DK1694660T3 - Fremgangsmåde til fremstilling af vandfri og hydrerede aktive farmaceutiske bestanddele (API's); stabile farmaceutiske sammensætninger fremstillet af disse og anvendelser af disse sammensætninger - Google Patents
Fremgangsmåde til fremstilling af vandfri og hydrerede aktive farmaceutiske bestanddele (API's); stabile farmaceutiske sammensætninger fremstillet af disse og anvendelser af disse sammensætningerInfo
- Publication number
- DK1694660T3 DK1694660T3 DK04801143T DK04801143T DK1694660T3 DK 1694660 T3 DK1694660 T3 DK 1694660T3 DK 04801143 T DK04801143 T DK 04801143T DK 04801143 T DK04801143 T DK 04801143T DK 1694660 T3 DK1694660 T3 DK 1694660T3
- Authority
- DK
- Denmark
- Prior art keywords
- beta
- apis
- preparation
- compositions
- anhydrous
- Prior art date
Links
- 239000008186 active pharmaceutical agent Substances 0.000 title abstract 6
- 238000000034 method Methods 0.000 title abstract 4
- 239000000203 mixture Substances 0.000 title 1
- 239000008194 pharmaceutical composition Substances 0.000 title 1
- HYJVYOWKYPNSTK-UONOGXRCSA-N (2r,3s)-3-benzamido-2-hydroxy-3-phenylpropanoic acid Chemical compound N([C@H]([C@@H](O)C(O)=O)C=1C=CC=CC=1)C(=O)C1=CC=CC=C1 HYJVYOWKYPNSTK-UONOGXRCSA-N 0.000 abstract 1
- ZVAFCKLQJCZGAP-UHFFFAOYSA-N 2-hydroxy-3-[(2-methylpropan-2-yl)oxycarbonylamino]-3-phenylpropanoic acid Chemical compound CC(C)(C)OC(=O)NC(C(O)C(O)=O)C1=CC=CC=C1 ZVAFCKLQJCZGAP-UHFFFAOYSA-N 0.000 abstract 1
- PSSVSAXRAMDXPH-DELBANIYSA-N O.O.O.C(C)(C)(C)OC(=O)N[C@H]([C@H](C(=O)O)O)C1=CC=CC=C1 Chemical compound O.O.O.C(C)(C)(C)OC(=O)N[C@H]([C@H](C(=O)O)O)C1=CC=CC=C1 PSSVSAXRAMDXPH-DELBANIYSA-N 0.000 abstract 1
- 238000004519 manufacturing process Methods 0.000 abstract 1
- DKPFODGZWDEEBT-QFIAKTPHSA-N taxane Chemical class C([C@]1(C)CCC[C@@H](C)[C@H]1C1)C[C@H]2[C@H](C)CC[C@@H]1C2(C)C DKPFODGZWDEEBT-QFIAKTPHSA-N 0.000 abstract 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D305/00—Heterocyclic compounds containing four-membered rings having one oxygen atom as the only ring hetero atoms
- C07D305/14—Heterocyclic compounds containing four-membered rings having one oxygen atom as the only ring hetero atoms condensed with carbocyclic rings or ring systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Veterinary Medicine (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Medicinal Chemistry (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Engineering & Computer Science (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Biochemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Epoxy Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| BR0305824 | 2003-12-12 | ||
| BRPI0405797 BRPI0405797B1 (pt) | 2004-12-08 | 2004-12-08 | processo para a preparação de princìpios farmacêuticos ativos (pfa's), anidros e hidratados; composições farmacêuticas estáveis a partir dos mesmos e usos das composições |
| PCT/BR2004/000242 WO2005061474A1 (en) | 2003-12-12 | 2004-12-10 | Process for the preparation of anhydrous and hydrated active pharmaceutical ingredients (apis); stable pharmaceutical compositions prepared from the same and uses of said compositions |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK1694660T3 true DK1694660T3 (da) | 2009-08-10 |
Family
ID=37719821
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK04801143T DK1694660T3 (da) | 2003-12-12 | 2004-12-10 | Fremgangsmåde til fremstilling af vandfri og hydrerede aktive farmaceutiske bestanddele (API's); stabile farmaceutiske sammensætninger fremstillet af disse og anvendelser af disse sammensætninger |
