ABSTRACT
This chapter discusses different excipients traditionally used in granulation applications and the emerging high-functionality co-processed excipients that can improve granulation processing. Successful manufacturing of tablets or capsules requires formulators to consider several factors. These determining factors include the dose level; the physicochemical characteristics of the drug itself, such as its stability, its solubility, flowability and compactability; and ultimately the equipment used to form the final dosage unit, that is, a capsule filling machine or a tablet press. For the various granulation processes, several excipients can be selected to address the challenges posed by adverse drug substance properties and impart the desired properties to the in-process material and finished product. The complexity, sources of variability, and costs associated with granulation processing have brought about the need for higher-performing excipients to better address these challenges and possibly avoid granulation altogether. The chapter discusses the importance of excipients in the production of various solid dosage forms, and how their characteristics affect quality attributes of the final dosage forms.
