ME02942B - Kruta disperzija dobivena ekstruzijom u rastaljenom stanju koja sadržava agens za induciranje apoptoze - Google Patents

Kruta disperzija dobivena ekstruzijom u rastaljenom stanju koja sadržava agens za induciranje apoptoze

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Publication number
ME02942B
ME02942B MEP-2017-299A MEP29917A ME02942B ME 02942 B ME02942 B ME 02942B ME P29917 A MEP29917 A ME P29917A ME 02942 B ME02942 B ME 02942B
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Montenegro
Prior art keywords
pharmaceutically acceptable
cancer
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MEP-2017-299A
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English (en)
French (fr)
Inventor
Esther RÖSCH
David J Lindley
Yeshwant D Sanzgiri
Ping Tong
Peter Hoelig
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Abbvie Ireland Unlimited Co
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Publication of ME02942B publication Critical patent/ME02942B/me

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Claims (37)

1. Kruta disperzija, naznačena time, da sadržava, uglavnom u nekristalnom obliku, tako da se analizom rentgenske difrakcije ne opaža više od oko 5 % kristalnosti, spoj formule I<!--[if gte vml 1]><v:shapetype id="_x0000_t75" coordsize="21600,21600" o:spt="75" o:preferrelative="t" path="m@4@5l@4@11@9@11@9@5xe" filled="f" stroked="f"> <v:stroke joinstyle="miter"/> <v:formulas> <v:f eqn="if lineDrawn pixelLineWidth 0"/> <v:f eqn="sum @0 1 0"/> <v:f eqn="sum 0 0 @1"/> <v:f eqn="prod @2 1 2"/> <v:f eqn="prod @3 21600 pixelWidth"/> <v:f eqn="prod @3 21600 pixelHeight"/> <v:f eqn="sum @0 0 1"/> <v:f eqn="prod @6 1 2"/> <v:f eqn="prod @7 21600 pixelWidth"/> <v:f eqn="sum @8 21600 0"/> <v:f eqn="prod @7 21600 pixelHeight"/> <v:f eqn="sum @10 21600 0"/> </v:formulas> <v:path o:extrusionok="f" gradientshapeok="t" o:connecttype="rect"/> <o:lock v:ext="edit" aspectratio="t"/></v:shapetype><v:shape id="_x0000_i1025" type="#_x0000_t75" style='width:202.5pt; height:116.25pt'> <v:imagedata src="file:///C:\Users\NATASA~1.VUK\AppData\Local\Temp\msohtmlclip1\01\clip_image001.emz" o:title=""/></v:shape><![endif]--><!--[if !vml]--><!--[endif]-->pri čemu:R0 je klor;R1 i R2 su H;R3 i R4 su metil;A1 je N i A2 je CH;R5 je nitro;X je -NH-;Y je -(CH2)n- pri čemu je n = 1; iR6 je odabran iz skupine koju čine tetrahidropiranil i 4-hidroksi-4-metilcikloheksil;ilinjegove farmaceutski prihvatljive soli; pri čemu je spoj Formule I ili njegovafarmaceutski prihvatljiva sol dispergiran u krutoj matrici koja sadržava (a)najmanje jedan farmaceutski prihvatljiv polimerni nosač topljiv u vodi i (b)barem jedan farmaceutski prihvatljiv surfaktant; pri čemu je spoj ili njegovafarmaceutski prihvatljiva sol prisutan u ekvivalentnoj količini od oko 5 % dooko 15 % težinskog udjela, barem jedan farmaceutski prihvatljiv polimerni nosačtopljiv u vodi prisutan je u količini od oko 70 % do oko 85 % težinskog udjelai najmanje jedan farmaceutski prihvatljiv surfaktant, koji je prisutan ukoličini od oko 5 % do oko 15 % težinskog udjela.
2. Čvrsta disperzija u skladu s patentnim zahtjevom 1, naznačena time, da je spoj Formule I 4-(4-{[2-(4-klorfenil)-4,4-dimetilcikloheks-1-en-1-il]metil}piperazin-1-il)-N-({3-nitro-4-[(tetrahidro-2H-piran-4-ilmetil)amino]fenil}sulfonil)-2-(1H-pirolo[2,3-b]piridin-5-iloksi)benzamid ili njegova farmaceutski prihvatljiva sol.
