RU2010139958A - Стабилизированная фармацевтическая композиция, cодержащая доцетаксель - Google Patents
Стабилизированная фармацевтическая композиция, cодержащая доцетаксель Download PDFInfo
- Publication number
- RU2010139958A RU2010139958A RU2010139958/15A RU2010139958A RU2010139958A RU 2010139958 A RU2010139958 A RU 2010139958A RU 2010139958/15 A RU2010139958/15 A RU 2010139958/15A RU 2010139958 A RU2010139958 A RU 2010139958A RU 2010139958 A RU2010139958 A RU 2010139958A
- Authority
- RU
- Russia
- Prior art keywords
- pharmaceutical composition
- docetaxel
- polysorbate
- less
- amount necessary
- Prior art date
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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)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Biochemistry (AREA)
- Dermatology (AREA)
- Molecular Biology (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Abstract
1. Жидкая фармацевтическая композиция доцетакселя для инъекционного введения, включающая: доцетаксель и его фармацевтически приемлемые соли, сурфактант, выбранный из группы, включающей полисорбат, сложные эфиры полиоксиэтиленгликоля и производные полиоксиэтилена касторового масла, растворитель, включающий безводный этанол в концентрации от 100 до 800 мг/мл в инъекционном растворе, и регулятор рН в количестве, необходимом для того, чтобы величина рН жидкой композиции составляла 5 и менее. ! 2. Фармацевтическая композиция по п.1, у которой величина рН находится в пределах от 3,0 до 5,0. ! 3. Фармацевтическая композиция по п.1, содержащая доцетаксель, полисорбат, безводный этанол и лимонную кислоту в количестве, необходимом для поддержания величины рН композиции на уровне 5,0 и менее.
Claims (3)
1. Жидкая фармацевтическая композиция доцетакселя для инъекционного введения, включающая: доцетаксель и его фармацевтически приемлемые соли, сурфактант, выбранный из группы, включающей полисорбат, сложные эфиры полиоксиэтиленгликоля и производные полиоксиэтилена касторового масла, растворитель, включающий безводный этанол в концентрации от 100 до 800 мг/мл в инъекционном растворе, и регулятор рН в количестве, необходимом для того, чтобы величина рН жидкой композиции составляла 5 и менее.
2. Фармацевтическая композиция по п.1, у которой величина рН находится в пределах от 3,0 до 5,0.
3. Фармацевтическая композиция по п.1, содержащая доцетаксель, полисорбат, безводный этанол и лимонную кислоту в количестве, необходимом для поддержания величины рН композиции на уровне 5,0 и менее.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| KR1020080019179A KR101053780B1 (ko) | 2008-02-29 | 2008-02-29 | 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물 |
| KR10-2008-00191792008 | 2008-02-29 | ||
| PCT/KR2009/000911 WO2009107983A2 (ko) | 2008-02-29 | 2009-02-26 | 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| RU2010139958A true RU2010139958A (ru) | 2012-04-10 |
| RU2478370C2 RU2478370C2 (ru) | 2013-04-10 |
Family
ID=41016586
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| RU2010139958/15A RU2478370C2 (ru) | 2008-02-29 | 2009-02-26 | Стабилизированная фармацевтическая композиция, содержащая доцетаксел |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US20100267818A1 (ru) |
| JP (1) | JP5552438B2 (ru) |
| KR (1) | KR101053780B1 (ru) |
| CN (1) | CN101959501B (ru) |
| AU (1) | AU2009217927B2 (ru) |
| BR (1) | BRPI0908859A2 (ru) |
| CA (1) | CA2714942C (ru) |
| MX (1) | MX2010009031A (ru) |
| MY (1) | MY152013A (ru) |
| NZ (1) | NZ587578A (ru) |
| RU (1) | RU2478370C2 (ru) |
| TR (1) | TR201005726T2 (ru) |
| WO (1) | WO2009107983A2 (ru) |
