FORMULATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLETS OF TRAMADOL HYDROCHLORIDE

摘要

The main objective of the present work was to develop sustained release matrix tablets of water soluble Tramadol hydrochloride using different polymers viz. Hydroxy propyl methyl cellulose (HPMC) and natural gums like Karaya gum (KG) and Carrageenan (CG). Varying ratios of drug and polymer like 1:1 and 1:2 were selected for the study. After fixing the ratio of drug and polymer for control the release of drug up to desired time, the release rates were modulated by combination of two different rates controlling material and triple mixture of three different rate controlling material. After evaluation of physical properties of tablet, the in vitro release study was performed in 0.1 N HCl pH 1.2 for 2 hrs and in phosphate buffer pH 6.8 up to 12 hrs. The effect of polymer concentration and polymer blend concentration were studied. Different ratios like 80:20, 60:40, 50:50, 40:60 and 20:80 were taken. Dissolution data was analyzed by Korsmeyer-Peppas power law expression and modified power law expression. It was observed that matrix tablets contained polymer blend of HPMC/CG were successfully sustained the release of drug upto 12 hrs. Among all the formulations, formulation F16 which contains 20% HPMC K15M and 80% of CG release the drug which follow Zero order kinetics via, swelling, diffusion and erosion and the release profile of formulation F16 was comparable with the marketed product. Stability studies (40±2oC/75±5%RH) for 3 months indicated that Tramadol hydrochloride was stable in the matrix tablets. The DSC and FTIR study revealed that there was no chemical interaction between drug and excipients