FORMULATION AND EVALUATION OF FAST DISSOLVING TABLETS OF NEBIVOLOL AND VALSARTANAbstract
Better patient compliance can be achieved using a combination of two drugs compared to a single drug. The main objective of the present research work has been done to prepare fast dissolving tablets of Nebivolol HCl (NEB) and Valsartan (VAL) using super disintegrating agents. Solid dispersions of VAL were prepared with Mannitol to improve the solubility and release behavior in dissolution fluid. Fast Dissolving tablets of NEB and VAL were formulated by employing the direct compression method. The prepared fast dissolving tablets were evaluated for various parameters like weight variation, hardness, friability, disintegration time, drug content, wetting time, in-vitro drug release, FTIR, DSC studies and short term stability studies. It was found that ratio 1:1 (VAL: Mannitol) shown satisfactory drug release compared to other prepared solid dispersion. Pre-formulation studies of both drugs were performed. The FTIR and DSC studies revealed that there is no chemical interaction with excipients. Percentage weight variation and drug content uniformity were found to be within the approved range of all the formulations. Evaluation parameters like hardness and friability indicated good mechanical resistance of the tablets for all the formulations. The in-vitro release studies showed that 99.6% of NEB and 99.5% VAL within 90 sec. Overall, in the formulations prepared by the direct compression method, F13, which contains 6% CCS as super disintegrants release 99% of (NEB and VAL) in 2 min was found to be the best formulation. The results concluded that fast dissolving tablets of NEB and VAL showing enhanced dissolution might lead to improved bioavailability and effective therapy for hypertension.
D. M. Patel *, D. J. Patel, S. K. Shah and A. S. Shah
Department of Pharmaceutics, Saraswati Institute of Pharmaceutical Sciences, Dhanap, Gandhinagar, Gujarat, India.
08 November 2019
16 March 2020
07 May 2020
01 November 2020