LIGIA SOFIA DE CASTRO PERREIRA,PAULA CRISTINA DE ALMEIDA JERÓNIMO,PEDRO MIGUEL DA COSTA BARROCAS,RICARDO JORGE DOS SANTOS LIMA,RUI CERDEIRA DE CAMPOS COSTA,TEÓFILO CARDOSO DE VASCONCELOS
申请号：
BR112013016818
公开号：
BR112013016818A2
申请日:
2011.12.30
申请国别(地区):
BR
年份:
2016
代理人:
摘要：
Formulation The invention relates to a solid pharmaceutical composition, the composition of which comprises eslicarbazepine acetate and one or more pharmaceutically acceptable excipients, wherein the composition is in the form of granules, and wherein at least 90% of the granules of the composition have a particle size of 90 µm or more, and / or wherein at least 50% of the granules of the composition have a particle size of 250 µm or more. The invention also relates to a process for producing a granular composition comprising a pharmaceutically active agent, which process comprises: (1) granulating a mixture comprising a pharmaceutically active agent and one or more pharmaceutically acceptable excipients using a first granulation liquid； (2) drying the granules formed in (1)； (3) optionally calibrating the size of the resulting granules of (2)； (4) granulating the granules resulting from (2) or (3) using a second granulation liquid； (5) drying the granules formed in (4)； (6) coating the granules resulting from (5) using a coating liquid； and (7) drying the coated granules formed in (6), wherein at least 90% of the coated granules that are produced have a particle size of 90 µm or more and / or at least 50% of the granules. Coated granules that are produced have a particle size of 250 µm or more. furthermore, the invention relates to the use of the composition in therapy and, in particular, in the treatment or prevention of a disorder selected from epilepsy, neuropathic pain, migraines, fibromyalgia and affective disorders.formulação a invenção refere-se a uma composição farmacêutica sólida, cuja composição compreende acetato de eslicarbazepina e um ou mais excipientes farmaceuticamente aceitáveis, em que a composição está na forma de grânulos, e em que, pelo menos, 90% dos grânulos da composição têm um tamanho de partícula de 90 um ou mais, e/ou em que, pelo menos, 50% dos grânulos da composiçãp têm um tamanho de partícula de 250 um ou mais. a invenção refere-se tam
