MX2017010945A - Preparacion solida. - Google Patents
Preparacion solida.Info
- Publication number
- MX2017010945A MX2017010945A MX2017010945A MX2017010945A MX2017010945A MX 2017010945 A MX2017010945 A MX 2017010945A MX 2017010945 A MX2017010945 A MX 2017010945A MX 2017010945 A MX2017010945 A MX 2017010945A MX 2017010945 A MX2017010945 A MX 2017010945A
- Authority
- MX
- Mexico
- Prior art keywords
- compound
- solid preparation
- formulating
- stabilizing
- fatty
- Prior art date
Links
- 239000007787 solid Substances 0.000 title abstract 6
- 150000001875 compounds Chemical class 0.000 abstract 7
- VBICKXHEKHSIBG-UHFFFAOYSA-N 1-monostearoylglycerol Chemical compound CCCCCCCCCCCCCCCCCC(=O)OCC(O)CO VBICKXHEKHSIBG-UHFFFAOYSA-N 0.000 abstract 4
- 238000000034 method Methods 0.000 abstract 3
- 239000002202 Polyethylene glycol Substances 0.000 abstract 2
- DOOTYTYQINUNNV-UHFFFAOYSA-N Triethyl citrate Chemical compound CCOC(=O)CC(O)(C(=O)OCC)CC(=O)OCC DOOTYTYQINUNNV-UHFFFAOYSA-N 0.000 abstract 2
- 229940075507 glyceryl monostearate Drugs 0.000 abstract 2
- 238000002844 melting Methods 0.000 abstract 2
- 230000008018 melting Effects 0.000 abstract 2
- 239000001788 mono and diglycerides of fatty acids Substances 0.000 abstract 2
- 229920001223 polyethylene glycol Polymers 0.000 abstract 2
- 230000000087 stabilizing effect Effects 0.000 abstract 2
- 239000000126 substance Substances 0.000 abstract 2
- 239000001069 triethyl citrate Substances 0.000 abstract 2
- VMYFZRTXGLUXMZ-UHFFFAOYSA-N triethyl citrate Natural products CCOC(=O)C(O)(C(=O)OCC)C(=O)OCC VMYFZRTXGLUXMZ-UHFFFAOYSA-N 0.000 abstract 2
- 235000013769 triethyl citrate Nutrition 0.000 abstract 2
- 125000006508 2,6-difluorobenzyl group Chemical group [H]C1=C([H])C(F)=C(C(F)=C1[H])C([H])([H])* 0.000 abstract 1
- DXASQZJWWGZNSF-UHFFFAOYSA-N n,n-dimethylmethanamine;sulfur trioxide Chemical group CN(C)C.O=S(=O)=O DXASQZJWWGZNSF-UHFFFAOYSA-N 0.000 abstract 1
- 125000001997 phenyl group Chemical group [H]C1=C([H])C([H])=C(*)C([H])=C1[H] 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/2031—Organic macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyethylene glycol, polyethylene oxide, poloxamers
-
- 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
-
- 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
- A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
-
- 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
- A61K47/14—Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
-
- 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
- A61K47/34—Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers
-
- 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
- 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
- A61K9/28—Dragees; Coated pills or tablets, e.g. with film or compression coating
- A61K9/2886—Dragees; Coated pills or tablets, e.g. with film or compression coating having two or more different drug-free coatings; Tablets of the type inert core-drug layer-inactive layer
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Public Health (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical Kinetics & Catalysis (AREA)
- General Chemical & Material Sciences (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Inorganic Chemistry (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Abstract
Se proporcionan: un preparado solido que mejora la estabilidad de la N-(4-(1-(2,6-difluorobencil)-5-((dimetilamino)metil)-3-(6-metox i-3-piridazinil)-,4-dioxo-1,2,3,4-tetrahidrotieno [2,3-d] pirimidin-6-i1) fenil) -N´- metoxiurea y una sal de esta que están presentes en el preparado solido; y un método para estabilizar el compuesto en el preparado sólido. Un comprimido que contiene el compuesto en una cantidad igual a al menos un 25% en masa; un preparado solido que contiene (1) el compuesto y (2) una sustancia grasa y oleosa que tiene un punto de fusión bajo seleccionada entre polietilenglicol, monoestearato de glicerilo y citrato de trietilo; un método para estabilizar el compuesto presente en el comprimido y que se caracteriza por formular el compuesto en una cantidad igual a al menos un 25% en masa; y un método para estabilizar el compuesto y que se caracteriza por formular una sustancia grasa y oleosa que tiene un punto de fusión bajo seleccionada entre polietilenglicol, monoestearato de glicerilo y citrato de trietilo en un preparado solido que contiene el compuesto.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| JP2015037462 | 2015-02-26 | ||
