TR201005726T2 - Docetaksel içeren stabilize tekli-sıvı farmasötik kompozisyon. - Google Patents
Docetaksel içeren stabilize tekli-sıvı farmasötik kompozisyon.Info
- Publication number
- TR201005726T2 TR201005726T2 TR2010/05726T TR201005726T TR201005726T2 TR 201005726 T2 TR201005726 T2 TR 201005726T2 TR 2010/05726 T TR2010/05726 T TR 2010/05726T TR 201005726 T TR201005726 T TR 201005726T TR 201005726 T2 TR201005726 T2 TR 201005726T2
- Authority
- TR
- Turkey
- Prior art keywords
- composition
- pharmaceutical composition
- liquid pharmaceutical
- docetaxel
- 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 3
- 229960003668 docetaxel Drugs 0.000 title abstract 3
- 239000007788 liquid Substances 0.000 title abstract 3
- 239000008194 pharmaceutical composition Substances 0.000 title abstract 2
- 239000000203 mixture Substances 0.000 abstract 5
- -1 polyoxyethylene Polymers 0.000 abstract 3
- 229920003171 Poly (ethylene oxide) Polymers 0.000 abstract 2
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 abstract 1
- 235000019738 Limestone Nutrition 0.000 abstract 1
- LYCAIKOWRPUZTN-UHFFFAOYSA-N ethylene glycol Natural products OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 abstract 1
- 239000012530 fluid Substances 0.000 abstract 1
- WGCNASOHLSPBMP-UHFFFAOYSA-N hydroxyacetaldehyde Natural products OCC=O WGCNASOHLSPBMP-UHFFFAOYSA-N 0.000 abstract 1
- 229940102223 injectable solution Drugs 0.000 abstract 1
- 238000002347 injection Methods 0.000 abstract 1
- 239000007924 injection Substances 0.000 abstract 1
- 239000006028 limestone Substances 0.000 abstract 1
- 239000007791 liquid phase Substances 0.000 abstract 1
- 239000003002 pH adjusting agent Substances 0.000 abstract 1
- 230000010412 perfusion Effects 0.000 abstract 1
- 229920000136 polysorbate Polymers 0.000 abstract 1
- 229950008882 polysorbate Drugs 0.000 abstract 1
- 238000002360 preparation method Methods 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
- 239000000243 solution Substances 0.000 abstract 1
- 239000002904 solvent Substances 0.000 abstract 1
- 239000004094 surface-active agent Substances 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
- 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
- A61K47/12—Carboxylic acids; Salts or anhydrides 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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)
- 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
Bu buluş docetaksel içeren enjeksiyon amaçlı tekli-sıvı bir farmasötik kompozisyonla ilgilidir Bu kompozisyon (A) docetaksel ve bunun farmasötik olarak kabul edilebilir tuzlarını, (B) polisorbat, polioksietilen glikol ester ve polioksietilen limityağı türevlerinden oluşan gruptan seçilen bir yüzey aktif madde, (C) enjekte edilebilir bir solüsyonda 100 ila 800 mg/ml arasında bir konsantrasyonda susuz etanol içeren bir solvent, ve (D) sıvı kompozisyonun pH derecesinin 5 ya da daha az olacak şekilde ayarlanması için uygun olan bir miktarda bir pH ayarlayıcı içermektedir. Bu kompozisyon, kompozisyonun enjekte edilebilir preparatlar için kullanılması durumunda bir ara seyreltik solüsyonun kullanımı olmadan bile bir perfüzyon sıvısında doğrudan seyreltilebilir çünkü bu kompozisyon tekli bir sıvı fazdadır
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 |
| PCT/KR2009/000911 WO2009107983A2 (ko) | 2008-02-29 | 2009-02-26 | 도세탁셀을 함유하는 단일액상의 안정한 약제학적 조성물 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| TR201005726T2 true TR201005726T2 (tr) | 2011-10-21 |
Family
ID=41016586
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| TR2010/05726T TR201005726T2 (tr) | 2008-02-29 | 2009-02-26 | Docetaksel içeren stabilize tekli-sıvı farmasötik kompozisyon. |
Country Status (14)
| Country | Link |
|---|---|
| US (1) | US20100267818A1 (tr) |
| JP (1) | JP5552438B2 (tr) |
| KR (1) | KR101053780B1 (tr) |
| CN (1) | CN101959501B (tr) |
| AU (1) | AU2009217927B2 (tr) |
| BR (1) | BRPI0908859A2 (tr) |
| CA (1) | CA2714942C (tr) |
| MX (1) | MX2010009031A (tr) |
| MY (1) | MY152013A (tr) |
| NZ (1) | NZ587578A (tr) |
| RU (1) | RU2478370C2 (tr) |
| TR (1) | TR201005726T2 (tr) |
| WO (1) | WO2009107983A2 (tr) |
| ZA (1) | ZA201004462B (tr) |
