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

Abstract

There are challenges in developing dispersible tablets with a high drug loading of a waterinsolubledrug having flexibility, either as dispersible in water or as dispersible in the oral cavity beforeswallowing with overall acceptability. Overall acceptability is determined by the characteristics of the drugproduct and user acceptance. This study aimed to design and optimise the flexible dispersible tablets designusing 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 inputparameters on target responses were characterised based on the half-normal plot for the magnitude ofeffects, pareto chart for standardised effects, and variance analysis for the statistically significant model. Thecharacterised design was optimised using the response surface method (RSM). The optimised targetresponse was statistically confirmed based on the extent of statistical significance (very significant