Country Status (8)
| Country | Link |
|---|---|
| US (2) | US7838551B2 (da) |
| EP (2) | EP1947094A3 (da) |
| AT (1) | ATE427943T1 (da) |
| DE (1) | DE602004020506D1 (da) |
| DK (1) | DK1694660T3 (da) |
| ES (1) | ES2325506T3 (da) |
| PT (1) | PT1694660E (da) |
| WO (1) | WO2005061474A1 (da) |
Families Citing this family (19)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| DE602004020506D1 (de) | 2003-12-12 | 2009-05-20 | Quiral Quimica Do Brasil | Verfahren zur herstellung von wasserfreien und hydratisierten pharmazeutischen wirkstoffen (apis); aus diesen hergestellte stabile pharmazeutische zusammensetzungen und anwendungen für diese zusammensetzungen |
| EP3659589A1 (en) | 2005-08-31 | 2020-06-03 | Abraxis BioScience, LLC | Compositions comprising poorly water soluble pharmaceutical agents and antimicrobial agents |
| KR101643416B1 (ko) * | 2005-08-31 | 2016-07-27 | 아브락시스 바이오사이언스, 엘엘씨 | 증가된 안정성을 가진 수 난용성 약물의 조성물 및 제조방법 |
| KR100995390B1 (ko) * | 2006-01-02 | 2010-11-19 | 주식회사 삼양제넥스 | 무정형, 무수결정형 또는 수화 결정형 도세탁셀의 제조방법 |
| BRPI0600194A (pt) * | 2006-01-30 | 2007-10-23 | Quiral Quimica Do Brasil S A | composições farmacêuticas contendo docetaxel e um inibidor de degradação e processo de obtenção das mesmas |
| EP2012749A2 (en) | 2006-05-03 | 2009-01-14 | I.Q.A., A.S. | Pharmaceutical composition containing a taxane derivative, destined for the preparation of an infusion solution, method of preparation thereof and use thereof |
| EP2094084A4 (en) * | 2006-10-20 | 2010-01-13 | Scinopharm Singapore Pte Ltd | PROCESS FOR PREPARING CRYSTALLINE WATER-FREE DOCETAXEL |
| WO2008102374A1 (en) * | 2007-02-20 | 2008-08-28 | Dabur Pharma Limited | Amorphous form of docetaxel |
| KR100878455B1 (ko) * | 2007-04-10 | 2009-01-13 | 한미약품 주식회사 | 안정한 무수결정형 도세탁셀 및 이의 제조방법 |
| EP2080764B1 (en) | 2008-01-18 | 2012-08-22 | INDENA S.p.A. | Solid forms of ortataxel |
| EP2080763A1 (en) * | 2008-01-18 | 2009-07-22 | INDENA S.p.A. | Crystalline form I of ortataxel |
| KR100965867B1 (ko) * | 2009-06-23 | 2010-06-24 | 주식회사 삼양제넥스 | 수화결정형 도세탁셀의 제조방법 |
| KR101149600B1 (ko) * | 2009-12-31 | 2012-05-29 | 주식회사 삼양제넥스바이오 | 고순도 무수결정형 도세탁셀 제조방법 |
| WO2011139899A2 (en) | 2010-05-03 | 2011-11-10 | Teikoku Pharma Usa, Inc. | Non-aqueous taxane pro-emulsion formulations and methods of making and using the same |
| CN102250047B (zh) * | 2011-08-26 | 2013-06-05 | 贺金凤 | 一种紫杉醇化合物的制备方法 |
| WO2013096596A1 (en) * | 2011-12-20 | 2013-06-27 | Latham Keith R | Sustained drug release and improved product stability using non-covalent particle coating methods |
| JO3685B1 (ar) | 2012-10-01 | 2020-08-27 | Teikoku Pharma Usa Inc | صيغ التشتيت الجسيمي للتاكسين غير المائي وطرق استخدامها |
| US10004824B2 (en) * | 2015-05-11 | 2018-06-26 | Laboratoires Vivacy | Compositions comprising at least one polyol and at least one anesthetic |
| CN111718316A (zh) * | 2020-07-02 | 2020-09-29 | 无锡紫杉药业有限公司 | 一种三水多西他赛生产工艺 |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5475120A (en) * | 1990-11-02 | 1995-12-12 | University Of Florida | Method for the isolation and purification of taxol and its natural analogues |
| MX9102128A (es) | 1990-11-23 | 1992-07-08 | Rhone Poulenc Rorer Sa | Derivados de taxano,procedimiento para su preparacion y composicion farmaceutica que los contiene |
| US5698582A (en) * | 1991-07-08 | 1997-12-16 | Rhone-Poulenc Rorer S.A. | Compositions containing taxane derivatives |
| CA2149150C (en) * | 1992-11-27 | 2000-08-01 | David R. Carver | Injectable taxol composition with improved stability |
