JP2010514737A - 室温で安定している、半合成ビンカアルカロイドと炭水化物の凍結乾燥注射用医薬組合せ - Google Patents
室温で安定している、半合成ビンカアルカロイドと炭水化物の凍結乾燥注射用医薬組合せ Download PDFInfo
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- JP2010514737A JP2010514737A JP2009543478A JP2009543478A JP2010514737A JP 2010514737 A JP2010514737 A JP 2010514737A JP 2009543478 A JP2009543478 A JP 2009543478A JP 2009543478 A JP2009543478 A JP 2009543478A JP 2010514737 A JP2010514737 A JP 2010514737A
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- carbohydrate
- vinca alkaloid
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- 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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4375—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having nitrogen as a ring heteroatom, e.g. quinolizines, naphthyridines, berberine, vincamine
-
- 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
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/475—Quinolines; Isoquinolines having an indole ring, e.g. yohimbine, reserpine, strychnine, vinblastine
-
- 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
- A61K9/14—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
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- Health & Medical Sciences (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Chemical & Material Sciences (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Engineering & Computer Science (AREA)
- Dermatology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Organic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Steroid Compounds (AREA)
Abstract
Description
1).製造に必要な、サッカロースおよびビンフルニン二酒石酸塩を酢酸/酢酸ナトリウム0.1M緩衝液 pH=3.5の大部分に攪拌しながら連続して溶かし、
2).酢酸/酢酸ナトリウム0.1M緩衝液 pH=3.5で最終容量に調整し、得られた溶液をホモジナイズし、
3).親水性0.22μmフッ化ポリビニリデンメンブレンでの濾過により前記溶液を滅菌し、タイプIガラス瓶に分配し、
4).次の条件:
−48℃での製品凍結、
0.100ミリバール下、0.03℃/分の割合で37時間の一次乾燥、
0.010ミリバール下、20℃で16時間の二次乾燥
下で凍結乾燥操作を行い、
5).前記瓶に栓をし、キャップにねじ込む。
・25℃および60%相対湿度で6ヶ月後の再構成溶液の420nmにおける吸光度(図1に示した)
・25℃および60%相対湿度で6ヶ月後の総不純物(割合として表し、図2に示した)
:の変化を記録することによってモニタリングした。
Claims (9)
- 室温で安定している、半合成水溶性ビンカアルカロイド誘導体からなる医薬組成物であって、該誘導体が、少なくとも1種の炭水化物の存在下で得られる凍結乾燥形態である、医薬組成物。
- 前記半合成水溶性ビンカアルカロイド誘導体が水溶性塩の形態である、請求項1に記載の組成物。
- 半合成ビンカアルカロイド誘導体の前記水溶性塩がビンフルニンまたはビノレルビンである、請求項2に記載の組成物。
- 凍結乾燥賦形剤としての炭水化物に加えて、少なくとも1種の緩衝系を含む、請求項1〜3のいずれか一項に記載の組成物。
- 前記炭水化物が、還元もしくは非還元の単糖類、オリゴ糖類またはイヌリンなどの多糖類、より特定的には二糖類の中から選択される、請求項1〜4のいずれか一項に記載の組成物。
- 前記炭水化物が、サッカロース、トレハロースおよびラクトースの中から選択される、請求項5に記載の組成物。
- pHを制御するために選択される前記緩衝系が3〜4の値を有し、より具体的には約3.5のpHを有し、かつ、0.005M〜0.5M、より具体的には0.05M〜0.2Mのモル濃度を有するものである、請求項4〜6のいずれか一項に記載の組成物。
- 不活性ガス雰囲気下で、かつ/または処方中への親水性抗酸化剤の配合を伴って、製造され、パッケージングされる、請求項1〜7のいずれか一項に記載の組成物。
- 静脈内経路での注入による投与に適した形態にある、請求項1〜8のいずれか一項に記載の組成物。
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR0656044A FR2910812B1 (fr) | 2006-12-29 | 2006-12-29 | Compositions pharmaceutiques injectables lyophilisees de derives hemi-synthetiques d'alcaloide de vinca stables a temperature ambiante |
US89705907P | 2007-01-24 | 2007-01-24 | |
PCT/EP2007/064612 WO2008080968A1 (en) | 2006-12-29 | 2007-12-28 | Freeze-dried injectable pharmaceutical combination of semisynthetic vinca alkaloids and carbohydrate stable at room temperature |
Publications (1)
Publication Number | Publication Date |
---|---|
