Formulation and evaluation of bilayer sustained release tablets of tramadol hydrochloride by using natural and synthetic polymers..
Author(s): Habeeb M. D., Vasanth P. M., Suresh K., Ramesh T., Ramesh Malothu*
Abstract
The main objective of the present work was to develop sustained release bilayer tablets ofwater soluble drug tramadol using Guargum, HPMC, NaCMC and Xanthan gum, either alone or in combinations. Tablets were prepared by immediate release direct compression and sustained release wet granulation method and evaluated for various physical parameters. The drug release studies were performed using USP apparatus type ??? using 0.1N Hcl and pH 6.8 phosphate buffer as dissolution medium. The drug release was dependent on the type and concentration of the polymer. Drug release was faster from tablets prepared with Guargum, NaCMC and HPMC alone. However, in combination with HPMC, NaCMC, Guargum with Xanthan gum it sustained drug release effectively. The rate and mechanism of release of Tramadol Hcl analysed by fitting the dissolution data into the zero order, First order, Higuchi, Korsmeyer-Peppas and hexon crowel equations. All the Formulations (F1-F10) followed Zero order release Mechanism. Higuchi plots for all the formulations were linear indicating the drug release by diffusion controlled. Hixon-Crowell cube root model showed high r2 value proportionality due to erosion of hydrophilic gel layer. To explore the release pattern, results of the in-vitro dissolution data were fitted to the Korsmeyer-Peppas equation, which characterizes the transport mechanism indicates the non fickian transport it refer to combination of both diffusion and erosion rate release. It can be concluded that the optimized batch F7 by adopting biphasic drug release pattern in a single dosage could improve patient compliance and give better disease management.
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