HRP20180328T1 - FARMACEUTSKI PRIPRAVAK N-[2,4-bis(1,1-DIMETILETIL)-5-HIDROKSIFENIL]-1,4-DIHIDRO-4-OKSOKINOLIN-3-KARBOKSAMIDA I NJEGOVO DAVANJE - Google Patents

FARMACEUTSKI PRIPRAVAK N-[2,4-bis(1,1-DIMETILETIL)-5-HIDROKSIFENIL]-1,4-DIHIDRO-4-OKSOKINOLIN-3-KARBOKSAMIDA I NJEGOVO DAVANJE Download PDF

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Publication number
HRP20180328T1
HRP20180328T1 HRP20180328TT HRP20180328T HRP20180328T1 HR P20180328 T1 HRP20180328 T1 HR P20180328T1 HR P20180328T T HRP20180328T T HR P20180328TT HR P20180328 T HRP20180328 T HR P20180328T HR P20180328 T1 HRP20180328 T1 HR P20180328T1
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Croatia
Prior art keywords
mass
disease
pharmaceutical preparation
preparation
tablet
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HRP20180328TT
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English (en)
Inventor
William Rowe
Patricia Hurter
Christopher Young
Kirk Dinehart
Marinus Jacobus Verwijs
Kirk Overhoff
Peter D. J. Grootenhuis
Martyn Botfield
Alfredo Grossi
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Vertex Pharmaceuticals Inc.
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First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41206223&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=HRP20180328(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Vertex Pharmaceuticals Inc. filed Critical Vertex Pharmaceuticals Inc.
Publication of HRP20180328T1 publication Critical patent/HRP20180328T1/hr

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    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1652—Polysaccharides, e.g. alginate, cellulose derivatives; Cyclodextrin
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
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    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
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Claims (13)

