Development and evaluation of non-saccharide polymer-based taste-masked clarithromycin tablets: a novel approach to improve pediatric compliance

Background: Clarithromycin, a macrolide antibiotic, is commonly prescribed for respiratory and skin infections. However, its intensely bitter taste significantly hampers patient compliance, especially in pediatric and geriatric populations. The present study focused on formulating a novel taste-masked clarithromycin tablet using non-saccharide polymers to improve palatability while maintaining pharmacological performance. Methodology: Taste masking was accomplished by employing Eudragit E-100, Ethyl Cellulose, and Hydroxypropyl-β-Cyclodextrin (HP-β-CD) as coating agents. Granules were formulated using a bottom-spray fluidized bed coating process, followed by compression into tablets. These were assessed for physical parameters, disintegration time, in vitro drug release, and sensory evaluation using an electronic tongue system. The dissolution behavior was compared with that of a marketed clarithromycin formulation. Stability testing was conducted under accelerated (40°C/75% RH) and long-term (25°C/60% RH) storage conditions. Result and Discussion: The optimized formulation (Batch B9) demonstrated complete taste masking, exhibiting a bitterness score of 0 on the electronic tongue. Sensory data projected an over 85% improvement in patient acceptability. The tablets disintegrated within 60 seconds and showed a drug release of 98.1% within 30 minutes. Comparative dissolution profiling indicated no statistically significant difference (p > 0.05) between the test and reference products. Stability studies confirmed robust physicochemical stability for six months under both storage conditions. Conclusion: The study successfully developed a taste-masked clarithromycin tablet employing non-saccharide polymers, ensuring effective taste masking, rapid disintegration, and consistent drug release. This formulation offers a promising approach to enhance treatment compliance, particularly in populations sensitive to taste.