The program is designed to assess nanomilling as a dissolution/solubility enhancement option for a client's active pharmaceutical ingredient (API). In as little as eight weeks, Particle Sciences will nanomill an API with GRAS-approved excipients, measure particle size distribution and obtain short-term stability data to identify promising formulations. Pre-clinical test samples will then be made available to clients for pharmacokinetic studies.
Up to 90 percent of APIs in the discovery pipeline are poorly water-soluble, resulting in poor bioavailability and challenges for dosage form development. Nanomilling is commercially validated with 12 nanomilled drug products approved by the FDA since 2000 including Aristada and Invega Sustenna. Over the years, Particle Sciences has nanomilled many of APIs, including new chemical entities as well as those found in marketed products.
"With so many poorly water-soluble drug candidates emerging from drug discovery, advanced formulation techniques like nanomilling are increasingly in demand and may provide an excellent route to improved bioavailability and enhanced therapeutic effect,” said Robert Lee, president, Particle Sciences. “While several companies now have nanomilling equipment, few have the extensive knowledge on stabilizing nanoparticulate suspensions and the analytical capabilities that we do. We are also the only CDMO that offers cGMP nanomilling under aseptic conditions."
Particle Sciences has decades of experience developing nanoparticulate suspensions, both with commercial milling equipment and its own proprietary mills. The CDMO has the facilities and equipment to produce clinical and commercial-scale nanomilled formulations.
"Our expertise in this area means we can determine within a short timeframe if nanomilling is a viable technology to improve the solubility of a client's API and facilitate the decision-making process for their project,” said Dr. Lee.