3. Čvrsta disperzija u skladu s patentnim zahtjevom 1, naznačena time, da je spoj Formule I 4-(4-{[2-(4-klorfenil)-4,4-dimetilcikloheks-1-en-1-il]metil}piperazin-1-il)-N-[(4-{[(trans-4-hidroksi-4-metilcikloheksil)metil]amino}-3-nitrofenil)sulfonil]-2-(1H-pirolo[2,3-b]piridin-5-iloksi)benzamid ili njegova farmaceutski prihvatljiva sol. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
4. Čvrsta disperzija u skladu s patentnim zahtjevom 1, naznačena time, da je spoj Formule I 4-(4-{[2-(4-klorfenil)-4,4-dimetilcikloheks-1-en-1-il]metil}piperazin-il)-N-[(4-{[(cis-4-hidroksi-4-metilcikloheksil)metil]amino}-3-nitrofenil)sulfonil]-2-(1H-pirolo[2,3-b]piridin-5-iloksi)benzamid ili njegova farmaceutski prihvatljiva sol. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
5. Čvrsta disperzija u skladu s patentnim zahtjevom 1, naznačena time, da je najmanje jedan farmaceutski prihvatljiv polimerni nosač topljiv u vodi kopovidon.
6. Čvrsta disperzija u skladu s patentnim zahtjevom 5, naznačena time, da je najmanje jedan farmaceutski prihvatljiv surfaktant polisorbat. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
7. Čvrsta disperzija u skladu s patentnim zahtjevom 6, naznačena time, da nadalje sadržava najmanje jedan lubrikant. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
8. Čvrsta disperzija u skladu s patentnim zahtjevom 7, naznačena time, da najmanje jedan lubrikant sadržava koloidni silicijev dioksid. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
9. Postupak za pripravu krute disperzije, naznačen time, da obuhvaća: (a) podvrgavanje povišenoj temperaturi (i) aktivnog farmaceutskog sastojka (API) koji je spoj Formule Ipri čemu: R0 je klor; R1 i R2 su H; R3 i R4 su metil; A1 je N i A2 je CH; R5 je nitro; X je -NH-; Y je -(CH2)n- pri čemu je n 1; i R6 je odabran iz skupine koju čine tetrahidropiranil i 4-hidroksi-4-metilcikloheksil; ili njegove farmaceutski prihvatljive soli, (ii) farmaceutski prihvatljiv polimerni nosač koji je topljiv u vodi i (iii) farmaceutski prihvatljiv surfaktant, čime se dobiva polukrutina koja se može obrađivati ekstruzijom; (b) ekstruziju polukrute smjese; i (c) hlađenje dobivenog ekstrudata radi dobivanja čvrste matrice koja sadržava farmaceutski prihvatljiv polimerni nosač topljiv u vodi i farmaceutski prihvatljiv surfaktant, u kojem su spoj Formule I ili njegova farmaceutski prihvatljivu sol dispergirani u njegovom uglavnom nekristalnom obliku, tako da se analizom rentgenske difrakcije ne opaža više od oko 5 % kristalnosti.
10. Postupak u skladu s patentnim zahtjevom 9, naznačen time, da nadalje obuhvaća korak miješanja API-ja, farmaceutski prihvatljivog polimernog nosača topljivog u vodi i farmaceutski prihvatljivog surfaktanta prije navedenog koraka podvrgavanja povišenoj temperaturi; ili nadalje obuhvaća korak miješanja API-ja, farmaceutski prihvatljivog polimernog nosača topljivog u vodi i farmaceutski prihvatljivog surfaktanta tijekom navedenog koraka podvrgavanja povišenoj temperaturi. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
11. Postupak u skladu s patentnim zahtjevom 9, naznačen time, da je navedena povišena temperatura od oko 70 °C do oko 250 °C ili od oko 90 °C do oko 160 °C. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
12. Postupak u skladu s patentnim zahtjevom 9, naznačen time, da nadalje sadržava korak kalendriranja ekstrudata prije ili tijekom navedenog koraka hlađenja.
