WO2009107983A3 - 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물 - Google Patents

도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물 Download PDF

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Publication number
WO2009107983A3
WO2009107983A3 PCT/KR2009/000911 KR2009000911W WO2009107983A3 WO 2009107983 A3 WO2009107983 A3 WO 2009107983A3 KR 2009000911 W KR2009000911 W KR 2009000911W WO 2009107983 A3 WO2009107983 A3 WO 2009107983A3
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WO
WIPO (PCT)
Prior art keywords
composition
present
docetaxel
liquid
injection
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PCT/KR2009/000911
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English (en)
French (fr)
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WO2009107983A2 (ko
Inventor
유무희
차봉진
김정훈
장선우
원동한
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동아제약 주식회사
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41016586&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=WO2009107983(A3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Priority to TR2010/05726T priority Critical patent/TR201005726T2/xx
Priority to RU2010139958/15A priority patent/RU2478370C2/ru
Priority to JP2010548611A priority patent/JP5552438B2/ja
Priority to CN2009801064987A priority patent/CN101959501B/zh
Priority to CA2714942A priority patent/CA2714942C/en
Application filed by 동아제약 주식회사 filed Critical 동아제약 주식회사
Priority to MX2010009031A priority patent/MX2010009031A/es
Priority to NZ587578A priority patent/NZ587578A/xx
Priority to BRPI0908859A priority patent/BRPI0908859A2/pt
Priority to AU2009217927A priority patent/AU2009217927B2/en
Publication of WO2009107983A2 publication Critical patent/WO2009107983A2/ko
Publication of WO2009107983A3 publication Critical patent/WO2009107983A3/ko
Priority to ZA2010/04462A priority patent/ZA201004462B/en
Priority to US12/826,278 priority patent/US20100267818A1/en

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/335Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin
    • A61K31/337Heterocyclic compounds having oxygen as the only ring hetero atom, e.g. fungichromin having four-membered rings, e.g. taxol
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic 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

본 발명은 도세탁셀을 함유하는 주사용 액상조성물에 관한 것으로서, (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 조성물에 관한 것이다. 본 발명의 조성물은 주사용 제제로 사용함에 있어서, 도세탁셀 함유 주사용 약제학적 조성물이 단일액상으로 되어있어 중간희석액의 사용없이 바로 관류액에 희석하여 사용할 수 있고, 제제학적 안정성이 현저히 개선된 것이므로 도세탁셀을 효과적으로 투여하는데 적합하다.
PCT/KR2009/000911 2008-02-29 2009-02-26 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물 WO2009107983A2 (ko)

Priority Applications (11)

Application Number Priority Date Filing Date Title
AU2009217927A AU2009217927B2 (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
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
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
CA2714942A CA2714942C (en) 2008-02-29 2009-02-26 Stabilized single-liquid pharmaceutical composition containing docetaxel
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.
RU2010139958/15A RU2478370C2 (ru) 2008-02-29 2009-02-26 Стабилизированная фармацевтическая композиция, содержащая доцетаксел
BRPI0908859A BRPI0908859A2 (pt) 2008-02-29 2009-02-26 composição farmacêutica estabilizada de líquído único contedo docetaxel
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 (2)

Application Number Priority Date Filing Date Title
KR1020080019179A KR101053780B1 (ko) 2008-02-29 2008-02-29 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물
KR10-2008-0019179 2008-02-29

Related Child Applications (1)

Application Number Title Priority Date Filing Date
US12/826,278 Continuation US20100267818A1 (en) 2008-02-29 2010-06-29 Stabilized single-liquid pharmaceutical composition containing docetaxel

Publications (2)

Publication Number Publication Date
WO2009107983A2 WO2009107983A2 (ko) 2009-09-03
WO2009107983A3 true WO2009107983A3 (ko) 2009-12-03

Family

ID=41016586

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2009/000911 WO2009107983A2 (ko) 2008-02-29 2009-02-26 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)

Families Citing this family (16)

* Cited by examiner, † Cited by third party
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

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001049286A1 (en) * 2000-01-05 2001-07-12 Neurim Pharmaceuticals (1991) Ltd. Method and formulation for treating resistance to antihypertensives and related conditions
WO2006091780A2 (en) * 2005-02-24 2006-08-31 Elan Pharma International Limited Nanoparticulate formulations of docetaxel and analogues thereof
WO2006133510A1 (en) * 2005-06-17 2006-12-21 Hospira Australia Pty Ltd Liquid pharmaceutical formulations of docetaxel
KR20070072786A (ko) * 2006-01-02 2007-07-05 주식회사 삼양제넥스 무정형, 무수결정형 또는 수화 결정형 도세탁셀의 제조방법
KR20070112725A (ko) * 2006-05-22 2007-11-27 에스케이케미칼주식회사 우수한 안정성을 갖는 도세탁셀 함유 주사제 조성물 및이의 제조방법

Family Cites Families (12)

* Cited by examiner, † Cited by third party
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
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
GB0517092D0 (en) * 2005-08-19 2005-09-28 Novartis Ag New compositions containing taxane derivatives
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
AU2008269179A1 (en) * 2007-06-22 2008-12-31 Scidose Llc Solubilized formulation of docetaxel without Tween 80

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001049286A1 (en) * 2000-01-05 2001-07-12 Neurim Pharmaceuticals (1991) Ltd. Method and formulation for treating resistance to antihypertensives and related conditions
WO2006091780A2 (en) * 2005-02-24 2006-08-31 Elan Pharma International Limited Nanoparticulate formulations of docetaxel and analogues thereof
WO2006133510A1 (en) * 2005-06-17 2006-12-21 Hospira Australia Pty Ltd Liquid pharmaceutical formulations of docetaxel
KR20070072786A (ko) * 2006-01-02 2007-07-05 주식회사 삼양제넥스 무정형, 무수결정형 또는 수화 결정형 도세탁셀의 제조방법
KR20070112725A (ko) * 2006-05-22 2007-11-27 에스케이케미칼주식회사 우수한 안정성을 갖는 도세탁셀 함유 주사제 조성물 및이의 제조방법

Also Published As

Publication number Publication date
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
RU2010139958A (ru) 2012-04-10
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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