Trazodone and trazodone hydrochloride in purified form

Details Trazodone and trazodone hydrochloride in purified form Trazodone and trazodone hydrochloride in purified form

C - Chemistry, Metallurgy

07

D

C07D 249/18 (2006.01) A61K 31/4196 (2006.01) A61P 25/22 (2006.01) A61P 25/24 (2006.01)

Patent

CA 2693095

A process of production of trazodone or trazodone hydrochloride that comprises the steps of: (a) preparing an organic phase comprising trazodone in at least one organic solvent; (b) preparing an aqueous phase comprising at least one basic compound; (c) mixing said aqueous phase with said organic phase; (d) heating at a temperature o at least 40°C for at least 30 minutes; (e) recovering said trazodone; and, optionally, (f) treating said trazodone with hydrochloric acid to obtain trazodone hydrochloride. Trazodone or trazodone hydrochloride comprising less than 15 ppm of alkylating substances, and a pharmaceutical composition comprising said trazodone hydrochloride.

Cette invention se rapporte à un procédé de production du trazodone ou du chlorhydrate de trazodone qui comprend les étapes consistant : (a) à préparer une phase organique comprenant du trazodone dans au moins un solvant organique ; (b) à préparer une phase aqueuse comprenant au moins un composé basique ; (c) à mélanger ladite phase aqueuse avec ladite phase organique ; (d) à chauffer à une température d'au moins 40 °C pendant une durée d'au moins 30 minutes ; (e) à récupérer ledit trazodone ; et éventuellement (f) à traiter ledit trazodone avec de l'acide chlorhydrique pour obtenir du chlorhydrate de trazodone. L'invention concerne également le trazodone ou le chlorhydrate de trazodone comprenant moins de 15 ppm de substances alkylantes, et une composition pharmaceutique comprenant ledit chlorhydrate de trazodone.

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