ABSTRACT
As advances are made in drug discovery, active pharmaceutical ingredients (APIs) are becoming increasingly selective and potent. From the business standpoint, this is beneficial. With a smaller therapeutic dose, the tablet or capsule delivering, it can be smaller requiring lower amounts of raw materials and the expensive active ingredient. The costs to manufacture APIs are very high and being able to use less per given dose offers a significant saving in the cost of goods sold for the manufacturer. Another cost savings derived from having a smaller tablet or capsule is that more units can come from each batch. Nearly four times as many l00-mg tablets as 400-mg tablets can be compressed out of the same amount of bulk granulation. It is the intent of this chapter to complement the information presented in the previous edition of Drug Products for Clinical Trials, which dealt with handling potent compounds in an aseptic processing environment. In this edition we will discuss handling these compounds in oral solid dosage form processing as it seems to be a growing concern for many organizations.
