Abstract
In solid dosage forms, fast dissolving tablets has shows the superior way for ease of administration for the patients. The present senario involves in the optimization andevaluation of starch glutarate as a novel superdintegrant in the formulation of fast dissolving tablets of Ibesartan employing 23 factorial design. Starch glutarate was synthesized by esterification process. The synthesized starch glutarate was subjected to physical and micromeritic evaluation. The, fast dissolving tablets of Irbesartan were prepared by employing starch glutarate as a superdisintegrant in different proportions by using 23 factorial design and by direct compression method. All the preparedbatches of fast dissolving tablets were evaluated for drug content, hardness, friability, disintegration time and other dissolution characteristics like percent dissolved in 5 min (PD5), Dissolution efficiency in 5 min (DE5%) and first order rate constant (K1). The starch glutarate prepared was found to be fine, free flowing amorphous powder it exhibited good swelling in water. Fourier transform infrared spectra (FTIR) and Differential scanning calorimetry (DSC) study indicated the absence of interaction between Irbesartan and starch glutarate. All the batches of fast dissolving tablets formulated by employing starch glutarate were of good quality with regard to drug content (100±5%), hardness (3.6–4 kg/sq. cm), and friability (0.12–0.15%). The optimized formulation F8 has the least disintegration time i.e., 30±0.02s. The in vitro wetting time was less (i.e., 90s) in optimized formulation F8. The cumulative drug dissolved in the optimized formulation F8 was found to be 99.15±0.56% in 10 min. Starch glutarate was found to be a superdisintegrant which enhanced the dissolution efficiency when combined with crospovidone, croscarmellose sodium, with the Irbesartan and hence it could be used in the formulation of fast dissolving tablets to provide immediate release of the contained drug within 15 minutes.
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