Experimental Design Approach to Fabricate and Optimize Floating Tablets of Levofloxacin for Helicobacter Pylori Infection

Abstract

Objective: To improve the treatment of H. pylori infection, by achieving the required bactericidal concentrations of antibiotics in the stomach, by delivering the antibiotics to the mucus layer and release the drug at the site of infection for a prolonged period would be significantly more effective than conventional dosage forms. Methods: The experimental method of the research was designed to prepare Levofloxacin floating by using Hydroxypropyl Methylcellulose (HPMC K4M), Hydroxypropyl Methylcellulose (HPMC K100M) and Xanthan gum by Three-level Box–Behnken design optimization method. The prepared tablets were evaluated for Thickness, Hardness, Friability, Weight variation, Swelling index (SI), Floating lag time (FLT) and Time required to release 90% of the drug from the tablet (T90%). Results: It was found that the Thickness-3.12±0.11 mm to 3.28±0.10 mm, Hardness-4.52±0.36 kg/cm2 to 4.81±0.24 kg/cm2, Friability-0.81±0.02g to 0.86±0.12g, Weight variation-480±1.90 mg to 523±0.89 mg, Swelling index (SI)-61.9±0.624% to 99.95±0.226%, Floating lag time (FLT)-81.12±0.63 s to 119.7±0.567 s and Time required to release 90% of the drug from the tablet (T90%)-7.0±0.55 h to 10.33±0.289 h. HPMC K100M and Xanthan gum showed good swelling as compared to HPMC K4M. The study revealed that HPMC K100M grade had a significant effect on drug release. Conclusion: The developed gastro-floating tablets can extend levofloxacin duration in the stomach and produce a prolonged release effect. The prepared levofloxacin floating tablet oral drug delivery system appears to be a promising choice for the efficient eradication of H. pylori