FI2815753T4 - Oraalisesti annettava farmaseuttinen koostumus, joka käsittää A,A,A-trifluoritymidiiniä ja 5-kloori-6-(2-iminopyrrolidin-1-yyli)metyyli-2,4 (1H,3H)-pyrimidiinidionihydrokloridia - Google Patents
Oraalisesti annettava farmaseuttinen koostumus, joka käsittää A,A,A-trifluoritymidiiniä ja 5-kloori-6-(2-iminopyrrolidin-1-yyli)metyyli-2,4 (1H,3H)-pyrimidiinidionihydrokloridiaInfo
- Publication number
- FI2815753T4 FI2815753T4 FIEP13749171.8T FI13749171T FI2815753T4 FI 2815753 T4 FI2815753 T4 FI 2815753T4 FI 13749171 T FI13749171 T FI 13749171T FI 2815753 T4 FI2815753 T4 FI 2815753T4
- Authority
- FI
- Finland
- Prior art keywords
- weight
- sugar
- relative humidity
- pharmaceutical composition
- critical relative
- Prior art date
Links
Classifications
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- 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
- A61K31/70—Carbohydrates; Sugars; Derivatives thereof
- A61K31/7042—Compounds having saccharide radicals and heterocyclic rings
- A61K31/7052—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides
- A61K31/706—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom
- A61K31/7064—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines
- A61K31/7068—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid
- A61K31/7072—Compounds having saccharide radicals and heterocyclic rings having nitrogen as a ring hetero atom, e.g. nucleosides, nucleotides containing six-membered rings with nitrogen as a ring hetero atom containing condensed or non-condensed pyrimidines having oxo groups directly attached to the pyrimidine ring, e.g. cytidine, cytidylic acid having two oxo groups directly attached to the pyrimidine ring, e.g. uridine, uridylic acid, thymidine, zidovudine
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- 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
- A61K31/513—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim having oxo groups directly attached to the heterocyclic ring, e.g. cytosine
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- 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
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- 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
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- 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
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- 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
- A61K9/1623—Sugars or sugar alcohols, e.g. lactose; Derivatives thereof; Homeopathic globules
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
- A61K9/2018—Sugars, or sugar alcohols, e.g. lactose, mannitol; Derivatives thereof, e.g. polysorbates
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2300/00—Mixtures or combinations of active ingredients, wherein at least one active ingredient is fully defined in groups A61K31/00 - A61K41/00
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- 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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Animal Behavior & Ethology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Molecular Biology (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Biophysics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Nutrition Science (AREA)
- Physiology (AREA)
- Inorganic Chemistry (AREA)
- Biochemistry (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicinal Preparation (AREA)
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2012031143 | 2012-02-15 | ||
| PCT/JP2013/053513 WO2013122134A1 (ja) | 2012-02-15 | 2013-02-14 | 経口投与用医薬組成物 |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| FI2815753T4 true FI2815753T4 (fi) | 2026-02-05 |
Family
ID=48984243
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FIEP13749171.8T FI2815753T4 (fi) | 2012-02-15 | 2013-02-14 | Oraalisesti annettava farmaseuttinen koostumus, joka käsittää A,A,A-trifluoritymidiiniä ja 5-kloori-6-(2-iminopyrrolidin-1-yyli)metyyli-2,4 (1H,3H)-pyrimidiinidionihydrokloridia |
Country Status (26)
| Country | Link |
|---|---|
| US (2) | US20140356431A1 (https=) |
| EP (1) | EP2815753B2 (https=) |
| JP (1) | JP5798641B2 (https=) |
| KR (2) | KR101951575B1 (https=) |
| CN (1) | CN104105491B (https=) |
| AU (1) | AU2013219382C1 (https=) |
| BR (1) | BR112014018273B1 (https=) |
| CA (1) | CA2861480C (https=) |
| CY (1) | CY1120530T1 (https=) |
| DK (1) | DK2815753T4 (https=) |
| ES (1) | ES2683825T5 (https=) |
| FI (1) | FI2815753T4 (https=) |
| HR (1) | HRP20181193T4 (https=) |
| HU (1) | HUE039487T2 (https=) |
| LT (1) | LT2815753T (https=) |
| MX (1) | MX355885B (https=) |
| MY (1) | MY155922A (https=) |
| PL (1) | PL2815753T5 (https=) |
| PT (1) | PT2815753T (https=) |
| RS (1) | RS57505B1 (https=) |
