MA30501B1 - Composition pharmaceutique stable contenant du docetaxel et son procede de preparation. - Google Patents
Composition pharmaceutique stable contenant du docetaxel et son procede de preparation.Info
- Publication number
- MA30501B1 MA30501B1 MA31456A MA31456A MA30501B1 MA 30501 B1 MA30501 B1 MA 30501B1 MA 31456 A MA31456 A MA 31456A MA 31456 A MA31456 A MA 31456A MA 30501 B1 MA30501 B1 MA 30501B1
- Authority
- MA
- Morocco
- Prior art keywords
- pharmaceutical composition
- containing docetaxel
- stable pharmaceutical
- preparation
- preparing
- Prior art date
Links
- ZDZOTLJHXYCWBA-VCVYQWHSSA-N N-debenzoyl-N-(tert-butoxycarbonyl)-10-deacetyltaxol Chemical compound O([C@H]1[C@H]2[C@@](C([C@H](O)C3=C(C)[C@@H](OC(=O)[C@H](O)[C@@H](NC(=O)OC(C)(C)C)C=4C=CC=CC=4)C[C@]1(O)C3(C)C)=O)(C)[C@@H](O)C[C@H]1OC[C@]12OC(=O)C)C(=O)C1=CC=CC=C1 ZDZOTLJHXYCWBA-VCVYQWHSSA-N 0.000 title abstract 4
- 229960003668 docetaxel Drugs 0.000 title abstract 4
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- 238000004519 manufacturing process Methods 0.000 title 1
- 239000000203 mixture Substances 0.000 abstract 3
- 238000002360 preparation method Methods 0.000 abstract 3
- 229920000858 Cyclodextrin Polymers 0.000 abstract 2
- 239000002202 Polyethylene glycol Substances 0.000 abstract 2
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 abstract 2
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 abstract 2
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 abstract 2
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 abstract 2
- 238000002347 injection Methods 0.000 abstract 2
- 239000007924 injection Substances 0.000 abstract 2
- 238000000034 method Methods 0.000 abstract 2
- 229920001223 polyethylene glycol Polymers 0.000 abstract 2
- 229920000036 polyvinylpyrrolidone Polymers 0.000 abstract 2
- 239000001267 polyvinylpyrrolidone Substances 0.000 abstract 2
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 abstract 2
- HFHDHCJBZVLPGP-UHFFFAOYSA-N schardinger α-dextrin Chemical compound O1C(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC(C(O)C2O)C(CO)OC2OC(C(C2O)O)C(CO)OC2OC2C(O)C(O)C1OC2CO HFHDHCJBZVLPGP-UHFFFAOYSA-N 0.000 abstract 2
- 150000001875 compounds Chemical class 0.000 abstract 1
- 239000012153 distilled water Substances 0.000 abstract 1
- 229940079593 drug Drugs 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 1
- 229920003169 water-soluble polymer Polymers 0.000 abstract 1
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)
- Veterinary Medicine (AREA)
- Medicinal Chemistry (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Abstract
La présente invention concerne une composition pharmaceutique stable pour injection contenant du docétaxel et son procédé de préparation. Plus particulièrement, la présente invention concerne une composition pharmaceutique pour injection contenant du docétaxel et présentant une stabilité au stockage améliorée par comparaison avec les médicaments classiques. La préparation de cette composition consiste à dissoudre du docétaxel, un composé hydro-insoluble, dans de l'eau distillée après son mélange avec de la cyclodextrine (CD) et un polymère hydrosoluble tel que l'hydroxypropyl méthylcellulose (HPMC), le polyéthylène glycol (PEG) ou la polyvinylpyrrolidone (PVP), puis à lyophiliser le mélange. L'invention concerne également un procédé de préparation de cette composition.
