PT1334964E - Processo para a produção de cristais de nateglinida na forma b - Google Patents
Processo para a produção de cristais de nateglinida na forma b Download PDFInfo
- Publication number
- PT1334964E PT1334964E PT01976819T PT01976819T PT1334964E PT 1334964 E PT1334964 E PT 1334964E PT 01976819 T PT01976819 T PT 01976819T PT 01976819 T PT01976819 T PT 01976819T PT 1334964 E PT1334964 E PT 1334964E
- Authority
- PT
- Portugal
- Prior art keywords
- crystals
- nateglinide
- type
- wet
- solvated
- Prior art date
Links
- 239000013078 crystal Substances 0.000 title claims abstract description 84
- 229960000698 nateglinide Drugs 0.000 title claims abstract description 42
- OELFLUMRDSZNSF-BRWVUGGUSA-N nateglinide Chemical compound C1C[C@@H](C(C)C)CC[C@@H]1C(=O)N[C@@H](C(O)=O)CC1=CC=CC=C1 OELFLUMRDSZNSF-BRWVUGGUSA-N 0.000 title claims abstract description 40
- 238000000034 method Methods 0.000 title claims abstract description 20
- 238000001035 drying Methods 0.000 claims abstract description 12
- 238000006243 chemical reaction Methods 0.000 claims abstract description 10
- 239000002904 solvent Substances 0.000 claims abstract description 10
- 238000002425 crystallisation Methods 0.000 claims description 7
- 230000008025 crystallization Effects 0.000 claims description 7
- 238000001816 cooling Methods 0.000 claims description 4
- 238000010438 heat treatment Methods 0.000 claims description 4
- 150000004677 hydrates Chemical class 0.000 claims description 2
- -1 nateglinide hydrates Chemical class 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 abstract description 12
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 description 18
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 5
- 239000012453 solvate Substances 0.000 description 4
- XEKOWRVHYACXOJ-UHFFFAOYSA-N Ethyl acetate Chemical compound CCOC(C)=O XEKOWRVHYACXOJ-UHFFFAOYSA-N 0.000 description 3
- KFZMGEQAYNKOFK-UHFFFAOYSA-N Isopropanol Chemical compound CC(C)O KFZMGEQAYNKOFK-UHFFFAOYSA-N 0.000 description 3
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 3
- 238000004090 dissolution Methods 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 238000002844 melting Methods 0.000 description 3
- 230000008018 melting Effects 0.000 description 3
- 238000003756 stirring Methods 0.000 description 3
- 230000000052 comparative effect Effects 0.000 description 2
- 206010012601 diabetes mellitus Diseases 0.000 description 2
- 239000003814 drug Substances 0.000 description 2
- 239000008194 pharmaceutical composition Substances 0.000 description 2
- 238000000926 separation method Methods 0.000 description 2
- 229940124597 therapeutic agent Drugs 0.000 description 2
- OELFLUMRDSZNSF-OFLPRAFFSA-N (2R)-2-[[oxo-(4-propan-2-ylcyclohexyl)methyl]amino]-3-phenylpropanoic acid Chemical compound C1CC(C(C)C)CCC1C(=O)N[C@@H](C(O)=O)CC1=CC=CC=C1 OELFLUMRDSZNSF-OFLPRAFFSA-N 0.000 description 1
- QTBSBXVTEAMEQO-UHFFFAOYSA-M Acetate Chemical compound CC([O-])=O QTBSBXVTEAMEQO-UHFFFAOYSA-M 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- XBDQKXXYIPTUBI-UHFFFAOYSA-M Propionate Chemical compound CCC([O-])=O XBDQKXXYIPTUBI-UHFFFAOYSA-M 0.000 description 1
- KXKVLQRXCPHEJC-UHFFFAOYSA-N acetic acid trimethyl ester Natural products COC(C)=O KXKVLQRXCPHEJC-UHFFFAOYSA-N 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 238000011109 contamination Methods 0.000 description 1
