New process for Synthesis of agomelatine cristalna and new Form and Pharmaceutical compositions containing it

摘要

Refeire is a process for the Industrial Synthesis of agomelatine or N - [2 - (7 - methoxy - 1-naphthyl) ethyl] acetamide of formula (i), which comprises reacting 7 - methoxy - 1 - tetralona acid cianoacetico in conditions that remove the water formed in the presence of a a catalytic amount of C Comprised of formula (V), where R and R 'are independently (C3 - C10 alkyl, aryl,)Alkyl aryl (C1 - C6), among others, to produce (7 - methoxy - 3,4-dihydro - 1-naphthalenyl] acetonitrile which is reacted with a hydrogenation catalyst in the presence of a compound Allyl couple then a Reduction with Hydrogen and then convert it into a Salt using HCl.And then subjected to the action of SODIUM ACETATE and acetic anhydride to produce the compound of formula (i) is isolated in solid form. It also relates to a Crystalline Form II of agomelatine and a Pharmaceutical composition that comprises being useful in the treatment of Sleep Disorders, stress, Anxiety or depression