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Stability of an Extemporaneously Formulated Levothyroxine Sodium Syrup Compounded from Commercial Tablets

Author(s):  Alexander Kenneth S, Kothapalli Madhu R, Dollimor David

Issue:  Jan/Feb 1997 - Hospice Care
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Note:  Electronic version includes errata or revisions.

Abstract:  The stability of a 40-µg/mL extemporaneously formulated syrup from commercially available levothyroxine sodium tablets, using sorbitol 70% as the diluting vehicle, was studied. The concentration of levothyroxine sodium in the formulation was 40 µg/mL. The protocol included accelerated stability testing at temperatures of 40°, 50°, 60° and 70°C and a high-performance liquid chromatography assay procedure using testosterone propionate as the internal standard. The data were analyzed using an Arrhenius plot to determine the shelf-life of the formulation. The shelf-life was found to be approximately 15 days at 25°C and 47 days at 5°C.

Related Keywords: Synthroid

Related Categories: GERIATRICS, PEDIATRICS, PEER-REVIEWED

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