New API screening programme is available from the CDMO
Particle Sciences, a Lubrizol Life Sciences company, has launch of a new Nanomilling Feasibility Programme.
The initiative 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 made available to clients for pharmacokinetic studies," the company said.
According to Lubrizol up to 90% of APIs in the discovery pipeline are poorly water-soluble, resulting in poor bioavailability and challenges for dosage form development.
The company explained: "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 twelve FDA-approved, nanomilled drug products since 2000, including Aristada and Invega Sustenna.
Dr. Robert Lee, president of Particle Sciences, said: “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.
"While several companies now have nanomilling equipment, few have the extensive knowledge on stabilising nanoparticulate suspensions and the analytical capabilities that we do. We are also the only CDMO that offers cGMP nanomilling under aseptic conditions.”
Over the years, PSI has nanomilled scores of APIs, including new chemical entities as well as those found in marketed products.
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.”