Formulation and Quality – Chemical
2019 PharmSci 360
Drug discovery programs provide a high number of drug candidates that have promising in vitro behavior, but clinical applications are often restricted due to the poor aqueous solubility. The increased surface area of nanoparticles enhances the oral bioavailability via faster dissolution.
In Controlled Expansion of Supercritical Solution (CESS(TM)) method, nanoscale particles are produced (“nanoformed”) by re-crystallization using supercritical carbon dioxide (scCO2). Unlike other nanoparticle manufacturing methods there is no need for excipients, thus pure and homogenous drug nanoformed particles are produced.
Typically, a homogeneous powder blend must be achieved to administrate drug as an oral solid dosage form. Nanoparticles can pose challenging properties (eg. electrostatic charging) due to their small size thus their handling is can be nontrivial. Nanoformed particles often form loosely packed aggregates that can be redispersed back to individual particles. This makes the handling of them much easier and allows formulating efficient solid dosage forms.