Incorporation of Fenofibrate Nanoparticles Prepared by Melt Emulsification into Polymeric Films

The aims of this study are to develop polymeric films loaded with nanoparticles of fenofibrate (FNB), a poorly water-soluble drug, prepared via melt emulsification (ME) and study the short-term physical stability of the ME-based suspensions, with the ultimate goal of enhancing FNB dissolution. FNB particles in water were heated above the melting point to form an oil-in-water emulsion, whose cooling turned FNB droplets into solidified FNB nanoparticles. The resulting FNB suspensions, along with a suspension of as-received FNB, were mixed with hydroxypropyl methylcellulose (HPMC)-glycerin solution to prepare film precursor suspensions, which were then casted and dried into films. The effects of the presence of Pluronic F68 (PF68) as stabilizer and the sonication during the cooling step on the physical stability of the suspensions were investigated. For films, drug content, redispersibility, and drug release in a USP IV dissolution test were studied. The results show that cooling the FNB-PF68 emulsion in the presence of sonication produced suspensions with acceptable 7-day physical stability, whereas cooling the same without sonication led to severe particle aggregation within 20 min. The film redispersion in water led to effective recovery of FNB nanoparticles only when PF68 and sonication during the cooling step were used. Good drug content uniformity and enhanced FNB dissolution were obtained from the films containing FNB nanoparticles stabilized with PF68, but the impact of sonication on the FNB dissolution was not discernible. Overall, feasibility of films carrying ME-based drug nanoparticles for enhanced dissolution has been demonstrated.