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Abstract:  Previous reports indicate that pharmacists are assigning a wide variety of beyond-use dates to extemporaneously compounded medications in topical Pluronic lecithin organogel. The objective of this study was to evaluate the stability of ketoprofen in Pluronic lecithin organogel over a period of six months and to determine an appropriate beyond-use date for this formulation. A stability-indicating high-performance liquid chromatography method for ketoprofen in Pluronic lecithin organogel was validated in our laboratory. Samples of the formulation were analyzed by high-performance liquid chromatography at 0, 7, 14, 21, 28, 45, 60, 90, and 180 days. At each time point, the average concentration and average percent of initial concentration were calculated. The beyond-use date was determined as the time period that the samples were physically stable and maintained at least 90% of the initial concentration. Ketoprofen in Pluronic lecithin organogel was chemically and physically stable for six months when stored at room temperature and protected from light. Therefore, a beyond-use date of six months is appropriate for this preparation.

Related Keywords: Gina F. Peacock, PhD, Jurgita Sauvageot, PharmD, Richard T. Addo, PhD, ketoprofen, Pluronic lecithin organogel, topical preparations, transdermal vehicle, stability, beyond-use dates, formulations

Related Categories: EXCIPIENTS, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, ALLERGY/IMMUNOLOGY/INFLAMMATION, DOSAGE FORMS/DRUG CARRIERS, STORAGE

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