Formulation Development and Evaluation of a Gastroretentive in situ oral gel of Cefuroxime Axetil

Abstract

: Objective: To develop a gastroretentive in situ oral gel to improve the bioavailability of the cephalosporin antibiotic drug, Cefuroxime Axetil. Methodology: Sodium alginate and pectin were the ionic dependent gel forming polymer. Calcium chloride was used as complexing agent to increase cross linking along with sodium citrate. Mucoadhesion was enhanced with the help of polymer HPMC K4M. Two factors and three levels factorial design was used for the optimization of formulation using design expert software version 7.1.6. The In situ gel system was evaluated for the content uniformity, pH, gelling capacity, viscosity of gel, in-vitro drug release and mucoadhesion study. Results and Discussion: Optimized formula showed more than 24% Drug release after 1 hour and prolonged release up to 12 hour, Viscosity of gel formed was 6423.9 cps and 3.668 N/cm2. The results revealed that as the concentration of Sodium alginate was directly proportional to mucoadhesion, inversely proportional to drug release while concentration of pectin directly proportional to drug release. Conclusion: The study point to the potential of in situ oral gel in terms of ease of administration, better patient compliance and prolonged gastro-retention.Key words: Gastro-retentive drug delivery system, Mucoadhesive Oral In-situ gel, Cefuroxime Axetil.