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    Supercritical fluid micronization techniques for gastroresistant insulin formulations

    Access Status
    Fulltext not available
    Authors
    Tandya, A.
    Zhuang, H.
    Mammucari, R.
    Foster, Neil
    Date
    2016
    Type
    Journal Article
    
    Metadata
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    Citation
    Tandya, A. and Zhuang, H. and Mammucari, R. and Foster, N. 2016. Supercritical fluid micronization techniques for gastroresistant insulin formulations. Journal of Supercritical Fluids. 107: pp. 9-16.
    Source Title
    Journal of Supercritical Fluids
    DOI
    10.1016/j.supflu.2015.08.009
    ISSN
    0896-8446
    School
    Department of Chemical Engineering
    URI
    http://hdl.handle.net/20.500.11937/55560
    Collection
    • Curtin Research Publications
    Abstract

    © 2015 Published by Elsevier B.V. The application of three supercritical processes to the micronization of gastroresistant insulin formulations is presented. As pharmaceutical applications of the supercritical anti-solvent micronization processes are becoming established at the bench scale, it is timely that they are compared in terms of product characteristics and scalability aspects. The formulation of insulin with the gastroresistant coating hydroxypropyl methyl cellulose phthalate was conducted by the Gas Anti-Solvent (GAS), the Aerosol Solvent Extraction System (ASES) and the Atomized Rapid Injection for Solvent Extraction (ARISE) processes and results have been compared in terms of insulin content of the microparticles, product morphology and recovery. The insulin content in products was in the range of 9-47%. The particles produced by the GAS process were flake-like in the 1-2 µm range with bi-modal distribution, while particles produced by the ASES and ARISE processes were spherical in the 100-300 nm particle size range with unimodal size distribution. Compared to GAS and ASES, the ARISE process produced the highest recoveries and insulin loadings: 77% and 47%, respectively. Particle characteristics, process recoveries and operational aspects indicate that ARISE should be the process of choice for scale-up.

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