Development of fast-disintegrating pellets in a rotary processor.

The aim of the present work was to formulate fast-disintegrating pellets by direct pelletization in a rotary processor. Formulations containing kaolin or bentonite and lactose were agglomerated with or without the addition of crospovidone in an instrumented rotary processor. The effects of the excipients on the amount of wall adhesion, the size and size distribution, the disintegration time, and the shape of the agglomerates, as well as the content of agglomerates > 2800 microns, were investigated. Further, pellets containing a model drug having a low aqueous solubility were prepared, and the drug dissolution profile was compared to that of pellets containing microcrystalline cellulose (MCC). Formulations containing kaolin resulted in fast-disintegrating pellets. Pellets containing bentonite eroded, but did not disintegrate, and the formulations gave rise to large amounts of wall adhesion. The addition of crospovidone increased the water content at the end of liquid addition for all formulations, and resulted in slightly more spherical agglomerates. When comparing formulations containing kaolin and MCC, kaolin gave rise to wider size distributions and a higher amount of agglomerates > 2800 microns, but the drug dissolution rate was much faster. Complete (100%) drug release was seen after 8 min with the kaolin formulation, whereas only 40% was released after 2 hr from the MCC formulation.