ME01901B - Kombinacija inhibitora HMG-CoA reduktaze atorvastatina ili simvastatina sa fosfodiesteraza 4 inhibitorom, kao što je roflumilast za lečenje inflamatornih pulmonarnih oboljenja - Google Patents

Kombinacija inhibitora HMG-CoA reduktaze atorvastatina ili simvastatina sa fosfodiesteraza 4 inhibitorom, kao što je roflumilast za lečenje inflamatornih pulmonarnih oboljenja

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Publication number
ME01901B
ME01901B MEP-2014-91A MEP9114A ME01901B ME 01901 B ME01901 B ME 01901B ME P9114 A MEP9114 A ME P9114A ME 01901 B ME01901 B ME 01901B
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ME
Montenegro
Prior art keywords
roflumilast
pharmaceutically acceptable
hmg
acceptable salt
coa reductase
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MEP-2014-91A
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English (en)
Inventor
Stefan-Lutz Wollin
Andrea Wohlsen
Clemens Braun
Degenhard Marx
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Astrazeneca Ab
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Publication date
Application filed by Astrazeneca Ab filed Critical Astrazeneca Ab
Publication of ME01901B publication Critical patent/ME01901B/me

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Claims (56)

1.Farmaceutska kompozicija koja sadrži farmaceutsku formulaciju koja obuhvata količinu PDE4 inhibitora, količinu inhibitora HMG-CoA reduktaze i najmanje jednu farmaceutski prihvatljivu pomoćnu supstancu, pri čemu je PDE4 inhibitor odabran iz grupe koja se sastoji od ROFLUMILAST-a, farmaceutski prihvatljive soli ROFLUMILAST-a, ROFLUMILAST-N- oksida i farmaceutski prihvatljive soli ROFLUMILAST-N-oksida, inhibitor HMG-CoA reduktaze je SIMVASTATIN ili njegova farmaceutski prihvatljiva so, i pri čemu prva količina i druga količina zajedno obuhvataju efikasnu količinu za prevenciju ili lečenje inflamatornog pulmonarnog oboljenja.
2.Proizvod kombinacije koji sadrži komponente: (A) količinu PDE4 inhibitora; (B) količinu inhibitora HMGCoA reduktaze; pri čemu prva i druga količina zajedno obuhvataju efikasnu količinu za prevenciju ili lečenje inflamatornog pulmonarnog oboljenja i pri čemu svaka od komponenti (A) i (B) je formulisana u smeši sa najmanje jednom farmaceutski prihvatljivom pomoćnom supstancom, i pri čemu je PDE4 inhibitor odabran iz grupe koja se sastoji od ROFLUMILAST-a, farmaceutski prihvatljive soli ROFLUMILAST-a, ROFLUMILAST-N-oksida i farmaceutski prihvatljive soli ROFLUMILAST-N-oksida, i inhibitor HMG-CoA reduktaze je SIMVASTATIN ili njegova farmaceutski prihvatljiva so.
3.Oprema koja sadrži komponente: (A) farmaceutsku formulaciju koja obuhvata količinu PDE4 inhibitora, u smeši sa najmanje jednom farmaceutski prihvatljivom pomoćnom supstancom; (B) farmaceutsku formulaciju koja obuhvata količinu inhibitora HMG-CoA reduktaze, u smeši sa najmanje jednom farmaceutski prihvatljivom pomoćnom supstancom; pri čemu prva i druga količina zajedno obuhvataju efikasnu količinu za prevenciju ili lečenje inflamatornog pulmonarnog oboljenja, i pri čemu je PDE4 inhibitor odabran iz grupe koja se sastoji od ROFLUMILAST-a, farmaceutski prihvatljive soli ROFLUMILAST-a, ROFLUMILAST-N-oksida i farmaceutski prihvatljive soli ROFLUMILAST-N-oksida, i inhibitor HMG-CoA reduktaze je SIMVASTATIN ili njegova farmaceutski prihvatljiva so.
4.Farmaceutska kompozicija prema zahtevu 1, pri čemu PDE4 inhibitor je ROFLUMILAST.
5.Farmaceutska kompozicija prema zahtevu 1, pri čemu PDE4 inhibitor je ROFLUMILAST- N-oksid.
6.Farmaceutska kompozicija prema bilo kom od zahteva 1,4 ili 5, pri čemu inhibiot HMG- CoA reduktaze je SIMVASTATIN.
7. Proizvod kombinacije prema zahtevu 2, pri čemu PDE4 inhibitor je ROFLUMILAST.
8. Proizvod kombinacije prema zahtevu 2, pri čemu PDE4 inhibitor je ROFLUMILAST-N- oksid.
9.Proizvod kombinacije prema bilo kom od zahteva 2, 7 i 8, pri čemu inhibitor HMG-CoA reduktaze je SIMVASTATIN.
