Challenges and considerations of automated agglomeration detection method development with image analysis in dissolution testing

Dissolution testing is widely used during all stages of drug development. The potential to develop an imaging analysis method to automatically detect agglomerations during dissolution testing has recently been explored. The stages of the method development were manual observation of pre-recorded videos from the dissolution testing, choice of parameters for agglomerate identification and 2-stage method validation (internal and external). This work presents the two main challenges faced during the agglomeration identification method (AIM) development a) attaining an optimal number of particle detections in a video frame and b) discerning different objects (e.g., air bubbles, single particles and agglomerates) based on their specifications.