DK2440177T3 - Farmaceutisk doseringsform til oral administration af en hæmmer af BCL-2-familien - Google Patents
Farmaceutisk doseringsform til oral administration af en hæmmer af BCL-2-familien Download PDFInfo
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- DK2440177T3 DK2440177T3 DK10742875.7T DK10742875T DK2440177T3 DK 2440177 T3 DK2440177 T3 DK 2440177T3 DK 10742875 T DK10742875 T DK 10742875T DK 2440177 T3 DK2440177 T3 DK 2440177T3
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- DK
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- cancer
- dosage form
- pharmaceutically acceptable
- active ingredient
- solubilizer
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- 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
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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
- A61K31/535—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
- A61K31/5375—1,4-Oxazines, e.g. morpholine
- A61K31/5377—1,4-Oxazines, e.g. morpholine not condensed and containing further heterocyclic rings, e.g. timolol
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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
- A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
- A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
-
- 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
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- 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
- A61K9/20—Pills, tablets, discs, rods
-
- 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
- A61K9/2027—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
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- 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
-
- 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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
-
- 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
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K2121/00—Preparations for use in therapy
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- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Chemical & Material Sciences (AREA)
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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- General Chemical & Material Sciences (AREA)
- Biophysics (AREA)
- Molecular Biology (AREA)
- Hematology (AREA)
- Oncology (AREA)
- Medicinal Preparation (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
Claims (24)
1. Farmaceutisk doseringsform, som omfatter et produkt i form af en fast dispersion, der omfatter en farmaceutisk aktiv bestanddel, mindst én farmaceutisk acceptabel polymer og mindst én farmaceutisk acceptabel solubilisator, hvilken farmaceutisk aktive bestanddel er N-(4-(4-((2-(4-chlorphenyl)-5,5-dimethyl-1-cyclohex-1 -en-1 -yl)methyl)piperazin-1 -yl)benzoyl)-4-(((1 R)-3-(morpholin-4-yl)-1 -((phenylsulfanyl)methyl)propyl)amino)-3-((trifluormethyl)sulfonyl)benzensulfon-amid, et salt, hydrat eller solvat deraf.
2. Doseringsform ifølge krav 1, hvor den farmaceutisk acceptable solubilisator er valgt fra gruppen bestående af ikke-ioniske solubilisatorer, anioniske solubili-satorer og kombinationer deraf.
3. Doseringsform ifølge krav 2, hvor den farmaceutisk acceptable ikke-ioniske solubilisator er valgt fra gruppen bestående af polyolfedtsyreestere, polyalkoxy-lerede polyolfedtsyreestere, polyalkoxylerede fedtalkoholethere, tocopherylfor-bindelser og blandinger af to eller flere deraf, og hvor den farmaceutisk acceptable anioniske solubilisator er valgt fra gruppen bestående af alkylsulfater, al-kylcarboxylater, alkylbenzolsulfater og sekundære alkansulfonater.
4. Doseringsform ifølge krav 1, hvor den farmaceutisk acceptable solubilisator er valgt fra gruppen bestående af tocopherylforbindelser med en polyalkylengly-coldel, sorbitanfedtsyreestere og polyoxyethylensorbitanfedtsyreestere.
5. Doseringsform ifølge krav 1, hvor den farmaceutisk acceptable solubilisator omfatter mindst én af alfa-tocopherylpolyethylenglycolsuccinat, sorbitanmono-laurat og polyoxyethylensorbitanmonolaurat.
6. Doseringsform ifølge krav 2, som omfatter mindst én farmaceutisk acceptabel ikke-ionisk solubilisator og mindst én farmaceutisk acceptabel anionisk solubilisator.
7. Doseringsform ifølge krav 6, hvor den farmaceutisk acceptable ikke-ioniske solubilisator er valgt fra gruppen bestående af sorbitanfedtsyreestere, polyoxy-ethylensorbitanfedtsyreestere og alfa-tocopherylpolyethylenglycolsuccinat, og den farmaceutisk acceptable anioniske solubilisator er natriumlaurylsulfat.