1. Farmaceutski pripravak u obliku tablete, naznačen time da sadrži a. 34.1 mas% krute disperzije, u odnosu na masu pripravka, pri čemu se navedena disperzija sastoji od 80 mas% u osnovi amorfnog, ili uglavnom amorfnog N-[2,4-bis(1,1-dimetiletil)-5-hidroksifenil]-1,4-dihidro-4-oksohinolin-3-karboksamida (spoj 1), u odnosu na masu disperzije, 19.5 mas% HPMCAS, u odnosu na masu disperzije, i 0.5 mas% SLS, u odnosu na masu disperzije; b. 30.5 mas% mikrokristalne celuloze, u odnosu na masu pripravka; c. 30.4 mas% laktoze, u odnosu na masu pripravka; d. 3 mas% natrijeve kroskarameloze, u odnosu na masu pripravka; e. 0.5 mas% SLS, u odnosu na masu pripravka; f. 0.5 mas% koloidnog silicijevog-dioksida, u odnosu na masu pripravka; i g. 1.0 mas% magnezijevog-stearata, u odnosu na masu pripravka.
2. Farmaceutski pripravak prema zahtjevu 1, naznačen time da navedeni farmaceutski pripravak predstavlja obložena tableta.
3. Farmaceutski pripravak prema zahtjevu 2, naznačen time da je navedena obložena tableta obojena.
4. Farmaceutski pripravak prema zahtjevu 1, naznačen time da farmaceutski pripravak predstavlja tableta koja je obložena sredstvom za bojenje, premazana voskom i zatim upotrebom pogodne tinte obilježena s nekim logom, nekim drugim simbolom i/ili tekstom.
5. Farmaceutski pripravak prema zahtjevu 1, naznačen time da navedena tableta sadrži 150 mg spoja 1.
6. Farmaceutski pripravak prema zahtjevu 1, naznačen time da navedena tableta sadrži 100 mg spoja 1.
7. Farmaceutski pripravak prema bilo kojem od zahtjeva 1 - 6, naznačen time da je za uporabu za liječenje ili smanjivanje ozbiljnosti bolesti kod pacijenta, pri čemu se navedena bolest bira od cistične fibroze, astme, KOPB izazvane pušenjem, kroničnog bronhitisa, rinosinusitisa, konstipacije, pankreatitisa, insuficijencije gušterače, neplodnosti muškarca izazvane kongenitalnom bilateralnom odsutnosti vas deferens (CBAVD), blage plućne bolesti, idiopatskog pankreatitisa, alergijske bronhopulmonalne aspergiloze (ABPA), bolesti jetre, nasljednog emfizema, nasljedne kemokromatoze, deficitarnosti koagulacije-fibrinolize, kao što je deficitarnost proteina C, tipa 1 hereditarnog angioedema, deficitarnosti obrade lipida, kao što je obiteljska hiperkolesterolemija, tip 1 kilomikronemije, abetalipoproteinemije, lizosomske bolesti nakupljanja, kao što je pseudo-Hurlerova bolest I-stanica, mukopolisaharidoze, Sandhof/Tay-Sachsova, Crigler-Najjarova tipa II, poliendokrinopatija/ hiperinzulinemija, dijabetes melitus, Laronovog dvarfizma, deficitarnost mijeloperoksidaze, primarni hipoparatiroidizam, melanom, glikanoza COG tipa 1, kongenitalni hipertiroidizam, osteogeneza imperfekta, nasljedna hipofibrinogenemija, deficitarnost ACT, dijabetes insipidus (DI), neurohipofizealni DI, nefrogeni DI, Charcot-Marie Toothov sindrom, Pelizaeus-Merzbacherova bolest, neurodegenerativne bolesti, kao što su Alzheimerova bolest, Parkinsonova bolest, amiotrofna lateralna skleroza, progresivna supranuklearna paraliza, Pickova bolest, nekoliko poliglutaminskih neuroloških poremećaja, kao što su Huntingtonova bolest, spinocerebelarna ataksija tipa I, spinalna i bulbarna mišićna atrofija, entatorubralna palidoluizianska atrofija i miotonična distrofija, kao i encefalopatije spužvastog oblika, kao što je hereditarna Creutzfeldt-Jakobova bolest (zbog nedostataka u obradi proteina priona), Fabryeva bolest, Gerstmann-Straussler Scheinkerov sindrom, KOPB, bolest suhog oka, ili Sjögrenova bolest, osteoporoza, osteopenija, Gorhamov sindrom, kloridne kanalopatije, kao što je kongenitalna miotonija (Thomson-ov i Beckerov oblik), Bartterov sindrom tipa III, Dentova bolest, hiperekpleksija, epilepsija, bolest lizosomske pohrane, Angelmanov sindrom i primarna cilijarna diskineza (PCD), naziv za hereditarne poremećaje strukture i/ili funkcije cilije, uključujući PCD sa situs inversus (također poznata kao Kartagenerov sindrom), PCD bez situs inversus i cilijarne aplazije.
8. Farmaceutski pripravak za uporabu prema zahtjevu 7, naznačen time da navedena bolest predstavlja cističnu fibrozu.
9. Farmaceutski pripravak za uporabu prema zahtjevu 7, naznačen time da navedeni pacijent ima receptor transmembranske cistične fibroze (CFTR) s mutacijom ΔF508.
10. Farmaceutski pripravak za uporabu prema zahtjevu 7, naznačen time da navedeni pacijent ima receptor transmembranske cistične fibroze (CFTR) s mutacijom R117H.
11. Farmaceutski pripravak za uporabu prema zahtjevu 7, naznačen time da navedeni pacijent ima receptor transmembranske cistične fibroze (CFTR) s mutacijom G551D.
12. Farmaceutski pripravak za uporabu prema bilo kojem od zahtjeva 7 - 11, naznačen time da se navedena tableta pacijentu daje oralnim putem, jednom dnevno, ili svakih 12 h.
13. Farmaceutski pripravak za uporabu prema zahtjevu 12, naznačen time da se navedena tableta daje oralno svakih 12 h.
HRP20180328TT 2008-08-13 2009-08-13 FARMACEUTSKI PRIPRAVAK N-[2,4-bis(1,1-DIMETILETIL)-5-HIDROKSIFENIL]-1,4-DIHIDRO-4-OKSOKINOLIN-3-KARBOKSAMIDA I NJEGOVO DAVANJE HRP20180328T1 (hr)

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US8870408P 2008-08-13 2008-08-13
US8880108P 2008-08-14 2008-08-14
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