Improvement of pellet density with highly drug content prepared by extrusion/spheronization process

摘要

Extrusion/spheronization is recognized as an appropriate method for producing spherical granules with a highly drug content in a single step of manufacture. The effects of formulation and process variables on the characteristics of high dose product have been examined by a factorial approach by Hileman et al. The Response Surface Methodology was also utilized to optimize the desired properties of high dose pellets produced by this method. There is a continuing need to maximize the pellet density in order to accommodate a high dose of drug desired in one capsule. In this study, the improvement on pellet density by the modification of powder characteristics used in the extrusion/spheronization process was examined using Etofibrate as a model drug.