CN119365186A - 包含5,10-亚甲基-(6r)-四氢叶酸二钠的组合物 - Google Patents

包含5,10-亚甲基-(6r)-四氢叶酸二钠的组合物 Download PDF

Info

Publication number
CN119365186A
CN119365186A CN202380045351.1A CN202380045351A CN119365186A CN 119365186 A CN119365186 A CN 119365186A CN 202380045351 A CN202380045351 A CN 202380045351A CN 119365186 A CN119365186 A CN 119365186A
Authority
CN
China
Prior art keywords
tetrahydrofolate
methylene
citrate
lyophilized composition
disodium salt
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.)
Pending
Application number
CN202380045351.1A
Other languages
English (en)
Chinese (zh)
Inventor
R·莫泽
V·格罗恩
T·阿曼
J-P·克纳普
M·斯瓦尔德
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Merck Patent GmbH
Original Assignee
Merck Patent GmbH
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 Merck Patent GmbH filed Critical Merck Patent GmbH
Publication of CN119365186A publication Critical patent/CN119365186A/zh
Pending legal-status Critical Current

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
    • A61K9/14—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
    • 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
    • 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
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1611—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
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1617—Organic compounds, e.g. phospholipids, fats
    • 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
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1682—Processes
    • A61K9/1694—Processes resulting in granules or microspheres of the matrix type containing more than 5% of excipient
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Inorganic Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
CN202380045351.1A 2022-06-08 2023-06-05 包含5,10-亚甲基-(6r)-四氢叶酸二钠的组合物 Pending CN119365186A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP22177932 2022-06-08
EP22177932.5 2022-06-08
PCT/EP2023/064972 WO2023237484A1 (en) 2022-06-08 2023-06-05 Compositions comprising disodium 5,10-methylene-(6r)-tetrahydrofolate

Publications (1)

Publication Number Publication Date
CN119365186A true CN119365186A (zh) 2025-01-24

Family

ID=81984853

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202380045351.1A Pending CN119365186A (zh) 2022-06-08 2023-06-05 包含5,10-亚甲基-(6r)-四氢叶酸二钠的组合物

Country Status (9)

Country Link
US (1) US20250360135A1 (enExample)
EP (1) EP4536187A1 (enExample)
JP (1) JP2025518274A (enExample)
KR (1) KR20250022145A (enExample)
CN (1) CN119365186A (enExample)
AU (1) AU2023282347A1 (enExample)
CA (1) CA3258734A1 (enExample)
IL (1) IL317395A (enExample)
WO (1) WO2023237484A1 (enExample)

Family Cites Families (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
AU575814B2 (en) 1983-03-03 1988-08-11 Bengt Gustavsson A device for transferring a substance
CH682664A5 (en) * 1991-10-15 1993-10-29 Eprova Ag Stable salts of 5,10-methylene tetrahydrofolate.
CN1122456C (zh) * 1996-01-31 2003-10-01 南亚拉巴马医学科学基金会 含有天然的还原叶酸盐异构体的食品和维生素制品
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
EP2837631A1 (en) * 2013-08-14 2015-02-18 Merck & Cie New stable salt of 5,10-methylene-(6R)-tetrahydrofolic acid
US10059710B2 (en) * 2016-02-17 2018-08-28 Merck & Cie Stable formulations of 5,10-methylene-(6R)-tetrahydrofolic acid
ES2902051T3 (es) * 2017-08-16 2022-03-24 Merck Patent Gmbh Liofilizados estables que contienen ácido 5,10-metilen-(6R)-tetrahidrofólico y un ácido dicarboxílico
CN107892692A (zh) * 2017-12-28 2018-04-10 华东理工大学 (6s)‑5‑甲基四氢叶酸锌盐的制备方法及其应用

Also Published As

Publication number Publication date
CA3258734A1 (en) 2023-12-14
JP2025518274A (ja) 2025-06-12
WO2023237484A1 (en) 2023-12-14
IL317395A (en) 2025-02-01
US20250360135A1 (en) 2025-11-27
EP4536187A1 (en) 2025-04-16
KR20250022145A (ko) 2025-02-14
AU2023282347A1 (en) 2025-01-16

Similar Documents

Publication Publication Date Title
EP2991619B1 (en) Stable pharmaceutical composition containing folates
US20090325978A1 (en) Stable lyophilized preparation
BG65827B1 (bg) Фармацевтични разтвори от левосимендан
US9180128B2 (en) Stable pharmaceutical compositions of 5,10-methylene tetrahydrofolate
EP2991618B1 (en) Stable high strength pharmaceutical composition of levoleucovorin
US4883805A (en) Stable, Injectable solutions of vinca dimer salts
AU2006320388A1 (en) Stable pharmaceutical compositions of 5,10 methylenetetrahydrofolate
CN119365186A (zh) 包含5,10-亚甲基-(6r)-四氢叶酸二钠的组合物
US20060063833A1 (en) Ready-to-use oxaliplatin solutions
US20220151923A1 (en) Stable liquid compositions of pemetrexed
RU2449791C2 (ru) Лиофилизированная инъецируемая фармацевтическая композиция полусинтетических алкалоидов vinca и углевода, стабильная при комнатной температуре
US20250319089A1 (en) Stable lyophilisates comprising 5,10-methylene-(6r)-tetrahydrofolic acid
US20250319022A1 (en) Concentrated solutions comprising sodium 5,10-methylene-(6r)-tetrahydrofolate
JP4906546B2 (ja) レボホリナート含有水溶液製剤
EP1039905B1 (en) Pharmaceutical formulation comprising glycine as a stabilizer
CN119325373A (zh) 包含5,10-亚甲基-(6r)-四氢叶酸的浓缩溶液
EP4536185A1 (en) Stable pharmaceutical compositions comprising 5,10-methylene-(6r)-tetrahydrofolic acid and nacl
CA3137265A1 (en) A stable, ready to use aqueous pharmaceutical composition of pemetrexed
WO2025165852A1 (en) Liquid formulations of lurbinectedin

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination