DK3725778T3 - Formuleringer af enzalutamid - Google Patents
Formuleringer af enzalutamid Download PDFInfo
- Publication number
- DK3725778T3 DK3725778T3 DK20177837.0T DK20177837T DK3725778T3 DK 3725778 T3 DK3725778 T3 DK 3725778T3 DK 20177837 T DK20177837 T DK 20177837T DK 3725778 T3 DK3725778 T3 DK 3725778T3
- Authority
- DK
- Denmark
- Prior art keywords
- enzalutamide
- formulations
- enzalutamide formulations
- 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
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
-
- 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
- A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
- A61K31/4164—1,3-Diazoles
- A61K31/4166—1,3-Diazoles having oxo groups directly attached to the heterocyclic ring, e.g. phenytoin
-
- 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
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- 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
- A61K47/38—Cellulose; Derivatives thereof
-
- 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
- A61K9/10—Dispersions; Emulsions
-
- 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
- A61K9/141—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers
- A61K9/146—Intimate drug-carrier mixtures characterised by the carrier, e.g. ordered mixtures, adsorbates, solid solutions, eutectica, co-dried, co-solubilised, co-kneaded, co-milled, co-ground products, co-precipitates, co-evaporates, co-extrudates, co-melts; Drug nanoparticles with adsorbed surface modifiers with organic macromolecular 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
-
- 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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/1629—Organic macromolecular compounds
- A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
-
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
-
- 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
- A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P13/00—Drugs for disorders of the urinary system
- A61P13/08—Drugs for disorders of the urinary system of the prostate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/08—Drugs for genital or sexual disorders; Contraceptives for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/14—Drugs for genital or sexual disorders; Contraceptives for lactation disorders, e.g. galactorrhoea
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07D—HETEROCYCLIC COMPOUNDS
- C07D233/00—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings
- C07D233/54—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings having two double bonds between ring members or between ring members and non-ring members
- C07D233/66—Heterocyclic compounds containing 1,3-diazole or hydrogenated 1,3-diazole rings, not condensed with other rings having two double bonds between ring members or between ring members and non-ring members with hetero atoms or with carbon atoms having three bonds to hetero atoms with at the most one bond to halogen, e.g. ester or nitrile radicals, directly attached to ring carbon atoms
- C07D233/86—Oxygen and sulfur atoms, e.g. thiohydantoin
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201261699351P | 2012-09-11 | 2012-09-11 | |
