Compartment based population balance model development of a high shear wet granulation process via dry and wet binder addition

Chaturbedi, Anik; Bandi, Chandra Kanth; Reddy, D. Maheshwar; Pandey, Preetanshu; Narang, Ajit S.; Bindra, Dilbir S.; Tao, Li; Zhao, Junshu; Li, Jinjiang; Hussain, Munir; Ramachandran, Rohit

doi:10.1016/j.cherd.2017.04.017

Cited by 17 publications

(5 citation statements)

References 33 publications

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“…Considerable efforts have been invested in understanding the underlying mechanisms involved in granulation processes to enable rational process design by exploiting regime maps (90)(91)(92) and population balance models (93)(94)(95). Similarly, the importance of instrument configuration and associated process variables has been studied extensively (88,96).…”

Section: Wet Granulationmentioning

confidence: 99%

Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing

Burcham

Florence

Johnson

2018

Annu. Rev. Chem. Biomol. Eng.

131

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The pharmaceutical industry has found new applications for the use of continuous processing for the manufacture of new therapies currently in development. The transformation has been encouraged by regulatory bodies as well as driven by cost reduction, decreased development cycles, access to new chemistries not practical in batch, improved safety, flexible manufacturing platforms, and improved product quality assurance. The transformation from batch to continuous manufacturing processing is the focus of this review. The review is limited to small, chemically synthesized organic molecules and encompasses the manufacture of both active pharmaceutical ingredients (APIs) and the subsequent drug product. Continuous drug product is currently used in approved processes. A few examples of production of APIs under current good manufacturing practice conditions using continuous processing steps have been published in the past five years, but they are lagging behind continuous drug product with respect to regulatory filings.

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Section: Wet Granulationmentioning

confidence: 99%

Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing

Burcham

Florence

Johnson

2018

Annu. Rev. Chem. Biomol. Eng.

131

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“…The wetting behavior of the liquid drop on the solid sphere is determined by the contact angle value. An expression for the radius of the wet patch in case of liquid addition to powder blend consisting of pre-mixed dry binder particles previously used in [29] has been adapted in this work. The expression for the base radius of the wet patch is given as:…”

Section: Particle Wetness Classificationmentioning

confidence: 99%

“…However, in the PBM model developed in our study, the kernel rather depends on the properties of the colliding particles/granules. The kernel that was developed in [29] has been adapted in this work and has been described as follows:…”

Section: Aggregation Kernel Developmentmentioning

confidence: 99%

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Model Development and Validation of Fluid Bed Wet Granulation with Dry Binder Addition Using a Population Balance Model Methodology

et al. 2018

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An experimental study in industry was previously carried out on a batch fluid bed granulation system by varying the inlet fluidizing air temperature, binder liquid spray atomization pressure, the binder liquid spray rate and the disintegrant composition in the formulation. A population balance model framework integrated with heat transfer and moisture balance due to liquid addition and evaporation was developed to simulate the fluid bed granulation system. The model predictions were compared with the industry data, namely, the particle size distributions (PSDs) and geometric mean diameters (GMDs) at various time-points in the granulation process. The model also predicted the trends for binder particle dissolution in the wetting liquid and the temperatures of the bed particles in the fluid bed granulator. Lastly, various process parameters were varied and extended beyond the region studied in the aforementioned experimental study to identify optimal regimes for granulation.

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“…The solvent is usually water or a polymer solution [ 1 , 2 , 3 , 4 , 5 ]. The size enlargement process occurs in the presence of binder that is added either in a dry state and mixed along with the formulation/primary powders in the granulator or dissolved in the liquid binder solvent [ 6 , 7 ]. The addition of the binder in the wet granulation process facilitates the formation of liquid capillary bridges that hold the primary particles together via granulation mechanisms such as nucleation, aggregation, consolidation, breakage and layering [ 8 ].…”

Section: Introductionmentioning

confidence: 99%

A Semi-Mechanistic Prediction of Residence Time Metrics in Twin Screw Granulation

2021

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This work is concerned with the semi-mechanistic prediction of residence time metrics using historical data from mono-component twin screw wet granulation processes. From the data, several key parameters such as powder throughput rate, shafts rotation speed, liquid binder feed ratio, number of kneading elements in the shafts and the stagger angle between the kneading elements were identified and physical factors were developed to translate those varying parameters into expressions affecting the key intermediate phenomena in the equipment, holdup, flow and mixing. The developed relations were then tested across datasets to evaluate the performance of the model, applying a k-fold optimization technique. The semi-mechanistic predictions were evaluated both qualitatively through the main effects plots and quantitatively through the parity plots and correlations between the tuning constants across datasets. The root mean square error (RMSE) was used as a metric to compare the degree of goodness of fit for different datasets using the developed semi-mechanistic relations. In summary this paper presents a new approach at estimating both the residence time metrics in twin screw wet granulation, mean residence time (MRT) and variance through semi-mechanistic relations, the validity of which have been tested for different datasets.

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Compartment based population balance model development of a high shear wet granulation process via dry and wet binder addition

Cited by 17 publications

References 33 publications

Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing

Continuous Manufacturing in Pharmaceutical Process Development and Manufacturing

Model Development and Validation of Fluid Bed Wet Granulation with Dry Binder Addition Using a Population Balance Model Methodology

A Semi-Mechanistic Prediction of Residence Time Metrics in Twin Screw Granulation

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