13. Postupak u skladu s patentnim zahtjevom 12, naznačen time, da se korak kalendriranja ekstrudata provodi prije navedenog koraka hlađenja.
14. Postupak u skladu s patentnim zahtjevom 13, naznačen time, da je API 4-(4-{[2-(4-klorfenil)-4,4-dimetilcikloheks-1-en-1-il]metil}piperazin-1-il)-N-({3-nitro-4-[(tetrahidro-2H-piran-4-ilmetil)amino]fenil}sulfonil)-2-(1H-pirolo[2,3-b]piridin-5-iloksi)benzamid ili njegova farmaceutski prihvatljive soli. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
15. Postupak u skladu s patentnim zahtjevom 9, naznačen time, da je API 4-(4-{[2-(4-klorfenil)-4,4-dimetilcikloheks-1-en-1-il]metil}piperazin-1-il)-N-[(4-{[(trans-4-hidroksi-4-metilcikloheksil)metil]amino }-3-nitrofenil)sulfonil]-2-(1H-pirolo[2,3-b]piridin-5-iloksi)benzamid ili njegova farmaceutski prihvatljiva sol. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
16. Postupak u skladu s patentnim zahtjevom 9, naznačen time, da je API 4-(4-{[2-(4-klorfenil)-4,4-dimetilcikloheks-1-en-1-il] metil}piperazin-1-il)-N-[(4-{[(cis-4-hidroksi-4-metilcicloheksil)metil]amino}-3-nitrofenil)sulfonil]-2-(1H-pirolo[2,3-b]piridin-5-iloksi)benzamid ili njegova farmaceutski prihvatljiva sol. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
17. Postupak u skladu s patentnim zahtjevom 14, naznačen time, da je farmaceutski prihvatljiv polimerni nosač topljiv u vodi kopovidon. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
18. Postupak u skladu s patentnim zahtjevom 14, naznačen time, da je farmaceutski prihvatljiv surfaktant polisorbat. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
19. Farmaceutski oblik doziranja za oralnu primjenu, naznačen time, da sadržava krutu disperziju koja sadržava uglavnom nekristalni oblik, tako da se analizom rentgenske difrakcije ne opaža više od oko 5 % kristalnosti, spoj Formule I <!--[if gte vml 1]><v:shapetype id="_x0000_t75" coordsize="21600,21600" o:spt="75" o:preferrelative="t" path="m@4@5l@4@11@9@11@9@5xe" filled="f" stroked="f"> <v:stroke joinstyle="miter"/> <v:formulas> <v:f eqn="if lineDrawn pixelLineWidth 0"/> <v:f eqn="sum @0 1 0"/> <v:f eqn="sum 0 0 @1"/> <v:f eqn="prod @2 1 2"/> <v:f eqn="prod @3 21600 pixelWidth"/> <v:f eqn="prod @3 21600 pixelHeight"/> <v:f eqn="sum @0 0 1"/> <v:f eqn="prod @6 1 2"/> <v:f eqn="prod @7 21600 pixelWidth"/> <v:f eqn="sum @8 21600 0"/> <v:f eqn="prod @7 21600 pixelHeight"/> <v:f eqn="sum @10 21600 0"/> </v:formulas> <v:path o:extrusionok="f" gradientshapeok="t" o:connecttype="rect"/> <o:lock v:ext="edit" aspectratio="t"/> </v:shapetype><v:shape id="_x0000_i1025" type="#_x0000_t75" style='width:175.5pt; height:101.25pt'> <v:imagedata src="file:///C:\Users\NATASA~1.VUK\AppData\Local\Temp\msohtmlclip1\01\clip_image001.emz" o:title=""/> </v:shape><![endif]--><!--[if !vml]--><!--[endif]--> pri čemu: R0 je klor; R1 i R2 su H; R3 i R4 su metil; A1 je N i A2 je CH; R5 je nitro; X je -NH-; Y je -(CH2)n- pri čemu je n 1; i R6 je odabran iz skupine koju čine tetrahidropiranil i 4-hidroksi-4-metilcikloheksil ili njegove farmaceutski prihvatljive soli; dispergiran u krutoj matrici koja sadržava (a) najmanje jedan farmaceutski prihvatljiv polimerni nosač topljiv u vodi i (b) najmanje jedan farmaceutski prihvatljiv surfaktant; pri čemu je spoj ili njegova farmaceutski prihvatljiva sol prisutan u ekvivalentnoj količini od oko 5 % do oko 15 % težinskog udjela, barem jedan farmaceutski prihvatljiv polimerni nosač topljiv u vodi je prisutan u količini od oko 70 % do oko 85 % težinskog udjela i najmanje jedan farmaceutski prihvatljiv surfaktant prisutan u količini od oko 5 % do oko 15 % težinskog udjela.
