JP2013194009A - ドセタキセル製剤 - Google Patents
ドセタキセル製剤 Download PDFInfo
- Publication number
- JP2013194009A JP2013194009A JP2012064459A JP2012064459A JP2013194009A JP 2013194009 A JP2013194009 A JP 2013194009A JP 2012064459 A JP2012064459 A JP 2012064459A JP 2012064459 A JP2012064459 A JP 2012064459A JP 2013194009 A JP2013194009 A JP 2013194009A
- Authority
- JP
- Japan
- Prior art keywords
- docetaxel
- preparation
- formulation
- examples
- alcohol
- 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
- 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 claims abstract description 48
- 229960003668 docetaxel Drugs 0.000 title claims abstract description 41
- 239000000203 mixture Substances 0.000 title claims abstract description 27
- 238000009472 formulation Methods 0.000 title claims abstract description 25
- LFQSCWFLJHTTHZ-UHFFFAOYSA-N Ethanol Chemical compound CCO LFQSCWFLJHTTHZ-UHFFFAOYSA-N 0.000 claims abstract description 11
- 239000002202 Polyethylene glycol Substances 0.000 claims abstract description 10
- 229920001223 polyethylene glycol Polymers 0.000 claims abstract description 10
- 206010020751 Hypersensitivity Diseases 0.000 abstract description 4
- 239000012669 liquid formulation Substances 0.000 abstract description 3
- 238000002360 preparation method Methods 0.000 description 39
- 239000000126 substance Substances 0.000 description 12
- 230000000052 comparative effect Effects 0.000 description 11
- 229940063683 taxotere Drugs 0.000 description 9
- WEVYAHXRMPXWCK-UHFFFAOYSA-N Acetonitrile Chemical compound CC#N WEVYAHXRMPXWCK-UHFFFAOYSA-N 0.000 description 6
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical group OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 description 6
- OKKJLVBELUTLKV-UHFFFAOYSA-N Methanol Chemical compound OC OKKJLVBELUTLKV-UHFFFAOYSA-N 0.000 description 6
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 6
- 238000001802 infusion Methods 0.000 description 6
- 238000001990 intravenous administration Methods 0.000 description 6
- 238000004128 high performance liquid chromatography Methods 0.000 description 5
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 description 5
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 description 5
- 229920000053 polysorbate 80 Polymers 0.000 description 5
- 229940068968 polysorbate 80 Drugs 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- 102000029749 Microtubule Human genes 0.000 description 3
- 108091022875 Microtubule Proteins 0.000 description 3
- DNIAPMSPPWPWGF-UHFFFAOYSA-N Propylene glycol Chemical compound CC(O)CO DNIAPMSPPWPWGF-UHFFFAOYSA-N 0.000 description 3
- 229960004543 anhydrous citric acid Drugs 0.000 description 3
- 210000004688 microtubule Anatomy 0.000 description 3
- 239000003381 stabilizer Substances 0.000 description 3
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 3
- WQNHWIYLCRZRLR-UHFFFAOYSA-N 2-(3-hydroxy-2,5-dioxooxolan-3-yl)acetic acid Chemical compound OC(=O)CC1(O)CC(=O)OC1=O WQNHWIYLCRZRLR-UHFFFAOYSA-N 0.000 description 2
- YWLXLRUDGLRYDR-ZHPRIASZSA-N 5beta,20-epoxy-1,7beta,10beta,13alpha-tetrahydroxy-9-oxotax-11-ene-2alpha,4alpha-diyl 4-acetate 2-benzoate Chemical compound O([C@H]1[C@H]2[C@@](C([C@H](O)C3=C(C)[C@@H](O)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 YWLXLRUDGLRYDR-ZHPRIASZSA-N 0.000 description 2
- NBIIXXVUZAFLBC-UHFFFAOYSA-N Phosphoric acid Chemical compound OP(O)(O)=O NBIIXXVUZAFLBC-UHFFFAOYSA-N 0.000 description 2
