Development of a nystatin nanosuspension formulation using high pressure homogenisation

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Nystatin is the current treatment of choice for Oropharyngeal candidiasis (OPC), a common fungal infection of the oral cavity. Poorly soluble nystatin is formulated as a suspension intended for local application. The bioavailability of the active ingredient after oral administration is limited and principally eliminated in the faeces. Nanosizing of poorly soluble drugs has been reported as an attractive approach to improve their efficacy after oral administration. A previous publication showed that nanosizing provides a promising approach to increasing the efficacy of topically administered nystatin in the treatment of OPC. A foregoing formulation screening of nystatin using three different nanomilling processes showed that high pressure homogenisation technique offered a better milling yield than the wet milling while the size of 90% of particles in the obtained suspension were smaller than 1.9 µm. The goal of the present project is to explore new formulations of nystatin suspension in order to obtain better results in terms of particle size and physical stability, using the high pressure homogeniser. The new formulations will be compared with the commercial nystatin suspension milled in the same conditions. The chemical stability, the physicochemical stability, the presence of residual contamination and the nanoparticle aggregation will be assessed during the long-term stability study of the promising formulation of nystatin nanosuspension.