| abstract |
The present invention relates to the field of pharmaceuticals and relates to the use of safinamide (a) or ralfinamide (b) of high purity or their pharmaceutically acceptable acid salt, where the content of the corresponding impurity (S) -2- [3- (3-fluorobenzyl) -4- ( 3-fluorobenzyloxy) benzylamino] propanamide (IIa) or (S) -2- [3- (2-fluorobenzyl) -4- (2-fluorobenzyloxy) benzylamino] propanamide (IIb) or their pharmaceutically acceptable acid salt below 0.03 wt. .% for the manufacture of a medicinal product for the treatment, respectively: (a) epilepsy, Parkinson's disease, Alzheimer's disease depression, tired leg syndrome and migraine, or (b) painful conditions, including chronic pain and neuropathic pain, migraines, bipolar disorders, depression, cardiovascular, inflammatory, urinary, metabolic and gastrointestinal disturbances in conditions that do not interfere with activity cytochromes of the CYP450 system and do not exhibit blocking properties in relation to the HERG channel. The invention also relates to a pharmaceutical composition containing said compounds for treating said conditions, as well as a method for treating said conditions using said high purity safinamide or ralphinamide, or a pharmaceutically acceptable acid salt thereof. The claimed invention allows to increase the safety of treatment of these conditions using agents based on safinamide and ralfinamide, and also allows the possibility of such treatment to be extended to groups of patients to whom it has not previously been available. |