Formulation and Evaluation of Fast Dissolving Tablet of a Model Anti-Diabetic Drug By Inclusion Complexation Using Beta Cyclodextrin

  In the present investigation an attempt was made to formulate fast dissolving tablets using BCS class II drug Repaglinide, ie low solubility and high permeability to form an inclusion complex to improve the dissolution rate, thus enhancing the bioavailability. Beta-CD inclusion complex was made in varying ratios 1:1, 1:3 and 1:5 of drug and polymer by solvent evaporation method. The complexes were evaluated for phase solubility, drug content and drug release. Phase solubility study revealed AL type indicating linear increase in solubility with increase in the carrier concentrations. The inclusion complex 1:1 ratio prepared by spray dried was studied for drug content uniformity which was ranging from 85-98%, FTIR showed no any compatibility of the drug and beta-CD; DSC and XRD showed distinct loss of drug crystallinity accounting for enhancement in the dissolution rate. SEM revealed spherical shape of the inclusion complex. The drug release study was carried out in 0.1N HCL using USP type paddle dissolution apparatus revealed to be 93% within 5 mins. The FDT was formulated by direct compression method six batches of tablets were prepared with varying ratios of superdisintegrants (F1-F6). The tablets were evaluated for hardness, friability, weight variation, disintegration which was found within the official range, drug content ranging from 89-94%. The formulation F3 containing Crosspovidone was optimized which showed maximum drug release of 98% within 10 mins. Kinetics of drug release from all the tablets followed zero order release with non-Fickian type diffusion. Key words: Repaglinide, Beta- Cyclodextrin, Spray drying and fast dissolving tablets