MX2010009031A - Composicion farmaceutica de un solo liquido estabilizada que contiene docetaxel. - Google Patents
Composicion farmaceutica de un solo liquido estabilizada que contiene docetaxel.Info
- Publication number
- MX2010009031A MX2010009031A MX2010009031A MX2010009031A MX2010009031A MX 2010009031 A MX2010009031 A MX 2010009031A MX 2010009031 A MX2010009031 A MX 2010009031A MX 2010009031 A MX2010009031 A MX 2010009031A MX 2010009031 A MX2010009031 A MX 2010009031A
- Authority
- MX
- Mexico
- Prior art keywords
- composition
- present
- docetaxel
- liquid
- injection
- Prior art date
Links
- ZDZOTLJHXYCWBA-VCVYQWHSSA-N N-debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol Chemical compound O([C@H]1[C@H]2[C@@](C([C@H](O)C3=C(C)[C@@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C=4C=CC=CC=4)C[C@]1(O)C3(C)C)=O)(C)[C@@H](O)C[C@H]1OC[C@]12OC(=O)C)C(=O)C1=CC=CC=C1 ZDZOTLJHXYCWBA-VCVYQWHSSA-N 0.000 title abstract 4
- 229960003668 docetaxel Drugs 0.000 title abstract 4
- 239000007788 liquid Substances 0.000 title abstract 4
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 abstract 7
- 238000002347 injection Methods 0.000 abstract 3
- 239000007924 injection Substances 0.000 abstract 3
- -1 polyoxyethylene Polymers 0.000 abstract 3
- 229920003171 Poly (ethylene oxide) Polymers 0.000 abstract 2
- 239000000243 solution Substances 0.000 abstract 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 abstract 1
- 239000004359 castor oil Substances 0.000 abstract 1
- 235000019438 castor oil Nutrition 0.000 abstract 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N ethylene glycol Natural products OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 abstract 1
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 abstract 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 abstract 1
- 239000007791 liquid phase Substances 0.000 abstract 1
- 239000003002 pH adjusting agent Substances 0.000 abstract 1
- 230000010412 perfusion Effects 0.000 abstract 1
- 229920000136 polysorbate Polymers 0.000 abstract 1
- 229950008882 polysorbate Drugs 0.000 abstract 1
- 238000002360 preparation method Methods 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 239000002904 solvent Substances 0.000 abstract 1
- 239000004094 surface-active agent Substances 0.000 abstract 1
Classifications
-
- 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
- A61K9/08—Solutions
-
- 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
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/335—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
- A61K31/337—Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
-
- 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
- A61K47/26—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
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Epidemiology (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Dermatology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
Esta invención se relaciona a una composición farmacéutica de un solo líquido para inyección que contiene docetaxel. La composición incluye (A) docetaxel y sales farmacéuticamente aceptables del mismo, (B) un surfactante seleccionado del grupo que consiste de polysorbate, éster de polioxietilenglicol y derivados de aceite de ricino de polioxietileno, (C) un solvente que comprende etanol anhidro en un intervalo de concentración de 100 a 800 mg/Ml en una solución inyectable, y (D) un ajustador de pH de una cantidad adecuada para ajustar el pH de la composición líquida a 5 o menos. La composición puede ser directamente diluida en un líquido de perfusión aun sin el uso de una solución diluida intermediaria en caso de que la composición sea utilizada para las preparaciones inyectables puesto que la composición está en una fase de un solo líquido. Además, la composición es adecuada para la administración efectiva de docetaxel puesto que la estabilidad farmacéutica de la composición es significantemente mejorada.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1020080019179A KR101053780B1 (ko) | 2008-02-29 | 2008-02-29 | 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물 |
