Abstract:
The objective of present work was to formulate and evaluate once a daily sustained release matrix tablet of Tramadol hydrochloride using Rice bran wax. Matrices were prepared by melt granulation technique using Rice bran wax as a release retardant. Pre-compression results revealed that granules of all formulations possessed satisfactory flow-properties and compressibility. All the tablet formulations showed acceptable Pharmacopoeial limit specifications for weight variation, drug content, hardness, thickness and friability. The in vitro release of drug from the formulations was studied in pH 1.2 acidic buffers and pH 6.8 phosphate buffer, and it was found that formulation F6 (30% of wax) exhibited good drug release pattern to provide sufficient concentration for achieving satisfactory therapeutic value for extended period of time. The formulation was optimized on the basis of acceptable tablet properties and in-vitro drug release. The release of Tramadol hydrochloride from the tablets was diffusion controlled and the release mechanism was non-Fickian. Stability studies (40±2°C/75±5% RH) for 3 months indicated that no appreciable difference was observed for the drug content and drug release.

Keywords: Tramadol Hydrochloride, Matrix Tablet, Rice Bran Wax, Sustained Release.