Dehydroepiandrosterone supplementation is used to treat a variety of conditions. Rapid-dissolving
tablets are a relatively novel choice for compounded
dehydroepiandrosterone dosage forms. While rapid-dissolving
tablets offer ease of administration, there are uncertainties about the physical and chemical stability of the drug and
dosage form during preparation and over long-term storage. This study was designed to evaluate the stability of
dehydroepiandrosterone rapid-dissolving
tablets just after preparation and over six months of storage. The Professional Compounding Centers of America rapid-dissolving
tablet mold and base formula were used to prepare 10-mg strength
dehydroepiandrosterone rapid-dissolving
tablets. The formulation was heated at 100°C to 110°C for 30 minutes, released from the mold, and cooled at room temperature for 30 minutes. The resulting rapid-dissolving
tablets were individually packaged in
amber blister packs and stored in a stability chamber maintained at 25°C and 60% relative humidity. The stability samples were pulled at pre-determined time points for evaluation, which included visual inspection,
tablet weight check, United States Pharmacopeia disintegration test, and stability-indicating high-performance liquid chromatography. The freshly prepared
dehydroepiandrosterone rapiddissolving
tablets exhibited satisfactory chemical and physical stability. Time 0 samples disintegrated within 40 seconds in water kept at 37°C. The high-performance liquid chromatographic results confirmed that the initial potency was 101.9% of label claim and that there was no chemical degradation from the heating procedure. Over six months of storage, there were no significant changes in visual appearance, physical integrity, or disintegration time for any of the stability samples. The high-performance liquid chromatographic results also indicated that
dehydroepiandrosterone rapid-dissolving
tablets retained >95% label claim with no detectable degradation products. The
dehydroepiandrosterone rapid-dissolving
tablets investigated in this pilot study were physically and chemically stable during preparation and over six months of storage at 25°C and 60% relative humidity.