Aziende Chimiche Riunite Angelini Francesco A.c.r.a.f. S.p.a.

Marcello Marchetti

Tommaso Iacoangeli

Giovanni Battista Ciottoli

Mario Pinza

Giuseppe Biondi

Mauro Valenti

Lorella Ragni

Francesca Mariotti

Paolo Scarpetti

Antonello Fazio

Franca Segnalini

Francesco De Vita

Mario Chiavarini

A stable liquid pharmaceutical composition comprising an aqueous solution of a pharmaceutically acceptable salt of acid addition of trazodone, characterized in that said pharmaceutical composition has a pH value between 5.0 and 6.0, and comprises at least two cosolvents selected from the group comprising glycols and polyglycols.

Stable liquid pharmaceutical composition based on trazodone

The present invention relates to a method of preparation of metaxalone comprising reaction of triglycidyl isocyanurate (TGIC) with m-xylenol, characterized in that said reaction is carried out in a solvent mixture comprising an aprotic polar solvent with dielectric constant greater than or equal to 30 and at least one other solvent selected from the group comprising apolar solvents and aprotic polar solvents with dielectric constant below 30 said solvent mixture comprising from 5 to 40 wt. % of said first solvent and from 95 to 60 wt. % of said second solvent, adding the TGIC at a temperature between 30&#xb0; C. and 50&#xb0; C., and after adding the TGIC, raising the temperature of the reaction solution to a value between 80&#xb0; C. and 180&#xb0; C. in a time between 120 and 180 minutes at a rate of increase not greater that 1.25&#xb0; C. per minute. The invention also relates to a metaxalone with a reduced content of impurities derived from incomplete reactions and/or side reactions of the method of production.

Method of preparation of metaxalone

A process of production of trazodone or trazodone hydrochloride that comprises: (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&#xb0; 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 and trazodone hydrochloride in purified form

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&#xb0; 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. 

Method for preparing a compound comprising protonated glucosamine and Cl, Naand SOions, in which (a) glucosamine hydrochloride and a stoichiometric excess of sodium sulphate are placed in water, (b) the mixture obtained from the preceding step (a) is heated, (c) the mixture is cooled, and (d) the solid present in the said cooled mixture is recovered by filtration. Compound comprising protonated glucosamine and Cl, Naand SOions and having the X-ray diffraction diagram of FIG.

Method for preparing a glucosamine compound and compound thus obtained

Sodium hypochlorite disinfectant solution having a pH of between 10.1 and 10.7 and comprising from 0.021 to 5.76% (w/v) of sodium hypochlorite and, relative to the said amount of sodium hypochlorite, not more than 2% of sodium chlorate.

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Rome, Italy

Marcello Marchetti