Design and Evaluation of Fast Dissolving Tablets a Novel Natural Superdisintegrant is used in the Development of a BCS Class -II Drug

Abstract

The main objective of the present investigation was to develop fast dissolving tablets for aceclofenac employing Ocimum gratissimum mucilage, a novel superdisintegrant by using 23factorial design. The mucilage was extracted from the seeds of Ocimum gratissimum and tested for flow properties. The senior development of fast dissolving tablets of Aceclofenac with novel natural mucilage as a superdisinitegrant in different ratios (0-5%) by using the direct compression method and Pre-compression and post-compression characteristics like water absorption (percent) and percent of drug dissolved at 5 min were evaluated for all of the formulated fast dissolving tablets. In all acceptable solvents and buffers, the mucilage powder was found to be a fine, free-flowing amorphous powder with good swelling properties. According to the FTIR and DSC investigations, there were no interactions between aceclofenac and the novel natural mucilage powder. In terms of drug content (98.0±0.14 to 99.9±0.05), hardness (3.8±0.03to 3.9±0.31), and friability (0.11±0.012 to 0.12±0.79), all of the formulation batches are of excellent quality. The batch with the improved formulation had a shorter disintegrant time (27±0.83). The improved formulation F2 has a shorter In–Vitro wetting time (19±0.69). The designed tablets' water absorption ratio was determined to be within the limit at (392.1±0.81). In 10 minutes, the cumulative drug dissolved in the optimised formulation F2 was determined to be (99.93%). As an outcome, it could be used in the formulation of fast dissolving tablets to provide an immediate release of the contained drug within 5 minutes.