- 238000000113 differential scanning calorimetry Methods 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- GBMDVOWEEQVZKZ-UHFFFAOYSA-N methanol;hydrate Chemical compound O.OC GBMDVOWEEQVZKZ-UHFFFAOYSA-N 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 238000001953 recrystallisation Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000000725 suspension Substances 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C227/00—Preparation of compounds containing amino and carboxyl groups bound to the same carbon skeleton
- C07C227/38—Separation; Purification; Stabilisation; Use of additives
- C07C227/40—Separation; Purification
- C07C227/42—Crystallisation
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C231/00—Preparation of carboxylic acid amides
- C07C231/22—Separation; Purification; Stabilisation; Use of additives
- C07C231/24—Separation; Purification
-
- 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
- A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
- A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07C—ACYCLIC OR CARBOCYCLIC COMPOUNDS
- C07C2601/00—Systems containing only non-condensed rings
- C07C2601/12—Systems containing only non-condensed rings with a six-membered ring
- C07C2601/14—The ring being saturated
Landscapes
- Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Health & Medical Sciences (AREA)
- Diabetes (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Emergency Medicine (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Endocrinology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Crystallography & Structural Chemistry (AREA)
- Organic Low-Molecular-Weight Compounds And Preparation Thereof (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2000324375 | 2000-10-24 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| PT1334964E true PT1334964E (pt) | 2007-09-20 |
Family
ID=18801920
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| PT01976819T PT1334964E (pt) | 2000-10-24 | 2001-10-23 | Processo para a produção de cristais de nateglinida na forma b |
Country Status (18)
| Country | Link |
|---|---|
| US (2) | US20030229249A1 (https=) |
| EP (1) | EP1334964B1 (https=) |
| JP (1) | JP4225057B2 (https=) |
| KR (1) | KR100810930B1 (https=) |
| CN (1) | CN100422143C (https=) |
| AT (1) | ATE370115T1 (https=) |
| AU (1) | AU2001296001A1 (https=) |
| BR (1) | BR0114846A (https=) |
| CA (1) | CA2426745C (https=) |
| CY (1) | CY1106839T1 (https=) |
| DE (1) | DE60130014T2 (https=) |
| DK (1) | DK1334964T3 (https=) |
| ES (1) | ES2288997T3 (https=) |
| MX (1) | MXPA03003575A (https=) |
| PT (1) | PT1334964E (https=) |
| RU (1) | RU2275354C2 (https=) |
| TW (1) | TWI293290B (https=) |
| WO (1) | WO2002034713A1 (https=) |
Families Citing this family (73)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20070104953A (ko) * | 2000-03-17 | 2007-10-29 | 아지노모토 가부시키가이샤 | 신경 장애용 약제 |
| ATE368641T1 (de) * | 2000-10-18 | 2007-08-15 | Ajinomoto Kk | Verfahren zur herstellung von nateglinidin- kristallen |
| CN1273442C (zh) * | 2000-10-18 | 2006-09-06 | 味之素株式会社 | 酰基苯丙氨酸的制备方法 |
| MXPA03003685A (es) * | 2000-10-24 | 2004-01-26 | Ajinomoto Kk | Preparaciones que contienen nateglinida. |
| AU2001296000A1 (en) * | 2000-10-24 | 2002-05-27 | Ajinomoto Co., Inc. | Nateglinide-containing hydrophilic drug preparations |
| US7411089B2 (en) | 2002-04-15 | 2008-08-12 | Ajinomoto Co., Inc. | Nateglinide crystals |
| JP4538842B2 (ja) * | 2002-04-15 | 2010-09-08 | 味の素株式会社 | 新規ナテグリニド結晶 |