Families Citing this family (16)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| 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 |
| 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 |
| JP5847942B2 (ja) * | 2012-07-19 | 2016-01-27 | 富士フイルム株式会社 | タキサン系活性成分含有液体組成物、その製造方法及び液体製剤 |
| 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 |
| TWI715636B (zh) * | 2015-09-30 | 2021-01-11 | 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 |
Family Cites Families (17)
| 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. |
| ES2224200T3 (es) * | 1992-11-27 | 2005-03-01 | Mayne Pharma (Usa) Inc. | Composicion inyectable estable de paclitaxel. |
| WO1997023208A1 (en) * | 1995-12-21 | 1997-07-03 | Genelabs Technologies, Inc. | Taxane composition and method |
| US5922754A (en) * | 1998-10-02 | 1999-07-13 | Abbott Laboratories | Pharmaceutical compositions containing paclitaxel |
| HK1052655A1 (zh) * | 2000-01-05 | 2003-09-26 | 纽里姆药品(1991)有限公司 | 用於治療對抗高血壓藥的抗藥性和相關病症的方法和製劑 |
| EP1337273A2 (en) * | 2000-11-28 | 2003-08-27 | Transform Pharmaceuticals, Inc. | Pharmaceutical formulations comprising paclitaxel, derivatives, and pharmaceutically acceptable salts thereof |
| MXPA03006404A (es) * | 2001-01-18 | 2004-12-02 | Upjohn Co | Composiciones quimioterapeuticas de microemulsion de paclitaxel con biodisponibilidad oral mejorada. |
| 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 |
| MX2007010394A (es) * | 2005-02-24 | 2008-02-19 | Elan Pharma Int Ltd | Formulaciones nanoparticuladas de docetaxel y analogos del mismo. |
| EP2138164A1 (en) * | 2005-06-17 | 2009-12-30 | Hospira Australia Pty Ltd | Liquid pharmaceutical formulations of docetaxel |
| GB0517092D0 (en) * | 2005-08-19 | 2005-09-28 | Novartis Ag | New compositions containing taxane derivatives |
| KR100995390B1 (ko) * | 2006-01-02 | 2010-11-19 | 주식회사 삼양제넥스 | 무정형, 무수결정형 또는 수화 결정형 도세탁셀의 제조방법 |
| 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 |
| EP2012749A2 (en) * | 2006-05-03 | 2009-01-14 | I.Q.A., A.S. | Pharmaceutical composition containing a taxane derivative, destined for the preparation of an infusion solution, method of preparation thereof and use thereof |
| KR100917809B1 (ko) * | 2006-05-22 | 2009-09-18 | 에스케이케미칼주식회사 | 우수한 저장안정성을 갖는 도세탁셀 함유 주사제 조성물 |
| JP2010530872A (ja) * | 2007-06-22 | 2010-09-16 | サイドース・エルエルシー | Tween80を含まないドセタキセル可溶化製剤 |
-
2008
- 2008-02-29 KR KR1020080019179A patent/KR101053780B1/ko active Active
-
2009
- 2009-02-26 CN CN2009801064987A patent/CN101959501B/zh active Active
- 2009-02-26 AU AU2009217927A patent/AU2009217927B2/en not_active Ceased
- 2009-02-26 CA CA2714942A patent/CA2714942C/en active Active
- 2009-02-26 MY MYPI20103954 patent/MY152013A/en unknown
- 2009-02-26 JP JP2010548611A patent/JP5552438B2/ja not_active Expired - Fee Related
- 2009-02-26 MX MX2010009031A patent/MX2010009031A/es active IP Right Grant
- 2009-02-26 WO PCT/KR2009/000911 patent/WO2009107983A2/ko not_active Ceased
- 2009-02-26 NZ NZ587578A patent/NZ587578A/xx not_active IP Right Cessation
- 2009-02-26 TR TR2010/05726T patent/TR201005726T2/tr unknown
- 2009-02-26 BR BRPI0908859A patent/BRPI0908859A2/pt not_active IP Right Cessation
- 2009-02-26 RU RU2010139958/15A patent/RU2478370C2/ru not_active IP Right Cessation
-
2010
- 2010-06-24 ZA ZA2010/04462A patent/ZA201004462B/en unknown
- 2010-06-29 US US12/826,278 patent/US20100267818A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| KR20090093581A (ko) | 2009-09-02 |
| ZA201004462B (en) | 2011-04-28 |
| JP2011513299A (ja) | 2011-04-28 |
| WO2009107983A3 (ko) | 2009-12-03 |
| AU2009217927B2 (en) | 2012-06-07 |
| CN101959501A (zh) | 2011-01-26 |
| MX2010009031A (es) | 2010-09-10 |
| US20100267818A1 (en) | 2010-10-21 |
| CA2714942A1 (en) | 2009-09-03 |
| CN101959501B (zh) | 2012-08-29 |
| RU2010139958A (ru) | 2012-04-10 |
| AU2009217927A1 (en) | 2009-09-03 |
| RU2478370C2 (ru) | 2013-04-10 |
| KR101053780B1 (ko) | 2011-08-02 |
| NZ587578A (en) | 2012-08-31 |
| JP5552438B2 (ja) | 2014-07-16 |
| WO2009107983A2 (ko) | 2009-09-03 |
| CA2714942C (en) | 2014-06-17 |
| MY152013A (en) | 2014-08-15 |
| BRPI0908859A2 (pt) | 2017-06-06 |
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