Pharmaceutical issues such as chemical and physical stability and therapeutic and clinical performance are often related to the solid state properties of active pharmaceutical ingredients (API's). Current industrial approaches for their preparation are via a molecule to crystal, crystal to particle, and particle to dosage form strategy. The approach, which is limited by conventional crystallization techniques, typically requires the use of mechanical comminution techniques (e.g. micronisation) for the processing of colloidal sized particles. These destructive based techniques are severely limited by long processing times, low yields, high polydispersity in particle size and can adversely affect a whole range of highly important physicochemical properties.

There is a need, therefore, for development of a commercializable, widely applicable, molecule to particle approach with specific control of the surface characteristics and surface geometry of colloidal and nano-sized particles which ultimately govern the characteristic properties of the particles. Alternative processes for production, for example with the use of supercritical fluids have recently generated significant interest. They have had limited technical success and even then can only applied to a narrow range of pharmaceutical moieties. Hence there remains the need to develop technologies that specifically address the physico-chemical requirements for controlling dispersion behaviour and solid-state interactions of colloidal particles.

Prosonix have recently entered into a strategic collaboration with the University of Bath (Bath, UK) to commercialize a novel sonocrystallization technology Solution Atomisation and Crystallization by Sonication (SAX ™ ).

This unique single, solution-to-particle-technology, incorporates solution atomisation and anti-solvent sonocrystallization and is set to revolutionize the manufacturing of a range of pharmaceutical moieties.

Preliminary findings have shown significant benefits in the production of particles, particularly for colloidal particles and potential in the production of nanoparticles. The technology allows the production a well-defined particle size range as well as controlling the macroscopic morphology, including polymorphism, and mesoscopic surface topography.