ES2525495T1 - Composición farmacéutica de liberación controlada que comprende éster de ácido fumárico - Google Patents
Composición farmacéutica de liberación controlada que comprende éster de ácido fumárico Download PDFInfo
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- ES2525495T1 ES2525495T1 ES14172390.8T ES14172390T ES2525495T1 ES 2525495 T1 ES2525495 T1 ES 2525495T1 ES 14172390 T ES14172390 T ES 14172390T ES 2525495 T1 ES2525495 T1 ES 2525495T1
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Abstract
Composición farmacéutica de liberación controlada para uso oral que consiste en fumarato de dimetilo como principio activo, en la que la dosificación diaria es de desde 480 hasta 720 mg de principio activo administrado en de una a tres dosis, en la que la composición farmacéutica consiste en una forma de dosificación de liberación controlada adaptada para liberar fumarato de dimetilo a largo de un periodo de tiempo predeterminado, según un perfil de disolución in vitro cuando se mide según la USP en ácido clorhídrico 0,1 N durante las primeras 2 horas y luego tampón fosfato 0,05 M a un pH de 6,5 ó 6,8, en la que como máximo el 5% p/p de la cantidad total del fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 2 horas tras el inicio de la prueba, y/o en la que desde aproximadamente el 20% hasta aproximadamente el 75% p/p de la cantidad total del fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 3 horas Iras el inicio de la prueba, y/o en la que desde aproximadamente el 50% hasta aproximadamente el 90% p/p de la cantidad total del fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 4 horas tras el inicio de la prueba, y/o en la que desde aproximadamente el 60% hasta aproximadamente el 90% p/p de la cantidad total del fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 5 horas tras el inicio de la prueba, y/o en la que desde aproximadamente el 70% hasta aproximadamente el 95% p/p de la cantidad total del fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 6 horas tras el inicio de la prueba, y/o en la que desde aproximadamente el 75% hasta aproximadamente el 97% p/p de la cantidad total del fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 7 horas tras el inicio de la prueba.
Claims (12)
- REIVINDICACIONES1. Composición farmacéutica de liberación controlada para uso oral que consiste en fumarato de dimetilo como principio activo, en la que la dosificación diaria es de desde 480 hasta 720 mg de principio activo administrado en de una a tres dosis, 5en la que la composición farmacéutica consiste en una forma de dosificación de liberación controlada adaptada para liberar fumarato de dimetilo a largo de un periodo de tiempo predeterminado, según un perfil de disolución in vitro cuando se mide según la USP en ácido clorhídrico 0,1 N durante las primeras 2 horas y luego tampón fosfato 0,05 M a un pH de 6,5 ó 6,8, 10en la que como máximo el 5% p/p de la cantidad total del fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 2 horas tras el inicio de la prueba, y/oen la que desde aproximadamente el 20% hasta aproximadamente el 75% p/p de la cantidad total del 15 fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 3 horas Iras el inicio de la prueba, y/oen la que desde aproximadamente el 50% hasta aproximadamente el 90% p/p de la cantidad total del fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 4 horas tras el inicio 20 de la prueba, y/oen la que desde aproximadamente el 60% hasta aproximadamente el 90% p/p de la cantidad total del fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 5 horas tras el inicio de la prueba, y/o 25en la que desde aproximadamente el 70% hasta aproximadamente el 95% p/p de la cantidad total del fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 6 horas tras el inicio de la prueba, y/o30en la que desde aproximadamente el 75% hasta aproximadamente el 97% p/p de la cantidad total del fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 7 horas tras el inicio de la prueba.
- 2. Composición según la reivindicación 1, en la que como máximo el 5% p/p de la cantidad total del fumarato 35 de dimetilo contenido en la composición se libera en el plazo de las primeras 2 horas tras el inicio de la prueba.
- 3. Composición según las reivindicaciones 1 ó 2, en la que el perfil de disolución se mide usando el método de la cesta o el método de paletas a 100 rpm. 40
- 4. Composición según la reivindicación 1, en la que la dosificación diaria es de desde 480 hasta 600 mg de principio activo.
- 5. Composición según la reivindicación 1, en la que la dosificación diaria es de desde 600 hasta 720 mg de 45 principio activo.
- 6. Composición según la reivindicación 1, en la que la dosificación diaria es de 480 mg de principio activo.
- 7. Composición según la reivindicación 1, en la que la forma de dosificación contiene 120, 180 ó 240 mg de 50 principio activo.
- 8. Composición según la reivindicación 1, para su uso en el tratamiento de artritis psoriásica, neurodermatitis, enfermedad inflamatoria del intestino y una enfermedad autoinmunitaria.55
- 9. Composición según la reivindicación 8, en la que la enfermedad autoinmunitaria se selecciona de:i. poliartritisii. esclerosis múltiple (EM) 60iii. diabetes mellitus de comienzo juveniliv. tiroiditis de Hashimoto65v. enfermedad de Gravevi. LES (Iupus eritematoso sistémico)vii . síndrome de Sjogren 5viii. anemia perniciosaix. hepatitis crónica activa (Iupoide)10x. artritis reumatoide (AR)xi. neuritis óptica
- 10. Composición según la reivindicación 9, en la que la enfermedad autoinmunitaria es esclerosis múltiple, 15
- 11. Composición de liberación controlada para uso oral que consiste en fumarato de dímetilo como principio activo , en la que la dosificación diaria es de 480 mg de principio activo administrado en de una a tres dosis,en la que la composición farmacéutica consiste en una forma de dosificación de liberación controlada 20 adaptada para liberar fumarato de dímetilo a 10 largo de un periodo de tiempo predeterminado, según un perfil de disolución in vitro de cuando se mide según la USP en ácido clorhídrico 0,1 N durante las primeras 2 horas y luego tampón fosfato 0,05 M a un pH de 6,5 ó 6,8,en la que como máximo el 5% p/p de la cantidad total del fumarato de dimetilo contenido en la composición 25 se libera en el plazo de las primeras 2 horas tras el inicio de la prueba, y/oen la que desde aproximadamente el 20% hasta aproximadamente el 75% p/p de la cantidad total del fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 3 horas tras el inicio de la prueba, y/o 30en la que desde aproximadamente el 50% hasta aproximadamente el 90% p/p de la cantidad total del fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 4 horas Iras el inicio de la prueba, y/o35en la que desde aproximadamente el 60% hasta aproximadamente el 90% p/p de la cantidad total del fumarato de dimetíto contenido en la composición se libera en el plazo de las primeras 5 horas tras el inicio de la prueba, y/oen la que desde aproximadamente el 70% hasta aproximadamente el 95% p/p de la cantidad total del 40 fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 6 horas tras el inicio de la prueba, y/oen la que desde aproximadamente el 75% hasta aproximadamente el 97% p/p de la cantidad total del fumarato de dimetilo contenido en la composición se libera en el plazo de las primeras 7 horas tras el inicio 45 de la prueba.
- 12. Composición según la reivindicación 11, para su uso en el tratamiento de esclerosis múltiple.
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