Abstract

The objective of this work was to develop sustained release tablets (Once in a day) of highly water soluble Tramadol HCl using hydrophilic polymers (HPMC K100M, HPMC K15M, HPMC K 4M) as cost effective, non toxic easily available and suitable hydrophilic matrix system. Sustained release tablet of 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 performed in 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 parameters and increasing the polymer concentration, decreasing the drug release. Higher viscosity grade HPMC K100M is more drug retarding agent as compare to HPMC K15M & HPMC K4M.  In combination of HPMC K4M, HPMC K15M & HPMC K100M, T7 batch having drug releasing up to 24 hrs as compare to others. Kinetics treatment of the box-behken design batches, concluded that zero order R² value is near to 0.999 as compared to the first order R² value. So, all batches follow the Zero order release mechanism. From the korsmeyer-peppas model, concluded that drug release mechanism is diffusion with dissolution or anomalous diffusion (Non-fickian). From the statastical analysis full model and reduced model was analyzed and got the significant effect of X₃ polymer as compared to X₁ & X₂. X₃ having more negative value than the X₁ & X₂ so concluded that the X₃ polymer is effective to retardation of the drug release. T1-T15 batches are compared with marketed product (Tramazac OD tab.). T7 batch had more 73.58 similarity factor (f₂) when Marketed formulation taken as a reference. So T7 batch is optimized batch. The optimized batch is passed the accelerated stability studies, No significant change in the dissolution profile.

Keywords

Box-Behnken Design, Hydroxypropylmethylcellulose, PVP K-30, Sustained Release, Tramadol HCl, Wet Granulation

Cite This Article

Gandhi, C.K., Mehta, T.J., Patel, M.R., Patel, K.R., Patel, N.M. (2012). Box-Behnken Design for Optimization of Formulation Variables of Tramadol HCl Sustained Release Matrix Tablet, International Journal for Pharmaceutical Research Scholars (IJPRS), 1(2), 99-114.