ECSP088951A - /composición farmacéutica estable que contiene docetaxel y método para su fabricación - Google Patents

/composición farmacéutica estable que contiene docetaxel y método para su fabricación

Info

Publication number
ECSP088951A
ECSP088951A EC2008008951A ECSP088951A ECSP088951A EC SP088951 A ECSP088951 A EC SP088951A EC 2008008951 A EC2008008951 A EC 2008008951A EC SP088951 A ECSP088951 A EC SP088951A EC SP088951 A ECSP088951 A EC SP088951A
Authority
EC
Ecuador
Prior art keywords
pharmaceutical composition
containing docetaxel
stable pharmaceutical
manufacturing
composition containing
Prior art date
Application number
EC2008008951A
Other languages
English (en)
Inventor
Nam Ho Kim
Jin Young Lee
Jae-Sun Kim
Nam Kyu Lee
Woo Jae Jang
Joon Gyo Oh
Yoon-Jung Lee
Woong Sik Kim
Jin-Heung Sung
Key An Um
Original Assignee
Sk Chemicals Co Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=39090946&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=ECSP088951(A) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sk Chemicals Co Ltd filed Critical Sk Chemicals Co Ltd
Publication of ECSP088951A publication Critical patent/ECSP088951A/es

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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A61K31/716—Glucans
    • A61K31/724—Cyclodextrins
    • 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
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
    • 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/38—Cellulose; Derivatives 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
    • A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
    • A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
    • A61K47/40—Cyclodextrins; Derivatives thereof
    • 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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Inorganic Chemistry (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Dermatology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Molecular Biology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

La presente invención se relaciona con una composición farmacéutica estable para inyección que contiene docetaxel y un método de preparación de la misma. Más particularmente, la presente invención se relaciona con una composición farmacéutica para inyección que contiene docetaxel que tiene mejor estabilidad de almacenamiento que las medicaciones convencionales, que se prepara disolviendo el docetaxel, un compuesto insoluble en agua, en agua destilada después de mezclarlo con la ciclodextrina (CD) y un polímero soluble en agua, tal como metilcelulosa hidroxipropil (HPMC), glicol de polietileno (PEG ) o (PVP) y liofilizando la mezcla, y un método para prepararla.
EC2008008951A 2006-05-22 2008-12-11 /composición farmacéutica estable que contiene docetaxel y método para su fabricación ECSP088951A (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR20060045715 2006-05-22
KR1020070049340A KR100917809B1 (ko) 2006-05-22 2007-05-21 우수한 저장안정성을 갖는 도세탁셀 함유 주사제 조성물

Publications (1)

Publication Number Publication Date
ECSP088951A true ECSP088951A (es) 2009-02-27

Family

ID=39090946

Family Applications (1)

Application Number Title Priority Date Filing Date
EC2008008951A ECSP088951A (es) 2006-05-22 2008-12-11 /composición farmacéutica estable que contiene docetaxel y método para su fabricación

Country Status (24)

Country Link
US (1) US8791152B2 (es)
EP (1) EP2019664B1 (es)
JP (1) JP5369332B2 (es)
KR (2) KR100917809B1 (es)
CN (1) CN101484137B (es)
AU (1) AU2007252371B2 (es)
BR (1) BRPI0711893A2 (es)
CA (1) CA2653124C (es)
CR (1) CR10485A (es)
EA (1) EA014071B1 (es)
EC (1) ECSP088951A (es)
ES (1) ES2560641T3 (es)
GE (1) GEP20115200B (es)
GT (1) GT200800257A (es)
IL (1) IL195459A (es)
MA (1) MA30501B1 (es)
MX (1) MX2008014948A (es)
MY (1) MY149627A (es)
NO (1) NO20084932L (es)
NZ (1) NZ573202A (es)
SV (1) SV2008003106A (es)
TN (1) TNSN08475A1 (es)
WO (1) WO2007136219A1 (es)
ZA (1) ZA200809998B (es)

