(766g) Modeling Dissolution of Polymer Strip Films Loaded with Poorly Water-Soluble Drug Nanoparticles

Thanks to a wide variety of excipients, APIs, and their interactions, reliable prediction of the performance of any solid dosage form is a significant challenge. This is especially true for swellable polymeric strip films containing poorly water-soluble drug nanoparticles, as several different mechanisms may potentially control the rate of drug release. These limiting mechanisms include diffusion of the dissolved drug out of the swollen polymer gel layer, erosion of the polymer matrix, and dissolution of the poorly water-soluble drug particles. The objective of this work is to develop a predictive model for drug release from nanoparticle-laden polymer strip films based on various formulation parameters and inherent drug/excipient properties. This model utilizes first principles to estimate evolution of film thickness, dissolved drug concentration, drug particle size, and water concentration throughout the film over time during the dissolution process. Diffusion of dissolved drug and solvent, drug particle dissolution, polymer erosion, and film swelling/shrinkage are all taken into consideration. Results from this model will be used to better understand the fundamental driving forces behind drug release from poorly water-soluble drug particle-laden polymer strip films, allowing for more intelligent formulation design of targeted applications.