FI3182975T3 - Rukaparibin suuren annosvahvuuden tabletteja - Google Patents
Rukaparibin suuren annosvahvuuden tablettejaInfo
- Publication number
- FI3182975T3 FI3182975T3 FIEP15833096.9T FI15833096T FI3182975T3 FI 3182975 T3 FI3182975 T3 FI 3182975T3 FI 15833096 T FI15833096 T FI 15833096T FI 3182975 T3 FI3182975 T3 FI 3182975T3
- Authority
- FI
- Finland
- Prior art keywords
- tablet according
- weight
- active pharmaceutical
- pharmaceutical ingredient
- tablet
- Prior art date
Links
Classifications
-
- 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
-
- 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
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
-
- 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
- A61K9/2009—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
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—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
- A61K9/20—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
-
- 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)
- Medicinal Chemistry (AREA)
- Veterinary Medicine (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Epidemiology (AREA)
- Inorganic Chemistry (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Nitrogen Condensed Heterocyclic Rings (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (20)
1. Tabletti, joka käsittää 45—90 painoprosenttia vaikuttavaa farmaseuttista ainetta, 8-fluori-2-14-[(metyyliamino)metyyli]fenyyli]-1,3,4,5-tetrahydro-6H-atsepino[5,4,3- —cdJindol-6-onikamsylaattia, jolloin tabletti sisältää 200 mg tai enemmän 8-fluori-2-{4- [(metyyliamino)metyyli]fenyyli]-1,3,4,5-tetrahydro-6H-atsepino[5,4,3-cd]indol-6-onia.
2. Patenttivaatimuksen 1 mukainen tabletti johon sisältyy vaikuttavaa farmaseuttista ainesosaa 50-90 %.
3. Patenttivaatimuksen 1 mukainen tabletti johon sisältyy vaikuttavaa farmaseuttista ainesosaa 55-90 %.
4. Patenttivaatimuksen 1 mukainen tabletti johon sisältyy vaikuttavaa farmaseuttista ainesosaa 60-90 %.
5. Patenttivaatimuksen 1 mukainen tabletti johon sisältyy vaikuttavaa farmaseuttista ainesosaa 65—85 %.
6. Patenttivaatimuksen 1 mukainen tabletti johon sisältyy vaikuttavaa farmaseuttista ainesosaa 70-80 %.
7. Jonkin edellisen patenttivaatimuksen mukainen tabletti, joka käsittää lisäksi 5-50 painoprosenttia täyteainetta; 1-20 painoprosenttia hajotusainetta; 0,20-2,5 painoprosenttia voiteluainetta.
8. Patenttivaatimuksen 7 mukainen tabletti, jossa vaikuttavaa farmaseuttista ainesosaa on 50-90 painoprosenttia, täyteainetta on 5—45 painoprosenttia, — hajotusainetta on 2-10 painoprosenttia, voiteluainetta on 0,25—2,5 painoprosenttia.
9. Patenttivaatimuksen 8 mukainen tabletti, johon vaikuttavaa farmaseuttista ainesosaa sisältyy 70-80 painoprosenttia.
EP3182975 2
10. — Jonkin edellisen patenttivaatimuksen mukainen tabletti, jolloin tabletti sisältää 250 mg tai enemmän 8-fluori-2-(4-[(metyyliamino)metyyli]fenyyli]-1,3,4,5-tetrahydro- 6H-atsepino[5,4,3-cd]indol-6-onia.
11. Jonkin edellisen patenttivaatimuksen mukainen tabletti, jolloin tabletti sisältää 300 mg tai enemmän 8-fluori-2-14-[(metyyliamino)metyyli]fenyylil-1,3,4,5-tetrahydro- 6H-atsepino[5,4,3-cd]indol-6-onia.
12. Patenttivaatimuksen 9 mukainen tabletti, jossa täyteaine on mikrokiteinen — selluloosa.
13. Patenttivaatimuksen 9 mukainen tabletti, jossa voiteluaine on magnesiumstearaatti.
14. Patenttivaatimuksen 9 mukainen tabletti, jossa hajotusaine on natriumtarkkelysglykolaatti.
15. Patenttivaatimuksen 9 mukainen tabletti, jossa täyteaine on mikrokiteinen selluloosa, hajotusaine on € natriumtärkkelysoalykolaatti ja = voiteluaine on —magnesiumstearaatti.
