CN103476397B - 一种制备用于注射的含培美曲塞或其盐的无抗氧化剂溶液形式的药物制剂的方法 - Google Patents

一种制备用于注射的含培美曲塞或其盐的无抗氧化剂溶液形式的药物制剂的方法 Download PDF

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Publication number
CN103476397B
CN103476397B CN201280012405.6A CN201280012405A CN103476397B CN 103476397 B CN103476397 B CN 103476397B CN 201280012405 A CN201280012405 A CN 201280012405A CN 103476397 B CN103476397 B CN 103476397B
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CN
China
Prior art keywords
injection
pemetrexed
solution
scavenging
less
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Expired - Fee Related
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CN201280012405.6A
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English (en)
Chinese (zh)
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CN103476397A (zh
Inventor
宋泰昊
徐城基
李磨世
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Kuhnil Pharmaceutical Co Ltd
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Kuhnil Pharmaceutical Co Ltd
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    • 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
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • 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
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • 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
    • A61K47/02—Inorganic compounds
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Inorganic Chemistry (AREA)
  • Dermatology (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
CN201280012405.6A 2011-03-10 2012-03-05 一种制备用于注射的含培美曲塞或其盐的无抗氧化剂溶液形式的药物制剂的方法 Expired - Fee Related CN103476397B (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
KR10-2011-0021224 2011-03-10
KR1020110021224A KR101069128B1 (ko) 2011-03-10 2011-03-10 페메트렉시드 또는 그의 염을 포함하는 항산화제-비함유 주사용 용액 형태의 약학적 제제의 제조방법
PCT/KR2012/001601 WO2012121523A2 (fr) 2011-03-10 2012-03-05 Procédé de préparation d'une formulation pharmaceutique sous la forme d'une solution exempte d'antioxydant pour une injection contenant du pemetrexed ou son sel

Publications (2)

Publication Number Publication Date
CN103476397A CN103476397A (zh) 2013-12-25
CN103476397B true CN103476397B (zh) 2016-03-30

Family

ID=44958114

Family Applications (1)

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CN201280012405.6A Expired - Fee Related CN103476397B (zh) 2011-03-10 2012-03-05 一种制备用于注射的含培美曲塞或其盐的无抗氧化剂溶液形式的药物制剂的方法

Country Status (4)

Country Link
KR (1) KR101069128B1 (fr)
CN (1) CN103476397B (fr)
TW (1) TWI476013B (fr)
WO (1) WO2012121523A2 (fr)

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US20150073000A1 (en) * 2012-03-27 2015-03-12 Fresenius Kabi Oncology Limited Stable ready-to-use pharmaceutical composition of pemetrexed
EP3210629A1 (fr) * 2012-05-30 2017-08-30 Fresenius Kabi Oncology Ltd Composition pharmaceutique de pemetrexed
KR101260636B1 (ko) * 2012-11-29 2013-05-13 씨제이제일제당 (주) 안정화된 페메트렉시드 제제
KR101485243B1 (ko) 2013-05-08 2015-01-21 씨제이헬스케어 주식회사 안정화된 페메트렉시드 제제
DK3040074T3 (en) 2013-10-03 2018-10-08 Fujifilm Corp INJECTION PREPARATION AND METHOD OF PREPARING IT
WO2015092758A1 (fr) * 2013-12-19 2015-06-25 Dr. Reddy' S Laboratories Ltd Formulations pharmaceutiques liquides de pemetrexed
KR101703980B1 (ko) * 2013-12-30 2017-02-08 주식회사 삼양바이오팜 항산화제를 함유하지 않는 약학 조성물 및 그의 제조방법
JP6099810B2 (ja) 2014-03-28 2017-03-22 富士フイルム株式会社 注射液製剤及びその製造方法
PT3206666T (pt) 2014-10-16 2020-03-11 Synthon Bv Composição farmacêutica líquida compreendendo pemetrexedo
WO2016082714A1 (fr) * 2014-11-26 2016-06-02 台湾东洋药品工业股份有限公司 Procédé de préparation de médicament de solution d'injection sans antioxydant ayant une stabilité à long terme
JP6869899B2 (ja) * 2015-02-13 2021-05-12 サン・ファーマシューティカル・インダストリーズ・リミテッド 静脈内注入剤形
KR101919436B1 (ko) * 2015-05-28 2018-11-16 주식회사 삼양바이오팜 안정화된 약학 조성물 및 그의 제조방법
JP6501399B2 (ja) * 2015-07-01 2019-04-17 日本化薬株式会社 ペメトレキセドを含有する注射用溶液製剤
EP3120837A1 (fr) 2015-07-22 2017-01-25 Stada Arzneimittel Ag Solution de bortezomib prêts à l'emploi
EP3120836A1 (fr) 2015-07-22 2017-01-25 Stada Arzneimittel Ag Solution de bortezomib prêts à l'emploi
WO2018002956A1 (fr) * 2016-06-27 2018-01-04 Sun Pharmaceutical Industries Ltd. Solution stable injectable de pémétrexed
JP6837895B2 (ja) * 2017-04-04 2021-03-03 日本化薬株式会社 医薬品溶液製剤の製造方法
ES2959975T3 (es) 2017-10-10 2024-02-29 Sun Pharmaceutical Ind Ltd Forma de dosificación para infusión intravenosa de pemetrexed
JPWO2019244965A1 (ja) * 2018-06-20 2020-06-25 日本化薬株式会社 ペメトレキセドナトリウム注射用溶液製剤、並びにその製造方法
CA3137265A1 (fr) 2019-05-01 2020-11-05 Intas Pharmaceuticals Ltd. Composition pharmaceutique aqueuse stable et prete a l'emploi de pemetrexed
EP4537814A1 (fr) * 2022-06-09 2025-04-16 Shanghai Aurora Biotechnology Co., Ltd. Composition liquide de pémétrexed disodique, son procédé de préparation et son utilisation

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1396828A (zh) * 2000-02-04 2003-02-12 伊莱利利公司 含有培美西德以及一硫代甘油l－半胱氨酸或巯乙酸的药物组合物
US20090253722A1 (en) * 2008-04-08 2009-10-08 Arpida Ag Aqueous pharmaceutical formulation

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4347695A (en) * 1980-03-26 1982-09-07 General Foods Corporation Beverage bottling method
CA2400155C (fr) * 2000-02-25 2009-09-15 Eli Lilly And Company Nouvelle forme cristalline de n-[4-[2-(2-amino-4,7-dihydro-4-oxo-3h-pyrrolo[2,3-d]pyrimidin-5-yl)ethyl]benzoyl]-l-acide glutamique et procede correspondant
EP2270012A1 (fr) * 2006-08-14 2011-01-05 Sicor, Inc. Forme cristalline de diacide de pemetrexed et son procédé de préparation
WO2010030598A2 (fr) * 2008-09-11 2010-03-18 Dr. Reddy's Laboratories Limited Formulations pharmaceutiques comprenant du pemetrexed

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN1396828A (zh) * 2000-02-04 2003-02-12 伊莱利利公司 含有培美西德以及一硫代甘油l－半胱氨酸或巯乙酸的药物组合物
US20090253722A1 (en) * 2008-04-08 2009-10-08 Arpida Ag Aqueous pharmaceutical formulation

Also Published As

Publication number Publication date
WO2012121523A3 (fr) 2012-11-01
TW201300139A (zh) 2013-01-01
TWI476013B (zh) 2015-03-11
CN103476397A (zh) 2013-12-25
KR101069128B1 (ko) 2011-09-30
WO2012121523A2 (fr) 2012-09-13

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Granted publication date: 20160330

Termination date: 20170305