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Volume 112
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Non-destructive imaging of internal structural changes in humidified oral phosphate granules using pharmaceutical-based X-ray computed tomography: A feasibility pilot study
Takahiro Amemiya a *, Kazuhiro Suzuki b, Takashi Tomita c
a Faculty of Pharmaceutical Sciences, Teikyo Heisei University, 4-21-2 Nakano, Nakano-ku, Tokyo, 164-8530, Japan
b Semiconductor Evaluation Laboratory, Evaluation and Analysis Technology Center, Toshiba Nanoanalysis Corporation, 1 Komukai-Toshiba-Cho, Saiwai-ku, Kawasaki, Kanagawa, 212-8583, Japan
c Department of Pharmaceutical Sciences, School of Pharmacy at Narita, International University of Health and Welfare, 4-3 Kozunomori, Narita, Chiba, 286-8686, Japan
10.1016/j.partic.2026.03.011
Volume 112, May 2026, Pages 299-305
Received 12 January 2026, Revised 12 March 2026, Accepted 12 March 2026, Available online 20 March 2026, Version of Record 28 March 2026.
E-mail: t.amemiya@thu.ac.jp
Highlights

• X-ray CT precisely reveals 3D internal changes in granule pharmaceuticals.

• X-ray CT shows moisture-induced void formation in Phosribbon® Combination Granule.

• Moisture-induced internal granule structural changes occur even at room temperature.

• X-ray CT enables quality control and formulation optimization in granule production.


Abstract

A detailed study of the internal structure of pharmaceutical granules is essential for understanding their formulation and physical properties and ensuring safe use. Although X-ray computed tomography (CT) is a well-established tool for non-invasive analysis of internal structural changes, its application in the analysis of humidity-induced structural changes in granules has not been examined. Therefore, we aimed to evaluate the utility of X-ray CT for non-destructive evaluation of the internal structural changes in the Phosribbon® Combination Granule under humidified conditions. A single Phosribbon® Combination Granule was stored at 40 °C under 75% relative humidity for 7 days, and then stored at room temperature (22 °C–27 °C) until day 9. X-ray CT revealed significant internal structural changes in the Phosribbon® Combination Granule due to moisture absorption; particularly, the volume of the internal voids increased by approximately threefold. Furthermore, these internal structural changes progressed even during subsequent storage at room temperature. These results emphasize that X-ray CT is an effective tool for precise, three-dimensional, non-destructive, and comprehensive evaluation of moisture-induced structural changes in pharmaceutical granules.

Graphical abstract
Keywords
X-ray computed tomography; Phosribbon® combination granule; Humidification; Pharmaceutical formulation; Quality management
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