Effects of Xanthan, CMC-Na, and Avicel RC-591 on Sucralfate Suspension Characteristics and Physical Stability

Abstract

Sucralfate is a medicine for peptic ulcers that is practically insoluble in water and might to be developed into a suspension. The choice of suspending agents is essential for formula development. This study aimed to determine the physical characteristics and physical stability of xanthan gum, CMC-Na, and Avicel RC-591 in a sucralfate suspension by conducting a characterization and stability study and analyzing the formulations. Suspensions were prepared with 0.3% w/v xanthan gum (XG), 1% w/v CMC-Na (SCMC), and 1% w/v Avicel RC-591 (ARC) and then evaluated for physical appearance, pH, density, viscosity, sedimentation, and redispersibility in a six-month stability study conducted under various storage conditions. The pH results ranged between 5.113 ± 0.001 and 4.622 ± 0.033 (p > 0.05). The density of the SCMC formula (1.1459 ± 0.0003) is greater than the density of the ARC formula (1.1396 ± 0.0002) and XG (1.1162 ± 0.0002), but statistically, the three formulas are not significantly different (p > 0.05). The viscosity of XG is greater than SCMC and ARC. The formulas indicated that XG had greater sedimentation than SCMC and ARC (p > 0.05). The redispersibility of all formulations is ARC > SCMC > XG. In conclusion, ARC and SCMC exhibit acceptable suspension characteristics and robust physical stability. Conversely, formulations utilizing XG fail to meet the required quality standards for sucralfate suspensions regarding redispersibility.