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 < 30 o , 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 MCM 3 was tested for in vitro drug release pattern in pH 6.8 phosphate buffer and stability (at 40 0 C/75 % RH for 3 months), drug excipients interaction (IR spectroscopy) were studied. Among the designed formulations, the formulation (MCM 3 ) containing 8 % w/w of co-processed superdisintegrant (1:3 mixture of microcrystalline cellulose and mannitol) emerged as the overall best formulation (t 50% 1.6 min) based on drug release characteristics in pH 6.8 phosphate buffer compared to commercial conventional tablet formulation (t 50% 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).
ABSTRACT:The aim of the present work was to prepare and evaluate fast dissolving tablets of nebivolol with a view to enhance patient compliance and minimize the side effects. In this study, fast dissolving tablets of nebivolol were formulated by direct compression method using mucilages of tapioca seeds (Manihot esculenta), basella climb (Basella alba), red sorrel (Hibiscus sabdariffa) as natural disintegrants and crosspovidone as a synthetic superdisintegrant in different ratios with directly compressible mannitol (Pearlitol SD 200) as a diluent to enhance the mouth feel. The prepared formulations were evaluated for hardness, friability, drug content, in vitro dispersion time, wetting time, water absorption ratio, in vitro drug release, stability and excipients interaction. Among all the formulations, the formulation (FHD 3 ) containing 8% w/w mucilage of Hibiscus sabdariffa was the overall best formulation (t 50% 1.7 min) based on in vitro drug release studies. Stability studies on the formulations indicated that there are no significant changes in drug content and in vitro dispersion time (p<0.05). From the above studies, it can be concluded that fast dissolving tablets of nebivolol can be prepared using different mucilages as natural disintegrants for faster dispersion and disintegration in the mouth.
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