Production of pseudoephedrine hcl pellets in a high-shear mixer-granulator

Abstract

Pelletization in a high shear mixer-granulator was tested as an alternative for the most widely used pelletization process, which is extrusion followed by spheronization. High dosage range pellets were produced with pseudoephedrine HCl as a model drug substance and microcrystalline cellulose as the main excipient. Strong pellets with a relatively narrow particle size distribution were produced. Two conclusions could be made. Firstly, the pseudoephedrine HCl concentration and particle size of the pellets influenced the bulk and true density; secondly, pseudoephedrine HCl was completely released from the pellets in a few minutes accordingly the Higuchi equation.status: publishe