| PCT/KR2009/000911 WO2009107983A2 (ko) | 2008-02-29 | 2009-02-26 | 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MX2010009031A true MX2010009031A (es) | 2010-09-10 |
Family
ID=41016586
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2010009031A MX2010009031A (es) | 2008-02-29 | 2009-02-26 | Composicion farmaceutica de un solo liquido estabilizada que contiene docetaxel. |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US20100267818A1 (es) |
| JP (1) | JP5552438B2 (es) |
| KR (1) | KR101053780B1 (es) |
| CN (1) | CN101959501B (es) |
| AU (1) | AU2009217927B2 (es) |
| BR (1) | BRPI0908859A2 (es) |
| CA (1) | CA2714942C (es) |
| MX (1) | MX2010009031A (es) |
| MY (1) | MY152013A (es) |
| NZ (1) | NZ587578A (es) |
| RU (1) | RU2478370C2 (es) |
| TR (1) | TR201005726T2 (es) |
| WO (1) | WO2009107983A2 (es) |
| ZA (1) | ZA201004462B (es) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| BR112012028037A2 (pt) | 2010-05-03 | 2016-08-02 | Teikoku Pharma Usa Inc | formulação de pró-emulsão líquida de taxano não aquosa, métodos para administrar um taxano a um paciente e para fabricar uma formulação de pró-emulsão de taxano, composição de emulsão de taxano, e, kit |
| WO2012161520A2 (ko) * | 2011-05-23 | 2012-11-29 | 에스케이케미칼 주식회사 | 도세탁셀을 함유하는 액상 주사용 조성물 |
| JP2013194009A (ja) * | 2012-03-21 | 2013-09-30 | Nipro Corp | ドセタキセル製剤 |
| CN108158991A (zh) | 2012-07-19 | 2018-06-15 | 富士胶片株式会社 | 含紫杉烷系活性成分的液体组合物、其制造方法及液体制剂 |
| JO3685B1 (ar) | 2012-10-01 | 2020-08-27 | Teikoku Pharma Usa Inc | صيغ التشتيت الجسيمي للتاكسين غير المائي وطرق استخدامها |
| CN103040739B (zh) * | 2013-01-11 | 2014-07-23 | 罗诚 | 一种含有多西他赛化合物的药物组合物 |
| JP6124633B2 (ja) * | 2013-03-18 | 2017-05-10 | ダイト株式会社 | 安定なドセタキセル注射剤 |
| KR20140147336A (ko) * | 2013-06-19 | 2014-12-30 | 에스케이케미칼주식회사 | 도세탁셀을 함유하는 액상 주사용 조성물 |
| CN103432109B (zh) * | 2013-09-01 | 2015-09-23 | 吴静 | 紫杉醇的药物组合物 |
| CN104546694A (zh) * | 2013-10-15 | 2015-04-29 | 悦康药业集团有限公司 | 一种多西他赛注射液及其制备方法 |
| TWI715636B (zh) * | 2015-09-30 | 2021-01-11 | 香港商慧源香港創新有限公司 | 口服紫杉烷組合物及方法 |
| CN105395540A (zh) * | 2015-12-01 | 2016-03-16 | 海南通用康力制药有限公司 | 一种多西他赛注射液及其制备方法 |
| JP6292267B2 (ja) * | 2016-09-13 | 2018-03-14 | ニプロ株式会社 | ドセタキセル製剤 |
| JP2018115178A (ja) * | 2018-03-15 | 2018-07-26 | ニプロ株式会社 | ドセタキセル製剤 |
| KR102401546B1 (ko) * | 2020-03-25 | 2022-05-27 | 주식회사 보령 | 탁산, 이의 약학적으로 허용되는 염, 또는 그의 수화물을 함유하는 안정성이 향상된 신규 약제학적 제형 |
| US20230364172A1 (en) * | 2022-05-14 | 2023-11-16 | Syncotrance, LLC | Modulation of solubility, palatability, absorption, and bioavailability of mitragyna speciosa-derived compounds for oral and buccal delivery |
Family Cites Families (17)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| FR2678833B1 (fr) * | 1991-07-08 | 1995-04-07 | Rhone Poulenc Rorer Sa | Nouvelles compositions pharmaceutiques a base de derives de la classe des taxanes. |
| ES2119996T3 (es) * | 1992-11-27 | 1998-10-16 | Napro Biotherapeutics Inc | Composicion inyectable que comprende faclitaxel. |
| AU724842B2 (en) * | 1995-12-21 | 2000-09-28 | Genelabs Technologies, Inc. | Taxane composition and method |
