BARBANTI, ELENA,CACCIA, CARLA,SALVATI, PATRICIA,VELARDI, FRANCESCO,RUFFILLI, TIZIANO,BOGOGNA, LUIGI
申请号:
NZ59573707
公开号:
NZ595737A
申请日:
2007.06.08
申请国别(地区):
NZ
年份:
2013
代理人:
摘要:
595737 Disclosed is a composition comprising safinamide or ralfinamide or a salt thereof with a pharmaceutically acceptable acid, with a content of the respective impurity (S)-2-[3-(3-fluorobenzyl)-4-(3-fluorobenzyloxy)-benzylamino]propanamide (IIa) and (S)-2-[3-(2-fluorobenzyl)-4-(2-fluorobenzyloxy)-benzylamino]propanamide (IIb) or a salt thereof with a pharmaceutically acceptable acid which is lower than 0.03% (by weight of the safinamide or ralfinamide). Further disclosed is the use of a composition comprising safinamide or ralfinamide as defined above for the manufacture of a medicament for the treatment of pain conditions including chronic and neuropathic pain, migraine, bipolar disorders, depressions, cardiovascular, inflammatory, urogenital, metabolic or gastrointestinal disorders under conditions that are not interfering with the cytochromes of the CYP450 system, in particular CYP3A4, CYP2D6, CYP2C19, CYP2C9 and do not inhibit HERG channel blocking properties.