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    Effects of Moisture-Induced Crystallization on the Aerosol Performance of Spray Dried Amorphous Ciprofloxacin Powder Formulations

    Access Status
    Fulltext not available
    Authors
    Shetty, N.
    Zeng, L.
    Mangal, S.
    Nie, H.
    Rowles, Matthew
    Guo, R.
    Han, Y.
    Park, J.
    Zhou, Q.
    Date
    2018
    Type
    Journal Article
    
    Metadata
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    Citation
    Shetty, N. and Zeng, L. and Mangal, S. and Nie, H. and Rowles, M. and Guo, R. and Han, Y. et al. 2018. Effects of Moisture-Induced Crystallization on the Aerosol Performance of Spray Dried Amorphous Ciprofloxacin Powder Formulations. Pharmaceutical Research. 35: 7.
    Source Title
    Pharmaceutical Research
    DOI
    10.1007/s11095-017-2281-5
    ISSN
    0724-8741
    School
    School of Electrical Engineering, Computing and Mathematical Science (EECMS)
    URI
    http://hdl.handle.net/20.500.11937/65842
    Collection
    • Curtin Research Publications
    Abstract

    © 2017, Springer Science+Business Media, LLC, part of Springer Nature. Purpose: This study aims to investigate the influence of different storage humidity conditions on crystallization and aerosol performance of inhalable spray dried amorphous powder formulations (Ciprofloxacin hydrochloride as the model drug). Methods: The spray dried samples were stored at 20%, 55% and 75% relative humidity (RH). Crystallinity was monitored by Powder X-ray diffraction (PXRD), and particle morphology was measured by scanning electron microscopy (SEM) and atomic force microscopy (AFM). Aerosol performance was evaluated using a multi-stage liquid impinger (MSLI). Results: PXRD diffractograms showed the spray dried Ciprofloxacin stored at 20% RH for three weeks were amorphous; whereas those stored at 55% RH and 75% RH started crystallizing after one hour. Fine particle fraction (FPF) of the particles was improved from 28% to 42% after storage at 55% RH for three days. Such improvement was attributed to the crystallization of amorphous powders, which led to increased particle roughness and reduced particulate contact area, as visualized by SEM and quantified by AFM. A linear relationship was observed between degree of crystallinity/crystallite size and FPF (R 2 = 0.94 and R 2 = 0.96, respectively). However, deterioration in aerosol performance was observed after storage at 75% RH due to formation of inter-particulate liquid/solid bridges, as confirmed by SEM. Conclusions: This study provides a fundamental understanding in moisture-induced physical and aerosol instability of the spray dried powder formulations.

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