Compatibility of Estradiol, Estriol, Estrone, Progesterone, and Testosterone Single Formulation in Fitalite, Versatile, or HRT Supreme Cream Base.

In this work, we focus on three ready-to-use vehicles: Fitalite, Versatile, and HRT Supreme Cream Base. Fitalite is a natural, light, hydrophilic gel-cream that contains vitamin E and oil bodies from plant sources (phytosomes), providing antioxidant and skinmoisturizing properties. Versatile is a vanishing oil-inwater cream base which retains its consistency with a broad range and high concentrations of active pharmaceutical ingredients, dermaceutical ingredients, and solvents. Finally, HRT Supreme Cream Base is a paraben-free, dye-free, fragrance-free O/W emulsion base, formulated with a complex of botanical oils to soothe and provide moisture to dry and sensitive skin. In the current study, we evaluated the beyond-use date of formulations containing estradiol, estriol, estrone, progesterone, and testosterone in combination, compounded with these three vehicles. Validated, stability-indicating high-performance liquid chromatography methods were used throughout a 180-day period. A beyond-use date of 180 days was observed for all vehicles stored both at refrigerated and at room temperature. The combination of five ingredients represents a worst-case scenario since there are more possibilities of cross reactions. Therefore, we expect the same or greater stability as individual ingredients are removed from the tested formulation. The extended beyond-use dates provide convenience for both the compounding pharmacist and the patient.

Stability of Fagron's Phytobase Cream Compounded with Various Hormones.

The objective of this study was to evaluate the stability of 5 common hormones used as active pharmaceutical ingredients in Fagron Phytobase cream. The active pharmaceutical ingredients were tested using a bracketed format, as well as individually, and in one combination: estrone 0.1%, estrone 1%, estradiol 0.05%, estradiol 2%, estriol 0.05%, estriol 2%, progesterone 0.1%, progesterone 20%, testosterone 0.1%, testosterone 20%; combination (estradiol 0.05%, estriol 0.05%, progesterone 0.5%), and combination (estradiol 2%, estriol 1%, progesterone 20%). All creams were stored at controlled room temperature (20ÆC to 25ÆC) in a Topi-CLICK container-closure. Stability was assessed by measuring the percent recovery at varying time points throughout a 180-day period. Active pharmaceutical ingredients' quantifications were performed by highperformance liquid chromatography via a stabilityindicating method. Antimicrobial effectiveness testing per United States Pharmacopeia Chapter <51> guidelines was carried out for each compounded formulation. Given the percent recovery of the active pharmaceutical ingredients within the cream base, the beyond-use date was determined to be 180 days in all samples except estrone, which was determined to be 150 days. This suggests that Phytobase cream is able to maintain the stability of various compounded hormones in the base over an extended time of storage.