Cefuroxime Axetil (CA) is a broad spectrum cephalosporin. The literature survey reveals that its intake causes diarrhoea. The objective of the present study was to address challenges in research and development associated with its bitter taste and poor aqueous solubility. The inclusion complex of CA-HPβCD was prepared in molar ratio of 1:1. Banana starch was added as natural antidiarrheal agent to CA-HPβCD inclusion complex and taste masking followed by direct compression as MDTs at 150 psi compression pressure. Bitter taste threshold, DSC, PXRD, saturation solubility, in-vitro dissolution studies were carried out for pure drug CA, commercial tablet CEFTUM and prepared CA MDTs. The central composite factorial design with two factors was adopted to optimize the responses namely disintegration time and 75% drug release. Formulation F7 was selected as optimized batch that was subjected to accelerated stability studies at 40C±2C/75% ±5% RH for 3months as per ICH guidelines. The results demonstrated that the combination of CA-HPβCD inclusion complex and banana starch can efficiently act as antidiarrheal agent and mask the bitter taste of CA and significantly enhance its aqueous solubility and possess improved physical stability with comparable solubility and dissolution profile.
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