Validation of an image analysis method for estimating coating thickness on pellets

C.C. Larsen, Jørn Sonnergaard, P. Bertelsen, P. Holm

    33 Citations (Scopus)

    Abstract

    A digital image analysis method for the estimation of mean pellet size and coating thickness employing optical microscopy was evaluated. The coating thickness was expressed as the difference in mean projected area radius of the uncoated and the coated pellets. The repeatability, the intermediate precision and the robustness of the image analysis method were investigated. The repeatability and the intermediate precision of the image analysis method was excellent with a low degree of scatter between the measurements. The robustness investigation on the image analysis method illustrated the importance of controlling and monitoring the illumination technique utilised. Calibration of the image analysis equipment was of the highest importance. Using pellets with a high degree of sphericity and narrow size distribution, it was sufficient to use 1000 pellets to estimate the mean pellet size and the coating thickness with an accuracy of ±1.2 μm. An equation is presented for an approximation of the number of pellets necessary to achieve a given accuracy in the estimation of mean pellet size and coating thickness.
    Original languageEnglish
    JournalEuropean Journal of Pharmaceutical Sciences
    Volume18
    Issue number2
    Pages (from-to)191-196
    Number of pages6
    ISSN0928-0987
    DOIs
    Publication statusPublished - 1 Feb 2003

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