MXPA05014232A - Composiciones farmaceuticas estables de 5,10-metilentetrahidrofolato. - Google Patents
Composiciones farmaceuticas estables de 5,10-metilentetrahidrofolato.Info
- Publication number
- MXPA05014232A MXPA05014232A MXPA05014232A MXPA05014232A MXPA05014232A MX PA05014232 A MXPA05014232 A MX PA05014232A MX PA05014232 A MXPA05014232 A MX PA05014232A MX PA05014232 A MXPA05014232 A MX PA05014232A MX PA05014232 A MXPA05014232 A MX PA05014232A
- Authority
- MX
- Mexico
- Prior art keywords
- stable
- mthf
- solutions
- tetrahydrofolate
- methylene
- Prior art date
Links
Classifications
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- 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
-
- 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
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/191—Carboxylic acids, e.g. valproic acid having two or more hydroxy groups, e.g. gluconic acid
-
- 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
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P3/00—Drugs for disorders of the metabolism
- A61P3/02—Nutrients, e.g. vitamins, minerals
-
- 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)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Epidemiology (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Engineering & Computer Science (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Nutrition Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Diabetes (AREA)
- Hematology (AREA)
- Obesity (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
Abstract
La invencion se refiere a composiciones farmaceuticas estables de 5,10-metilen-(6R)-, -(6S)- o (6R,S)-tetrahidrofolato mediante el ajuste a un valor pH basico y el uso simultaneo de citrato. La estabilizacion tiene lugar incluso en ausencia de un agente reductor. la presente invencion es particularmente adecuada para producir soluciones para liofilizar y productos liofilizados o polvos secos y mezclas anhidras, en virtud de que las soluciones estables de MTHF se pueden llenar en altas concentraciones en envases correspondientes como, por ejemplo, tubos, ampollas, etc. Los productos liofilizados son sorprendentemente bien almacenables y estables. Mediante la adicion de agua o soluciones acuosas se pueden reconstituir sin problemas, siendo que tambien las soluciones inyectables transparentes terminadas tienen a su vez excelentes propiedades de estabilidad. La presente invencion permite ademas preparar incluso sales de calcio o acidas de MTHF dificilmente solubles en altas concentraciones y como soluciones isotonicas fisiologicamente tolerables.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CH01123/03A CH697021A5 (de) | 2003-06-26 | 2003-06-26 | Stabile pharmazeutische Zusammensetzungen von 5, 10-Methylentetrahydrofolat. |
| PCT/EP2004/006944 WO2004112761A2 (de) | 2003-06-26 | 2004-06-28 | Stabile pharmazeutische zusammensetzungen von 5,10-methylentetrahydrofolat |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| MXPA05014232A true MXPA05014232A (es) | 2006-02-24 |
Family
ID=33520351
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MXPA05014232A MXPA05014232A (es) | 2003-06-26 | 2004-06-28 | Composiciones farmaceuticas estables de 5,10-metilentetrahidrofolato. |
Country Status (16)
| Country | Link |
|---|---|
| US (2) | US9180128B2 (es) |