Families Citing this family (24)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20140070676A (ko) 2002-09-06 2014-06-10 인설트 테라페틱스, 인코퍼레이티드 공유결합된 치료제 전달을 위한 사이클로덱스트린-기초 중합체
US20080176958A1 (en) 2007-01-24 2008-07-24 Insert Therapeutics, Inc. Cyclodextrin-based polymers for therapeutics delivery
US20080262078A1 (en) * 2007-04-20 2008-10-23 Namdeo Alok B Pharmaceutical Compositions
KR101502533B1 (ko) * 2007-11-22 2015-03-13 에스케이케미칼주식회사 우수한 안정성을 갖는 택산 유도체 함유 주사제용동결건조 조성물 및 이의 제조방법
PL2231144T3 (pl) * 2007-12-24 2014-12-31 Sun Pharma Advanced Res Co Ltd Nanodyspersja
KR101053780B1 (ko) * 2008-02-29 2011-08-02 동아제약주식회사 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물
US8778364B2 (en) 2009-06-19 2014-07-15 Sun Pharma Advanced Research Company Ltd. Nanodispersion of a drug and process for its preparation
EA201200486A1 (ru) * 2009-09-15 2012-08-30 Серулин Фарма Инк. Лечение онкологических заболеваний
BR112012012210B8 (pt) 2009-11-23 2021-05-25 Cerulean Pharma Inc conjugado de (cdp)-taxano de polímero contendo ciclodextrina, composição, composição farmacêutica, forma de dosagem, kit e uso de um conjugado de cdp-taxano
JP5824511B2 (ja) 2010-05-03 2015-11-25 テイコク ファーマ ユーエスエー インコーポレーテッド 非水タキサンプロエマルジョン配合物ならびにそれを調製および使用する方法
KR20120130740A (ko) * 2011-05-23 2012-12-03 에스케이케미칼주식회사 도세탁셀을 함유하는 액상 주사용 조성물
WO2012161520A2 (ko) * 2011-05-23 2012-11-29 에스케이케미칼 주식회사 도세탁셀을 함유하는 액상 주사용 조성물
JO3685B1 (ar) 2012-10-01 2020-08-27 Teikoku Pharma Usa Inc صيغ التشتيت الجسيمي للتاكسين غير المائي وطرق استخدامها
WO2014055493A1 (en) 2012-10-02 2014-04-10 Cerulean Pharma Inc. Methods and systems for polymer precipitation and generation of particles
EP2777691A1 (en) * 2013-03-14 2014-09-17 Pharmachemie B.V. Taxoid - Purification of Liquid Excipients
KR20140147336A (ko) * 2013-06-19 2014-12-30 에스케이케미칼주식회사 도세탁셀을 함유하는 액상 주사용 조성물
KR20170012555A (ko) * 2014-06-12 2017-02-02 더 유니버시티 오브 노트르 담 듀락 신경 질환 및 대뇌 상해의 치료를 위한 조성물 및 방법
CN111714449A (zh) * 2015-03-16 2020-09-29 湖南省金准医疗科技有限公司 含有紫杉烷-环糊精复合物的药物组合物、制造方法和使用方法
US11844782B2 (en) 2015-10-20 2023-12-19 Spepharm Ag Aqueous composition comprising dantrolene
US20190224332A1 (en) * 2016-09-07 2019-07-25 Cadila Healthcare Limited Sterile injectable compositions comprising drug micelles
CN113559277B (zh) * 2018-01-11 2023-11-17 比卡生物科技（广州）有限公司 一种注射用卡巴他赛组合物及其制备方法
EP3827822B1 (en) * 2018-07-25 2024-11-06 Bika Biotechnology (Guangzhou) Co., Ltd. Docetaxel composition for injection and preparation method therefor
CN111603387A (zh) * 2020-06-03 2020-09-01 芜湖市第二人民医院 一种多西他赛注射液存储装置及其配制方法
CN116355289B (zh) * 2023-03-31 2026-02-03 北京工商大学 一种纳米纤维膜及其原料、制备方法和应用

