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Analysis of granulation mechanism in a high-shear wet granulation method using near-infrared spectroscopy and stirring power consumption

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Abstract

The dynamic granulation process of high-speed shear wet granulation (HSWG) was measured by in-line near-infrared spectroscopy (NIRS) and agitation power consumption (APC) methods. Molecular interactions between powder particles and the binding liquid were analyzed based on both NIRS and APC data by multivariable regression analysis. The granulated sample used glass beads (d50 = 46 μm) with or without hydroxypropyl cellulose, and the binder solution used purified water. The HSWG granulator (2-L volume) with APC device and NIRS was used, and the agitator was rotated at 600 min−1 and the chopper at 2000 min−1 with glass beads to be granulated being 920 g (0.6 L), and a total of 360 mL of purified water was added at 10 mL/min. In order to establish calibration models to predict APC and amount of binding water of the granular formulations, NIRS spectra of the granular samples were recorded every 10 s for 40 min. The calibration models to predict moisture content and APC were constructed based on the corrected NIRS spectral data by partial least-squares regression (PLSR) analysis. The relationships between actual and predicted values for moisture content and APC produced a straight line, respectively. The regression vector (RV) of the PLS model to predict the water content showed the presence of free water between the bead powder particles. On the other hand, the RV for the APC showed the presence of bound water between the particles.

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Funding

This research received financial support in part from Musashino University Creating Happiness Incubation (No. 23), Japan Agency for Medical Research and Development (JP19mk0101105h0102), and Earthtechnica Corporation Limited.

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Authors and Affiliations

  1. Graduate School of Pharmaceutical Sciences, Musashino University, 1-1-20 Shinmachi, Nishi- Tokyo, Tokyo, 202-8585, Japan

    Keita Koyanagi, Yusuke Hattori & Makoto Otsuka

  2. Earthtechnica Corporation Limited, 1780 Kamikouya, Yachiyo, Chiba, 276-0022, Japan

    Keita Koyanagi & Akinori Ueno

  3. Graduate School of Medical Photonics, Shizuoka University, 3-5-1, Johoku, Naka-ku, Hamamatsu, Shizuoka, 432-8011, Japan

    Tetsuo Sasaki

  4. Division of Drugs, National Institute of Health Sciences, 3-25-26 Tonomachi, Kawasaki-ku, Kawasaki City, Kanagawa, 210-9501, Japan

    Tomoaki Sakamoto

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  1. Keita Koyanagi
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  2. Akinori Ueno
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Correspondence to Makoto Otsuka.

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The research results were achieved in a collaborative research agreement with Musashino University and Earthtechnica Corporation Limited. The authors declare that they have no conflicts of interest to disclose.

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Koyanagi, K., Ueno, A., Hattori, Y. et al. Analysis of granulation mechanism in a high-shear wet granulation method using near-infrared spectroscopy and stirring power consumption. Colloid Polym Sci 298, 977–987 (2020). https://doi.org/10.1007/s00396-020-04655-y

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  • DOI: https://doi.org/10.1007/s00396-020-04655-y

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