JP2010514737A true JP2010514737A (ja) | 2010-05-06 |
Family
ID=38293420
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2009543478A Pending JP2010514737A (ja) | 2006-12-29 | 2007-12-28 | 室温で安定している、半合成ビンカアルカロイドと炭水化物の凍結乾燥注射用医薬組合せ |
Country Status (24)
Country | Link |
---|---|
US (1) | US8304424B2 (ja) |
EP (1) | EP2120934B1 (ja) |
JP (1) | JP2010514737A (ja) |
KR (1) | KR20090097883A (ja) |
CN (1) | CN101534821B (ja) |
AR (1) | AR064715A1 (ja) |
AU (1) | AU2007341231B2 (ja) |
BR (1) | BRPI0722076A2 (ja) |
CA (1) | CA2673232A1 (ja) |
CL (1) | CL2007003838A1 (ja) |
FR (1) | FR2910812B1 (ja) |
HK (1) | HK1130439A1 (ja) |
IL (1) | IL199556A (ja) |
MA (1) | MA30892B1 (ja) |
MX (1) | MX2009006949A (ja) |
NO (1) | NO20092726L (ja) |
NZ (1) | NZ576583A (ja) |
RU (1) | RU2449791C2 (ja) |
SA (1) | SA07280720B1 (ja) |
TN (1) | TN2009000258A1 (ja) |
TW (1) | TWI415631B (ja) |
UA (1) | UA96977C2 (ja) |
WO (1) | WO2008080968A1 (ja) |
ZA (1) | ZA200903115B (ja) |
Families Citing this family (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN102151249A (zh) * | 2010-02-11 | 2011-08-17 | 石药集团中奇制药技术(石家庄)有限公司 | 一种长春氟宁的药用组合物 |
JO3112B1 (ar) * | 2010-03-29 | 2017-09-20 | Ferring Bv | تركيبة دوائية سريعة التحلل |
CN102772373B (zh) * | 2011-05-11 | 2015-09-02 | 石药集团中奇制药技术(石家庄)有限公司 | 一种注射用酒石酸长春瑞滨粉针剂及其制备方法 |
EP3843885A1 (en) * | 2018-08-31 | 2021-07-07 | FUJIFILM Irvine Scientific, Inc. | Venting system for a mixing apparatus |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH02290822A (ja) * | 1989-04-04 | 1990-11-30 | Eli Lilly & Co | 医薬製剤 |
JP2001518892A (ja) * | 1997-04-10 | 2001-10-16 | ピエール、ファーブル、メディカマン | ビンカアルカロイドの抗有糸分裂性ハロ誘導体 |
JP2005518434A (ja) * | 2002-02-22 | 2005-06-23 | シェーリング コーポレイション | 抗新生物薬剤、特にテモゾロミドの薬学的処方物、その同一物の製造方法および使用方法 |
WO2005070425A1 (fr) * | 2003-12-23 | 2005-08-04 | Pierre Fabre Medicament | Composition pharmaceutique de vinflunine destinee a une administration parenterale, procede de preparation et utilisation |
WO2006099258A1 (en) * | 2005-03-14 | 2006-09-21 | Wyeth | Tigecycline compositions and methods of preparation |
Family Cites Families (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
IT1170152B (it) * | 1982-07-19 | 1987-06-03 | Lilly Co Eli | Miglioramenti a o riguardanti formulazioni di vinca-alcaloidi |
US4619935A (en) * | 1983-03-17 | 1986-10-28 | Eli Lilly And Company | Stable oncolytic formulations |
US4923876A (en) * | 1988-04-18 | 1990-05-08 | Cetus Corporation | Vinca alkaloid pharmaceutical compositions |
US6143276A (en) * | 1997-03-21 | 2000-11-07 | Imarx Pharmaceutical Corp. | Methods for delivering bioactive agents to regions of elevated temperatures |
CN103948545B (zh) * | 2004-05-03 | 2017-10-03 | 益普生生物制药公司 | 用于药物输送的脂质体 |
-
2006
- 2006-12-29 FR FR0656044A patent/FR2910812B1/fr active Active
-
2007
- 2007-12-25 TW TW096149863A patent/TWI415631B/zh not_active IP Right Cessation
- 2007-12-27 CL CL200703838A patent/CL2007003838A1/es unknown
- 2007-12-28 US US12/514,668 patent/US8304424B2/en active Active
- 2007-12-28 JP JP2009543478A patent/JP2010514737A/ja active Pending
- 2007-12-28 NZ NZ576583A patent/NZ576583A/en not_active IP Right Cessation
- 2007-12-28 WO PCT/EP2007/064612 patent/WO2008080968A1/en active Application Filing
