BETHANECHOL CHLORIDE ORAL SOLUTIONS - STABILITY AND USE IN INFANTS

OBJECTIVE: TO assess the stability of a bethanechol chloride oral solu tion prepared from tablets. METHOD: The initial concentrations were de termined, These solutions were stored at 4 degrees C for 90 days. Duri ng this period, the concentrations of the bethanechol chloride solutio ns were determined by spectrophotometry. The clinical efficacy of the oral solution was tested in five infants with gastroesophageal reflux disease by comparison of gastric pH before and after treatment. RESULT S: Significant decomposition of bethanechol chloride occurred in the t wo formulations. Bethanechol oral solution in sterile water for irriga tion was well tolerated by five pediatric patients, and the clinical e fficacy was equivalent to that of the tablet formulation. CONCLUSIONS: The bethanechol chloride oral solution 1 mg/mL in sterile water for i rrigation was stable at least 30 days when stored at 4 degrees C and a t an initial pH of 6.5, This formulation appears to be clinically acce ptable and provides a convenient dosage form for use in pediatric pati ents.