Novel co-processed spray dried super disintegrants designing of fast dissolving tablets using

Abstract

In the present study, novel co-processed superdisintegrants were developed by spray drying method
using microcrystalline cellulose and mannitol in different ratios (1:1, 1:2 and 1:3) for use in the fast dissolving tablet
formulations. The developed excipients 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 < 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 22.23 sec), promising
formulation MCM3 was tested for in vitro drug release pattern in pH 6.8 phosphate buffer and stability (at 40 0C/75
% RH for 3 months), drug excipients interaction (IR spectroscopy) were studied. Among the designed formulations,
the formulation (MCM3) containing 8 % w/w of co-processed superdisintegrant (1:3 mixture of microcrystalline
cellulose and mannitol) emerged as the overall best formulation (t50% 1.6 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).