Abstract
Objective: To developed mucoadhesive gastro-retentive films of amoxicillin trihydrate, metronidazole and famotidine by using polymers and plasticizer for eradication of H. pylori infection.
 Methods: The mucoadhesive gastro-retentive films of amoxicillin trihydrate, metronidazole and famotidine were prepared using solvent casting method. The optimized gastro-retentive films were characterized by using various parameters such as DSC, drug content uniformity, in vitro drug release, FTIR spectroscopy, SEM and ex-vivo drug permeation studies across the mucous membrane. The prepared mucoadhesive gastro-retentive films were evaluated with in vitro growth inhibition study and in vivo bacterial clearance study.
 Results: The FTIR spectra indicated that there was no any interaction between the drugs and polymer. Drugs content was found to be in the range and there was no significant change in the surface morphology of the films after under storage. The bioadhesive property of prepared films exhibited highly bioadhesive property when increased the amount of chitosan and PAA (Polyacrylic Acid) used. We found that CH-PAA IPC (Chitosan-Polyacrylic Acid Inter-polymer Complex) films exhibited greater bioadhesion. The percent of growth inhibition by using each drug such as amoxicillin, metronidazole and famotidine was found to be 51.61%, 46.59% and 34.76%, respectively whereas the combination of drugs were exhibited highest % growth inhibition. The % inhibition was found to be 81.00%. The optimized formulation CH-PAA IPC (C1P2G2) and CH film (C1G2) showed highest growth inhibition of H. pylori bacteria. The growth inhibition was found to be 96.77% and 92.26%, respectively. In vivo Bacterial Clearance Studies showed that the drugs loaded CH-PAA IPC film (C1P2G2) formulation exhibited better clearance from infection than CH film (C1G2) formulation and plain drugs solution at same doses. Drugs loaded CH-PAA IPC film formulation was found to be effective in the treatment of H. pylori infections effectively.
 Conclusion: The developed gastro-retentive films of amoxicillin trihydrate, metronidazole and famotidine combination could be used for batter management of mucosal ulcer disease and eradication of H. pylori bacteria.
Highlights
Helicobacter pylorus (H. pylori) is one of the most common pathogenic bacterial infections and it is found in the stomachs of approximately half of the world’s population
Triple therapies consisting of the combined use of antibiotics are frequently used in the clinical treatment of H. pylori associated with gastroduodenal disease
Mucoadhesive gastroretentive films of amoxicillin trihydrate, metronidazole and famotidine were formulated by using polymers and plasticizer to combat the H. pylori bacteria
Summary
Helicobacter pylorus (H. pylori) is one of the most common pathogenic bacterial infections and it is found in the stomachs of approximately half of the world’s population. It is the primary known cause of gastritis, gastroduodenal ulcer disease and gastric cancer. Combined drug therapy as the general treatment in the clinic, the rise of antibiotic-resistant bacteria, adverse reactions and poor patient compliance are major obstacles to the eradication of H. pylori [1]. Gastroretentive drug delivery systems potentially prolong the gastric retention time and controlled/sustained release of a drug, thereby increasing the concentration of the drug at the application site, potentially improving its bioavailability and reducing the necessary dosage. Mucoadhesive gastroretentive films of amoxicillin trihydrate, metronidazole and famotidine were formulated by using polymers and plasticizer to combat the H. pylori bacteria
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