DE14172390T1 - Gesteuerte Freisetzung von pharmazeutischen Zusammensetzungen mit Fumarinsäureester - Google Patents
Gesteuerte Freisetzung von pharmazeutischen Zusammensetzungen mit Fumarinsäureester Download PDFInfo
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- DE14172390T1 DE14172390T1 DE14172390.8T DE14172390T DE14172390T1 DE 14172390 T1 DE14172390 T1 DE 14172390T1 DE 14172390 T DE14172390 T DE 14172390T DE 14172390 T1 DE14172390 T1 DE 14172390T1
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Abstract
Pharmazeutische Zusammensetzung mit kontrollierter Freisetzung zur oralen Verwendung bestehend aus Dimethylfumarat als Wirkstoff, wobei die tägliche Dosierung zwischen 480 und 720 mg Wirkstoff verabreicht in einer bis drei Dosierungen liegt, wobei die pharmazeutische Zusammensetzung aus einer Dosierungsform mit kontrollierter Freisetzung besteht, welche geeignet ist, um Dimethylfumarat über eine bestimmte Zeitdauer freizusetzen, gemäß einem in vitro Auflösungsprofil, gemessen nach USP in 0,1 N Salzsäure während der ersten 2 Stunden und danach in 0,05 M Phosphatpuffer bei einem pH-Wert von 6,5 oder 6,8, wobei höchstens 5% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 2 Stunden nach dem Testbeginn freigesetzt werden, und/oder wobei zwischen etwa 20 und etwa 75% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 3 Stunden nach dem Testbeginn freigesetzt werden, und/oder wobei zwischen etwa 50 und etwa 90% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 4 Stunden nach dem Testbeginn freigesetzt werden, und/oder wobei zwischen etwa 60 und etwa 90% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 5 Stunden nach dem Testbeginn freigesetzt werden, und/oder wobei zwischen etwa 70 und etwa 95% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 6 Stunden nach dem Testbeginn freigesetzt werden, und/oder wobei zwischen etwa 75 und etwa 97% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 7 Stunden nach dem Testbeginn freigesetzt werden.
Claims (12)
- Pharmazeutische Zusammensetzung mit kontrollierter Freisetzung zur oralen Verwendung bestehend aus Dimethylfumarat als Wirkstoff, wobei die tägliche Dosierung zwischen 480 und 720 mg Wirkstoff verabreicht in einer bis drei Dosierungen liegt, wobei die pharmazeutische Zusammensetzung aus einer Dosierungsform mit kontrollierter Freisetzung besteht, welche geeignet ist, um Dimethylfumarat über eine bestimmte Zeitdauer freizusetzen, gemäß einem in vitro Auflösungsprofil, gemessen nach USP in 0,1 N Salzsäure während der ersten 2 Stunden und danach in 0,05 M Phosphatpuffer bei einem pH-Wert von 6,5 oder 6,8, wobei höchstens 5% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 2 Stunden nach dem Testbeginn freigesetzt werden, und/oder wobei zwischen etwa 20 und etwa 75% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 3 Stunden nach dem Testbeginn freigesetzt werden, und/oder wobei zwischen etwa 50 und etwa 90% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 4 Stunden nach dem Testbeginn freigesetzt werden, und/oder wobei zwischen etwa 60 und etwa 90% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 5 Stunden nach dem Testbeginn freigesetzt werden, und/oder wobei zwischen etwa 70 und etwa 95% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 6 Stunden nach dem Testbeginn freigesetzt werden, und/oder wobei zwischen etwa 75 und etwa 97% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 7 Stunden nach dem Testbeginn freigesetzt werden.
- Zusammensetzung nach Anspruch 1, wobei höchstens 5% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 2 Stunden nach dem Testbeginn freigesetzt werden.
- Zusammensetzung nach Anspruch 1 oder 2, wobei das Auflösungsprofil durch die Verwendung des Korbverfahrens oder des Paddelverfahrens bei 100 Upm gemessen wird.
- Zusammensetzung nach Anspruch 1, wobei die tägliche Dosierung zwischen 480 und 600 mg Wirkstoff liegt.
- Zusammensetzung nach Anspruch 1, wobei die tägliche Dosierung zwischen 600 und 720 mg Wirkstoff liegt.
- Zusammensetzung nach Anspruch 1, wobei die tägliche Dosierung 480 mg Wirkstoff ist.
- Zusammensetzung nach Anspruch 1, wobei die Dosierungsform 120, 180 oder 240 mg Wirkstoff umfasst.
- Zusammensetzung nach Anspruch 1 zur Verwendung bei der Behandlung von psoriatischer Arthritis, Neurodermitis, entzündlicher Darmerkrankung, und einer Autoimmunkrankheit.