8. Doseringsform ifølge krav 1, som indeholder et ikke-flygtigt opløsningsmiddel for den farmaceutisk aktive bestanddel, hvilket opløsningsmiddel er flydende ved omgivelsestemperatur.
9. Doseringsform ifølge krav 8, hvor det ikke-flygtige opløsningsmiddel er pro-pylenglycol.
10. Doseringsform ifølge krav 1, hvor den farmaceutisk acceptable polymer er en homopolymer eller copolymer af N-vinylpyrrolidon.
11. Doseringsform ifølge krav 1, hvor den farmaceutisk acceptable polymer er en copolymer af N-vinylpyrrolidon og vinylacetat.
12. Doseringsform ifølge krav 1, hvor den farmaceutisk aktive bestanddel er valgt fra gruppen bestående af den fri base, natriumsaltet og dihydrochloridsaltet af N-(4-(4-((2-(4-chlorphenyl)-5,5-dimethyl-1 -cyclohex-1 -en-1 -yl)methyl)pipera-zin-1 -yl)benzoyl)-4-(((1 R)-3-(morpholin-4-yl)-1 -((phenylsulfanyl)methyl)propyl)-amino)-3-((trifluormethyl)sulfonyl)benzensulfonamid og kombinationer deraf.
13. Doseringsform ifølge krav 1, som indeholder mindst ét additiv valgt blandt strømningsregulatorer, desintegrationsmidler, fyldstoffer og smøremidler.
14. Doseringsform ifølge krav 1, hvor produktet i form af en fast dispersion omfatter fra ca. 0,5 til 40 vægtprocent af den farmaceutisk aktive bestanddel, 40 til 97,5 vægtprocent af den mindst ene farmaceutisk acceptable polymer, 2 til 20 vægtprocent af den mindst ene solubilisator og 0 til 15 vægtprocent additiver.
15. Doseringsform ifølge krav 1, som omfatter mindre end 1,5 vægtprocent sul-foxidnedbrydningsprodukter af den aktive bestanddel i forhold til vægten af den aktive bestanddel.
16. Doseringsform ifølge krav 1, som omfatter mindre end 1,2 vægtprocent sul-foxidnedbrydningsprodukter af den aktive bestanddel i forhold til vægten af den aktive bestanddel.
17. Doseringsform ifølge krav 1, som omfatter mindre end 0,9 vægtprocent sul-foxidnedbrydningsprodukter af den aktive bestanddel i forhold til vægten af den aktive bestanddel.
18. Doseringsform ifølge krav 1, hvor produktet i form af en fast dispersion er en smelteforarbejdet størknet blanding.
19. Doseringsform ifølge krav 1 til anvendelse til behandling af en proliferativ sygdom ved administration til et individ med behov derfor.
20. Doseringsform ifølge krav 19, hvor den proliferative sygdom er valgt blandt tumorer og cancere.
21. Doseringsform ifølge krav 20, hvor den proliferative sygdom er valgt fra gruppen bestående af mesotheliom, blærecancer, pancreascancer, hudcancer, hoved- eller halscancer, kutant eller intraokulært melanom, ovariecancer, mamma-cancer, uteruscancer, tubakarcinom, endometriekarcinom, cervixkarcinom, vagi-nakarcinom, vulvakarcinom, knoglecancer, cervixcancer, coloncancer, rektal cancer, cancer i analregionen, mavecancer, gastrointestinal (ventrikel-, colorek-tal og duodenal) cancer, kronisk lymfatisk leukæmi, akut lymfatisk leukæmi, oesophaguscancer, tyndtarmscancer, cancer i det endokrine system, thyroi-deacancer, parathyroideacancer, binyrecancer, bløddelssarkom, urethracancer, peniscancer, testikelcancer, hepatocellulær cancer (lever-galdevejscancer), primær eller sekundær tumor i centralnervesystemet, primær eller sekundær hjer- netumor, Hodgkins sygdom, kronisk eller akut leukæmi, kronisk myeloid leukæmi, lymfatisk lymfom, lymfoblastisk leukæmi, follikulært lymfom, lymfoide ma-ligniteter af T-celle- eller B-celleoprindelse, melanom, myelomatose, oral cancer, ovariecancer, ikke-småcellet lungecancer, prostatacancer, småcellet lungecancer, nyre- og uretercancer, renalcellekarcinom, pelvis renalis-karcinom, neoplas-mer i centralnervesystemet, primært lymfom i centralnervesystemet, non-Hodg-kins lymfom, spinaltumorer, hjernestammegliom, hypofyseadenom, adrenokorti-kal cancer, galdeblærecancer, miltcancer, kolangiokarcinom, fibrosarkom, neu-roblastom, retinoblastom og kombinationer deraf.
