Xspray’s RightSize-technology platform has overcome the above mentioned difficulties since the technology constructs hybrid nanoparticles (HyNap) of the active PKI-substance which is a stable, amorphous and solid dispersion. Normally, this is not the case with amorphous substances who, given time, tends to pass on to a more thermodynamically stable crystalline form. Recent data confirms that Xspray’s HyNap-particles remain amorphous and without any traces of crystals for more than two years, affirming the product’s long term usability.
The technology is based on super critical liquid extraction (SCF). The criteria for meeting a super critical condition is met when there no longer is a discernible boundary between liquid and gas and the temperature is raised above the so called thermodynamically critical point.
Molecules in super critical condition are able to move quickly, like when in a gas, while at the same time having the ability, like in liquid, to dissolve substances. The super critical fluid is used as an anti solvent in controlled particle precipitation of API with or without the addition of excipients. SCF-technology was developed in the pharmaceutical industry during the 1990s and despite large investments in SCF-plants with its known advantages, commercial production scale was not possible because of upscaling difficulties.
Xspray has overcome this obstacle through the company’s first invention, a mouth-piece capable of scalability never seen before. In one particular example, the measured productivity was 100 times higher than compared to previously published results.
The underlying reason behind the successful upscaling of Xspray technology is the unique mouth-piece design which enables a robust manufacturing of fast dispersion nanoparticles according to a bottom up-process (construction of particles from a solution). At present, there is no available production scale technology that manufacture hybrid nanoparticles of PKI’s in this manner. The established top down-process where bigger particles are grinded down to smaller ones have many disadvantages in the following separation process.
The unique mouth piece-design keeps mixing conditions constant, regardless of the dimension of the said piece. This enables the upscaling from smaller laboratory quantities to larger batches for clinical and commercial production.