Microstructure Characterization for Optimizing Topical Drug Delivery

The optimization of topical drug delivery systems is increasingly being driven by a deeper understanding of product microstructure. The growing emphasis from regulatory agencies on demonstrating equivalence for semi-solid dosage forms has brought microstructural characterization to the forefront of pharmaceutical development. Microstructure analysis enables rational optimization of formulation composition and processing conditions by elucidating the internal organization of phases, dispersion of active ingredients, and rheological behavior. This, in turn, enhances drug delivery efficiency, ensures batch-to-batch consistency, and improves patient outcomes. This presentation explores the evolving landscape of microstructure characterization, highlighting its rising significance in the development and regulatory evaluation of topical products. 

Drawing from recent literature, this presentation summarizes studies in which microstructure, though not the primary endpoint, provided key insights that supported formulation decisions and conclusive outcomes. These case studies illustrate how microstructural insights can guide rational formulation strategies and enhance the quality and performance of topical therapeutics.