- 150000001875 compounds Chemical class 0.000 description 2
- 239000007857 degradation product Substances 0.000 description 2
- 238000001514 detection method Methods 0.000 description 2
- 238000004090 dissolution Methods 0.000 description 2
- 239000003978 infusion fluid Substances 0.000 description 2
- 229960003511 macrogol Drugs 0.000 description 2
- 230000014759 maintenance of location Effects 0.000 description 2
- 239000003002 pH adjusting agent Substances 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- MQLACMBJVPINKE-UHFFFAOYSA-N 10-[(3-hydroxy-4-methoxyphenyl)methylidene]anthracen-9-one Chemical compound C1=C(O)C(OC)=CC=C1C=C1C2=CC=CC=C2C(=O)C2=CC=CC=C21 MQLACMBJVPINKE-UHFFFAOYSA-N 0.000 description 1
- VOXXWSYKYCBWHO-UHFFFAOYSA-N 3-phenyllactic acid Chemical compound OC(=O)C(O)CC1=CC=CC=C1 VOXXWSYKYCBWHO-UHFFFAOYSA-N 0.000 description 1
- WQZGKKKJIJFFOK-GASJEMHNSA-N Glucose Natural products OC[C@H]1OC(O)[C@H](O)[C@@H](O)[C@@H]1O WQZGKKKJIJFFOK-GASJEMHNSA-N 0.000 description 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 1
- 241001116498 Taxus baccata Species 0.000 description 1
- 239000004480 active ingredient Substances 0.000 description 1
- 229910000147 aluminium phosphate Inorganic materials 0.000 description 1
- 150000008064 anhydrides Chemical class 0.000 description 1
- 230000001093 anti-cancer Effects 0.000 description 1
- 239000002246 antineoplastic agent Substances 0.000 description 1
- 239000002585 base Substances 0.000 description 1
- 239000011230 binding agent Substances 0.000 description 1
- 239000004359 castor oil Substances 0.000 description 1
- 235000019438 castor oil Nutrition 0.000 description 1
- 210000004027 cell Anatomy 0.000 description 1
- 239000003795 chemical substances by application Substances 0.000 description 1
- 239000011248 coating agent Substances 0.000 description 1
- 239000007884 disintegrant Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000003995 emulsifying agent Substances 0.000 description 1
- 238000005187 foaming Methods 0.000 description 1
- 239000011521 glass Substances 0.000 description 1
- 239000008103 glucose Substances 0.000 description 1
- ZEMPKEQAKRGZGQ-XOQCFJPHSA-N glycerol triricinoleate Natural products CCCCCC[C@@H](O)CC=CCCCCCCCC(=O)OC[C@@H](COC(=O)CCCCCCCC=CC[C@@H](O)CCCCCC)OC(=O)CCCCCCCC=CC[C@H](O)CCCCCC ZEMPKEQAKRGZGQ-XOQCFJPHSA-N 0.000 description 1
- 150000004677 hydrates Chemical class 0.000 description 1
- 238000010253 intravenous injection Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 239000000314 lubricant Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000011278 mitosis Effects 0.000 description 1
- 208000002154 non-small cell lung carcinoma Diseases 0.000 description 1
- 239000000546 pharmaceutical excipient Substances 0.000 description 1
- 239000002504 physiological saline solution Substances 0.000 description 1
- 239000004014 plasticizer Substances 0.000 description 1
- -1 polyoxyethylene Polymers 0.000 description 1
- 239000000843 powder Substances 0.000 description 1
- 239000002244 precipitate Substances 0.000 description 1
- 239000002243 precursor Substances 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 239000004094 surface-active agent Substances 0.000 description 1
- 208000029729 tumor suppressor gene on chromosome 11 Diseases 0.000 description 1
Landscapes
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2012064459A JP2013194009A (ja) | 2012-03-21 | 2012-03-21 | ドセタキセル製剤 |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2012064459A JP2013194009A (ja) | 2012-03-21 | 2012-03-21 | ドセタキセル製剤 |
