HRP20171902T1 - Farmaceutski oblik za doziranje za oralnu primjenu inhibitora iz obitelji bcl-2 - Google Patents
Farmaceutski oblik za doziranje za oralnu primjenu inhibitora iz obitelji bcl-2 Download PDFInfo
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- HRP20171902T1 HRP20171902T1 HRP20171902TT HRP20171902T HRP20171902T1 HR P20171902 T1 HRP20171902 T1 HR P20171902T1 HR P20171902T T HRP20171902T T HR P20171902TT HR P20171902 T HRP20171902 T HR P20171902T HR P20171902 T1 HRP20171902 T1 HR P20171902T1
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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
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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
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
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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
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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
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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
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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
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
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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
- A61K9/2004—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
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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
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4833—Encapsulating processes; Filling of capsules
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- 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
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- 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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- Molecular Biology (AREA)
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- 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 (18)
1. Farmaceutski oblik za doziranje koji sadržava proizvod u obliku čvrste disperzije koji sadržava farmaceutski aktivni sastojak, najmanje jedan farmaceutski prihvatljiv polimer koji sadržava homopolimer ili kopolimer N-vinil pirolidona i najmanje jedan farmaceutski prihvatljiv solubilizator koji sadržava tokoferilni spoj s polialkilen glikolnom skupinom, naznačen time, da je navedeni farmaceutski aktivni sastojak N-(4-(4-((2-(4-klorfenil) -5,5-dimetil-l-cikloheks-l-en-l-il)metil)piperazin-l-il)benzoil)-4-(((lR)-3-(morfolin-4-il)-l-((fenilsulfanil)metil)propil)amino)-3-((trifluorometil)sulfonil)benzensulfonamid ili njegova sol ili hidrat.
2. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da farmaceutski prihvatljivo otapalo sadržava alfa tokoferil polietilen glikol sukcinat.
3. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da sadržava nehlapljivo otapalo za farmaceutski aktivni sastojak, a navedeno otapalo je tekućina pri sobnoj temperaturi.
4. Oblik za doziranje u skladu s patentnim zahtjevom 3, naznačen time, da je navedeno nehlapljivo otapalo propilen glikol.
5. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da je navedeni farmaceutski prihvatljiv polimer kopolimer N-vinilpirolidona i vinil acetata.
6. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da je navedeni farmaceutski aktivni sastojak odabran iz skupine koju čine slobodna baza, natrijeva sol i dihidrokloridna sol N-(4-(4- ((2-(4- klorfenil) -5,5-dimetil-l-cikloheks-l-en- 1-il) metil )piperazin-l-il )benzoil)-4-((( lR)-3-( morfolin-4-il)-1- ((fenil sulfanil) metil)propil)amino)-3-((trifluorometil)sulfonil)benzensulfonamida i njihove kombinacije.
7. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da sadržava najmanje jedan aditiv odabran između regulatora protoka, sredstava za raspršivanje, punila i maziva.
8. Oblik za doziranje u skladu s patentnim zahtjevom 7, naznačen time, da sadržava regulator protoka, a regulator protoka sadržava koloidni silicijev dioksid.
9. Oblik za doziranje u skladu s patentnim zahtjevom 7, naznačen time, da sadržava sredstvo za raspršivanje, a sredstvo za raspršivanje sadržava umreženu natrijevu karboksimetil celulozu.
10. Oblik za doziranje u skladu s patentnim zahtjevom 7, naznačen time, da sadržava lubrikant, a lubrikant sadržava natrij stearil fumarat.
11. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da kruti disperzijski proizvod sadržava od oko 0,5 do 40 % težinskih udjela farmaceutski aktivnog sastojka, 40 do 97,5 % težinskih udjela navedenog barem jednog farmaceutski prihvatljivog polimera, 2 do 20 % težinskih udjela navedenog najmanje jednog solubilizatora i 0 do 15 % težinskih udjela aditiva.
12. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da sadržava manje od 1,5 % težinskih udjela sulfoksidnih produkata raspadanja aktivnog sastojka, u odnosu na težinu aktivnog sastojka ili manje od 1,2 % težinskih udjela sulfoksidnih produkata raspadanja aktivnog sastojka, u odnosu na težinu aktivnog sastojka ili manje od 0,9 % težinskih udjela sulfoksidnih proizvoda raspadanja aktivnog sastojka, u odnosu na težinu aktivnog sastojka.
