Background: Anti reflux formulation is one of the popular formulation across the globe in pharmaceutical industry used specifically for management of gastro oesophageal reflux disease. But, this formulation is less explored with respect to research. Anti-reflux formulation has challenges to show its antacid functionality, which could have synergies the management of refluxes in gastro oesophageal reflux disease.
Objective: The objective of this work is to investigate the significance of alkalizing agent in the sodium alginate based oral liquid anti-reflux suspension for the management of gastro oesophageal reflux disease (GERD). Alkalizing agents act as antacid and improve the acid neutralization capacity in the anti-reflux formulation, and to be used appropriately as it affects raft strength beyond certain (optimum) limits.
Method: In the present study, the formulation was prepared using sodium alginate along with different alkalizing agent like calcium carbonate and sodium bicarbonate at different levels. The formulation was further studied for in-vitro characterization like pH, viscosity, acid neutralization capacity (ANC), thickness, formation speed, flotation, and raft strength.
Results: The formulation with higher level of calcium carbonate as alkalizing agent, shown positive effect on the acid neutralization capacity (20.83mEq) and raft strength (16.95g) as well. Whereas, formulation with higher level of sodium bi-carbonate (4.01%) shown improved acid neutralization (22.31mEq) but shown negative effect on raft strengths (10.08g).
Conclusion: Based on the study, the optimum levels include 5% sodium alginate, 1.6% calcium carbonate and 2.67% sodium bicarbonate to achieve good liquid suspension formulation possessing good acid neutralization capacity as well as raft strength.