escitalopram oxalate crystalline particles, solid single dosage form, and methods for the manufacture of escitalopram oxalate crystalline particles and for reducing the amount of hydroxyl containing impurities in citalopram, escitalopram or a non-racemic mixture of r- and s -citalopram

摘要

Crystalline Particles Of Scithalop Oxalate, Form Of Solid Only Dosage, And Methods For The Manufacture Of Scithalopra Oxide And To Reduce The Amount Of HYDROXYAL SCRIPTURE IN THE SCPALOPHRAM The present invention discloses escitalopram oxalate crystalline particles having a broad particle size distribution or comprising at least 0.01% (w / w) of Z-4- (4-dimethylamino-1- (4-fluoro). phenyl) -but-1-enyl) -3-hydroxymethylbenzonitrile, said particles being suitable for use in direct compression. In addition, the invention discloses a novel single pharmaceutical dosage form containing such escitalopram oxalate crystalline particles as well as methods for the manufacture of such escitalopram oxalate crystalline particles. Finally, the invention provides a method for reducing the amount of hydroxyl containing impurities in a citalopram or escitalopram solution.