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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.
1-23. (canceled)
A pharmaceutical composition comprising a therapeutically effective amount of sertraline hydrochloride Form V and a pharmaceutically acceptable carrier.
25-90. (canceled)
Sertraline hydrochloride Form V.
Sertraline hydrochloride Form V characterized by an x-ray powder diffraction pattern comprising peaks at about 5.2°±0.2, 10.4°±0.2, 11.0°±0.2, 14.3°±0.2, 16.5°±0.2, 17.3°±0.2, 18.4°±0.2, 19.1°±0.2, 19.7°±0.2, 20.9°±0.2, 22.0°±0.2, 23.2°±0.2, 23.6°±0.2, 25.5°±0.2, 26.0°±0.2, and 29.1°±0.2 degrees 2 theta.
Crystalline sertraline hydrochloride having a powder XRD pattern as substantially depicted in FIG. 1.
Sertraline hydrochloride having an IR spectrum with bands at 773 cm−1, 822 cm−1, 1012 cm−1, 1032 cm−1, 1054 cm−1, 1133 cm−1, 1328 cm−1, 1562 cm−1 and 1590 cm−1.
Dependencies are inferred from the claim text.