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WO2012121523A3 - Process for preparing pharmaceutical formulation in form of antioxidant-free solution for injection containing pemetrexed or its salt - Google Patents

Process for preparing pharmaceutical formulation in form of antioxidant-free solution for injection containing pemetrexed or its salt Download PDF

Info

Publication number
WO2012121523A3
WO2012121523A3 PCT/KR2012/001601 KR2012001601W WO2012121523A3 WO 2012121523 A3 WO2012121523 A3 WO 2012121523A3 KR 2012001601 W KR2012001601 W KR 2012001601W WO 2012121523 A3 WO2012121523 A3 WO 2012121523A3
Authority
WO
WIPO (PCT)
Prior art keywords
antioxidant
salt
pharmaceutical formulation
free solution
preparing pharmaceutical
Prior art date
Application number
PCT/KR2012/001601
Other languages
French (fr)
Other versions
WO2012121523A2 (en
Inventor
Tae-Ho Song
Sung-Ki Seo
Mase LEE
Original Assignee
Kuhnil Pharm. Co., Ltd.
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Kuhnil Pharm. Co., Ltd. filed Critical Kuhnil Pharm. Co., Ltd.
Priority to CN201280012405.6A priority Critical patent/CN103476397B/en
Publication of WO2012121523A2 publication Critical patent/WO2012121523A2/en
Publication of WO2012121523A3 publication Critical patent/WO2012121523A3/en

Links

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
    • 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
    • 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
    • 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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (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)

Abstract

The present invention provides a method for preparing a pharmaceutical formulation in the form of an antioxidant-free solution for injection, the method of which comprises: (a) controlling a dissolved oxygen concentration in a solution for injection comprising pemetrexed or its salt to 1 ppm or less; and (b) filling a container for injection with the solution obtained from the step (a), in a closed system having an oxygen partial pressure of 0.2 %v/v or less.
PCT/KR2012/001601 2011-03-10 2012-03-05 Process for preparing pharmaceutical formulation in form of antioxidant-free solution for injection containing pemetrexed or its salt WO2012121523A2 (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN201280012405.6A CN103476397B (en) 2011-03-10 2012-03-05 A kind of method containing the pharmaceutical preparation without antioxidant solution form of pemetrexed or its salt for the preparation of injection

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
KR1020110021224A KR101069128B1 (en) 2011-03-10 2011-03-10 Process for the preparation of a pharmaceutical preparation in the form of an antioxidant-free injectable solution comprising pemetrexed or salt thereof
KR10-2011-0021224 2011-03-10

Publications (2)

Publication Number Publication Date
WO2012121523A2 WO2012121523A2 (en) 2012-09-13
WO2012121523A3 true WO2012121523A3 (en) 2012-11-01

Family

ID=44958114

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/KR2012/001601 WO2012121523A2 (en) 2011-03-10 2012-03-05 Process for preparing pharmaceutical formulation in form of antioxidant-free solution for injection containing pemetrexed or its salt

Country Status (4)

