Abstract
Objective: The aim of this work was to develop triple action controlled release anti-reflux suspension of ranitidine and its in-vitro evaluation of anti-reflux and controlled release properties.Methods: The formulation was optimized using sodium alginate as a gelling agent along with calcium carbonate, sodium bicarbonate, magnesium hydroxide, aluminium hydroxide as alkalizing agents and colloidal microcrystalline cellulose (MCC) as a suspending agent at various concentrations and arrived at an optimized formulation for its best quality attributes. To avoid initial release in water before administration, ranitidine coated MCC sphere was incorporated into powder formulation and subjected to in vitro characteristics like raft strength, acid neutralizing capacity, pH, viscosity and dissolution study. The obtained results were assessed using Minitab 17 statistical software to conclude the study design.Results: Formulation containing 300 mg of ranitidine along with 750 mg alginate has shown better anti-reflux characteristics like raft strength 18±2g, acid neutralizing capacity 17±1 mEq compared to other formulations. This formulation has also shows zero-order controlled release in the simulated gastric fluid (SGF) up to 10 h compared to the formulation without alginate. Further, to this optimized formulation has shown negligible change in the assay of ranitidine even after 3 mo at 40 °C temperature and 75% RH.Conclusion: The developed stable sustained release powder for suspension has the combined therapeutic efficacy as an antacid and anti-reflux drug suitable for the management and treatment of gastro-oesophageal reflux disease (GERD) unlike the existing drugs possessing only reflux resistance action.
Highlights
Anti-reflux formulation has been known since the last couple of decades
gastro-oesophageal reflux disease (GERD) is diagnosed with symptoms of acid reflux, in which stomach acid and content backs up into the esophagus resulting in heartburn, regurgitation
The viscosity of formulationR1, R2, and R3shows that the alginate acts as a viscosifying agent and helps to form a stable suspension
Summary
Anti-reflux formulation has been known since the last couple of decades. Anti-reflux formulations are available in different dosage forms in the global market as a liquid suspension [3, 4] as granules [5] for suspension and as a chewable tablet [6]. Alginate and bicarbonate in the presence of acid forms raft that acts as a physical barrier and prevents the reflux in GERD. Alginate gets converted to alginic acid gel and bicarbonate liberates carbon dioxide in the presence of stomach acid. The evolved carbon dioxide gets entrapped into the gel-forming raft [710]. Alginate has the favorable adhesion property that makes it adhere to the oesophageal tissue and help the raft to act strongly against acid refluxes [11]
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