Process for crystallising bupropion hydrochloride

C - Chemistry – Metallurgy – 07 – C

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C07C 221/00 (2006.01) C07C 225/16 (2006.01)

Patent

CA 2549350

Process for crystallising Bupropion hydrochloride comprising the following stages: a) Bupropion hydrochloride is dissolved in a mixture comprising methanol and a precipitating solvent for Bupropion hydrochloride; b) any insoluble residue is removed; c) the solution is distilled at atmospheric pressure until the precipitation reaction is triggered; d) the following are added: I) a precipitating solvent for Bupropion hydrochloride and II) hydrochloric acid until a pH <= 2 is obtained; e) the mass is cooled to a temperature less than 10~ C, preferably between 0 and 3~ C and the precipitate obtained is separated.

L'invention concerne un procédé de cristallisation d'hydrochlorure de bupropion consistant (a) à dissoudre de l'hydrochlorure de bupropion dans un mélange comprenant du méthanol et un solvant de précipitation pour l'hydrochlorure de bupropion, (b) à enlever tout résidu insoluble, (c) à distiller la solution à une pression atmosphérique jusqu'au déclenchement de la réaction de précipitation, (d) à ajouter (I) un solvant de précipitation pour l'hydrochlorure de bupropion et (II) de l'acide chlorhydrique jusqu'à l'obtention d'un pH inférieur ou égal à 2, (e) à refroidir la masse à une température inférieure à 10 ·C, de préférence entre 0 et 3 ·C, et à séparer le précipité ainsi obtenu.

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