Attribute transmission and effects of diluents and granulation liquids on granule properties and tablet quality for high shear wet granulation and tableting process
This study aims to examine (i) the effect of diluent types (lactose monohydrate, corn starch, and microcrystalline cellulose) and granulation liquids (20% polyvinylpyrrolidone K30, 65% alcohol, and dispersion containing 40% model drug– Pithecellobium clypearia Benth extracted powder) on granule properties and tablet quality for high shear wet granulation and tableting (HSWG-T) and, more importantly, (ii) the attribute transmission in the process. In general, the impact of diluents on granule properties and tablet quality was more dominant than that of granulation liquids. Attribute transmission patterns were revealed as follows. The granules’ ISO. Roundness and density correlated with raw material (i.e., model drug, diluent, and/or granulation liquid) properties such as density and viscosity. The granules’ compressibility parameter a correlated with the granules’ Span, and parameter y0 correlated with the granules’ flowability and friability. Compactibility parameters ka and kb correlated mainly with granules’ flowability and density, and parameter b correlated significantly and positively with tablet tensile strength. The compressibility correlated negatively with tablet solid fraction (SF) and friability, while the compactibility correlated positively with tablet disintegration time. Moreover, the rearrangement and elasticity of granules correlated positively with SF and friability, respectively. Overall, this study provides some guides for achieving high-quality tablets via HSWG-T.
Materials
The PCB extract (Batch: MF2022091103; Xinyang Shi Mufan Biological Technology Co., Ltd, Xinyang, China) was prepared by extracting Pithecellobium clypearia Benth with 10 times volume of water twice, followed by concentration. LM (Pharmatose 200 M) (Batch: 105J3TW) and MCC (PH 101) (Batch: 100727) were supplied by DFE pharma (Goch, Germany). CS (Batch: 170905; Shanhe Pharmaceutical Excipients co., Ltd., Anhui, China). Alcohol of analytical grade (Batch: 20211214; Sinopharm Chemical Reagent Co.,
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LiangFeng Wang, LiJie Zhao, YanLong Hong, Lan Shen, Xiao Lin, Attribute transmission and effects of diluents and granulation liquids on granule properties and tablet quality for high shear wet granulation and tableting process, International Journal of Pharmaceutics, Volume 642, 2023, 123177, ISSN 0378-5173,
https://doi.org/10.1016/j.ijpharm.2023.123177.