10 | Mai De Ltd. | Anhydrous amorphous form of fluvastatin sodium |
| WO2006021967A1 (en) * | 2004-08-26 | 2006-03-02 | Biocon Limited | Process for the preparation of fluvastatin sodium form a. |
| WO2006030304A2 (en) * | 2004-09-17 | 2006-03-23 | Ranbaxy Laboratories Limited | Novel forms of fluvastatin sodium, processes for preparation and pharmaceutical compositions thereof |
| WO2006085338A2 (en) * | 2005-02-11 | 2006-08-17 | Jubilant Organosys Limited | Novel polymorphic forms of fluvastatin sodium and process for preparing the same |
| WO2006109147A1 (en) * | 2005-04-12 | 2006-10-19 | Glenmark Pharmaceuticals Limited | Substantially pure amorphous fluvastatin, processes for its preparation and pharmaceutical compositions containing same |
| WO2007039784A2 (en) * | 2005-10-06 | 2007-04-12 | Wockhardt Limited | A novel crystalline polymorph of fluvastatin sodium and process for preparing it |
| WO2007054951A1 (en) * | 2005-11-14 | 2007-05-18 | Hetero Drugs Limited | Process for amorphous esomeprazole |
| JP2007246522A (ja) * | 2006-02-27 | 2007-09-27 | Teva Pharmaceutical Industries Ltd | フルバスタチンナトリウムの新規形及びその調製方法 |
| WO2009122425A1 (en) * | 2008-04-04 | 2009-10-08 | Shodhana Laboratories Limited | Novel crystalline form of carvedilol dihydrogen phosphate and related processes |
| CN101684121B (zh) * | 2008-09-22 | 2013-04-03 | 重庆医药工业研究院有限责任公司 | 培美曲塞二酸的新晶型及其制备方法 |
| JP6115288B2 (ja) * | 2012-04-27 | 2017-04-19 | 株式会社島津製作所 | 質量分析におけるピーク検出方法及びそのシステム |
| TW201806928A (zh) * | 2016-07-01 | 2018-03-01 | 第一三共股份有限公司 | 胺基羧酸之酸加成鹽的結晶及其製造方法 |
Family Cites Families (7)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS60500015A (ja) * | 1982-11-22 | 1985-01-10 | サンド・アクチエンゲゼルシヤフト | メバロラクトン同族体とその誘導体、これらの製造法およびこれらを含有する製薬学的組成物 |
| US4739073A (en) * | 1983-11-04 | 1988-04-19 | Sandoz Pharmaceuticals Corp. | Intermediates in the synthesis of indole analogs of mevalonolactone and derivatives thereof |
| HU204253B (en) * | 1982-11-22 | 1991-12-30 | Sandoz Ag | Process for producing mevalonolactone analogues and derivatives and pharmaceutical compositions containing them |
| HU9203780D0 (en) * | 1991-12-12 | 1993-03-29 | Sandoz Ag | Stabilized pharmaceutical products of hmg-coa reductase inhibitor and method for producing them |
| 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) |
| WO1997049681A1 (en) * | 1996-06-24 | 1997-12-31 | Astra Aktiebolag (Publ) | Polymorphic compounds |
| US6858643B2 (en) * | 2000-10-31 | 2005-02-22 | Ciba Specialty Chemicals Corporation | Crystalline forms of Fluvastatin sodium |
-
2002
- 2002-07-25 IL IL15986102A patent/IL159861A0/xx active IP Right Grant
- 2002-07-25 PL PL02366905A patent/PL366905A1/xx not_active Application Discontinuation
- 2002-07-25 EP EP02794517A patent/EP1429757B8/en not_active Expired - Lifetime
- 2002-07-25 KR KR1020047001615A patent/KR100975782B1/ko not_active Expired - Fee Related
- 2002-07-25 CA CA002454072A patent/CA2454072A1/en not_active Abandoned
- 2002-07-25 WO PCT/EP2002/008276 patent/WO2003013512A2/en not_active Ceased
- 2002-07-25 JP JP2003518521A patent/JP4681808B2/ja not_active Expired - Fee Related
- 2002-07-25 HU HU0401141A patent/HUP0401141A3/hu unknown
- 2002-07-25 DE DE60226044T patent/DE60226044T2/de not_active Expired - Lifetime
- 2002-07-25 CN CN028151321A patent/CN1536999B/zh not_active Expired - Fee Related
- 2002-07-25 AU AU2002333271A patent/AU2002333271B2/en not_active Ceased
- 2002-07-25 AT AT02794517T patent/ATE391502T1/de not_active IP Right Cessation
- 2002-07-25 CN CN2011103995817A patent/CN102516150A/zh active Pending
- 2002-07-25 ES ES02794517T patent/ES2304140T3/es not_active Expired - Lifetime
- 2002-07-25 RU RU2004106528/04A patent/RU2334738C2/ru not_active IP Right Cessation
- 2002-07-30 US US10/208,687 patent/US6696479B2/en not_active Expired - Lifetime
- 2002-08-01 AR ARP020102927A patent/AR036205A1/es unknown
-
2004
- 2004-01-14 IL IL159861A patent/IL159861A/en not_active IP Right Cessation
-
2010
- 2010-07-23 JP JP2010165635A patent/JP2010265308A/ja active Pending
Also Published As
| Publication number | Publication date |
|---|---|
| KR100975782B1 (ko) | 2010-08-17 |
| WO2003013512A2 (en) | 2003-02-20 |
| IL159861A (en) | 2009-02-11 |
| CN102516150A (zh) | 2012-06-27 |
| JP4681808B2 (ja) | 2011-05-11 |
| DE60226044T2 (de) | 2009-05-14 |
| RU2334738C2 (ru) | 2008-09-27 |
| AU2002333271B2 (en) | 2007-08-09 |
| CN1536999A (zh) | 2004-10-13 |
| CN1536999B (zh) | 2012-08-08 |
| CA2454072A1 (en) | 2003-02-20 |
| PL366905A1 (en) | 2005-02-07 |
| HUP0401141A3 (en) | 2011-07-28 |
| EP1429757A2 (en) | 2004-06-23 |
| JP2010265308A (ja) | 2010-11-25 |
| AR036205A1 (es) | 2004-08-18 |
| US20030032666A1 (en) | 2003-02-13 |
| RU2004106528A (ru) | 2005-07-27 |
| WO2003013512A3 (en) | 2003-11-20 |
| US6696479B2 (en) | 2004-02-24 |
| IL159861A0 (en) | 2004-06-20 |
| EP1429757B1 (en) | 2008-04-09 |
| HUP0401141A2 (hu) | 2004-09-28 |
| JP2005501838A (ja) | 2005-01-20 |
| EP1429757B8 (en) | 2008-07-16 |
| ATE391502T1 (de) | 2008-04-15 |
| KR20040022226A (ko) | 2004-03-11 |
| DE60226044D1 (de) | 2008-05-21 |
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