As many as 90% of active pharmaceutical ingredients (APIs) in the discovery pipeline are poorly water-soluble, resulting in poor bioavailability or prohibiting injectable dosage form development.
If you have an insoluble API, nanomilling may be the solution.
Particle Sciences is a leader in nanomilling—an efficient, reproducible, and scalable approach for improving the rate of dissolution and bioavailability of BCS Class II and IV compounds. In just 8 weeks, our nanomilling feasibility program allows us to:
Nanomilling is a proven, commercially validated process for formulating just about any poorly water-soluble API. Numerous BCS class II and IV APIs have benefited from this technology and 10+ nanomilled drug products have gained FDA approval since 2000, including both solid and liquid dosage forms. The key to nanomilling is particle size reduction, which increases the surface area of an API and improves dissolution rate. Compared to other solubilization approaches, nanomilling has key advantages, including:
Particle Sciences has decades of experience developing nanoparticulate suspensions, both with commercial milling equipment and our own proprietary mills. We are the only CDMO capable of performing nanomilling under aseptic conditions. If you choose to move forward with your nanomilling project, we have the personnel, facilities, and equipment to produce clinical and commercial scale nanomilled formulations. If you have an insoluble API, contact us today to learn how nanomilling can help to solve your formulation challenges, and let us take your product from concept to commercial.