Film-forming polymer granulated excipients as matrix materials for the production of pellets by Extrusion/Spheronization

The composition of excipients may greatly affect the manufacture processes and the characteristics of pellets produced by the extrusion/spheronization method. Pellets prepared by the matrix materials of film-forming polymers granulated excipients with microcrystalline cellulose (MCC) were evaluated. Two model drugs, nifedipine and captopril, were tested in this study. Both polymeric granulated lactose and dibasic calcium phosphate (DCP) with either Eudragit RL 30D, RS 30D or Surelease as well as their native forms were used. Spray granulating either lactose or DCP with polymeric materials of Eudragit RS/RL or Surelease did not affect the overall performance of the pellets. Nifedipine and captopril pellets prepared by the same excipient compositions required quite different amount of water during the preparation due to their differences in solubility. Using polymeric granulated excipients could somewhat affect the dissolution profiles yet the extent was limited.