Family Cites Families (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU2548992A (en) * 1991-08-13 1993-03-16 Temple University - Of The Commonwealth System Of Higher Education Modulation of blood pressure and inhibition of platelet activation with kininogen fragment
US5472954A (en) * 1992-07-14 1995-12-05 Cyclops H.F. Cyclodextrin complexation
HUT73844A (en) * 1994-11-11 1996-09-30 Chinoin Gyogyszer Es Vegyeszet New taxol complexes and pharmaceutical compositions containing them
US6458373B1 (en) 1997-01-07 2002-10-01 Sonus Pharmaceuticals, Inc. Emulsion vehicle for poorly soluble drugs
GB9711643D0 (en) * 1997-06-05 1997-07-30 Janssen Pharmaceutica Nv Glass thermoplastic systems
HUP9701945A3 (en) * 1997-11-10 2000-04-28 Hexal Ag Pharmaceutical composition for injection containing cyclodextrin and taxoids
US6133473A (en) * 1998-06-25 2000-10-17 Rohm And Haas Company Synthesis of carbamate compounds
US6294192B1 (en) 1999-02-26 2001-09-25 Lipocine, Inc. Triglyceride-free compositions and methods for improved delivery of hydrophobic therapeutic agents
KR100310839B1 (ko) 1999-03-23 2001-10-12 정기련 안정성이 개선된 파크리탁셀 가용화 주사제 조성물
KR20070058028A (ko) 1999-05-24 2007-06-07 소너스파머슈티칼즈인코포레이티드 난용성 약물용 에멀젼 부형제
HK1048956B (zh) 1999-05-27 2006-07-28 阿库斯菲尔公司 多孔药物基质及其制造方法
US6395300B1 (en) 1999-05-27 2002-05-28 Acusphere, Inc. Porous drug matrices and methods of manufacture thereof
US20030157161A1 (en) 2001-05-01 2003-08-21 Angiotech Pharmaceuticals, Inc. Compositions and methods for treating inflammatory conditions utilizing protein or polysaccharide containing anti-microtubule agents
DE60216287T2 (de) * 2001-07-13 2007-05-31 Nanocarrier Co., Ltd. Lyophilisierende zusammensetzung von wirkstoff-verkapselnder polymer-mizelle und verfahren zu ihrer herstellung
KR20030041577A (ko) 2001-11-20 2003-05-27 디디에스텍주식회사 난용성 약물과 치환된 시클로덱스트린을 함유하는고체분산체 및 이를 함유하는 약제학적 조성물
JP2003342168A (ja) * 2002-05-24 2003-12-03 Nano Career Kk 注射用薬物含有ポリマーミセル製剤の製造方法
WO2004022100A1 (en) * 2002-08-15 2004-03-18 Yunqing Liu Soild nano pharmaceutical formulation and preparation method thereof
CN1502332A (zh) * 2002-11-25 2004-06-09 刘云清 抗癌药紫杉醇自乳化固体纳米粒——注射用紫杉醇的制备方法
US20040127551A1 (en) 2002-12-27 2004-07-01 Kai Zhang Taxane-based compositions and methods of use
JP2005075783A (ja) 2003-09-01 2005-03-24 Otsuka Pharmaceut Factory Inc 難溶性化合物の可溶化または分散化用組成物
CN101137395B (zh) * 2005-03-14 2012-10-31 株式会社大塚制药工场 含有水难溶性药物的医药组合物

Also Published As

Publication number Publication date
AU2007252371B2 (en) 2013-07-25
CN101484137A (zh) 2009-07-15
US20090163574A1 (en) 2009-06-25
KR20070112725A (ko) 2007-11-27
CA2653124A1 (en) 2007-11-29
JP2009538294A (ja) 2009-11-05
EA200870559A1 (ru) 2009-04-28
CA2653124C (en) 2014-04-22
GEP20115200B (en) 2011-04-11
MA30501B1 (fr) 2009-06-01
JP5369332B2 (ja) 2013-12-18
CN101484137B (zh) 2014-05-14
US8791152B2 (en) 2014-07-29
SV2008003106A (es) 2010-04-30
KR100917809B1 (ko) 2009-09-18
BRPI0711893A2 (pt) 2012-01-10
MY149627A (en) 2013-09-13
EP2019664A4 (en) 2013-03-13
ZA200809998B (en) 2009-11-25
GT200800257A (es) 2010-10-19
IL195459A (en) 2013-09-30
NZ573202A (en) 2010-08-27
IL195459A0 (en) 2009-08-03
KR20090101145A (ko) 2009-09-24
HK1128874A1 (zh) 2009-11-13
KR100983376B1 (ko) 2010-09-20
CR10485A (es) 2009-03-02
EP2019664A1 (en) 2009-02-04
WO2007136219A1 (en) 2007-11-29
ES2560641T3 (es) 2016-02-22
TNSN08475A1 (en) 2010-04-14
EA014071B1 (ru) 2010-08-30
AU2007252371A1 (en) 2007-11-29
MX2008014948A (es) 2009-02-03
NO20084932L (no) 2008-12-19
EP2019664B1 (en) 2016-01-06

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