Effects of Particle Morphology in Selecting Pharmaceutical Excipients

Abstract

Knowledge of the morphic features of solid excipients used in drug formulation, is important to validate the quality of raw materials and to identify changes in the production line. This paper describes a quantitative method for the characterization of solid excipients based on the analysis of individual particles and quanti-fying the particle shape. The study suggests that Fourier descriptors determined from the particle image data offer valuable and more definitive preformulation parameters. As a consequence, deviation in the performance of the pharmaceutical excipient could be predicted if the particle signature changed.