Optimization and In vitro Evaluation of Famotidine Loaded Effervescent Orally Disintegrating Tablets Using Central Composite Design

Background: Over the years, effervescent orally disintegrating tablets (ODTs) have proved their worth over conventional tablets in overcoming the swallowing problems associated with the geriatric and pediatric population. The addition of effervescent agents in ODT provides a rapid disintegration along with masking of the slight bitter taste of drugs and is worth exploring. Objective: The present research investigation deals with the preparation of effervescent ODTs by direct compression with rapid disintegration and adequate hardness using the central composite design response surface methodology. Methods: Central composite design was used to study the effect of concentration of crospovidone (X1) and concentration of citric acid and sodium bicarbonate (X2) as independent factors on the two responses: disintegration time (Y1) and drug release (Y2). The tablets were prepared by direct compression approach using directly compressible mannitol. Results: The optimization results obtained after application of ANOVA revealed that increase in the concentration of X1 and X2 resulted in the increase in disintegration time and % CDR. Following the statistical analysis of the results, the formulation batch (F-7) with a desirability index of 0.95 was chosen as optimized batch and exhibited 99±0.8 % release of the drug after 5 min, and rapid disintegrating time of 31±3 sec. All other tablet attributes were well within the official limits. Conclusion: The results obtained in the present investigation clearly revealed a successful development of famotidine effervescent ODTs with a better release profile in comparison to marketed formulation.