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 |
|---|---|
| MA30501B1 true MA30501B1 (fr) | 2009-06-01 |
Family
ID=39090946
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MA31456A MA30501B1 (fr) | 2006-05-22 | 2008-12-05 | Composition pharmaceutique stable contenant du docetaxel et son procede de preparation. |
Country Status (24)
| Country | Link |
|---|---|
| US (1) | US8791152B2 (fr) |
| EP (1) | EP2019664B1 (fr) |
| JP (1) | JP5369332B2 (fr) |
| KR (2) | KR100917809B1 (fr) |
| CN (1) | CN101484137B (fr) |
| AU (1) | AU2007252371B2 (fr) |
| BR (1) | BRPI0711893A2 (fr) |
| CA (1) | CA2653124C (fr) |
| CR (1) | CR10485A (fr) |
| EA (1) | EA014071B1 (fr) |
| EC (1) | ECSP088951A (fr) |
| ES (1) | ES2560641T3 (fr) |
| GE (1) | GEP20115200B (fr) |
| GT (1) | GT200800257A (fr) |
| IL (1) | IL195459A (fr) |
| MA (1) | MA30501B1 (fr) |
| MX (1) | MX2008014948A (fr) |
| MY (1) | MY149627A (fr) |
| NO (1) | NO20084932L (fr) |
| NZ (1) | NZ573202A (fr) |
| SV (1) | SV2008003106A (fr) |
| TN (1) | TNSN08475A1 (fr) |
| WO (1) | WO2007136219A1 (fr) |
| ZA (1) | ZA200809998B (fr) |
Families Citing this family (23)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PT2277551E (pt) | 2002-09-06 | 2013-08-22 | Cerulean Pharma Inc | Polímeros à base de ciclodextrina para a administração de medicamentos ligados por ligação covalente |
| JP2010516625A (ja) | 2007-01-24 | 2010-05-20 | インサート セラピューティクス， インコーポレイテッド | 制御された薬物送達のためのテザー基を有するポリマー−薬物コンジュゲート |
| WO2009007992A2 (fr) * | 2007-04-20 | 2009-01-15 | Sun Pharmaceutical Industries Limited | Compositions pharmaceutiques |
| KR101502533B1 (ko) * | 2007-11-22 | 2015-03-13 | 에스케이케미칼주식회사 | 우수한 안정성을 갖는 택산 유도체 함유 주사제용동결건조 조성물 및 이의 제조방법 |
| UA100543C2 (ru) * | 2007-12-24 | 2013-01-10 | Сан Фарма Адвансед Ресерч Компани Лимитед | Нанодисперсия, включающая наночастицы, которые содержат производное таксана |
| KR101053780B1 (ko) * | 2008-02-29 | 2011-08-02 | 동아제약주식회사 | 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물 |
| KR20120050414A (ko) | 2009-06-19 | 2012-05-18 | 썬 파마 어드밴스트 리서치 컴패니 리미티드 | 약물의 나노분산액 및 그의 제조 방법 |
| CA2774015A1 (fr) * | 2009-09-15 | 2011-03-24 | Cerulean Pharma Inc. | Conjugue de cdp-camptothecine, composition a distribution des orientations de particules et leurs utilisations |
| CN102781237A (zh) | 2009-11-23 | 2012-11-14 | 天蓝制药公司 | 用于传递治疗剂的基于环糊精的聚合物 |
| 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 (fr) * | 2011-05-23 | 2012-11-29 | 에스케이케미칼 주식회사 | Composition liquide injectable contenant du docétaxel |
| JO3685B1 (ar) | 2012-10-01 | 2020-08-27 | Teikoku Pharma Usa Inc | صيغ التشتيت الجسيمي للتاكسين غير المائي وطرق استخدامها |
| US20140094432A1 (en) | 2012-10-02 | 2014-04-03 | Cerulean Pharma Inc. | Methods and systems for polymer precipitation and generation of particles |
| EP2777691A1 (fr) * | 2013-03-14 | 2014-09-17 | Pharmachemie B.V. | Taxoïde - purification des excipients liquides |
| KR20140147336A (ko) * | 2013-06-19 | 2014-12-30 | 에스케이케미칼주식회사 | 도세탁셀을 함유하는 액상 주사용 조성물 |
| MX2016016311A (es) * | 2014-06-12 | 2017-10-12 | Univ Notre Dame Du Lac | Composición y método para el tratamiento de enfermedades neurológicas y lesión cerebral. |
| 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 |
| MX384080B (es) | 2015-10-20 | 2025-03-14 | Spepharm Ag | Composición acuosa que contiene dantroleno. |
