ABSTRACT
A quality by design approach to the development of pharmaceutical dosage forms
requires the careful characterization and understanding of the properties and limitations
of the product and process. In solid dosage form development, tablets are the most
common, and often least expensive, vehicle for dosing active pharmaceutical ingredients
(API). One of the most significant challenges early in tablet development is the limited
quantity and high cost of bulk material (usually API) that is available for laboratory
experimentation and manufacturing process scale-up. Therefore, “material sparing” tools
for powder characterization and process understanding, such as compaction simulators,
are key to the efficient and cost-effective development of tablets.