| PCT/JP2016/055540 WO2016136849A1 (ja) | 2015-02-26 | 2016-02-25 | 固形製剤 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| MX2017010945A true MX2017010945A (es) | 2018-07-06 |
| MX373225B MX373225B (es) | 2020-04-08 |
Family
ID=56789547
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| MX2017010945A MX373225B (es) | 2015-02-26 | 2016-02-25 | Preparado sólido. |
Country Status (24)
| Country | Link |
|---|---|
| US (2) | US10350170B2 (es) |
| EP (3) | EP4233847B1 (es) |
| JP (1) | JP6730978B2 (es) |
| CN (1) | CN107249590A (es) |
| AU (1) | AU2016224503B2 (es) |
| BR (1) | BR112017018173A2 (es) |
| CA (1) | CA2978223A1 (es) |
| CY (1) | CY1126118T1 (es) |
| DK (2) | DK3263110T3 (es) |
| ES (2) | ES2950995T3 (es) |
| FI (2) | FI3263110T3 (es) |
| HR (1) | HRP20230613T1 (es) |
| HU (1) | HUE062269T2 (es) |
| IL (1) | IL254132B (es) |
| LT (1) | LT3263110T (es) |
| MX (1) | MX373225B (es) |
| MY (1) | MY180680A (es) |
| PL (2) | PL3263110T3 (es) |
| PT (1) | PT3263110T (es) |
| RS (1) | RS64377B1 (es) |
| SI (2) | SI4233847T1 (es) |
| SM (1) | SMT202300221T1 (es) |
| TW (1) | TWI744224B (es) |
| WO (1) | WO2016136849A1 (es) |
Families Citing this family (13)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PT3415517T (pt) | 2012-09-28 | 2022-05-13 | Takeda Pharmaceuticals Co | Forma cristalina de 1-(4-1-(2,6-difluorobenzil)-5- dimetilaminometil-3-(6-metoxipiridazin-3-il)-2,4-dioxo- 1,2,3,4-tetrahidrotieno(2,3-d)-pirimidin-6-il)fenil)-3- metoxiureia |
| EP3518932B1 (en) * | 2016-09-30 | 2024-11-13 | Sumitomo Pharma Switzerland GmbH | Treatment of prostate cancer |
| ES2912929T5 (en) | 2016-09-30 | 2025-05-09 | Sumitomo Pharma Switzerland Gmbh | Methods of treating uterine fibroids and endometriosis |
| CA3073229A1 (en) | 2017-08-18 | 2019-02-21 | Abbvie Inc. | Pharmaceutical formulations for treating endometriosis, uterine fibroids, polycystic ovary syndrome or adenomyosis |
| TW201912157A (zh) | 2017-08-18 | 2019-04-01 | 美商艾伯維有限公司 | 治療子宮內膜異位症、子宮纖維瘤、多囊性卵巢症候群及子宮腺肌症之固體醫藥調配物 |
| EP3765464A1 (en) | 2018-03-14 | 2021-01-20 | Teva Pharmaceuticals USA, Inc. | Solid state forms of relugolix |
| WO2021026011A1 (en) | 2019-08-02 | 2021-02-11 | Johnson Matthey Public Limited Company | Solid-state forms of relugolix |
| CN115279769A (zh) | 2019-10-10 | 2022-11-01 | 梦欧文科学有限责任公司 | N-(4-(1-(2,6-二氟苄基)-5-((二甲基氨基)甲基)-3-(6-甲氧基-3-哒嗪基)-2,4-二氧代-1,2,3,4-四氢噻吩并[2,3-d]嘧啶-6-基)苯基)-n’-甲氧基脲的结晶形式 |
| EP4151219A4 (en) | 2020-05-15 | 2024-05-15 | Shionogi & Co., Ltd | DRUG COMPOSITION WITH INHIBITED IMPURITIES PRODUCTION |
| CA3185151A1 (en) | 2020-05-29 | 2021-12-02 | Myovant Sciences Gmbh | Combination solid oral dosage forms of gonadotropin-releasing hormone antagonists |
| EP4243829A1 (en) | 2020-11-11 | 2023-09-20 | Myovant Sciences GmbH | Methods of administering relugolix |
| EP4419530A1 (en) | 2021-10-18 | 2024-08-28 | Sumitomo Pharma Switzerland GmbH | Crystalline form of an ethanol solvate of n-(4-(1-(2,6-difluorobenzyl)-5-((dimethylamino)methyl)-3-(6-methoxy-3-pyridazinyl)-2,4-dioxo-1,2,3,4-tetrahydrothieno[2,3-d]pyrimidin-6-yl)phenyl)-n'-methoxyurea |
| CN115671069A (zh) * | 2022-11-24 | 2023-02-03 | 北京鑫开元医药科技有限公司 | 一种瑞卢戈利片剂及其制备方法 |
Family Cites Families (15)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| TW284688B (es) | 1991-11-20 | 1996-09-01 | Takeda Pharm Industry Co Ltd | |