| EP13766437.1A EP2895463A1 (en) | 2012-09-11 | 2013-09-11 | Formulations of enzalutamide |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK3725778T3 true DK3725778T3 (da) | 2021-09-20 |
Family
ID=49231627
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK20177837.0T DK3725778T3 (da) | 2012-09-11 | 2013-09-11 | Formuleringer af enzalutamid |
Country Status (28)
| Country | Link |
|---|---|
| US (9) | US20140179749A1 (da) |
| EP (5) | EP3971167A1 (da) |
| JP (5) | JP6404217B2 (da) |
| KR (1) | KR102225416B1 (da) |
| CN (2) | CN109897004A (da) |
| AU (2) | AU2013315619B2 (da) |
| BR (1) | BR112015005432B1 (da) |
| CA (1) | CA2884795C (da) |
| CY (1) | CY1124729T1 (da) |
| DK (1) | DK3725778T3 (da) |
| EA (2) | EA033374B9 (da) |
| ES (1) | ES2892029T3 (da) |
| HK (1) | HK1212701A1 (da) |
| HR (1) | HRP20211423T1 (da) |
| HU (1) | HUE057701T2 (da) |
| IL (1) | IL237604B (da) |
| IN (1) | IN2015DN02875A (da) |
| LT (1) | LT3725778T (da) |
| MX (3) | MX363974B (da) |
| PH (1) | PH12015500525A1 (da) |
| PL (1) | PL3725778T3 (da) |
| PT (1) | PT3725778T (da) |
| RS (1) | RS62676B1 (da) |
| SI (1) | SI3725778T1 (da) |
| TW (1) | TWI673051B (da) |
| UA (1) | UA117353C2 (da) |
| WO (1) | WO2014043208A1 (da) |
| ZA (1) | ZA201501847B (da) |
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| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN109897004A (zh) | 2012-09-11 | 2019-06-18 | 麦迪威森前列腺医疗有限责任公司 | 恩杂鲁胺制剂 |
| ES2836424T3 (es) | 2012-09-26 | 2021-06-25 | Aragon Pharmaceuticals Inc | Antiandrógenos para tratar el cáncer de próstata no metastásico y resistente a la castración |
| CA2908957C (en) | 2013-04-17 | 2021-05-18 | Signal Pharmaceuticals, Llc | Combination therapy comprising a dihydropyrazino-pyrazine compound and an androgen receptor antagonist for treating prostate cancer |
| KR20200015830A (ko) * | 2014-02-05 | 2020-02-12 | 레크 파마슈티칼스 디.디. | 안드로겐 수용체 길항제의 고체 제약 조성물 |
| CN104356068A (zh) * | 2014-10-30 | 2015-02-18 | 杭州新博思生物医药有限公司 | 恩杂鲁胺新晶型及其制备方法 |
| ES2839128T3 (es) * | 2014-12-05 | 2021-07-05 | Aragon Pharmaceuticals Inc | Composiciones anticancerosas |
| MA41107A (fr) * | 2014-12-05 | 2017-10-10 | Aragon Pharmaceuticals Inc | Compositions anti-cancéreuses |
| US10285948B2 (en) | 2014-12-05 | 2019-05-14 | Janssen Pharmaceutica Nv | Anticancer compositions |
| CN104546714A (zh) * | 2015-02-11 | 2015-04-29 | 江苏慧博生物科技有限公司 | 一种恩杂鲁胺胶束制剂及其制备方法 |
| CA2976360A1 (en) * | 2015-02-11 | 2016-08-18 | Aptevo Research And Development Llc | Compositions and methods for combination therapy with prostate-specific membrane antigen binding proteins |
| CN104857517B (zh) * | 2015-05-14 | 2018-04-27 | 南京海纳医药科技股份有限公司 | 一种恩杂鲁胺软胶囊及其制备方法 |
| CN105030685B (zh) * | 2015-07-21 | 2018-02-27 | 福格森（武汉）生物科技股份有限公司 | 一种恩杂鲁胺固体分散体口服制剂 |
| WO2017027665A1 (en) | 2015-08-12 | 2017-02-16 | Medivation Prostate Therapeutics, Inc. | Treatment of cancer using a combination of enzalutamide and a cyp3a4 inducer |
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| EP3352760A4 (en) | 2015-09-21 | 2019-03-06 | Aptevo Research and Development LLC | CD3 BINDING POLYPEPTIDES |
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| KR20190137920A (ko) | 2017-04-28 | 2019-12-11 | 아스텔라스세이야쿠 가부시키가이샤 | 엔잘루타미드를 함유하는 경구 투여용 의약 조성물 |
