JP2018512395A - タキサン−シクロデキストリン複合体を含む医薬組成物、作成方法、および使用方法 - Google Patents
タキサン−シクロデキストリン複合体を含む医薬組成物、作成方法、および使用方法 Download PDFInfo
- Publication number
- JP2018512395A JP2018512395A JP2017546904A JP2017546904A JP2018512395A JP 2018512395 A JP2018512395 A JP 2018512395A JP 2017546904 A JP2017546904 A JP 2017546904A JP 2017546904 A JP2017546904 A JP 2017546904A JP 2018512395 A JP2018512395 A JP 2018512395A
- Authority
- JP
- Japan
- Prior art keywords
- liquid pharmaceutical
- pharmaceutical composition
- cyclodextrin
- taxane
- composition according
- Prior art date
- Legal status (The legal status 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 status listed.)
- Pending
Links
Classifications
-
- 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
- A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/69—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit
- A61K47/6949—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes
- A61K47/6951—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the conjugate being characterised by physical or galenical forms, e.g. emulsion, particle, inclusion complex, stent or kit inclusion complexes, e.g. clathrates, cavitates or fullerenes using cyclodextrin
-
- 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
- A61K47/10—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
- 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
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/08—Solutions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
- C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
- C08B37/0006—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid
- C08B37/0009—Homoglycans, i.e. polysaccharides having a main chain consisting of one single sugar, e.g. colominic acid alpha-D-Glucans, e.g. polydextrose, alternan, glycogen; (alpha-1,4)(alpha-1,6)-D-Glucans; (alpha-1,3)(alpha-1,4)-D-Glucans, e.g. isolichenan or nigeran; (alpha-1,4)-D-Glucans; (alpha-1,3)-D-Glucans, e.g. pseudonigeran; Derivatives thereof
- C08B37/0012—Cyclodextrin [CD], e.g. cycle with 6 units (alpha), with 7 units (beta) and with 8 units (gamma), large-ring cyclodextrin or cycloamylose with 9 units or more; Derivatives thereof
- C08B37/0015—Inclusion compounds, i.e. host-guest compounds, e.g. polyrotaxanes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Inorganic Chemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Dermatology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Molecular Biology (AREA)
- Biochemistry (AREA)
- Materials Engineering (AREA)
- Polymers & Plastics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Applications Claiming Priority (5)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201562133698P | 2015-03-16 | 2015-03-16 | |
| US62/133,698 | 2015-03-16 | ||
| US201662304543P | 2016-03-07 | 2016-03-07 | |
| US62/304,543 | 2016-03-07 | ||
| PCT/US2016/022247 WO2016149162A1 (en) | 2015-03-16 | 2016-03-14 | Pharmaceutical compositions containing taxane-cyclodextrin complexes, method of making and methods of use |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2018512395A true JP2018512395A (ja) | 2018-05-17 |
| JP2018512395A5 JP2018512395A5 (enExample) | 2019-04-18 |
Family
ID=56919342
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2017546904A Pending JP2018512395A (ja) | 2015-03-16 | 2016-03-14 | タキサン−シクロデキストリン複合体を含む医薬組成物、作成方法、および使用方法 |
Country Status (6)
| Country | Link |
|---|---|
| US (1) | US10398785B2 (enExample) |
| EP (1) | EP3270912B1 (enExample) |
| JP (1) | JP2018512395A (enExample) |
| CN (4) | CN111714449A (enExample) |
| PL (2) | PL3270912T3 (enExample) |
| WO (1) | WO2016149162A1 (enExample) |
Families Citing this family (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2009538294A (ja) * | 2006-05-22 | 2009-11-05 | エスケー ケミカルズ カンパニー リミテッド | 安定性を有するドセタキセル含有医薬組成物、及びその製造方法 |
