Quality by design approach for optimizing the formulation properties of escitalopram oxalate Oro-dispersible tablets

The quality by design (QbD) approach was applied for optimizing the formulation of Escitalopram oxalate (ES) orodispersible tablets (ODTs) using Design-Expert Software. To Optimize ES-ODTs a quality target product profile was established in which critical quality attributes (CQAs) such as wetting time, dispersion time, disintegration time and drug release rates were defined and quantified. As critical formulation parameters (CFP) that were evaluated for their effect on the CQA. Percentage of Crospovidone (CP) and Croscaramellose (CCS) were choosen. Response surface methodology (RSM) such as Central Composite Design (CCD) was used to evaluate the effects of the CFPs on the CQAs of the final product. The main factor affecting disintegration, wetting time, dispersion time and release rate was the combination of CP and CCS. Disintegration time, wetting time and dispersion time were found to be sensitive to the percentage of CP and CCS. From the results a design space could be created. The results suggest QbD appears to be a useful approach for the rational design of ES-ODTs. The chosen model helps to visualize the different effects of the CFPs on the CQAs.