Abstract

FORMULATION DEVELOPMENT AND EVALUATION OF TASTE MASKED CEFUROXIME AXETIL DISPERSIBLE TABLETS BY INCLUSION COMPLEXATION WITH ?-CYCLODEXTRIN METHOD

Helen Sonia A*, Rajesh M, Sampath Kumar R, Sugi Pappa R, Jenila Jose Jancy V,Regitha RN

Abstract

The preparation of taste masked Cefuroxime Axetil dispersible tablets was aimed to formulate dispersible tablets in paediatric strength and to overcome the drawbacks of conventional Cefuroxime Axetil tablets such as swallowing difficulty and bitter taste. Taste masking was done by adopting inclusion complexation with β-Cyclodextrin technique. Six formulations(F1-F6) were prepared by direct compression method using two superdisintegrants namely croscarmellose sodium and sodium starch glycolate in the concentration of 5%, 7% and 8%.The prepared formulations were evaluated for various precompression parameters like angle of repose, bulk density, tapped density, compressibility index, hausner’s ratio and post compression parameters like appearance, thickness, hardness, weight variation, friability, disintegration time, drug content, wetting time, water absorption ratio, fineness of dispersion, in vitro drug release and taste evaluation. The formulation (F2) prepared using 7% croscarmellose sodium as superdisintegrant was considered as optimized formulation. The drug release of formulation (F2) was 94.08±0.74% in 30 minutes. The FT-IR studies of pure Cefuroxime axetil and optimized formulation (F2) indicated the absence of interaction between the drug and excipients used. Stability studies on optimized formulation (F2) revealed that there were no significant changes in color, disintegration time, drug content and in vitro drug release during the storage period of 3 months at 40±2°C/75±5%RH. The antimicrobial assay proved that optimized formulation (F2) exhibited good antimicrobial activity against Escherichia coli, Streptococcus pneumoniae, Staphylococcus aureus, Salmonella typhi and Haemophilus influenzae. From all the above observations, formulation (F2) containing croscarmellose sodium as superdisintegrant was better one which satisfied all the criteria for dispersible tablets.

Keywords: Cefuroxime axetil, ?-Cyclodextrin, dispersible tablets, inclusion complexation, taste masking.