10. Oprema prema zahtevu 3, pri čemu PDE4 inhibitor je ROFLUMILAST.
11. Oprema prema zahtevu 3, pri čemu PDE4 inhibitor je ROFLUMILAST-N-oksid.
12.Oprema prema bilo kom od zahteva 3, 10 ili 11, pri čemu inhibitor HMG-CoA reduktaze je SIMVASTATIN.
13.Farmaceutska kompozicija prema bilo kom od zahteva 1,4, 5 ili 6, gde je inflamatorno pulmonarno oboljenje odabrano iz grupe koja se sastoji od astme, COPD, skleroze, alveolitisa, sarkoidoze, idiopatične pulmonarne fibroze i pulmonarne hipertenzije.
14.Farmaceutska kompozicija prema bilo kom od zahteva 1,4, 5 ili 6, gde je inflamatorno pulmonarno oboljenje COPD.
15.Proizvod kombinacije prema bilo kom od zahteva 2, 7, 8 ili 9, gdeje inflamatorno pulmonarno oboljenje odabrano iz grupe koja se sastoji od astme, COPD, skleroze, alveolitisa, sarkoidoze, idiopatične pulmonarne fibroze i pulmonarne hipertenzije.
16.Proizvod kombinacije prema bilo kom od zahteva 2, 7, 8 or 9, gde je inflamatorno pulmonarno oboljenje COPD.
17.Oprema prema bilo kom od zahteva 3, 10, 11 ili 12, gde je inflamatorno pulmonarno oboljenje odabrano iz grupe koja se sastoji od astme, COPD, skleroze, alveolitisa, sarkoidoze, idiopatične pulmonarne fibroze i pulmonarne hipertenzije.
18.Oprema prema bilo kom od zahteva 3, 10, 11 ili 12, gdeje inflamatorno pulmonarno oboljenje COPD.
19.Primena PDE4 inhibitora ili njegove farmaceutski prihvatljive soli i inhibitora HMG-CoA reduktaze ili njegove farmaceutski prihvatljive soli za proizvodnju medikamenta, prvenstveno farmaceutske kompozicije prema pronalasku, za prevenciju ili lečenje inflamatornog pulmonarnog oboljenja, pri čemu je PDE4 inhibitor odabran iz grupe koja se sastoji od ROFLUMILAST-a, farmaceutski prihvatljive soli ROFLUMILAST-a, ROFLUMILAST-N-oksida i farmaceutski prihvatljive soli ROFLUMILAST-N-oksida i inhibitor HMG-CoA reduktaze je SIMVASTATIN ili njegova farmaceutski prihvatljiva so.
20.Primena PDE4 inhibitora ili njegove farmaceutski prihvatljive soli i inhibitora HMG-CoA reduktaze ili njegove farmaceutski prihvatljive soli za proizvodnju sekvencijalnog ili odvojenog medikamenta za istovremenu primenu, prvenstveno proizvoda kombinacije ili opreme prema pronalasku, za prevenciju ili lečenje inflamatornog pulmonarnog oboljenja, pri čemu je PDE4 inhibitor odabran iz grupe koja se sastoji od ROFLUMILAST-a, farmaceutski prihvatljive soli ROFLUMILAST-a, ROFLUMILAST-N-oksida i farmaceutski prihvatljive soli ROFLUMILAST-N-oksida i inhibitor HMG-CoA reduktaze je SIMVASTATIN ili njegova farmaceutski prihvatljiva so.
21.Primena prema bilo kom od zahteva 19 ili 20, pri čemu PDE4 inhibitor je ROFLUMILAST.
22.Primena prema bilo kom od zahteva 19 ili 20, pri čemu PDE4 inhibitor je ROFLUMILAST-N-oksid.
23.Primena prema bilo kom od zahteva 19, 20, 21 ili 22, pri čemu inhbitor HMG-CoA reduktaze je SIMVASTATIN.
24.Primena prema bilo kom od zahteva 19 do 23, gde je inflamatorno pulmonarno oboljenje odabrano iz grupe koja se sastoji od astme, COPD, skleroze, alveolitisa, sarkoidoze, idiopatične pulmonarne fibroze i pulmonarne hipertenzije.
25.Primena prema bilo kom od zahteva 19 do 23, gde je inflamatorno pulmonarno oboljenje COPD.
26.Postupak za dobijanje farmaceutske kompozicije kao što je definisano u bilo kom od zahteva 1,4, 5, 6, 13 ili 14, koji obuhvata mešanje PDE4 inhibitora ili njegove farmaceutski prihvatljive soli sa inhibitorom HMG-CoA reduktaze ili njegove farmaceutski prihvatljive soli.
