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AssigneeTeva Pharmaceutical Industries Ltd.
InventorsEduard Schwartz, Tamar Nidam, Anita Liberman, Marioara Mendelovici, Judith Aronhime, Claude Singer, Evgeni Valdman
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The present invention is directed to forms II, III, V, VI, VII, VIII, IX and X of sertraline hydrochloride and novel methods for their preparation. According to the present invention, sertraline hydrochloride polymorph II may be produced by slurrying sertraline hydrochloride polymorph VI in aprotic organic solvent. Sertraline hydrochloride polymorphic form III may be produced by heating sertraline hydrochloride polymorphs V and VI. Sertraline hydrochloride forms V and VI may be produced from either sertraline hydrochloride or sertraline base by crystallization. Sertraline hydrochloride Form VII may be produced by suspending sertraline chloride polymorph V in water, followed by filtration. Sertraline hydrochloride Forms VIII and IX may be produced by suspending sertraline base in water followed by acidification and filtration. Sertraline hydrochloride Form X may be produced by suspending sertraline hydrochloride in benzyl alcohol with heating, followed by filtration.
Amorphous sertraline hydrochloride prepared by a process comprising spray drying an aqueous solution of sertraline hydrochloride.
Amorphous sertraline hydrochloride.
A process for the preparation of sertraline hydrochloride in amorphous form which comprises dissolving crystalline sertraline hydrochloride in suitable solvent(s) or dissolving sertraline base in suitable solvent(s) and adding suitable solvent(s) containing hydrogen chloride and recovering sertraline hydrochloride in the amorphous form from the solution thereof by the removal of the solvent by spray drying.
Dependencies are inferred from the claim text.