A review of high shear wet granulation for better process understanding, control and product development

Liu, Binbin; Wang, Jiamiao; Jia, Zeng; Zhao, Lihua; Wang, Youjie; Feng, Yi; Du, Ruofei

doi:10.1016/j.powtec.2020.11.051

Cited by 47 publications

(20 citation statements)

References 215 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…7,[11][12][13] However, the determination of the optimum water content for iron ore granulation is still empirical. 14,15) Furthermore, in the manufacturing of pig iron, different types of iron ores from various regions are mixed and used as raw powders, leading to significant variations in the properties of the raw powder, such as particle size distribution, wettability, and porosity. This makes the determination of the optimum water content much more difficult.…”

Section: Determining Optimum Water Content For Iron Ore Granulation U...mentioning

confidence: 99%

Determining Optimum Water Content for Iron Ore Granulation using Agitation Torque of Wet Ore Powder

et al. 2022

View full text Add to dashboard Cite

Wet granulation of iron ore powders is a key process in ironmaking. In wet granulation, it is important to determine the optimum content of water added to the original ore powders. To determine the optimum water content, it is important to understand the saturation state in wet ore powder, which can be done by measuring the agitation torque of the wet powder. This study proposes a methodology for determining the optimum water content of various iron ore powders using the agitation torque of wet ore powders. First, measurement of the agitation torque and wet granulation of various iron ore powders were conducted. By comparing the results, it was found that the optimum water content, which was defined as the minimum water content required to diminish fine particles in the original powder, corresponded to the water content exhibiting the maximum agitation torque, regardless of the original powder. Using the agitation torque at different water contents, the saturation degree S, which is the volume ratio of water to the interparticle voids, was calculated, resulting in a range of 0.999 ≤ S ≤ 1.173 at the optimum water content. This suggests that the state between the funicular and capillary states is a suitable saturation state for the wet granulation of ore powders. Consequently, it was demonstrated that it is possible to determine the optimum water content for wet granulation of various iron ore powders based on the water content exhibiting the maximum agitation torque of wet ore powders.

show abstract

Section: Determining Optimum Water Content For Iron Ore Granulation U...mentioning

confidence: 99%

Determining Optimum Water Content for Iron Ore Granulation using Agitation Torque of Wet Ore Powder

et al. 2022

View full text Add to dashboard Cite

show abstract

“…The bulk density of metformin HCl granules leveled off after approximately 420 s (massing time 60 s), after which there were no significant changes in bulk density. As shown in Figure 10 , the bulk density increased with increasing massing time, possibly because the longer massing time caused the coalescence and growth of granules, resulting in denser granules [ 69 , 70 ]. The granule agglomeration increased with the increasing liquid saturation of granules, accompanied by granule densification [ 71 ].…”

Section: Resultsmentioning

confidence: 99%

Development of a Robust Control Strategy for Fixed-Dose Combination Bilayer Tablets with Integrated Quality by Design, Statistical, and Process Analytical Technology Approach

et al. 2021

View full text Add to dashboard Cite

Control strategy and quality by design (QbD) are widely used to develop pharmaceutical products and improve drug quality; however, studies on fixed-dose combination (FDC) bilayer tablets are limited. In this study, the bilayer tablet consisted of high-dose metformin HCl in a sustained-release layer and low-dose dapagliflozin l-proline in an immediate-release layer. The formulation and process of each layer were optimized using the QbD approach. A d-optimal mixture design and response surface design were applied to optimize critical material attributes and critical process parameters, respectively. The robust design space was developed using Monte Carlo simulations by evaluating the risk of uncertainty in the model predictions. Multivariate analysis showed that there were significant correlations among impeller speed, massing time, granule bulk density, and dissolution in the metformin HCl layer, and among roller pressure, ribbon density, and dissolution in the dapagliflozin l-proline layer. Process analytical technology (PAT) was used with in–line transmittance near-infrared spectroscopy to confirm the bulk and ribbon densities of the optimized bilayer tablet. Moreover, the in vitro drug release and in vivo pharmacokinetic studies showed that the optimized test drug was bioequivalent to the reference drug. This study suggested that integrated QbD, statistical, and PAT approaches can develop a robust control strategy for FDC bilayer tablets by implementing real-time release testing based on the relationships among various variables.

show abstract

“…Prior to the tableting process, it is necessary to improve the flow properties of the materials so that the press can be evenly filled, resulting in tablets with uniform weight that can be manufactured [ 2 ]. This can be accomplished through the granulation process, which can be divided into two types: dry and wet granulation, depending on whether or not a liquid binder is utilized [ 3 ].…”

Section: Introductionmentioning

confidence: 99%

Design Space Approach for the Optimization of Green Fluidized Bed Granulation Process in the Granulation of a Poorly Water-Soluble Fenofibrate Using Design of Experiment

et al. 2022

View full text Add to dashboard Cite

In the pharmaceutical industry, the systematic optimization of process variables using a quality-by-design (QbD) approach is highly precise, economic and ensures product quality. The current research presents the implementation of a design-of-experiment (DoE) driven QbD approach for the optimization of key process variables of the green fluidized bed granulation (GFBG) process. A 32 full-factorial design was performed to explore the effect of water amount (X1; 1–6% w/w) and spray rate (X2; 2–8 g/min) as key process variables on critical quality attributes (CQAs) of granules and tablets. Regression analysis have demonstrated that changing the levels of X1 and X2 significantly affect (p ≤ 0.05) the CQAs of granules and tablets. Particularly, X1 was found to have the pronounced effect on the CQAs. The GFBG process was optimized, and a design space (DS) was built using numerical optimization. It was found that X1 and X2 at high (5.69% w/w) and low (2 g/min) levels, respectively, demonstrated the optimum operating conditions. By optimizing X1 and X2, GFBG could enhance the disintegration and dissolution of tablets containing a poorly water-soluble drug. The prediction error values of dependent responses were less than 5% that confirm validity, robustness and accuracy of the generated DS in optimization of GFBG.

show abstract

A review of high shear wet granulation for better process understanding, control and product development

Cited by 47 publications

References 215 publications

Determining Optimum Water Content for Iron Ore Granulation using Agitation Torque of Wet Ore Powder

Determining Optimum Water Content for Iron Ore Granulation using Agitation Torque of Wet Ore Powder

Development of a Robust Control Strategy for Fixed-Dose Combination Bilayer Tablets with Integrated Quality by Design, Statistical, and Process Analytical Technology Approach

Design Space Approach for the Optimization of Green Fluidized Bed Granulation Process in the Granulation of a Poorly Water-Soluble Fenofibrate Using Design of Experiment

Contact Info

Product

Resources

About