CA2489295A1 — Spherical pellet containing a water-soluble active ingredient

USPTO Abstract

A process for preparing spherical pellets comprising (a) a water-soluble active ingredient soluble, freely soluble or very soluble in water; and in particular having a water-solubility of >= 0.5 g/ml; (b) a spheronizing agent; (c) a dry lubricant, said method comprising preparing a mixture of the active ingredient, the spheronising agent, the dry lubricant; and an amount of water which is less than 5%, w/w relative to the total weight of the mixture; extruding said mixture to obtain an extrudate; and spheronising the extrudate to form spherical pellets. The invention further concerns pellets obtained by this process and sustained release oral dosage forms containing said pellets.