27.Farmaceutska kompozicija koja sadrži farmaceutsku formulaciju koja obuhvata količinu PDE4 inhibitora, količinu inhibitora HMG-CoA reduktaze i najmanje jednu farmaceutski prihvatljivu pomoćnu supstancu, pri čemu je PDE4 inhibitor odabran iz grupe koja se sastoji od ROFLUMILAST-a, farmaceutski prihvatljive soli ROFLUMILAST-a, ROFLUMILAST-N- oksida i farmaceutski prihvatljive soli ROFLUMILAST-N-oksida, inhibitor HMG-CoA reduktaze je ATORVASTATIN ili njegova farmaceutski prihvatljiva so, i pri čemu prva količina i druga količina zajedno obuhvataju efikasnu količinu za prevenciju ili lečenje inflamatornog pulmonarnog oboljenja.
28.Proizvod kombinacije koji sadrži komponente: (A) količinu PDE4 inhibitora; (B) količinu inhibitora HMGCoA reduktaze; pri čemu prva i druga količina zajedno obuhvataju efikasnu količinu za prevenciju ili lečenje inflamatornog pulmonarnog oboljenja i pri čemu svaka od komponenti (A) i (B) je formulisana u smeši sa najmanje jednom farmaceutski prihvatljivom pomoćnom supstancom, i pri čemu je PDE4 inhibitor odabran iz grupe koja se sastoji od ROFLUMILAST-a, farmaceutski prihvatljive soli ROFLUMILAST-a, ROFLUMILAST-N-oksida i farmaceutski prihvatljive soli ROFLUMILAST-N-oksida i inhibitor HMG-CoA reduktaze je ATORVASTATIN ili njegova farmaceutski prihvatljiva so.
29.Oprema koja sadrži komponente: (A) farmaceutsku formulaciju koja obuhvata količinu PDE4 inhibitora, u smeši sa najmanje jednom farmaceutski prihvatljivom pomoćnom supstancom; (B) farmaceutsku formulaciju koja obuhvata količinu inhibitora HMG-CoA reduktaze, u smeši sa najmanje jednom farmaceutski prihvatljivom pomoćnom supstancom; pri čemu prva i druga količina zajedno obuhvataju efikasnu količinu za prevenciju ili lečenje inflamatornog pulmonarnog obolenja, i pri čemu je PDE4 inhibitor odabran iz grupe koja se sastoji od ROFLUMILAST-a, farmaceutski prihvatljive soli ROFLUMILAST-a, ROFLUMILAST-N-oksida i farmaceutski prihvatljive soli ROFLUMILAST-N-oksida i inhibitor HMG-CoA reduktaze je ATORVASTATIN ili njegova farmaceutski prihvatljiva so.
30.Farmaceutska kompozicija prema zahtevu 27, pri čemu PDE4 inhibitor je ROFLUMILAST.
31.Farmaceutska kompozicija prema zahtevu 27, pri čemu PDE4 inhibitor je ROFLUMILASTN-oxide.
32.Farmaceutska kompozicija prema bilo kom od zahteva 27, 30 ili 31, pri čemu inhibitor HMG-CoA reduktaze je ATORVASTATIN.
33.Farmaceutska kompozicija prema bilo kom od zahteva 27, 30 ili 31, pri čemu inhibitor HMG-CoA reduktaze je ATORVASTATIN hemi-kalcijum seks-hidrat.
34.Proizvod kombinacije prema zahtevu 28, pri čemu PDE4 inhibitor je ROFLUMILAST.
35.Proizvod kombinacije prema zahtevu 28, pri čemu PDE4 inhibitor je ROFLUMILAST-N- oksid.
36.Proizvod kombinacije prema bilo kom od zahteva 28, 34 i 35, pri čemu inhibitor HMG- CoA reduktaze je ATORVASTATIN.
37.Proizvod kombinacije prema bilo kom od zahteva 28, 34 i 35, pri čemu inhibitor HMG- CoA reduktaze je ATORVASTATIN hemi-kalcijum seks-hidrat.
38.Oprema prema zahtevu 29, pri čemu PDE4 inhibitor je ROFLUMILAST.
39.Oprema prema zahtevu 29, pri čemu PDE4 inhibitor je ROFLUMILAST-N-oksid.
40.Oprema prema bilo kom od zahteva 29, 38 ili 39, pri čemu inhibitor HMG-CoA reduktaze je ATORVASTATIN.
41.Oprema prema bilo kom od zahteva 29, 38 ili 39, pri čemu inhibitor HMG-CoA reduktaze je ATORVASTATIN hemikalcijum seks-hidrat.
