MURAL - Maynooth University Research Archive Library



    Polymorphism in Commercial Sources of Fusidic Acid: A Comparative Study of the In Vitro Release Characteristics of Forms I and III from a Marketed Pharmaceutical Cream


    Byrne, Jonathan and Reinhardt, Robert and Velasco-Torrijos, Trinidad (2017) Polymorphism in Commercial Sources of Fusidic Acid: A Comparative Study of the In Vitro Release Characteristics of Forms I and III from a Marketed Pharmaceutical Cream. Journal of Analytical Methods in Chemistry, 2017 (349309). ISSN 2090-8865

    [img]
    Preview
    Download (1MB) | Preview


    Share your research

    Twitter Facebook LinkedIn GooglePlus Email more...



    Add this article to your Mendeley library


    Abstract

    A comparison of the polymorphic forms of 3 commercial sources of fusidic acid using FTIR and XRPD techniques has been performed in this study. It has been demonstrated that polymorphic Forms I and III are currently available on the commercial market. The influence of the observed polymorphism on the stability of the drug substance in bulk form has been investigated through stability and stress testing according to current ICH guidelines. Significant differences were detected between commercial sources with regard to the stability of the bulk substance under photolytic and humidity stress conditions. When properly packaged in an inert atmosphere, fusidic acid from all 3 manufacturers showed a comparable stability. The effects of the observed polymorphic differences on the intrinsic dissolution rate of the drug substance and its in vitro release from the marketed drug product Fusicutan® plus Betamethasone cream have been investigated. Results indicated that the release rate of the drug substance is similar for polymorphic Forms I and III, allowing both forms to be used during manufacture without affecting the safety or efficacy of the drug product.

    Item Type: Article
    Keywords: Chemistry, analytical; Antibiotics; Infections; Engineering, civil; Inhibition; Antibacterial activity; Resistance; Staphyloccolos-Aureus; Derivatives; Morphological variation; Pharmaceutical research; Comparative analysis; Product safety; Analysis;
    Academic Unit: Faculty of Science and Engineering > Chemistry
    Faculty of Science and Engineering > Research Institutes > Human Health Institute
    Item ID: 11795
    Identification Number: https://doi.org/10.1155/2017/3493096
    Depositing User: Dr. Trinidad Velasco-Torrijos
    Date Deposited: 21 Nov 2019 15:45
    Journal or Publication Title: Journal of Analytical Methods in Chemistry
    Publisher: Hindawi
    Refereed: Yes
    URI:

    Repository Staff Only(login required)

    View Item Item control page

    Downloads

    Downloads per month over past year