| FR2710637B1 (fr) * | 1993-09-28 | 1995-12-08 | Roquette Freres | Mannitol pulvérulent de friabilité modérée et son procédé de préparation. |
| JP3854648B2 (ja) * | 1994-04-19 | 2006-12-06 | 武田薬品工業株式会社 | 縮合チオフェン誘導体、その製造法及び用途 |
| TW449600B (en) | 1994-04-19 | 2001-08-11 | Takeda Chemical Industries Ltd | Condensed-ring thiophene derivatives, their production and use |
| TWI225863B (en) * | 1999-03-24 | 2005-01-01 | Takeda Chemical Industries Ltd | Thienopyrimidine compounds, their production and use |
| WO2003064429A1 (en) | 2002-01-30 | 2003-08-07 | Takeda Chemical Industries, Ltd. | Thienopyrimidines, process for preparing the same and use thereof |
| JP5072166B2 (ja) * | 2002-01-30 | 2012-11-14 | 武田薬品工業株式会社 | チエノピリミジン化合物、その製造法および用途 |
| PL208114B1 (pl) * | 2002-02-26 | 2011-03-31 | Astrazeneca Ab | Kompozycja farmaceutyczna, sposób jej wytwarzania i zastosowanie |
| PT1591446E (pt) | 2003-01-29 | 2013-06-12 | Takeda Pharmaceutical | Compostos de tienopirimidina e sua utilização |
| JP4039574B2 (ja) * | 2003-01-29 | 2008-01-30 | 武田薬品工業株式会社 | チエノピリミジン化合物およびその用途 |
| JP2006035365A (ja) * | 2004-07-26 | 2006-02-09 | Hitachi Koki Co Ltd | 携帯用切断工具 |
| WO2010026993A1 (ja) | 2008-09-03 | 2010-03-11 | 武田薬品工業株式会社 | 製剤における吸収性改善方法および吸収性が改善された製剤 |
| JP2015037462A (ja) | 2012-06-01 | 2015-02-26 | 株式会社コナミデジタルエンタテインメント | ゲーム装置、ゲーム方法、及びプログラム |
| PT3415517T (pt) | 2012-09-28 | 2022-05-13 | Takeda Pharmaceuticals Co | Forma cristalina de 1-(4-1-(2,6-difluorobenzil)-5- dimetilaminometil-3-(6-metoxipiridazin-3-il)-2,4-dioxo- 1,2,3,4-tetrahidrotieno(2,3-d)-pirimidin-6-il)fenil)-3- metoxiureia |
| DK2945628T3 (da) | 2013-01-15 | 2020-05-04 | Aragon Pharmaceuticals Inc | Androgen receptormodulator i kombination med abirateronacetat og prednison til behandling af prostatacancer |
-
2016
- 2016-02-25 FI FIEP16755593.7T patent/FI3263110T3/fi active
- 2016-02-25 ES ES16755593T patent/ES2950995T3/es active Active
- 2016-02-25 AU AU2016224503A patent/AU2016224503B2/en active Active
- 2016-02-25 PT PT167555937T patent/PT3263110T/pt unknown
- 2016-02-25 LT LTEPPCT/JP2016/055540T patent/LT3263110T/lt unknown
- 2016-02-25 MX MX2017010945A patent/MX373225B/es active IP Right Grant
- 2016-02-25 ES ES23172275T patent/ES2988678T3/es active Active
- 2016-02-25 EP EP23172275.2A patent/EP4233847B1/en active Active
- 2016-02-25 PL PL16755593.7T patent/PL3263110T3/pl unknown
- 2016-02-25 SI SI201631852T patent/SI4233847T1/sl unknown
- 2016-02-25 HU HUE16755593A patent/HUE062269T2/hu unknown
- 2016-02-25 WO PCT/JP2016/055540 patent/WO2016136849A1/ja not_active Ceased
- 2016-02-25 PL PL23172275.2T patent/PL4233847T3/pl unknown
- 2016-02-25 MY MYPI2017702655A patent/MY180680A/en unknown
- 2016-02-25 EP EP24187441.1A patent/EP4454708A3/en active Pending
- 2016-02-25 JP JP2017502452A patent/JP6730978B2/ja active Active
- 2016-02-25 DK DK16755593.7T patent/DK3263110T3/da active
- 2016-02-25 DK DK23172275.2T patent/DK4233847T3/da active
- 2016-02-25 CN CN201680012266.5A patent/CN107249590A/zh active Pending
- 2016-02-25 HR HRP20230613TT patent/HRP20230613T1/hr unknown
- 2016-02-25 BR BR112017018173-8A patent/BR112017018173A2/pt not_active Application Discontinuation
- 2016-02-25 TW TW105105637A patent/TWI744224B/zh active
- 2016-02-25 CA CA2978223A patent/CA2978223A1/en active Pending
- 2016-02-25 SM SM20230221T patent/SMT202300221T1/it unknown
- 2016-02-25 RS RS20230582A patent/RS64377B1/sr unknown
- 2016-02-25 EP EP16755593.7A patent/EP3263110B1/en active Active
- 2016-02-25 SI SI201631725T patent/SI3263110T1/sl unknown
- 2016-02-25 FI FIEP23172275.2T patent/FI4233847T3/fi active
- 2016-02-25 US US15/553,852 patent/US10350170B2/en active Active
-
2017
- 2017-08-24 IL IL254132A patent/IL254132B/en active IP Right Grant
-
2019
- 2019-06-05 US US16/432,091 patent/US20200000730A1/en not_active Abandoned
-
2023
- 2023-07-28 CY CY20231100374T patent/CY1126118T1/el unknown
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| FG | Grant or registration |