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 °C. Dosage uniformity was assessed by repeated sampling of the formulation prepared from tablets at 5 and 25 °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 °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 °C for at least 30 days. They provide flexible and convenient dosage forms for pediatric patients.