Application of Response Surface Optimization Methodology in Designing Ordispersible Tablets of Antdiabetic Drug

Abstract

Objectives: The aim of the present investigation is to study the applicationof Response Surface Methodology (RSM), a mathematical model andgraphical representation to formulate and Optimize Orodispersible Tablets ODTs) of sitagliptin phosphate, a class III BCS drug. Methods: ODTs were prepared by direct compression method using dibasic calcium phosphate(DCP), asdiluent and croscarmellose sodium sodium (CCS) as superdisintegrant. Formulation was designed using design expert software 9.0version. RSM based 22 full factorial design, considering DCP and CCS asvariables and dissolution time at 5, 15 and 30 min was taken as response.Mathematical models in the form of regression equations and graphs weredeveloped. Results: The adequacy of the developed mathematical modelswas statistically checked through the analysis of variance (ANOVA). The responses were analyzed using ANOVA and polynomial equation wasgenerated for each response using RSM. Responses were mostly affected by the specific combinations of independent variable. R2 predicted and R2adjusted values for the constructed models, which revealed the competencefor the proposed mathematical model. Based on the results obtained DF1formulation was optimized. The developed mathematical models can besuccessfully used for their prediction of measured responses. Conclusion:DoE Concept in formulation could pave way for adaptation of Quality BasedDesign (QbD) in pharmaceutical industry RSM was successfully appliedto optimize diluents and disintegrate concentration of ODTs. The variablesemployed in the study had a great effect on the quality of formulation.Modeling of experimental data allowed the generation of useful equations for prediction of responses.