Abstract

Solid drug nanoparticles (SDNs) have been produced commercially using technologies such as milling where large fragments of crystalised drug are ground into particles with diameters measurable in nanometers. This approach has been shown to overcome bioavailability issues for some poorly absorbed and insoluble drugs but does have some limitations because of incompatibility with drugs with certain physiochemical properties. Using a novel technology that produces SDNs through freeze drying or spray drying emulsions may be more broadly applicable across drugs. The application of this new approach to the formulation of poorly soluble antiretroviral drugs will be discussed, including benefits for oral bioavailability in pre-clinical species. The SDN formulations have shown the potential for reduced doses and benefits for paediatric administration formats for antiretroviral drugs. These formulations have undergone GMP manufacture and are in stability testing to support regulatory documentation for clinical evaluation in 2014.