title: Stability of Hydrocortisone Preservative-Free Oral Solutions.
abstract: OBJECTIVE
  The physical and chemical stability of a preservative-free oral solution of hydrocortisone succinate was studied at different pH values and storage temperatures.
  
  
  METHODS
  Oral solutions of hydrocortisone 1 mg/mL were prepared by dissolving hydrocortisone succinate powder in citrate buffers at pH 4.0, 5.5, and 6.5, or with sterile water (pH 7.4) stored in amber glass vials. Three identical samples of the formulations were prepared and stored under refrigeration (3-7°C), ambient temperature (20-22°C) and high temperature (29-31°C). A 200-μL sample was withdrawn from each of the 3 samples immediately after preparation and at 1, 7, 14, 21, and 35 days. Samples were assayed in duplicate using stability-indicating liquid chromatography. Stability was determined by evaluating the percentage of the initial concentration remaining at each time point; stability was defined as the retention of at least 90% of the initial concentration of hydrocortisone succinate.
  
  
  RESULTS
  At least 92% of the initial hydrocortisone succinate concentration in solutions pH 5.5, 6.5, and 7.4 remained throughout the 14-day study period under refrigeration. There were no detectable changes in color, odor, or pH and no visible microbial growth in these samples. In other storage conditions, hydrocortisone succinate was rapidly degraded.
  
  
  CONCLUSIONS
  The hydrocortisone succinate preservative-free oral solutions at pH 5.5, 6.5, or 7.4 are chemically stable when stored under refrigeration for at least 14 days. They provide flexible and convenient dosage forms without any preservatives for pediatric patients.
authors.affiliation: Department of Pharmacy, The University Hospital of Jean Verdier-APHP, Bondy, France.
authors.forename: Julie
authors.initials: J
authors.lastname: Chappe
authors.affiliation: Department of Pharmacy, The University Hospital of Jean Verdier-APHP, Bondy, France.
authors.forename: Névine
authors.initials: N
authors.lastname: Osman
authors.affiliation: Department of Pharmacy, The University Hospital of Jean Verdier-APHP, Bondy, France.
authors.forename: Salvatore
authors.initials: S
authors.lastname: Cisternino
authors.affiliation: Department of Pharmacy, The University Hospital of Jean Verdier-APHP, Bondy, France.
authors.forename: Jean-Eudes
authors.initials: JE
authors.lastname: Fontan
authors.affiliation: Department of Pharmacy, The University Hospital of Jean Verdier-APHP, Bondy, France.
authors.forename: Joël
authors.initials: J
authors.lastname: Schlatter
keywords: drug stability; hydrocortisone; infant; pharmaceutical solutions