20. Farmaceutski oblik doziranja za oralnu primjenu u skladu s patentnim zahtjevom 19, naznačen time, da kruti disperzijski pripravak sadržava 4-(4-{[2-(4-klorfenil)-4,4-dimetilcikloheks-1-en-1-il]metil}piperazin-1-il)-N-({3-nitro-4-[(tetrahidro-2H-piran-4-ilmetil)amino]fenil}sulfonil)-2-(1H-pirolo[2,3-b]piridin-5- iloksi)benzamid ili njegovu farmaceutski prihvatljivu sol. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
21. Farmaceutski oblik doziranja za oralnu primjenu u skladu s patentnim zahtjevom 19, naznačen time, da kruti disperzijski pripravak sadržava 4-(4-{[2-(4-klorfenil)-4,4-dimetilcikloheks-1-en-1-il]metil}piperazin-1-il)-N-[(4-{[(trans-4-hidroksi-4-metilcikloheksil)metil]amino}-3- nitrofenil)sulfonil]-2-(1H-pirolo[2,3-b]piridin-5-iloksi)benzamid ili njegovu farmaceutski prihvatljivu sol. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
22. Farmaceutski oblik doziranja za oralnu primjenu u skladu s patentnim zahtjevom 19, naznačen time, da kruti disperzijski pripravak sadržava 4-(4-{[2-(4-klorfenil)-4,4-dimetilcikloheks-1-en-1-il]metil}piperazin-1-il)-N-[(4-[(cis-4-hidroksi-4-metilcikloheksil)metil]amino}-3-nitrofenil)sulfonil]-2-(1H-pirolo[2,3- b]piridin-5-iloksi)benzamid ili njegovu farmaceutski prihvatljivu sol. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
23. Farmaceutski oblik doziranja za oralnu primjenu u skladu s patentnim zahtjevom 19, naznačen time, da je barem jedan farmaceutski prihvatljiv polimerni nosač kopovidon, a barem jedan surfaktant polisorbat. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
24. Farmaceutski oblik doziranja za oralnu primjenu u skladu s patentnim zahtjevom 19, naznačen time, da je oblik doziranja kapsula. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
25. Farmaceutski oblik doziranja za oralnu primjenu u skladu s patentnim zahtjevom 19, naznačen time, da je oblik za doziranje tableta.
26. Farmaceutski oblik doziranja za oralnu primjenu u skladu s patentnim zahtjevom 19, naznačen time, da je jedinična doza spoja Formule I između 10 mg i 1000 mg. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
27. Kruta disperzija u skladu s patentnim zahtjevom 1, naznačena time, da se koristi kao lijek
28. Kruta disperzija u skladu s patentnim zahtjevom 27, naznačena time, da se koristi za liječenje neoplastične, imune ili autoimune bolesti. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
29. Kruta disperzija za uporabu u skladu s patentnim zahtjevom 28, naznačena time, da se koristi za liječenje neoplastične bolesti izabrane iz skupine koju čine rak, mezoteliom, rak mokraćnog mjehura, rak gušterače, rak kože, rak glave ili vrata, kožni ili intraokularni melanom, rak jajnika, rak dojke, rak maternice, karcinom jajovoda, karcinom endometrija, karcinom cerviksa, karcinom vagine, karcinom vulve, rak kostiju, rak debelog crijeva, rak rektuma, rak analnog područja, rak želuca, gastrointestinalni rak (želuca, kolorektalni i / ili duodenalni), kronična limfocitna leukemija, akutna limfocitna leukemija, rak jednjaka, rak tankog crijeva, rak endokrinog sustava, rak štitne žlijezde, rak paratiroidnih žlijezda, rak nadbubrežne žlijezde, sarkoma mekog tkiva, rak uretre, rak penisa, rak testisa, hepatocelularni rak (hepatičnog i / ili žučnog kanala), primarni ili sekundarni tumor središnjeg živčanog sustava, primarni ili sekundarni tumor