Importance of free water in controlling granule and tablet properties in a novel granulation method, green fluidized bed granulation (GFBG)

[Display omitted] In the pharmaceutical field, green fluidized bed granulation (GFBG) is a novel and eco-friendly manufacturing technology used to produce desired granules via simple blending and spraying steps at ambient temperature using a standard fluidized bed granulator. However, the relations...

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Bibliographic Details
Published in:	International journal of pharmaceutics Vol. 570; p. 118647
Main Authors:	Takasaki, Hiroshi, Sakurai, Atsushi, Katayama, Takuma, Matsuura, Yuka, Ohyagi, Naoko, Mizoguchi, Masashi, Takano, Junichi, Wada, Koichi, Matsui, Koh, Nagato, Takuya, Ishikawa, Agata, Yonemochi, Etsuo
Format:	Journal Article
Language:	English
Published:	Netherlands Elsevier B.V 30-10-2019
Subjects:	Continuous process Drug Compounding - methods Free water Green fluidized bed granulation Moisture-activated dry granulation Powders - metabolism Tablets - chemistry Tensile Strength Water - chemistry Continuous process Moisture-activated dry granulation Free water Green fluidized bed granulation
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Summary:	[Display omitted] In the pharmaceutical field, green fluidized bed granulation (GFBG) is a novel and eco-friendly manufacturing technology used to produce desired granules via simple blending and spraying steps at ambient temperature using a standard fluidized bed granulator. However, the relations between water content and granule and tablet qualities have not yet been elucidated for GFBG. The purpose of this study was to elucidate the influence of different water quantities used in the GFBG process on granule and tablet qualities. In addition, results from the GFBG process were compared with those from the moisture-activated dry granulation (MADG) process. In terms of tablet tensile strength and disintegration time, GFBG had a wider acceptable range for added water quantity (2.0–5.0%) than did MADG. For all added water quantities, the GFBG granules were within the upper limit of water activity (a surrogate of free water amount), which was 0.61 for tensile strength and 0.55 for disintegration time. The air flow in the GFBG process may have reduced the excess free water on the granules during the absorption process. It was concluded that as compared with MADG, GFBG may be a more robust process for manufacturing granules and tablets with superior properties.
Bibliography:	ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	0378-5173 1873-3476
DOI:	10.1016/j.ijpharm.2019.118647