Quality Evaluation of the Finasteride Polymorphic Forms I and II in Capsules

    December 2014 in “ Journal of Pharmaceutical and Biomedical Analysis ”
    Lucélia Magalhães da Silva, Cristina Martiniano Montanari, Olimpia Maria Martins Santos, Edith Cristina Laignier Cazedey, Marilene Lopes Ângelo, Magali Benjamim Araújo
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    TLDR Finasteride's polymorphic form affects capsule quality and drug effect, requiring strict control.
    The study evaluated the quality and stability of Finasteride polymorphic forms I and II in capsules. The study found that the use of a polymorphic form other than the one used during the formulation development process will significantly alter the dissolution properties of FNS capsules, which can alter the expected effect of this drug. Therefore, the FNS polymorphic form must be strictly controlled in the raw material by using the techniques presented in this paper (PXRD, FTIR, and DSC). The study also developed and validated a new method for evaluating the quality of Finasteride in capsules.
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