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 PDFInfo
- 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
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
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.
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 |
---|---|---|---|
KR10-2011-0021224 | 2011-03-10 | ||
KR1020110021224A KR101069128B1 (en) | 2011-03-10 | 2011-03-10 | Process for preparing pharmaceutical formulation in form of antioxidant-free solution for injection comprising pemetrexed or its salt |
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 (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20150073000A1 (en) * | 2012-03-27 | 2015-03-12 | Fresenius Kabi Oncology Limited | Stable ready-to-use pharmaceutical composition of pemetrexed |
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 |
CN110051625A (en) * | 2013-10-03 | 2019-07-26 | 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 |
US10869867B2 (en) | 2015-02-13 | 2020-12-22 | Sun Pharmaceutical Industries Ltd. | Intravenous infusion dosage form |
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 |
EP3120837A1 (en) | 2015-07-22 | 2017-01-25 | Stada Arzneimittel Ag | Ready-to-use solution of bortezomib |
EP3120836A1 (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 |
ES2835375T3 (en) | 2017-10-10 | 2021-06-22 | Sun Pharmaceutical Ind Ltd | Pemetrexed Intravenous Infusion Dosage Form |
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 |
CN117693334A (en) * | 2022-06-09 | 2024-03-12 | 上海云晟研新生物科技有限公司 | Pemetrexed disodium liquid composition, preparation method and application thereof |
Citations (6)
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 |
-
2011
- 2011-03-10 KR KR1020110021224A patent/KR101069128B1/en not_active IP Right Cessation
-
2012
- 2012-03-05 CN CN201280012405.6A patent/CN103476397B/en not_active Expired - Fee Related
- 2012-03-05 WO PCT/KR2012/001601 patent/WO2012121523A2/en active Application Filing
- 2012-03-07 TW TW101107682A patent/TWI476013B/en not_active IP Right Cessation
Patent Citations (6)
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 |
TW201300139A (en) | 2013-01-01 |
TWI476013B (en) | 2015-03-11 |
KR101069128B1 (en) | 2011-09-30 |
WO2012121523A2 (en) | 2012-09-13 |
CN103476397B (en) | 2016-03-30 |
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