Abstract
In the present study, novel co-processed superdisintegrants were developed by Spray drying method using MCC, Crospovidone, and Aerosil in the different ratios (88:10:2, 90:8:2, 92:6:2) for use in the fast dissolving tablet formulations. The developed superdisintegrants were evaluated for angle of repose, Carr’s index and Hausner’s ratio in comparison with physical mixture of superdisintegrants. The angle of repose of the developed superdisintegrants was found to be < 30o, Carr’s index in the range of 9-15% and Hausner’s ratio in the range of 1.12-1.16. Fast dissolving tablets of glibenclamide were prepared using the above co-processed superdisintegrants and evaluated for pre-compression and post-compression parameters. Based on in vitro dispersion time (approximately 12.56 sec), promising formulation MCPA3 was tested for in vitro drug release pattern in pH 6.8 Phosphate buffer and stability (at 400C/75% RH for 3 months), drug excipients interaction (IR spectroscopy) were studied. Among the designed formulations, the formulation (MCPA3) containing 8% w/w of co-processed superdisintegrant (92:6:2 mixture of MCC, Crospovidone and Aerosil) emerged as the overall best formulation (t50% 1.5 min) based on drug release characteristics in pH 6.8 phosphate buffer compared to commercial conventional tablet formulation (t50% 6 min). Stability studies on promising formulation indicated that there were no significant changes in drug content and in vitro dispersion time (p<0.05). It can be concluded that Co-processed superdisitegrants prepared by spray drying method consisting of MCC, Crospovidone and Aerosil exhibited good flow and compression characteristics.