Related Child Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2016179034A Division JP6292267B2 (ja) | 2016-09-13 | 2016-09-13 | ドセタキセル製剤 |
| JP2018048154A Division JP2018115178A (ja) | 2018-03-15 | 2018-03-15 | ドセタキセル製剤 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| JP2013194009A true JP2013194009A (ja) | 2013-09-30 |
| JP2013194009A5 JP2013194009A5 (enrdf_load_stackoverflow) | 2014-12-04 |
Family
ID=49393388
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2012064459A Pending JP2013194009A (ja) | 2012-03-21 | 2012-03-21 | ドセタキセル製剤 |
Country Status (1)
| Country | Link |
|---|---|
| JP (1) | JP2013194009A (enrdf_load_stackoverflow) |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2015134724A (ja) * | 2014-01-16 | 2015-07-27 | ナガセ医薬品株式会社 | エタノールフリードセタキセル医薬組成物 |
| JP2016216504A (ja) * | 2016-09-13 | 2016-12-22 | ニプロ株式会社 | ドセタキセル製剤 |
Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH06507913A (ja) * | 1991-07-08 | 1994-09-08 | ローン−プーラン・ロレ・ソシエテ・アノニム | タキサン類の誘導体を基とする新規組成物 |
| 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 |
| JP2008543789A (ja) * | 2005-06-17 | 2008-12-04 | ホスピラ オーストラリア ピーティーワイ エルティーディー | ドセタキセルの液体薬学的処方物 |
| JP2009524700A (ja) * | 2006-01-30 | 2009-07-02 | キラル キミカ ド ブラジル ソシエダッド アノニマ | ドセタキセルと分解阻害剤を含む医薬組成物およびその医薬組成物の製造方法 |
| US20090275647A1 (en) * | 2007-10-01 | 2009-11-05 | Intas Pharmaceuticals Limited | Taxane derivative composition |
| WO2011047637A1 (zh) * | 2009-10-23 | 2011-04-28 | 天津天士力集团有限公司 | 一种含有pH值调节剂的紫杉烷类药物溶液及其制备方法 |
| JP2011513299A (ja) * | 2008-02-29 | 2011-04-28 | ドン−エー ファーム．カンパニー リミテッド | ドセタキセルを含有する単一液状の安定した薬剤学的組成物 |
| JP2011523620A (ja) * | 2007-11-22 | 2011-08-18 | 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、安定性が改良された凍結乾燥医薬組成物、及びその製法 |
| US8044093B2 (en) * | 2006-02-20 | 2011-10-25 | Beijing Century Biocom Pharmaceutical Technology Co., Ltd. | Pharmaceutical compositions comprising docetaxel and methods for preparation thereof |
-
2012
- 2012-03-21 JP JP2012064459A patent/JP2013194009A/ja active Pending
Patent Citations (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JPH06507913A (ja) * | 1991-07-08 | 1994-09-08 | ローン−プーラン・ロレ・ソシエテ・アノニム | タキサン類の誘導体を基とする新規組成物 |
| 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 |
| JP2008543789A (ja) * | 2005-06-17 | 2008-12-04 | ホスピラ オーストラリア ピーティーワイ エルティーディー | ドセタキセルの液体薬学的処方物 |
| JP2009524700A (ja) * | 2006-01-30 | 2009-07-02 | キラル キミカ ド ブラジル ソシエダッド アノニマ | ドセタキセルと分解阻害剤を含む医薬組成物およびその医薬組成物の製造方法 |
| US8044093B2 (en) * | 2006-02-20 | 2011-10-25 | Beijing Century Biocom Pharmaceutical Technology Co., Ltd. | Pharmaceutical compositions comprising docetaxel and methods for preparation thereof |
| US20090275647A1 (en) * | 2007-10-01 | 2009-11-05 | Intas Pharmaceuticals Limited | Taxane derivative composition |
| JP2011523620A (ja) * | 2007-11-22 | 2011-08-18 | 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、安定性が改良された凍結乾燥医薬組成物、及びその製法 |
| JP2011513299A (ja) * | 2008-02-29 | 2011-04-28 | ドン−エー ファーム．カンパニー リミテッド | ドセタキセルを含有する単一液状の安定した薬剤学的組成物 |
| WO2011047637A1 (zh) * | 2009-10-23 | 2011-04-28 | 天津天士力集团有限公司 | 一种含有pH值调节剂的紫杉烷类药物溶液及其制备方法 |
Cited By (2)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| JP2015134724A (ja) * | 2014-01-16 | 2015-07-27 | ナガセ医薬品株式会社 | エタノールフリードセタキセル医薬組成物 |
| JP2016216504A (ja) * | 2016-09-13 | 2016-12-22 | ニプロ株式会社 | ドセタキセル製剤 |
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