| US6861553B2 (en) | 2002-07-03 | 2005-03-01 | Teva Pharmaceuticals Industries Ltd. | Process for preparing nateglinide and intermediates thereof |
| US7358390B2 (en) | 2002-07-18 | 2008-04-15 | Teva Pharmaceutical Industries Ltd. | Polymorphic forms of nateglinide |
| US7420084B2 (en) * | 2002-07-18 | 2008-09-02 | Teva Pharmaceutical Industries Ltd. | Polymorphic forms of nateglinide |
| US7534913B2 (en) | 2002-07-18 | 2009-05-19 | Teva Pharmaceutica Industries Ltd. | Crystalline form of nateglinide |
| US7148376B2 (en) | 2002-07-18 | 2006-12-12 | Teva Pharmaceutical Industries Ltd. | Polymorphic forms of nateglinide |
| IL166308A0 (en) * | 2002-07-18 | 2006-01-15 | Polymorphic forms of nateglinide | |
| EP1535900B1 (en) * | 2003-11-26 | 2006-12-27 | A.M.S.A. ANONIMA MATERIE SINTETICHE E AFFINI S.p.A. | Process for the preparation of nateglinide, preferably in b-form |
| US20060004102A1 (en) * | 2004-05-07 | 2006-01-05 | Shlomit Wizel | Polymorphic forms of nateglinide |
| WO2005110395A1 (en) * | 2004-05-19 | 2005-11-24 | University Of South Carolina | System and device for magnetic drug targeting with magnetic drug carrier particles |
| US20080096970A1 (en) * | 2004-05-20 | 2008-04-24 | Sundaram Venkataraman | Stable Nateglinide Form B Compositions |
| US7425648B2 (en) | 2005-01-03 | 2008-09-16 | A.M.S.A. Anonima Materie Sintetiche E. Affini S.P.A. | Process for the preparation of nateglinide, preferably in B-form |
| WO2006080524A1 (ja) * | 2005-01-31 | 2006-08-03 | Ajinomoto Co., Inc. | 血糖降下剤を含有する、耐糖能異常、境界型糖尿病、インスリン抵抗性及び高インスリン血症の改善ないし治療用医薬組成物 |
| WO2007135533A1 (en) * | 2006-05-23 | 2007-11-29 | Aurobindo Pharma Limited | Process for preparing nateglinide b-type crystals |
| KR100837843B1 (ko) * | 2006-12-26 | 2008-06-13 | 씨제이제일제당 (주) | 나테글리나이드 결정형, 그 제조방법, 및 그를 포함하는약제학적 조성물 |
| AU2011266820A1 (en) | 2010-06-14 | 2013-01-24 | Cipla Limited | A process for the preparation of nateglinide |
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| US9096537B1 (en) | 2014-12-31 | 2015-08-04 | Mahesh Kandula | Compositions and methods for the treatment of mucositis |
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| JP6564868B2 (ja) | 2014-10-27 | 2019-08-21 | セリックス バイオ プライヴェート リミテッドＣｅｌｌｉｘ Ｂｉｏ Ｐｒｉｖａｔｅ Ｌｉｍｉｔｅｄ | 多発性硬化症の治療のための、フマル酸モノメチルエステルとピペラジン又はエチレンジアミンとの３つの成分の塩 |
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| US9290486B1 (en) | 2014-11-05 | 2016-03-22 | Cellix Bio Private Limited | Compositions and methods for the treatment of epilepsy |
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| CN104402756B (zh) * | 2014-11-27 | 2016-08-31 | 天方药业有限公司 | 一种高纯度那格列奈的制备方法 |
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| US9206111B1 (en) | 2014-12-17 | 2015-12-08 | Cellix Bio Private Limited | Compositions and methods for the treatment of neurological diseases |
| SG11201705524SA (en) | 2015-01-06 | 2017-08-30 | Cellix Bio Private Ltd | Compositions and methods for the treatment of inflammation and pain |
| CN109369443A (zh) * | 2018-11-05 | 2019-02-22 | 扬子江药业集团江苏海慈生物药业有限公司 | 一种新的那格列奈h晶型的制备方法 |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPS6354321A (ja) * | 1985-03-27 | 1988-03-08 | Ajinomoto Co Inc | 血糖降下剤 |
| AU615966B2 (en) * | 1987-12-04 | 1991-10-17 | Takeda Chemical Industries Ltd. | Crystals of cephem hydrochloride |
| US5463116A (en) * | 1991-07-30 | 1995-10-31 | Ajinomoto Co., Inc. | Crystals of N- (trans-4-isopropylcyclohexlycarbonyl)-D-phenylalanine and methods for preparing them |
