Integration of critical performance attributes through a QbD-informed stability-indicating insight for a novel ungual dosage form.

In this document, we describe the formulation and characterization of a series of preparations of a proprietary modified coconut oil, which have been found to have a strong antifungal character. The physicochemical assessments described show multi source data being collected in a product development and stability testing context and the leveraging of that amalgamated data to make decisions about optimal formulation pathways that can be subsequently pursued and/or scaled up. We believe this to be a novel, yet highly practical adoption of the principles of quality by design and one that does not demand higher order knowledge of statistical concepts, thereby making it both readable and accessible for both practitioners and those with a more general interest in dosage form design.