Evaluation of Polymorphism Influence in Finasteride

    August 2014 in “ Acta Crystallographica ”
    Lucélia da Silva, Cristina Martiniano Montanari, Marilene Lopes Ângelo, Edith Cristina Laignier Cazedey, Rudy Bonfílio, Magali Benjamim Araújo
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    TLDR Different forms of finasteride dissolve and remain stable differently, affecting capsule quality.
    The study investigated the influence of polymorphism on the physicochemical properties, dissolution profile, and stability of finasteride, a medication used for treating benign prostatic hyperplasia, prostate cancer, and androgenetic alopecia. Two polymorphic forms of finasteride, Form I and Form II, were characterized using X-ray diffraction, infrared spectroscopy, and thermal analysis. Form II was created by heating Form I to 235°C for 30 minutes. The solubility of both forms was assessed, with Form II showing higher solubility at most pH levels. Dissolution tests in water using a basket apparatus indicated that capsules containing Form I released more drug than those with Form II. Stability studies conducted at 50°C for 3 months showed that finasteride content remained stable in both forms, but the dissolution profile of Form II declined more than that of Form I. The results suggest that polymorphism can affect the quality of finasteride capsules and highlight the need for polymorphic quality control in this dosage form.
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