| EP (1) | EP1641460B1 (es) |
| JP (1) | JP4755980B2 (es) |
| KR (1) | KR101156074B1 (es) |
| CN (1) | CN1842337B (es) |
| AT (1) | ATE439842T1 (es) |
| AU (1) | AU2004248923B2 (es) |
| CA (1) | CA2529531C (es) |
| CH (2) | CH697021A5 (es) |
| DE (1) | DE502004009927D1 (es) |
| ES (1) | ES2334030T3 (es) |
| MX (1) | MXPA05014232A (es) |
| PT (1) | PT1641460E (es) |
| RU (1) | RU2343923C2 (es) |
| WO (1) | WO2004112761A2 (es) |
| ZA (1) | ZA200510349B (es) |
Families Citing this family (18)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CH697021A5 (de) * | 2003-06-26 | 2008-03-31 | Merck Eprova Ag | Stabile pharmazeutische Zusammensetzungen von 5, 10-Methylentetrahydrofolat. |
| US20090221594A1 (en) * | 2005-12-02 | 2009-09-03 | Chen Andrew X | Stable pharmaceutical compositions of 5, 10 methylenetrahydrofolate |
| EP2598148A4 (en) * | 2010-07-28 | 2014-05-28 | Eagle Pharmaceuticals Inc | PHARMACEUTICAL COMPOSITIONS CONTAINING PEMETREXED HAVING EXTENDED STORAGE STABILITY |
| CN102827272B (zh) * | 2010-11-08 | 2014-04-02 | 上海汉升生物科技有限公司 | 一种叶酸偶联抗体药物及其制备方法与应用 |
| EP2617422A1 (en) | 2012-01-20 | 2013-07-24 | Isofol Medical AB | Anti-tumor activity of reduced folates like methylene-tetrahydrofolate, tetrahydrofolate or methyl-tetrahydrofolate |
| EP2617421A1 (en) | 2012-01-20 | 2013-07-24 | Isofol Medical AB | Tetrahydrofolates in combination with EGFR-inhibitors in the use of treating cancer |
| KR101260636B1 (ko) * | 2012-11-29 | 2013-05-13 | 씨제이제일제당 (주) | 안정화된 페메트렉시드 제제 |
| EP2799060A1 (en) * | 2013-04-30 | 2014-11-05 | Aprofol AG | Stable high dose pharmaceutical composition comprising levoleucovorin |
| 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 |
| US10059710B2 (en) | 2016-02-17 | 2018-08-28 | Merck & Cie | Stable formulations of 5,10-methylene-(6R)-tetrahydrofolic acid |
| US20170239250A1 (en) | 2016-02-19 | 2017-08-24 | Eagle Pharmaceuticals, Inc. | Pemetrexed formulations |
| DK3668516T3 (da) * | 2017-08-16 | 2021-12-13 | Merck Patent Gmbh | Stabile lyofilisater omfattende 5,10-methylen-(6r)-tetrahydrofolsyre og en dicarboxylsyre |
| WO2023237483A1 (en) | 2022-06-08 | 2023-12-14 | Merck Patent Gmbh | Concentrated solutions comprising 5,10-methylene-(6r)-tetrahydrofolic acid |
| WO2023237485A1 (en) | 2022-06-08 | 2023-12-14 | Merck Patent Gmbh | Stable lyophilisates comprising 5,10-methylene-(6r)-tetrahydrofolic acid |
| WO2023237480A1 (en) | 2022-06-08 | 2023-12-14 | Merck Patent Gmbh | Stable pharmaceutical compositions comprising 5,10-methylene-(6r)-tetrahydrofolic acid and nacl |
| WO2023237484A1 (en) * | 2022-06-08 | 2023-12-14 | Merck Patent Gmbh | Compositions comprising disodium 5,10-methylene-(6r)-tetrahydrofolate |
| WO2023237482A1 (en) | 2022-06-08 | 2023-12-14 | Merck Patent Gmbh | Concentrated solutions comprising sodium 5,10-methylene-(6r)- tetrahydrofolate |
Family Cites Families (8)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4931441A (en) * | 1988-11-09 | 1990-06-05 | Luitpold Pharmaceuticals, Inc. | Stabilized aqueous leucovorin calcium compositions |
| US5434087A (en) * | 1993-02-24 | 1995-07-18 | Abbott Laboratories | Folate immunoassay utilizing folate binding protein in a multiclonal antibody format |
| NL9400530A (nl) | 1994-04-05 | 1995-11-01 | Pharmachemie Bv | Stabiele waterige folinaatoplossing. |
