Abstract

FORMULATION AND EVALUATION OF SUSTAINED RELEASE MATRIX TABLET OF TRAMADOL HYDROCHLORIDE USING NOVEL ISOLATED RELEASE MODIFIER

Kumar Sanjeev* and Singh Arun Kumar

Abstract

The objective of the present investigation was to find out an effective natural release retardant that can be used as an alternative source for synthetic excipients In the formulation and development of sustained release matrix system. Black gram (Vigna mungo) seed polysaccharide (BSP) was isolated and the yield was found to be 76.66%. The microbiological studies confirmed that BSP does not support microbial growth. Sustained release tablets of Tramadol Hydrochloride (TH) were prepared using the isolated. The major advantage of sustained release formulation development is that they can often be taken less frequently than instant release formulations of the same drug. This system provides a steady state concentration of the drug in blood plasma. The release profile of the prepared tablets was compared with different ratios of the natural polysaccharide. The drug content of all the formulations ranged from 99.74 to 101 %. Formulation F6 showed release up to 14 h which was selected as the best formulation. The results indicated that as the concentration of polymer was increased the release rate of the drug from the matrix system was delayed. The release data when fitted into various kinetic equations revealed that the drug release was by matrix and zero order release kinetics model with R2 values above 0.9. Stability studies of formulation F6 was carried out and was found to be stable with no change in physical appearance and minimal decrease in drug content. Thus, a stable, safe natural release retardant could be isolated from black gram seed polysaccharide, which can be effectively used in tablet formulation.

Keywords: Tramadol hydrochloride, Black gram , Matrix tablet, Sustained release.