Evaluation of the effect of granule size of raw tableting materials on critical quality attributes of tablets during the continuous tablet manufacturing process using near-infrared spectroscopy

Oct. 17, 2023, midnight - by Makoto Otsuka , Tokiro Ogata , Yusuke Hattori , Tetsuo Sasaki

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The impact of granule size variation in raw materials on tablet hardness (TH) and weight (TW) within the continuous tablet manufacturing process (CTMP) was explored through the application of near-infrared spectroscopy (NIRS). Granule materials of distinct sizes were created through extrusion granulation, utilizing a standard granule formula powder that included lactose/starch and 4.5% acetaminophen. These granules, categorized as large, small, and medium-sized, were successively loaded into a hopper, and tablets were continuously produced using a single-shot tableting machine. Subsequently, after organizing approximately 500 tablets, near-infrared spectroscopy (NIRS) was employed. The 450 NIRS datasets were segregated into three groups, consisting of 150 datasets each (calibration, validation 1, and validation 2 datasets).

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