Development Of Cefuroxime axetil nanosuspension and evalution of Pharmacokinetics Parameters using RP HPLC

Abstract

Abstract newlineThe rapid development of drug-resistant microorganisms is a challenge to mankind. Nano-formulated compounds have proved to be an effective strategy to combat bacterial drug resistance. The poor water solubility of drugs such as cefuroxime axetil is a significant hurdle in drug formulation. Therefore, this study aimed to prepare a nanosuspension of cefuroxime axetil, a poorly water-soluble drug, using an antisolvent precipitation method, followed by ultrasonication. This work aims to develop and validate an accurate, simple, specific, and precise RP HPLC method for the detection of cefuroxime axetil, in bulk and tablet dosage forms. A linear calibration curve was found to be linear in concentrations between 1-5 and#956;g/ml (R2 =0.9995). The percentage recoveries of cefuroxime axetil were found to be in the range of 95.68-96.98%. The percentage Relative Standard Deviations in intra-day trials were found to be 0.61, 0.66, and 0.88, respectively, and in inter-day studies were 0.06, 0.16, and 0.29, respectively, demonstrating good accuracy and little variance. The bioavailability of the formulation was assessed in rats. The results indicated that increasing the stirring speed and reducing the poloxamer concentration decreased the size of the nanoparticles. The optimized formulation showed particle size and zeta potential of 170 nm and -31.3 mV, respectively. The developed Nano formulation showed a 7.12-fold improvement in the oral bioavailability of cefuroxime axetil. The anti-solvent precipitation process successfully produced a stable amorphous nanosuspension with a notably reduced particle size and improved bioavailability by evaluating and optimizing the critical process and formulation parameters. newlineKeywords: Factorial design; amorphization newline