Design and Evaluation of Orally Disintegrating Tramadol Hydrochloride Tablets by Direct Compression Method

Aims: To design and evaluate an orally disintegrating tramadol hydrochloride tablets (ODT).

Methods: Tramadol hydrochloride orally disintegrating tablets were designed and manufactured by direct compression method, using Cross povidone, Precirol, EPO, Sorbitol, PEG 6000, Aerosol, HCL, magnesium stearate, xylitol, acesulfame potassium, as key excipients, and peppermint flavor and sweetener, respectively. These formulations were then evaluated using pharmacopoeial and non-pharmacopoeial physical and chemical tests. Dissolution and assay tests were performed using USP apparatus II and ultraviolet (UV) spectrophotometry, respectively.

Results: The tablet formulation prepared with crospovidone (F1) showed good flow properties, low disintegration time (13 s) and improved drug release (100% at 30 min) compared with those of the other formulations (84 % at 30 min). All the formulations exhibited satisfactory physicochemical characteristics. The results indicated that suitable ODT of tramadol could be prepared.

Conclusion: A suitable preparation of tramadol Hcl ODT which contains Crospovidone (superdisintegrant) and sorbitol (bulking agent) was found to be the best among Tramadol hydrochloride ODT formulations prepared by direct compression method, because it has exhibited good disintegration time and good dissolution profile when compared to other formulations.