Novel processes for preparing sertraline hydrochloride...

C - Chemistry – Metallurgy – 07 – C

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C07C 209/86 (2006.01) C07C 211/42 (2006.01)

Patent

CA 2588777

The present invention discloses novel and improved processes for preparation of sertraline hydrochloride crystalline form II. Thus, for example, sertraline free base is dissolved in isoamyl alcohol at 25 - 30°C, pH of the mass is adjusted to 2.0 with conc. hydrochloric acid (36%) at 25 - 30°C and then stirred for 14 hours at 25 - 30°C. Filtered the solid and dried at 65°C for 4 hours to give sertraline hydrochloride crystalline form II. The present invention also provides a novel process for preparation of sertraline hydrochloride crystalline form I.

La présente invention a pour objet des procédés nouveaux et améliorés pour la préparation de la forme cristalline II du chlorhydrate de sertraline. Ainsi, par exemple, une base libre de sertraline est dissoute dans l'alcool isoamylique à 25-30 oC, le pH de la masse est ajusté à 2,0 avec l'acide chlorhydrique concentré (36 %) à 25-30 oC, puis la solution est agitée pendant 14 h à 25-30 oC. Le solide est filtré et séché à 65 oC pendant 4 h pour donner la forme cristalline II du chlorhydrate de sertraline. La présente invention a également pour objet un nouveau procédé de préparation de la forme cristalline I du chlorhydrate de sertraline.

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