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Spanish to English: Osmotica General field: Science Detailed field: Chemistry; Chem Sci/Eng
Source text - Spanish Quetiapina comprimidos de liberación prolongada es un producto de una toma diaria indicado para el tratamiento de la esquizofrenia y episodios agudos maníacos asociados al desorden bipolar. Cada comprimido contiene 200, 300 y 400 mg de Quetiapina base equivalente a 230.2, 345.3 y 460.4 mg de Quetiapina Hemifumarato respectivamente.
El desarrollo de este producto de liberación prolongada esta alineado sobre el concepto ANDA (Abreviated New Drug Application).
En el presente reporte se incluyen todas las actividades relacionadas al estudio del principio activo, el desarrollo de la fórmula y la elaboración de un lote clínico.
Todas estas actividades fueron llevadas a cabo en las instalaciones de R&D de Osmótica Pharmaceutical en Argentina.
El dispositivo desarrollado es un sistema matricial (Matriz Hidrofílica), bajo la forma de comprimidos de administración oral, el cual está basado en la utilización de polímeros hidrofílicos que controlan la liberación del principio activo.
Translation - English Quetiapine tablets of extended release are a product which should be ingesting daily because of schizophrenia treatments and serious maniac episodes related to bipolar disorders. Each tablet contains 200, 300 and 400 mg of Quetiapine base equivalent to 230.2, 345.3 and 460.4 mg of Quetiapine Hemifumarate respectively.
The development of that product of extended release is lined up over the concept of ANDA (Abbreviated New Drug Application)
In this report, it is included all the activities related to the active principle study, the formula development and the elaboration of a clinical batch.
All this activities were made in the installations of R&D of Osmotic Pharmaceutical in Argentina.
The developed device is a matrix system (Hydrophilic Matrix), shaped as tablets of oral use, which is base on the usage of polymers hydrophilic that control the active principle release.
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Years of experience: 4. Registered at ProZ.com: May 2011.
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