Manufacturability and Properties of Granules and Tablets Using the Eco-Friendly Granulation Method Green Fluidized Bed Granulation Compared to Direct Compression

This study aimed to compare the manufacturability and granule and tablet properties of green fluidized bed granulation (GFBG) and of direct compression (DC). Acetaminophen was used as a low compactabil- ity model drug. The process time of GFBG to produce final mixtures was comparable to that of DC, and thus GFBG could be considered a simple process. DC could not produce 30% drug load tablets owing to poor granule flowability, whereas no problems were observed in the GFBG tableting process up to 80% of drug load.

Tablets prepared with GFBG showed higher tensile strength than those prepared using DC. Compactability evaluation results show that the yield pressure of the granules prepared with GFBG was significantly lower than that of DC, suggesting that the granules prepared with GFBG were easily plastically deformed. Moreover, tablets prepared with GFBG showed fast disintegration, which was faster than that of DC. We conclude that GFBG produces granules with higher drug content and desired physicochemical prop- erties at low cost.

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or continue reading here: Agata Ishikawa, Hiroshi Takasaki, Atsushi Sakurai, Takuma Katayama, Koichi Wada, Takayuki Furuishi, Kaori Fukuzawa, Yasuko Obata, Etsuo Yonemochi, Manufacturability and Properties of Granules and Tablets Using the Eco-Friendly Granulation Method Green Fluidized Bed Granulation Compared to Direct Compression, Chemical and Pharmaceutical Bulletin, 2021, Volume 69, Issue 5, Pages 447-455, Released May 01, 2021, Online ISSN 1347-5223, Print ISSN 0009-2363, https://doi.org/10.1248/cpb.c20-00970, https://www.jstage.jst.go.jp/article/cpb/69/5/69_c20-00970/_article/-char/en

Materials
Lactose monohydrate and agglomerated lactose (Granulac 200 and Tablettose 80, respectively) from Meggle (Wasserburg, Germany), polyvidone (Povidone K12) and crospovidone (Kollidon CL) from BASF (Ludwigshafen, Germany), microcrystalline cellulose (Avicel PH102 SCG) from FMC (Philadelphia, PA, U.S.A.), colloidal silicon dioxide (Aerosil 200) from Degussa (Frankfurt, Germany), and magnesium stearate (magnesium stearate vegetable) from Faci (Carasco, Italy).