Characterization and comparison of deferasirox fast disintegrating tablets prepared by direct compression and lyophilization methods

The aim of this study was to develop direct compressed and lyophilized fast disintegrating/dissolving tablets (FDTs) that enhanced disintegration and dissolution of deferasirox, a drug with poor solubility and bioavailability. Although there are conventional oral tablets and tablets for oral suspension of deferasirox in the market, deferasirox oral FDTs are not yet available in the market and under investigation. Direct compression and lyophilization methods were used to obtain deferasirox FDTs. The influence of formulation content and production methods on the disintegration time, in vitro dissolution, and permeability of deferasirox from FDTs, along with other tablet characteristics, such as thickness, diameter, hardness, friability, weight variation, and water absorption ratio were evaluated. Additionally, flow characteristics of powder prepared for direct compression method were detected. Results indicates that the powder is suitable for tablet compression with its fair flow, good compressibility, and low moisture content. Results of disintegration and dissolution studies demonstrated that lyophilized FDTs disintegrated within 5 s and showed a faster dissolution rate compared to the direct compressed FDTs. We suggest that deferasirox FDTs prepared by direct compression or lyophilization methods can be promising formulations resulting in increased patient compliance and rapid onset of action.