Comparative evaluation of Polygel Dual and commonly used alginate-antacid formulations (ACIDUAL Study)

Abstract

Purpose: To compare Polygel Dual (PD) and four marketed alginate-antacid combination products, with respect to raft formation and antacid properties. Methods: The pharmacopeial tests used were selected based on demonstrable performance of raft-forming potential, including speed and thickness, for all selected products. Evidence-based methods were used to determine the antacid effects in terms of acid-neutralizing capacity and increase in pH. Results: Raft-forming ability was demonstrated by three products, with AF-4 and PD outperforming in speed and thickness. PD, AF-1 and AF-2 exhibited superior antacid properties. However, PD was the only product that demonstrated superior performance with respect to raft-formation and antacid potential. Raft-forming capacity was exhibited by 3 out of 5 products, viz, PD, AF-1 and AF-4. Raft formation was faster in AF-4 (15 s), followed by in PD (25 s). Similarly, raft thickness (14.79 mm) was highest in AF-4, followed by (4.39 mm) in PD. Preliminary antacid test results showed that AF-4 failed to raise pH above 3.5, but PD raised pH to 5.86, while AF-1 raised pH to 5.88. Similarly, periodic test analysis revealed that PD maintained pH above 7 for the entire test duration of 210 min, whereas AF-4 failed to raise pH to 7 during the test period. Conclusion: Polygel dual (PD) demonstrates desirable raft-forming potential and antacid properties. Moreover, it effectively raises pH and maintains it for longer duration than any of the other antacid products. Thus, PD may be considered a potentially effective treatment for acid-reflux problems. However, this claim should be validated in suitable clinical trials.