FORMULATION AND EVALUATION OF IMMEDIATE RELEASE (IR) TABLETS OF VALACYCLOVIR

The objective of this research work was to formulate, develop and evaluate the immediate release (IR) tablets of valacyclovir 500 mg. The tablets were prepared by direct compression method. For the Immediate release formulation the disintegration time of the tablet must be optimised in order to have a faster release of drug in the dissolution profile. The disintegration time is managed by using the superdisintegrants like sodium starch glycollate and HPC in the formulation. The formulation Trails were optimised by incorporating varying composition of HPC as binder, Sodium starch glycollate as Superdisintegrants, Talc as Glidant and Magnesium Stearate as Lubricant. The different excipients were tested for their compatibility with Valacyclovir, which revealed that there was no chemical and physical interaction occurred. The preformulation parameters such as bulk density, tapped density, compressibility index and Hausner ratio were analysed for prepared granules before compression. The thickness, hardness, friability, weight variation, disintegration time and drug content uniformity was evaluated for tablets. The effect of these variables on the drug release profile of Valacyclovir was also studied. The in-vitro drug release studied were performed in the USP Apparatus-II (Paddle) using water with phosphate buffer PH 6.8 as a dissolution media at 50rpm speed and temperature of 37°C ± 2°c. The sampling was done at periodic time intervals of 5, 10,15,20,25 and 30 minutes and was replaced with equal volume of dissolution media after each withdrawal. The cumulative amount of drug release at different time interval was estimated using UV method based on the evaluation result F7 trial formulation was selected as the best formulation. These results indicated that the selected formulation was stable during the test period of accelerated stability studies.