Formulation Development and Evaluation of Direct compressed Cefpodoxime proxetil Effervescent Tablets

摘要

Cefpodoxime proxetil is an orally administered, extended spectrum, semi-synthetic antibiotic of the cephalosporin class. It belongs to BCS class IV drugs and has a limited aqueous solubility of 0.4 mg/ml. Hence the present aim of the study is to enhance the solubility of Cefpodoxime proxetil through complexation with HP-P-cyclodextrin. Binary mixture of sodium bicarbonate and citric acid to be used as effervescent materials. The disintegration to be further enhanced using superdisintegrants such as croscarmellose sodium, sodium starchglycolate and polacrilin K. Seven such formulations were prepared with varying composition and proportion of superdisintegrants. All formulations indicated a fair weight variation with in the pharmacopoeial limit. The result varies from ±1.23% to ±3.58% against ±5%. Thickness range was determined between 4mm -4.2mm. Hardness test result revealed a good strength of more than 4.5 kg/cm2 in every tablet. The percent friability was found within the specification. All formulation took fair time for completion of effervescence except F1 that don’t contain any superdisintegrant. Drug content of all formulations were found to be excellent with more than 98%. Formulation F7 showed excellent effervescent time as compare to other formulation. It showed a consistent drug release with more than 80 % drug released in just 30 minutes. In the FTIR spectra, presence of all significant peaks of drug and absence of any new peak in the formulations revealed that there was no interaction of drug with the excipients. Hence the present study could be an excellent approach to the delivery of the poorly soluble Cefpodoxime proxetil as effervescent tablet.