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Quality Control and Physical and Chemical Stability of Hydrocortisone Oral Suspension: An Interlaboratory Study

Author(s):  Santoveña A, Llabrés M, Fariña JB

Issue:  Sep/Oct 2010 - Supporting Quality Pharmaceutical Compounding World Wide
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Abstract:  There were two objectives of this study, one of which was to ensure that different 1-mg/mL hydrocortisone oral suspensions that were prepared as compounded preparations in four accredited laboratories using the same standard operating procedure were in accordance with the general quality controls of these disperse systems and the specific requirements of the European Pharmacopeia, the Royal Spanish Pharmacopeia, and the United States Pharmacopeia. The other objective was to confirm the shelf-life of 90 days that was established for this type of compounded preparation. All the suspensions were in accordance with the organoleptic controls and with the theoretically calculated volume per unit of the preparation, but the amount of active ingredient per volume of the preparations were smaller than the theoretically expected. This result was attributed to the standard operating procedure because no significative differences between laboratories and days were detected, in which an excess of active ingredient is necessary to include in the process to ensure the declared dose. By high-performance liquid chromatography, it was possible to confirm the 90 days of stability of the drug at 5°C.

Related Keywords: A. Santoveña, PhD, M. Llabrés, J.B. Fariña, hydrocortisone oral suspension, formulation, stability


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