| US5922754A (en) * | 1998-10-02 | 1999-07-13 | Abbott Laboratories | Pharmaceutical compositions containing paclitaxel |
| IL150190A0 (en) * | 2000-01-05 | 2002-12-01 | Neurim Pharma 1991 | Method and formulation for treating resistance to antihypertensives and related conditions |
| US6919370B2 (en) * | 2000-11-28 | 2005-07-19 | Transform Pharmaceuticals, Inc. | Pharmaceutical formulations comprising paclitaxel, derivatives, and pharmaceutically acceptable salts thereof |
| CA2434641A1 (en) * | 2001-01-18 | 2002-08-22 | Pharmacia And Upjohn Company | Chemotherapeutic microemulsion compositions of paclitaxel with improved oral bioavailability |
| EP1510206A1 (en) * | 2003-08-29 | 2005-03-02 | Novagali Pharma SA | Self-nanoemulsifying oily formulation for the administration of poorly water-soluble drugs |
| JP2005225818A (ja) * | 2004-02-13 | 2005-08-25 | Otsuka Pharmaceut Factory Inc | パクリタキセル又はドセタキセルの医薬組成物 |
| WO2006091780A2 (en) * | 2005-02-24 | 2006-08-31 | Elan Pharma International Limited | Nanoparticulate formulations of docetaxel and analogues thereof |
| CA2611592A1 (en) * | 2005-06-17 | 2006-12-21 | Hospira Australia Pty Ltd | Liquid pharmaceutical formulations of docetaxel |
| GB0517092D0 (en) * | 2005-08-19 | 2005-09-28 | Novartis Ag | New compositions containing taxane derivatives |
| 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 |
| AU2007246077A1 (en) * | 2006-05-03 | 2007-11-08 | I.Q.A., A.S. | Pharmaceutical composition containing taxane derivative destined for the preparation of an infusion solution, method of preparation thereof and use thereof |
| KR100917809B1 (ko) * | 2006-05-22 | 2009-09-18 | 에스케이케미칼주식회사 | 우수한 저장안정성을 갖는 도세탁셀 함유 주사제 조성물 |
| EP2170319A4 (en) * | 2007-06-22 | 2011-10-12 | Scidose Llc | SOLVENT FORMULATION FROM DOCETAXEL WITHOUT TWEEN 80 |
-
2008
- 2008-02-29 KR KR1020080019179A patent/KR101053780B1/ko active Active
-
2009
- 2009-02-26 AU AU2009217927A patent/AU2009217927B2/en not_active Ceased
- 2009-02-26 CA CA2714942A patent/CA2714942C/en active Active
- 2009-02-26 BR BRPI0908859A patent/BRPI0908859A2/pt not_active IP Right Cessation
- 2009-02-26 WO PCT/KR2009/000911 patent/WO2009107983A2/ko active Application Filing
- 2009-02-26 MY MYPI20103954 patent/MY152013A/en unknown
- 2009-02-26 JP JP2010548611A patent/JP5552438B2/ja not_active Expired - Fee Related
- 2009-02-26 TR TR2010/05726T patent/TR201005726T2/xx unknown
- 2009-02-26 RU RU2010139958/15A patent/RU2478370C2/ru not_active IP Right Cessation
- 2009-02-26 NZ NZ587578A patent/NZ587578A/xx not_active IP Right Cessation
- 2009-02-26 MX MX2010009031A patent/MX2010009031A/es active IP Right Grant
- 2009-02-26 CN CN2009801064987A patent/CN101959501B/zh active Active
-
2010
- 2010-06-24 ZA ZA2010/04462A patent/ZA201004462B/en unknown
- 2010-06-29 US US12/826,278 patent/US20100267818A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| CA2714942A1 (en) | 2009-09-03 |
| CN101959501B (zh) | 2012-08-29 |
| US20100267818A1 (en) | 2010-10-21 |
| KR20090093581A (ko) | 2009-09-02 |
| KR101053780B1 (ko) | 2011-08-02 |
| JP2011513299A (ja) | 2011-04-28 |
| RU2010139958A (ru) | 2012-04-10 |
| JP5552438B2 (ja) | 2014-07-16 |
| TR201005726T2 (tr) | 2011-10-21 |
| WO2009107983A3 (ko) | 2009-12-03 |
| MY152013A (en) | 2014-08-15 |
| RU2478370C2 (ru) | 2013-04-10 |
| AU2009217927A1 (en) | 2009-09-03 |
| CA2714942C (en) | 2014-06-17 |
| NZ587578A (en) | 2012-08-31 |
| CN101959501A (zh) | 2011-01-26 |
| WO2009107983A2 (ko) | 2009-09-03 |
| AU2009217927B2 (en) | 2012-06-07 |
| ZA201004462B (en) | 2011-04-28 |
| BRPI0908859A2 (pt) | 2017-06-06 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG | Grant or registration |