Application of an AI image analysis and classification approach to characterise dissolution and precipitation events in the flow through apparatus

Abstract

Imaging and artificial intelligence (AI) approaches have been used with increasing frequency in pharmaceutical industry in recent years. Characterisation of processes such as drug dissolution and precipitation is vital in quality control testing and drug manufacture. To support existing techniques like in vitro dissolution testing, novel process analytical technologies (PATs) can give an insight into these processes. The aim of this study was to create and explore the potential of an automated image classification model based on image analysis to identify events (dissolution and precipitation) occurring in the flow-through apparatus (FTA) test cell, and the ability to characterise a dissolution process over time. Several precipitation conditions were tested in a USP 4 FTA test cell with images recorded during early (plume formation) and late (particulate re-formation) stages of precipitation. An available MATLAB code was used as a base to develop and validate an anomaly classification model able to detect different events occurring during the precipitation process in the dissolution cell. Two variants of the model were tested on images from a dissolution test in the FTA, with a view to application of the image analysis system to quantitative characterization of the dissolution process over time. It was found that the classification model is highly accurate (>90%) in detecting events occurring in the FTA test cell. The model showed potential to be used to characterise the stages of dissolution and precipitation processes, and as a proof of concept demonstrates potential for deep machine learning image analysis to be applied to kinetics of other pharmaceutical processes.

Keywords: Artificial Intelligence (AI); Dissolution; Flow-through apparatus; Image analysis; Image classification; Machine Learning (ML); Precipitation.