Barbanti, Elena,Caccia, Carla,Salvati, Patricia,Velardi, Francesco,Ruffilli, Tiziano,Bogogna, Luigi
申请号：
ES12163085
公开号：
ES2602069T3
申请日:
2007.06.08
申请国别(地区):
ES
年份:
2017
代理人:
摘要：
Safinamide (a) or ralfinamide (b) of high purity grade or a salt thereof with a pharmaceutically acceptable acid, in which the respective impurity (S) -2- [3- (3-fluorobenzyl) -4- ( 3-fluorobenzyloxy) - benzylamino] propanamide (IIa) or (S) -2- [3- (2-fluorobenzyl) -4- (2-fluorobenzyloxy) -benzylamino] propanamide (IIb) ** Formula ** or a salt of the same with a pharmaceutically acceptable acid that is less than 0.03% (by weight), for use in the treatment of, respectively, (a) epilepsy, Parkinson's disease, Alzheimer's disease, depressions, restless legs syndrome and migraine, or (b) pain conditions that include chronic and neuropathic pain, migraine, bipolar disorders, depressions, cardiovascular, inflammatory, urogenital, metabolic and gastrointestinal disorders under conditions that do not interfere with the cytochromes of the CYP450 system, in particular CYP3A4, CYP2D6, CYP2C19, CYP2C9, and which do not have channel blocking properties of HERG in patients that are classified as poor metabolizers (PM) or in patients who concomitantly take other drugs that are known to interact with the cytochromes of the CYP450 system and / or that are known to have blocking properties of the HERG channel.Safinamida (a) o ralfinamida (b) de grado de pureza elevado o una sal de la misma con un ácido farmacéuticamente aceptable, en la que la impureza respectiva (S)-2-[3-(3-fluorobencil)-4-(3-fluorobenciloxi)- bencilamino]propanamida (IIa) o (S)-2-[3-(2-fluorobencil)-4-(2-fluorobenciloxi)-bencilamino]propanamida (IIb)**Fórmula** o una sal de la misma con un ácido farmacéuticamente aceptable que es inferior a 0,03% (en peso), para la utilización en el tratamiento de, respectivamente, (a) epilepsia, enfermedad de Parkinson, enfermedad de Alzheimer, depresiones, síndrome de las piernas inquietas y migraña, o (b) afecciones de dolor que incluyen dolor crónico y neuropático, migraña, trastornos bipolares, depresiones, trastornos cardiovasculares, inflamatorios, urogenitales, metabólicos
