Romanian Society of Pharmaceutical Sciences
 

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RESPONSE SURFACE METHODOLOGY FOR OPTIMIZATION OF DICLOFENAC SODIUM ORODISPERSIBLE TABLETS (ODTs)

VALERIU IANCU1*, FLORENTINA RONCEA1, RADU GEORGE CAZACINCU1,2, CARMEN ELENA LUPU1, HORATIU MIRESAN1,2, CRISTINA NICOLETA DĂNĂILĂ1, COSMIN ROSCA1, DUMITRU LUPULEASA3

1.˝Ovidius˝ University of Constanţa, Faculty of Pharmacy, 1 University Alley, Campus, Corp B, Constanţa, Romania
2.Magistra C&C, 82A Aurel Vlaicu Blvd., Constanta, Romania
3.˝Carol Davila˝ University of Medicine and Pharmacy, Faculty of Pharmacy, 6 Traian Vuia, Bucharest, Romania

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The aim of this study was to optimize 25 mg diclofenac sodium orodispersible tablets. For this it was used a Box - Behnken experimental design to establish the relation between independent variables, such as, concentration of PharmaburstTM 500 (X1), Avicel PH 102 (X2) and compression force (X3), and dependent variables: friability (Y1), disintegration time (Y2), wetting time (Y3) and hardness (Y4) in order to obtain the optimal formula of the technological process using Response Surface Methodology (RSM). To calculate the coefficients for the response equation we used Design Expert Trial version 7.0.0 software (Stat - Ease Inc. Minneapolis). ANOVA test was performed to estimate the significance of the model. At 5% level of significance, a model is considered significant, if the p - value is less than 0.05. The estimation error values proved the validity of the used mathematical method. After generating the polynomial equations that relate the dependent and independent variables, the process was optimized for all four responses. The optimum formulation was selected based on the constraints set on independent variables: Y1 (0 - 1%), Y2 (0 - 180 s), Y3 (55 - 75 s) and Y4 (63 - 123 N). The optimum formulation for diclofenac sodium 25 mg ODTs was: 71.4% (X1), 9.65% (X2) at 10 kN (X3) compression force, providing good tablet properties (friability, disintegration time, wetting time and hardness).