| PT750907E (pt) * | 1995-06-30 | 2002-08-30 | American Cyanamid Co | Formulacoes de vacinas estaveis para administracao parenterica metodo para a sua utilizacao e processo para a sua preparacao |
| ES2218662T3 (es) * | 1996-01-31 | 2004-11-16 | South Alabama Medical Science Foundation | Preparaciones de alimento y vitaminas que contienen isomeros naturales de folatos reducidos. |
| US6544994B2 (en) * | 2000-06-07 | 2003-04-08 | Eprov Ag | Pharmaceutical preparation for treating or preventing cardiovascular or neurological disorders by modulating of the activity of nitric oxide synthase |
| US20020183277A1 (en) * | 2001-05-15 | 2002-12-05 | Lise Binderup | Combination of vitamin D analogue and pyrimidine nucleoside analogue |
| CH697021A5 (de) * | 2003-06-26 | 2008-03-31 | Merck Eprova Ag | Stabile pharmazeutische Zusammensetzungen von 5, 10-Methylentetrahydrofolat. |
-
2003
- 2003-06-26 CH CH01123/03A patent/CH697021A5/de not_active IP Right Cessation
-
2004
- 2004-06-28 US US10/562,200 patent/US9180128B2/en active Active
- 2004-06-28 MX MXPA05014232A patent/MXPA05014232A/es active IP Right Grant
- 2004-06-28 WO PCT/EP2004/006944 patent/WO2004112761A2/de active Application Filing
- 2004-06-28 JP JP2006516067A patent/JP4755980B2/ja active Active
- 2004-06-28 AU AU2004248923A patent/AU2004248923B2/en active Active
- 2004-06-28 AT AT04763030T patent/ATE439842T1/de active
- 2004-06-28 DE DE502004009927T patent/DE502004009927D1/de active Active
- 2004-06-28 KR KR1020057024793A patent/KR101156074B1/ko active IP Right Grant
- 2004-06-28 EP EP04763030A patent/EP1641460B1/de active Active
- 2004-06-28 CH CH00311/05A patent/CH698204B1/de not_active IP Right Cessation
- 2004-06-28 CN CN2004800177913A patent/CN1842337B/zh active Active
- 2004-06-28 RU RU2006102028/15A patent/RU2343923C2/ru active
- 2004-06-28 CA CA2529531A patent/CA2529531C/en active Active
- 2004-06-28 PT PT04763030T patent/PT1641460E/pt unknown
- 2004-06-28 ES ES04763030T patent/ES2334030T3/es active Active
-
2005
- 2005-12-20 ZA ZA200510349A patent/ZA200510349B/en unknown
-
2015
- 2015-10-15 US US14/883,797 patent/US20160030573A1/en not_active Abandoned
Also Published As
| Publication number | Publication date |
|---|---|
| WO2004112761A3 (de) | 2005-03-03 |
| RU2006102028A (ru) | 2007-08-10 |
| KR101156074B1 (ko) | 2012-06-20 |
| ES2334030T3 (es) | 2010-03-04 |
| JP4755980B2 (ja) | 2011-08-24 |
| KR20060082035A (ko) | 2006-07-14 |
| PT1641460E (pt) | 2009-12-28 |
| EP1641460B1 (de) | 2009-08-19 |
| CH698204B1 (de) | 2009-06-15 |
| DE502004009927D1 (de) | 2009-10-01 |
| CA2529531A1 (en) | 2004-12-29 |
| CN1842337B (zh) | 2010-05-26 |
| ATE439842T1 (de) | 2009-09-15 |
| ZA200510349B (en) | 2007-12-27 |
| CH697021A5 (de) | 2008-03-31 |
| CA2529531C (en) | 2012-02-21 |
| CN1842337A (zh) | 2006-10-04 |
| WO2004112761A2 (de) | 2004-12-29 |
| AU2004248923A1 (en) | 2004-12-29 |
| US9180128B2 (en) | 2015-11-10 |
| AU2004248923B2 (en) | 2010-12-02 |
| EP1641460A2 (de) | 2006-04-05 |
| RU2343923C2 (ru) | 2009-01-20 |
| JP2009514776A (ja) | 2009-04-09 |
| US20160030573A1 (en) | 2016-02-04 |
| US20070099866A1 (en) | 2007-05-03 |
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Legal Events
| Date | Code | Title | Description |
|---|---|---|---|
| FG | Grant or registration | ||
| GB | Transfer or rights | ||
| HC | Change of company name or juridical status |