Development of Levodon Dosage Form with Controlled Release of the Active Substance

Antibacterial therapy remains a cornerstone of modern medicine due to the persistent prevalence of infectious diseases and the growing challenge of antimicrobial resistance. This study reports the comprehensive development of Levodon, a novel effervescent tablet formulation based on a polymeric complex of levofloxacin with polyvinylpyrrolidone (PVP). The formulation was designed to provide controlled release of the active pharmaceutical ingredient, thereby enhancing the therapeutic efficacy of antibacterial treatment. Preclinical in vivo investigations demonstrated significant dose-dependent antibacterial activity of the developed complex. The formulation and manufacturing process of high-dose effervescent tablets (1110 mg) were successfully optimized. Quality evaluation confirmed that the finished dosage form complied with the requirements of the State Pharmacopoeia of the Republic of Uzbekistan for key pharmaceutical parameters, including identity, disintegration, hardness, and assay. In vitro biopharmaceutical studies revealed a prolonged release profile of levofloxacin across media with varying pH conditions, indicating sustained drug release characteristics. Toxicological assessment further demonstrated that the formulation possesses low acute toxicity (LD₅₀ > 5000 mg/kg) and weak cumulative properties. These findings suggest that Levodon is a promising controlled-release antibacterial dosage form with potential therapeutic advantages in the management of infectious diseases.

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