| RU (1) | RU2600831C2 (https=) |
| SG (1) | SG11201403874SA (https=) |
| SI (1) | SI2815753T2 (https=) |
| SM (1) | SMT201800415T1 (https=) |
| TW (1) | TWI503122B (https=) |
| WO (1) | WO2013122134A1 (https=) |
Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106551946B (zh) * | 2015-09-24 | 2020-02-14 | 江苏奥赛康药业有限公司 | 一种含三氟胸苷和盐酸替比嘧啶的药物组合物及制备方法 |
| CN106913580A (zh) * | 2015-12-27 | 2017-07-04 | 南京圣和药业股份有限公司 | 一种含曲氟尿苷盐酸替哌拉索的药物组合物及其应用 |
| CN106018573B (zh) * | 2016-03-16 | 2018-09-18 | 江苏悦兴药业有限公司 | 一种tas-102中盐酸替比拉西的纯度检测方法 |
| CN105963271A (zh) * | 2016-06-01 | 2016-09-28 | 国药心制药有限公司 | 一种药用辅料组合物及一种曲氟尿苷、盐酸替匹嘧啶薄膜衣片 |
| US10866219B2 (en) | 2017-12-22 | 2020-12-15 | Taiho Pharmaceutical Co., Ltd. | Method for detecting trifluridine- and/or tipiracil-related substance |
| EP3730935A4 (en) | 2017-12-22 | 2022-02-23 | Taiho Pharmaceutical Co., Ltd. | METHOD OF DETECTING ANALOGUES OF TRIFLURIDIN AND/OR TIPIRACIL |
| WO2019135405A1 (ja) | 2018-01-05 | 2019-07-11 | 大鵬薬品工業株式会社 | トリフルリジン由来の類縁物質の検出方法 |
| US10816517B2 (en) | 2018-01-05 | 2020-10-27 | Taiho Pharmaceutical Co., Ltd. | Method for detecting trifluridine-related substance by high-performance liquid chromatography |
| US11730753B2 (en) | 2018-03-03 | 2023-08-22 | Natco Pharma Limited | Stable pharmaceutical compositions comprising trifluridine and tipiracil hydrochloride |
Family Cites Families (12)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR100424934B1 (ko) * | 1995-03-29 | 2004-07-27 | 다이호야쿠힌고교 가부시키가이샤 | 우라실유도체및이를함유하는항종양효과증강제및항종양제 |
| JPH11322604A (ja) * | 1998-05-06 | 1999-11-24 | Pola Chem Ind Inc | ジフェニルピペラジン化合物を含有する製剤 |
| WO2000071117A1 (en) | 1999-05-21 | 2000-11-30 | Kissei Pharmaceutical Co., Ltd. | Immediate release medicinal compositions for oral use |
| JP4110347B2 (ja) * | 1999-11-05 | 2008-07-02 | 大鵬薬品工業株式会社 | 抗ｈｉｖ剤 |
| JP4601934B2 (ja) * | 2003-10-06 | 2010-12-22 | ナガセ医薬品株式会社 | ユビデカレノン錠 |
| JP2005314413A (ja) * | 2004-04-02 | 2005-11-10 | Ono Pharmaceut Co Ltd | 経口投与用医薬組成物 |
| PE20060484A1 (es) * | 2004-07-14 | 2006-07-06 | Ucb Farchim Sa | Preparaciones farmaceuticas liquidas que comprenden un compuesto de benzhidril piperizina |
| US7799783B2 (en) * | 2005-01-26 | 2010-09-21 | Taiho Pharmaceutical Co., Ltd. | Method of administrating an anticancer drug containing α, α, α-trifluorothymidine and thymidine phosphorylase inhibitor |
| JP5576591B2 (ja) * | 2005-01-26 | 2014-08-20 | 大鵬薬品工業株式会社 | α，α，α−トリフルオロチミジンとチミジンホスホリラーゼ阻害剤とを配合した抗癌剤 |
| ATE554770T1 (de) * | 2006-04-13 | 2012-05-15 | Taiho Pharmaceutical Co Ltd | Therapeutisches mittel gegen entzündliche darmerkrankungen |
| JP2007284390A (ja) * | 2006-04-18 | 2007-11-01 | Ohara Yakuhin Kogyo Kk | 塩酸イミダプリル含有錠剤 |
| RU2346684C2 (ru) * | 2007-04-04 | 2009-02-20 | Закрытое акционерное общество "Биологические исследования и системы" | Фармацевтическая композиция на основе сигетина |
-
2013
- 2013-02-08 TW TW102105456A patent/TWI503122B/zh active
- 2013-02-14 CN CN201380008603.XA patent/CN104105491B/zh active Active
- 2013-02-14 PT PT13749171T patent/PT2815753T/pt unknown
- 2013-02-14 MX MX2014009833A patent/MX355885B/es active IP Right Grant
- 2013-02-14 WO PCT/JP2013/053513 patent/WO2013122134A1/ja not_active Ceased
- 2013-02-14 RU RU2014137096/15A patent/RU2600831C2/ru active
- 2013-02-14 US US14/373,426 patent/US20140356431A1/en not_active Abandoned
- 2013-02-14 SM SM20180415T patent/SMT201800415T1/it unknown
- 2013-02-14 LT LTEP13749171.8T patent/LT2815753T/lt unknown
- 2013-02-14 EP EP13749171.8A patent/EP2815753B2/en active Active
- 2013-02-14 PL PL13749171.8T patent/PL2815753T5/pl unknown
- 2013-02-14 KR KR1020177006141A patent/KR101951575B1/ko active Active
- 2013-02-14 SG SG11201403874SA patent/SG11201403874SA/en unknown
- 2013-02-14 ES ES13749171T patent/ES2683825T5/es active Active
- 2013-02-14 RS RS20180890A patent/RS57505B1/sr unknown
- 2013-02-14 HU HUE13749171A patent/HUE039487T2/hu unknown
- 2013-02-14 SI SI201331103T patent/SI2815753T2/sl unknown
- 2013-02-14 KR KR20147022337A patent/KR20150001717A/ko not_active Ceased
- 2013-02-14 CA CA2861480A patent/CA2861480C/en active Active
- 2013-02-14 MY MYPI2014002000A patent/MY155922A/en unknown
- 2013-02-14 FI FIEP13749171.8T patent/FI2815753T4/fi active
- 2013-02-14 HR HRP20181193TT patent/HRP20181193T4/hr unknown
- 2013-02-14 BR BR112014018273-6A patent/BR112014018273B1/pt active IP Right Grant
- 2013-02-14 DK DK13749171.8T patent/DK2815753T4/da active
- 2013-02-14 JP JP2013558722A patent/JP5798641B2/ja active Active
- 2013-02-14 AU AU2013219382A patent/AU2013219382C1/en active Active
-
2018
- 2018-08-07 CY CY20181100820T patent/CY1120530T1/el unknown
-
2021
- 2021-04-08 US US17/225,232 patent/US20210220384A1/en not_active Abandoned
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