Physicochemical characterization and enhancement of oral bioavailability of aceclofenac: Gelucire 14/44 solid dispersion

In this study,the significant effect of gelucire 14/44 on improving the dissolution rate and bioavailability of aceclofenac has been demonstrated by spray drying method. solid dispersion of aceclofenac and gelucire 14/44 (1:10) was prepared. the spray dried drug and the prepared solid dispersion were characterized in terms of solubility,drug content and thermal behavior by differential scanning calorimetry (dsc),x-ray diffraction (xrd) and scanning electron microscopy (sem),in in vitro drug release and stability study systems. the in vivo performance was assessed by pharmacokinetic studies. the dsc showed a decrease in the melting enthalpy indicating disorder in the crystalline content. the xrd also revealed a characteristic decrease in crystallinity. the dissolution studies demonstrated a marked increase in the dissolution rate in comparison with pure drug. a considerable improvement in the dissolution rate of aceclofenac from solid dispersion formulation was attributed to the wetting effect of gelucire 14/44,decreased drug crystallinity,altered surface morphology. the solid dispersion exhibited excellent stability on storage at accelerated conditions. the in vivo studies revealed that the solid dispersion formulation provided improved pharmacokinetic parameters in rats compared to the pure drug.