FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLETS OF DONEPEZIL HYDROCHLORIDE USING MODIFIED POLYSACCHARIDES

ABSTRACT The objective of the study was to prepare and evaluate orodispersible tablets of Donepezil Hydrochloride (DPH) using natural modified polysaccharides such as modified karaya gum and modified agar with glycine and mannitol. The prepared formulations were compared with Kyron T-314, super disintegrant, spray dried lactose, diluent for improvement in DT and other ODT parameters. FTIR studies revealed no interaction between DPH and excipients. Precompression parameters for all formulations were found to be satisfactory. The oral dispersible tablets formulated using modified agar with glycine showed better disintegration time compared to modified karaya gum formulations. Different concentrations of mannitol and glycine were used in the formulation to study the improvement in the DT. The glycine formulations with modified agar gave better ODT parameters than modified karaya gum with mannitol and glycine formulations. The optimized formulations of modified agar with glycine in different concentrations were prepared with spray dried lactose as diluent and compared with formulations of Kyron T-314 as superdisintegrant with spray dried lactose as diluent. The results of lactose and spray dried lactose as diluents in these formulations did not show any significant difference in ODT evaluation parameters. The formulations were optimized using ODT parameters such as disintegration time, wetting time, water absorption ratio and other physicochemical evaluation parameters.  The accelerated stability studies of optimized formulation did not show significant changes compare to initial physicochemical evaluation parameters to conclude, modified polysaccharides with glycine can be used as superdisintegrant, which may be a cost effective alternative in comparison to synthetic superdisintegrant like Kyron T-314.