Quality by design-based evaluation and optimization of ceftibuten flexible dispersible tablet design with high drug loading using Design-Expert software

There are challenges in developing dispersible tablets with a high drug loading of a waterinsoluble drug having flexibility, either as dispersible in water or as dispersible in the oral cavity before swallowing with overall acceptability. Overall acceptability is determined by the characteristics of the drug product and user acceptance. This study aimed to design and optimise the flexible dispersible tablets design using a model drug, namely ceftibuten with the drug loading of about 72%w/w of targeted tablet weight, in a statistically significant manner using design-expert software. The significant effects of screened input parameters on target responses were characterised based on the half-normal plot for the magnitude of effects, pareto chart for standardised effects, and variance analysis for the statistically significant model. The characterised design was optimised using the response surface method (RSM). The optimised target response was statistically confirmed based on the extent of statistical significance (very significant <0.01, significant <0.05 but >0.01). Among the input factors studied, crospovidone concentration shows a statistically very significant effect (<0.0001) on target response namely in vitro disintegration time, in vivo disintegration time, and overall acceptability of intended flexible dispersible tablet design. The outcome of designed and evaluated flexible dispersible tablets (FDT) using design-expert software demonstrated its ability to predict the design space with a statistical significance, which maximises the robust product characteristics and overall user acceptance.