Formulation Optimization and Evaluation of Novel Oro-dispersible Tablet of Bilastine

Abstract

The current study focuses on the development, optimization, and assessment of bilastine orodispersible tablets (ODTs) for the treatment of allergic disorders such as rhino-conjunctivitis and urticaria flavour concealed by an organoleptic technique. The formulation was optimized based on the direct compression method by the use of various super disintegrants such as cross povidone, sodium starch glycolate and croscarmellose sodium. The excellent product performance of ODTs in terms of disintegration time and in-vitro drug release may be achieved by varying the amount of super disintegrants. The direct compression approach was used to create novel anti-histamine Orodispersible tablets of bilastine. Design expert software was used to create nine formulations (BLS1-BLS9) by altering super disintegrant concentrations in order to optimise the optimal formulation using 32 factorial design and central composite design in the quadratic model (version 13.0.5.0). Pre-Compression studies like bulk density, tapped density, angle of repose, carr's index, Hausner’s ratio to note flow properties of powder and compatibility such as Fourier transform infrared spectroscopy (FTIR) and differential scanning calorimetry (DSC) were performed to check any interaction between drug and various super disintegrant. The hardness, thickness, diameter, weight variation, friability, disintegration time, dissolution studies, wetting time, and uniformity of content of formulated ODTs were all evaluated. All the results were within the acceptable pharmacopeial limits and were evaluated statistically by using one-way ANOVA test. From the result, BLS8 was observed optimized formulation prepared by taste masking by an organoleptic method as a novel technique using direct compression as conventional technology containing a combination of various sweetening and flavoring agents such as orange and peppermint flavor.