Mechanistic modeling for optimal design of dissolvable microneedle-based patches for transdermal drug delivery

Polymeric microneedle (MN)-based patches are an efficient, non-invasive, and painless means of drug delivery through the skin to systemic circulation. The design of these MN-based patches can be customized for various drug delivery applications, particularly modified release of drugs. In this study, we developed a mathematical model of drug delivery via MN-based patches to study the effect of patch design properties on drug delivery kinetics and systemic pharmacokinetics (PK). We calibrated the model against two representative formulations: a rapid release patch of naloxone and a sustained-release patch of levonorgestrel. The model was then applied to assess the relative significance of model parameters in governing systemic PK of drugs and obtain optimal design parameters to achieve therapeutically meaningful drug levels in a clinical setting. We identified the importance of drug loading fraction, MN base radius, and MN height as the key control parameters responsible for drug PK.Clinical Relevance- Through the application of modeling and simulation, we can improve drug delivery from MN-based patches by identifying optimal design parameters to support the clinical translation of these novel drug delivery systems.