Development and Optimization of Taste-Masked Moxifloxacin Hydrochloride Resinates Using Ion-Exchange Resins for Oral Dry Suspension
Abstract
Moxifloxacin hydrochloride is a broad-spectrum fluoroquinolone antibiotic with an intensely bitter taste, which can limit acceptability of oral liquid formulations. The present study aimed to develop and optimize taste-masked moxifloxacin hydrochloride resinates using ion-exchange resins and to formulate the optimized resinate into an oral dry suspension. Moxifloxacin hydrochloride was complexed with different ion-exchange resins, namely Tulsion 339, Tulsion 344, Tulsion 335, and Indion 414, at drug-to-resin ratios of 1:1, 1:2, and 1:3. Drug loading was optimized by varying pH, stirring speed, and drug-resin ratio. The optimized resinate was characterized by Fourier-transform infrared spectroscopy, differential scanning calorimetry, X-ray diffraction, scanning electron microscopy, in-vitro drug release, drug release in simulated salivary fluid, and taste evaluation. Tulsion 339 at a drug-resin ratio of 1:2 produced the optimized resinate batch, designated F2, with drug loading of 91.3%. Optimum loading was obtained at pH 6.0 and stirring speed of 400-500 rpm. The F2 resinate showed minimal drug release in simulated salivary fluid, indicating effective taste masking, while maintaining satisfactory drug release in dissolution medium. The optimized batch released 69.3% drug in distilled water at 60 min and 94.1% at 120 min. Release in simulated gastric fluid containing sodium chloride was 74.9% at 60 min. Taste panel results showed marked reduction in bitterness compared with…
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