Development and In Vitro Evaluation of Fast Dissolving Tablets of Tapentadol

The objective of this research was to formulate fast dissolving tablets of tapentadol that disintegrate in the oral cavity upon contact with saliva and there by improve therapeutic efficacy. Tapentadol is used for the treatment of moderate to severe pain for both acute (following injury, surgery, etc.) and chronic musculoskeletal pain). Fast dissolving tablets of tapentadol were prepared by direct compression method comprising of three different superdisintegrants-Sodium starch glycollate, Crosscarmellose sodium and Crosspovidone (2%, 4%, 6% and 8%) and diluent viz: microcrystalline cellulose. Twelve formulations were prepared and evaluated for hardness, thickness, friability, weight variation, drug content, in vitro disintegration time, in vitro dispersion time, wetting time, water absorption ratio and in vitro dissolution studies. FTIR and DSC studies revealed that there was no chemical interaction between the drug and the excipients. Formulation M12 was found to be the best on the basis of wetting time, in vitro disintegration time and in vitro drug release. The formulation M12 containing microcrystalline cellulose as diluent and crosspovidone (8%) as disintegrant was found to be the optimized combination. Stability studies were carried out at 25°C±2°C/60%±5% RH and 40°C±2°C/75%±5% RH for formulation M12 for 60 days. The results of stability studies indicated no significant changes with respect to physicochemical properties, in vitro disintegration time, wetting time and in vitro drug release.