Box-Behnken Statistical Approach For Development And Characterization Of Buoyant Oral Levofloxacin Tablets Using Natural And Synthetic Polymers

Abstract

Objective: The eradication of Helicobacter pylori infections is hampered by a number of factors, includingshort residence time antibiotics at the site of infection. This study developed a gastro-retentive buoyant tablets of levofloxacin by factorial experimental design approach with the ability to carry levofloxacin to increase its efficacy against H. pylori.
Materials and Methods: A three-level Box-Behnken statistical technique was used in this study to develop and evaluate buoyant oral Levofloxacin tablets using polymers such as guar gum and hydroxypropyl methylcellulose (HPMC) K100M and K4M. Several post-compression properties of the produced tablets were assessed, including hardness, friability, weight variation, floating lag time (FLT), swelling index (SI), and the time required to release 90% (T90%) of the medicine from the buoyant tablets.
Result: The following parameters were measured: thickness (3.18±0.10mm to 3.28±0.17mm), hardness (4.54±0.66kg/ cm2 to 4.85±0.20kg/cm2), friability (0.71±0.02g to 0.76±0.11g), weight variation (479±1.94mg to 518±0.72mg), swelling index (SI) (60.21±0.657% to 97.46±0.223%), floating lag time (FLT) (79.35±1.226 to 110.8±0.35s), and time required to release 90% of the drug from the tablet (T90%) (6.3±0.208h to 10.2±0.252h).Swelling was better with guar gum and HPMC K100M than with HPMC K4M.According to the study's findings, the HPMC K100M grade greatly impacted the drug release.
Conclusion: The designed gastro-retentive buoyant tablets were able to increase the amount of time that levofloxacin spends in the stomach and producing an effect of prolonged release. The oral drug delivery system consisting of levofloxacin buoyant tablets promise to be an effective approach for the complete eradication of H.pylori.