Contract development and manufacturing organisation (CDMO) Particle Sciences has launched a new active pharmaceutical ingredient (API) screening programme in order to strengthen its nanomilling offering.
Particle Sciences
The company’s Nanomilling Feasibility Programme is designed to assess nanomilling as a dissolution/solubility enhancement option for a client’s active pharmaceutical ingredient (API). Through the programme, Particle Sciences can nanomill an API in eight weeks and obtain short-term stability data to identify promising formulations. Afterwards, pre-clinical test samples can be 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 higher bioavailability for BCS class II and IV compounds.
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.”