Suresh. V, R. Kumaravelrajan
The objective of the present study is to develop a pharmaceutically stable formulation of oral dispersible tablet of Tramadol hydrochloride . In this study oral dispersible tablets of Tramadol hydrochloride were prepared by Direct compression method. Several trial formulations i.e, from F1-F9 have been taken to optimize and develop a robust formulation. The study is to clarify the effect of different superdisintegrants like Crospovidone (CP)(F1,F2,F3), Croscarmellose sodium (CCS)(F4,F5,F6), Sodium starch glycolate (SSG)(F7,F8,F9) on disintegration and dissolution properties of the drug. The prepared tablets were evaluated for weight variation, wetting time, hardness, thickness, friability, % drug content, disintegration time, in vitro drug release and in vivo release study. Formulation F3 showed a drug release of 99.18% in 30mins which is faster than the other 2 superdisintegrants used in the study and also with the innovator product. The stability studies, shown that the formulation F3 was stable enough at 40?C / 75% RH for a period of 1 month. Th e comparision of pharmacokinetic parameters between the ODTs Tramadol HCl and conventional tablet, showed no major changes in the pharmacokinetic parameters. Therefore it can be concluded that the formulation F3 is robust and stable.
