APPLICATION OF LOW SUBSTITUTED HYDROXYPROPYLCELLULOSE (L-HPC) IN THE PRODUCTION OF PELLETS USING EXTRUSION SPHERONIZATION

Low-substituted hydroxypropyl cellulose (L-HPC) was used as a binder and disintegrant in granulation and tabletting. The influences of L-HPC on the extrusion process and the characteristics of pellets prepared by extrusion/spheronization were studied. In one trial the type of L-HPC was varied, in a second the amount of L-HPC LH 20. In both trials pellets were manufactured using different quantities of granulation fluid. Depending on the formulation a working range for water contents leading to beads was defined. In the upper part of the working range the quality of the spheres was good in terms of aspect ratio and sphericity. However, the dissolution rate was found to decrease as the water content of the extrudate increased. All types of L-HPC accelerated the dissolution of acetaminophen. There was no strong correlation between porosity and dissolution time, but increasing porosity tended to lead to faster dissolution. Pellets without L-HPC combined low dissolution rate with low porosity while those with L-HPC LH 20 showed the highest dissolution rate and the greatest porosity.