Formulation and In-Vitro Evaluation of Orally Disintegrating Tablets (ODTs) of Tramadol Hydrochloride

Abstract

Since orally disintegrating tablets (ODTs) of tramadol hydrochloride are not available in the market, so an attempt has been taken to formulate and evaluate ODT preparation of tramadol hydrochloride. In this present work, direct compression was the technique used for preparing ODT using superdisintegrants like croscarmellose sodium, sodium starch glycolate and crospovidone at different concentrations. Prepared formulations were evaluated for various quality parameters- angle of repose, Carr’s index, Hausner ratio, weight variation, friability, hardness, drug content, dispersion time, wetting time and in-vitro dissolution. The angle of repose data indicated that the flow property of all the formulations was good to excellent. Comparing with the specifications, the results of Carr's index (%) and Hausner’s ratio indicated that the flowability of all the formulations blend was significantly good. Prepared formulations showed average wetting time ranging from 40-45 seconds, average dispersion time with 3-6 minutes. In-vitro dissolution profile indicated the cumulative % drug release between 30-80% for most of the cases.
 Keywords: Orally disintegrating tablets, Tramadol hydrochloride, Superdisintegrants, Direct compression.