| ZA (1) | ZA201004462B (ru) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP2566474B1 (en) | 2010-05-03 | 2017-11-15 | Teikoku Pharma USA, Inc. | Non-aqueous taxane pro-emulsion formulations and methods of making and using the same |
| 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 |
| EP2875814B1 (en) * | 2012-07-19 | 2018-08-22 | FUJIFILM Corporation | Liquid composition containing taxane-based active ingredient, process for producing same, and liquid medicinal preparation |
| 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 |
| TWI838700B (zh) * | 2015-09-30 | 2024-04-11 | 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. |
| CA2149150C (en) * | 1992-11-27 | 2000-08-01 | David R. Carver | Injectable taxol composition with improved stability |
| CN1209059A (zh) * | 1995-12-21 | 1999-02-24 | 基因实验室技术有限公司 | 紫杉烷类组合物及方法 |
| US5922754A (en) * | 1998-10-02 | 1999-07-13 | Abbott Laboratories | Pharmaceutical compositions containing paclitaxel |
| HU227002B1 (en) * | 2000-01-05 | 2010-04-28 | Neurim Pharma 1991 | Use of melatonin in the manufacture of controlled release medicament for the prevention or treatment of symptoms of hypertension |
| JP2004536026A (ja) * | 2000-11-28 | 2004-12-02 | トランスフォーム ファーマシューティカルズ，インコーポレーティッド． | パクリタキセル、その誘導体、および薬剤として許容される塩を含む医薬品製剤 |
| EP1365759A2 (en) * | 2001-01-18 | 2003-12-03 | PHARMACIA & 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 |
| BRPI0608173A2 (pt) * | 2005-02-24 | 2010-11-09 | Elan Pharma Int Ltd | composição, uso da mesma, e, método de produzir uma composição de docetaxel nanoparticulada ou análogo do mesmo |
| KR20080030024A (ko) * | 2005-06-17 | 2008-04-03 | 호스피라 오스트레일리아 피티와이 리미티드 | 도세탁셀의 약제학적 액상제제 |
| 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 |
| AU2008269179A1 (en) * | 2007-06-22 | 2008-12-31 | Scidose Llc | Solubilized formulation of docetaxel without Tween 80 |
-
2008
- 2008-02-29 KR KR1020080019179A patent/KR101053780B1/ko active IP Right Review Request
-
2009
- 2009-02-26 MY MYPI20103954 patent/MY152013A/en unknown
- 2009-02-26 WO PCT/KR2009/000911 patent/WO2009107983A2/ko active Application Filing
- 2009-02-26 JP JP2010548611A patent/JP5552438B2/ja not_active Expired - Fee Related
- 2009-02-26 RU RU2010139958/15A patent/RU2478370C2/ru not_active IP Right Cessation
- 2009-02-26 CA CA2714942A patent/CA2714942C/en active Active
- 2009-02-26 CN CN2009801064987A patent/CN101959501B/zh active Active
- 2009-02-26 BR BRPI0908859A patent/BRPI0908859A2/pt not_active IP Right Cessation
- 2009-02-26 TR TR2010/05726T patent/TR201005726T2/xx unknown
- 2009-02-26 NZ NZ587578A patent/NZ587578A/xx not_active IP Right Cessation
- 2009-02-26 AU AU2009217927A patent/AU2009217927B2/en not_active Ceased
- 2009-02-26 MX MX2010009031A patent/MX2010009031A/es active IP Right Grant
-
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 |
|---|---|
| WO2009107983A3 (ko) | 2009-12-03 |
| MX2010009031A (es) | 2010-09-10 |
| CN101959501A (zh) | 2011-01-26 |
| NZ587578A (en) | 2012-08-31 |
| CN101959501B (zh) | 2012-08-29 |
| CA2714942C (en) | 2014-06-17 |
| AU2009217927B2 (en) | 2012-06-07 |
| AU2009217927A1 (en) | 2009-09-03 |
| BRPI0908859A2 (pt) | 2017-06-06 |
| KR20090093581A (ko) | 2009-09-02 |
| WO2009107983A2 (ko) | 2009-09-03 |
| MY152013A (en) | 2014-08-15 |
| US20100267818A1 (en) | 2010-10-21 |
| KR101053780B1 (ko) | 2011-08-02 |
| JP2011513299A (ja) | 2011-04-28 |
| ZA201004462B (en) | 2011-04-28 |
| CA2714942A1 (en) | 2009-09-03 |
| JP5552438B2 (ja) | 2014-07-16 |
| RU2478370C2 (ru) | 2013-04-10 |
| TR201005726T2 (tr) | 2011-10-21 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM4A | The patent is invalid due to non-payment of fees |
Effective date: 20180227 |