JP2020531415A5 - - Google Patents
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- Publication number
- JP2020531415A5 JP2020531415A5 JP2020508004A JP2020508004A JP2020531415A5 JP 2020531415 A5 JP2020531415 A5 JP 2020531415A5 JP 2020508004 A JP2020508004 A JP 2020508004A JP 2020508004 A JP2020508004 A JP 2020508004A JP 2020531415 A5 JP2020531415 A5 JP 2020531415A5
- Authority
- JP
- Japan
- Prior art keywords
- product according
- acid
- pharmaceutically acceptable
- water
- reconstituted
- 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.)
- Granted
Links
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims 5
- OFOBLEOULBTSOW-UHFFFAOYSA-N Malonic acid Chemical compound OC(=O)CC(O)=O OFOBLEOULBTSOW-UHFFFAOYSA-N 0.000 claims 4
- 150000003839 salts Chemical class 0.000 claims 4
- MUBZPKHOEPUJKR-UHFFFAOYSA-N Oxalic acid Chemical compound OC(=O)C(O)=O MUBZPKHOEPUJKR-UHFFFAOYSA-N 0.000 claims 3
- HEMHJVSKTPXQMS-UHFFFAOYSA-M Sodium hydroxide Chemical compound [OH-].[Na+] HEMHJVSKTPXQMS-UHFFFAOYSA-M 0.000 claims 3
- QYNUQALWYRSVHF-OLZOCXBDSA-N (6R)-5,10-methylenetetrahydrofolic acid Chemical compound C([C@H]1CNC=2N=C(NC(=O)C=2N1C1)N)N1C1=CC=C(C(=O)N[C@@H](CCC(O)=O)C(O)=O)C=C1 QYNUQALWYRSVHF-OLZOCXBDSA-N 0.000 claims 2
- VZCYOOQTPOCHFL-OWOJBTEDSA-N Fumaric acid Chemical compound OC(=O)\C=C\C(O)=O VZCYOOQTPOCHFL-OWOJBTEDSA-N 0.000 claims 2
- 238000000034 method Methods 0.000 claims 2
- VZCYOOQTPOCHFL-UHFFFAOYSA-N trans-butenedioic acid Natural products OC(=O)C=CC(O)=O VZCYOOQTPOCHFL-UHFFFAOYSA-N 0.000 claims 2
- BJEPYKJPYRNKOW-REOHCLBHSA-N (S)-malic acid Chemical compound OC(=O)[C@@H](O)CC(O)=O BJEPYKJPYRNKOW-REOHCLBHSA-N 0.000 claims 1
- FEWJPZIEWOKRBE-JCYAYHJZSA-N Dextrotartaric acid Chemical compound OC(=O)[C@H](O)[C@@H](O)C(O)=O FEWJPZIEWOKRBE-JCYAYHJZSA-N 0.000 claims 1
- 206010028980 Neoplasm Diseases 0.000 claims 1
- KDYFGRWQOYBRFD-UHFFFAOYSA-N Succinic acid Natural products OC(=O)CCC(O)=O KDYFGRWQOYBRFD-UHFFFAOYSA-N 0.000 claims 1
- FEWJPZIEWOKRBE-UHFFFAOYSA-N Tartaric acid Natural products [H+].[H+].[O-]C(=O)C(O)C(O)C([O-])=O FEWJPZIEWOKRBE-UHFFFAOYSA-N 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 claims 1
- BJEPYKJPYRNKOW-UHFFFAOYSA-N alpha-hydroxysuccinic acid Natural products OC(=O)C(O)CC(O)=O BJEPYKJPYRNKOW-UHFFFAOYSA-N 0.000 claims 1
- 239000007853 buffer solution Substances 0.000 claims 1
- KDYFGRWQOYBRFD-NUQCWPJISA-N butanedioic acid Chemical compound O[14C](=O)CC[14C](O)=O KDYFGRWQOYBRFD-NUQCWPJISA-N 0.000 claims 1
- 201000011510 cancer Diseases 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 230000008014 freezing Effects 0.000 claims 1
- 238000007710 freezing Methods 0.000 claims 1
- 239000001530 fumaric acid Substances 0.000 claims 1
- 235000011087 fumaric acid Nutrition 0.000 claims 1
- 239000007788 liquid Substances 0.000 claims 1
- VZCYOOQTPOCHFL-UPHRSURJSA-N maleic acid Chemical compound OC(=O)\C=C/C(O)=O VZCYOOQTPOCHFL-UPHRSURJSA-N 0.000 claims 1
- 239000011976 maleic acid Substances 0.000 claims 1
- 239000001630 malic acid Substances 0.000 claims 1
- 235000011090 malic acid Nutrition 0.000 claims 1
- 235000006408 oxalic acid Nutrition 0.000 claims 1
- 239000008227 sterile water for injection Substances 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
- 239000011975 tartaric acid Substances 0.000 claims 1
- 235000002906 tartaric acid Nutrition 0.000 claims 1
- 239000003981 vehicle Substances 0.000 claims 1
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| EP17186518 | 2017-08-16 | ||
| EP17186518.1 | 2017-08-16 | ||
| PCT/EP2018/072077 WO2019034673A1 (en) | 2017-08-16 | 2018-08-15 | STABLE LYOPHILISATES COMPRISING 5,10-METHYLENE- (6R) -TETRAHYDROFOLIC ACID AND DICARBOXYLIC ACID |
Publications (3)
| Publication Number | Publication Date |
|---|---|
| JP2020531415A JP2020531415A (ja) | 2020-11-05 |
| JP2020531415A5 true JP2020531415A5 (enExample) | 2021-09-24 |
| JP7232815B2 JP7232815B2 (ja) | 2023-03-03 |
Family
ID=59699495
