Past, current, and future: Application of image analysis in small molecule pharmaceutical development.

ABSTRACT

The often-perceived limitations of application of image analysis have for many years impeded the widespread application of such systems as first line characterisation tools. Image analysis has, however, undergone a notable resurgence in the pharmaceutical industry fuelled by developments system capabilities and the desire of scientists to characterize the morphological nature of their particles more adequately. The importance of particle shape as well as size is now widely acknowledged. With the increasing use of modelling and simulations, and ongoing developments though the integration of machine learning and artificial intelligence, the utility of image analysis is increasing significantly driven by the richness of the data obtained. Such datasets provide means to circumvent the requirement to rely on less informative descriptors and enable the move towards the use of whole distributions. Combining the improved particle size and shape measurement and description with advances in modelling and simulations is enabling improved means to elucidate the link between particle and bulk powder properties. In addition to improved capabilities to describe input materials, approaches to characterize single components within multicomponent systems are providing scientists means to understand how their material may change during manufacture thus providing a means to link the behaviour of final dosage forms with the particle properties at the point of action. The aim is to provide an overview of image analysis and update readers with innovations and capabilities to other methods in the small molecule arena. We will also describe the use of AI for the improved analysis using image analysis.