FORMULATION OF ORALLY DISINTEGRATING TABLET OF DONEPEZIL AND ITS COMPARATIVE BIOAVAILABILITY IN HEALTHY VOLUNTEERS

Donepezil is clinically used for treatment of the symptoms of Alzheimer’s disease. It has a very bitter taste and taste masking techniques should be used in orally disintegrating tablets to enhance patient compliance. Many techniques are available to mask the bitter taste of drugs. The objective of the study was to formulate donepezil using ion exchange resin in orally disintegrating tablet and to compare its bioavailability with Aricept® Evess ODT as the reference product as well as to evaluate the in vitro release studies. The in vitro dissolution studies were carried out in three different media. Twenty male volunteers were included in this single-dose, open-label, randomized, two-way crossover study with an overnight fasting and three-week wash out period. Blood samples were drawn up to 72 h following drug administration. Plasma concentration of donepezil was determined by liquid chromatography-tandem mass spectrometry method. Pharmacokinetic data was available for 14 volunteers. No significant differences in pharmacokinetic parameters were detected between both formulation (p-value >0.05). The 90% confidence intervals (CI) for AUC0-72h and Cmax were 93.65%-104.16% and 91.39%-107.32%, respectively. The result of this study indicates that the different technique of taste masking used in the test formulation exhibits pharmacokinetic profiles comparable to reference product in healthy volunteers.