42.Farmaceutska kompozicija prema bilo kom od zahteva 27, 30, 31, 32 ili 33, gdeje inflamatorno pulmonarno oboljenje odabrano iz grupe koja se sastoji od astme, COPD, skleroze, alveolitisa, sarkoidoze, idiopatične pulmonarne fibroze i pulmonarne hipertenzije.
43.Farmaceutska kompozicija prema bilo kom od zahteva 27, 30, 31, 32 ili 33, gde je inflamatorno pulmonarno oboljenje COPD.
44.Proizvod kombinacije prema bilo kom od zahteva 28, 34, 35, 36 ili 37, gde je inflamatorno pulmonarno oboljenje odabrano iz grupe koja se sastoji od astme, COPD, skleroze, alveolitisa, sarkoidoze, idiopatične pulmonarne fibroze i pulmonarne hipertenzije.
45.Proizvod kombinacije prema bilo kom od zahteva 28, 34, 35, 36 ili 37, gde je inflamatorno pulmonarno oboljenje COPD.
46.Oprema prema bilo kom od zahteva 29, 38, 39, 40 ili 41, gde je inflamatorno pulmonarno oboljenje odabrano iz grupe koja se sastoji od astme, COPD, skleroze, alveolitisa, sarkoidoze, idiopatične pulmonarne fibroze i pulmoname hipertenzije.
47.Oprema prema bilo kom od zahteva 29, 38, 39, 40 ili 41, gde je inflamatorno pulmonarno oboljenje COPD.
48.Primena PDE4 inhibitor ili njegove farmaceutski prihvatljive soli i inhibitora HMG-CoA reduktaze ili njegove farmaceutski prihvatljive soli za proizvodnju medikamenta, prvenstveno farmaceutske kompozicije prema pronalasku, za prevenciju ili lečenje inflamatornog pulmonarnog oboljenja, pri čemu je PDE4 inhibitor odabran iz grupe koja se sastoji od ROFLUMILAST-a, farmaceutski prihvatljive soli ROFLUMILAST-a, ROFLUMILAST-N-oksida i farmaceutski prihvatljive soli ROFLUMILAST-N-oksida i inhibitor HMG-CoA reduktaze je ATORVASTATIN ili njegova farmaceutska prihvatljiva so.
49.Primena PDE4 inhibitora ili njegove farmaceutski prihvatljive soli i inhibitora HMG-CoA reduktaze ili njegove farmaceutski prihvatljive soli za proizvodnju sekvencijalnog ili odvojenog medikamenta za istovremenu primenu, prvenstveno proizvoda kombinacije ili opreme prema pronalasku, za prevenciju ili lečenje inflamatornog pulmonarnog oboljenja, pri čemu je PDE4 inhibitor odabran iz grupe koja se sastoji od ROFLUMILAST-a, farmaceutski prihvatljive soli ROFLUMILAST-a, ROFLUMILAST-N-oksida i farmaceutski prihvatljive soli ROFLUMILAST-N-oksida i inhibitor HMG-CoA reduktaze je ATORVASTATIN ili njegova farmaceutska prihvatljiva so.
50.Primena prema bilo kom od zahteva 48 ili 49, pri čemu PDE4 inhibitor je ROFLUMILAST.
51.Primena prema bilo kom od zahteva 48 ili 49, pri čemu PDE4 inhibitor je ROFLUMILAST-N-oksid.
52.Primena prema bilo kom od zahteva 48, 49, 50 ili 51, pri čemu inhibitor HMG-CoA reduktaze je ATORVASTATIN.
53.Primena prema bilo kom od zahteva 48, 49, 50 ili 51, pri čemu inhibitor HMG-CoA reduktaze je ATORVASTATIN hemi-kalcijum seks-hidrat.
54.Primena prema bilo kom od zahteva 48 do 53, gde je inflamatorno pulmonarno oboljenje odabrano iz grupe koja se sastoji od astme, COPD, skleroze, alveolitisa, sarkoidoze, idiopatične pulmonarne fibroze i pulmonarne hipertenzije.
55.Primena prema bilo kom od zahteva 48 do 53, gde je inflamatorno pulmonamo oboljenje COPD.
56.Postupak za dobijanje farmaceutske kompozicije kao što je definisano u bilo kom od zahteva 27, 30, 31,32, 33, 42 ili 43, koji obuhvata mešanje PDE4 inhibitora ili njegove farmaceutski prihvatljive soli sa inhibitorom HMG-CoA reduktaze ili njegove farmaceutski prihvatljive soli.
MEP-2014-91A 2006-07-05 2007-07-03 Kombinacija inhibitora HMG-CoA reduktaze atorvastatina ili simvastatina sa fosfodiesteraza 4 inhibitorom, kao što je roflumilast za lečenje inflamatornih pulmonarnih oboljenja ME01901B (me)

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