Original Research Article Formulation and Evaluation of Mouth Dissolving Tablets of

Purpose: To prepare, and evaluate in vitro and in vivo tramadol hydrochloride mouth dissolving tablets (MDT). Methods: Tramadol HCl MDT were prepared by direct compression using Pharmaburst as co-processed excipient and compared with a reference product (Rybix ODT, 50 mg). Physicochemical parameters including hardness, friability, weight variation, disintegration time and dissolution studies were determined for all the formulations. In-vivo studies were performed for the optimized formulation (F13), using as reference, a commercial product (Trambax IR, 50 mg), by a two-way crossover design under fasting conditions on eight healthy adult human subjects. Drug-plasma concentrations obtained from the bioequivalence study for test and reference products were analyzed in each subject by high performance liquid chromatography (HPLC), and basic pharmacokinetic parameters, including Cmax, Tmax, AUC0-t, AUC0-∞, t and λz, were calculated. Results: The tablet formulation prepared with Pharmaburst (F13) showed good flow properties, low disintegration time (15 s) and improved drug release (99 % at 30 min) compared with those of the reference product (88 % at 30 min) and passed 6 months accelerated stability test. Bioequivalence o