16. Patenttivaatimuksen 9 mukainen tabletti, jossa vähintään 95 painoprosenttia vaikuttavasta farmaseuttisesta aineosasta vapautuu 30 minuutin kuluessa testattuna 0,01 N HCI:ssa USP II -lapamenetelmällä ja nopeudella 75 1/min.
17. — Patenttivaatimuksen 16 mukainen tabletti, jossa vähintään 95 painoprosenttia vaikuttavasta farmaseuttisesta aineosasta vapautuu 15 minuutin kuluessa testattuna 0,01 N HCI:ssa USP II -lapamenetelmällä ja nopeudella 75 1/min.
18. Patenttivaatimuksen 16 mukainen tabletti, jossa vähintään 95 painoprosenttia vaikuttavasta farmaseuttisesta aineosasta vapautuu 10 minuutin kuluessa testattuna 0,01 N HCI:ssa USP II -lapamenetelmällä ja nopeudella 75 1/min.
EP3182975 3
19. — Jonkin — edellisen — patenttivaatimuksen — mukainen = tabletti, joka on kuivarakeistettu.
20. Jonkin patenttivaatimuksen 1-19 mukainen tabletti käytettäväksi nisäkkään — syövän hoitomenetelmässä, jolloin menetelmä käsittää terapeuttisesti tehokkaan määrän mainitun patenttivaatimuksen mukaista tablettia antamisen nisäkkäälle.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US201462040849P | 2014-08-22 | 2014-08-22 | |
| US201562101739P | 2015-01-09 | 2015-01-09 | |
| PCT/US2015/045522 WO2016028689A1 (en) | 2014-08-22 | 2015-08-17 | High dosage strength tablets of rucaparib |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| FI3182975T3 true FI3182975T3 (fi) | 2025-11-13 |
Family
ID=55347324
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| FIEP15833096.9T FI3182975T3 (fi) | 2014-08-22 | 2015-08-17 | Rukaparibin suuren annosvahvuuden tabletteja |
Country Status (19)
| Country | Link |
|---|---|
| US (3) | US9987285B2 (fi) |
| EP (1) | EP3182975B1 (fi) |
| JP (3) | JP6574477B2 (fi) |
| KR (2) | KR102803917B1 (fi) |
| CN (2) | CN113209033A (fi) |
| AU (2) | AU2015305696B2 (fi) |
| BR (1) | BR112017000865A2 (fi) |
| CA (1) | CA2955495C (fi) |
| DK (1) | DK3182975T3 (fi) |
| FI (1) | FI3182975T3 (fi) |
| IL (1) | IL249946B (fi) |
| LT (1) | LT3182975T (fi) |
| MX (1) | MX367260B (fi) |
| NZ (1) | NZ728392A (fi) |
| PT (1) | PT3182975T (fi) |
| RS (1) | RS67356B1 (fi) |
| RU (1) | RU2705156C2 (fi) |
| SG (1) | SG11201700265VA (fi) |
| WO (1) | WO2016028689A1 (fi) |
Families Citing this family (25)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR20230107902A (ko) | 2014-02-05 | 2023-07-18 | 머크 샤프 앤드 돔 엘엘씨 | Cgrp-활성 화합물에 대한 정제 제제 |
| US12168004B2 (en) | 2014-02-05 | 2024-12-17 | Merck Sharp & Dohme Llc | Treatment of migraine |
| RS67356B1 (sr) * | 2014-08-22 | 2025-11-28 | Pharma& Schweiz Gmbh | Tablete rukapariba visoke doze |
| CN106008530B (zh) * | 2016-07-24 | 2018-06-26 | 石家庄久正生物科技有限公司 | 一种抗卵巢癌药物Rucaparib关键中间体的制备方法 |
| CN108201534A (zh) * | 2016-12-16 | 2018-06-26 | 苏州苏融生物医药有限公司 | 一种瑞卡帕布口服缓控释药物组合物及其用途 |
