Preparation of Deferasirox Dispersible Tablets Based on the Concept of Quality by Design
Based on the concept of quality by design,the key risk factors affecting the quality of deferasirox dispersible tablets were screened out by cause and effect matrix combined with failure mode and effect analysis.The proportion of internal adding microcrystalline cellulose,the proportion of internal adding cross-linked polyvinylpyrrolidone(PVPP)and the concentration of adhesive(PVP K30)were optimized by a full-factorial design with Minitab 17 Software,with the dissolution rate at 15 min as the evaluation index.By implementing validated experiments,the dissolution rates of three batches of the self-made deferasirox dispersible tablets were lower than 40％in pH 1.0 or pH 4.5 media containing 0.5％Tween-20,but the dissolution rates at 15 min were more than 90％in pH 6.8 medium containing 0.5％Tween-20.And the dissolution behaviors between the self-made dispersible tablets and the reference listed drug(Exjade ®)were similar.
quality by designdeferasiroxdispersible tabletin vitro dissolution
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