Simultaneous in-line particle size distribution determination of drug and excipient from their powder blend using endoscopic imaging and AI.

This paper presents a method capable of simultaneously measuring component-based particle size distribution and API concentration via direct, in situ measurements in bulk powders. The method uses real-time imaging with a probe connected to a digital camera, and machine vision combined with artificial intelligence to process the images. The pharmaceutical processing environment was simulated with a conveyor belt. The blends consisted of acetylsalicylic acid (ASA) and calcium hydrogen phosphate (CHP). The determined component-based particle size distributions were compared to references measured using a microscope, and the results showed good correlation. The method not only proved effective in real-time component-based particle size distribution determination but was also able to provide information about the API concentration of the blends. This technique could provide valuable, real-time information about bulk powders used in pharmaceutical processing environments. Therefore, the method has the potential to play a central role in monitoring product quality in bulk powder processing providing assistance in the development of pharmaceutical quality control.