Formulation and Evaluation of Film-Coated Alalevonadifloxacin Mesylate Tablet using Opadry®

Abstract

Purpose: In this work, film-coated tablets of the antibiotic alalevonadifloxacin mesylate (AFM) were made using Opadry® yellow as the film coating material, and their different parameters, including in-vitro drug release, were assessed. Method: Direct compression was used in the production of film-coated tablets of AFM. The film-coating substance was an aqueous coating dispersion that was opadry yellow. In 900 mL of 0.1N HCL solution, the film-coated tablets’ rate of dissolution was assessed. In-vitro drug release was also evaluated. The generated film-coated tablets’ stability was assessed in accordance with ICH recommendations. Result: The coated tablets were subjected to gastrointestinal pH testing to ascertain the effectiveness of the film coating, and high-performance liquid chromatography was used to assess drug release. The coated tablets were in perfect condition. The AFM release satisfied the study’s requirement of being at least after 30 minutes, 80% was dissolved in a 0.5% HCl solution. Conclusion: According to these results, opadry yellow aqueous film coating is a simple, repeatable, and affordable method for creating stable AFM film-coated tablets without changing the properties of the medication release.