Box-Behnken Design for Development of Meloxicam Fast Disintegrating Sublingual Tablets with Enhanced Solubility and Dissolution by Dispersion Technique in the Management of Acute Pain

Abstract

Meloxicam (MOC) is selected as the model drug with poor aqueous solubility and bitter taste to maximize its potential over sublingual absorption. Fast disintegrating sublingual tablets (FDSTs) of MOC are fabricated to eliminate first-pass hepatic metabolism deliberating faster onset of action. Three-level and three-factor Box-Behnken Design (BBD) of experimentation was employed to develop FDSTs employing dispersion technology. The combined influence of three independent variables, namely, the concentration of super disintegrant (X1), the concentration of subliming agent (X2), and the ratio of drug: β-CD (X3), were estimated on dependent responses such as percent dissolution efficiency (% DE) (Y1), in vitro disintegration time (Y2) and force of adhesion (Y3). The results of the relevant responses are within the following ranges, 70.71- 95.75 % of DE, 30.3-132.8 sec of in vitro disintegration time, and 0.009-0.018 N of mucoadhesive force. Pre-compression and post-compression parameters also showed promising results, and the model was cross-validated by calculating the percent prediction error. The promising results of biopharmaceutical characterization of the developed FDSTs make this formulation an ideal sublingual drug delivery system for MOC with reduced GIT drug-related adverse reactions and faster onset of action in managing mild-to-medium-level acute pain.