Rapidly Disintegrating Ciprofloxacin Hydrochloride Tablets: A Novel Formulation Approach Using Superdisintegrant Technology

Abstract

Background: This study focused on developing fast-disintegrating tablets of ciprofloxacin hydrochloride by combining superdisintegrant technology with a novel drug-resin complex, Kyron T-314, to achieve improved dissolution and patient acceptability. Kyron T-314 (Polacrilin Potassium) was selected not only for its ability to enhance solubility and mask the drug bitter taste, but also for its capacity to promote rapid tablet breakdown, supporting an immediate-release profile. Materials and Methods: The drug-resin complex prepared with Kyron T-314 functioned as both the superdisintegrant and taste-masking component, while Hydroxypropyl Methylcellulose (HPMC) was incorporated as a binder in tablets formulated through direct compression. By altering the proportions of HPMC and Kyron T-314, nine different formulations (F1-F9) were produced. Each batch was evaluated for essential quality attributes, including hardness, friability, disintegration time, drug content, and in vitro dissolution behavior. Results: Among all the developed formulations, F9 showed the most favorable performance. It exhibited a rapid disintegration time of 47.0 ± 1.8 sec, adequate mechanical strength with a hardness of 5.2 ± 0.2 kg/cm², uniform drug content of 99.5 ± 0.4%, and cumulative drug release of 98.7 ± 0.8% within three minutes. Drug-release kinetics were best described by the zero-order model combined with non-Fickian diffusion (R² = 0.9783), indicating that both diffusion mechanisms and polymer relaxation contributed to the release profile. Accelerated stability testing conducted at 40 ± 2°C and 75 ± 5% relative humidity for six months revealed that the optimized formulation remained stable, with no meaningful alterations in its physical or chemical characteristics. Conclusion: The optimized Formulation (F9) produced a stable, cost-effective, and scalable rapidly disintegrating tablet of Ciprofloxacin Hydrochloride. The DRC-based strategy using Kyron T-314 offers a promising approach for developing fast-acting, palatable, and patient-friendly immediate-release tablets.