PMID: 33217743Nov 21, 2020Paper

Development of Stable and Simple Finasteride 333-μg,mL Suspensions that Minimize Occupational Exposure

International Journal of Pharmaceutical Compounding
Nathan MaScott Walker

Abstract

Finasteride is not commercially available in a liquid format, which stimulated the development of a stable and simple finasteride suspension formulation. The objectives of this work were to develop and test a finasteride suspension for 1) simplicity to compound, 2) pharmaceutical acceptability, 3) stability, and 4) potential for occupational exposure. The stability of commercial 5-mg finasteride tablets (50 mg/150 mL) was evaluated in water, Oral Mix, and OralMix SF in amber polyethylene terephthalate bottles at 25°C or 4°C. Additional stability studies were carried out using sugar-free Finasteride Powder USP in amber polyethylene terephthalate bottles and tablets in water in polypropylene oral syringes. On study days 0, 1, 3, 7, 14, 28, 38, 49, 63, and 90, the finasteride concentration was determined using a validated stability-indicating liquid chromatographic method. The potential occupational airborne exposure was evaluated by attempting to measure finasteride in 1000 liters of room air following shaking and nebulization. Finasteride suspension/dispersion formulations were prepared in water, Oral Mix, and Oral Mix SF from tablets and pure powder. All formulations retained more than 94.3% of the initial finasteride concentra...Continue Reading

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