ORIGINAL RESEARCH ARTICLE Open Access The First Scale-Up Production of Theranostic

Theranostic nanomedicines are a promising new technological advancement toward personalized medicine. Although much progress has been made in pre-clinical studies, their clinical utilization is still under development. A key ingredient for successful theranostic clinical translation is pharmaceutical process design for production on a sufficient scale for clinical testing. In this study, we report, for the first time, a successful scale-up of a model theranostic nanoemulsion. Celecoxib-loaded near-infrared-labeled perfluorocarbon nanoemulsion was pro-duced on three levels of scale (small at 54mL, medium at 270mL, and large at 1,000mL) using microfluidization. The average size and polydispersity were not affected by the equipment used or production scale. The overall nanoemulsion stability was maintained for 90 days upon storage and was not impacted by nanoemulsion pro-duction scale or composition. Cell-based evaluations show comparable results for all nanoemulsions with no sig-nificant impact of nanoemulsion scale on cell toxicity and their pharmacological effects. This report serves as the first example of a successful scale-up of a theranostic nanoemulsion and a model for future studies on theranos-tic nanomedicine production and development. Key words: drug development technologies; drug discovery; inflammatio