Innovative Formulation and Evaluation of Sumatriptan Fast Dissolving Tablets through 3² Factorial Design

Abstract

In this study, the objective aims to develop and analyse fast-dissolving tablets (FDTs) of sumatriptan using superdisintegrants primojel and crospovidone by direct compression technique. In each case tri concentrations of super disintegrant (3, 4 and 5 %) were used in the preparation of FDT’s. The tablets prepared were analysed for disintegration rate, disintegration time, hardness, friability, and drug concentration. The following conclusions are derived from the obtained results. A 3-level-2-factorial experimental design is chosen to specify the percentage of the independent variables primojel crospovidone that were included in the formulation of Sumatriptan Fast Dissolving Tablets. All FDTs prepared disintegrated within 34 sec. Among the nine formulations F9 gave 100 % drug release 6 min. All of the prepared FDTs led sumatriptan to dissociate rapidly. In each instance, the levels of super disintegrant increased along with the sumatriptan's rate of disintegration.A series of equations were generated for disintegration time (DT), percent drug disintegrated in 10 minutes (PD10).Y1= 74.00 – 7.83 X1 -22.67 X2-2.75 X1X2 +1.50X12 -6X22 (DT), Y2= 96.22 + 3.17X1 +5.33 X2 -2.50 X1X2 +1.71 X12 – 4.33 X22 (PD10m). The findings indicate that a higher concentration of Superdisintegrants results in a shorter disintegration time for the dosage form, and that a suitable selection of X1 and X2 levels can alter the drug release pattern.To check the validity of equation DT was selected for 40 sec and PD10 for 98.00. The Final Formula DT Values and PD10were found to be 39 sec and 98.64 % indicating the validity of equation. Thus sumatriptan tablets could be successfully prepared using primojel and Crospovidone using 3² Factorial Design.