Multiple unite sustained released floating of sodium diclofenac: Formulation and evaluation using factorial design

Abstract

The aim of this study was prepare and evaluate floating granules of sodium diclofenac with lipid excipient for prolonged gastric residence and reduced dose regimen. Floating granules prepared by extruder-spheronization technique. Compritol and gelucire as lipid excipient, HPMC as retardant and tween 80 as emulsifier were used. The effect of drug/lipid, drug/HPMC, drug amount, percentage of tween and type of lipid on floating ability, morphology and dissolution parameters were evaluated by factorial design. Results showed floating ability of granules was influenced by proportion of drug/lipid, drug/HPMC and percentage of tween. Floating property of Compritol was more than gelucire and provided good floating particles. Compritol granules provided suitable sustained release pattern in the manner that increase in D/L reduced D8 and MDT and increase in %T increased MDT. Higuchi model was the best fitted for dissolution data of granules prepared by Compritol and gelucire. In conclusion, Compritol provided more suitable floating ability and sustained release property. Keywords: Sodium diclofenac; Floating granules; Gastric residence time; Extruder-spheronization