HRP20190733T1 - Formulacije (s)-3-(4-((4-(morfolinometil)benziloksi)-1-oksoizoindolin-2-il)piperidin-2,6-diona - Google Patents

Formulacije (s)-3-(4-((4-(morfolinometil)benziloksi)-1-oksoizoindolin-2-il)piperidin-2,6-diona Download PDF

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HRP20190733T1
HRP20190733T1 HRP20190733TT HRP20190733T HRP20190733T1 HR P20190733 T1 HRP20190733 T1 HR P20190733T1 HR P20190733T T HRP20190733T T HR P20190733TT HR P20190733 T HRP20190733 T HR P20190733T HR P20190733 T1 HRP20190733 T1 HR P20190733T1
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cancer
dosage form
amount
disease
lactose
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HRP20190733TT
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Darshan PARIKH
Anil Menon
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Celgene Corporation
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Claims (15)

1. Oralni oblik doziranja u obliku kapsule naznačen time što sadrži: 1) spoj A sa sljedećom strukturom: ili njegovu farmaceutski prihvatljivu sol, hidrat, stereoizomer, tautomer ili njihove racemične smjese, u količini od oko 0,1 do oko 3 težinska postotka ukupne težine oblika za doziranje; 2) nosač ili pomoćnu tvar u količini od oko 90 do 99,9 težinskih postotaka ukupne težine oralnog oblika za doziranje, pri čemu je nosač ili pomoćna tvar smjesa škroba i laktoze; i 3) sredstvo za povećanje skliskosti, pri čemu je sredstvo za povećanje skliskosti stearinska kiselina.
2. Oralni oblik doziranja prema zahtjevu 1, naznačen time što je spoj A prisutan u količini od oko 0,1 do oko 1 težinskog postotka ukupne težine oblika za doziranje; proizvoljno pri čemu je nosač ili pomoćna tvar prisutna u količini od oko 95 do oko 99,9 težinskih postotaka ukupne težine oblika za doziranje; ili pri čemu težinski omjer laktoze prema škrobu u oralnom obliku za doziranje iznosi od oko 1:1 do oko 5:1; naročito je težinski omjer laktoze prema škrobu u oralnom obliku za doziranje oko 3:1; ili pri čemu je škrob preželatinizirani škrob; ili pri čemu laktoza je bezvodna laktoza; ili pri čemu je sredstvo za povećanje skliskosti prisutno u količini od 0,01 do 1 težinskog postotka ukupne težine oblika za doziranje; naročito pri čemu je sredstvo za povećanje skliskosti prisutno u količini od 0,1 do 0,5 težinskih postotaka ukupne težine oblika za doziranje.
3. Oralni oblik doziranja prema zahtjevu 1, naznačen time što teži oko 75 mg i sadrži: 1) spoj A sa sljedećom strukturom: ili njegovu farmaceutski prihvatljivu sol, hidrat, stereoizomer, tautomer ili njihove racemične smjese, u količini koja osigurava 0,3 mg potentnosti spoja A; 2) farmaceutski prihvatljiv nosač ili pomoćnu tvar, pri čemu je nosač ili pomoćna tvar smjesa škroba i laktoze; i 3) sredstvo za povećanje skliskosti, pri čemu je sredstvo za povećanje skliskosti stearinska kiselina.
4. Oblik doziranja prema zahtjevu 3, naznačen time što je škrob preželatinizirani škrob, proizvoljno pri čemu je preželatinizirani škrob prisutan u količini od oko 18,075 mg; ili pri čemu je stearinska kiselina prisutna u količini od oko 0,225 mg, ili pri čemu laktoza je bezvodna laktoza, proizvoljno pri čemu je bezvodna laktoza prisutna u količini koja daje ukupnu težinu pripravka od oko 75 mg, ili koji je u obliku kapsule veličine 4 ili veće kapsule.
5. Oralni oblik doziranja prema zahtjevu 1, naznačen time što teži oko 75 mg i sadrži: 1) spoj A sa sljedećom strukturom: ili njegovu farmaceutski prihvatljivu sol, hidrat, stereoizomer, tautomer ili njihove racemične smjese, u količini koja osigurava 0,1 mg potentnosti spoja A; 2) farmaceutski prihvatljiv nosač ili pomoćnu tvar, pri čemu je nosač ili pomoćna tvar smjesa škroba i laktoze; i 3) sredstvo za povećanje skliskosti, pri čemu je sredstvo za povećanje skliskosti stearinska kiselina.
