Stability of hydrocortisone oral suspensions prepared from tablets and powder

OBJECTIVE: To assess the stability, dosage uniformity, and clinical acceptability of hydrocortisone oral suspensions prepared from tablets and powder. DESIGN: Hydrocortisone 2.5 mg/mL oral suspensions were stored in the dark for 91 days at 5, 25, and 40 degrees C. Dosage uniformity was assessed by repeated sampling of the formulation prepared from tablets at 5 and 25 degrees C. The formulation was clinically evaluated in 2 pediatric patients. SETTING: A university pharmacy school and affiliated urban teaching hospital. PARTICIPANTS: A brother (4 y old) and sister (1 y old) with congenital adrenal hyperplasia maintained on a commercially available hydrocortisone cypionate suspension. MAIN OUTCOME MEASURES: Samples removed at 5 time points were analyzed for hydrocortisone to assess decomposition over 90 days. Dosage uniformity was evaluated by intra- and interday variability. Palatability was examined in the 2 children and urinary cortisol concentrations were measured in the boy before and 5 days after commencing the formulation prepared from tablets. RESULTS: Decomposition of hydrocortisone was not significant except in the formulation that was prepared from tablets and stored at 40 degrees C. Dosage uniformity gave coefficients of variation less than 4.5%. The formulation was well-tolerated and resulted in satisfactory urinary cortisol concentrations in the boy. CONCLUSIONS: The hydrocortisone oral suspensions supply a uniform dose and are chemically stable when stored in the dark at 5 and 25 degrees C for at least 30 days. They provide flexible and convenient dosage forms for pediatric patients.