| ES2100291T3 (es) | 1991-07-30 | 1997-06-16 | Ajinomoto Kk | Cristales de n-(trans-4-isopropilciclohexilcarbonil)-d-fenilalanina y metodos para prepararlos. |
| ATE503472T1 (de) * | 1996-11-15 | 2011-04-15 | Ajinomoto Kk | Nateglinide-tablettenzubereitungen |
| US6844006B1 (en) * | 1999-07-09 | 2005-01-18 | Pennfield Oil Company | Process and apparatus for the preparation of chlortetracycline-containing animal feed compositions |
| CA2395993A1 (en) * | 1999-12-28 | 2001-07-05 | Ajinomoto Co., Inc. | Antidiabetic preparation for oral administration |
| KR20070104953A (ko) * | 2000-03-17 | 2007-10-29 | 아지노모토 가부시키가이샤 | 신경 장애용 약제 |
| CN1273442C (zh) * | 2000-10-18 | 2006-09-06 | 味之素株式会社 | 酰基苯丙氨酸的制备方法 |
| ATE368641T1 (de) * | 2000-10-18 | 2007-08-15 | Ajinomoto Kk | Verfahren zur herstellung von nateglinidin- kristallen |
| MXPA03003685A (es) * | 2000-10-24 | 2004-01-26 | Ajinomoto Kk | Preparaciones que contienen nateglinida. |
| US7411089B2 (en) | 2002-04-15 | 2008-08-12 | Ajinomoto Co., Inc. | Nateglinide crystals |
-
2001
- 2001-10-23 RU RU2003111948/04A patent/RU2275354C2/ru not_active IP Right Cessation
- 2001-10-23 CA CA002426745A patent/CA2426745C/en not_active Expired - Fee Related
- 2001-10-23 DK DK01976819T patent/DK1334964T3/da active
- 2001-10-23 AT AT01976819T patent/ATE370115T1/de active
- 2001-10-23 KR KR1020037005671A patent/KR100810930B1/ko not_active Expired - Fee Related
- 2001-10-23 EP EP01976819A patent/EP1334964B1/en not_active Expired - Lifetime
- 2001-10-23 DE DE60130014T patent/DE60130014T2/de not_active Expired - Lifetime
- 2001-10-23 JP JP2002537707A patent/JP4225057B2/ja not_active Expired - Fee Related
- 2001-10-23 BR BR0114846-0A patent/BR0114846A/pt not_active IP Right Cessation
- 2001-10-23 WO PCT/JP2001/009293 patent/WO2002034713A1/ja not_active Ceased
- 2001-10-23 MX MXPA03003575A patent/MXPA03003575A/es active IP Right Grant
- 2001-10-23 PT PT01976819T patent/PT1334964E/pt unknown
- 2001-10-23 CN CNB018212999A patent/CN100422143C/zh not_active Expired - Fee Related
- 2001-10-23 AU AU2001296001A patent/AU2001296001A1/en not_active Abandoned
- 2001-10-23 ES ES01976819T patent/ES2288997T3/es not_active Expired - Lifetime
- 2001-10-24 TW TW090126305A patent/TWI293290B/zh not_active IP Right Cessation
-
2003
- 2003-04-24 US US10/421,888 patent/US20030229249A1/en not_active Abandoned
-
2007
- 2007-06-04 US US11/757,769 patent/US7544834B2/en not_active Expired - Fee Related
- 2007-08-28 CY CY20071101136T patent/CY1106839T1/el unknown
Also Published As
| Publication number | Publication date |
|---|---|
| US20070232829A1 (en) | 2007-10-04 |
| CA2426745C (en) | 2009-09-15 |
| EP1334964B1 (en) | 2007-08-15 |
| ES2288997T3 (es) | 2008-02-01 |
| DK1334964T3 (da) | 2007-09-24 |
| TWI293290B (https=) | 2008-02-11 |
| EP1334964A4 (en) | 2005-09-28 |
| ATE370115T1 (de) | 2007-09-15 |
| KR100810930B1 (ko) | 2008-03-10 |
| JP4225057B2 (ja) | 2009-02-18 |
| BR0114846A (pt) | 2004-02-25 |
| MXPA03003575A (es) | 2003-07-14 |
| CA2426745A1 (en) | 2003-04-23 |
| WO2002034713A1 (en) | 2002-05-02 |
| KR20030059212A (ko) | 2003-07-07 |
| CN1483018A (zh) | 2004-03-17 |
| JPWO2002034713A1 (ja) | 2004-03-04 |
| DE60130014T2 (de) | 2008-05-08 |
| US20030229249A1 (en) | 2003-12-11 |
| EP1334964A1 (en) | 2003-08-13 |
| AU2001296001A1 (en) | 2002-05-06 |
| RU2275354C2 (ru) | 2006-04-27 |
| CN100422143C (zh) | 2008-10-01 |
| US7544834B2 (en) | 2009-06-09 |
| CY1106839T1 (el) | 2012-05-23 |
| DE60130014D1 (de) | 2007-09-27 |
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