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| JP2020508004A Active JP7232815B2 (ja) | 2017-08-16 | 2018-08-15 | ５，１０－メチレン－（６ｒ）－テトラヒドロ葉酸を含む安定な凍結乾燥物 |
Country Status (11)
| Country | Link |
|---|---|
| US (1) | US11337978B2 (enExample) |
| EP (1) | EP3668516B1 (enExample) |
| JP (1) | JP7232815B2 (enExample) |
| KR (1) | KR102753593B1 (enExample) |
| CN (1) | CN110996958B (enExample) |
| AU (1) | AU2018317789B2 (enExample) |
| CA (1) | CA3073127A1 (enExample) |
| DK (1) | DK3668516T3 (enExample) |
| ES (1) | ES2902051T3 (enExample) |
| PT (1) | PT3668516T (enExample) |
| WO (1) | WO2019034673A1 (enExample) |
Families Citing this family (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP4536184A1 (en) | 2022-06-08 | 2025-04-16 | Merck Patent GmbH | Concentrated solutions comprising sodium 5,10-methylene-(6r)- tetrahydrofolate |
| WO2023237484A1 (en) * | 2022-06-08 | 2023-12-14 | Merck Patent Gmbh | Compositions comprising disodium 5,10-methylene-(6r)-tetrahydrofolate |
| CN119325374A (zh) * | 2022-06-08 | 2025-01-17 | 默克专利股份有限公司 | 包含5,10-亚甲基-(6r)-四氢叶酸的稳定的冻干物 |
| EP4536186A1 (en) * | 2022-06-08 | 2025-04-16 | Merck Patent GmbH | Concentrated solutions comprising 5,10-methylene-(6r)-tetrahydrofolic acid |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| EP0165926B1 (en) | 1983-05-20 | 1990-10-24 | Bengt Gustavsson | A device for transferring a substance |
| US5747469A (en) | 1991-03-06 | 1998-05-05 | Board Of Regents, The University Of Texas System | Methods and compositions comprising DNA damaging agents and p53 |
| CH682664A5 (en) | 1991-10-15 | 1993-10-29 | Eprova Ag | Stable salts of 5,10-methylene tetrahydrofolate. |
| CH684644A5 (de) | 1992-07-13 | 1994-11-15 | Eprova Ag | 5,10-Methylentetrahydrofolsäure-Cyclodextrin-Einschlussverbindungen. |
| US20020103126A1 (en) | 1997-04-18 | 2002-08-01 | Roche Diagnostics Gmbh | Stable pharmaceutical form of administration for peptides, proteins and nucleic acids |
| GB9904387D0 (en) | 1999-02-25 | 1999-04-21 | Pharmacia & Upjohn Spa | Antitumour synergistic composition |
| CH696628A5 (de) | 2002-02-26 | 2007-08-31 | Eprova Ag | Verwendung von Folaten zur Herstellung einer Zubereitung geeignet zur Vorbeugung und Behandlung von Entzündungen und entzündungsassoziierter Krankheiten, im Speziellen zur Beeinflussung der |
| CH697021A5 (de) | 2003-06-26 | 2008-03-31 | Merck Eprova Ag | Stabile pharmazeutische Zusammensetzungen von 5, 10-Methylentetrahydrofolat. |
| KR20080074201A (ko) * | 2005-12-02 | 2008-08-12 | 어드벤트륵스 파마슈티칼스, 인크. | 5,10 메틸렌테트라히드로폴레이트의 안정한 약학 조성물 |
| AU2012234323A1 (en) | 2011-03-29 | 2013-10-17 | Sanofi | Otamixaban formulations with improved stability |
| JP6235779B2 (ja) | 2012-03-28 | 2017-11-22 | 株式会社コーセー | 葉酸含有組成物及び葉酸の安定化方法 |
| EP2799061A1 (en) | 2013-04-30 | 2014-11-05 | Aprofol AG | Stable high dose pharmaceutical composition containing folates |
| EP2837631A1 (en) | 2013-08-14 | 2015-02-18 | Merck & Cie | New stable salt of 5,10-methylene-(6R)-tetrahydrofolic acid |
| CN107812195B (zh) | 2014-09-04 | 2021-04-20 | 连云港金康和信药业有限公司 | (6s)‐5‐甲基‐四氢叶酸钙盐的稳定药物组合物 |
| US10059710B2 (en) * | 2016-02-17 | 2018-08-28 | Merck & Cie | Stable formulations of 5,10-methylene-(6R)-tetrahydrofolic acid |
-
2018
- 2018-08-15 EP EP18752161.2A patent/EP3668516B1/en active Active
- 2018-08-15 CA CA3073127A patent/CA3073127A1/en active Pending
- 2018-08-15 PT PT187521612T patent/PT3668516T/pt unknown
- 2018-08-15 AU AU2018317789A patent/AU2018317789B2/en active Active
- 2018-08-15 DK DK18752161.2T patent/DK3668516T3/da active
- 2018-08-15 WO PCT/EP2018/072077 patent/WO2019034673A1/en not_active Ceased
- 2018-08-15 JP JP2020508004A patent/JP7232815B2/ja active Active
- 2018-08-15 US US16/638,528 patent/US11337978B2/en active Active
- 2018-08-15 CN CN201880052764.1A patent/CN110996958B/zh active Active
- 2018-08-15 ES ES18752161T patent/ES2902051T3/es active Active
- 2018-08-15 KR KR1020207007389A patent/KR102753593B1/ko active Active
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