FORMULATION DEVELOPMENT AND EVALUATION OF MOUTH DISSOLVING TABLET OF TRAMADOL HYDROCHLORIDE

Abstract

The objective of the research work undertaken was to develop a dosage form which would give more rapid onset of action compared to oral conventional dosage forms and to improve patient compliance. Suitable analytical method (UV Spectroscopy) was established and validated in phosphate buffer solution, pH 6.8. 10 batches of orodispersible tablets of Tramadol hydrochloride were prepared by superdisintegrant addition method. The superdisintegrants, sodium starch glycolate (0.5%, 5% and 2%), croscarmellose sodium (2%, 3% and 5%) and crospovidone (2% and 5%) were used in different proportions and in different combinations. Prepared formulations were evaluated for pharmacopoeial and non pharmacopoeial tests. For orodispersible tablets in vitro release was carried out in phosphate buffer solution, pH 6.8, using USP type II apparatus at 50 rpm. Based on the results, formula ‘G' containing combination of croscarmellose sodium (5%) and crospovidone (5%) was identified as the most effective formulation amongst all formulations developed for orodispersible tablets. In vitro release of optimized formulation of Tramadol hydrochloride orodispersible tablets (G) was almost found to be 99% within 15 min. with in vitro dispersion time being 15 sec and 35 sec. Formulation ‘G' of Tramadol hydrochloride orodispersible tablets were taken for comparison with marketed conventional tablet of Tramadol hydrochloride. The conclusion arrived from the work indicated that the orodispersible tablet of Tramadol hydrochloride prepared in this investigation released drug better than that of conventional tablets, based on in vitro release studies.