Formulation, Development and Evaluation of Famotidine Orodispersible Tablets

The main objective of present research work is to formulate the famotidine orodispersible tablets. Famotidine is a selective H2 receptor antagonist or H2 blocker belongs to BCS Class-II and is used to treat heartburn and duodenal ulcers.

The Orodispersible tablets of famotidine were prepared employing different concentrations of sodium starch glycolate, Crospovidone and Croscarmellose sodium in different combinations as superdisintegrants by direct compression. Mannitol and sodium saccharine were added to microcrystalline cellulose Magnesium stearate as a diluent to improve the organoleptic qualities of the tablets. using 2³ factorial design mothod was used to formulate orodispersible tablet. Prepared tablets were then subjected to different tests for tablets like Wetting time, Water absorption ratio in-vitro disintegration time, thickness, diameter, hardness, friability, weight variation, drug content, and in-vitro dissolution study were all assessed for the tablets. Design expert study was conducted to know the interaction between different superdisintegrants and to select best optimized formulation in among all formulations.

The tablets’ good mechanical strength was indicated by the hardness and friability data. The tablets quickly dispersed in the mouth in less than 12 seconds, according to the F5 in vitro disintegration time results respectively, and 99.24% of the drug release in 15 minutes. The optimal formulations of Famotidine Orodispersible tablets for enhancing the drug's bioavailability and onset of action were determined to be F5.

The optimized formulation showed increased drug release compared to commercially available orodispersible tablets. No changes in disintegration time, drug content and in in vitro drug release from optimized formulation on storage for 1months at 40°C ± 2°C /75% RH ± 5% RH were observed during stability studies which confirmed the stability of the optimized formulation.