- Zusammensetzung nach Anspruch 8, wobei die Autoimmunkrankheit ausgewählt ist aus: i. Polyarthritis ii. multipler Sklerose (MS), iii. juveniler Diabetes Mellitus, iv. Hashimoto-Thyreoiditis, v. Grave's disease vi. SLE (systemischem Lupus Erythematodes), vii. Sjögren Syndrom, viii. perniziöser Anämie, ix. chronisch aktiver (lupoider) Hepatitis, x. rheumatoider Arthritis (RA), xi. optischer Neuritis.
- Zusammensetzung nach Anspruch 9, wobei die Autoimmunkrankheit multiple Sklerose ist.
- Pharmazeutische Zusammensetzung mit kontrollierter Freisetzung zur oralen Verwendung bestehend aus Dimethylfumarat als Wirkstoff, wobei die tägliche Dosierung 480 mg Wirkstoff verabreicht in einer bis drei Dosierungen ist, wobei die pharmazeutische Zusammensetzung aus einer Dosierungsform mit kontrollierter Freisetzung besteht, welche geeignet ist, um Dimethylfumarat über eine bestimmte Zeitdauer freizusetzen, gemäß einem in vitro Auflösungsprofil, gemessen nach USP in 0,1 N Salzsäure während der ersten 2 Stunden und danach in 0,05 M Phosphatpuffer bei einem pH-Wert von 6,5 oder 6,8, wobei höchstens 5% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 2 Stunden nach dem Testbeginn freigesetzt werden, und/oder wobei zwischen etwa 20 und etwa 75% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 3 Stunden nach dem Testbeginn freigesetzt werden, und/oder wobei zwischen etwa 50 und etwa 90% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 4 Stunden nach dem Testbeginn freigesetzt werden, und/oder wobei zwischen etwa 60 und etwa 90% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 5 Stunden nach dem Testbeginn freigesetzt werden, und/oder wobei zwischen etwa 70 und etwa 95% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 6 Stunden nach dem Testbeginn freigesetzt werden, und/oder wobei zwischen etwa 75 und etwa 97% Gew./Gew. der Gesamtmenge des in der Zusammensetzung enthaltenen Dimethylfumarats, während der ersten 7 Stunden nach dem Testbeginn freigesetzt werden.
- Zusammensetzung nach Anspruch 11 zur Verwendung bei der Behandlung von multipler Sklerose.
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EP14172390.8A EP2801354B1 (de) | 2004-10-08 | 2005-10-07 | Gesteuerte Freisetzung von pharmazeutischen Zusammensetzungen mit Fumarinsäureester |
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DE202005022112.0U Expired - Lifetime DE202005022112U1 (de) | 2004-10-08 | 2005-10-07 | Pharmazeutische Zusammensetzungen mit kontrollierter Freisetzung, umfassend einen Fumarsaureester |
DE14172398.1T Pending DE14172398T1 (de) | 2004-10-08 | 2005-10-07 | Gesteuerte Freisetzung von pharmazeutischen Zusammensetzungen mit Fumarinsäureester |
DE14172396.5T Pending DE14172396T1 (de) | 2004-10-08 | 2005-10-07 | Gesteuerte Freisetzung von pharmazeutischen Zusammensetzungen mit Fumarinsäureester |
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DE14172398.1T Pending DE14172398T1 (de) | 2004-10-08 | 2005-10-07 | Gesteuerte Freisetzung von pharmazeutischen Zusammensetzungen mit Fumarinsäureester |
DE14172396.5T Pending DE14172396T1 (de) | 2004-10-08 | 2005-10-07 | Gesteuerte Freisetzung von pharmazeutischen Zusammensetzungen mit Fumarinsäureester |
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- 2018-05-24 US US15/988,628 patent/US20180263947A1/en not_active Abandoned
- 2018-07-26 US US16/046,509 patent/US20180325855A1/en not_active Abandoned
- 2018-11-29 US US16/204,403 patent/US20190091191A1/en not_active Abandoned
- 2018-11-29 US US16/204,503 patent/US20190091192A1/en not_active Abandoned
- 2018-11-29 US US16/204,559 patent/US20190091193A1/en not_active Abandoned
- 2018-12-20 US US16/227,287 patent/US11229619B2/en active Active
-
2019
- 2019-03-06 US US16/294,038 patent/US20190201368A1/en not_active Abandoned
- 2019-05-20 JP JP2019094350A patent/JP6896792B2/ja active Active
- 2019-07-29 US US16/525,392 patent/US11052062B2/en active Active
-
2021
- 2021-02-25 US US17/185,600 patent/US20210220318A1/en not_active Abandoned
- 2021-12-16 US US17/553,367 patent/US20220105064A1/en not_active Abandoned
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