Manufacturing Nanosized Fenofibrate by Salt Assisted Milling

Purpose  The aim of this study is to develop a new process for manufacturing a nano-sized form of the popular cholesterol-reducing drug fenofibrate which can be implemented on industrial scale with minimal changes of currently used production schemes. Methods  Salt-assisted milling was used to reduce particle size of commercial fenofibrate from micron-sized particles to nanometer domains. Results  The optimal parameters for the salt milling are reported, allowing one to reduce the particle size from tens of micrometers to a hundred of nanometers. Dissolution of nano-sized fenofibrate was studied in various formulations and compared against the micron-sized commercially available fenofibrate. Conclusions  The nano-sized fenofibrate demonstrates faster dissolution kinetics in aqueous media, simulating stomach environment, within the first 60 min as compared to the micronized form. The highest dissolution rate is achieved with the nano-sized fenofibrate when surfactants, such as sodium dodecyl sulfate or inclusion complex forming agents such as alpha-cyclodextrin, are used.