22. Fremgangsmåde til fremstilling af en fast doseringsform ifølge krav 1, hvilken fremgangsmåde omfatter: (a) at fremstille en homogen smelte af den farmaceutisk aktive bestanddel eller et salt, hydrat eller solvat deraf, den mindst ene farmaceutisk acceptable polymer og den mindst ene solubilisator og (b) at lade smelten størkne for at opnå et produkt i form af en fast dispersion.
23. Fremgangsmåde ifølge krav 22, hvilken fremgangsmåde endvidere omfatter at formale produktet, som foreligger i form af en fast dispersion, og komprimere produktet, som foreligger i form af en fast dispersion, til en tablet.
24. Fremgangsmåde ifølge krav 22, hvilken fremgangsmåde endvidere omfatter at formale produktet, som foreligger i form af en fast dispersion, og at fylde produktet, som foreligger i form af en fast dispersion, i en kapselskal.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US18513009P | 2009-06-08 | 2009-06-08 | |
| PCT/IB2010/001659 WO2010143074A2 (en) | 2009-06-08 | 2010-06-08 | Pharmaceutical dosage form for oral administration of a bcl-2 family inhibitor |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| DK2440177T3 true DK2440177T3 (da) | 2015-12-21 |
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Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK10742875.7T DK2440177T3 (da) | 2009-06-08 | 2010-06-08 | Farmaceutisk doseringsform til oral administration af en hæmmer af BCL-2-familien |
| DK15184904.9T DK2982366T3 (da) | 2009-06-08 | 2010-06-08 | Farmaceutisk doseringsform til oral administration af en hæmmer af BCL-2-familien |
Family Applications After (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| DK15184904.9T DK2982366T3 (da) | 2009-06-08 | 2010-06-08 | Farmaceutisk doseringsform til oral administration af en hæmmer af BCL-2-familien |
Country Status (37)
| Country | Link |
|---|---|
| US (6) | US9642796B2 (da) |
| EP (3) | EP2982366B1 (da) |
| JP (2) | JP5872459B2 (da) |
| KR (2) | KR101751216B1 (da) |
| CN (2) | CN102802606A (da) |
| AR (2) | AR077021A1 (da) |
| AU (1) | AU2010258367B2 (da) |
| BR (2) | BRPI1012831B1 (da) |
| CA (1) | CA2763441C (da) |
| CL (1) | CL2011003054A1 (da) |
| CO (1) | CO6480964A2 (da) |
| CR (1) | CR20170037A (da) |
| CY (1) | CY1119663T1 (da) |
| DK (2) | DK2440177T3 (da) |
| DO (2) | DOP2011000375A (da) |
| EC (1) | ECSP12011580A (da) |
| ES (2) | ES2551860T3 (da) |
| HR (2) | HRP20151342T1 (da) |
| HU (2) | HUE025638T2 (da) |
| IL (2) | IL216494A (da) |
| LT (1) | LT2982366T (da) |
| MX (1) | MX2011013164A (da) |
| MY (1) | MY159824A (da) |
| NO (1) | NO2982366T3 (da) |
| NZ (1) | NZ597241A (da) |
| PE (2) | PE20160043A1 (da) |
| PL (2) | PL2440177T3 (da) |
| PT (2) | PT2440177E (da) |
| RU (2) | RU2711359C2 (da) |
| SG (1) | SG176264A1 (da) |