13. Oblik za doziranje u skladu s patentnim zahtjevom 1, naznačen time, da je smjesa dobivena taljenjem i skrućivanjem.
14. Oblik za doziranje u skladu s patentnim zahtjevom 1, za uporabu u postupku liječenja proliferacijskog poremećaja, naznačen time, da uključuje oblik za doziranje u skladu s patentnim zahtjevom 1 subjektu kojem je to potrebno.
15. Oblik za doziranje za uporabu u skladu s patentnim zahtjevom 14, naznačen time, da je proliferativni poremećaj odabran između tumora i karcinoma.
16. Oblik za doziranje za uporabu u skladu s patentnim zahtjevom 15, naznačen time, da je proliferativni poremećaj odabran iz skupine koju čine mezoteliom, rak mjehura, rak gušterače, rak kože, rak glave ili vrata, kožni ili intraokularni melanom, rak jajnika, rak dojke, rak maternice, rak jajovoda, rak endometrija, rak grlića maternice, rak vagine, rak vulve, rak kostiju, rak grlića maternice, rak debelog crijeva, rak rektuma, rak analnog područja, rak želuca, gastrointestinalni rak (rak želuca, kolorektalni rak i rak dvanaesnika), kronična limfocitna leukemija, akutna limfocitna leukemija, rak jednjaka, rak tankog crijeva, rak endokrinog sustava, rak tiroidne žlijezde, rak paratiroidne žlijezde, rak nadbubrežne žlijezde, sarkom mekog tkiva, rak uretre, rak penisa, rak testisa, hepatocelularni rak (jetre i žučnih kanala), primarni ili sekundarni tumor centralnog živčanog sustava, primarni ili sekundarni tumor mozga, Hodgkinova bolest, kronična ili akutna leukemija, kronična mijeloična leukemija, limfocitni limfom, limfoblastična leukemija, folikularni limfom, limfoidne maligne bolesti uzrokovane T-stanicama ili B-stanicama, melanom, višestruki mijelom, rak usne šupljine, rak jajnika, rak ne-malih stanica pluća, rak prostate, rak malih stanica pluća, rak bubrega i mokraćovoda, rak bubrežnih stanica, rak bubrežne čašice, neoplazam središnjeg živčanog sustava, primarni limfom centralnog živčanog sustava, ne-Hodgkinov limfom, tumori spinalne osi, gliom moždanog stabla, adenom hipofize, rak ovojnice nadbubrežne žlijezde, rak žučnog mjehura, rak slezene, kolangiokarcinom, fibrosarkom, neuroblastom, retinoblastom i njihove kombinacije.
17. Postupak za pripravu farmaceutskog oblika doziranja koji sadržava proizvod u obliku čvrste disperzije u skladu s patentnim zahtjevom 1, naznačen time, da obuhvaća: (a) pripremu homogene taline farmaceutski aktivnog sastojka ili njegove soli ili hidrata, najmanje jednog farmaceutski prihvatljivog polimera koji sadržava homopolimer ili kopolimer N-vinil pirolidona i najmanje jedan solubilizator koji sadržava tokoferilni spoj s polialkilen glikolnom skupinom, navedeni farmaceutski aktivni sastojak je N-(4-(4-((2-(4-klorfenil)-5,5- dimetil-l-cikloheks-l-en-l-il)metil)piperazin-l-il)benzoil)-4-(((lR)-3-(morfolin-4-il)-l-((fenilsulfanil)metil)propil)amino)-3-((trifluorometil)sulfonil)benzensulfonamid ili njegova sol ili hidrat i (b) ostavljanje taline da se skrutne kako bi se dobio kruti disperzijski produkt.
