FORMULATION DESIGN AND OPTIMIZATION OF FAST DISINTEGRATING TABLETS OF VALSARTAN: EFFECT OF SUPERDISINTEGRANTS

Oral disintegrating tablets are a novel attractive dosage form in which the tablet disintegrates or dissolves in the buccal cavity within seconds without the use of water. The major drawback in designing this dosage form is unpleasant taste and low solubility of active entity. Valsartan is an antihypertension drug used in treatment of high blood pressure, congestive heart failure (CHF) and post-myocardial infarction (MI). It is characterized by its bitter taste, which effects the patient's compliance. Despite this, it belong to the BCS II Classification in which drugs have low solubility and high permeability. The aim of the present research work was to formulate orally disintegrating tablets of valsartan using natural and synthetic superdisintegrants. The drug was characterized according to different compendia methods, on the basis of identification by UV spectroscopy, pH, organoleptic properties and other tests. Drugpolymer compatibility was carried out by FTIR. The values of pre-compression parameters assessed were within specified limits and showed good free flowing properties. The data on post-compression parameters such as weight variation, hardness, friability, wetting time, water absorption ratio, content uniformity, disintegration time and dissolution was found to be within the prescribed limits. Batch F9 with disintegration time 24 sec was selected as the optimized formulation. Batch F9 was also subjected to stability studies for three months and was tested for its appearance, average weight, hardness, disintegration time, percent friability and its release rate, which were in prescribed ranges and satisfactory.