KR20090093581A - 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물 - Google Patents
도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물Info
- Publication number
- KR20090093581A KR20090093581A KR1020080019179A KR20080019179A KR20090093581A KR 20090093581 A KR20090093581 A KR 20090093581A KR 1020080019179 A KR1020080019179 A KR 1020080019179A KR 20080019179 A KR20080019179 A KR 20080019179A KR 20090093581 A KR20090093581 A KR 20090093581A
- Authority
- KR
- South Korea
- Prior art keywords
- docetaxel
- stability
- composition
- solution
- dilution
- Prior art date
Links
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
Description
Claims (3)
- (A) 도세탁셀 및 약학적으로 허용가능한 염, (B) 폴리소르베이트, 폴리옥시에틸렌 글리콜 에스테르 및 폴리옥시에틸렌 피마자유 유도체 중에서 선택되는 계면활성제, (C) 주사용액 중 무수에탄올을 100 내지 800mg/ml의 농도 범위로 포함하는 용매, (D) 액상 조성물의 pH를 5이하로 조절하기에 적당한 양의 pH조절제를 포함하는 단일액상의 도세탁셀 함유 주사용 약제학적 조성물.
- 제 1 항에 있어서, 조성물의 pH가 3.0 내지 5.0을 나타내는 것을 특징으로 하는 단일액상의 도세탁셀 함유 주사용 약제학적 조성물.
- 제 1 항에 있어서, 도세탁셀, 폴리소르베이트, 무수에탄올, 조성물의 pH를 5이하로 조절할 수 있는 적당한 양의 구연산을 포함하는 것을 특징으로 하는 단일액상의 도세탁셀 함유 주사용 약제학적 조성물.
Priority Applications (14)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020080019179A KR101053780B1 (ko) | 2008-02-29 | 2008-02-29 | 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물 |
CA2714942A CA2714942C (en) | 2008-02-29 | 2009-02-26 | Stabilized single-liquid pharmaceutical composition containing docetaxel |
BRPI0908859A BRPI0908859A2 (pt) | 2008-02-29 | 2009-02-26 | composição farmacêutica estabilizada de líquído único contedo docetaxel |
JP2010548611A JP5552438B2 (ja) | 2008-02-29 | 2009-02-26 | ドセタキセルを含有する単一液状の安定した薬剤学的組成物 |
TR2010/05726T TR201005726T2 (tr) | 2008-02-29 | 2009-02-26 | Docetaksel içeren stabilize tekli-sıvı farmasötik kompozisyon. |
MX2010009031A MX2010009031A (es) | 2008-02-29 | 2009-02-26 | Composicion farmaceutica de un solo liquido estabilizada que contiene docetaxel. |
MYPI20103954 MY152013A (en) | 2008-02-29 | 2009-02-26 | Stabilized single-liquid pharmaceutical composition containing docetaxel |
NZ587578A NZ587578A (en) | 2008-02-29 | 2009-02-26 | Stabilized single-liquid pharmaceutical composition containing docetaxel |
PCT/KR2009/000911 WO2009107983A2 (ko) | 2008-02-29 | 2009-02-26 | 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물 |
AU2009217927A AU2009217927B2 (en) | 2008-02-29 | 2009-02-26 | Stabilized single-liquid pharmaceutical composition containing docetaxel |
CN2009801064987A CN101959501B (zh) | 2008-02-29 | 2009-02-26 | 稳定的含多西紫杉醇的单液药用组合物 |
RU2010139958/15A RU2478370C2 (ru) | 2008-02-29 | 2009-02-26 | Стабилизированная фармацевтическая композиция, содержащая доцетаксел |
ZA2010/04462A ZA201004462B (en) | 2008-02-29 | 2010-06-24 | Stabilized single-liquid pharmaceutical composition containing docetaxel |
US12/826,278 US20100267818A1 (en) | 2008-02-29 | 2010-06-29 | Stabilized single-liquid pharmaceutical composition containing docetaxel |
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
KR1020080019179A KR101053780B1 (ko) | 2008-02-29 | 2008-02-29 | 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물 |
Publications (2)
Publication Number | Publication Date |
---|---|
KR20090093581A true KR20090093581A (ko) | 2009-09-02 |
KR101053780B1 KR101053780B1 (ko) | 2011-08-02 |
Family
ID=41016586
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
KR1020080019179A KR101053780B1 (ko) | 2008-02-29 | 2008-02-29 | 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물 |
Country Status (14)
Country | Link |
---|---|
US (1) | US20100267818A1 (ko) |
JP (1) | JP5552438B2 (ko) |
KR (1) | KR101053780B1 (ko) |
CN (1) | CN101959501B (ko) |
AU (1) | AU2009217927B2 (ko) |
BR (1) | BRPI0908859A2 (ko) |
CA (1) | CA2714942C (ko) |
MX (1) | MX2010009031A (ko) |
MY (1) | MY152013A (ko) |
NZ (1) | NZ587578A (ko) |
RU (1) | RU2478370C2 (ko) |
TR (1) | TR201005726T2 (ko) |
WO (1) | WO2009107983A2 (ko) |
ZA (1) | ZA201004462B (ko) |
Cited By (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2012161520A2 (ko) * | 2011-05-23 | 2012-11-29 | 에스케이케미칼 주식회사 | 도세탁셀을 함유하는 액상 주사용 조성물 |