- 2007-12-28 MX MX2009006949A patent/MX2009006949A/es active IP Right Grant
- 2007-12-28 CN CN2007800423856A patent/CN101534821B/zh not_active Expired - Fee Related
- 2007-12-28 UA UAA200907929A patent/UA96977C2/ru unknown
- 2007-12-28 AU AU2007341231A patent/AU2007341231B2/en not_active Ceased
- 2007-12-28 EP EP07866320.0A patent/EP2120934B1/en active Active
- 2007-12-28 CA CA002673232A patent/CA2673232A1/en not_active Abandoned
- 2007-12-28 AR ARP070105992A patent/AR064715A1/es unknown
- 2007-12-28 BR BRPI0722076-6A2A patent/BRPI0722076A2/pt not_active IP Right Cessation
- 2007-12-28 RU RU2009128327/15A patent/RU2449791C2/ru not_active IP Right Cessation
- 2007-12-28 KR KR1020097012321A patent/KR20090097883A/ko not_active Application Discontinuation
- 2007-12-29 SA SA7280720A patent/SA07280720B1/ar unknown
-
2009
- 2009-05-06 ZA ZA200903115A patent/ZA200903115B/xx unknown
- 2009-05-14 MA MA31876A patent/MA30892B1/fr unknown
- 2009-06-23 TN TNP2009000258A patent/TN2009000258A1/fr unknown
- 2009-06-25 IL IL199556A patent/IL199556A/en not_active IP Right Cessation
- 2009-07-20 NO NO20092726A patent/NO20092726L/no not_active Application Discontinuation
- 2009-11-10 HK HK09110427.3A patent/HK1130439A1/xx not_active IP Right Cessation
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH02290822A (ja) * | 1989-04-04 | 1990-11-30 | Eli Lilly & Co | 医薬製剤 |
JP2001518892A (ja) * | 1997-04-10 | 2001-10-16 | ピエール、ファーブル、メディカマン | ビンカアルカロイドの抗有糸分裂性ハロ誘導体 |
JP2005518434A (ja) * | 2002-02-22 | 2005-06-23 | シェーリング コーポレイション | 抗新生物薬剤、特にテモゾロミドの薬学的処方物、その同一物の製造方法および使用方法 |
WO2005070425A1 (fr) * | 2003-12-23 | 2005-08-04 | Pierre Fabre Medicament | Composition pharmaceutique de vinflunine destinee a une administration parenterale, procede de preparation et utilisation |
WO2006099258A1 (en) * | 2005-03-14 | 2006-09-21 | Wyeth | Tigecycline compositions and methods of preparation |
Non-Patent Citations (2)
Title |
---|
JPN5010000244; HATLEY R H M: DRUG STABILITY V1 N2, 1996, P73-85, RADCLIFF MEDICAL PRESS * |
JPN6013004620; Journal of Pharmaceutical Sciences 93, 3, 2004, p.713-725 * |
Also Published As
Publication number | Publication date |
---|---|
RU2009128327A (ru) | 2011-02-10 |
TW200833369A (en) | 2008-08-16 |
UA96977C2 (ru) | 2011-12-26 |
MA30892B1 (fr) | 2009-11-02 |
AR064715A1 (es) | 2009-04-22 |
RU2449791C2 (ru) | 2012-05-10 |
CN101534821A (zh) | 2009-09-16 |
EP2120934B1 (en) | 2014-05-07 |
EP2120934A1 (en) | 2009-11-25 |
ZA200903115B (en) | 2010-04-28 |
NO20092726L (no) | 2009-07-20 |
FR2910812A1 (fr) | 2008-07-04 |
NZ576583A (en) | 2012-01-12 |
IL199556A (en) | 2014-09-30 |
KR20090097883A (ko) | 2009-09-16 |
US8304424B2 (en) | 2012-11-06 |
SA07280720B1 (ar) | 2012-02-07 |
CL2007003838A1 (es) | 2008-07-04 |
AU2007341231A1 (en) | 2008-07-10 |
US20100087473A1 (en) | 2010-04-08 |
TWI415631B (zh) | 2013-11-21 |
AU2007341231B2 (en) | 2013-03-21 |
CA2673232A1 (en) | 2008-07-10 |
HK1130439A1 (en) | 2009-12-31 |
FR2910812B1 (fr) | 2009-03-20 |
WO2008080968A1 (en) | 2008-07-10 |
CN101534821B (zh) | 2012-01-25 |
MX2009006949A (es) | 2009-07-14 |
BRPI0722076A2 (pt) | 2014-04-08 |
TN2009000258A1 (en) | 2010-10-18 |
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