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
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- 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 |
|---|---|---|---|
| KR10-2008-00191792008 | 2008-02-29 | ||
| 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 (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 |
|---|---|---|---|---|
| KR101752944B1 (ko) * | 2010-05-03 | 2017-07-03 | 테이코쿠 팔마 유에스에이, 인코포레이티드 | 비수성의 탁산 프로에멀젼 제제, 및 그의 제조 및 사용 방법 |
| 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 |
| TWI752750B (zh) * | 2015-09-30 | 2022-01-11 | 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. |
| 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 |
| EE200200379A (et) * | 2000-01-05 | 2003-10-15 | Neurim Pharmaceuticals (1991) Ltd. | Meetod ja preparaat antihüpertensiivsete ainete suhtes resistentsuse ja sellega seotud haigusseisundite raviks |
| WO2002043765A2 (en) * | 2000-11-28 | 2002-06-06 | Transform Pharmaceuticals, Inc. | Pharmaceutical formulations comprising paclitaxel, derivatives, and pharmaceutically acceptable salts thereof |
| JP2004520398A (ja) * | 2001-01-18 | 2004-07-08 | ファルマシア・アンド・アップジョン・カンパニー | 経口生物学的利用能が改善されたパクリタキセルの化学療法マイクロエマルジョン組成物 |
| 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 |
| EP2308467A3 (en) * | 2005-06-17 | 2011-06-22 | 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 |
| CA2649335A1 (en) * | 2006-05-03 | 2007-11-08 | 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 |
| KR100917809B1 (ko) * | 2006-05-22 | 2009-09-18 | 에스케이케미칼주식회사 | 우수한 저장안정성을 갖는 도세탁셀 함유 주사제 조성물 |
| KR20100023862A (ko) * | 2007-06-22 | 2010-03-04 | 싸이도우스 엘엘씨. | 트윈 80을 함유하지 않은 도세탁셀의 용해 제제 |
-
2008
- 2008-02-29 KR KR1020080019179A patent/KR101053780B1/ko active IP Right Review Request
-
2009
- 2009-02-26 BR BRPI0908859A patent/BRPI0908859A2/pt not_active IP Right Cessation
- 2009-02-26 CA CA2714942A patent/CA2714942C/en active Active
- 2009-02-26 NZ NZ587578A patent/NZ587578A/xx not_active IP Right Cessation
- 2009-02-26 RU RU2010139958/15A patent/RU2478370C2/ru not_active IP Right Cessation
- 2009-02-26 TR TR2010/05726T patent/TR201005726T2/xx unknown
- 2009-02-26 AU AU2009217927A patent/AU2009217927B2/en not_active Ceased
- 2009-02-26 JP JP2010548611A patent/JP5552438B2/ja not_active Expired - Fee Related
- 2009-02-26 MY MYPI20103954 patent/MY152013A/en unknown
- 2009-02-26 CN CN2009801064987A patent/CN101959501B/zh active Active
- 2009-02-26 WO PCT/KR2009/000911 patent/WO2009107983A2/ko active Application Filing
- 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 |
| TR201005726T2 (tr) | 2011-10-21 |
| AU2009217927A1 (en) | 2009-09-03 |
| ZA201004462B (en) | 2011-04-28 |
| CA2714942A1 (en) | 2009-09-03 |
| CN101959501B (zh) | 2012-08-29 |
| MY152013A (en) | 2014-08-15 |
| JP5552438B2 (ja) | 2014-07-16 |
| CN101959501A (zh) | 2011-01-26 |
| NZ587578A (en) | 2012-08-31 |
| WO2009107983A2 (ko) | 2009-09-03 |
| KR20090093581A (ko) | 2009-09-02 |
| CA2714942C (en) | 2014-06-17 |
| KR101053780B1 (ko) | 2011-08-02 |
| JP2011513299A (ja) | 2011-04-28 |
| MX2010009031A (es) | 2010-09-10 |
| BRPI0908859A2 (pt) | 2017-06-06 |
| US20100267818A1 (en) | 2010-10-21 |
| RU2478370C2 (ru) | 2013-04-10 |
| AU2009217927B2 (en) | 2012-06-07 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| MM4A | The patent is invalid due to non-payment of fees |
Effective date: 20180227 |