mozga, Hodgkinova bolest, kronična ili akutna leukemija, kronična mijeloidna leukemija, limfocitni limfom, limfoblastična leukemija, folikularni limfom, limfoidni malignitet uzrokovan T-stanicama ili B-stanicama, melanom, multipli mijelom, oralni karcinom, rak ne-malih stanica pluća, rak prostate, rak malih stanica pluća, karcinom bubrega i / ili uretera, karcinom bubrežnih stanica, karcinom bubrežne zdjelice, neoplazam središnjeg živčanog sustava, primarni limfom središnjeg živčanog sustava, ne-Hodgkinov limfom, tumor kralježnice, gliom moždanog debla, adenom hipofize, adrenokortikalni rak, rak žučnog mjehura, raka slezene, kolangiokarcinom, fibrosarkom, neuroblastom, retinoblastom i njihovih kombinacija. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
30. Kruta disperzija za uporabu u skladu s patentnim zahtjevom 29, naznačena time, da je neoplastična bolest ne-Hodgkinov limfom. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
31. Kruta disperzija za uporabu u skladu s patentnim zahtjevom 29, naznačena time, da je neoplastična bolest kronična limfocitna leukemija ili akutna limfocitna leukemija. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
32. Kruta disperzija u skladu s patentnim zahtjevom 28, naznačena time, da se koristi za liječenje imune ili autoimune bolesti. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
33. Kruta disperzija za uporabu u skladu s patentnim zahtjevom 28, naznačena time, da je kruta disperzija namijenjena za davanje u ekvivalentnoj dozi matičnog spoja od oko 50 do oko 500 mg na dan spoja Formule I ili njegove farmaceutski prihvatljive soli pri prosječnom trajanju tretmana od oko 3 sata do oko 7 dana; ili pri čemu je kruta disperzija namijenjena za davanje u ekvivalentnoj dozi matičnog spoja od oko 50 do oko 500 mg na dan spoja Formule I ili njegove farmaceutski prihvatljive soli. <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
34. Kruta disperzija u skladu s patentnim zahtjevom 2, naznačena time, da nadalje sadržava: između 0,1 % i 2 % težinskih udjela koloidnog silicijevog dioksida.
35. Kruta disperzija u skladu s patentnim zahtjevom 34, naznačena time, da sadržava: između 5 % i 12 % težinskih udjela 4-(4-{[2-(4-klorfenil)-4,4-dimetilcikloheks-1-en-1-il]metil}piperazin-1-il)-N-({3-nitro-4-[(tetrahidro-2H-piran-4-ilmetil)amino]fenil}sulfonil)-2-(1H-pirolo[2,3-b]piridin-5-iloksi)benzamid ili njegovu farmaceutski prihvatljivu sol u količini koja je ekvivalentna matičnom spoju. <!--[if !supportLineBreakNewLine]--> <!--[endif]--> <!--[if !supportLineBreakNewLine]--> <!--[endif]-->
36. Kruta disperzija u skladu s patentnim zahtjevom 35, naznačena time, da je polimerni nosač kopovidon, surfaktant je polisorbat, a lubrikant je koloidni silicijev dioksid.
37. Kruta disperzija u skladu s patentnim zahtjevom 35, naznačena time, da sadržava: 12 težinskih udjela aktivnog farmaceutskog sastojka (API) koji sadržava 4-(4-{[2-(4-klorfenil)-4,4-dimetilcikloheks-1-en-1-il]metil}piperazin-1-il)-N-({3-nitro-4-[(tetrahidro-2H-piran-4-ilmetil)amino]fenil}sulfonil)-2-(1H-pirolo[2,3-b]piridin-5-iloksi)benzamid ili njegovu farmaceutski prihvatljivu sol u količini koja je ekvivalentna matičnom spoju; 80 težinskih udjela kopovidona 60/40; 7 težinskih udjela polisorbata 80; i 1 težinski udio koloidnog silicijevog dioksida.
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