New API screening program strengthens Particle Sciences' nanomilling offering

Advanced formulation techniques such as nanomilling may provide an excellent route to improved bioavailability and enhanced therapeutic effect.

The program is designed to assess nanomilling as a dissolution/solubility enhancement option for a client’s API. In as little as 8 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 made available to clients for pharmacokinetic studies.

Up to 90% of APIs in the discovery pipeline are poorly water-soluble, resulting in poor bioavailability and challenges for dosage form development. Nanomilling increases drug surface area, leading to an improved dissolution rate and, therefore, higher bioavailability for BCS class II and IV compounds. Nanomilling is commercially validated with 12 FDA-approved, nanomilled drug products since 2000, including Aristada and Invega Sustenna. Over the years, PSI has nanomilled scores of APIs, including new chemical entities as well as those found in marketed products.

Dr Robert Lee, president of Particle Sciences said: “With so many poorly water-soluble drug candidates emerging from drug discovery, advanced formulation techniques such as nanomilling are increasingly in demand and may provide an excellent route to improved bioavailability and enhanced therapeutic effect. 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.

Dr Lee continued: “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.”