| US10875870B2 (en) | 2017-01-24 | 2020-12-29 | Assia Chemical Industries Ltd. | Solid state forms of rucaparib and of rucaparib salts |
| MX2019011496A (es) | 2017-03-27 | 2020-01-23 | Tesaro Inc | Composiciones de niraparib. |
| BR112020006039A2 (pt) * | 2017-09-26 | 2020-10-06 | Tesaro, Inc. | formulações de niraparibe |
| WO2019130229A1 (en) | 2017-12-28 | 2019-07-04 | Mylan Laboratories Ltd | Methods and intermediates for preparing rucaparib |
| US10933069B2 (en) | 2018-01-05 | 2021-03-02 | Cybrexa 1, Inc. | Compounds, compositions, and methods for treatment of diseases involving acidic or hypoxic diseased tissues |
| US12383545B1 (en) | 2018-06-08 | 2025-08-12 | Allergan Pharmaceuticals International Limited | Treatment of migraine |
| CN109111454A (zh) * | 2018-08-01 | 2019-01-01 | 宁波金未生物科技有限公司 | 一种瑞卡帕布s-樟脑磺酸盐 |
| CN108853030B (zh) * | 2018-09-26 | 2021-10-01 | 上海朝晖药业有限公司 | 一种治疗恶性肿瘤的药物制剂及其制备方法 |
| WO2020113500A1 (zh) * | 2018-12-06 | 2020-06-11 | 上海诚妙医药科技有限公司 | 芦卡帕利樟脑磺酸盐的新晶型和制备方法及其用途 |
| PH12022550037A1 (en) | 2019-07-10 | 2023-04-12 | Cybrexa 3 Inc | Peptide conjugates of microtubule-targeting agents as therapeutics |
| EP3997093A1 (en) | 2019-07-10 | 2022-05-18 | Cybrexa 2, Inc. | Peptide conjugates of cytotoxins as therapeutics |
| ES3014370T3 (en) | 2020-04-28 | 2025-04-22 | Rhizen Pharmaceuticals Ag | Novel compounds useful as poly(adp-ribose) polymerase (parp) inhibitors |
| EP4182318B1 (en) | 2020-07-14 | 2025-08-27 | Assia Chemical Industries Ltd. | Solid state forms of rucaparib salts |
| AU2021319090A1 (en) | 2020-07-29 | 2023-03-02 | Allergan Pharmaceuticals International Limited | Treatment of migraine |
| WO2022090938A1 (en) | 2020-10-31 | 2022-05-05 | Rhizen Pharmaceuticals Ag | Phthalazinone derivatives useful as parp inhibitors |
| WO2022140537A1 (en) | 2020-12-22 | 2022-06-30 | Allergan Pharmaceuticals International Limited | Treatment of migraine |
| AU2022255809A1 (en) | 2021-04-08 | 2023-10-26 | Incozen Therapeutics Pvt. Ltd. | Inhibitors of poly(adp-ribose) polymerase |
| JP2024533756A (ja) | 2021-09-27 | 2024-09-12 | アラガン ファーマスーティカルズ インターナショナル リミテッド | アトゲパントを含む片頭痛の併用療法 |
| JP2024543323A (ja) * | 2021-11-10 | 2024-11-21 | クリチテック，インコーポレイテッド | ルカパリブ粒子およびその使用 |
| EP4463232A1 (en) | 2022-01-11 | 2024-11-20 | Assia Chemical Industries Ltd. | Solid state forms of rucaparib tosylate |
Family Cites Families (10)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| PL210415B1 (pl) | 1999-01-11 | 2012-01-31 | Agouron Pharma | Pochodne indolu, środek farmaceutyczny i zastosowanie pochodnych indolu |
| EP1611137A1 (en) | 2003-03-31 | 2006-01-04 | Pfizer Inc. | Salts of tricyclic inhibitors of poly(adp-ribose) polymerases |
| ATE454893T1 (de) | 2003-07-25 | 2010-01-15 | Cancer Rec Tech Ltd | Tricyclische parp-hemmer |
| MX2007003311A (es) | 2004-09-22 | 2007-05-16 | Pfizer | Procedimiento para preparar inhibidores de poli (adp-ribosa) polimerasas. |
