Formulation of Barium Sulfate Suspension (2% w/v) for Use as a Fecal Tagging Agent in Computed Tomography Colonography"

Abstract

Objective : This research aimed to develop and evaluate barium sulfate suspension (2% w/v) for use as a fecal tagging agent in computed tomography colonography. The study focused on the formulation's physical, chemical, and biological stability, as well as its efficacy.

Methods : The study was conducted in three phases. Phase 1 involved compounding and formulating the vehicle of barium sulfate suspension (2% w/v) with varying concentrations of Carboxymethylcellulose sodium (0.2%, 0.3%, 0.4%, 0.5% w/v CMC sodium). Phase 2 assessed the physical, chemical, and biological stability of the formulations. Phase 3 evaluated the efficacy of the formulations as fecal tagging agents in computed tomography colonography.

Result : In Phase 1, the formulations containing 0.2% (A2-L) and 0.3% (A3-L) NaCMC received the highest overall satisfaction scores for taste, smell, viscosity, and composition, with scores of 71.17% and 62.33%, respectively. In Phase 2, the BaSO4-A2-L and BaSO4-A3-L formulations showed no changes in physical, chemical, or biological characteristics. The sedimentation volume (F=0.913-0.99) remained stable under all storage conditions, with pH values ranging from 4.31 to 4.47. No growth of E. coli, Salmonella, S. aureus, or P. aeruginosa was detected during the six-month storage period. In Phase 3, the efficacy of both formulations as fecal tagging agents was not significantly different (p-value 0.311) at the 0.05 significance level.

Conclusion : Mahasarakham hospital has selected the barium sulfate suspension (2% w/v) prepared with 0.2% CMC sodium for use under refrigerated storage conditions. The designated storage duration is six months after the preparation for clinical use.