WO2014204172A1 (ko) * | 2013-06-19 | 2014-12-24 | 에스케이케미칼 주식회사 | 도세탁셀을 함유하는 액상 주사용 조성물 |
KR20150066542A (ko) * | 2012-10-01 | 2015-06-16 | 테이코쿠 팔마 유에스에이, 인코포레이티드 | 비수성 탁산 나노분산 제형 및 이의 사용 방법 |
KR20200038895A (ko) * | 2020-03-25 | 2020-04-14 | 보령제약 주식회사 | 탁산, 이의 약학적으로 허용되는 염, 또는 그의 수화물을 함유하는 안정성이 향상된 신규 약제학적 제형 |
Families Citing this family (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
MX341082B (es) * | 2010-05-03 | 2016-08-08 | Teikoku Pharma Usa Inc | Formulaciones de pro-emulsion de taxano no acuosas y metodos para hacer y usar las mismas. |
JP2013194009A (ja) * | 2012-03-21 | 2013-09-30 | Nipro Corp | ドセタキセル製剤 |
ES2687705T3 (es) * | 2012-07-19 | 2018-10-26 | Fujifilm Corporation | Composición líquida que contiene un principio activo a base de taxano, proceso de producción de la misma y preparación medicinal líquida |
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 |
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 |
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. |
DE69320206T2 (de) * | 1992-11-27 | 1999-02-11 | Napro Biotherapeutics Inc | Paclitaxel enthaltende injizierbare zusammensetzung |
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 |
DE60034373T2 (de) * | 2000-01-05 | 2007-12-20 | Neurim Pharmaceuticals (1991) Ltd. | Methode und zusammensetzung zur behandlung von resistenz gegen antihypertensiva und verwandten zuständen |
WO2002043765A2 (en) * | 2000-11-28 | 2002-06-06 | Transform Pharmaceuticals, Inc. | Pharmaceutical formulations comprising paclitaxel, derivatives, and pharmaceutically acceptable salts thereof |
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 |
KR20080003322A (ko) * | 2005-02-24 | 2008-01-07 | 엘란 파마 인터내셔널 리미티드 | 도세탁셀 및 이의 유사체의 나노입자 배합물 |
EP1904052A4 (en) * | 2005-06-17 | 2008-12-10 | Hospira Australia Pty Ltd | LIQUID PHARMACEUTICAL COMPOSITIONS OF DOCATEXEL |
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 |
US20090156660A1 (en) * | 2006-05-03 | 2009-06-18 | Michal Svoboda | 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 |
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 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 AU AU2009217927A patent/AU2009217927B2/en not_active Ceased
- 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 CN CN2009801064987A patent/CN101959501B/zh active Active
- 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 MX MX2010009031A patent/MX2010009031A/es active IP Right Grant
- 2009-02-26 BR BRPI0908859A patent/BRPI0908859A2/pt not_active IP Right Cessation
- 2009-02-26 CA CA2714942A patent/CA2714942C/en 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
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
WO2012161520A2 (ko) * | 2011-05-23 | 2012-11-29 | 에스케이케미칼 주식회사 | 도세탁셀을 함유하는 액상 주사용 조성물 |
WO2012161520A3 (ko) * | 2011-05-23 | 2013-03-21 | 에스케이케미칼 주식회사 | 도세탁셀을 함유하는 액상 주사용 조성물 |
KR20150066542A (ko) * | 2012-10-01 | 2015-06-16 | 테이코쿠 팔마 유에스에이, 인코포레이티드 | 비수성 탁산 나노분산 제형 및 이의 사용 방법 |
WO2014204172A1 (ko) * | 2013-06-19 | 2014-12-24 | 에스케이케미칼 주식회사 | 도세탁셀을 함유하는 액상 주사용 조성물 |
KR20200038895A (ko) * | 2020-03-25 | 2020-04-14 | 보령제약 주식회사 | 탁산, 이의 약학적으로 허용되는 염, 또는 그의 수화물을 함유하는 안정성이 향상된 신규 약제학적 제형 |
Also Published As
Publication number | Publication date |
---|---|
AU2009217927B2 (en) | 2012-06-07 |
WO2009107983A2 (ko) | 2009-09-03 |
TR201005726T2 (tr) | 2011-10-21 |
WO2009107983A3 (ko) | 2009-12-03 |
NZ587578A (en) | 2012-08-31 |
JP2011513299A (ja) | 2011-04-28 |
RU2010139958A (ru) | 2012-04-10 |
CN101959501A (zh) | 2011-01-26 |
RU2478370C2 (ru) | 2013-04-10 |
JP5552438B2 (ja) | 2014-07-16 |
MY152013A (en) | 2014-08-15 |
CA2714942A1 (en) | 2009-09-03 |
CN101959501B (zh) | 2012-08-29 |
CA2714942C (en) | 2014-06-17 |
ZA201004462B (en) | 2011-04-28 |
BRPI0908859A2 (pt) | 2017-06-06 |
MX2010009031A (es) | 2010-09-10 |
KR101053780B1 (ko) | 2011-08-02 |
US20100267818A1 (en) | 2010-10-21 |
AU2009217927A1 (en) | 2009-09-03 |
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