ECSP088951A - /composición farmacéutica estable que contiene docetaxel y método para su fabricación - Google Patents
/composición farmacéutica estable que contiene docetaxel y método para su fabricaciónInfo
- 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
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
- 238000000034 method Methods 0.000 title abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 3
- 238000004519 manufacturing process Methods 0.000 title 1
- 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
- 229920001223 polyethylene glycol Polymers 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
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 abstract 2
- 229920000858 Cyclodextrin Polymers 0.000 abstract 1
- 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
- 238000002483 medication Methods 0.000 abstract 1
- 239000000203 mixture Substances 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)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Engineering & Computer Science (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Dermatology (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.
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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR101476067B1 (ko) | 2002-09-06 | 2014-12-23 | 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 |
| WO2009007992A2 (en) * | 2007-04-20 | 2009-01-15 | Sun Pharmaceutical Industries Limited | Pharmaceutical composition produced by microprecipitation |
| KR101502533B1 (ko) * | 2007-11-22 | 2015-03-13 | 에스케이케미칼주식회사 | 우수한 안정성을 갖는 택산 유도체 함유 주사제용동결건조 조성물 및 이의 제조방법 |
| MX2010007076A (es) * | 2007-12-24 | 2010-09-30 | Sun Pharma Advanced Res Co Ltd | Nanodispersion. |
| 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 |
| WO2011034954A1 (en) * | 2009-09-15 | 2011-03-24 | Cerulean Pharma Inc. | Treatment of cancer |
| 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 |
| SG185389A1 (en) | 2010-05-03 | 2012-12-28 | 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 |
| KR20120130740A (ko) * | 2011-05-23 | 2012-12-03 | 에스케이케미칼주식회사 | 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 |
| US20140094432A1 (en) | 2012-10-02 | 2014-04-03 | 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 |
| 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. |
| EP3270912B1 (en) * | 2015-03-16 | 2021-08-18 | Meridian Lab | Pharmaceutical compositions containing taxane-cyclodextrin complexes, method of making and methods of use |
| ES2898425T3 (es) * | 2015-10-20 | 2022-03-07 | Braun Melsungen Ag | Composición acuosa que comprende dantroleno |
| EP3509569A1 (en) * | 2016-09-07 | 2019-07-17 | 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 |
| US12414914B2 (en) * | 2018-07-25 | 2025-09-16 | 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)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US5472945A (en) * | 1991-08-13 | 1995-12-05 | 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 |
| CA2373994A1 (en) * | 1999-05-24 | 2000-11-30 | Sonus Pharmaceuticals, Inc. | Emulsion vehicle for poorly soluble drugs |
| KR100883477B1 (ko) * | 1999-05-27 | 2009-02-16 | 아쿠스피어 인코포레이티드. | 다공성 약물 매트릭스의 약제 조성물 |
| 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 |
| CN1268321C (zh) * | 2001-07-13 | 2006-08-09 | 那野伽利阿株式会社 | 内部包有药物的高分子胶束的冻结干燥用组合物和该胶束的制备方法 |
| 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 |
| AU2003257791A1 (en) | 2002-08-15 | 2004-03-29 | Tong 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 |
-
2007
- 2007-05-21 KR KR1020070049340A patent/KR100917809B1/ko active Active
- 2007-05-22 WO PCT/KR2007/002479 patent/WO2007136219A1/en not_active Ceased
- 2007-05-22 GE GEAP200711018A patent/GEP20115200B/en unknown
- 2007-05-22 CA CA2653124A patent/CA2653124C/en not_active Expired - Fee Related
- 2007-05-22 US US12/301,700 patent/US8791152B2/en not_active Expired - Fee Related
- 2007-05-22 BR BRPI0711893-7A patent/BRPI0711893A2/pt not_active IP Right Cessation
- 2007-05-22 AU AU2007252371A patent/AU2007252371B2/en not_active Ceased
- 2007-05-22 CN CN200780024837.8A patent/CN101484137B/zh not_active Expired - Fee Related
- 2007-05-22 EP EP07746627.4A patent/EP2019664B1/en 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 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 MX MX2008014948A patent/MX2008014948A/es active IP Right Grant
- 2007-05-22 ES ES07746627.4T patent/ES2560641T3/es active Active
-
2008
- 2008-11-21 TN TNP2008000475A patent/TNSN08475A1/en unknown
- 2008-11-21 GT GT200800257A patent/GT200800257A/es 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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