Expediting Formulation Optimization and Manufacturing Risk Assessment of Complex Products with Micro-Imaging and Generative AI

Being able to visualize and quantify where the drug and/or excipient resides within a multiphasic formulation, how the drug diffuses and is released from the dosage form, the delivery and disposition of the drug and performance of the dosage form can be a powerful tool towards development of dermal drug products. However, image-based datasets are typically enormous and complex. Efficient ML and AI based tools can greatly enhance our ability to utilize such datasets efficiently during drug product development.

This presentation will discuss how image-based physicochemical and structural characterization techniques can be utilized to visualize and quantify where the drug and/or excipient resides within a multiphasic formulation and how the drug diffuses within and is released from the dosage form. The talk will discuss how currently available ML based algorithms can be utilized to enhance the consistency and efficiency in data collection and analysis. Methodologies for direct visualization and quantification of drug localization within the tissue and disposition of the drug, as well as in silico and generative AI method to advance understanding of drug bioavailability and localization in the skin and to enhance the evaluation of drug product efficacy, comparative product performance and formulation optimization will be discussed.