Taste abatement and dry suspension formulation of fluoroquinolone resinates

Abstract

newlineThe bitter taste of oral medications, particularly fluoroquinolone antibiotics such as Moxifloxacin HCl, poses a significant challenge to patient compliance, especially among pediatric and geriatric populations. This research was undertaken to formulate and evaluate taste-masked resinates of Moxifloxacin HCl using ion-exchange resins, with the objective of developing a palatable dry suspension. Four different ion-exchange resins Tulsion 339, Tulsion 344, Tulsion 335, and Indion 414 were screened for their efficiency in masking the bitter taste. Among these, Tulsion 339 in a 1:2 drug-to-resin ratio was identified as the most effective based on taste-masking performance and physicochemical stability. newlineComprehensive preformulation studies, including solubility analysis, pH determination, and flow property evaluation, were conducted. Structural characterization of the drug-resinate complexes was confirmed using Fourier-transform infrared spectroscopy (FTIR), X-ray diffraction (XRD), and differential scanning calorimetry (DSC), indicating successful complex formation and improved stability. The optimized resinate formulation (F2) underwent further evaluation for drug content, taste-masking efficiency using an electronic tongue, in vitro drug release in simulated salivary and gastric conditions, and the influence of various electrolytes. newlineA dry suspension was then developed using the F2 complex and was assessed for key parameters including sedimentation volume, redispersibility, viscosity, pH, and drug content uniformity over a 7-day period. The formulation exhibited excellent taste masking, acceptable rheological and physicochemical properties, and sustained drug release under physiological conditions. Stability studies conducted in accordance with ICH guidelines confirmed the formulation s robustness over time. newlineOverall, this study successfully demonstrates the utility of ion-exchange resin technology, particularly with Tulsion 339, for effective taste masking of bitter drugs like Moxifloxacin HCl.