FORMULATION AND EVALUATION OF ORODISPERSIBLE TABLETS OF TRAMADOL HYDROCHLORIDE USING NOVEL CO-PROCESSED SUPERDISINTEGRANTS

Abstract

In the present work, orodispersible tablets of Tramadol hydrochloride were prepared using novel co-processed superdisintegrants consisting of crospovidone and sodium starch glycolate in the different ratios (1:1, 1:2 & 1:3). 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 excipients was found to be < 25^o, Carr’s index in the range of 11-15% and Hausner’s ratio in the range of 1.12-1.17. Orodispesible tablets of Tramadol hydrochloride were prepared using the above co- processed superdisintegrants and evaluated for pre-compression and post-compression parameters. Based on in vitro disintegration time (approximately 18 sec), promising formulation CP1 was tested for in vitro drug release pattern in 0.1N HCl and drug excipients interaction (FT-IR spectroscopy, DSC) were studied. Among the designed formulations, the formulation (CP1) containing 4% w/w of co-processed superdisintegrant (1:1 mixture of crospovidone and sodium starch glycolate) emerged as the overall best formulation (t50% 1.46 min) based on drug release characteristics in 0.1N HCl compared to commercial conventional tablet formulation (t50%> 8 min).