ABSTRACT
Extrusion-spheronization is a pelletization process for making pellets that are amenable for immediate and controlled-release preparations. It includes the processes of blending, granulation, extrusion, spheronization, drying, screening, functional coating (if needed), and encapsulation or compression into tablets. The major advantages in formulating drugs as pellets include (1) a high drug loading, improved homogeneity from uniform distribution of ingredients and improved wetting/dissolution due to a larger surface area than a single unit, such as a tablet. From a bioavailability standpoint, pellets minimize inter-and intrasubject variability and food effects as they undergo gradual but continuous and uniform gastric emptying. In addition, pellets are less prone to dose dumping that is commonly associated with a single unit, such as a tablet. Other advantages include improved flow properties, dust control, and marketing appeal. A list of marketed pellet dosage forms is shown in Table 1.