18. Postupak u skladu s patentnim zahtjevom 17, naznačen time, da nadalje obuhvaća mljevenje navedenog proizvoda u obliku čvrste disperzije i komprimiranje navedenog proizvoda u obliku čvrste disperzije u tabletu ili punjenje navedenog krutog disperzijskog produkta u čahuru kapsule.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US18513009P | 2009-06-08 | 2009-06-08 | |
| EP15184904.9A EP2982366B1 (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 |
|---|---|
| HRP20171902T1 true HRP20171902T1 (hr) | 2018-01-26 |
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Family Applications (2)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20151342TT HRP20151342T1 (hr) | 2009-06-08 | 2010-06-08 | Farmaceutski oblik doziranja za oralnu primjenu inhibitora iz obitelji bcl-2 |
| HRP20171902TT HRP20171902T1 (hr) | 2009-06-08 | 2017-12-07 | Farmaceutski oblik za doziranje za oralnu primjenu inhibitora iz obitelji bcl-2 |
Family Applications Before (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| HRP20151342TT HRP20151342T1 (hr) | 2009-06-08 | 2010-06-08 | Farmaceutski oblik doziranja za oralnu primjenu inhibitora iz obitelji bcl-2 |
Country Status (37)
| Country | Link |
|---|---|
| US (6) | US9642796B2 (hr) |
| EP (3) | EP2440177B1 (hr) |
| JP (2) | JP5872459B2 (hr) |
| KR (2) | KR101751216B1 (hr) |
| CN (2) | CN106074391A (hr) |
| AR (2) | AR077021A1 (hr) |
| AU (1) | AU2010258367B2 (hr) |
| BR (2) | BR122018076978B1 (hr) |
| CA (1) | CA2763441C (hr) |
| CL (1) | CL2011003054A1 (hr) |
| CO (1) | CO6480964A2 (hr) |
| CR (1) | CR20170037A (hr) |
| CY (1) | CY1119663T1 (hr) |
| DK (2) | DK2440177T3 (hr) |
| DO (2) | DOP2011000375A (hr) |
| EC (1) | ECSP12011580A (hr) |
| ES (2) | ES2551860T3 (hr) |
| HR (2) | HRP20151342T1 (hr) |
| HU (2) | HUE025638T2 (hr) |
| IL (2) | IL216494A (hr) |
| LT (1) | LT2982366T (hr) |
| MX (1) | MX2011013164A (hr) |
| MY (1) | MY159824A (hr) |
| NO (1) | NO2982366T3 (hr) |
| NZ (1) | NZ597241A (hr) |
| PE (2) | PE20121084A1 (hr) |
| PL (2) | PL2440177T3 (hr) |
| PT (2) | PT2440177E (hr) |
| RU (2) | RU2711359C2 (hr) |
| SG (1) | SG176264A1 (hr) |
| SI (2) | SI2440177T1 (hr) |
| SM (1) | SMT201500317B (hr) |
| TW (2) | TWI540132B (hr) |
| UA (1) | UA104471C2 (hr) |
| UY (1) | UY32695A (hr) |
| WO (1) | WO2010143074A2 (hr) |
| ZA (1) | ZA201108853B (hr) |
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| KR20130109092A (ko) | 2010-06-09 | 2013-10-07 | 아보트 러보러터리즈 | 키나제 억제제를 함유하는 고체 분산물 |
| 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 | |
| SG10201801794WA (en) * | 2010-10-29 | 2018-04-27 | Abbvie Inc | Solid dispersions containing an apoptosis-inducing agent |
| MY165884A (en) | 2010-11-23 | 2018-05-18 | Abbvie Ireland Unlimited Co | Methods of treatment using selective bcl-2 inhibitors |
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| WO2014160071A1 (en) * | 2013-03-14 | 2014-10-02 | St. Jude Children's Research Hospital | Methods and compositions for the treatment of glutamine-addicted cancers |
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| CN113925833A (zh) | 2016-02-29 | 2022-01-14 | 豪夫迈·罗氏有限公司 | 包含酪氨酸蛋白激酶抑制剂的剂型组合物 |
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| EP4110298A1 (en) * | 2020-02-24 | 2023-01-04 | Guangzhou Lupeng Pharmaceutical Company Ltd. | Hot melt extruded solid dispersions containing a bcl2 inhibitor |
| JP2023551056A (ja) * | 2020-11-25 | 2023-12-06 | アセンテージ ファーマ（スーチョウ）カンパニー，リミティド | 固体分散体、医薬製剤、その製造方法及び応用 |
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