| US20100041625A1 (en) * | 2006-09-12 | 2010-02-18 | Nanjing Huge-Ring Medicine Technology Development Co., Ltd. | Pharmaceutical composition comprising cyclodextrin paclitaxel inclusion and preparation method thereof |
| JP2011509925A (ja) * | 2007-11-22 | 2011-03-31 | エスケー ケミカルズ カンパニー リミテッド | タキサン誘導体を含有する、改良された再構成時間を有する凍結乾燥医薬組成物及びその製法 |
| WO2012161520A2 (ko) * | 2011-05-23 | 2012-11-29 | 에스케이케미칼 주식회사 | 도세탁셀을 함유하는 액상 주사용 조성물 |
| JP2013531067A (ja) * | 2010-07-19 | 2013-08-01 | バイエル ヘルスケア リミティド ライアビリティ カンパニー | 疾病及び状態の処置及び予防のためのフルオロ置換オメガ−カルボキシアリールジフェニル尿素を用いた組み合わせ薬 |
| KR20140147336A (ko) * | 2013-06-19 | 2014-12-30 | 에스케이케미칼주식회사 | 도세탁셀을 함유하는 액상 주사용 조성물 |
Family Cites Families (11)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN1676125A (zh) | 2004-03-31 | 2005-10-05 | 张昊 | 含有紫杉碱类或难溶药物的纳米级乳剂 |
| US20060105045A1 (en) | 2004-11-08 | 2006-05-18 | Buchanan Charles M | Cyclodextrin solubilizers for liquid and semi-solid formulations |
| CN100508969C (zh) * | 2005-06-17 | 2009-07-08 | 上海艾力斯医药科技有限公司 | 紫杉烷环糊精包合物纳米粒及其制备方法 |
| CN101020059B (zh) * | 2006-02-15 | 2011-01-05 | 中国科学院上海药物研究所 | 一种含多烯紫杉醇类物质的药物组合物及其制备方法 |
| CN100411688C (zh) | 2006-09-12 | 2008-08-20 | 南京师范大学 | 含有环糊精/多烯紫杉醇包合物的药物组合物及其制备方法 |
| CN101439017B (zh) | 2007-11-20 | 2013-03-20 | 石茂光 | 紫杉烷类抗肿瘤药物的聚合物水溶液制剂的制备方法 |
| KR101502533B1 (ko) | 2007-11-22 | 2015-03-13 | 에스케이케미칼주식회사 | 우수한 안정성을 갖는 택산 유도체 함유 주사제용동결건조 조성물 및 이의 제조방법 |
| WO2009127072A1 (en) * | 2008-04-18 | 2009-10-22 | Angiochem Inc. | Pharmaceutical compositions of paclitaxel, paclitaxel analogs or paclitaxel conjugates and related methods of preparation and use |
| CN101366696B (zh) * | 2008-10-16 | 2012-04-11 | 姚定全 | 一种紫杉醇的水溶性注射用药物组合物、制备方法及用途 |
| CN101485652B (zh) * | 2009-02-25 | 2012-03-28 | 北京世纪博康医药科技有限公司 | 一种紫杉烷类化合物的组合物、其制备方法和用途 |
| US20120065255A1 (en) * | 2009-10-19 | 2012-03-15 | Nagesh Palepu | Cabazitaxel formulations and methods of preparing thereof |
-
2016
- 2016-03-14 EP EP16765533.1A patent/EP3270912B1/en active Active
- 2016-03-14 PL PL16765533T patent/PL3270912T3/pl unknown
- 2016-03-14 CN CN202010727929.XA patent/CN111714449A/zh active Pending
- 2016-03-14 PL PL16765533D patent/PL3270912T4/pl unknown
- 2016-03-14 JP JP2017546904A patent/JP2018512395A/ja active Pending
- 2016-03-14 CN CN202010718622.3A patent/CN111728941A/zh active Pending
- 2016-03-14 US US15/557,212 patent/US10398785B2/en active Active
- 2016-03-14 WO PCT/US2016/022247 patent/WO2016149162A1/en not_active Ceased
- 2016-03-14 CN CN202010718595.XA patent/CN111728940A/zh active Pending
- 2016-03-14 CN CN201680016066.7A patent/CN107427486B/zh active Active
Patent Citations (6)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2009538294A (ja) * | 2006-05-22 | 2009-11-05 | エスケー ケミカルズ カンパニー リミテッド | 安定性を有するドセタキセル含有医薬組成物、及びその製造方法 |
| US20100041625A1 (en) * | 2006-09-12 | 2010-02-18 | Nanjing Huge-Ring Medicine Technology Development Co., Ltd. | Pharmaceutical composition comprising cyclodextrin paclitaxel inclusion and preparation method thereof |
| JP2011509925A (ja) * | 2007-11-22 | 2011-03-31 | エスケー ケミカルズ カンパニー リミテッド | タキサン誘導体を含有する、改良された再構成時間を有する凍結乾燥医薬組成物及びその製法 |
| JP2013531067A (ja) * | 2010-07-19 | 2013-08-01 | バイエル ヘルスケア リミティド ライアビリティ カンパニー | 疾病及び状態の処置及び予防のためのフルオロ置換オメガ−カルボキシアリールジフェニル尿素を用いた組み合わせ薬 |
| WO2012161520A2 (ko) * | 2011-05-23 | 2012-11-29 | 에스케이케미칼 주식회사 | 도세탁셀을 함유하는 액상 주사용 조성물 |
| KR20140147336A (ko) * | 2013-06-19 | 2014-12-30 | 에스케이케미칼주식회사 | 도세탁셀을 함유하는 액상 주사용 조성물 |
Also Published As
| Publication number | Publication date |
|---|---|
| EP3270912A1 (en) | 2018-01-24 |
| CN107427486A (zh) | 2017-12-01 |
| EP3270912A4 (en) | 2018-11-14 |
| PL3270912T4 (pl) | 2022-04-19 |
| US20180050116A1 (en) | 2018-02-22 |
| EP3270912B1 (en) | 2021-08-18 |
| US10398785B2 (en) | 2019-09-03 |
| CN111714449A (zh) | 2020-09-29 |
| CN107427486B (zh) | 2020-07-10 |
| CN111728941A (zh) | 2020-10-02 |
| PL3270912T3 (pl) | 2022-04-19 |
| CN111728940A (zh) | 2020-10-02 |
| WO2016149162A1 (en) | 2016-09-22 |
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