Method of manufacturing sustained release microbeads containing venlafaxine HCL

摘要

A sustained release Venlafaxine composition that includes a plurality of non-agglomerated, uniformly-shaped and sized microbeads of inert core particles having a first coating layer. The first coating layer includes an active agent of Venlafaxine or a pharmaceutical acceptable salt thereof, a binder, and an anti-tack agent. The active agent is present in the first coating layer in a concentration of at least about 5% to about 70% by weight of the composition, the binder is present in an amount of at least 35% by weight of the active agent, or in a further layer located upon or below the first coating layer, or as an alternating layer between plural first layers, wherein the binder is present in an amount of less than about 2.5% by weight of the composition, and the anti-tack agent is present in the first coating layer in a concentration of about 2.5% to about 20% by weight based on the weight of the active agent. The composition is also substantially free of organic acid.