| BR112019027402A2 (pt) | 2017-06-22 | 2020-07-07 | Celgene Corporation | tratamento de carcinoma hepatocelular caracterizado por infecção pelo vírus da hepatite b |
| WO2019016747A1 (en) * | 2017-07-20 | 2019-01-24 | Dr. Reddy's Laboratories Limited | AMORPHOUS SOLID DISPERSIONS OF APALUTAMIDE AND PROCESS FOR THEIR PREPARATION |
| RU2020109948A (ru) * | 2017-08-08 | 2021-09-10 | Др. Редди'З Лабораториз Лимитед | Экструдированные композиции энзалутамида |
| EP3697398A1 (en) | 2017-10-16 | 2020-08-26 | Aragon Pharmaceuticals, Inc. | Anti-androgens for the treatment of non-metastatic castration-resistant prostate cancer |
| WO2019155416A2 (en) * | 2018-02-09 | 2019-08-15 | Kashiv Pharma Llc | A stable pharmaceutical composition of poorly soluble nonsteroidal antiandrogens |
| JP7244536B2 (ja) * | 2018-04-06 | 2023-03-22 | キャプシュゲル・ベルジウム・エヌ・ヴィ | メタクリル酸メチル－メタクリル酸コポリマーからなる低アスペクト比の粒子のための噴霧乾燥方法 |
| CZ2018234A3 (cs) | 2018-05-21 | 2019-12-04 | Zentiva Ks | Zvýšení rozpustnosti a biodostupnosti enzalutamidu |
| EA202191372A1 (ru) * | 2018-12-14 | 2021-09-16 | Фуджифилм Корпорэйшн | Таблетка и способ получения таблетки |
| CN109432016B (zh) * | 2018-12-26 | 2021-03-02 | 广州中医药大学(广州中医药研究院) | 一种恩杂鲁胺的三元固体制剂及其制备方法 |
| WO2020144647A1 (en) | 2019-01-10 | 2020-07-16 | Aragon Pharmaceuticals, Inc. | Pharmaceutical composition comprising apalutamide dispersed in apple sauce |
| EP3918607A1 (en) | 2019-01-30 | 2021-12-08 | Janssen Pharmaceutica NV | Methods of treating prostate cancer based on molecular subtypes |
| EP3917519A1 (en) | 2019-01-30 | 2021-12-08 | Aragon Pharmaceuticals, Inc. | Anti-androgens for the treatment of metastatic castration-sensitive prostate cancer |
| WO2020229702A1 (en) | 2019-05-16 | 2020-11-19 | Leon-Nanodrugs Gmbh | Method for producing nanoparticles |
| JP2022533463A (ja) | 2019-05-23 | 2022-07-22 | ヘルム・アクチエンゲゼルシャフト | エンザルタミドを含むナノ粒子 |
| WO2020239478A1 (en) | 2019-05-28 | 2020-12-03 | Pharma Mar, S.A. | Trabectedin for treating sarcomas based on genomic markers |
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| CN114727949A (zh) * | 2019-09-18 | 2022-07-08 | 百时美施贵宝公司 | Tyk2抑制剂的剂型 |
| US20230147869A1 (en) * | 2019-09-23 | 2023-05-11 | Bionomics Limited | Therapeutic formulations and uses thereof |
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| JP2023500935A (ja) | 2019-11-04 | 2023-01-11 | アラゴン ファーマシューティカルズ，インコーポレイテッド | 重度の肝障害を有する対象における非転移性去勢抵抗性前立腺癌の治療のためのアンドロゲン受容体阻害剤 |
| AR118925A1 (es) * | 2020-05-13 | 2021-11-10 | Novocap S A | Solución líquida concentrada de antiandrógenos no esteroideos y procedimiento para preparar la solución |
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| WO2021245285A1 (en) | 2020-06-05 | 2021-12-09 | Janssen Pharmaceutica Nv | Methods of treating prostate cancer based on molecular subtypes |
| CN114053243A (zh) * | 2020-08-05 | 2022-02-18 | 齐鲁制药有限公司 | 一种恩扎卢胺软胶囊及其制备方法 |
| WO2022049523A1 (en) | 2020-09-04 | 2022-03-10 | Aragon Pharmaceuticals, Inc. | Methods for treating prostate cancer |
| WO2022195407A1 (en) | 2021-03-19 | 2022-09-22 | Aragon Pharmaceuticals, Inc. | Methods for treating prostate cancer |
| CN115721612A (zh) * | 2021-08-26 | 2023-03-03 | 上海宣泰医药科技股份有限公司 | 一种恩扎卢胺固体制剂颗粒及其制备方法 |
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