FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLET OF BISOPROLOL FUMARATE

The main objective of this research work was to formulate and evaluate an Orodispersible tablet of Bisoprolol Fumarate for the treatment of hypertension and coronary artery disease. Formulation was designed using systat software version 13.2. 3² full factorial design was applied, in which two variables were varied at three levels. The tablets of Bisoprolol Fumarate were developed by direct compression method. The prepared tablets were evaluated for thickness, hardness, friability, weight variation, wetting time, content uniformity, disintegration time and in-vitro dissolution. FTIR studies indicated that drug and excipients were compatible. Pre-compression and post-compression parameters were satisfactorily within acceptable limits. The results indicated that concentration of croscarmellose sodium and diluents ratio significantly affected on disintegration and in-vitro dissolution study. Formulation SF9 showed shortest disintegration time (7.3 sec.), shortest wetting time (13.4 sec) and better drug release (99.8%) compared to other formulations. Hence it was selected as optimized formulation. The 3D response surface plots indicated that an increase in the concentration of croscarmellose sodium and an increase in the diluent ratio decreased in the in-vitro disintegration time and increased the percentage drug release. Kinetic study revealed that drug release from all formulations followed first-order kinetics. It was concluded that oral dispersible tablets of antihypertensive drug can be successfully formulated and used as a novel drug dosage form for pediatrics and geriatrics with improved patient compliance.