Development of Stable and Simple Finasteride 333-μg/mL Suspensions That Minimize Occupational Exposure

The study aimed to develop and test a stable and simple finasteride suspension formulation. The finasteride suspension was evaluated for simplicity to compound, pharmaceutical acceptability, stability, and potential for occupational exposure. The stability of commercial 5-mg finasteride tablets (50 mg/150 mL) was tested in water, Oral Mix, and OralMix SF in amber polyethylene terephthalate bottles at 25°C or 4°C. All formulations retained more than 94.3% of the initial finasteride concentration, with 95% confidence, when stored for up to 90 days at room temperature or 4°C. Occupational exposure simulations failed to demonstrate the presence of finasteride in room air following attempts to nebulize finasteride mixtures. However, given the analytical limits of the study, exposure would unlikely exceed 3.6-µg/1000 liters of room air. Despite this, the use of primary engineering controls and personal protective equipment is recommended due to regulations based on "no safe limit."