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AssigneeAziende Chimiche Riunite Angelini Francesco A.C.R.A.F. S.p.A.
InventorsMarcello Marchetti, Tommaso Iacoangeli, Giovanni Battista Ciottoli, Giuseppe Biondi
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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 of 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.
Trazodone or trazodone hydrochloride, wherein alkylating substances are present in a total amount which is less than 15 ppm and said alkylating substances are selected from the group consisting of 2,2-dichloroethylamine, 1-bromo-3-chloro-propane, N-(3-chlorophenyl)-N′-(3-chloropropyl)-piperazine, 2-(3-chloropropyl)-s-triazolo-[4,3-a]-pyridin-3-one, 3-chloro-N,N′-dichloroethyl-aniline, 2-{3-[bis-(2-chloroethyl)-amino]-propyl}-2H-[1,2,4]-triazolo[4,3-a]pyridin-3-one, 2,2-dibromoethylamine, 1,3-dichloropropane and a mixture thereof.
Dependencies are inferred from the claim text.