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Patient Compliant Dosage Form For Roxithromycin

Author(s): Poornima D Amin, Anita R Wadhwani, Namita B Prabhu

Roxithromycin, a macrolide antibiotic, is extremely bitter in taste. The present study deals with various techniques utilized for taste masking of roxithromycin viz granulation with Eudragit E 100 and complexation with ion exchange resins. Of these, complexation with ion exchange resins yielded complete taste masking. The drug resin complexation procedure was optimized with respect to parameters like taste of the resinate, drug to resin ratio and volume of medium. The complexation between roxithromycin and ion exchange resin was confirmed by differential scanning calorimetry. The taste-masked complex was then formulated into palatable mouth-dissolve tablets. The tablets were evaluated for various quality control parameters. Taste evaluation of the tablets showed complete masking of the bitterness of the drug. In vitro release studies revealed complete drug elution from the complex after a period of 30 min in pH 1.2 buffer.