| JP2008513435A (ja) | 2004-09-22 | 2008-05-01 | ファイザー・インク | ポリ（ａｄｐ−リボース）ポリメラーゼ阻害剤を含む治療用組成物 |
| MX2007002461A (es) | 2004-09-22 | 2008-03-13 | Pfizer | Formas polimorficas y amorfas de la sal fosfato de 8-fluoro-2-{4-[metilamino)metil]fenil}-1, 3, 4, 5-tetrahidro-6h-azepino [5, 4, 3-cd]indol-6-ona. |
| AU2009235426A1 (en) * | 2008-04-09 | 2009-10-15 | Lek Pharmaceuticals D.D. | Granulation of active pharmaceutical ingredients |
| CA3024216C (en) * | 2010-02-12 | 2021-03-30 | Pfizer Inc. | Salts and polymorphs of 8-fluoro-2-{4-[(methylamino)methyl]phenyl}-1,3,4,5-tetrahydro-6h-azepino[5,4,3-cd]indol-6-one |
| ES2654670T3 (es) | 2012-04-05 | 2018-02-14 | Vertex Pharmaceuticals Incorporated | Compuestos útiles como inhibidores de la cinasa ATR y terapias de combinación de los mismos |
| RS67356B1 (sr) * | 2014-08-22 | 2025-11-28 | Pharma& Schweiz Gmbh | Tablete rukapariba visoke doze |
-
2015
- 2015-08-17 RS RS20251082A patent/RS67356B1/sr unknown
- 2015-08-17 US US14/828,065 patent/US9987285B2/en active Active
- 2015-08-17 LT LTEPPCT/US2015/045522T patent/LT3182975T/lt unknown
- 2015-08-17 CN CN202110458329.2A patent/CN113209033A/zh active Pending
- 2015-08-17 NZ NZ728392A patent/NZ728392A/en unknown
- 2015-08-17 FI FIEP15833096.9T patent/FI3182975T3/fi active
- 2015-08-17 JP JP2017510539A patent/JP6574477B2/ja active Active
- 2015-08-17 DK DK15833096.9T patent/DK3182975T3/da active
- 2015-08-17 SG SG11201700265VA patent/SG11201700265VA/en unknown
- 2015-08-17 WO PCT/US2015/045522 patent/WO2016028689A1/en not_active Ceased
- 2015-08-17 RU RU2017109139A patent/RU2705156C2/ru active
- 2015-08-17 MX MX2017001540A patent/MX367260B/es active IP Right Grant
- 2015-08-17 CA CA2955495A patent/CA2955495C/en active Active
- 2015-08-17 KR KR1020237020594A patent/KR102803917B1/ko active Active
- 2015-08-17 EP EP15833096.9A patent/EP3182975B1/en active Active
- 2015-08-17 PT PT158330969T patent/PT3182975T/pt unknown
- 2015-08-17 AU AU2015305696A patent/AU2015305696B2/en active Active
- 2015-08-17 BR BR112017000865A patent/BR112017000865A2/pt not_active Application Discontinuation
- 2015-08-17 CN CN201580042815.9A patent/CN106794185A/zh active Pending
- 2015-08-17 KR KR1020177007284A patent/KR20170043597A/ko not_active Ceased
-
2017
- 2017-01-05 IL IL249946A patent/IL249946B/en active IP Right Grant
-
2018
- 2018-03-14 US US15/920,643 patent/US10130636B2/en active Active
- 2018-10-08 US US16/154,038 patent/US20190099430A1/en not_active Abandoned
-
2019
- 2019-08-15 JP JP2019149084A patent/JP6797980B2/ja active Active
- 2019-11-29 AU AU2019272064A patent/AU2019272064B2/en active Active
-
2020
- 2020-11-18 JP JP2020191356A patent/JP7127101B2/ja active Active
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