| SI (2) | SI2982366T1 (da) |
| SM (1) | SMT201500317B (da) |
| TW (2) | TWI471321B (da) |
| UA (1) | UA104471C2 (da) |
| UY (1) | UY32695A (da) |
| WO (1) | WO2010143074A2 (da) |
| ZA (1) | ZA201108853B (da) |
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| BR112012031516A2 (pt) | 2010-06-09 | 2016-11-08 | Abbott Lab | dispersões sólidas contendo inibidores de quinase |
| TWI535712B (zh) | 2010-08-06 | 2016-06-01 | 阿斯特捷利康公司 | 化合物 |
| UA113500C2 (xx) | 2010-10-29 | 2017-02-10 | Одержані екструзією розплаву тверді дисперсії, що містять індукуючий апоптоз засіб | |
| CA3152557A1 (en) * | 2010-10-29 | 2012-05-03 | Abbvie Inc. | Solid dispersions containing an apoptosis-inducing agent |
| PT2643322T (pt) | 2010-11-23 | 2017-11-13 | Abbvie Inc | Sais e formas cristalinas de um agente indutor de apoptose |
| ES2603129T3 (es) | 2010-11-23 | 2017-02-23 | Abbvie Ireland Unlimited Company | Métodos de tratamiento utilizando inhibidores selectivos de Bcl-2 |
| KR102191562B1 (ko) * | 2012-11-07 | 2020-12-15 | 에스케이바이오팜 주식회사 | 난용성 약물의 고체분산체 및 이의 제조방법 |
| WO2014160071A1 (en) * | 2013-03-14 | 2014-10-02 | St. Jude Children's Research Hospital | Methods and compositions for the treatment of glutamine-addicted cancers |
| US20140275082A1 (en) | 2013-03-14 | 2014-09-18 | Abbvie Inc. | Apoptosis-inducing agents for the treatment of cancer and immune and autoimmune diseases |
| WO2015051252A1 (en) * | 2013-10-03 | 2015-04-09 | Duke University | Compositions and methods for treating cancer with jak2 activity |
| JP2017509337A (ja) * | 2014-03-12 | 2017-04-06 | ノバルティス アーゲー | イムノコンジュゲートを作製する抗体を修飾するための特定部位 |
| WO2015193309A1 (en) * | 2014-06-18 | 2015-12-23 | F. Hoffmann-La Roche Ag | New pharmaceutical composition comprising non-ionic surfactants |
| CN105616419A (zh) * | 2014-11-07 | 2016-06-01 | 江苏豪森药业集团有限公司 | 含有细胞周期蛋白抑制剂固体分散体的药物组合物及其制备方法 |
| WO2017148837A1 (en) | 2016-02-29 | 2017-09-08 | F. Hoffmann-La Roche Ag | Dosage form compositions comprising an inhibitor of bruton's tyrosine kinase |
| TWI773730B (zh) | 2017-02-22 | 2022-08-11 | 瑞典商阿斯特捷利康公司 | 治療性樹枝狀聚合物 |
| US11872237B2 (en) * | 2018-12-28 | 2024-01-16 | Ascentage Pharma (Suzhou) Co., Ltd. | Pharmaceutical composition and preparation method thereof |
| KR20220098755A (ko) | 2019-11-05 | 2022-07-12 | 애브비 인코포레이티드 | 나비토클락스를 사용한 골수섬유증 및 mpn 관련 장애 치료에 사용하기 위한 투약 레지멘 |
| JP7849296B2 (ja) * | 2020-02-24 | 2026-04-21 | グアンジョウ・ルペン・ファーマシューティカル・カンパニー・リミテッド | Ｂｃｌ２阻害剤を含むホットメルト押出し固体分散体 |
| CN114533677A (zh) * | 2020-11-25 | 2022-05-27 | 苏州亚盛药业有限公司 | 固体分散体、制剂、其制备方法及其应用 |
| CN116847835A (zh) * | 2021-01-08 | 2023-10-03 | 赛罗斯制药有限公司 | 利用固定剂量的他米巴罗汀的治疗方案 |
| CN113520995B (zh) * | 2021-08-16 | 2023-03-10 | 海南鑫开源医药科技有限公司 | 一种离子敏感型眼用原位凝胶、其制备方法及应用 |
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