Development of a process map: A step towards a regime map for steady-state high shear wet twin screw granulation

Kumar, Ashish; Dhondt, Jens; Vercruysse, Jurgen; Leersnyder, Fien De; Vanhoorne, Valérie; Remon, Jean Paul; Gernaey, Krist V.; Beer, Thomas De

doi:10.1016/j.powtec.2015.11.067

Cited by 42 publications

(29 citation statements)

References 27 publications

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“…From Figure 3(b), it was also observed that as the L/S ratio increased, the yield decreased. The additional granulation liquid mainly contributed to formation of oversized granules as shown in Figure 3(c) (Kumar, Dhondt et al, 2016). Comparing three figures of Figure 3(b), it can be concluded that all the three variables of L/S ratio, throughput and screw speed should be controlled at low levels for maximum yield of desirable granules.…”

Section: Resultsmentioning

confidence: 99%

Optimization of critical quality attributes in continuous twin-screw wet granulation via design space validated with pilot scale experimental data

Liu

Galbraith

Ricart

et al. 2017

International Journal of Pharmaceutics

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In this study, the influence of key process variables (screw speed, throughput and liquid to solid (L/S) ratio) of a continuous twin screw wet granulation (TSWG) was investigated using a central composite face-centered (CCF) experimental design method. Regression models were developed to predict the process responses (motor torque, granule residence time), granule properties (size distribution, volume average diameter, yield, relative width, flowability) and tablet properties (tensile strength). The effects of the three key process variables were analyzed via contour and interaction plots. The experimental results have demonstrated that all the process responses, granule properties and tablet properties are influenced by changing the screw speed, throughput and L/S ratio. The TSWG process was optimized to produce granules with specific volume average diameter of 150 μm and the yield of 95% based on the developed regression models. A design space (DS) was built based on volume average granule diameter between 90 and 200 μm and the granule yield larger than 75% with a failure probability analysis using Monte Carlo simulations. Validation experiments successfully validated the robustness and accuracy of the DS generated using the CCF experimental design in optimizing a continuous TSWG process.

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Section: Resultsmentioning

confidence: 99%

Optimization of critical quality attributes in continuous twin-screw wet granulation via design space validated with pilot scale experimental data

Liu

Galbraith

Ricart

et al. 2017

International Journal of Pharmaceutics

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“…Wet granulation is a complex process where accurate models predictions are still difficult in terms of measurable properties such as particle size/PSD. 23 Model validation yet remains a major issue and is one of the key factors contributing to failure of efficient scale-up at the industrial level. 24 The prediction of kernel prefactors plays a major role in validating experiments and also in exploring the theoretical scaleup strategies.…”

Section: Introductionmentioning

confidence: 99%

“…Wet granulation is a complex process where accurate models predictions are still difficult in terms of measurable properties such as particle size/PSD . Model validation yet remains a major issue and is one of the key factors contributing to failure of efficient scale‐up at the industrial level .…”

Section: Introductionmentioning

confidence: 99%

Investigation on agglomeration kinetics of acetaminophen using fluidized bed wet granulation

Suresh

Kumar

Surasani

2020

Asia-Pacific J Chem Eng

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Acetaminophen is a well‐known medicine frequently used as analgesic in fever treatment. In pharmaceutical formulation procedure, batch fluidized bed wet granulation is a bottleneck process for the continuous processing of acetaminophen from powder to solid dosage form. To meet the market demand and reduce operating costs, fluid bed wet granulation needs process intensification by converting batch to continuous process. For the scale‐up and batch to continuous conversion procedure, investigation on acetaminophen agglomeration kinetics is necessary. Therefore, this work investigates agglomeration kinetics of acetaminophen through batch fluidized bed wet granulation experiments, and the kinetic parameters are estimated using inverse modeling. Experiments are conducted on a 5‐L capacity pilot scale batch fluidized bed granulator. The effects of various process parameters, namely, binder concentration, spray rate, atomization pressure, and batch size, on particle size distribution are investigated. A 1‐D population balance model with Equi‐Kinetic Energy kernel for agglomeration is simulated to compare with the experimental data. The mean particle diameter increased when binder spray rate and binder concentration are increased and that the mean particle diameter decreased with increase in the atomization pressure and batch size. Experiments data comparison with the model can be used for process intensification with reasonable accuracy.

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“…Most of these studies considered a ‘changing one single variable at a time’ (COST) approach (in other words, a univariate approach) (as described by Vercruysse, Córdoba Díaz et al [ 1 ]), which means that either powder feed rate, liquid to solid ratio (L/S), or screw speed was varied at a time during a run or experiment. For instance, some studies concentrated on understanding the effects of varying powder feed rate [ 2 , 3 , 4 , 5 , 6 , 7 , 8 , 9 ]; some on L/S [ 8 , 9 , 10 , 11 ], while others focused on binder viscosity [ 7 , 10 , 12 , 13 , 14 , 15 , 16 , 17 , 18 ], screw speed [ 2 , 3 , 5 , 14 , 15 , 18 , 19 , 20 ], and screw configuration [ 5 , 11 , 12 , 18 , 19 , 21 , 22 ]. From these COST-based studies, it is clear that this approach results in the production of granules with varying attributes (e.g., size, shape, structure).…”

Section: Introductionmentioning

confidence: 99%

Twin Screw Granulation: An Investigation of the Effect of Barrel Fill Level

2018

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This paper focuses on investigating the influence of varying barrel fill levels on the mean residence time, granule properties (median size, size distribution, and shape), and tensile strength of tablets. Specific feed load (SFL) (powder feed rate divided by screw speed) and powder feed number (PFN) (i.e., powder mass flow rate divided by the product of screw speed, screw diameter, and the material density in the denominator) were considered as surrogates for the barrel fill level. Two type of powders (lactose and microcrystalline cellulose (MCC)) were granulated separately at varying fill levels at different liquid-to-solid ratios (L/S). It was observed that by controlling the barrel fill level, the granule size, shape, and tablet tensile strength can be maintained at specific L/S. It was also noticed that the mean residence time decreased with increasing fill levels in the case of both lactose and MCC powder. However, it was only found to be related to the change in granule size in case of granulating microcrystalline cellulose at varying fill levels. At very high fill levels, granule size decreased, owing to a limited interaction between MCC powder and liquid at high throughput force and short residence time.

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Development of a process map: A step towards a regime map for steady-state high shear wet twin screw granulation

Cited by 42 publications

References 27 publications

Optimization of critical quality attributes in continuous twin-screw wet granulation via design space validated with pilot scale experimental data

Optimization of critical quality attributes in continuous twin-screw wet granulation via design space validated with pilot scale experimental data

Investigation on agglomeration kinetics of acetaminophen using fluidized bed wet granulation

Twin Screw Granulation: An Investigation of the Effect of Barrel Fill Level

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