Abstract

FORMULATION AND EVALUATION OF TASTE MASKED DISPERSIBLE TABLETS OF GATIFLOXACIN HCL FOR BETTER PATIENT COMPLIANCE

G. S. Dash,*, P. N. Murthy and K. A. Chowdary

ABSTRACT

An attempt has been initiated for masking the bitter taste and to formulate the bitter less dispersible tablets of Gatifloxacin HCl. Ion exchange method was implemented to mask the bitter taste of Gatifloxacin HCl. After preliminary evaluation of the ion exchange resins (IERs), Indion 234 (IER) was selected as the best one among them for drug resin complexation. It was found that the drug resin ratio (1:2.5) has shown maximum drug loading and optimized for this research work. Drug resin complex (DRC) was characterized by FTIR (Fourier transform Infrared) spectroscopy, XRD (X-ray diffraction) and DSC (Differential Scanning colorimetric. The results revealed that the complexation between drug and resin had been taken place and the crystallographic nature of the drug has been changed in drug resin complex (DRC). The bitterless taste of DRC (resinate) was evaluated by a panel of human volunteers and with in vitro drug release rate in simulated salivary fund (pH 6.8). The human volunteers rated the DRC (resinate) bitter less and the percentage of drug release from DRC in simulated salivary fluid (pH 6.8) after 3 min was below the threshold concentration for bitterness. So it was concluded that the bitterness of Gatifloxacin HCl masked completely by this ion exchange technique using Indion 234. The in vitro cummulative percentage of drug release of DRC was calculated again in simulate gastric fluid and found that more than 90% of the drug released within 15 min. The formulated novel taste masked dispersible tablets of Gatifloxacin HCl using the prepared DRC (resinate) has shown better quality and all the evaluation parameters are within the official specification. The dissolution profile of dispersible tablets has complied with the in vitro drug release rate of DRC.

Keywords: Taste masking, Ion exchange method, Indion 234, Crospovidone, Dispersible tablets, Patient compliance.