BOX-BEHNKEN DESIGN FOR OPTIMIZATION OF FORMULATION VARIABLES OF TRAMADOL HCL SUSTAINED RELEASE MATRIX TABLETS

The objective of this work was to develop sustained release tablets (Once in a day) of highly watersoluble Tramadol HCl using hydrophilic polymers (HPMC K100M, HPMC K15M, HPMC K 4M) ascost effective, non toxic easily available and suitable hydrophilic matrix system. Sustained release tabletof Tramadol HCl (dose 200mg) were produced by wet granulation method by PVP K30 5% solution.After the evaluation of physical characteristics of granules & tablets, The dissolution test was performedin 0.1 N HCl for 2 hr and remaining 22 hr performed in 6.8 pH buffer solution. We concluded that T1-T15 batches of Box-behnken design passed the pre-compressional and post-compressional parametersand increasing the polymer concentration, decreasing the drug release. Higher viscosity grade HPMCK100M is more drug retarding agent as compare to HPMC K15M & HPMC K4M. In combination ofHPMC K4M, HPMC K15M & HPMC K100M, T7 batch having drug releasing up to 24 hrs as compareto others. Kinetics treatment of the box-behken design batches, concluded that zero order R2 value isnear to 0.999 as compared to the first order R2 value. So, all batches follow the Zero order releasemechanism. From the korsmeyer-peppas model, concluded that drug release mechanism is diffusionwith dissolution or anomalous diffusion (Non-fickian). From the statastical analysis full model andreduced model was analyzed and got the significant effect of X3 polymer as compared to X1 & X2. X3having more negative value than the X1 & X2 so concluded that the X3 polymer is effective toretardation of the drug release. T1-T15 batches are compared with marketed product (Tramazac ODtab.). T7 batch had more 73.58 similarity factor (f2) when Marketed formulation taken as a reference. SoT7 batch is optimized batch. The optimized batch is passed the accelerated stability studies, Nosignificant change in the dissolution profile.