Deepak Kaushik *, Harish Dureja
- Department of Pharmaceutical Sciences, M.D. University, Rohtak 124001, Haryana, India
Purpose: The purpose of the present investigation was to formulate taste masked dispersible tablets of azithromycin using complexation by ion exchange resin applying the central composite design.Methodology: The basic methodology behind the present work was the application of ion exchange resin complexation for masking the bitter taste of azithromycin. The central composite design (CCD) was applied to study the effect of two critical factors i.e. swelling time (X1) and stirring time (X2) on percent drug complexed and cumulative percentage drug release. ANOVA was applied to percent drug complexed and cumulative percentage drug release to study the ?tting and the signi?cance of the model. The drug resinate was ?nally formulated into dispersible tablets by direct compression method.Findings: The drug resin ratio of 1:3 and pH 6 were found to have maximum drug loading onto the resin (Tulsion 335). The maximum drug release was found at high values of swelling and stirring time. The techniques of differential scanning calorimetry (DSC), X-ray diffraction (XRD) and Fourier transform infrared spectroscopy (FTIR) clearly indicated the formation of drug resin complex. Further, the formulated tablets were found to be within the pharmacopoeial limits.Originality: The present work is a novel attempt to prepare optimized taste masked formulation of extremely bitter drug azithromycin to overcome the problem of swallowing conventional tablets in case of paediatric patients.Conclusion: The technique of ion exchange resin complexation was successfully applied to prepare the taste masked azithromycin dispersible tablets. Data revealed that the developed dispersible tablets showed better taste pro?le when compared with the marketed formulation and were found to be stable.
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