Formulation Development and Evaluation of Nimesulide Mucoadhesive Tablets using Bael (Aegle marmelos) gum powder as Binder

The aim of the study was to formulate mucoadhesive tablet of Nimesulide (as a model drug), using extracted mucoadhesive gum from Aegle mermelos fruit and carbopol-934 at different concentration as mucoadhesive binder and the evaluation of its mucoadhesive properties.

Nine formulations were prepared by software Design expert 9 using 2.27%, 0%, 10%, 5.99%, 0.37%, 10%, 6.32%, 10%, 10% w/w of Aegle marmelos gum powder and 2.72%, 10%, 0%, 6.14%, 10%, 0.37%, 6.29%, 9.7%, 10% w/w of carbopol-934 by wet granulation compression method (F1, F2, F3…. F9 respectively). Drug excipients interaction studies like FTIR and DSC were carried out. Different parameters such as weight variation, hardness, friability, drug content uniformity or assay, release rate study, mucoadhesive study were evaluated for the tablets of all the formulation batches.

The primary evaluation of Aegle marmelos gum powder was evaluated to check the flow properties. The result showed that bulk density 0.40g/cm3, tapped density 0.43g/cm3, angle of repose 30º. The in-vitro drug release of F7 exhibits a good drug release (22.49%) of Nimesulide in 12 hours following Korsmeyer-Pepas model (Power law) release kinetic. The F7 formulation shows mucoadhesion force of 3.163N and have a good percentage drug content of 100.52%. Thus it is concluded that F7 is considered to be the optimized formulation.

From the study it can be concluded that the Aegle marmelos gum powder can be used as mucoadhesive agent to formulate mucoadhesive sustained release formulation.