Managing Director, DigiM Solution
Abstract
The morphological properties of powdered drug intermediates and excipients play a critical role in their downstream compaction, and ultimately the performance of the final dosage form. At the simplest level, particle size distribution is one such parameter. However, when particles deviate from a perfect sphere, there is a larger suite of critical attributes that need to be considered during powder process development and manufacture of the final product. Amongst these include porosity, wall thickness, internal and external surface areas, and inter-ingredient interactions. A suite of high-resolution imaging and AI-based image analysis tools to visualize and quantify these various properties has been developed to assist in process selection and optimization of performance. In this talk, the use of these tools to enhance understanding of tablet mechanical strength, dissolution, and disintegration will be discussed. Further, the connection between upstream processing parameters with downstream behaviors will be reviewed. In total, this new suite of analytics provides an efficient pathway to readily evaluate and optimize different manufacturing processes and their large parameter space. The quantified attributes can be adopted into mechanistic and predictive models for use in current and future programs in both development and regulatory support. Applications presented include spray drying, granulation, hot melt extrusion, and compaction.