| WO2018047074A1 (fr) * | 2016-09-07 | 2018-03-15 | Cadila Healthcare Limited | Compositions stériles injectables comprenant médicament micellaires |
| 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 (fr) * | 2018-07-25 | 2024-11-06 | Bika Biotechnology (Guangzhou) Co., Ltd. | Composition de docétaxel pour injection et son procédé de préparation |
| 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 |
Family Cites Families (21)
| 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 |
| AU5273200A (en) * | 1999-05-24 | 2000-12-12 | Sonus Pharmaceuticals, Inc. | Emulsion vehicle for poorly soluble drugs |
| DE60024811T3 (de) | 1999-05-27 | 2010-01-07 | Acusphere, Inc., Watertown | Poröse arzneistoffmatrizen und deren herstellungsverfahren |
| 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 |
| EP1415648B1 (fr) * | 2001-07-13 | 2006-11-22 | NanoCarrier Co., Ltd. | Composition de lyophilisation de micelle polymere d'encapsulation de medicaments et procede de preparation associe |
| 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 |
| 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 |
| EP1543841A4 (fr) * | 2002-08-15 | 2011-03-16 | Yunqing Liu | Formulation nanopharmaceutique et son procede de preparation |
| 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 |
| JP4929158B2 (ja) * | 2005-03-14 | 2012-05-09 | 株式会社大塚製薬工場 | 難水溶性薬物を含有する医薬組成物 |
-
2007
- 2007-05-21 KR KR1020070049340A patent/KR100917809B1/ko active Active
- 2007-05-22 AU AU2007252371A patent/AU2007252371B2/en not_active Ceased
- 2007-05-22 NZ NZ573202A patent/NZ573202A/en not_active IP Right Cessation
- 2007-05-22 EA EA200870559A patent/EA014071B1/ru not_active IP Right Cessation
- 2007-05-22 GE GEAP200711018A patent/GEP20115200B/en unknown
- 2007-05-22 ES ES07746627.4T patent/ES2560641T3/es active Active
- 2007-05-22 MY MYPI20084753A patent/MY149627A/en unknown
- 2007-05-22 JP JP2009511943A patent/JP5369332B2/ja not_active Expired - Fee Related
- 2007-05-22 MX MX2008014948A patent/MX2008014948A/es active IP Right Grant
- 2007-05-22 CN CN200780024837.8A patent/CN101484137B/zh not_active Expired - Fee Related
- 2007-05-22 CA CA2653124A patent/CA2653124C/fr not_active Expired - Fee Related
- 2007-05-22 BR BRPI0711893-7A patent/BRPI0711893A2/pt not_active IP Right Cessation
- 2007-05-22 US US12/301,700 patent/US8791152B2/en not_active Expired - Fee Related
- 2007-05-22 WO PCT/KR2007/002479 patent/WO2007136219A1/fr not_active Ceased
- 2007-05-22 EP EP07746627.4A patent/EP2019664B1/fr active Active
-
2008
- 2008-11-21 GT GT200800257A patent/GT200800257A/es unknown
- 2008-11-21 TN TNP2008000475A patent/TNSN08475A1/en unknown
- 2008-11-23 IL IL195459A patent/IL195459A/en not_active IP Right Cessation
- 2008-11-24 SV SV2008003106A patent/SV2008003106A/es unknown
- 2008-11-25 ZA ZA200809998A patent/ZA200809998B/xx unknown
- 2008-11-25 NO NO20084932A patent/NO20084932L/no not_active Application Discontinuation
- 2008-12-05 MA MA31456A patent/MA30501B1/fr unknown
- 2008-12-09 CR CR10485A patent/CR10485A/es unknown
- 2008-12-11 EC EC2008008951A patent/ECSP088951A/es unknown
-
2009
- 2009-08-26 KR KR1020090079337A patent/KR100983376B1/ko active Active
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