Refers to a hydrochloride hydrate agomelatine of formula (i) where X is chlorine, whose Peaks of diffraction Angles are expressed in degrees two Theta 9076 (0.2 13.635 (0.2, 0.2 - 0.2 16.872 14427 ( 18.176 (0.2, 0.2 - 0.2 22.259 21610 ( 22.794 + \/ - 0.2 23.878 24.214 + \/ - 0.2 [+ \/ - 0.2 0.2 25.457 25.714 (0.2, 0.2 and 0.2 29.207 27.430 + +.It also relates to a Pharmaceutical Composition and a method for preparing agomelatine hydrochloride hydrate which comprises Dissolving agomelatine in an organic Solvent such as ethyl acetate (b) adding an aqueous solution of HCl dropwise to precipitate the crista L the product being the Reaction temperature of Zero Degrees to 20 degrees (c) washing and drying The Solid after dAnd Crystallization. This hydrochloride hydrate agomelatine is useful in the treatment of melatoninergico System disorders, Sleep Disorders, anxiety, depression, SchizophreniaSE REFIERE A UN HIDRATO DE HIDROCLORURO DE AGOMELATINA DE FORMULA (I) DONDE X ES CLORO, CUYOS PICOS DE ANGULOS DE DIFRACCION EXPRESADOS EN GRADOS 2-THETA SON 9.076 ± 0.2 13.635 ± 0.2 14.427 ± 0.2 16.872 ± 0.2 18.176 ± 0.2 21.610 ± 0.2 22.259 ± 0.2 22.794 ± 0.2 23.878 ± 0.2 24.214 ± 0.2 25.457 ± 0.2 25.714 ± 0.2 27.430 ± 0.2 Y 29.207 ± 0.2. TAMBIEN SE REFIERE A UNA COMPOSICION FARMACEUTICA Y A UN PROCEDIMIENTO DE PREPARACION DEL HIDRATO DE HIDROCLORURO DE AGOMELATINA QUE COMPRENDE A) DISOLVER LA AGOMELATINA EN UN DISOLVENTE ORGANICO TAL COMO ACETATO DE ETILO B) ANADIR UNA DISOLUCION ACUOSA DE HCl GOTA A GOTA PARA PRECIPITAR EL CRISTAL DEL PRODUCTO SIENDO LA TEMPERATURA DE REACCION DE 0ºC A 20ºC C) LAVAR Y SECAR EL SOLIDO DESPUES DE LA CRISTALIZACION. DICHO HIDRATO DE HIDROCLORURO DE AGOMELATINA ES UTIL EN EL TRATAMIENTO DE TRANSTORNOS DEL SISTEMA MELATONINERGICO, TRANSTORNOS DEL SUENO, ANSIEDAD, DEPRESION MAYOR, ESQUIZOFRENIA
