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

Alexander, Kenneth S; Kothapalli, Madhu R; Dollimor, David

Abstract

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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Page(s): 60-63

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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.

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