6. Oblik doziranja prema zahtjevu 5, naznačen time što je škrob preželatinizirani škrob, proizvoljno pri čemu je preželatinizirani škrob prisutan u količini od oko 18,75 mg, ili pri čemu je stearinska kiselina prisutna u količini od oko 0,225 mg, ili pri čemu laktoza je bezvodna laktoza, proizvoljno pri čemu je bezvodna laktoza prisutna u količini koja daje ukupnu težinu pripravka od oko 75 mg, ili koji je u obliku kapsule veličine 4 ili veće kapsule.
7. Oralni oblik doziranja prema zahtjevu 1, naznačen time što teži oko 150 mg i sadrži: 1) spoj A sa sljedećom strukturom: ili njegovu farmaceutski prihvatljivu sol, hidrat, stereoizomer, tautomer ili njihove racemične smjese, u količini koja osigurava 0,2 mg potentnosti spoja A; 2) farmaceutski prihvatljiv nosač ili pomoćnu tvar, pri čemu je nosač ili pomoćna tvar smjesa škroba i laktoze; i 3) sredstvo za povećanje skliskosti, pri čemu je sredstvo za povećanje skliskosti stearinska kiselina.
8. Oblik doziranja prema zahtjevu 7, naznačen time što je škrob preželatinizirani škrob, proizvoljno pri čemu je preželatinizirani škrob prisutan u količini od oko 37,5 mg, ili pri čemu je stearinska kiselina prisutna u količini od oko 0,45 mg, ili pri čemu je laktoza bezvodna laktoza, proizvoljno pri čemu je bezvodna laktoza prisutna u količini koja daje ukupnu težinu pripravka od oko 150 mg, ili koji je u obliku kapsule veličine 3 ili veće kapsule.
9. Oralni oblik doziranja prema zahtjevu 1, naznačen time što teži oko 125 mg i sadrži: 1) spoj A sa sljedećom strukturom: ili njegovu farmaceutski prihvatljivu sol, hidrat, stereoizomer, tautomer ili njihove racemične smjese, u količini koja osigurava 0,5 mg potentnosti spoja A; 2) farmaceutski prihvatljiv nosač ili pomoćnu tvar, pri čemu je nosač ili pomoćna tvar smjesa škroba i laktoze; i 3) sredstvo za povećanje skliskosti, pri čemu je sredstvo za povećanje skliskosti stearinska kiselina.
10. Oblik doziranja prema zahtjevu 9, naznačen time što je škrob preželatinizirani škrob, proizvoljno pri čemu je preželatinizirani škrob prisutan u količini od oko 31,25 mg, ili pri čemu je stearinska kiselina prisutna u količini od oko 0,375 mg, ili pri čemu je laktoza bezvodna laktoza, proizvoljno pri čemu je bezvodna laktoza prisutna u količini koja daje ukupnu težinu pripravka od oko 125 mg, ili koji je u obliku kapsule veličine 3 ili veće kapsule.
11. Oralni oblik doziranja prema bilo kojem od zahtjeva 1 do 10, naznačen time što je za upotrebu u postupku za liječenje, prevenciju ili upravljanje bolešću ili poremećajem, pri čemu postupak sadrži davanje pacijentu oralnog oblika doziranja, pri čemu je bolest ili poremećaj rak, lupus, skleroderma, lupus pernio, sarkoidoza, Sjogrenov sindrom, ANCA-inducirani vaskulitis, antifosfolipidni sindrom, mijastenija gravis, Addisonova bolest, alopecija areata, ankilozantni spondilitis, sindrom antifosfolipidnog protutijela, antifosfolipidni sindrom, primarni ili sekundarni antifosfolipidni sindrom, astma, autoimuni gastritis, autoimuna hemolitička anemija, autoimuni hepatitis, autoimuna bolest unutarnjeg uha, autoimuna limfoproliferativna bolest, autoimuna trombocitopenijska purpura, Balo bolest, Behcetova bolest, bulozni pemfigoid, kardiomiopatija, celijakija, Chagasova bolest, kronična upalna demijelinacijska polineuropatija, ožiljkasti pemfigoid, naročito pemfigoid sluznice, bolest hladnih aglutinina, Degosova bolest, dermatitis hepatiformis, esencijalna miješana krioglobulinemija, Goodpastureov sindrom, Gravesova bolest, Guillain-Barreov sindrom, Hashimotov tireoiditis (Hashimotova bolest; autoimuni tiroditis), idiopatska plućna fibroza, idiopatska trombocitopenija purpura, IgA nefropatija, juvenilni artritis, lichen planus, Menierova bolest, mješovita bolest vezivnog tkiva, morfea, narkolepsija, neuromiotonija, pedijatrijski autoimuni neuropsihijatrijski poremećaji (PANDA), pemfigus vulgaris, perniciozna anemija, poliarteritis nodoza, polihondritis, polimialgija reumatika, primarna agamaglobulinemija, primarna bilijarna ciroza, Rainaudova bolest (Rainaudov fenomen), Reiterov sindrom, recidivirajući polihondritis, reumatska groznica, Sjogrenov sindrom, sindrom ukočene osobe (Moersch-Woltmannov sindrom), Takayasuov arteritis, temporalni arteritis (arteritis divovskih stanica), uveitis, vaskulitis, naročito vaskulitis koji nije povezan s eritemskim lupusom, vitiligo ili Wegenerova granulomatoza.
