Abstract

DEVELOPMENT AND EVALUATION OF TRAMADOL HCL BI-LAYERED TABLET

Dr. Shankrayya M., Kavya S. U.*, Annapoorna T., Madhushree Badashetti and Thanmai K.

Abstract

The aim of the present work was to design Bilayer tablet of Tramadol HCL for bi-phasic release. Tramadol HCl is a synthetic opioid analgesic, BCS class I drug (high solubility, high permeability). Bi-layered tablets of tramadol HCl was prepared by utilizing of macromolecules (polymers) such as HPMC K100 and Xanthan gum using HPMC K100M and Xanthan gum as rate retarding polymer in sustained release layer and cross carmellose sodium as super disintigrants in immediate release layer. Nine formulations were developed and were checked using pharmacopoeial tests. The results showed that all the batches were within the standard limits. The dissolution parameters of all formulations were subjected to kinetic fitting and various statistical parameters were determined. Formulation F3, containing 34.14 mg of HPMC K100 and 10 mg of Xanthan gum produced desirable release characteristics. The best formulation (F3) follows first order, Higuchi’s kinetics and non-Fickian diffusion order kinetics. F3 may be administered for the effective management to relieve moderate to moderately severe pain, including pain after surgery.

Keywords: Tramadol HCl, sustained release tablet, HPMC K100, Xanthan gum and, zero order kinetics, non-Fickian diffusion mechanism.