Solid Dosage Form QbD Quantitative Measurements Of CQAS: Porosity, Density, Surface Area

The purpose of Quality by Design (QbD) is to design and develop formulations and manufacturing processes to ensure a predefined quality. The challenge of QbD is to accurately and quantitatively determine the functional relationship between material/ physical Critical Quality Attributes (CQAs) and Unit Operation Critical Process Parameters (CPPs) and their impact on the finished dosage forms.

Density, porosity, and surface area can be quantitatively correlated to the mechanical properties of the tablet/capsule and used to control key variables within the manufacturing process, as well as being an indicator of content uniformity and dissolution profile performance.