NINETY DAY CHEMICAL STABILITY OF COMPOUNDED ESTRADIOL, ESTRONE, AND ESTRIOL COMBINATION AND BEYOND-USE-DATE

Abstract

Author(s): Arindam Basu Sarkar*, Akshitha Kandimalla, Roshini Durga Paruchuri2, Richard Dudley

Hormone replacement therapy utilizing estrogens formulated in topical preparations is routinely used. While most commercially available estrogen-containing topical preparations contain estradiol, a therapeutic use for other estrogens including estriol and estrone has been realized. However, the commercial availability of estriol and estrone-containing topical preparations is lacking. Using a HPLC method developed in our lab for the separation and quantitation of estriol, estrone, and estradiol, we determined the 30, 60, and 90 day stability of compounded estrogens in Medisca Inc.’s proprietary HRT Cream Base at room temperature and 4°C. Area under the curve (AUC) measurements for all three time points (30, 60, and 90 day analysis) reveal that the compounded preparations retain > 90% of the stated initial potency regardless of temperature storage conditions.