A Comparative Study of Different Proportions of Superdisintegrants: Formulation and Evaluation of Orally Disintegrating Tablets of Salbutamol Sulphate.

Objectives: Superdisintegrants play important role in disintegration of orally disintegrating tablets (ODTs). Action of three different superdisintegrants, viz. croscarmellose sodium, sodium starch glycolate and Indion 414, were studied individually or in their binary combinations for their fast disintegrant action in ODTs of salbutamol sulphate prepared by direct compression.

Materials And Methods: ODTs were prepared in three different superdisintegrant combinations A, B and C. In each combination, five formulations were prepared with superdisintegrants in ratios 10:90, 25:75, 50:50, 75:25, and 90:10. Three ODT formulations were prepared with single superdisintegrant and two ODT batches were prepared from marketed ODT excipient blends, viz. Prosolv-ODT and F-Melt. Prepared ODT formulations were evaluated and compared for weight variation, hardness, friability, wetting time, disintegration and drug release.

Results: All ODTs disintegrated quickly in 32 s or less. ODT formulation F3, containing croscarmellose sodium and sodium starch glycolate, disintegrated very quickly in 19.28±3.11 s. Results of F3 were compared with the batches (F19 and F20) containing marketed coprocessed excipients and found in good agreement for various evaluation parameters. Formulation F20 was hygroscopic, while F3 did not suffer this disadvantage.

Conclusion: Thus, we may conclude that superdisintegrants in combinations may offer additive and/or synergistic disintegration possible due to their different mechanism.