Exploring the potential of polacrilin potassium as a novel superdisintegrant in microcrystalline cellulose based pellets prepared by extrusion-spheronization

Polacrilin potassium (PP), an ion exchange resin, was used as a superdisintegrant to improve the dissolution of rifampicin, from microcrystalline cellulose (MCC) based pellets prepared by extrusion-spheronization. Production of fast release pellets by extrusion-spheronization using MCC is a complicated process. In the present study, pellets were prepared containing 50% w/w rifampicin (BCS class II drug) and 40% w/w MCC as extrusion-spheronization aid. Different levels of PP and lactose ratio investigated were 0:10, 2:8, 4:6, 6:4, 8:2, and 10:0. Pellets were evaluated for yield, size, size distribution, shape, porosity, friability, residual moisture, and dissolution efficiency (DE) at 30 minutes. Incorporation of this novel superdisintegrant had no adverse effect on the mechanical and micromeritic characteristics of pellets. All the batches of pellets showed high yields′, ~90%; narrow particle size distribution; aspect ratio, 1.0-1.1; friability, <1%; and porosity, 45.51-49.84%. Dissolution profiles were compared using model-independent approaches; DE and similarity factor, f 2 . Addition of Polacrilin results in significant improvement in the DE of rifampicin. The dissolution profiles were significantly different from the dissolution profile of pellets formulated without PP. This preliminary study indicates that PP can serve as an effective superdisintegrant in MCC pellets prepared by extrusion-spheronization.