12. Oralni oblik doziranja prema bilo kojem od zahtjeva 1 do 10 za upotrebu prema zahtjevu 11, naznačen time što je bolest ili poremećaj rak, te pri čemu je rak napredujuća maligna bolest, amiloidoza, neuroblastom, meningiom, hemangiopericitom, višestruke moždane metastaze, multiformni glioblastom, glioblastom, gliom moždanog stabla, maligni tumor mozga s lošom prognozom, maligni gliom, anaplastični astrocitom, anaplastični oligodendrogliom, neuroendokrini tumor, rektalni adenokarcinom, rak debelog crijeva Dukes C i D, neodstranjivi kolorektalni karcinom, metastatski hepatocelularni karcinom, Kaposijev sarkom, kariotip akutne mijeloblastne leukemije, Hodgkinov limfom, ne-Hodgkinov limfom, kožni T-stanični limfom, kožni B-stanični limfom, difuzni limfom velikih B-stanica, folikularni limfom niskog stupnja, maligni melanom, maligni mezoteliom, sindrom malignog mezotelioma pleuralnog izljeva, peritonealni karcinom, papilarni serozni karcinom, ginekološki sarkom, sarkom mekog tkiva, sklerodermija, kožni vaskulitis, histiocitoza Langerhansovih stanica, leiomiosarkom, fibrodysplasia ossificans progressiva, rak prostate refraktoran na hormone, operabilni visokorizični sarkom mekog tkiva, neoperabilni hepatocelularni karcinom, Waldenstromova makroglobulinemija, tinjajući mijelom, indolentni mijelom, rak jajovoda, androgen-neovisni karcinom prostate, androgen ovisni ne-metastazirajući rak prostate stupanj IV, rak prostate koji nije osjetljiv na hormone, rak prostate koji nije osjetljiv na kemoterapiju, papilarni karcinom štitnjače, folikularni karcinom štitnjače, medularni karcinom štitnjače ili leiomiom.
13. Oralni oblik doziranja prema bilo kojem od zahtjeva 1 do 10 za upotrebu prema zahtjevu 11, naznačen time što je bolest ili poremećaj rak, te pri čemu je rak tumor koji se prenosi krvlju, proizvoljno pri čemu je rak mijelom, leukemija ili limfom, ili pri čemu je rak solidni tumor, proizvoljno pri čemu se rak odnosi na rak dojke, rak debelog crijeva, jajnika, prostate, rak gušterače ili rak bubrega, ili pri čemu je rak hepatocelularni karcinom, rak prostate, rak jajnika ili glioblastom, ili pri čemu je rak ne-Hodgkinov limfom, proizvoljno pri čemu je ne-Hodgkinov limfom difuzni limfom velikih B-stanica, naročito pri čemu je difuzni limfom velikih B-stanica aktiviranog fenotipa B-stanica, preciznije pri čemu se difuzni limfom velikih B-stanica odlikuje ekspresijom jednog ili više biomarkera koji su prekomjerno eksprimirani u staničnim lnijama RIVA, U2932, TMD8 ili OCI-Ly10; ili pri čemu je rak multipli mijelom.
14. Oralni oblik doziranja prema bilo kojem od zahtjeva 1 do 10 za upotrebu prema bilo kojem od zahtjeva 11 do 13, naznačen time što je rak relapsirajući ili refraktoran.
15. Oralni oblik doziranja prema bilo kojem od zahtjeva 1 do 10 za upotrebu prema bilo kojem od zahtjeva 11 do 14, naznačen time što je rak otporan na lijekove.
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