Quality by design optimisation of active pharmaceutical ingredient dispersions based on physicochemical parameters

Abstract

Current information lacks richness in systematic methods that may give an indication as to the effectiveness of a specific set of dispersing conditions prior to their application, particularly for dispersions in hydrophobic media. This study addressed the possibility of constructing a predictive model that may indicate the effectiveness of a specific set of dispersion conditions prior to their application, particularly for dispersions in hydrophobic media. In particular, the objectives were to determine the physicochemical characteristics of the dispersing media that are potentially influential in the dispersability of powders, to characterise the properties of the active pharmaceutical ingredients that could contribute to the ability to form stable dispersions, and to characterise the dispersions of the active pharmaceutical ingredients (APIs) in the dispersing media or dispersing media-surfactant mixtures.