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

Families Citing this family (21)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2013144814A1 (en) * 2012-03-27 2013-10-03 Fresenius Kabi Oncology Ltd. Stable ready-to-use pharmaceutical composition of pemetrexed
PT2854768T (en) * 2012-05-30 2017-05-19 Fresenius Kabi Oncology Ltd PEMETREXED PHARMACEUTICAL COMPOSITIONS
KR101260636B1 (en) * 2012-11-29 2013-05-13 씨제이제일제당 (주) A stabilized pemetrexed preparation
KR101485243B1 (en) * 2013-05-08 2015-01-21 씨제이헬스케어 주식회사 A stabilized pemetrexed preparation
CN105611932B (en) * 2013-10-03 2019-02-12 富士胶片株式会社 Injection formulation and its manufacturing method
WO2015092758A1 (en) * 2013-12-19 2015-06-25 Dr. Reddy' S Laboratories Ltd Liquid pharmaceutical formulations of pemetrexed
KR101703980B1 (en) * 2013-12-30 2017-02-08 주식회사 삼양바이오팜 Antioxidant-free pharmaceutical composition and preparation method thereof
DK3124026T3 (en) 2014-03-28 2018-10-01 Fujifilm Corp INJECTION PREPARATION AND METHOD OF PREPARING IT
RS60183B1 (en) 2014-10-16 2020-06-30 Synthon Bv Liquid pharmaceutical composition comprising pemetrexed
WO2016082714A1 (en) * 2014-11-26 2016-06-02 台湾东洋药品工业股份有限公司 Method for preparing medicament of antioxidant-free injection solution with long-term stability
ES2928018T3 (en) * 2015-02-13 2022-11-15 Sun Pharmaceutical Ind Ltd Dosage form for intravenous infusion
KR101919436B1 (en) * 2015-05-28 2018-11-16 주식회사 삼양바이오팜 Stabilized pharmaceutical composition and preparation method thereof
JP6501399B2 (en) * 2015-07-01 2019-04-17 日本化薬株式会社 Injection solution containing pemetrexed
EP3120836A1 (en) 2015-07-22 2017-01-25 Stada Arzneimittel Ag Ready-to-use solution of bortezomib
EP3120837A1 (en) 2015-07-22 2017-01-25 Stada Arzneimittel Ag Ready-to-use solution of bortezomib
JP6957233B2 (en) * 2016-06-27 2021-11-02 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Ｓｕｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌ Ｉｎｄｕｓｔｒｉｅｓ Ｌｔｄ． Stable injectable solution of pemetrexed
JP6837895B2 (en) * 2017-04-04 2021-03-03 日本化薬株式会社 Manufacturing method of pharmaceutical solution preparation
AU2018349426B2 (en) 2017-10-10 2024-01-18 Sun Pharmaceutical Industries Limited Intravenous infusion dosage form for pemetrexed
JPWO2019244965A1 (en) * 2018-06-20 2020-06-25 日本化薬株式会社 Pemetrexed sodium injection solution formulation and method for producing the same
WO2020222151A1 (en) 2019-05-01 2020-11-05 Intas Pharmaceuticals Ltd. A stable, ready to use aqueous pharmaceutical composition of pemetrexed
TW202412808A (en) * 2022-06-09 2024-04-01 大陸商上海雲晟研新生物科技有限公司 Liquid composition containing pemetrexed disodium, preparation method and application thereof

Citations (6)

* 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
WO2001056575A1 (en) * 2000-02-04 2001-08-09 Eli Lilly And Company Pharmaceutical composition comprising pemetrexed together with monothioglycerol l-cystein or thioglycolic acid
WO2001062760A2 (en) * 2000-02-25 2001-08-30 Eli Lilly And Company A NOVEL CRYSTALLINE FORM OF N-[4-[2-(2-AMINO-4,7-DIHYDRO-4-OXO-3H-PYRROLO[2,3-d]PYRIMIDIN-5-YL)ETHYL]BENZOYL]-L-GLUTAMIC ACID AND PROCESS THEREFOR
WO2008021405A1 (en) * 2006-08-14 2008-02-21 Sicor Inc. Crystalline forms of pemetrexed diacid and processes for the preparation thereof
US20090253722A1 (en) * 2008-04-08 2009-10-08 Arpida Ag Aqueous pharmaceutical formulation
WO2010030598A2 (en) * 2008-09-11 2010-03-18 Dr. Reddy's Laboratories Limited Pharmaceutical formulations comprising pemetrexed

Patent Citations (6)

* 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
WO2001056575A1 (en) * 2000-02-04 2001-08-09 Eli Lilly And Company Pharmaceutical composition comprising pemetrexed together with monothioglycerol l-cystein or thioglycolic acid
WO2001062760A2 (en) * 2000-02-25 2001-08-30 Eli Lilly And Company A NOVEL CRYSTALLINE FORM OF N-[4-[2-(2-AMINO-4,7-DIHYDRO-4-OXO-3H-PYRROLO[2,3-d]PYRIMIDIN-5-YL)ETHYL]BENZOYL]-L-GLUTAMIC ACID AND PROCESS THEREFOR
WO2008021405A1 (en) * 2006-08-14 2008-02-21 Sicor Inc. Crystalline forms of pemetrexed diacid and processes for the preparation thereof
US20090253722A1 (en) * 2008-04-08 2009-10-08 Arpida Ag Aqueous pharmaceutical formulation
WO2010030598A2 (en) * 2008-09-11 2010-03-18 Dr. Reddy's Laboratories Limited Pharmaceutical formulations comprising pemetrexed

Also Published As

Publication number Publication date
CN103476397A (en) 2013-12-25
CN103476397B (en) 2016-03-30
TW201300139A (en) 2013-01-01
WO2012121523A2 (en) 2012-09-13
TWI476013B (en) 2015-03-11
KR101069128B1 (en) 2011-09-30

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