| TW406020B (en) * | 1993-09-29 | 2000-09-21 | Bristol Myers Squibb Co | Stabilized pharmaceutical composition and its method for preparation and stabilizing solvent |
| FR2722191B1 (fr) | 1994-07-08 | 1996-08-23 | Rhone Poulenc Rorer Sa | Procede de preparation du trihydrate du (2r,3s)-3-tertbutoxycarbonylamino-2-hydroxy-3-phenylpropionate de 4-acetoxy2alpha-benzoyloxy-5beta,20epoxy-1,7beta,10beta trihydroxy-9-oxo-tax-11-en-13alpha-yle |
| FR2729666A1 (fr) | 1995-01-25 | 1996-07-26 | Rhone Poulenc Rorer Sa | Procede de preparation du trihydrate du (2r, 3s)- benzoylamino-2-hydroxy-3-phenylpropionate de 4,10-diacetoxy- 2alpha-benzoyloxy-5beta,20-epoxy-1,7beta-dihydroxy-9-oxo- tax-11-en-13alpha-yle |
| US5679807A (en) | 1995-01-30 | 1997-10-21 | Hauser, Inc. | Preparation of taxol and docetaxel through primary amines |
| US6040330A (en) * | 1999-01-08 | 2000-03-21 | Bionumerik Pharmaceuticals, Inc. | Pharmaceutical formulations of taxanes |
| US6002025A (en) * | 1999-02-24 | 1999-12-14 | Bcm Developement Inc. | Method for the purification of taxanes |
| GB9920548D0 (en) * | 1999-08-31 | 1999-11-03 | Rhone Poulenc Rorer Sa | Treatment of hepatocellular carcinoma |
| JP5409981B2 (ja) * | 2000-05-15 | 2014-02-05 | セルジーン コーポレイション | 癌治療用の組成物および方法 |
| PL203300B1 (pl) | 2000-10-31 | 2009-09-30 | Akad Medyczna | Stabilna postać farmaceutyczna leku przeciwnowotworowego oraz sposób wytwarzania stabilnej postaci farmaceutycznej leku przeciwnowotworowego |
| AU2002239282A1 (en) * | 2000-11-28 | 2002-06-11 | Transform Pharmaceuticals, Inc. | Pharmaceutical formulations comprising paclitaxel, derivatives, and pharmaceutically acceptable salts thereof |
| ITMI20020680A1 (it) | 2002-03-29 | 2003-09-29 | Acs Dobfar Spa | Composizione antitumorale migliorata a base di paclitaxel e metodo per il suo ottenimento |
| US6838569B2 (en) * | 2002-12-16 | 2005-01-04 | Dabur India Limited | Process for preparation of paclitaxel trihydrate and docetaxel trihydrate |
| DE602004020506D1 (de) | 2003-12-12 | 2009-05-20 | Quiral Quimica Do Brasil | Verfahren zur herstellung von wasserfreien und hydratisierten pharmazeutischen wirkstoffen (apis); aus diesen hergestellte stabile pharmazeutische zusammensetzungen und anwendungen für diese zusammensetzungen |
-
2004
- 2004-12-10 DE DE602004020506T patent/DE602004020506D1/de not_active Expired - Lifetime
- 2004-12-10 WO PCT/BR2004/000242 patent/WO2005061474A1/en not_active Ceased
- 2004-12-10 ES ES04801143T patent/ES2325506T3/es not_active Expired - Lifetime
- 2004-12-10 DK DK04801143T patent/DK1694660T3/da active
- 2004-12-10 PT PT04801143T patent/PT1694660E/pt unknown
- 2004-12-10 US US10/582,385 patent/US7838551B2/en not_active Expired - Fee Related
- 2004-12-10 EP EP08152493A patent/EP1947094A3/en not_active Withdrawn
- 2004-12-10 AT AT04801143T patent/ATE427943T1/de active
- 2004-12-10 EP EP04801143A patent/EP1694660B1/en not_active Expired - Lifetime
-
2008
- 2008-08-07 US US12/188,157 patent/US8304450B2/en not_active Expired - Fee Related
Also Published As
| Publication number | Publication date |
|---|---|
| DE602004020506D1 (de) | 2009-05-20 |
| US20090069409A1 (en) | 2009-03-12 |
| ES2325506T3 (es) | 2009-09-07 |
| US7838551B2 (en) | 2010-11-23 |
| ATE427943T1 (de) | 2009-04-15 |
| US8304450B2 (en) | 2012-11-06 |
| EP1694660A1 (en) | 2006-08-30 |
| WO2005061474A1 (en) | 2005-07-07 |
| EP1947094A3 (en) | 2009-02-18 |
| EP1947094A2 (en) | 2008-07-23 |
| PT1694660E (pt) | 2009-07-16 |
| EP1694660B1 (en) | 2009-04-08 |
| US20080051450A1 (en) | 2008-02-28 |
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